Journal articles
Chivers Seymour K, Pickering R, Rochester L, Roberts H, Ballinger C, Hulbert S, Kunkel D, Marian I, Fitton C, McIntosh E, et al (In Press). A multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s. Journal of Neurology, Neurosurgery and Psychiatry
Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE (In Press). An Online Hand Exercise Intervention for Adults with Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing (Preprint).
Ryan EG, Williamson E, Lamb SE, Gates S (In Press). Bayesian adaptive designs for multi-arm trials: an orthopaedic case study. Trials
Author) AGCFC, McAuley JH, Lamb SE, Hopewell S, Kamper SJ, Williams CM, Henschke N, Author) HLNC (In Press). Development of a Guideline for Reporting Mediation Analyses (AGReMA).
Abstract:
Development of a Guideline for Reporting Mediation Analyses (AGReMA)
Abstract
. Background There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). Methods/Design AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. Discussion the development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.
Abstract.
Lee H, Mistry D, Smith T, Finnegan S, Fordham B, Sheehan B, Lamb SE (In Press). Mechanisms to Reduce the Burden on Dementia Caregivers.
Roswell A, Ashburn A, Fitton C, Goodwin V, Hulbert S, Lamb S, McIntosh E, Nieuwboer A, Pickering R, Rochester L, et al (In Press). Participant expectations and experiences of a tailored physiotherapy intervention for. people with Parkinson’s and a history of falls. Disability and Rehabilitation
Goodwin V, Allan L, Bethel A, Cowley A, Cross J, Day J, Drummond A, Howard M, Morley N, Thompson Coon J, et al (In Press). Rehabilitation to enable recovery from COVID-19: a rapid systematic review. Physiotherapy
Lamb S, Hulme C (In Press). Screening and intervention to prevent falls and fractures in older people.
New England Journal of MedicineAbstract:
Screening and intervention to prevent falls and fractures in older people.
Background: Community screening and therapeutic prevention strategies may reduce falls. Effects on fractures, health resource use and health-related quality of life are unknown.
Methods: in a pragmatic, three-arm, cluster randomized controlled trial we estimated the effect of advice-by-mail, falls risk screening and targeted interventions (multi-factorial fall prevention (MFFP) or exercise for people at increased falls risk) in comparison to advice-by-mail only. The primary outcome was fracture rate over 18 months. Secondary outcomes were falls, health related quality of life, frailty and a parallel economic evaluation.
Results: We randomized 9803 people aged 70 years and older from 63 general practices across England. Completed falls risk screening questionnaires were returned by 2925/3279 (89%) people randomized to the exercise strategy, and 2854/3301 (87%) for MFFP. of these, 37% (2153/5779) were considered at increased risk and invited for intervention. Fracture data were available for 9802/9803 participants. Screening and targeted intervention did not reduce fracture rates (exercise versus advice-by-mail rate ratio (RaR) 1.20 (95% CI 0.91 to 1.59, favoring advice) and MFFP versus advice-by-mail RaR 1.30 (95% CI 0.99 to 1.71, favoring advice). The exercise strategy had a short-term reduction in falls rate, small gains in health-related quality of life and lowest overall costs. There were three adverse events, one of which was serious.
Conclusion: Advice-by-mail, screening for fall risk and targeted exercise or MFFP interventions did not prevent fractures compared to advice-by-mail alone.
(Funder, National Institute of Health Research, clinical trials registration ISRCTN71002650).
Abstract.
Lamb S, Nicolson P, Williamson E, Lee H, Morris A, Garrett A, Sanchez M (In Press). Synergistic effects of hip/knee osteoarthritis and comorbidities on mobility and self-care limitations among older adults: analysis of the Oxford Pain, Activity and Lifestyle cohort study. Journal of Comorbidity
Lamb S, Nicholson P, Williamson E, Lee H, Sanchez M, Garrett A, Morris A (In Press). Synergistic effects of hip/knee osteoarthritis and comorbidities on mobility and self-care limitations among older adults: analysis of the Oxford Pain, Activity and Lifestyle cohort study. Journal of Comorbidity
Lamb S, Lee H, Griffin XL, Costa ML, Sims AL, Keene DJ, Parsons N, Cook JA (In Press). The findings of a surgical hip fracture trial were generalisable to the UK national hip fracture database. Journal of Clinical Epidemiology
Siragy T, Russo Y, Young W, Lamb SE (2023). Comparison of over-ground and treadmill perturbations for simulation of real-world slips and trips: a systematic review.
Gait Posture,
100, 201-209.
Abstract:
Comparison of over-ground and treadmill perturbations for simulation of real-world slips and trips: a systematic review.
BACKGROUND: Trips and slips increase fall risk for young and older adults. To examine recovery responses, studies utilized treadmill and/or over-ground methods to simulate real-world perturbations. However, differences in the recovery response between treadmill and over-ground perturbations remain unexamined. RESEARCH QUESTION: to assess the current literature on the reactive recovery responses between over-ground- and split-belt treadmill trips and slips as well as the effect of aging on these responses. METHODS: PubMed, Medline, Web of Science, SCOPUS, and Cochrane databases were searched for publications examining trips and slips in healthy young, healthy older adults, and older adults who fall. Included articles were in English, full-text accessible, and biomechanically quantified the reactive recovery responses for slips and trips during either over-ground or split-belt treadmill protocols. The initial database search yielded 1075 articles and 31 articles were included after title, abstract, and full-text screening. RESULTS: for slips, 7 articles utilized lubricated surfaces while 5 articles used treadmills. Further, 3 studies examined differences between older and younger adults. For trips, 9 articles utilized obstacles and 7 used treadmills. Further, 4 articles examined differences between older and young adults and 1 article only examined older adults during over-ground trips. For both perturbations, treadmill and over-ground protocols demonstrated similar anteroposterior destabilization on the center of mass. In the mediolateral direction, over-ground slips consistently found a lateral destabilization while treadmill articles did not examine this direction. Foot placement recovery responses varied less for both perturbation directions on a treadmill compared to over-ground. SIGNIFICANCE: Although treadmill and over-ground perturbations destabilize the center of mass similarly, the recovery response to these perturbations were different on treadmills. Specifically, recovery responses were more consistent for both slips and trips on treadmills. As older adults have difficulty in perturbation recovery scaling, treadmills may be limited in their ability to investigate the variety of aging impairments on perturbation recovery responses.
Abstract.
Author URL.
Mandy M, Kamran K, Marian IR, Dutton SJ, Esther W, Lamb SE, Stavros P (2023). Economic costs, health-related quality of life outcomes and cost-utility of a physical and psychological group intervention targeted at older adults with neurogenic claudication.
Cost Effectiveness and Resource Allocation,
21(1).
Abstract:
Economic costs, health-related quality of life outcomes and cost-utility of a physical and psychological group intervention targeted at older adults with neurogenic claudication
Background: Emerging evidence suggests that structured and progressive exercise underpinned by a cognitive behavioural approach can improve functional outcomes in patients with neurogenic claudication (NC). However, evidence surrounding its economic benefits is lacking. Objectives: to estimate the economic costs, health-related quality of life outcomes and cost-effectiveness of a physical and psychological group intervention (BOOST programme) versus best practice advice (BPA) in older adults with NC. Methods: an economic evaluation was conducted based on data from a pragmatic, multicentre, superiority, randomised controlled trial. The base-case economic evaluation took the form of an intention-to-treat analysis conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective and separately from a societal perspective. Costs (£ 2018–2019 prices) were collected prospectively over a 12 month follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit (INMB) of the BOOST programme in comparison to BPA. Sensitivity and pre-specified subgroup analyses explored uncertainty and heterogeneity in cost-effectiveness estimates. Results: Participants (N = 435) were randomised to the BOOST programme (n = 292) or BPA (n = 143). Mean (standard error [SE]) NHS and PSS costs over 12 months were £1,974 (£118) in the BOOST arm versus £1,827 (£169) in the BPA arm (p = 0.474). Mean (SE) QALY estimates were 0.620 (0.009) versus 0.599 (0.006), respectively (p = 0.093). The probability that the BOOST programme is cost-effective ranged between 67 and 83% (NHS and PSS perspective) and 79–89% (societal perspective) at cost-effectiveness thresholds between £15,000 and £30,000 per QALY gained. INMBs ranged between £145 and £464 at similar cost-effectiveness thresholds. The cost-effectiveness results remained robust to sensitivity analyses. Conclusions: the BOOST programme resulted in modest QALY gains over the 12 month follow-up period. Future studies with longer intervention and follow-up periods are needed to address uncertainty around the health-related quality of life impacts and cost-effectiveness of such programmes. Trial registration This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674. Registered on 10 November 2015.
Abstract.
Bruce J, Hossain A, Ji C, Lall R, Arnold S, Padfield E, Underwood M, Lamb SE (2023). Falls and fracture risk screening in primary care: update and validation of a postal screening tool for community dwelling older adults recruited to UK Prevention of Falls Injury Trial (PreFIT).
BMC Geriatrics,
23(1).
Abstract:
Falls and fracture risk screening in primary care: update and validation of a postal screening tool for community dwelling older adults recruited to UK Prevention of Falls Injury Trial (PreFIT)
Background: Postal screening has not previously been validated as a method for identifying fall and fracture risk in community-dwelling populations. We examined prognostic performance of a postal risk screener used in the UK Prevention of Falls Injury Trial (PreFIT; ISRCTN71002650), to predict any fall, recurrent falls, and fractures over 12 months. We tested whether adding variables would improve screener performance. Methods: Nine thousand eight hundred and eight community-dwelling participants, aged 70 years and older, and 63 general practices in the UK National Health Service (NHS) were included in a large, pragmatic cluster randomised trial comparing screen and treat fall prevention interventions. The short postal screener was sent to all participants in the trial intervention arms as an A4 sheet to be completed and returned to the GP (n = 6,580). The postal screener items were embedded in the baseline pre-randomisation postal questionnaire for all arms of the trial (n = 9,808). We assessed discrimination and calibration using area under the curve (AUC). We identified additional predictors using data from the control arm and applied these coefficients to internal validation models in the intervention arm participants. We used logistic regression to identify additional predictor variables. Findings: a total of 10,743 falls and 307 fractures were reported over 12 months. Over one third of participants 3,349/8,136 (41%) fell at least once over 12 month follow up. Response to the postal screener was high (5,779/6,580; 88%). Prediction models showed similar discriminatory ability in both control and intervention arms, with discrimination values for any fall AUC 0.67 (95% CI 0.65 to 0.68), and recurrent falls (AUC 0.71; 95% CI 0.69, 0.72) but poorer discrimination for fractures (AUC 0.60; 95% CI 0.56, 0.64). Additional predictor variables improved prediction of falls but had modest effect on fracture, where AUC rose to 0.71 (95% CI 0.67 to 0.74). Calibration slopes were very close to 1. Conclusion: a short fall risk postal screener was acceptable for use in primary care but fall prediction was limited, although consistent with other tools. Fracture and fall prediction were only partially reliant on fall risk although were improved with the additional variables.
Abstract.
Jennison T, Taher S, Ukoumunne O, Lamb S, Sharpe I, Goldberg A (2023). Pulmonary Embolism, Mortality, and Medical Complications Following a Total Ankle Replacement: a Systematic Review and Meta-analysis.
Foot & Ankle International,
44(3), 223-231.
Abstract:
Pulmonary Embolism, Mortality, and Medical Complications Following a Total Ankle Replacement: a Systematic Review and Meta-analysis
Background: There is sparse data on the incidence of thromboembolic and medical complications following total ankle replacements. The aim of this systematic review was to determine the risk of deep vein thrombosis and pulmonary embolism as well as mortality and medical complications following ankle replacements. Methods: a systematic review was undertaken using all levels of evidence following PRISMA guidelines. Of the 1657 articles identified, 25 met the inclusion criteria. The inclusion criteria were a primary total ankle replacement with the recording of medical complications and/or thromboembolic events and/or mortality data. Two reviewers independently reviewed all articles. Quantitative methods were used to pool the percentages with complications across studies. Results: the pooled percentage with reported symptomatic deep vein thrombosis across 18 studies was 0.07% (95% CI 0.001%-0.59%). The pooled percentage with reported postoperative pulmonary embolism across 8 studies was 0.01% (95% CI 0.001%-0.03%). The pooled postoperative reported mortality was 0.06% (95% CI 0.001%-0.24%). Other medical complications had low incidences. Conclusion: Our study indicates rates of reported thromboembolic events of less than 1 in 1000. Notably the level of evidence analyzed was mainly Level III and IV, likely underestimating the true incidence of these events because of recall and medical record limitations, and we had insufficient information on usage of chemoprophylaxis among these patients Level of Evidence: Level IV, systematic review based on all levels of evidence including case series.
Abstract.
Tutton E, Gould J, Lamb SE, Costa ML, Keene DJ (2023). ‘It Makes Me Feel Old’: Understanding the Experience of Recovery from Ankle Fracture at 6 Months in People Aged 50 Years and Over.
Qualitative Health ResearchAbstract:
‘It Makes Me Feel Old’: Understanding the Experience of Recovery from Ankle Fracture at 6 Months in People Aged 50 Years and Over
Ankle fracture is a common injury, and depending on injury severity, treatment may be a support boot, cast or surgery. Older people, particularly those with severe injuries who are asked to restrict weight bearing, struggle with early recovery. To elicit older peoples’ experience of recovery 6 months after injury, we drew on a phenomenological approach using interviews. Findings revealed that getting on with life was a way of accepting what it feels like to ‘be vulnerable’, needing to ‘be safe’ while determinedly working hard to ‘be myself’. Being vulnerable identified endurance of inactivity, loneliness and dependency in the non-weight bearing period of recovery, followed by a struggle to weight bear while lacking confidence and being fearful of falling and causing further damage. Being safe conveyed fragility where sensations, pain and stiffness acted as bodily reminders of injury. Lack of function and awareness of danger led to carefulness where planning or curtailing of activities ensured their safety. Being myself showed a determination to push away from a disrupted self-identify of being older or disabled while being challenged by the continuous process of learning to be more mobile. A lack of readiness for old age created a drive to age well. Despite loss of ability, participants hoped to regain their pre-injury way of living. This study challenges practice that disregards the hard work required to recover from ankle fracture. As comorbidity increases with age, failure to consider this aspect may contribute to frailty in this group of older people.
Abstract.
Stokes JR, Beard DJ, Davies L, Shirkey BA, Price A, Cook JA, Barker K, Carr A, Cook J, Davies L, et al (2022). ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial.
Trials,
23(1).
Abstract:
ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial
Background: Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active individuals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality evidence. We describe a statistical analysis plan (SAP) for the ACL SNNAP randomised controlled trial, which aims to investigate the necessity of surgical management in patients with ACL injuries. Methods/design: ACL SNNAP is a pragmatic, multi-centre, superiority, parallel-group randomised controlled trial in participants with a symptomatic non-acute ACL deficient knee. Participants are allocated in a 1:1 ratio to either non-surgical management (rehabilitation) or surgical management (reconstruction) with the aim of assessing the efficacy and cost-effectiveness. The primary outcome of the study is the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 18 months post-randomisation. The KOOS4 score at 18 months will be evaluated using a linear regression model adjusting for recruitment centre and baseline KOOS4 scores, allowing for intra-centre correlation. A secondary analysis of the primary outcome will be carried out using an area under the curve (AUC) approach using treatment estimates obtained from a mixed model using baseline, 6 months, 12 months, and 18 months post-randomisation outcome data. Secondary outcomes will be measured at 18 months and will include return to activity/level of sport participation, intervention-related complications, the EQ-5D-5L questionnaire, all 5 individual subscales of the KOOS questionnaire, the ACL-QOL score, expectations of return to activity and cost-effectiveness of the interventions. Missing primary outcome data will be investigated through a sensitivity analysis. Full details of the planned methods for the statistical analysis of clinical outcomes are presented in this paper. The study protocol for the ACL SNNAP trial has been published previously. Discussion: the methods of analysis for the ACL SNNAP trial have been described here to minimise the risk of data-driven results and reporting bias. Any deviations from the analysis methods described in this paper will be described in full and justified in the publications of the trial results. Trial registration: ISRCTN ISRCTN10110685. Registered on 16 November 2016
Abstract.
Nanchahal J, Ball C, Rombach I, Williams L, Kenealy N, Dakin H, O'Connor H, Davidson D, Werker P, Dutton SJ, et al (2022). Anti-tumour necrosis factor therapy for early-stage Dupuytren's disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial. The Lancet Rheumatology, 4(6), e407-e416.
Ahern L, Timmons PS, Lamb PSE, McCullagh DR (2022). Can behavioural change interventions improve self-efficacy and exercise adherence among people with Parkinson’s? a systematic review protocol.
HRB Open Research,
5, 15-15.
Abstract:
Can behavioural change interventions improve self-efficacy and exercise adherence among people with Parkinson’s? a systematic review protocol
Background: People with Parkinson’s (PwP) have a higher tendency to adopt sedentary lifestyle behaviours and have lower physical activity levels compared to their healthy peers. Previous research has indicated that personal factors including poor outcome expectation and low self-efficacy are stronger predictors of exercise adherence than disease severity.: the purpose of this review is to synthesize the best available evidence on interventions that encompass self-management strategies to overcome barriers to exercise and improve self-efficacy and exercise adherence among PwP. Methods: the following databases will be searched using a comprehensive search strategy: EBSCO, Medline, CINAHL, Web of Science, PubMed, Embase, Scopus, Google Scholar and Cochrane Library from database inception to 2020. Interventional studies including behavioural change interventions will be included in this review. The title, abstract and full-text screening will be conducted by two independent reviewers. The Joanne Briggs Institute Checklist will be used to assess the quality of each included study. Data will be extracted by two independent reviewers. The outcomes of interest will be self-efficacy outcomes and measures of exercise adherence. A systematic narrative synthesis will be conducted using a framework analysis, applying the Theoretical Domains Framework and Behaviour Change Wheel, producing findings focusing on practice-orientated outcomes. Presentation of data will include tables and text summarizing the characteristics and findings of the eligible studies. Data synthesis and statistical analysis will be performed in Review manager 5.3. The quality of evidence will be reviewed using the GRADE criteria. Discussion: the review will comprehensively synthesize the available evidence on interventions to enhance self-efficacy, improve quality of life, physical function, ultimately improving exercise adherence among PwP and provide invaluable information for healthcare professionals. This review will make recommendations for appropriate self-management strategies for maximum effect and may have implications for policy and practice regarding enhancing self-efficacy and long-term exercise adherence among PwP.
Abstract.
Ahern L, Timmons PS, Lamb PSE, McCullagh DR (2022). Can behavioural change interventions improve self-efficacy and exercise adherence among people with Parkinson’s? a systematic review protocol.
HRB Open Research,
5, 15-15.
Abstract:
Can behavioural change interventions improve self-efficacy and exercise adherence among people with Parkinson’s? a systematic review protocol
Context: People with Parkinson’s (PwP) have a higher tendency to engage in sedentary lifestyle behaviours and have lower physical activity levels compared to their healthy peers. Previous research has indicated that personal factors including poor outcome expectation and low self-efficacy are stronger predictors of exercise adherence than disease severity. Objectives: the purpose of this review is to synthesize the best available evidence on interventions that encompass self-management strategies to overcome barriers to exercise and improve self-efficacy and exercise adherence among PwP. Methods: the following databases will be searched using a comprehensive search strategy: EBSCO, Medline, Cinhal, Web of Science, PubMed, Embase, Scopus, Google Scholar and Cochrane Library from database inception to 2020. The title, abstract and full-text screening will be conducted by two independent reviewers. The Joanne Briggs Institute Checklist will be used to assess the quality of each included study. The quality of evidence will be reviewed using the GRADE criteria. Data will be extracted by two independent reviewers. The outcomes of interest will be self-efficacy outcomes and measures of exercise adherence. A systematic narrative synthesis will be conducted using a framework analysis, applying the Theoretical Domains Framework and Behaviour Change Wheel, producing findings focusing on practice-orientated outcomes. Presentation of data will include tables and text summarizing the characteristics and findings of the eligible studies. Discussion: the review will synthesize the best available evidence on interventions to enhance self-efficacy, improve quality of life, physical function, and ultimately improve exercise adherence among PwP and provide invaluable information for healthcare professionals. The findings of this review will be disseminated through publication in a peer-reviewed journal and presented at relevant conference proceedings. This review will make recommendations for appropriate self-management strategies for maximum effect and may have implications for policy and practice regarding enhancing self-efficacy and long-term exercise adherence among PwP.
Abstract.
Hopewell S, Keene DJ, Heine P, Marian IR, Dritsaki M, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, et al (2022). Corrigendum: Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.
Health Technology Assessment,
25(48), 159-160.
Abstract:
Corrigendum: Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT
Abstract
. Corrections to Table 15.
Abstract.
Dakin H, Rombach I, Dritsaki M, Gray A, Ball C, Lamb SE, Nanchahal J (2022). Cost-effectiveness of adalimumab for early-stage Dupuytren's disease : an economic evaluation based on a randomized controlled trial and individual-patient simulation model.
Bone Jt Open,
3(11), 898-906.
Abstract:
Cost-effectiveness of adalimumab for early-stage Dupuytren's disease : an economic evaluation based on a randomized controlled trial and individual-patient simulation model.
AIMS: to estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren's disease (DD) and the value of further research from an NHS perspective. METHODS: We used data from the Repurposing anti-TNF for Dupuytren's disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded. RESULTS: the within-trial economic evaluation found that adalimumab plus standard care cost £503,410 per quality-adjusted life year (QALY) gained versus standard care alone over a 12-month time horizon. The model-based extrapolation suggested that, over a lifetime, repeated courses of adalimumab could cost £14,593 (95% confidence interval £7,534 to £42,698) per QALY gained versus standard care alone. If the NHS was willing to pay £20,000/QALY gained, there is a 77% probability that adalimumab with retreatment is the best value for money. CONCLUSION: Repeated courses of adalimumab are likely to be a cost-effective treatment for progressive early-stage DD. The value of perfect parameter information that would eliminate all uncertainty around the parameters estimated in RIDD and the duration of quiescence was estimated to be £105 per patient or £272 million for all 2,584,411 prevalent cases in the UK. Cite this article: Bone Jt Open 2022;3(11):898-906.
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Author URL.
Png ME, Petrou S, Achten J, Ooms A, Lamb SE, Hedley H, Dias J, Costa ML, Cook JA, Dritsaki M, et al (2022). Cost-utility analysis of surgical fixation with Kirschner wire versus casting after fracture of the distal radius.
Bone and Joint Journal,
104 B(11), 1225-1233.
Abstract:
Cost-utility analysis of surgical fixation with Kirschner wire versus casting after fracture of the distal radius
Aims: the aim of this study was to compare the cost- effectiveness of surgical fixation with Kirschner (K-) wire ersus moulded casting after manipulation of a fracture of the distal radius in an operating theatre setting. Methods: an economic evaluation was conducted based on data collected from the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) multicentre randomized controlled trial in the UK. Resource use was collected at three, six, and 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from an NHS and personal social services perspective. Sensitivity analyses were conducted to examine the robustness of cost-effectiveness estimates, and decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results: in the base case analysis, surgical fixation with K-wire was more expensive (£29.65 (95% confidence interval (CI) -94.85 to 154.15)) and generated lower QALYs (0.007 (95% CI -0.03 to 0.016)) than moulded casting, but this difference was not statistically significant. The probability of K-wire being cost-effective at a £20,000 per QALY cost-effectiveness threshold was 24%. The cost-effectiveness results remained robust in the sensitivity analyses. Conclusion: the findings suggest that surgical fixation with K-wire is unlikely to be a cost-effective alternative to a moulded cast in adults, following manipulation of a fracture of the distal radius in a theatre setting.
Abstract.
Rapp K, Lamb SE, Roigk P, Becker C, Konnopka C, König H-H, Peter RS, Rothenbacher D, Büchele G (2022). Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial.
BMC Med,
20(1).
Abstract:
Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial.
BACKGROUND: Fractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about "safety in the living environment." the aim of this study was to evaluate this complex preventive intervention in a routine health care setting. METHODS: This cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70-85 years with prior fragility fractures and (b) all community-living women aged 75-80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days). RESULTS: Nine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase "safety in the living environment." the incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80-1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59-0.99). Mortality and nursing home admission did not differ between the intervention and the control group. CONCLUSIONS: a comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance. TRIAL REGISTRATION: German Clinical Trials Register DRKS-ID: 00009000.
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Author URL.
Ullrich P, Werner C, Schönstein A, Bongartz M, Eckert T, Beurskens R, Abel B, Bauer JM, Lamb SE, Hauer K, et al (2022). Effects of a Home-Based Physical Training and Activity Promotion Program in Community-Dwelling Older Persons with Cognitive Impairment after Discharge from Rehabilitation: a Randomized Controlled Trial.
J Gerontol a Biol Sci Med Sci,
77(12), 2435-2444.
Abstract:
Effects of a Home-Based Physical Training and Activity Promotion Program in Community-Dwelling Older Persons with Cognitive Impairment after Discharge from Rehabilitation: a Randomized Controlled Trial.
BACKGROUND: Older people with cognitive impairment (CI) are at high risk for mobility limitations and adverse outcomes after discharge from geriatric rehabilitation settings. The aim was to estimate the effects of a specifically designed home-based physical training and activity promotion program on physical capacity, different aspects of physical activity (PA), and psychosocial status. METHODS: Patients with mild to moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home after rehabilitation were included in this randomized, double-blind, placebo-controlled trial with a 12-week intervention and 12-week follow-up period. The intervention group performed a CI-specific, autonomous, home-based strength, balance, and walking training supported by tailored motivational strategies to foster training adherence and promote PA. The control group participated in an unspecific motor placebo activity. Primary outcomes were physical capacity (Short Physical Performance Battery [SPPB]) and PA (sensor-based activity time). RESULTS: Among 118 randomized participants (82.3 ± 6.0 years) with CI (MMSE: 23.3 ± 2.4) and high levels of multimorbidity, those participants undergoing home-based training demonstrated superior outcomes to the control group in SPPB (mean difference between groups 1.9 points; 95% CI: 1.0-2.8; p <. 001), with persistent benefits over the follow-up (1.3 points; 95% CI: 0.4-2.2; p <. 001). There were no differences in PA across any time points. Among secondary outcomes, fear of falling and activity avoidance behavior were reduced in the intervention group at all time points, life-space mobility improved short-term. CONCLUSIONS: the results demonstrate clinically important benefits of an individually tailored autonomous physical training and activity promotion program on physical capacity and secondary outcomes in different domains in a vulnerable, multimorbid population. CLINICAL TRIAL REGISTRATION: ISRCTN82378327.
Abstract.
Author URL.
Hamilton TW, Knight R, Stokes JR, Rombach I, Cooper C, Davies L, Dutton SJ, Barker KL, Cook J, Lamb SE, et al (2022). Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement: a Randomized Clinical Trial.
JAMA Surg,
157(6), 481-489.
Abstract:
Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement: a Randomized Clinical Trial.
IMPORTANCE: More than half of patients who undergo knee replacement surgery report substantial acute postoperative pain. OBJECTIVE: to evaluate the efficacy and cost-effectiveness of periarticular liposomal bupivacaine for recovery and pain management after knee replacement. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, patient-blinded, pragmatic, randomized clinical superiority trial involved 533 participants at 11 institutions within the National Health Service in England. Adults undergoing primary unilateral knee replacement for symptomatic end-stage osteoarthritis were enrolled between March 29, 2018, and February 29, 2020, and followed up for 1 year after surgery. Follow-up was completed March 1, 2021. A per-protocol analysis for each coprimary outcome was performed in addition to the main intention-to-treat analysis. INTERVENTIONS: Two hundred sixty-six milligrams of liposomal bupivacaine admixed with 100 mg of bupivacaine hydrochloride compared with 100 mg of bupivacaine hydrochloride alone (control) administered by periarticular injection at the time of surgery. MAIN OUTCOME AND MEASURES: the coprimary outcomes were Quality of Recovery 40 (QoR-40) score at 72 hours and pain visual analog scale (VAS) score area under the curve (AUC) from 6 to 72 hours. Secondary outcomes included QoR-40 and mean pain VAS at days 0 (evening of surgery), 1, 2, and 3; cumulative opioid consumption for 72 hours; functional outcomes and quality of life at 6 weeks, 6 months, and 1 year; and cost-effectiveness for 1 year. Adverse events and serious adverse events up to 12 months after randomization were also assessed. RESULTS: Among the 533 participants included in the analysis, the mean (SD) age was 69.0 (9.7) years; 287 patients were women (53.8%) and 246 were men (46.2%). Baseline characteristics were balanced between study groups. There was no difference between the liposomal bupivacaine and control groups in QoR-40 score at 72 hours (adjusted mean difference, 0.54 [97.5% CI, -2.05 to 3.13]; P = .64) or the pain VAS score AUC at 6 to 72 hours (-21.5 [97.5% CI, -46.8 to 3.8]; P = .06). Analyses of pain VAS and QoR-40 scores demonstrated only 1 statistically significant difference, with the liposomal bupivacaine arm having lower pain scores the evening of surgery (adjusted difference -0.54 [97.5% CI, -1.07 to -0.02]; P = .02). No difference in cumulative opioid consumption and functional outcomes was detected. Liposomal bupivacaine was not cost-effective compared with the control treatment. No difference in adverse or serious adverse events was found between the liposomal bupivacaine and control groups. CONCLUSIONS AND RELEVANCE: This study found no difference in postoperative recovery or pain associated with the use of periarticular liposomal bupivacaine compared with bupivacaine hydrochloride alone in patients who underwent knee replacement surgery. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN54191675.
Abstract.
Author URL.
Bruce J, Mazuquin B, Mistry P, Rees S, Canaway A, Hossain A, Williamson E, Padfield EJ, Lall R, Richmond H, et al (2022). Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT.
Health Technol Assess,
26(15), 1-124.
Abstract:
Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT.
BACKGROUND: Upper limb problems are common after breast cancer treatment. OBJECTIVES: to investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. DESIGN: This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). SETTING: Breast cancer centres, secondary care. PARTICIPANTS: Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. INTERVENTIONS: all participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). MAIN OUTCOME MEASURES: the primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. RESULTS: Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17; p = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77; p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04; p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (-£387, 95% CI -£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. LIMITATIONS: Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. CONCLUSIONS: This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. FUTURE WORK: Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. TRIAL REGISTRATION: This trial is registered as ISRCTN35358984. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 15. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Keene DJ, Srikesavan C, Achten J, Tutton E, Dutton SJ, Marian IR, Grant R, Gould J, Herbert K, Athwal A, et al (2022). Flexibility and resistance exercises versus usual care for improving pain and function after distal radius fracture in adults aged 50 years or over: protocol for the WISE randomised multicentre feasibility trial.
Pilot and Feasibility Studies,
8(1).
Abstract:
Flexibility and resistance exercises versus usual care for improving pain and function after distal radius fracture in adults aged 50 years or over: protocol for the WISE randomised multicentre feasibility trial
Background: Distal radius fractures represent about 1 in 5 of all fractures treated in UK hospitals. Most distal radius fractures occur in women aged 50 years or over after a fall. Distal radius fractures are managed using splints or casting, some are also treated with surgical fixation. Patients often experience long-term muscle weakness of the hand and arm that may impact their ability to do daily activities such as personal hygiene, routine household chores and food preparation. We propose a structured and tailored flexibility and resistance exercise programme for the hand and arm supplemented with behaviour change strategies to help perform daily exercise. The main aim of our study is to assess the feasibility of conducting a definitive randomised controlled trial. Methods: This study is a multicentre, parallel-group individually randomised feasibility trial. We will recruit a minimum of 72 adults aged 50 years or over with distal radius fracture treated surgically or non-surgically from at least three UK National Health Service (NHS) hospitals. They will be randomised 1:1:1 to receive usual care, usual care and independent exercise with a single therapy session or usual care and supervised exercise with three therapy sessions over 12 weeks. Our primary feasibility objectives are (1) patient engagement assessed by recruitment, (2) acceptability of the interventions assessed by adherence and patient and clinician experience and (3) retention of participants in the trial. Outcome measures will be assessed at baseline, 3 months and at 6 months after randomisation. A qualitative sub-study will explore the experiences of the trial participants and therapists delivering the exercises. Discussion: a definitive trial will be considered feasible without major modifications if our progression criteria are met. If successful, the findings will inform the design of a future definitive RCT to evaluate the clinical and cost-effectiveness of the WISE exercise programme. Trial registration: ISRCTN12290145.
Abstract.
Griffiths F, Srikesavan C, Ward L, Boniface G, Williamson E, Lamb SE (2022). Longitudinal qualitative study of living with neurogenic claudication.
BMJ Open,
12(9), e060128-e060128.
Abstract:
Longitudinal qualitative study of living with neurogenic claudication
ObjectivesNeurogenic claudication (NC) causes pain and reduced mobility, particularly in older people, and can negatively affect mental and social well-being, so limiting successful ageing. This qualitative study explored how people with NC changed over 12 months.DesignA longitudinal qualitative study using semi-structured interviews.SettingParticipants were recruited from a UK clinical trial of a physiotherapy intervention for NC.ParticipantsInterviews were undertaken at baseline, 1 month after receiving any intervention and at 12 months. We analysed 30 sets of three interviews.ResultsInterview data were summarised for each time point into biopsychosocial domains: pain, mobility and activities of daily living, psychological impact, and social and recreational participation. Through comparative analysis we explored participant trajectories over time.Progressive improvement in at least one domain was experienced by 13 participants, but there was variability in trajectories with early improvements that remained the same, transient changes and no change also commonly observed.Eleven participants described co-present improvement trajectories in all domains. Three participants described co-present improvement in all domains except participation; one had never stopped their participation and two had unattainable expectations. Five participants described co-present improvement in one domain and deterioration in another and 14 participants described co-present no change in one domain and change in another.There was evidence of interaction between domains; for example, improved mobility led to improved participation and for some participants, specific factors influenced change. of the 15 participants who experienced improved participation, 10 reported improvements in all other domains and five participants did not; for two, pain did not prevent participation, one used a walking aid and two had a positive psychological outlook.ConclusionThe daily lived experiences of older adults with NC are variable and include interaction between biopsychosocial domains. Therapist understanding of these trajectories and their interactions may help to provide personalised therapyTrial Registration NumberISRCTN12698674
Abstract.
Costa ML, Achten J, Ooms A, Png ME, Cook J, Dritsaki M, Lamb SE, Lerner R, Draper K, Campolier M, et al (2022). Moulded cast compared with K-wire fixation after manipulation of an acute dorsally displaced distal radius fracture: the DRAFFT 2 RCT.
Health Technology Assessment,
26(11), 1-80.
Abstract:
Moulded cast compared with K-wire fixation after manipulation of an acute dorsally displaced distal radius fracture: the DRAFFT 2 RCT
. Background
. Patients with a displaced fracture of the distal radius are frequently offered surgical fixation. Manipulation of the fracture and moulded plaster casting is an alternative treatment that avoids metal implants, but evidence of its effectiveness is lacking.
.
.
. Objective
. To compare functional outcomes, quality-of-life outcomes, complications and resource use among patients with a dorsally displaced fracture of the distal radius treated with manipulation and surgical fixation with Kirschner wires (K-wires) and those treated with manipulation and moulded cast.
.
.
. Design
. Pragmatic, superiority, multicentre, randomised controlled trial with a health economic evaluation.
.
.
. Setting
. A total of 36 orthopaedic trauma centres in the UK NHS.
.
.
. Participants
. Patients (aged ≥ 16 years) treated for an acute dorsally displaced fracture of the distal radius were potentially eligible. Patients were excluded if their injury had occurred > 2 weeks previously, if the fracture was open, if it extended > 3 cm from the radiocarpal joint or if it required open reduction, or if the participant was unable to complete questionnaires.
.
.
. Interventions
. Participants were randomly assigned in theatre (1 : 1) to receive a moulded cast (i.e. the cast group) or surgical fixation with K-wires (i.e. the K-wire group) after fracture manipulation.
.
.
. Main outcome measures
. The primary outcome measure was the Patient-Rated Wrist Evaluation score at 12 months, analysed on an intention-to-treat basis. Health-related quality of life was recorded using the EuroQol-5 Dimensions, five-level version, and resource use was recorded from a health and personal social care perspective.
.
.
. Results
. Between January 2017 and March 2019, 500 participants (mean age 60 years, 83% women) were randomly allocated to receive a moulded cast (n = 255) or surgical fixation with K-wire (n = 245) following a manipulation of their fracture. A total of 395 (80%) participants were included in the primary analysis at 12 months. There was no difference in the Patient-Rated Wrist Evaluation score at 1 year post randomisation [cast group: n = 200, mean score 21.2 (standard deviation 23.1); K-wire group: n = 195, mean score 20.7 (standard deviation 22.3); adjusted mean difference –0.34 (95% confidence interval –4.33 to 3.66); p = 0.87]. A total of 33 (13%) participants in the cast group required surgical fixation for loss of fracture position in the first 6 weeks, compared with one participant in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). The base-case cost-effectiveness analysis showed that manipulation and surgical fixation with K-wires had a higher mean cost than manipulation and a moulded cast, despite similar mean effectiveness. The use of K-wires is unlikely to be cost-effective, and sensitivity analyses found this result to be robust.
.
.
. Limitations
. Because the interventions were identifiable, neither patients nor clinicians could be blind to their treatment.
.
.
. Conclusions
. Surgical fixation with K-wires was not found to be superior to moulded casting following manipulation of a dorsally displaced fracture of the distal radius, as measured by Patient-Rated Wrist Evaluation score. However, one in eight participants treated in a moulded cast required surgery for loss of fracture reduction in the first 6 weeks. After a successful closed reduction, clinicians may consider a moulded cast as a safe and cost-effective alternative to surgical fixation with K-wires.
.
.
. Future work
. Further research should focus on optimal techniques for immobilisation and manipulation of this type of fracture, including optimal analgesia, and for rehabilitation of the patient after immobilisation.
.
.
. Trial registration
. This trial is registered as ISRCTN11980540 and UKCRN Portfolio 208830.
.
.
. Funding
. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 11. See the NIHR Journals Library website for further project information.
.
Abstract.
Amirpourabasi A, Lamb SE, Chow JY, Williams GKR (2022). Nonlinear Dynamic Measures of Walking in Healthy Older Adults: a Systematic Scoping Review.
Sensors,
22(12), 4408-4408.
Abstract:
Nonlinear Dynamic Measures of Walking in Healthy Older Adults: a Systematic Scoping Review
Background: Maintaining a healthy gait into old age is key to preserving the quality of life and reducing the risk of falling. Nonlinear dynamic analyses (NDAs) are a promising method of identifying characteristics of people who are at risk of falling based on their movement patterns. However, there is a range of NDA measures reported in the literature. The aim of this review was to summarise the variety, characteristics and range of the nonlinear dynamic measurements used to distinguish the gait kinematics of healthy older adults and older adults at risk of falling. Methods: Medline Ovid and Web of Science databases were searched. Forty-six papers were included for full-text review. Data extracted included participant and study design characteristics, fall risk assessment tools, analytical protocols and key results. Results: Among all nonlinear dynamic measures, Lyapunov Exponent (LyE) was most common, followed by entropy and then Fouquet Multipliers (FMs) measures. LyE and Multiscale Entropy (MSE) measures distinguished between older and younger adults and fall-prone versus non-fall-prone older adults. FMs were a less sensitive measure for studying changes in older adults’ gait. Methodology and data analysis procedures for estimating nonlinear dynamic measures differed greatly between studies and are a potential source of variability in cross-study comparisons and in generating reference values. Conclusion: Future studies should develop a standard procedure to apply and estimate LyE and entropy to quantify gait characteristics. This will enable the development of reference values in estimating the risk of falling.
Abstract.
Fordham B, Smith TO, Lamb S, Morris A, Winter SC (2022). Patient and physiotherapist perceptions of the Getting Recovery Right After Neck Dissection (GRRAND) rehabilitation intervention: a qualitative interview study embedded within a feasibility trial.
BMJ Open,
12(11).
Abstract:
Patient and physiotherapist perceptions of the Getting Recovery Right After Neck Dissection (GRRAND) rehabilitation intervention: a qualitative interview study embedded within a feasibility trial
Objective the Getting Recovery Right After Neck Dissection (GRRAND) intervention is a physiotherapy programme for patients with head and neck cancer who have undergone neck dissection. The aim of this qualitative study was to understand if the intervention was useful, acceptable and whether it was feasible to conduct a randomised controlled trial (RCT). Design This qualitative study was embedded within the GRRAND-Feasibility (GRRAND-F) Study. Setting Participants were recruited from four acute National Health Service hospitals in England between 2020 and 2021. Participants We interviewed four usual care and four intervention patient-participants from a single study site (Oxford). Six were male, two were female. All were white British ethnicity. We interviewed two physiotherapists from Oxford who delivered the GRRAND-F intervention, and physiotherapists from Birmingham, Poole and Norwich who were trained to deliver the intervention but were not able to deliver it within the study time frame. Results the analysis identified five themes: (1) Acceptability, (2) Adherence, (3) Outcomes, (4) Feasibility and (5) Stand-alone themes (prehabilitation, video consultations, healthcare use). Patient-participants and physiotherapist-participants agreed that usual care was not meeting patients' rehabilitation needs. The GRRAND intervention provided biopsychosocial support. In comparison to the usual care group, patient-participants who received the intervention were more confident that they could perform rehabilitation exercises and were more motivated to engage in long-term adaptive behaviour change. Physiotherapists felt they needed more administrative support to participate in an RCT. Conclusion Participants felt that usual care was insufficient. GRRAND provided much needed, biopsychosocial support to patients. Participants were supportive that it would be feasible to test GRRAND in an RCT. Trial registration number ISRCTN11979997.
Abstract.
Keene DJ, Alsousou J, Harrison P, O'Connor HM, Wagland S, Dutton SJ, Hulley P, Lamb SE, Willett K (2022). Platelet-rich plasma injection for acute Achilles tendon rupture.
Bone and Joint Journal,
104B(11), 1256-1265.
Abstract:
Platelet-rich plasma injection for acute Achilles tendon rupture
Aims: to determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. Methods: a randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to- treat. Results: a total of 230 participants were randomized, 114 to PRP and 116 to placebo. Two-year questionnaires were sent to 216 participants who completed a six-month questionnaire. Overall, 182/216 participants (84%) completed the two-year questionnaire. Participants were aged a mean of 46 years (SD 13.0) and 25% were female (57/230). The majority of participants received the allocated intervention (219/229, 96%). Mean ATRS scores at two years were 82.2 (SD 18.3) in the PRP group (n = 85) and 83.8 (SD 16.0) in the placebo group (n = 92). There was no evidence of a difference in the ATRS at two years (adjusted mean difference -0.752, 95% confidence interval -5.523 to 4.020; p = 0.757) or in other secondary outcomes, and there were no re-ruptures between 24 weeks and two years. Conclusion: PRP injection did not improve patient-reported function or quality of life two years after acute Achilles tendon rupture compared with placebo. The evidence from this study indicates that PRP offers no patient benefit in the longer term for patients with acute Achilles tendon rupture.
Abstract.
Keene DJ, Costa ML, Peckham N, Tutton E, Barber VS, Dutton SJ, Hopewell S, Redmond AC, Willett K, Lamb SE, et al (2022). Progressive exercise versus best practice advice for adults aged 50 years or over after ankle fracture: the AFTER pilot randomised controlled trial.
BMJ Open,
12(11).
Abstract:
Progressive exercise versus best practice advice for adults aged 50 years or over after ankle fracture: the AFTER pilot randomised controlled trial.
OBJECTIVE: the aim of the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study, a multicentre external pilot parallel-group randomised controlled trial (RCT), was to assess feasibility of a definitive trial comparing rehabilitation approaches after ankle fracture. SETTING: Five UK National Health Service hospitals. PARTICIPANTS: Participants were aged 50 years and over with an ankle fracture requiring immobilisation for at least 4 weeks. INTERVENTIONS: Participants were allocated 1:1 via a central web-based randomisation system to: (1) best practice advice (one session of physiotherapy, up to two optional additional advice sessions) or (2) progressive exercise (up to six sessions of physiotherapy). PRIMARY OUTCOME MEASURES: Feasibility: (1) participation rate, (2) intervention adherence and (3) retention. RESULTS: Sixty-one of 112 (54%) eligible participants participated, exceeding progression criteria for participation of 25%. Recruitment progression criteria was 1.5 participants per site per month and 1.4 was observed. At least one intervention session was delivered for 28/30 (93%) of best practice advice and 28/31 (90%) of progressive exercise participants, exceeding the 85% progression criteria. For those providing follow-up data, the proportion of participants reporting performance of home exercises in the best practice advice and the progressive exercise groups at 3 months was 20/23 (87%) and 21/25 (84%), respectively. Mean time from injury to starting physiotherapy was 74.1 days (95% CI 53.9 to 94.1 days) for the best practice advice and 72.7 days (95% CI 54.7 to 88.9) for the progressive exercise group. Follow-up rate (6-month Olerud and Molander Ankle Score) was 28/30 (93%) for the best practice advice group and 26/31 (84%) in the progressive exercise group with an overall follow-up rate of 89%. CONCLUSIONS: This pilot RCT demonstrated that a definitive trial would be feasible. The main issues to address for a definitive trial are intervention modifications to enable earlier provision of rehabilitation and ensuring similar rates of follow-up in each group. TRIAL REGISTRATION NUMBER: ISRCTN16612336.
Abstract.
Author URL.
Silva FM, Adegboye ARA, Curioni C, Gomes FS, Collins GS, Kac G, a De Beyer J, Cook JA, Cheikh Ismail L, Page MJ, et al (2022). Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations.
BMJ open,
12(12).
Abstract:
Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations
INTRODUCTION: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline establishes a minimum set of items to be reported in any randomised controlled trial (RCT) protocol. The Template for Intervention Description and Replication (TIDieR) reporting guideline was developed to improve the reporting of interventions in RCT protocols and results papers. Reporting completeness in protocols of diet or nutrition-related RCTs has not been systematically investigated. We aim to identify published protocols of diet or nutrition-related RCTs, assess their reporting completeness and identify the main reporting limitations remaining in this field. METHODS AND ANALYSIS: We will conduct a meta-research study of RCT protocols published in journals indexed in at least one of six selected databases between 2012 and 2022. We have run a search in PubMed, Embase, CINAHL, Web of Science, PsycINFO and Global Health using a search strategy designed to identify protocols of diet or nutrition-related RCTs. Two reviewers will independently screen the titles and abstracts of records yielded by the search in Rayyan. The full texts will then be read to confirm protocol eligibility. We will collect general study features (publication information, types of participants, interventions, comparators, outcomes and study design) of all eligible published protocols in this contemporary sample. We will assess reporting completeness in a randomly selected sample of them and identify their main reporting limitations. We will compare this subsample with the items in the SPIRIT and TIDieR statements. For all data collection, we will use data extraction forms in REDCap. This protocol is registered on the Open Science Framework (DOI: 10.17605/OSF.IO/YWEVS). ETHICS AND DISSEMINATION: This study will undertake a secondary analysis of published data and does not require ethical approval. The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.
Abstract.
Smith TO, Parsons S, Ooms A, Dutton S, Fordham B, Garrett A, Hing C, Lamb S, PEP-TALK Trial Collaborators (2022). Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.
BMJ Open,
12(5).
Abstract:
Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.
OBJECTIVE: to test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after total hip replacement (THR) or total knee replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial. SETTING: National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged ≥18 years, undergoing a primary THR or TKR deemed 'moderately inactive' or 'inactive'. INTERVENTION: Participants received either six, 30 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION AND BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 and 12-month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: of the 1254 participants assessed for eligibility, 224 were included (139 experimental: 85 usual care). Mean age was 68.4 years (SD: 8.7), 63% were women, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at 6 or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution. TRIAL REGISTRATION NUMBER: ISRCTN29770908.
Abstract.
Author URL.
Williamson E, Lamb SE (2022). Response to: Van Hoek et al. Letter to the Editor.
J Gerontol a Biol Sci Med Sci,
77(11).
Author URL.
Costa ML, Achten J, Ooms A, Png ME, Cook JA, Lamb SE, Hedley H, Dias J, DRAFFT2 Collaborators (2022). Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial.
BMJ,
376Abstract:
Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial.
OBJECTIVE: to assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires. DESIGN: Multicentre randomised clinical superiority trial, SETTING: 36 hospitals in the UK National Health Service (NHS). PARTICIPANTS: 500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation). INTERVENTIONS: Manipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice. MAIN OUTCOME MEASURES: the primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks. RESULTS: the mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). CONCLUSIONS: Among patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients' wrist function at 12 months compared with a cast. TRIAL REGISTRATION: ISRCTN registry ISRCTN11980540.
Abstract.
Author URL.
Williamson E, Boniface G, Marian IR, Dutton SJ, Garrett A, Morris A, Hansen Z, Ward L, Nicolson PJA, Rogers D, et al (2022). The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults with Neurogenic Claudication: the BOOST Randomized Controlled Trial.
J Gerontol a Biol Sci Med Sci,
77(8), 1654-1664.
Abstract:
The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults with Neurogenic Claudication: the BOOST Randomized Controlled Trial.
BACKGROUND: Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults' mobility and quality of life. METHODS: a randomized controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST program) compared to physiotherapy assessment and tailored advice (best practice advice [BPA]) for older adults with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records and randomized 2:1 to the BOOST program or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT), and falls. The primary analysis was intention-to-treat. RESULTS: the average age of participants was 74.9 years (standard deviation [SD] 6.0) and 57% (246/435) were female. There was no significant difference in ODI scores between treatment groups at 12 months (adjusted mean difference [MD]: -1.4 [95% confidence intervals (CI) -4.03, 1.17]), but, at 6 months, ODI scores favored the BOOST program (adjusted MD: -3.7 [95% CI -6.27, -1.06]). At 12 months, the BOOST program resulted in greater improvements in walking capacity (6MWT MD: 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD: -0.2 [95% CI -0.45, -0.01]) and reduced falls risk (odds ratio: 0.6 [95% CI 0.40, 0.98]) compared to BPA. No serious adverse events were related to either treatment. CONCLUSIONS: the BOOST program substantially improved mobility for older adults with NC. Future iterations of the program will consider ways to improve long-term pain-related disability. Clinical Trials Registration Number: ISRCTN12698674.
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Author URL.
Nicolson PJA, Duong V, Williamson E, Hopewell S, Lamb SE (2022). The Effect of Therapeutic Exercise Interventions on Physical and Psychosocial Outcomes in Adults Aged 80 Years and Older: a Systematic Review and Meta-Analysis.
J Aging Phys Act,
30(3), 517-534.
Abstract:
The Effect of Therapeutic Exercise Interventions on Physical and Psychosocial Outcomes in Adults Aged 80 Years and Older: a Systematic Review and Meta-Analysis.
This systematic review aimed to evaluate the effects of therapeutic exercise on physical and psychosocial outcomes in community-dwelling adults aged 80 years or older. Databases were searched from inception to July 8, 2020. Randomized controlled trials (RCTs) were screened by two reviewers who extracted data and assessed study quality. Sixteen RCTs (1,660 participants) were included. Compared to nonexercise controls there was no evidence of an effect of exercise on performance based (standardized mean differences: 0.58, 95% confidence interval: [-0.19, 1.36]; I2: 89%; six RCTs; 290 participants; very low-quality evidence) or self-reported physical function (standardized mean differences: 1.35, 95% confidence interval: [-0.78, 3.48]; I2: 96%; three RCTs; 280 participants; very low-quality evidence) at short-medium term follow-up. Four RCTs reporting psychosocial outcomes could not be combined in meta-analysis and reported varying results. Exercise appeared to reduce the risk of mortality during follow-up (risk ratio: 0.47, 95% confidence interval: [0.32, 0.70]; I2: 0.0%; six RCTs; 1,222 participants; low-quality evidence).
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Geohagen O, Hamer L, Lowton A, Guerra S, Milton-Cole R, Ellery P, Martin FC, Lamb SE, Sackley C, Sheehan KJ, et al (2022). The effectiveness of rehabilitation interventions including outdoor mobility on older adults' physical activity, endurance, outdoor mobility and falls-related self-efficacy: systematic review and meta-analysis.
Age Ageing,
51(6).
Abstract:
The effectiveness of rehabilitation interventions including outdoor mobility on older adults' physical activity, endurance, outdoor mobility and falls-related self-efficacy: systematic review and meta-analysis.
OBJECTIVE: to determine the effectiveness of community-based rehabilitation interventions which incorporate outdoor mobility on physical activity, endurance, outdoor mobility and falls-related self-efficacy in older adults. DESIGN: MEDLINE, Embase, CINAHL, PEDro and OpenGrey were searched systematically from inception to June 2021 for randomised controlled trials (RCTs) of community-based rehabilitation incorporating outdoor mobility on physical activity, endurance, outdoor mobility and/or falls-related self-efficacy in older adults. Duplicate screening, selection, extraction and appraisal were completed. Results were reported descriptively and with random-effects meta-analyses stratified by population (proactive [community-dwelling], reactive [illness/injury]). RESULTS: a total of 29 RCTs with 7,076 participants were identified (66% high bias for at least one domain). The outdoor mobility component was predominantly a walking programme with behaviour change. Rehabilitation for reactive populations increased physical activity (seven RCTs, 587 participants. Hedge's g 1.32, 95% CI: 0.31, 2.32), endurance (four RCTs, 392 participants. Hedges g 0.24; 95% CI: 0.04, 0.44) and outdoor mobility (two RCTs with 663 participants. Go out as much as wanted, likelihood of a journey) at intervention end versus usual care. Where reported, effects were preserved at follow-up. One RCT indicated a benefit of rehabilitation for proactive populations on moderate-to-vigorous activity and outdoor mobility. No effect was noted for falls-related self-efficacy, or other outcomes following rehabilitation for proactive populations. CONCLUSION: Reactive rehabilitation for older adults may include walking programmes with behaviour change techniques. Future research should address the potential benefit of a walking programme for proactive populations and address mobility-related anxiety as a barrier to outdoor mobility for both proactive and reactive populations.
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Srikesavan C, Williamson E, Thompson JY, Cranston T, Swales C, Lamb SE (2022). The online version of an evidence-based hand exercise program for people with rheumatoid arthritis: a mixed-method, proof-of-concept study. Journal of Hand Therapy, 35(3), 468-476.
Boniface G, Sanchez-Santos MT, Norris M, OConnell N, Williamson E, Lamb SE (2022). Understanding prescribed dose in hand strengthening exercise for rheumatoid arthritis: a secondary analysis of the SARAH trial.
Musculoskeletal Care,
20(4), 899-907.
Abstract:
Understanding prescribed dose in hand strengthening exercise for rheumatoid arthritis: a secondary analysis of the SARAH trial.
OBJECTIVE: 1) to identify therapist or participant characteristics associated with prescribed dose of hand strengthening exercise in adults with rheumatoid arthritis and 2) to determine the impact of dose prescribed on outcome (hand function and grip strength). METHODS: Overall dose was calculated using area under the curve (AUC). Analysis 1 assessed the association between therapist professional background, therapist grade, baseline participant physical and psychological characteristics and prescribed dose. Analyses 2 and 3 estimated the relationship between prescribed dose and overall hand function and grip strength. Generalised estimating equation linear regression analysis was used. RESULTS: Analysis 1: Being treated by an occupational therapist (β = -297.0, 95% CI -398.6, -195.4), metacarpophalangeal joint deformity (β = -24.1, 95% CI -42.3, -5.9), a higher number of swollen wrist/hand joints (β = -11.4, 95% CI -21.6, -1.2) and the participant feeling downhearted and low all of the time (β = -293.6, 95% CI -436.1, -151.1) were associated with being prescribed a lower dose. Being treated by a grade 6 therapist (β = 159.1, 95% CI 65.7, 252.5), higher baseline grip strength (β = 0.15, 95% CI 0.02, 0.28) and greater participant confidence to exercise without fear of making symptoms worse (β = 18.9, 95% CI 1.5, 36.3) were associated with being prescribed a higher dose. Analyses 2 and 3: Higher dose was associated with greater overall hand function (β = 0.005, 95% CI 0.001, 0.010) and full-hand grip strength (β = 0.014, 95% CI 0.000, 0.025) at 4-month. CONCLUSION: Higher dose was associated with better clinical outcomes. Prescription of hand strengthening exercise is associated with both therapist and participant characteristics.
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Author URL.
Taleshi N, Brownjohn JMW, Lamb SE, Zivanovic S, Williams GKR (2022). Vector coding reveals the underlying balance control strategies used by humans during translational perturbation.
Sci Rep,
12(1).
Abstract:
Vector coding reveals the underlying balance control strategies used by humans during translational perturbation.
Postural control research has focused on standing balance experiments on platforms moving with relatively large amplitudes (0.1-0.2 m). This study investigated balance strategies while standing on a platform moving 4 mm in anterior-posterior direction with frequency scaled linearly from 0.4 to 6 Hz. Platform motion and kinematic and kinetic information for nine healthy participants were recorded using motion capture and force plate systems. Coordination between hip, knee and ankle joint torque, and centre of mass (COM) and centre of pressure (COP) motion was quantified by vector coding. Significant main effect of platform frequency for knee-ankle and COP-COM phase relationship was observed (p = 0.023, p = 0.016). At frequencies below 2.11 and 2.34 Hz, ankle strategy was recruited. With ankle strategy, in-phase COP-COM motion with COP dominancy occurred at frequencies below 2.19 and 2.23 Hz during scaling up and down, respectively. As platform frequency passed these values, COM dominated over COP which was followed by anti-phase knee-ankle torque, called a knee strategy, and anti-phase motion between the COP and COM that allowed COP to regain dominance over COM. Collectively, we reveal knee strategy as a new and relevant strategy in real-life settings, and transition between ankle and knee strategies that underpinned transition between COP-COM relative motion.
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Lee H, Cashin AG, Lamb SE, Hopewell S, Vansteelandt S, VanderWeele TJ, MacKinnon DP, Mansell G, Collins GS, Golub RM, et al (2021). A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: the AGReMA Statement.
JAMA,
326(11), 1045-1056.
Abstract:
A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: the AGReMA Statement.
IMPORTANCE: Mediation analyses of randomized trials and observational studies can generate evidence about the mechanisms by which interventions and exposures may influence health outcomes. Publications of mediation analyses are increasing, but the quality of their reporting is suboptimal. OBJECTIVE: to develop international, consensus-based guidance for the reporting of mediation analyses of randomized trials and observational studies (A Guideline for Reporting Mediation Analyses; AGReMA). DESIGN, SETTING, AND PARTICIPANTS: the AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodological framework for developing reporting guidelines. The guideline development process included (1) an overview of systematic reviews to assess the need for a reporting guideline; (2) review of systematic reviews of relevant evidence on reporting mediation analyses; (3) conducting a Delphi survey with panel members that included methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors (n = 19; June-November 2019); (4) having a consensus meeting (n = 15; April 28-29, 2020); and (5) conducting a 4-week external review and pilot test that included methodologists and potential users of AGReMA (n = 21; November 2020). RESULTS: a previously reported overview of 54 systematic reviews of mediation studies demonstrated the need for a reporting guideline. Thirty-three potential reporting items were identified from 3 systematic reviews of mediation studies. Over 3 rounds, the Delphi panelists ranked the importance of these items, provided 60 qualitative comments for item refinement and prioritization, and suggested new items for consideration. All items were reviewed during a 2-day consensus meeting and participants agreed on a 25-item AGReMA statement for studies in which mediation analyses are the primary focus and a 9-item short-form AGReMA statement for studies in which mediation analyses are a secondary focus. These checklists were externally reviewed and pilot tested by 21 expert methodologists and potential users, which led to minor adjustments and consolidation of the checklists. CONCLUSIONS AND RELEVANCE: the AGReMA statement provides recommendations for reporting primary and secondary mediation analyses of randomized trials and observational studies. Improved reporting of studies that use mediation analyses could facilitate peer review and help produce publications that are complete, accurate, transparent, and reproducible.
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Smith T, Clark L, Khoury R, Man M-S, Hanson S, Welsh A, Clark A, Hopewell S, Pfeiffer K, Logan P, et al (2021). A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery.
Bone Jt Open,
2(11), 909-920.
Abstract:
A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery.
AIMS: This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. METHODS: This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a 'good' recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals. DISCUSSION: a multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article: Bone Jt Open 2021;2(11):909-920.
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Tonga E, Williamson E, Srikesavan C, Özen T, Sarıtaş F, Lamb SE (2021). A hand exercise mobile app for people with rheumatoid arthritis in Turkey: design, development and usability study.
Rheumatol Int,
41(6), 1151-1160.
Abstract:
A hand exercise mobile app for people with rheumatoid arthritis in Turkey: design, development and usability study.
To design and develop a smartphone application for a structured hand exercise programme for patients with rheumatoid arthritis (RA) in Turkey and to test its usability. We followed a two-stage process: (1) Design and Development and (2) Usability testing. In stage 1, we used a qualitative user-centered design approach. We conducted a focus group (8 therapists and people with RA) to discuss the content, features and design to produce a prototype of the application. In a second focus group session, the participants tested the prototype, provided feedback and further revisions were made. In stage 2, 17 participants with RA used the app for 4 to 6 weeks. The System Usability Scale and the adapted Usability, Satisfaction and Ease to Use Questionnaires were used to measure usability, ease of use. Semi-structured interviews were conducted to explore user experiences with the application with 17 participants. In stage 1, the following themes were identified from the focus groups (a) login techniques (b) self-monitoring (c) exercises, (d) exercise diary, (e) information, (f) behavioral change and encouragement (g) exercise adherence. In stage 2, 3 themes were determined from interviews: (a) learning and accuracy, (b) ease of use, (c) motivation and adherence. USE and SUS scores indicated that users reported a high level of usability, satisfaction and ease of use. A mobile app for hand exercise for people with RA was developed using a mixed-method and iterative design. Participants perceived the mobile app as easy to use with high levels of satisfaction.
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Perkins GD, Ji C, Achana F, Black JJM, Charlton K, Crawford J, de Paeztron A, Deakin C, Docherty M, Finn J, et al (2021). Adrenaline to improve survival in out-of-hospital cardiac arrest: the PARAMEDIC2 RCT.
HEALTH TECHNOLOGY ASSESSMENT,
25(25), 1-+.
Author URL.
Harrison P, Didembourg M, Wood A, Devi A, Dinsdale R, Hazeldine J, Alsousou J, Keene DJ, Hulley P, Wagland S, et al (2021). Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.
Platelets,
32(2), 273-279.
Abstract:
Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.
Platelet-rich plasma (PRP) is an autologous preparation that has been claimed to improve healing and mechanobiological properties of tendons both in vitro and in vivo. In this sub-study from the PATH-2 (PRP in Achilles Tendon Healing-2) trial, we report the cellular and growth factor content and quality of the Leukocyte-rich PRP (L-PRP) (N = 103) prepared using a standardized commercial preparation method across 19 different UK centers. Baseline whole blood cell counts (red cells, leukocyte and platelets) demonstrated that the two groups were well-matched. L-PRP analysis gave a mean platelet count of 852.6 x 109/L (SD 438.96), a mean leukocyte cell count of 15.13 x 109/L (SD 10.28) and a mean red blood cell count of 0.91 x 1012/L (SD 1.49). The activation status of the L-PRP gave either low or high expression levels of the degranulation marker CD62p before and after ex-vivo platelet activation respectively. TGF-β, VEGF, PDGF, IGF and FGFb mean concentrations were 131.92 ng/ml, 0.98 ng/ml, 55.34 ng/ml, 78.2 ng/ml and 111.0 pg/ml respectively with expected correlations with both platelet and leukocyte counts. While PATH-2 results demonstrated that there was no evidence L-PRP is effective for improving clinical outcomes at 24 weeks after Achilles tendon rupture, our findings support that the majority of L-PRP properties were within the method specification and performance.
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Fordham B, Sugavanam T, Edwards K, Hemming K, Howick J, Copsey B, Lee H, Kaidesoja M, Kirtley S, Hopewell S, et al (2021). Cognitive-behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis.
Health Technol Assess,
25(9), 1-378.
Abstract:
Cognitive-behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis.
BACKGROUND: Cognitive-behavioural therapy aims to increase quality of life by changing cognitive and behavioural factors that maintain problematic symptoms. A previous overview of cognitive-behavioural therapy systematic reviews suggested that cognitive-behavioural therapy was effective for many conditions. However, few of the included reviews synthesised randomised controlled trials. OBJECTIVES: This project was undertaken to map the quality and gaps in the cognitive-behavioural therapy systematic review of randomised controlled trial evidence base. Panoramic meta-analyses were also conducted to identify any across-condition general effects of cognitive-behavioural therapy. DATA SOURCES: the overview was designed with cognitive-behavioural therapy patients, clinicians and researchers. The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Child Development & Adolescent Studies, Database of Abstracts of Reviews of Effects and OpenGrey databases were searched from 1992 to January 2019. REVIEW METHODS: Study inclusion criteria were as follows: (1) fulfil the Centre for Reviews and Dissemination criteria; (2) intervention reported as cognitive-behavioural therapy or including one cognitive and one behavioural element; (3) include a synthesis of cognitive-behavioural therapy trials; (4) include either health-related quality of life, depression, anxiety or pain outcome; and (5) available in English. Review quality was assessed with a MeaSurement Tool to Assess systematic Reviews (AMSTAR)-2. Reviews were quality assessed and data were extracted in duplicate by two independent researchers, and then mapped according to condition, population, context and quality. The effects from high-quality reviews were pooled within condition groups, using a random-effect panoramic meta-analysis. If the across-condition heterogeneity was I2
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Cashin AG, McAuley JH, Lamb SE, Lee H (2021). Disentangling contextual effects from musculoskeletal treatments. Osteoarthritis and Cartilage, 29(3), 297-299.
Griffin XL, Achten J, Parsons N, Costa ML, Chesser T, Moppett I, McGibbon AJA, May K, Grant R, White S, et al (2021). Does performance-based remuneration improve outcomes in the treatment of hip fracture?: RESULTS FROM THE WHITE MULTICENTRE HIP FRACTURE COHORT.
Bone and Joint Journal,
103 B(5), 881-887.
Abstract:
Does performance-based remuneration improve outcomes in the treatment of hip fracture?: RESULTS FROM THE WHITE MULTICENTRE HIP FRACTURE COHORT
Aims the aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. Methods This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients. Results a total of 6,532 patients provided both baseline and four-month EQ-5D-5L, of whom 1,060 participants had died at follow-up. Best practice was achieved in the care of 57% of participants; there was no difference in age, cognitive ability, and mobility at baseline for the overall attainment and non-attainment groups. Attaining at least 'joint care by surgeon and orthogeriatrician', 'delirium assessment', and 'falls assessment' was associated with a large, clinically relevant increase in four months EQ-5D-5L of 0.094 (bootstrapped 95% confidence interval (CI) 0.046 to 0.146). Conclusion National standards with enhanced remuneration in hip fracture care results in improvement in individual patients' HRQoL.
Abstract.
Sheehan KJ, Fitzgerald L, Lambe K, Martin FC, Lamb SE, Sackley C (2021). Effectiveness of community-based rehabilitation interventions incorporating outdoor mobility on ambulatory ability and falls-related self-efficacy after hip fracture: a systematic review and meta-analysis.
Arch Osteoporos,
16(1).
Abstract:
Effectiveness of community-based rehabilitation interventions incorporating outdoor mobility on ambulatory ability and falls-related self-efficacy after hip fracture: a systematic review and meta-analysis.
UNLABELLED: There is limited evidence from 11 randomised controlled trials on the effect of rehabilitation interventions which incorporate outdoor mobility on ambulatory ability and/or self-efficacy after hip fracture. Outdoor mobility should be central (not peripheral) to future intervention studies targeting improvements in ambulatory ability. PURPOSE: Determine the extent to which outdoor mobility is incorporated into rehabilitation interventions after hip fracture. Synthesise the evidence for the effectiveness of these interventions on ambulatory ability and falls-related self-efficacy. METHODS: Systematic search of MEDLINE, Embase, PsychInfo, CINAHL, PEDro and OpenGrey for published and unpublished randomised controlled trials (RCTs) of community-based rehabilitation interventions incorporating outdoor mobility after hip fracture from database inception to January 2021. Exclusion of protocols, pilot/feasibility studies, secondary analyses of RCTs, nonrandomised and non-English language studies. Duplicate screening for eligibility, risk of bias, and data extraction sample. Random effects meta-analysis. Statistical heterogeneity with inconsistency-value (I2). RESULTS: RCTs (n = 11) provided limited detail on target or achieved outdoor mobility intervention components. There was conflicting evidence from 2 RCTs for the effect on outdoor walking ability at 1-3 months (risk difference 0.19; 95% confidence intervals (CI): 0.21, 0.58; I2 = 92%), no effect on walking endurance at intervention end (standardised mean difference 0.05; 95% CI: - 0.26, 0.35; I2 = 36%); and suggestive (CI crosses null) of a small effect on self-efficacy at 1-3 months (standardised mean difference 0.25; 95% CI: - 0.29, 0.78; I2 = 87%) compared with routine care/sham intervention. CONCLUSION: it was not possible to attribute any benefit observed to an outdoor mobility intervention component due to poor reporting of target or achieved outdoor mobility and/or quality of the underlying evidence. Given the low proportion of patients recovering outdoor mobility after hip fracture, future research on interventions with outdoor mobility as a central component is warranted. TRIAL REGISTRATION: PROSPERO registration: CRD42021236541.
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Rex SS, Kottam L, McDaid C, Brealey S, Dias J, Hewitt CE, Keding A, Lamb SE, Wright K, Rangan A, et al (2021). Effectiveness of interventions for the management of primary frozen shoulder : a systematic review of randomized trials.
Bone Jt Open,
2(9), 773-784.
Abstract:
Effectiveness of interventions for the management of primary frozen shoulder : a systematic review of randomized trials.
AIMS: This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. METHODS: MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. RESULTS: Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. CONCLUSION: the findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773-784.
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de Souto Barreto P, Maltais M, Rosendahl E, Vellas B, Bourdel-Marchasson I, Lamb SE, Pitkala K, Rolland Y (2021). Exercise Effects on Falls, Fractures, Hospitalizations, and Mortality in Older Adults with Dementia: an Individual-Level Patient Data Meta-analysis.
J Gerontol a Biol Sci Med Sci,
76(9), e203-e212.
Abstract:
Exercise Effects on Falls, Fractures, Hospitalizations, and Mortality in Older Adults with Dementia: an Individual-Level Patient Data Meta-analysis.
BACKGROUND: to study the effects of exercise on falls, fractures, hospitalizations, and death in people with dementia. METHOD: We conducted an individual-level patient data meta-analysis of 7 randomized controlled trials (RCTs). We looked for studies from the reference list of previous systematic reviews and undertook an electronic search for articles published between 2013 and 2019 in Ageline, CENTRAL, PsycINFO, PubMed, and SportsDiscus. Main (binary) outcome measures were the risk of mortality, hospitalization, faller, multiple faller, injurious faller, and fractures. Secondary (count) outcomes were the incident rates of hospitalizations, falls, and injurious falls. RESULTS: from the 1314 participants, 771 were allocated to the exercise group and 543 to the control group. The number of cases regarding the main outcome measures in exercisers and controls were, respectively: 45 (5.8%) and 31 (5.7%) deaths; 102 (14.4%) and 65 (13.4%) participants hospitalized; 221 (34.4%) and 175 (41.3%) had at least 1 fall; 128 (20.2%) and 92 (21.7%) had multiple falls; 78 (24.8%) and 92 (29.3%) had injurious falls; and 19 (2.9%) and 15 (3.5%) had suffered a fracture. Two-step meta-analysis found no effects of exercise on any outcome. One-step meta-analysis found exercise reduced the risk of falls (odds ratio 0.75; 95% CI: 0.57-0.99). Exploratory analysis showed exercise decreased the rate of incident falls in participants with the lowest functional ability (incident rate ratio 0.48; 95% CI: 0.30-0.79). CONCLUSIONS: Although the 2-step meta-analysis suggests exercise does not have an effect on the outcomes, 1-step meta-analysis suggested that exercise may reduce fall risk. Data from further high-quality RCTs are still needed.
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Bruce J, Mazuquin B, Canaway A, Hossain A, Williamson E, Mistry P, Lall R, Petrou S, Lamb SE, Rees S, et al (2021). Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation.
BMJ,
375Abstract:
Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation.
OBJECTIVE: to evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. DESIGN: Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. SETTING: 17 UK National Health Service cancer centres. PARTICIPANTS: 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). INTERVENTIONS: Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. MAIN OUTCOME MEASURES: Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. RESULTS: Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale -0.68, -1.23 to -0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) -2.02, -3.11 to -0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average -£387 (€457; $533) (95% confidence interval -£2491 to £1718; 2015 pricing) and was cost effective compared with usual care. CONCLUSIONS: the PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. TRIAL REGISTRATION: ISRCTN Registry ISRCTN35358984.
Abstract.
Author URL.
Srikesavan C, Toye F, Brealey S, Goodchild L, Northgraves M, Charalambous CP, Rangan A, Lamb S (2021). Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study.
BMJ Open,
11(6).
Abstract:
Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study
Objectives to explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR) with a 12-week early structured physiotherapy programme (ESP) in people with unilateral frozen shoulder referred to secondary care. Design Nested qualitative study with semistructured interviews. We used constant comparison method to develop our themes. Setting This qualitative study was nested within the UK FROST. Participants 44 trial participants (ESP: 14; MUA: 15; ACR: 15), and 8 surgeons and 8 physiotherapists who delivered the treatments in the trial. Results Trial participants found UK FROST treatments acceptable and satisfactory in terms of content, delivery and treatment benefits. Participants in all arms experienced improvements in pain, shoulder movements, and function. Participants said they would choose the same treatment that they received in the trial. Surgeons and physiotherapists felt that the content and delivery of UK FROST treatments was not significantly different to their routine practice except for the additional number of physiotherapy sessions offered in the trial. They had mixed feelings about the effectiveness of UK FROST treatments. Both stressed the value of including hydrodilatation as a comparator of other treatment options. Physiotherapists raised concerns about the capacity to deliver the number of UK FROST physiotherapy sessions in routine clinical settings. Shared perceptions of trial participants, surgeons and physiotherapists were: (1) Pain relief and return of shoulder movements and function are important outcomes and (2) Adherence to exercises leads to better outcomes. Conclusion in general, our findings indicated that trial participants, and surgeons and physiotherapists who delivered the treatments had positive experiences and perceptions in the UK FROST. Early qualitative investigations to explore the feasibility of delivering treatments in real-world settings are suggested in future trials in the frozen shoulder. Trial registration number International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014; Results
Abstract.
Shah RF, Gwilym SE, Lamb S, Williams M, Ring D, Jayakumar P (2021). Factors associated with persistent opioid use after an upper extremity fracture.
Bone Jt Open,
2(2), 119-124.
Abstract:
Factors associated with persistent opioid use after an upper extremity fracture.
AIMS: the increase in prescription opioid misuse and dependence is now a public health crisis in the UK. It is recognized as a whole-person problem that involves both the medical and the psychosocial needs of patients. Analyzing aspects of pathophysiology, emotional health, and social wellbeing associated with persistent opioid use after injury may inform safe and effective alleviation of pain while minimizing risk of misuse or dependence. Our objectives were to investigate patient factors associated with opioid use two to four weeks and six to nine months after an upper limb fracture. METHODS: a total of 734 patients recovering from an isolated upper limb fracture were recruited in this study. Opioid prescription was documented retrospectively for the period preceding the injury, and prospectively at the two- to four-week post-injury visit and six- to nine-month post-injury visit. Bivariate and multivariate analysis sought factors associated with opioid prescription from demographics, injury-specific data, Patient Reported Outcome Measurement Instrumentation System (PROMIS), Depression computer adaptive test (CAT), PROMIS Anxiety CAT, PROMIS Instrumental Support CAT, the Pain Catastrophizing Scale (PCS), the Pain Self-efficacy Questionnaire (PSEQ-2), Tampa Scale for Kinesiophobia (TSK-11), and measures that investigate levels of social support. RESULTS: a new prescription of opioids two to four weeks after injury was independently associated with less social support (odds ratio (OR) 0.26, p < 0.001), less instrumental support (OR 0.91, p < 0.001), and greater symptoms of anxiety (OR 1.1, p < 0.001). A new prescription of opioids six to nine months after injury was independently associated with less instrumental support (OR 0.9, p < 0.001) and greater symptoms of anxiety (OR 1.1, p < 0.001). CONCLUSION: This study demonstrates that potentially modifiable psychosocial factors are associated with increased acute and chronic opioid prescriptions following upper limb fracture. Surgeons prescribing opioids for upper limb fractures should be made aware of the screening and management of emotional and social health. Cite this article: Bone Jt Open 2021;2(2):119-124.
Abstract.
Author URL.
Bruce J, Hossain A, Lall R, Withers EJ, Finnegan S, Underwood M, Ji C, Bojke C, Longo R, Hulme C, et al (2021). Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT.
Health Technol Assess,
25(34), 1-114.
Abstract:
Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT.
BACKGROUND: Falls and fractures are a major problem. OBJECTIVES: to investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions. DESIGN: Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice. SETTING: Primary care. PARTICIPANTS: People aged ≥ 70 years. INTERVENTIONS: all practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling. MAIN OUTCOME MEASURES: the primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit. RESULTS: Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported. LIMITATIONS: the rate of fractures was lower than anticipated. CONCLUSIONS: Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective. FUTURE WORK: Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71002650. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 34. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Gallyer V, Smith TO, Fordham B, Dutton S, Chester-Jones M, Lamb SE, Winter SC, GRRAND-F Trial Collaborators (2021). Getting Recovery Right After Neck Dissection (GRRAND-F): mixed-methods feasibility study to design a pragmatic randomised controlled trial protocol.
BMJ Open,
11(6).
Abstract:
Getting Recovery Right After Neck Dissection (GRRAND-F): mixed-methods feasibility study to design a pragmatic randomised controlled trial protocol.
INTRODUCTION: We will evaluate the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention on pain, function and health-related quality of life following neck dissection (ND) after head and neck cancer (HNC). METHODS AND ANALYSIS: This is a pragmatic, multicentred, feasibility study. Participants are randomised to usual care (control) or usual care plus an individualised, rehabilitation programme (Getting Recovery Right After Neck Dissection, GRRAND intervention). Adults aged over 18 with HNC for whom ND is part of their care will be recruited from specialist clinics. Participants are randomised in 1:1 ratio using a web-based service. The target sample size is 60 participants. Usual care will be received by all participants during their postoperative inpatient stay consisting standard National Health Service care supplemented with a booklet advising on postoperative self-management strategies. The GRRAND intervention programme consists of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion (ROM) and progressive resistance exercises, advice and education. Between sessions participants will be advised to complete a home exercise programme. The primary outcome is to determine recruitment and retention rates from study participants across sites. Outcomes will be measured at 6 and 12 months. Participants and physiotherapists will be invited to an optional qualitative interview at the completion of their involvement in the study. The target qualitative sample size is 15 participants and 12 physiotherapists. Interviews aim to further investigate the feasibility and acceptability of the intervention and to determine wider experiences of the study design and intervention from patient and physiotherapist perspectives. ETHICS AND DISSEMINATION: Ethical approval was given on 29 October 2019 (National Research Ethics Committee Number: 19/SC/0457). Results will be reported at conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN11979997. STATUS: Trial recruitment is ongoing and is expected to be completed by 30 August 2021.
Abstract.
Author URL.
Marian IR, Goff M, Williams JAE, Gulati M, Chester-Jones M, Francis A, Watson M, Vincent TL, Woollacott S, Mackworth-Young C, et al (2021). Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial.
Pilot Feasibility Stud,
7(1).
Abstract:
Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial.
BACKGROUND: Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design. METHODS: This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60-90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study. DISCUSSION: Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference. TRIAL REGISTRATION: ISRCTN12196200 registered on 15 January 2019.
Abstract.
Author URL.
Cockayne S, Pighills A, Adamson J, Fairhurst C, Crossland S, Drummond A, Hewitt CE, Rodgers S, Ronaldson SJ, McCaffery J, et al (2021). Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.
Health Technol Assess,
25(46), 1-118.
Abstract:
Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.
BACKGROUND: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken. OBJECTIVE: to determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care. DESIGN: This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study. SETTING: Eight NHS trusts in primary and secondary care in England. PARTICIPANTS: in total, 1331 participants were randomised (intervention group, n = 430; usual-care group, n = 901) via a secure, remote service. Blinding was not possible. INTERVENTIONS: all participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist. MAIN OUTCOME MEASURES: the primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness. RESULTS: the primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38; p = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss -0.0042, 95% confidence interval -0.0041 to -0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree. LIMITATIONS: Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data. CONCLUSIONS: We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care. FUTURE WORK: an evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22202133. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 46. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Barker KL, Room J, Knight R, Dutton S, Toye F, Leal J, Kenealy N, Maia Schlüssel M, Collins G, Beard D, et al (2021). Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial.
BMJ Open,
11(8).
Abstract:
Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial.
OBJECTIVES: to evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. DESIGN: a prospective, single-blind, two-arm randomised controlled superiority trial. SETTING: 14 National Health Service physiotherapy departments in the UK. PARTICIPANTS: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. INTERVENTIONS: a multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. MAIN OUTCOME MEASURES: the primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. RESULTS: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. CONCLUSIONS: the CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. TRIAL REGISTRATION NUMBER: ISRCTN13517704.
Abstract.
Author URL.
Hee SW, Mistry D, Friede T, Lamb SE, Stallard N, Underwood M, Patel S, Repository Group (2021). Identification of subgroup effect with an individual participant data meta-analysis of randomised controlled trials of three different types of therapist-delivered care in low back pain.
BMC Musculoskelet Disord,
22(1).
Abstract:
Identification of subgroup effect with an individual participant data meta-analysis of randomised controlled trials of three different types of therapist-delivered care in low back pain.
BACKGROUND: Proven treatments for low back pain, at best, only provide modest overall benefits. Matching people to treatments that are likely to be most effective for them may improve clinical outcomes and makes better use of health care resources. METHODS: We conducted an individual participant data meta-analysis of randomised controlled trials of three types of therapist delivered interventions for low back pain (active physical, passive physical and psychological treatments). We applied two statistical methods (recursive partitioning and adaptive risk group refinement) to identify potential subgroups who might gain greater benefits from different treatments from our individual participant data meta-analysis. RESULTS: We pooled data from 19 randomised controlled trials, totalling 9328 participants. There were 5349 (57%) females with similar ratios of females in control and intervention arms. The average age was 49 years (standard deviation, SD, 14). Participants with greater psychological distress and physical disability gained most benefit in improving on the mental component scale (MCS) of SF-12/36 from passive physical treatment than non-active usual care (treatment effects, 4.3; 95% confidence interval, CI, 3.39 to 5.15). Recursive partitioning method found that participants with worse disability at baseline gained most benefit in improving the disability (Roland Morris Disability Questionnaire) outcome from psychological treatment than non-active usual care (treatment effects, 1.7; 95% CI, 1.1 to 2.31). Adaptive risk group refinement did not find any subgroup that would gain much treatment effect between psychological and non-active usual care. Neither statistical method identified any subgroups who would gain an additional benefit from active physical treatment compared to non-active usual care. CONCLUSIONS: Our methodological approaches worked well and may have applicability in other clinical areas. Passive physical treatments were most likely to help people who were younger with higher levels of disability and low levels of psychological distress. Psychological treatments were more likely to help those with severe disability. Despite this, the clinical importance of identifying these subgroups is limited. The sizes of sub-groups more likely to benefit and the additional effect sizes observed are small. Our analyses provide no evidence to support the use of sub-grouping for people with low back pain.
Abstract.
Author URL.
Cashin AG, McAuley JH, Lamb S, Hopewell S, Kamper SJ, Williams CM, Henschke N, Lee H (2021). Items for consideration in a reporting guideline for mediation analyses: a Delphi study.
BMJ Evid Based Med,
26(3).
Abstract:
Items for consideration in a reporting guideline for mediation analyses: a Delphi study.
OBJECTIVES: Mediation analysis is a widely used quantitative method for investigating how interventions and exposures in randomised controlled trials and observational studies have an effect on healthcare outcomes. This study aimed to assess the importance of items that should be considered in a consensus meeting aimed at developing a guideline for reporting mediation analyses. DESIGN: International online Delphi study. PARTICIPANTS: International experts in the development and application of mediation analysis. MAIN OUTCOME MEASURES: the Delphi panel were asked to rate the importance of a list of items for inclusion in a guideline for reporting mediation analyses. Thresholds for disagreement and consensus on importance for inclusion were specified a priori. We used the Research ANd Development/University of California Los Angeles appropriateness method to quantitatively assess the importance for inclusion and panel agreement. RESULTS: Nineteen expert panellists (10 female) from seven countries agreed to participate. All panellists contributed to all three rounds conducted between 10 June 2019 and 6 November 2019. The panel reached consensus on 34 unique reporting items for study design, analytic procedures and effect estimates, with three items rated 'optional'. Panellists added one extra item and provided 60 qualitative comments for item refinement and prioritisation. CONCLUSION: This Delphi study used a rigorous consensus process to reach consensus on 34 reporting items for studies that use mediation analysis. These results will inform a consensus meeting that will consolidate a core set of recommended items for reporting mediation analyses.
Abstract.
Author URL.
Webster RK, Bishop F, Collins GS, Evers AWM, Hoffmann T, Knottnerus JA, Lamb SE, Macdonald H, Madigan C, Napadow V, et al (2021). Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?. Journal of Clinical Epidemiology, 135, 176-181.
Ribeiro DC, Spiers K, Thomas L, Leilua K, Wilkes M, Norton S, Lamb SE (2021). Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.
BMJ Open,
11(2).
Abstract:
Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.
OBJECTIVES: to review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain. DESIGN: a review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain. METHODS: We included in our review a selection of 10 trials that were included in a Cochrane review and compared manual therapy and exercise intervention with another intervention. Trials were assessed independently by two reviewers using two checklists: the Template for Intervention Description and Replication (TIDieR) and the Health Behavior Change Consortium treatment fidelity (National Institutes of Health Behaviour Change Consortium/NIHBCC). RESULTS: TIDieR overall scores for individual trials ranged from 11.1% to 45% and fidelity scores ranged from 7% to 50%. On average, trials scored the following within each domain of NIHBCC: study design 51%; training of providers 8%; treatment delivery 15%; treatment receipt 14% and treatment enactment 2.5%. CONCLUSIONS: Little information about the monitoring, implementation and reporting of interventions was provided by trials and that is a barrier for implementing or replicating these interventions. The lack of information regarding the implementation of interventions needs to be taken into account when assessing whether effectiveness of interventions was impacted by their design or due to deviations from the protocol within trials.
Abstract.
Author URL.
Hopewell S, Keene DJ, Marian IR, Dritsaki M, Heine P, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, et al (2021). Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.
Lancet,
398(10298), 416-428.
Abstract:
Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.
BACKGROUND: Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. METHODS: in this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28. FINDINGS: Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference -0·66 [99% CI -4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (-1·11 [-4·47 to 2·26]). No serious adverse events were reported. INTERPRETATION: Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders. FUNDING: UK National Institute for Health Research Technology Assessment Programme.
Abstract.
Author URL.
Hopewell S, Keene DJ, Heine P, Marian IR, Dritsaki M, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, et al (2021). Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.
Health Technology Assessment,
25(48), 1-158.
Abstract:
Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT
. Background
. Rotator cuff-related shoulder pain is very common, but there is uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits of corticosteroid injections.
.
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. Objectives
. To assess the clinical effectiveness and cost-effectiveness of progressive exercise compared with best-practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.
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. Design
. This was a pragmatic multicentre superiority randomised controlled trial (with a 2 × 2 factorial design).
.
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. Setting
. Twenty NHS primary care-based musculoskeletal and related physiotherapy services.
.
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. Participants
. Adults aged ≥ 18 years with a new episode of rotator cuff-related shoulder pain in the previous 6 months.
.
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. Interventions
. A total of 708 participants were randomised (March 2017–May 2019) by a centralised computer-generated 1 : 1 : 1 : 1 allocation ratio to one of four interventions: (1) progressive exercise (n = 174) (six or fewer physiotherapy sessions), (2) best-practice advice (n = 174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise (n = 182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice (n = 178) (one physiotherapy session).
.
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. Main outcome measures
. The primary outcome was Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes included SPADI subdomains, the EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, pain self-efficacy, return to activity, Global Impression of Treatment and health resource use. Outcomes were collected by postal questionnaires at 8 weeks and at 6 and 12 months. A within-trial economic evaluation was also conducted. The primary analysis was intention to treat.
.
.
. Results
. Participants had a mean age of 55.5 (standard deviation 13.1) years and 49.3% were female. The mean baseline SPADI score was 54.1 (standard deviation 18.5). Follow-up rates were 91% at 8 weeks and 87% at 6 and 12 months. There was an overall improvement in SPADI score from baseline in each group over time. Over 12 months, there was no evidence of a difference in the SPADI scores between the progressive exercise intervention and the best-practice advice intervention in shoulder pain and function (adjusted mean difference between groups over 12 months –0.66, 99% confidence interval –4.52 to 3.20). There was also no difference in SPADI scores between the progressive exercise intervention and best-practice advice intervention when analysed at the 8-week and 6- and 12-month time points. Injection resulted in improvement in shoulder pain and function at 8 weeks compared with no injection (adjusted mean difference –5.64, 99% confidence interval –9.93 to –1.35), but not when analysed over 12 months (adjusted mean difference –1.11, 99% confidence interval –4.47 to 2.26), or at 6 and 12 months. There were no serious adverse events. In the base-case analysis, adding injection to best-practice advice gained 0.021 quality-adjusted life-years (p = 0.184) and increased the cost by £10 per participant (p = 0.747). Progressive exercise alone was £52 (p = 0.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs (p = 0.220). At a ceiling ratio of £20,000 per quality-adjusted life-year, injection plus best-practice advice had a 54.93% probability of being the most cost-effective treatment.
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. Limitations
. Participants and physiotherapists were not blinded to group allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns.
.
.
. Conclusions
. Progressive exercise was not superior to a best-practice advice session with a physiotherapist. Subacromial corticosteroid injection improved shoulder pain and function, but provided only modest short-term benefit. Best-practice advice in combination with corticosteroid injection was expected to be most cost-effective, although there was substantial uncertainty.
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. Future work
. Longer-term follow-up, including any serious adverse effects of corticosteroid injection.
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. Trial registration
. Current Controlled Trials ISRCTN16539266 and EudraCT 2016-002991-28.
.
.
. Funding
. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.
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Abstract.
Seppala LJ, Kamkar N, Ryg J, Masud T, Daams J, Montero-Odasso MM, Hartikainen S, Petrovic M, van der Velde N, Falls TFGG, et al (2021). Protocol for a systematic review and meta-analysis assessing the effectiveness of deprescribing in falls prevention in older people.
BMJ OPEN,
11(11).
Author URL.
Hauer K, Ullrich P, Heldmann P, Bauknecht L, Hummel S, Abel B, Bauer JM, Lamb SE, Werner C (2021). Psychometric properties of the proxy-reported life-space assessment in institutionalized settings (Lsa-is-proxy) for older persons with and without cognitive impairment.
International Journal of Environmental Research and Public Health,
18(8).
Abstract:
Psychometric properties of the proxy-reported life-space assessment in institutionalized settings (Lsa-is-proxy) for older persons with and without cognitive impairment
(1) Background: Life-space mobility assessments for institutionalized settings are scarce and there is a lack of comprehensive validation and focus on persons with cognitive impairment (CI). This study aims to evaluate the psychometric properties of the Life-Space Assessment for Institutionalized Settings by proxy informants (LSA-IS-proxy) for institutionalized, older persons, with and without CI. (2) Methods: Concurrent validity against the self-reported version of the LSA-IS, construct validity with established construct variables, test-retest reliability, sensitivity to change during early multidisciplinary geriatric rehabilitation treatment, and feasibility (completion rate, floor/ceiling effects) of the LSA-IS-proxy, were assessed in 94 hospitalized geriatric patients (83.3 ± 6.1 years), with and without CI. (3) Results: the LSA-IS-proxy total score showed good-to-excellent agreement with the self-reported LSA-IS (Intraclass Correlations Coefficient, ICC3,1 = 0.77), predominantly expected small-to-high correlations with construct variables (r = 0.21–0.59), good test–retest reliability (ICC3,1 = 0.74), significant sensitivity to change over the treatment period (18.5 ± 7.9 days; p < 0.001, standardized response mean = 0.44), and excellent completion rates (100%) with no floor/ceiling effects. These results were predominantly confirmed for the sub-scores of the LSA-IS-proxy and were comparable between the sub-groups with different cognitive status. (4) Conclusions: the LSA-IS-proxy has proven to be feasible, valid, reliable, and sensitive to change in hospitalized, geriatric patients with and without CI.
Abstract.
Lee H, Lamb SE (2021). Research Note: Transporting causal effects from randomised trials to target populations to improve external validity. Journal of Physiotherapy, 67(4), 315-318.
Nicolson PJA, Sanchez-Santos MT, Bruce J, Kirtley S, Ward L, Williamson E, Lamb SE (2021). Risk Factors for Mobility Decline in Community-Dwelling Older Adults: a Systematic Literature Review.
J Aging Phys Act,
29(6), 1053-1066.
Abstract:
Risk Factors for Mobility Decline in Community-Dwelling Older Adults: a Systematic Literature Review.
Mobility is essential to maintaining independence for older adults. This systematic review aimed to summarize evidence about self-reported risk factors for self-reported mobility decline; and to provide an overview of published prognostic models for self-reported mobility decline among community-dwelling older adults. Databases were searched from inception to June 2, 2020. Studies were screened by two independent reviewers who extracted data and assessed study quality. Sixty-one studies (45,187 participants) were included, providing information on 107 risk factors. High-quality evidence and moderate/large effect sizes for the association with mobility decline were found for older age beyond 75 years, the presence of widespread pain, and mobility modifications. Moderate-high quality evidence and small effect sizes were found for a further 21 factors. Three model development studies demonstrated acceptable model performance, limited by high risk of bias. These findings should be considered in intervention development, and in developing a prediction instrument for practical application.
Abstract.
Author URL.
Ooms A, Dutton SJ, Parsons S, Fordham B, Hing C, Lamb S, Smith T (2021). Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial.
Trials,
22(1).
Abstract:
Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial.
BACKGROUND: Total hip (THR) and total knee replacements (TKR) are two highly successful orthopaedic procedures that reduce pain for people with osteoarthritis. Previous evidence suggests that physical activity, at best, remains the same pre- to post-operatively, and in some instances declines. The PEP-TALK trial evaluates the effects of a group-based, behaviour change intervention on physical activity following a THR or TKR. METHODS: PEP-TALK is an open, phase III, pragmatic, multi-centre, parallel, two-arm, two-way superiority randomised controlled trial investigating the effectiveness of usual care plus a behaviour change therapy compared with usual care alone following primary THR or TKR. The primary outcome is the UCLA Activity Score at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes measured at 6 months and 12 months after randomisation include the UCLA Activity Score, Lower Extremity Functional Scale, Oxford Hip/Knee Score, Numerical Rating Scale for Pain, Generalised Self-Efficacy Scale, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression Scale, EuroQoL EQ-5D-5L index and EQ-VAS and complications or adverse events. Full details of the planned analysis approaches for the primary and secondary outcomes, as well as the planned sensitivity analyses to be undertaken due to the COVID-19 pandemic, are described here. The PEP-TALK study protocol has been published previously. DISCUSSION: This paper provides details of the planned statistical analyses for the PEP-TALK trial. This is aimed to reduce the risk of outcome reporting bias and enhance transparency in reporting. TRIAL REGISTRATION: International Standard Randomised Controlled Trials database, ISRCTN Number: 29770908. Registered on October 2018.
Abstract.
Author URL.
Williamson E, Sanchez Santos MT, Morris A, Garrett A, Conway O, Boniface G, Fairbank J, Lamb SE (2021). The Prevalence of Back and Leg Pain and the Cross-sectional Association with Adverse Health Outcomes in Community Dwelling Older Adults in England.
Spine (Phila Pa 1976),
46(1), 54-61.
Abstract:
The Prevalence of Back and Leg Pain and the Cross-sectional Association with Adverse Health Outcomes in Community Dwelling Older Adults in England.
STUDY DESIGN: Cross-sectional analysis of the Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study. OBJECTIVE: the aim of this study was to assess the prevalence of back pain (BP) and leg pain and determine their relationship with adverse health states among older adults in England. SUMMARY OF BACKGROUND DATA: Epidemiological data describing the prevalence of BP and leg pain in older adults in England is lacking. METHODS: a total of 5304 community-dwelling adults (aged 65-100 years) enrolled in the OPAL cohort study who provided data on BP and leg pain were included. Participants were classified into four groups based on reports of back and leg pain: no BP, BP only, BP and leg pain which was likely to be neurogenic claudication (NC), and BP and leg pain which was not NC. Adverse health states were frailty, falls, mobility decline, low walking confidence, poor sleep quality, and urinary incontinence. We collected demographic and socioeconomic information, health-related quality of life, and existing health conditions, and estimated the association between BP presentations and adverse health states using regression analysis. RESULTS: Thirty-four percent of participants (1786/5304) reported BP only, 11.2% (n = 594/5304) reported BP and NC and 8.3% (n = 441/5304) reported BP and non-NC leg pain. Participants with BP had worse quality of life compared to those without BP. All BP presentations were significantly associated with adverse health states. Those with NC were most affected. In particular, there was greater relative risk (RR) of low walking confidence (RR 3.11, 95% confidence interval [CI] 2.56-3.78), frailty (RR 1.88, 95% CI 1.67-2.11), and mobility decline (RR 1.74, 95% CI 1.54-1.97) compared to no BP. CONCLUSION: Back and leg pain is a common problem for older adults and associated with reduced quality of life and adverse health states. Findings suggest a need to develop more effective treatment for older adults with BP especially for those with neurogenic claudication. LEVEL OF EVIDENCE: 2.
Abstract.
Author URL.
Masoli M, Lanario JW, Hyland ME, Menzies-Gow A, Mansur AH, Allen D, Dodd JW, Hayes G, Valderas JM, Lamb SE, et al (2021). The Severe Asthma Questionnaire: sensitivity to change and minimal clinically important difference. European Respiratory Journal, 57(6), 2100300-2100300.
Fordham B, Sugavanam T, Edwards K, Stallard P, Howard R, das Nair R, Copsey B, Lee H, Howick J, Hemming K, et al (2021). The evidence for cognitive behavioural therapy in any condition, population or context: a meta-review of systematic reviews and panoramic meta-analysis.
Psychol Med,
51(1), 21-29.
Abstract:
The evidence for cognitive behavioural therapy in any condition, population or context: a meta-review of systematic reviews and panoramic meta-analysis.
The majority of psychological treatment research is dedicated to investigating the effectiveness of cognitive behavioural therapy (CBT) across different conditions, population and contexts. We aimed to summarise the current systematic review evidence and evaluate the consistency of CBT's effect across different conditions. We included reviews of CBT randomised controlled trials in any: population, condition, format, context, with any type of comparator and published in English. We searched DARE, Cochrane, MEDLINE, EMBASE, PsycINFO, CINAHL, CDAS, and OpenGrey between 1992 and January 2019. Reviews were quality assessed, their data extracted and summarised. The effects upon health-related quality of life (HRQoL) were pooled, within-condition groups. If the across-condition heterogeneity was I2 < 75%, we pooled effects using a random-effect panoramic meta-analysis. We summarised 494 reviews (221 128 participants), representing 14/20 physical and 13/20 mental conditions (World Health Organisation's International Classification of Diseases). Most reviews were lower-quality (351/494), investigated face-to-face CBT (397/494), and in adults (378/494). Few reviews included trials conducted in Asia, South America or Africa (45/494). CBT produced a modest benefit across-conditions on HRQoL (standardised mean difference 0.23; 95% confidence intervals 0.14-0.33, I2 = 32%). The effect's associated prediction interval -0.05 to 0.50 suggested CBT will remain effective in conditions for which we do not currently have available evidence. While there remain some gaps in the completeness of the evidence base, we need to recognise the consistent evidence for the general benefit which CBT offers.
Abstract.
Author URL.
Prats-Uribe A, Kolovos S, Berencsi K, Carr A, Judge A, Silman A, Arden N, Petersen I, Douglas IJ, Wilkinson JM, et al (2021). Unicompartmental compared with total knee replacement for patients with multimorbidities: a cohort study using propensity score stratification and inverse probability weighting.
Health Technol Assess,
25(66), 1-126.
Abstract:
Unicompartmental compared with total knee replacement for patients with multimorbidities: a cohort study using propensity score stratification and inverse probability weighting.
BACKGROUND: Although routine NHS data potentially include all patients, confounding limits their use for causal inference. Methods to minimise confounding in observational studies of implantable devices are required to enable the evaluation of patients with severe systemic morbidity who are excluded from many randomised controlled trials. OBJECTIVES: Stage 1 - replicate the Total or Partial Knee Arthroplasty Trial (TOPKAT), a surgical randomised controlled trial comparing unicompartmental knee replacement with total knee replacement using propensity score and instrumental variable methods. Stage 2 - compare the risk benefits and cost-effectiveness of unicompartmental knee replacement with total knee replacement surgery in patients with severe systemic morbidity who would have been ineligible for TOPKAT using the validated methods from stage 1. DESIGN: This was a cohort study. SETTING: Data were obtained from the National Joint Registry database and linked to hospital inpatient (Hospital Episode Statistics) and patient-reported outcome data. PARTICIPANTS: Stage 1 - people undergoing unicompartmental knee replacement surgery or total knee replacement surgery who met the TOPKAT eligibility criteria. Stage 2 - participants with an American Society of Anesthesiologists grade of ≥ 3. INTERVENTION: the patients were exposed to either unicompartmental knee replacement surgery or total knee replacement surgery. MAIN OUTCOME MEASURES: the primary outcome measure was the postoperative Oxford Knee Score. The secondary outcome measures were 90-day postoperative complications (venous thromboembolism, myocardial infarction and prosthetic joint infection) and 5-year revision risk and mortality. The main outcome measures for the health economic analysis were health-related quality of life (EuroQol-5 Dimensions) and NHS hospital costs. RESULTS: in stage 1, propensity score stratification and inverse probability weighting replicated the results of TOPKAT. Propensity score adjustment, propensity score matching and instrumental variables did not. Stage 2 included 2256 unicompartmental knee replacement patients and 57,682 total knee replacement patients who had severe comorbidities, of whom 145 and 23,344 had linked Oxford Knee Scores, respectively. A statistically significant but clinically irrelevant difference favouring unicompartmental knee replacement was observed, with a mean postoperative Oxford Knee Score difference of
Abstract.
Author URL.
Hulbert S, Chivers-Seymour K, Summers R, Lamb S, Goodwin V, Rochester L, Nieuwboer A, Rowsell A, Ewing S, Ashburn A, et al (2021). ‘PDSAFE’ - a multi-dimensional model of falls-rehabilitation for people with Parkinson’s. A mixed methods analysis of therapists’ delivery and experience. Physiotherapy, 110, 77-84.
Smith TO, Parsons S, Fordham B, Ooms A, Dutton S, Hing C, Barber VS, Png ME, Lamb S, PEP-TALK Trial Collaborators, et al (2020). Behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement (PEP-TALK): study protocol for a pragmatic randomised controlled trial.
BMJ Open,
10(7).
Abstract:
Behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement (PEP-TALK): study protocol for a pragmatic randomised controlled trial.
INTRODUCTION: While total hip replacement (THR) and total knee replacement (TKR) successfully reduce pain associated with chronic joint pathology, this infrequently translates into increased physical activity. This is a challenge given that over 50% of individuals who undergo these operations are physically inactive and have medical comorbidities such as hypertension, heart disease, diabetes and depression. The impact of these diseases can be reduced with physical activity. This trial aims to investigate the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after THR or TKR. METHODS AND ANALYSIS: the PEP-TALK trial is a multicentre, open-labelled, pragmatic randomised controlled trial. 260 adults who are scheduled to undergo a primary unilateral THR or TKR and are moderately inactive or inactive, with comorbidities, will be recruited across eight sites in England. They will be randomised post-surgery, prior to hospital discharge, to either six, 30 min weekly group-based exercise sessions (control), or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour approach discussion group. Participants will be followed-up to 12 months by postal questionnaire. The primary outcome is the University of California, Los Angeles (UCLA) Physical Activity Score at 12 months. Secondary outcomes include: physical function, disability, health-related quality of life, kinesiophobia, perceived pain, self-efficacy and health resource utilisation. ETHICS AND DISSEMINATION: Research ethics committee approval was granted by the NRES Committee South Central (Oxford B - 18/SC/0423). Dissemination of results will be through peer-reviewed, scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN29770908.
Abstract.
Author URL.
Marian IR, Williamson E, Garrett A, Lamb SE, Dutton SJ (2020). Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.
Trials,
21(1).
Abstract:
Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.
BACKGROUND: Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial. METHODS/DESIGN: BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol. DISCUSSION: the planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. TRIAL REGISTRATION: This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674. Registered on 10 November 2015.
Abstract.
Author URL.
Sanchez Santos MT, Williamson E, Bruce J, Ward L, Mallen CD, Garrett A, Morris A, Lamb SE, OPAL study team (2020). Cohort profile: Oxford Pain, Activity and Lifestyle (OPAL) Study, a prospective cohort study of older adults in England.
BMJ Open,
10(9).
Abstract:
Cohort profile: Oxford Pain, Activity and Lifestyle (OPAL) Study, a prospective cohort study of older adults in England.
PURPOSE: the 'Oxford Pain, Activity and Lifestyle' (OPAL) Cohort is a longitudinal, prospective cohort study of adults, aged 65 years and older, living in the community which is investigating the determinants of health in later life. Our focus was on musculoskeletal pain and mobility, but the cohort is designed with flexibility to include new elements over time. This paper describes the study design, data collection and baseline characteristics of participants. We also compared the OPAL baseline characteristics with nationally representative data sources. PARTICIPANTS: We randomly selected eligible participants from two stratified age bands (65-74 and 75 and over years). In total, 5409 individuals (42.1% of eligible participants) from 35 general practices in England agreed to participate between 2016 and 2018. The majority of participants (n=5367) also consented for research team to access their UK National Health Service (NHS) Digital and primary healthcare records. FINDINGS TO DATE: Mean participant age was 74.9 years (range 65-100); 51.5% (n=2784/5409) were women. 94.9% of participants were white, and 28.8% lived alone. Over 83.0% reported pain in at least one body area in the previous 6 weeks. Musculoskeletal symptoms were more prevalent in women (86.4%). One-third of participants reported having one or more falls in the last year. Most participants were confident in their ability to walk outside. The characteristics of OPAL Cohort participants were broadly similar to the general population of the same age. FUTURE PLANS: Postal follow-up of the cohort is being undertaken at annual intervals, with data collection ongoing. Linkage to NHS hospital admission data is planned. This English prospective cohort offers a large and rich resource for research on the longitudinal associations between demographic, clinical, and social factors and health trajectories and outcomes in community-dwelling older people.
Abstract.
Author URL.
Davies L, Cook J, Leal J, Areia CM, Shirkey B, Jackson W, Campbell H, Fletcher H, Carr A, Barker K, et al (2020). Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.
Trials,
21(1).
Abstract:
Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.
BACKGROUND: Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. The objective of the ACL SNNAP trial is to determine in patients with non-acute anterior cruciate ligament deficiency (ACLD) whether a strategy of non-surgical management (rehabilitation) (with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction) without prior rehabilitation with all patients followed up at 18 months. METHODS: the study is a pragmatic, multi-centre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Patients with a symptomatic non-acute ACL deficient knee will be randomised to either non-surgical management (rehabilitation) or surgical management (reconstruction). We aim to recruit 320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom. Randomisation will occur using a web-based randomisation system. Blinding of patients and clinicians to treatment allocation will not be possible because of the nature of the interventions. Participants will be followed up via self-reported questionnaires at 6, 12 and 18 months. The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 18 months post randomisation. Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage. DISCUSSION: at present, no evidence-based treatment of non-acute ACL deficiency exists, particularly in the NHS. Moreover, little consensus exists on the management approach for these patients. The proposed trial will address this gap in knowledge regarding the clinical and cost effectiveness of ACL treatment and inform future standards of care for this condition. TRIAL REGISTRATION: ISRCTN: 10110685. Registered on 16 November 2016. ClinicalTrials.gov: NCT02980367. Registered in December 2016.
Abstract.
Author URL.
Tonga E, Srikesavan C, Williamson E, Lamb SE (2020). Components, design and effectiveness of digital physical rehabilitation interventions for older people: a systematic review.
Journal of Telemedicine and Telecare,
28(3), 162-176.
Abstract:
Components, design and effectiveness of digital physical rehabilitation interventions for older people: a systematic review
Background with the rapid advancement in digital technologies, the use of digital health applications is increasing day by day. Although a large number of digital applications have been developed for rehabilitation of older people, there has been no review of the evidence for effectiveness of these interventions. Methods the aim of our study was to review the evidence of digital rehabilitation interventions on outcomes including pain, function and quality of life in older people. We focused on digital interventions that are designed to improve and restore physical functioning. We searched six electronic bibliographic databases and included randomised controlled trials. Cochrane risk of bias tool and Cochrane’s Grading of Recommendations, Assessment, Development and Evaluation approach was used to evaluate the risk of bias and grade the evidence. Results Eight trials were included. The short-term effects of digital rehabilitation interventions on physical activity, quality of life, vertigo symptoms and falls are uncertain. Quality of trials was rated as very low to moderate evidence. Conclusion More research is needed to estimate effectiveness of these interventions.
Abstract.
Achana F, Petrou S, Madan J, Khan K, Ji C, Hossain A, Lall R, Slowther A-M, Deakin CD, Quinn T, et al (2020). Cost-effectiveness of adrenaline for out-of-hospital cardiac arrest.
Crit Care,
24(1).
Abstract:
Cost-effectiveness of adrenaline for out-of-hospital cardiac arrest.
BACKGROUND: the 'Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest' (PARAMEDIC2) trial showed that adrenaline improves overall survival, but not neurological outcomes. We sought to determine the within-trial and lifetime health and social care costs and benefits associated with adrenaline, including secondary benefits from organ donation. METHODS: We estimated the costs, benefits (quality-adjusted life years (QALYs)) and incremental cost-effectiveness ratios (ICERs) associated with adrenaline during the 6-month trial follow-up. Model-based analyses explored how results altered when the time horizon was extended beyond 6 months and the scope extended to include recipients of donated organs. RESULTS: the within-trial (6 months) and lifetime horizon economic evaluations focussed on the trial population produced ICERs of £1,693,003 (€1,946,953) and £81,070 (€93,231) per QALY gained in 2017 prices, respectively, reflecting significantly higher mean costs and only marginally higher mean QALYs in the adrenaline group. The probability that adrenaline is cost-effective was less than 1% across a range of cost-effectiveness thresholds. Combined direct economic effects over the lifetimes of survivors and indirect economic effects in organ recipients produced an ICER of £16,086 (€18,499) per QALY gained for adrenaline with the probability that adrenaline is cost-effective increasing to 90% at a £30,000 (€34,500) per QALY cost-effectiveness threshold. CONCLUSIONS: Adrenaline was not cost-effective when only directly related costs and consequences are considered. However, incorporating the indirect economic effects associated with transplanted organs substantially alters cost-effectiveness, suggesting decision-makers should consider the complexity of direct and indirect economic impacts of adrenaline. TRIAL REGISTRATION: ISRCTN73485024. Registered on 13 March 2014.
Abstract.
Author URL.
Xin Y, Ashburn A, Pickering RM, Seymour KC, Hulbert S, Fitton C, Kunkel D, Marian I, Roberts HC, Lamb SE, et al (2020). Cost-effectiveness of the PDSAFE personalised physiotherapy intervention for fall prevention in Parkinson's: an economic evaluation alongside a randomised controlled trial.
BMC Neurology,
20(1).
Abstract:
Cost-effectiveness of the PDSAFE personalised physiotherapy intervention for fall prevention in Parkinson's: an economic evaluation alongside a randomised controlled trial
Background: PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective. Methods: Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap. Results: over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold. Conclusions: Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic. Trial registration: ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791.
Abstract.
Keene DJ, Soutakbar H, Hopewell S, Heine P, Jaggi A, Littlewood C, Hansen Z, Barker K, Hamilton W, Carr AJ, et al (2020). Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the ‘Getting it Right: Addressing Shoulder Pain’ (GRASP) trial.
Physiotherapy (United Kingdom),
107, 252-266.
Abstract:
Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the ‘Getting it Right: Addressing Shoulder Pain’ (GRASP) trial
Objectives: the Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2 × 2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions. Methods: Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service. Results: Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. Conclusion: GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020. Trial registration number: ISRCTN16539266; EudraCT number:2016-002991-28.
Abstract.
Cashin AG, McAuley JH, Lamb SE, Hopewell S, Kamper SJ, Williams CM, Henschke N, Lee H (2020). Development of a Guideline for Reporting Mediation Analyses (AGReMA).
BMC Med Res Methodol,
20(1).
Abstract:
Development of a Guideline for Reporting Mediation Analyses (AGReMA).
BACKGROUND: There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). METHODS/DESIGN: AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve the production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. DISCUSSION: the development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.
Abstract.
Author URL.
Jayakumar P, Teunis T, Vranceanu AM, Lamb S, Ring D, Gwilym S (2020). Early Psychological and Social Factors Explain the Recovery Trajectory After Distal Radial Fracture.
J Bone Joint Surg Am,
102(9), 788-795.
Abstract:
Early Psychological and Social Factors Explain the Recovery Trajectory After Distal Radial Fracture.
BACKGROUND: This prospective study identified the association of demographic, injury, psychological, and social variables, measured early during recovery, with limitations in function (measured by the Patient-Reported Outcomes Measurement Information System Upper Extremity Physical Function Computer Adaptive Test [PROMIS UE]) at 6 to 9 months after a distal radial fracture. Additionally, we assessed variables associated with the PROMIS UE; the abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); the Patient-Rated Wrist Evaluation (PRWE); and the 3-Level EuroQol 5 Dimensions Index (EQ-5D-3L) over time. METHODS: a total of 364 adult patients (73% female), with a median age of 65 years (interquartile range, 45.5 to 77 years), who sustained an isolated distal radial fracture completed questionnaires at 3 time periods after the fracture: within 1 week, between 2 and 4 weeks, and between 6 and 9 months. We created a multivariable regression model and a generalized least squares random effects model, accounting for multicollinearity using correlation matrices, the variable inflation factor, and the partial R. RESULTS: Multiple variables within a week of the injury correlated with 6 to 9-month limitations in bivariate analysis. Being retired (partial R = 0.19; p < 0.001), using opioids after the fracture (partial R = 0.04; p < 0.001), using antidepressants (partial R = 0.11; p < 0.001), greater pain interference (partial R = 0.03; p = 0.001), and greater pain catastrophization (partial R = 0.04; p = 0.002) within 1 week of the injury were strong predictors of greater limitations (PROMIS UE) at 6 to 9 months in multivariable analysis. Longitudinal analysis of variables over time demonstrated greater pain interference, greater fear of movement, lower self-efficacy, older age, and female sex as strong predictors of limitations. CONCLUSIONS: Recovery from a distal radial fracture is influenced by a series of demographic, psychological, and social variables. of these factors, being retired, using opioids, using antidepressants, greater pain interference, and greater pain catastrophization within a week of the injury explain the largest amounts of unique variance in self-perceived upper-extremity physical function. Evaluating the impact of change in variables over time underlined the influence of pain interference as well as the influence of fear of movement and self-efficacy (or resiliency) on limitations in physical function and general health. These findings have important implications for identifying individuals who can benefit from behavioral interventions for these psychological factors to optimize recovery. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Abstract.
Author URL.
Jayakumar P, Teunis T, Vranceanu AM, Lamb S, Ring D, Gwilym S (2020). Early Psychological and Social Factors Explain the Recovery Trajectory After Distal Radial Fracture.
J Bone Joint Surg AmAbstract:
Early Psychological and Social Factors Explain the Recovery Trajectory After Distal Radial Fracture.
BACKGROUND: This prospective study identified the association of demographic, injury, psychological, and social variables, measured early during recovery, with limitations in function (measured by the Patient-Reported Outcomes Measurement Information System Upper Extremity Physical Function Computer Adaptive Test [PROMIS UE]) at 6 to 9 months after a distal radial fracture. Additionally, we assessed variables associated with the PROMIS UE; the abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); the Patient-Rated Wrist Evaluation (PRWE); and the 3-Level EuroQol 5 Dimensions Index (EQ-5D-3L) over time. METHODS: a total of 364 adult patients (73% female), with a median age of 65 years (interquartile range, 45.5 to 77 years), who sustained an isolated distal radial fracture completed questionnaires at 3 time periods after the fracture: within 1 week, between 2 and 4 weeks, and between 6 and 9 months. We created a multivariable regression model and a generalized least squares random effects model, accounting for multicollinearity using correlation matrices, the variable inflation factor, and the partial R. RESULTS: Multiple variables within a week of the injury correlated with 6 to 9-month limitations in bivariate analysis. Being retired (partial R = 0.19; p < 0.001), using opioids after the fracture (partial R = 0.04; p < 0.001), using antidepressants (partial R = 0.11; p < 0.001), greater pain interference (partial R = 0.03; p = 0.001), and greater pain catastrophization (partial R = 0.04; p = 0.002) within 1 week of the injury were strong predictors of greater limitations (PROMIS UE) at 6 to 9 months in multivariable analysis. Longitudinal analysis of variables over time demonstrated greater pain interference, greater fear of movement, lower self-efficacy, older age, and female sex as strong predictors of limitations. CONCLUSIONS: Recovery from a distal radial fracture is influenced by a series of demographic, psychological, and social variables. of these factors, being retired, using opioids, using antidepressants, greater pain interference, and greater pain catastrophization within a week of the injury explain the largest amounts of unique variance in self-perceived upper-extremity physical function. Evaluating the impact of change in variables over time underlined the influence of pain interference as well as the influence of fear of movement and self-efficacy (or resiliency) on limitations in physical function and general health. These findings have important implications for identifying individuals who can benefit from behavioral interventions for these psychological factors to optimize recovery. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Abstract.
Author URL.
Smith TO, Gilbert AW, Sreekanta A, Sahota O, Griffin XL, Cross JL, Fox C, Lamb SE (2020). Enhanced rehabilitation and care models for adults with dementia following hip fracture surgery.
Cochrane Database of Systematic Reviews,
2020(2).
Abstract:
Enhanced rehabilitation and care models for adults with dementia following hip fracture surgery
Background: Hip fracture is a major injury that causes significant problems for affected individuals and their family and carers. Over 40% of people with hip fracture have dementia or cognitive impairment. The outcomes of these individuals after surgery are poorer than for those without dementia. It is unclear which care and rehabilitation interventions achieve the best outcomes for these people. This is an update of a Cochrane Review first published in 2013. Objectives: (a) to assess the effectiveness of models of care including enhanced rehabilitation strategies designed specifically for people with dementia following hip fracture surgery compared to usual care. (b) to assess for people with dementia the effectiveness of models of care including enhanced rehabilitation strategies that are designed for all older people, regardless of cognitive status, following hip fracture surgery, compared to usual care. Search methods: We searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group Specialised Register, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 16 October 2019. Selection criteria: We included randomised and quasi-randomised controlled trials evaluating the effectiveness of any model of enhanced care and rehabilitation for people with dementia after hip fracture surgery compared to usual care. Data collection and analysis: Two review authors independently selected trials for inclusion and extracted data. We assessed risk of bias of the included trials. We synthesised data only if we considered the trials to be sufficiently homogeneous in terms of participants, interventions, and outcomes. We used the GRADE approach to rate the overall certainty of evidence for each outcome. Main results: We included seven trials with a total of 555 participants. Three trials compared models of enhanced care in the inpatient setting with conventional care. Two trials compared an enhanced care model provided in inpatient settings and at home after discharge with conventional care. Two trials compared geriatrician-led care in-hospital to conventional care led by the orthopaedic team. None of the interventions were designed specifically for people with dementia, therefore the data included in the review were from subgroups of people with dementia or cognitive impairment participating in randomised controlled trials investigating models of care for all older people following hip fracture. The end of follow-up in the trials ranged from the point of acute hospital discharge to 24 months after discharge. We considered all trials to be at high risk of bias in more than one domain. As subgroups of larger trials, the analyses lacked power to detect differences between the intervention groups. Furthermore, there were some important differences in baseline characteristics of participants between the experimental and control groups. Using the GRADE approach, we downgraded the certainty of the evidence for all outcomes to low or very low. The effect estimates for almost all comparisons were very imprecise, and the overall certainty for most results was very low. There were no data from any study for our primary outcome of health-related quality of life. There was only very low certainty for our other primary outcome, activities of daily living and functional performance, therefore we were unable to draw any conclusions with confidence. There was low-certainty that enhanced care and rehabilitation in-hospital may reduce rates of postoperative delirium (odds ratio 0.04, 95% confidence interval (CI) 0.01 to 0.22, 2 trials, n = 141) and very low-certainty associating it with lower rates of some other complications. There was also low-certainty that, compared to orthopaedic-led management, geriatrician-led management may lead to shorter hospital stays (mean difference 4.00 days, 95% CI 3.61 to 4.39, 1 trial, n = 162). Authors' conclusions: We found limited evidence that some of the models of enhanced rehabilitation and care used in the included trials may show benefits over usual care for preventing delirium and reducing length of stay for people with dementia who have been treated for hip fracture. However, the certainty of these results is low. Data were available from only a small number of trials, and the certainty for all other results is very low. Determining the optimal strategies to improve outcomes for this growing population of patients should be a research priority.
Abstract.
Hall A, Richmond H, Bursey K, Hansen Z, Williamson E, Copsey B, Albury C, Asghari S, Curran V, Pike A, et al (2020). Evaluating the impact of a champion on implementation of the Back Skills Training (BeST) programme in Canada: a mixed methods feasibility study protocol.
BMJ Open,
10(11).
Abstract:
Evaluating the impact of a champion on implementation of the Back Skills Training (BeST) programme in Canada: a mixed methods feasibility study protocol
Introduction There is global recognition that low back pain (LBP) should be managed with a biopsychosocial approach. Previous implementation of this approach resulted in low uptake and highlighted the need for ongoing support. This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation. Methods a pragmatic cluster RCT with embedded qualitative study with physiotherapists treating LBP in publicly funded physiotherapy departments in Newfoundland and Labrador, Canada. Participants will complete a previously developed online training course to equip them to deliver a biopsychosocial intervention for LBP. Clusters randomised to the intervention arm will receive additional support from a champion. A minimum champion training package has been developed based on known barriers in the literature. This includes strategies to target barriers relating to group-based scheduling issues, lack of managerial support, perceived patient factors such as addressing patient expectations for other types of treatments or selecting which patients might be best suited for this intervention, and anxiety about delivering something new. This package will be further codeveloped with study champions based on identified implementation barriers using the Behaviour Change Wheel. Clusters will be monitored for 6 months to assess champion and physiotherapist recruitment and retention, acceptability and implementation of the champion training, and the viability of conducting a cluster RCT in this setting. A purposive sample of physiotherapists will be interviewed from both arms. Ethics and dissemination This study was approved by Newfoundland and Labrador Health Research Ethics Authority in December 2018. Results will be disseminated to academic audiences through conferences and peer reviewed publications; to all study participants, their clinical leads, and patients with LBP.
Abstract.
Sugavanam T, Williamson E, Fordham B, Hansen Z, Richmond H, Hall A, Ali U, Copsey B, Lamb SE (2020). Evaluation of the implementation of the Back Skills Training (BeST) programme using online training: a cohort implementation study.
Physiotherapy (United Kingdom),
109, 4-12.
Abstract:
Evaluation of the implementation of the Back Skills Training (BeST) programme using online training: a cohort implementation study
Objectives: 1) Evaluate implementation of the Back Skills Training (BeST) programme, a group cognitive behavioural approach for patients with low back pain (LBP) developed for a clinical trial, into the National Health Service (NHS) in the United Kingdom; 2) Compare patient outcomes with the BeST Trial results. Design: Two stage observational cohort implementation study. Participants: Stage 1: NHS Clinicians enrolled in BeST online training. Stage 2: Patients with LBP attending NHS physiotherapy departments and enrolled in the BeST programme. Intervention: an online training and implementation programme. Outcomes: Stage 1: LBP attitudes and beliefs, self-rated competence, intention and actual implementation were collected before, immediately, 4- and 12-months post-training. Stage 2: Patients rated pain, function, recovery and satisfaction before and up to one year after attending the BeST programme. Results: Stage 1: 1324 clinicians (157 NHS Trusts) enrolled in the training; 586 (44%) clinicians (101 NHS Trusts) completed training; 443/586 (76%) clinicians provided post-training data; 253/443 (57%) clinicians intended to implement the programme; 148/381 (39%) clinicians (54 NHS Trusts) provided follow-up data; 49/148 (33.1%) clinicians (27 NHS Trusts) implemented the programme. Attitudes and beliefs shifted towards a biopsychosocial model post-training. Stage 2: 923 patients were enrolled. Patients reported improvements in function (mean change: 1.55; 95%CI: 1.25, 1.86) and pain (−0.84; −1.1, −0.58) at follow-up. The majority rated themselves improved and satisfied with the programme. Conclusion: Online training had good reach into NHS Trusts although, not everyone went onto implement the programme. Improvements in function that were consistent with the original trial were demonstrated.
Abstract.
Keene DJ, Forde C, Sugavanam T, Williams MA, Lamb SE (2020). Exercise for people with a fragility fracture of the pelvis or lower limb: a systematic review of interventions evaluated in clinical trials and reporting quality.
BMC Musculoskelet Disord,
21(1).
Abstract:
Exercise for people with a fragility fracture of the pelvis or lower limb: a systematic review of interventions evaluated in clinical trials and reporting quality.
BACKGROUND: to aid design of exercise trials for people with pelvic and lower limb fragility fractures a systematic review was conducted to identify what types of exercise interventions and mobility outcomes have been assessed, investigate intervention reporting quality, and evaluate risk of bias in published trials. METHODS: Systematic searches of electronic databases (CENTRAL, MEDLINE, EMBASE, PEDro) 1996-2019 were conducted to identify randomised controlled trials of exercise for pelvic or lower limb fragility fractures. Two reviewers independently screened titles and abstracts. One reviewer extracted data, a second verified. Two reviewers independently assessed risk of bias. Intervention reporting quality was based on TIDieR, assessed by one reviewer and verified by a second. Narrative synthesis was undertaken. Registration: PROSPERO CRD42017060905. RESULTS: Searches identified 37 trials including 3564 participants, median sample size 81 (IQR 48-124), participants aged 81 years (IQR 79-82) and 76% (2536/3356) female. All trials focussed on people with hip fracture except one on ankle fracture. Exercise types focussed on resistance exercise in 14 trials, weight bearing exercise in 5 trials, 13 varied dose of sessions with health professionals, and 2 trials each focussed on treadmill gait training, timing of weight bearing or aerobic exercise. 30/37 (81%) of trials reported adequate sequence generation, 25/37 (68%) sufficient allocation concealment. 10/37 (27%) trials lacked outcome assessor blinding. of 65 exercise interventions, reporting was clear for 33 (51%) in terms of when started, 61 (94%) for where delivered, 49 (75%) for who delivered, 47 (72%) for group or individual, 29 (45%) for duration, 46 (71%) for session frequency, 8 (12%) for full prescription details to enable the exercises to be reproduced, 32 (49%) clearly reported tailoring or modification, and 23 (35%) reported exercise adherence. Subjectively assessed mobility was assessed in 22/37 (59%) studies and 29/37 (78%) used an objective measure. CONCLUSIONS: all trials focussed on hip fracture, apart from one ankle fracture trial. Research into pelvic and other lower limb fragility fractures is indicated. A range of exercise types were investigated but to date deficiencies in intervention reporting hamper reproducibility. Adoption of TIDieR and CERT guidelines should improve intervention reporting as use increases. Trials would be improved by consistent blinded outcome assessor use and with consensus on which mobility outcomes should be assessed.
Abstract.
Author URL.
Sherrington C, Fairhall N, Wallbank G, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb S (2020). Exercise for preventing falls in older people living in the community: an abridged Cochrane systematic review.
British Journal of Sports Medicine,
54(15), 885-891.
Abstract:
Exercise for preventing falls in older people living in the community: an abridged Cochrane systematic review
Objectives to assess the effects of exercise interventions for preventing falls in older people living in the community. Selection criteria We included randomised controlled trials evaluating the effects of any form of exercise as a single intervention on falls in people aged 60+years living in the community. Results Exercise reduces the rate of falls by 23% (rate ratio (RaR) 0.77, 95% CI 0.71 to 0.83; 12 981 participants, 59 studies; high-certainty evidence). Subgroup analyses showed no evidence of a difference in effect on falls on the basis of risk of falling as a trial inclusion criterion, participant age 75 years+ or group versus individual exercise but revealed a larger effect of exercise in trials where interventions were delivered by a health professional (usually a physiotherapist). Different forms of exercise had different impacts on falls. Compared with control, balance and functional exercises reduce the rate of falls by 24% (RaR 0.76, 95% CI 0.70 to 0.81; 7920 participants, 39 studies; high-certainty evidence). Multiple types of exercise (commonly balance and functional exercises plus resistance exercises) probably reduce the rate of falls by 34% (RaR 0.66, 95% CI 0.50 to 0.88; 1374 participants, 11 studies; moderate-certainty evidence). Tai Chi may reduce the rate of falls by 19% (RaR 0.81, 95% CI 0.67 to 0.99; 2655 participants, 7 studies; low-certainty evidence). We are uncertain of the effects of programmes that primarily involve resistance training, dance or walking. Conclusions and implications Given the certainty of evidence, effective programmes should now be implemented.
Abstract.
Khan I, Maredza M, Dritsaki M, Mistry D, Lall R, Lamb SE, Couper K, Gates S, Perkins GD, Petrou S, et al (2020). Is Protocolised Weaning that Includes Early Extubation Onto Non-Invasive Ventilation More Cost Effective Than Protocolised Weaning Without Non-Invasive Ventilation? Findings from the Breathe Study.
Pharmacoecon Open,
4(4), 697-710.
Abstract:
Is Protocolised Weaning that Includes Early Extubation Onto Non-Invasive Ventilation More Cost Effective Than Protocolised Weaning Without Non-Invasive Ventilation? Findings from the Breathe Study.
BACKGROUND: Optimising techniques to wean patients from invasive mechanical ventilation (IMV) remains a key goal of intensive care practice. The use of non-invasive ventilation (NIV) as a weaning strategy (transitioning patients who are difficult to wean to early NIV) may reduce mortality, ventilator-associated pneumonia and intensive care unit (ICU) length of stay. OBJECTIVES: Our objectives were to determine the cost effectiveness of protocolised weaning, including early extubation onto NIV, compared with weaning without NIV in a UK National Health Service setting. METHODS: We conducted an economic evaluation alongside a multicentre randomised controlled trial. Patients were randomised to either protocol-directed weaning from mechanical ventilation or ongoing IMV with daily spontaneous breathing trials. The primary efficacy outcome was time to liberation from ventilation. Bivariate regression of costs and quality-adjusted life-years (QALYs) provided estimates of the incremental cost per QALY and incremental net monetary benefit (INMB) overall and for subgroups [presence/absence of chronic obstructive pulmonary disease (COPD) and operative status]. Long-term cost effectiveness was determined through extrapolation of survival curves using flexible parametric modelling. RESULTS: NIV was associated with a mean INMB of £620 ($US885) (cost-effectiveness threshold of £20,000 per QALY) with a corresponding probability of 58% that NIV is cost effective. The probability that NIV is cost effective was higher for those with COPD (84%). NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained). CONCLUSIONS: the probability of NIV being cost effective relative to weaning without NIV ranged between 57 and 59% overall and between 82 and 87% for the COPD subgroup.
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Author URL.
Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, et al (2020). Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.
The Lancet,
396(10256), 977-989.
Abstract:
Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial
Background: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. Methods: in this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0–48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508. Findings: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (–1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release). Interpretation: all mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective. Funding: the National Institute for Health Research Health Technology Assessment programme.
Abstract.
Smith TO, Mistry D, Lee H, Dosanji S, Finnegan S, Fordham B, Nichols VP, Sheehan B, Lamb SE (2020). Moderators of Cognitive Outcomes from an Exercise Program in People with Mild to Moderate Dementia.
J Am Geriatr Soc,
68(9), 2095-2100.
Abstract:
Moderators of Cognitive Outcomes from an Exercise Program in People with Mild to Moderate Dementia.
BACKGROUND/OBJECTIVES: Our aim was to estimate whether baseline participant variables were able to moderate the effect of an exercise intervention on cognition in patients with mild to moderate dementia. DESIGN: Subgroup analysis of a multicenter pragmatic randomized controlled trial. SETTING: Community-based gym/rehabilitation centers. PARTICIPANTS: a total of 494 community-dwelling participants with mild to moderate dementia. INTERVENTION: Participants were randomized to a moderate- to high-intensity aerobic and strength exercise program or a usual care control group. Experimental group participants attended twice weekly 60- to 90-minute gym sessions for 4 months. Participants were prescribed home exercises for an additional hour per week during the supervised period and 150 minutes each week after the supervised period. MEASUREMENTS: Multilevel regression model analyses were undertaken to identify individual moderators of cognitive function measured through the Alzheimer Disease Assessment Scale-Cognitive Subscale score at 12 months. RESULTS: When tested for a formal interaction effect, only cognitive function assessed by the baseline number cancellation test demonstrated a statistically significant interaction effect (-2.7 points; 95% confidence interval = -5.14 to -0.21). CONCLUSION: People with worse number cancellation test scores may experience greater progression of cognitive decline in response to a moderate- to high-intensity exercise program. Further analyses to examine whether these findings can be replicated in planned sufficiently powered analyses are indicated.
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Author URL.
Nicolson PJA, Williamson E, Morris A, Sanchez‐Santos MT, Bruce J, Silman A, Lamb SE (2020). Musculoskeletal pain and loneliness, social support and social engagement among older adults: Analysis of the Oxford Pain, Activity and Lifestyle cohort. Musculoskeletal Care, 19(3), 269-277.
Barker KL, Room J, Knight R, Dutton SJ, Toye F, Leal J, Kent S, Kenealy N, Schussel MM, Collins G, et al (2020). Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee Arthroplasty: CORKA RCT.
Health Technology Assessment,
24(65), 1-115.
Abstract:
Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee Arthroplasty: CORKA RCT
Background: over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15–30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. Objectives: to compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. Design: an individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. Setting: the trial took place in 14 NHS physiotherapy departments. Participants: People identified as being at high risk of a poor outcome after knee arthroplasty. Interventions: a multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. Main outcome measures: the primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. Results: in total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4–7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2–6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval –0.89 to 1.88 points; p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. Limitations: the interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. Conclusions: This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. Trial registration: Current Controlled Trials ISRCTN13517704.
Abstract.
Demurtas J, Schoene D, Torbahn G, Marengoni A, Grande G, Zou L, Petrovic M, Maggi S, Cesari M, Lamb S, et al (2020). Physical Activity and Exercise in Mild Cognitive Impairment and Dementia: an Umbrella Review of Intervention and Observational Studies.
J Am Med Dir Assoc,
21(10), 1415-1422.e6.
Abstract:
Physical Activity and Exercise in Mild Cognitive Impairment and Dementia: an Umbrella Review of Intervention and Observational Studies.
OBJECTIVES: the aim of this umbrella review was to determine the effect of physical activity/exercise on improving cognitive and noncognitive outcomes in people with MCI (mild cognitive impairment) and dementia. DESIGN: Umbrella review of systematic reviews (SR), with or without meta-analyses (MAs), of randomized controlled trials (RCTs) and observational studies. SETTINGS AND PARTICIPANTS: People with MCI or dementia, confirmed through validated assessment measures. Any form of physical activity/exercise was included. As controls, we included participants not following any prespecified physical activity/exercise intervention or following the same standard protocol with the intervention group. METHODS: the protocol was registered in PROSPERO (CDR 164197). Major databases were searched until December 31, 2019. The certainty of evidence of statistically significant outcomes was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. SRs' findings, without a formal MA, were reported descriptively. RESULTS: Among 1160 articles initially evaluated, 27 SRs (all of RCTs, 9 without MA) for a total of 28,205 participants with MCI/dementia were included. In patients with MCI, mind-body intervention (standardized mean difference [SMD] = 0.36; 95% confidence intervals [CI] 0.20-0.52; low certainty) and mixed physical activity interventions (SMD = 0.30; 95% CI 0.11-0.49; moderate certainty) had a small effect on global cognition, whereas resistance training (SMD = 0.80; 95% CI 0.29-1.31; very low certainty) had a large effect on global cognition. In people affected by dementia, physical activity/exercise was effective in improving global cognition in Alzheimer disease (SMD = 1.10; 95% CI 0.65-1.64; very low certainty) and in all types of dementia (SMD = 0.48; 95% CI 0.22-0.74; low certainty). Finally, physical activity/exercise improved noncognitive outcomes in people with dementia including falls, and neuropsychiatric symptoms. CONCLUSIONS AND IMPLICATIONS: Supported by very low-to-moderate certainty of evidence, physical activity/exercise has a positive effect on several cognitive and noncognitive outcomes in people with MCI and dementia, but RCTs, with low risk of bias/confounding, are still needed to confirm these relationships.
Abstract.
Author URL.
Hanchard NCA, Goodchild L, Brealey SD, Lamb SE, Rangan A (2020). Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice.
Physiotherapy (United Kingdom),
107, 150-160.
Abstract:
Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice
Objectives: the United Kingdom Frozen Shoulder Trial (UK FROST) compares stand-alone physiotherapy and two operative procedures, both with post operative rehabilitation, for primary frozen shoulder in secondary care. We developed physiotherapy protocols for UK FROST, incorporating best evidence but recognizing uncertainty and allowing flexibility. Methods: We screened a UK Department of Health systematic review and UK evidence-based guidelines (Hanchard et al. 2012; Maund et al. 2012) for recommendations, and previous surveys of UK physiotherapists (Hanchard et al. 2011, 2013) for strong consensus. We conducted a two-stage, questionnaire-based, modified Delphi survey of shoulder specialist physiotherapists in the UK National Health Service. This required positive, negative or neutral ratings of possible interventions in four clinical contexts (stand-alone physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder; and post operative physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder). We proposed respectively mandating or recommending interventions with 100% and 90% positive consensus, and respectively disallowing or discouraging interventions with 90% and 80% negative consensus. Other interventions would be optional. Results: the systematic review and guideline recommended including steroid injection and manual mobilizations in non-operative care, and we mandated these for stand-alone physiotherapy. Consensus in the pre-existing surveys strongly favoured advice, education and home exercises, which we mandated across contexts. The Delphi survey led to recommendation of some supervised exercise modalities, plus the disallowing or discouragement—in various contexts—of immobilization and some ‘higher-tech’ electrotherapies and alternative therapies. Conclusions: We developed physiotherapy protocols despite incomplete empirical evidence. Their clear structure enabled implementation in data-sheets designed to facilitate recording, monitoring of fidelity and reporting of interventions. Other trials involving physiotherapy may benefit from this approach.
Abstract.
Costa ML, Achten J, Marian IR, Dutton SJ, Lamb SE, Ollivere B, Maredza M, Petrou S, Kearney RS, Abdallah A, et al (2020). Plaster cast versus functional brace for non-surgical treatment of Achilles tendon rupture (UKSTAR): a multicentre randomised controlled trial and economic evaluation. The Lancet, 395(10222), 441-448.
Costa ML, Achten J, Wagland S, Marian IR, Maredza M, Schlüssel MM, Liew AS, Parsons NR, Dutton SJ, Kearney RS, et al (2020). Plaster cast versus functional bracing for Achilles tendon rupture: the UKSTAR RCT.
Health Technol Assess,
24(8), 1-86.
Abstract:
Plaster cast versus functional bracing for Achilles tendon rupture: the UKSTAR RCT.
BACKGROUND: Achilles tendon rupture affects > 11,000 people each year in the UK, leading to prolonged periods away from work, sports and social activities. Traditionally, the ruptured tendon is held still in a plaster cast for ≥ 8 weeks. Functional bracing is an alternative treatment that allows patients to mobilise earlier, but there is little evidence about how bracing affects patients' recovery. OBJECTIVES: to measure the Achilles Tendon Rupture Score, quality of life, complications and resource use of patients receiving non-operative treatment for an Achilles tendon rupture treated with plaster cast compared with those treated with functional bracing. DESIGN: This was a multicentre, randomised, pragmatic, two-group superiority trial. SETTING: the setting was 39 NHS hospitals. PARTICIPANTS: a total of 540 adult patients treated non-operatively for Achilles tendon rupture were randomised from July 2016 to May 2018. Exclusion criteria included presenting after 14 days, having had previous rupture and being unable to complete questionnaires. INTERVENTIONS: a total of 266 participants had a plaster cast applied, with their toes initially pointing to the floor. The cast was changed over 8 weeks to bring the foot into a walking position. A total of 274 patients had a functional brace that facilitated immediate weight-bearing. The foot position was adjusted within the brace over the same 8-week period. MAIN OUTCOME MEASURES: Achilles Tendon Rupture Score is patient reported and assesses symptoms and physical activity related to the Achilles tendon (score 0-100, with 100 being the best possible outcome). The secondary outcomes were quality of life, complications and resource use at 8 weeks and at 3, 6 and 9 months. RESULTS: Participants had a mean age of 48.7 years, were predominantly male (79%) and had ruptured their tendon during sports (70%). Over 93% of participants completed follow-up. There was no statistically significant difference in Achilles Tendon Rupture Score at 9 months post injury (-1.38, 95% confidence interval -4.9 to 2.1). There was a statistically significant difference in Achilles Tendon Rupture Score at 8 weeks post injury in favour of the functional brace group (5.53, 95% confidence interval 2.0 to 9.1), but not at 3 or 6 months post injury. Quality of life showed the same pattern, with a statistically significant difference at 8 weeks post injury but not at later time points. Complication profiles were similar in both groups. Re-rupture of the tendon occurred 17 times in the plaster cast group and 13 times in the functional brace group. There was no difference in resource use. CONCLUSIONS: This trial provides strong evidence that early weight-bearing in a functional brace provides similar outcomes to traditional plaster casting and is safe for patients receiving non-operative treatment of Achilles tendon rupture. The probability that functional bracing is cost-effective exceeds 95% for the base-case imputed analysis, assuming a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. On average, functional brace is associated with lower costs (-£103, 95% confidence interval -£290 to £84) and more quality-adjusted life-years (0.015, 95% confidence interval -0.0013 to 0.030) than plaster cast. LIMITATIONS: Some patients declined to participate in the trial, but only a small proportion of these declined because they had a preference for one treatment or another. Overall, 58% of eligible patients agreed to participate, so the participants are broadly representative of the population under investigation. FUTURE WORK: Although the UK Study of Tendo Achilles Rehabilitation provides guidance with regard to early management, rehabilitation following Achilles tendon rupture is prolonged and further research is required to define the optimal mode of rehabilitation after the initial cast/brace has been removed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN62639639. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 8. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Marian IR, Hopewell S, Keene DJ, Cureton L, Lamb SE, Dutton SJ (2020). Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: Statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial.
Trials,
21(1).
Abstract:
Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: Statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial
Background: the Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. This article describes the statistical analysis plan for the GRASP randomised controlled trial. Methods/design: GRASP is a multicentre randomised controlled trial using a 2 × 2 factorial design. Adults aged ≥ 18 years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery, are randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection then best practice advice. The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score over 12 months. Secondary outcomes are as follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability. Here, we describe in detail the following: sample size calculation, descriptive statistics of the primary and secondary outcomes, statistical models used for the analysis of the main outcomes, handling of missing data, planned sensitivity and subgroup analyses. This pre-specified statistical analysis plan was written and submitted without prior knowledge of the trial results. Discussion: Publication of the statistical analysis plan for the GRASP trial aims to reduce the risk of outcome reporting bias and increase transparency of the data analysis. Any deviations or changes to the current SAP will be described and justified in the final study report and any results publications. Trial registration: International Standard Randomised Controlled Trial Number ISRCTN16539266. Registered on 14 June 2016. EudraCT number 2016-002991-28. Registered on 12 June 2016.
Abstract.
Brealey S, Northgraves M, Kottam L, Keding A, Corbacho B, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N, et al (2020). Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT.
Health Technol Assess,
24(71), 1-162.
Abstract:
Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT.
BACKGROUND: Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective. OBJECTIVES: to compare the clinical effectiveness and cost-effectiveness of three treatments in secondary care for adults with frozen shoulder; to qualitatively explore the acceptability of these treatments to patients and health-care professionals; and to update a systematic review to explore the trial findings in the context of existing evidence for the three treatments. DESIGN: This was a pragmatic, parallel-group, multicentre, open-label, three-arm, randomised superiority trial with unequal allocation (2 : 2 : 1). An economic evaluation and a nested qualitative study were also carried out. SETTING: the orthopaedic departments of 35 hospitals across the UK were recruited from April 2015, with final follow-up in December 2018. PARTICIPANTS: Participants were adults (aged ≥ 18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation in the affected shoulder to
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Author URL.
Howick J, Webster RK, Rees JL, Turner R, Macdonald H, Price A, Evers AWM, Bishop F, Collins GS, Bokelmann K, et al (2020). TIDieR-Placebo: a guide and checklist for reporting placebo and sham controls.
PLoS Medicine,
17(9).
Abstract:
TIDieR-Placebo: a guide and checklist for reporting placebo and sham controls
Background Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. Methods and findings We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e. features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. Conclusions We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.
Abstract.
Jayakumar P, Teunis T, Vranceanu AM, Williams M, Lamb S, Ring D, Gwilym S (2020). The impact of a patient's engagement in their health on the magnitude of limitations and experience following upper limb fractures.
Bone Joint J,
102-B(1), 42-47.
Abstract:
The impact of a patient's engagement in their health on the magnitude of limitations and experience following upper limb fractures.
AIMS: Patient engagement in adaptive health behaviours and interactions with their healthcare ecosystem can be measured using self-reported instruments, such as the Patient Activation Measure (PAM-13) and the Effective Consumer Scale (ECS-17). Few studies have investigated the influence of patient engagement on limitations (patient-reported outcome measures (PROMs)) and patient-reported experience measures (PREMs). First, we assessed whether patient engagement (PAM-13, ECS-17) within two to four weeks of an upper limb fracture was associated with limitations (the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), and Patient-Reported Outcome Measurement Information System Upper Extremity Physical Function computer adaptive test (PROMIS UE PF) scores) measured six to nine months after fracture, accounting for demographic, clinical, and psychosocial factors. Secondly, we assessed the association between patient engagement and experience (numerical rating scale for satisfaction with care (NRS-C) and satisfaction with services (NRS-S) six to nine months after fracture. METHODS: a total of 744 adults with an isolated fracture of the proximal humerus, elbow, or distal radius completed PROMs. Due to multicollinearity of patient engagement and psychosocial variables, we generated a single variable combining measures of engagement and psychosocial factors using factor analysis. We then performed multivariable analysis with p < 0.10 on bivariate analysis. RESULTS: Patient engagement and psychosocial factors combined to form a single factor (factor 1) accounting for 20% (QuickDASH, semi-partial R2 = 0.20) and 14% (PROMIS UE PF, semi-partial R2 = 0.14) of the variation in limitations six to nine months after fracture. Factor 1 also accounted for 17% (NRS-C, semi-partial R2 = 0.17) of variation in satisfaction with care, and 21% (NRS-S, semi-partial R2 = 0.21) of variation in satisfaction with services. Demographic factors (age, sex, work status) and measures of greater pathophysiology (type of fracture, high-energy injury, post-surgical complications), accounted for much less variation. CONCLUSION: Patients who actively manage their health and demonstrate effective emotional and social functioning share a common underlying trait. They have fewer limitations and greater satisfaction with care during recovery from upper limb fractures. Future efforts should focus on evaluating initiatives that optimize patient engagement, such as patient education, coaching, and a communication strategy for healthcare professionals. Cite this article: Bone Joint J 2020;102-B(1):42-47.
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Author URL.
Arnadottir SA, Bruce J, Lall R, Withers EJ, Underwood M, Shaw F, Sheridan R, Hossain A, Lamb SE, Martin F, et al (2020). The importance of different frailty domains in a population based sample in England.
BMC Geriatrics,
20(1).
Abstract:
The importance of different frailty domains in a population based sample in England
Background: the aim was to estimate the prevalence of frailty and relative contribution of physical/balance, nutritive, cognitive and sensory frailty to important adverse health states (falls, physical activity levels, outdoor mobility, problems in self-care or usual activities, and lack of energy or accomplishment) in an English cohort by age and sex. Methods: Analysis of baseline data from a cohort of 9803 community-dwelling participants in a clinical trial. The sample was drawn from a random selection of all people aged 70 or more registered with 63 general practices across England. Data were collected by postal questionnaire. Frailty was measured with the Strawbridge questionnaire. We used cross sectional, multivariate logistic regression to estimate the association between frailty domains and known correlates and adjusted for age. Some models were stratified by sex. Results: Mean age of participants was 78 years (sd 5.7), range 70 to 101 and 47.5% (4653/9803) were men. The prevalence of overall frailty was 20.7% (2005/9671) and there was no difference in prevalence by sex (Odds Ratio 0.98; 95% Confidence Interval 0.89 to 1.08). Sensory frailty was the most common and this was reported by more men (1823/4586) than women (1469/5056; Odds Ratio for sensory frailty 0.62, 95% Confidence Interval 0.57 to 0.68). Men were less likely than women to have physical or nutritive frailty. Physical frailty had the strongest independent associations with adverse health states. However, sensory frailty was independently associated with falls, less frequent walking, problems in self-care and usual activities, lack of energy and accomplishment. Conclusions: Physical frailty was more strongly associated with adverse health states, but sensory frailty was much more common. The health gain from intervention for sensory frailty in England is likely to be substantial, particularly for older men. Sensory frailty should be explored further as an important target of intervention to improve health outcomes for older people both at clinical and population level.
Abstract.
Williamson E, Srikesavan C, Thompson J, Tonga E, Eldridge L, Adams J, Lamb SE (2020). Translating the Strengthening and Stretching for Rheumatoid Arthritis of the Hand Programme from clinical trial to clinical practice: an effectiveness–implementation study.
Hand Therapy,
25(3), 87-97.
Abstract:
Translating the Strengthening and Stretching for Rheumatoid Arthritis of the Hand Programme from clinical trial to clinical practice: an effectiveness–implementation study
Introduction: the Strengthening and Stretching for Rheumatoid Arthritis of the Hand programme is a hand exercise programme for people with rheumatoid arthritis. It was clinically effective when delivered during a clinical trial but there was a need to evaluate translation into routine care. Methods: We conducted an effectiveness–implementation study. We adapted the trial training into an online format for National Health Service hand therapists. Educational outcomes included confidence and capability to deliver the programme. Implementation outcomes included training reach and adoption. Therapists were invited to collect clinical outcomes. Patients receiving the programme provided data on function (Michigan Hand Questionnaire function scale), pain and grip strength at baseline, treatment discharge and four-month follow-up. Results: a total of 790 therapists (188 National Health Service organizations) enrolled in the training; 584/790 (74%) therapists (162 National Health Service organizations) completed the training; 448/790 therapists (145 National Health Service organizations) (57%) evaluated the training and were confident (447/448, 99.8%) and capable (443/448, 99%) to deliver the programme with 85% intending to adopt it (379/448). Follow-up data were provided by 116/448 (26%) therapists. Two-thirds (77/116; 51 National Health Service organizations) reported adopting the programme. One hundred and eighteen patients (15 National Health Service trusts) participated. Patients reported improved function (mean change Michigan Hand Questionnaire scores: 10 (95% CI 6.5–13.6) treatment discharge; 7 (95% CI 3.8–10.2) 4-month follow-up). Grip strength increased 24.5% (left) and 31% (right). Pain was stable. Discussion: Online training was an effective way to train therapists with good reach. Clinical outcomes were similar to the clinical trial providing preliminary evidence of successful translation into routine care.
Abstract.
Comer C, Lee H, Williamson E, Lamb S (2020). Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.
BMJ Open,
10(9).
Abstract:
Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.
INTRODUCTION: Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme). METHODS AND ANALYSES: We will use causal mediation analysis to estimate the mechanistic effects of the BOOST programme on the primary outcome of disability (measured by the Oswestry Disability Index). The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity. All mediators will be measured at 6 months and the outcome will be measured at 12 months from randomisation. Patient characteristics and possible confounders of the mediator-outcome effect will be measured at baseline. Sensitivity analyses will be conducted to evaluate the robustness of the estimated effects to varying levels of residual confounding. ETHICS AND DISSEMINATION: Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). The results of this analysis will be disseminated in peer-reviewed journals and at relevant scientific conferences. TRIAL REGISTRATION NUMBER: ISRCTN12698674.
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Author URL.
Abel B, Bongartz M, Eckert T, Ullrich P, Beurskens R, Mellone S, Bauer JM, Lamb SE, Hauer K (2020). Will We Do If We Can? Habitual Qualitative and Quantitative Physical Activity in Multi-Morbid, Older Persons with Cognitive Impairment.
Sensors,
20(24), 7208-7208.
Abstract:
Will We Do If We Can? Habitual Qualitative and Quantitative Physical Activity in Multi-Morbid, Older Persons with Cognitive Impairment
This study aimed to identify determinants of quantitative dimensions of physical activity (PA; duration, frequency, and intensity) in community-dwelling, multi-morbid, older persons with cognitive impairment (CI). In addition, qualitative and quantitative aspects of habitual PA have been described. Quantitative PA and qualitative gait characteristics while walking straight and while walking turns were documented by a validated, sensor-based activity monitor. Univariate and multiple linear regression analyses were performed to delineate associations of quantitative PA dimensions with qualitative characteristics of gait performance and further potential influencing factors (motor capacity measures, demographic, and health-related parameters). In 94 multi-morbid, older adults (82.3 ± 5.9 years) with CI (Mini-Mental State Examination score: 23.3 ± 2.4), analyses of quantitative and qualitative PA documented highly inactive behavior (89.6% inactivity) and a high incidence of gait deficits, respectively. The multiple regression models (adjusted R2 = 0.395–0.679, all p < 0.001) identified specific qualitative gait characteristics as independent determinants for all quantitative PA dimensions, whereas motor capacity was an independent determinant only for the PA dimension duration. Demographic and health-related parameters were not identified as independent determinants. High associations between innovative, qualitative, and established, quantitative PA performances may suggest gait quality as a potential target to increase quantity of PA in multi-morbid, older persons.
Abstract.
Rodgers S, Sbizzera I, Cockayne S, Fairhurst C, Lamb SE, Vernon W, Watson J, Hewitt C, Torgerson D (2019). A study update newsletter or post-it® note did not increase postal questionnaire response rates in a falls prevention trial: an embedded randomised factorial trial.
F1000Research,
7Abstract:
A study update newsletter or post-it® note did not increase postal questionnaire response rates in a falls prevention trial: an embedded randomised factorial trial
Background: Participants not returning data collection questionnaires is a problem for many randomised controlled trials. The resultant loss of data leads to a reduction in statistical power and can result in bias. The aim of this study was to assess whether the use of a study update newsletter and/or a handwritten or printed Post-it® note sticker increased postal questionnaire response rates for participants of a randomised controlled trial. Method: This study was a factorial trial embedded within a host trial of a falls-prevention intervention among men and women aged ≥65 years under podiatric care. Participants were randomised into one of six groups: newsletter plus handwritten Post-it®; newsletter plus printed Post-it®; newsletter only; handwritten Post-it® only; printed Post-it® only; or no newsletter or Post-it®. The results were combined with those from previous embedded randomised controlled trials in meta-analyses. Results: the overall 12-month response rate was 803/826 (97.2%) (newsletter 95.1%, no newsletter 99.3%, printed Post-it® 97.5%, handwritten Post-it® 97.1%, no Post-it® 97.1%). The study update newsletter had a detrimental effect on response rates (adjusted odds ratio 0.14, 95% CI 0.04 to 0.48, p
Abstract.
Cashin AG, Lee H, Lamb SE, Hopewell S, Mansell G, Williams CM, Kamper SJ, Henschke N, McAuley JH (2019). An overview of systematic reviews found suboptimal reporting and methodological limitations of mediation studies investigating causal mechanisms.
Journal of Clinical Epidemiology,
111, 60-68.e1.
Abstract:
An overview of systematic reviews found suboptimal reporting and methodological limitations of mediation studies investigating causal mechanisms
Objectives: the objective of this study was to investigate whether systematic reviews of mediation studies identify limitations in reporting quality and methodological conduct. Study Design and Setting: We conducted an overview of systematic reviews. We searched four databases (MEDLINE, PsycINFO, Cochrane Database of Systematic Reviews, and PubMed) to identify systematic reviews of studies that used mediation analysis to investigate mechanisms of health care interventions or exposures in clinical populations between 2007 and 2017. Two reviewers independently screened titles and abstracts. Summary data on the characteristics, reporting quality, and methodological conduct of the studies included in the systematic reviews were extracted independently by two reviewers. The protocol was prospectively registered on PROSPERO (CRD42017059834). Results: Fifty-four systematic reviews were included, representing 11 health care fields, 26 health conditions, and 2008 mediation studies. Eighteen of fifty-four systematic reviews (33%) explicitly stated that the reporting of primary studies was suboptimal. of these, 14/18 (78%) reviews noted incomplete reporting of effect sizes and precision estimates from mediation analyses. Twenty-nine of fifty-four systematic reviews (54%) identified limitations in the methodological conduct of primary studies. Conclusion: the reporting and methodological conduct of studies investigating mechanisms in health care seems to be suboptimal. Guidance is needed to improve the quality, completeness, and transparency of mediation studies.
Abstract.
Smith TO, Pearson M, Pfeiffer K, Crotty M, Lamb SE (2019). Caregiver Interventions for Adults Discharged from the Hospital: Systematic Review and Meta-Analysis.
Journal of the American Geriatrics Society,
67(9), 1960-1969.
Abstract:
Caregiver Interventions for Adults Discharged from the Hospital: Systematic Review and Meta-Analysis
OBJECTIVES: to review the evidence evaluating the effectiveness of informal caregiver interventions to facilitate the recovery of older people discharged from the hospital. DESIGN: Systematic review and meta-analysis. SETTING: Hospital and community. METHODS: Published and unpublished randomized and nonrandomized controlled trials assessing the effectiveness of informal caregiver interventions to support the recovery of older people discharged from the hospital were identified (to March 2019). The primary outcome was patient health-related quality of life (HRQOL). Secondary outcomes included patient function, caregiver burden, caregiver HRQOL, psychological distress, adverse events, and health resource use. Studies were critically appraised and meta-analyzed. PARTICIPANTS: Adults who had been admitted to the hospital. RESULTS: a total of 23 studies were eligible (4695 participants). The indication for hospital admission was stroke in 21 trials (91%). Interventions consisted of training and/or skills-based programs, with or without home visits/telephone follow-up. Caregiver interventions for patients following stroke may provide no benefit for patient HRQOL at 12 months (standardized mean difference =.29; 95% confidence interval = -.12 to.69; low-quality evidence). Caregiver interventions demonstrated benefit for caregiver burden and both patient and caregiver anxiety at 12 months. No consistent effect was found on functional outcomes, depression, HRQOL, adverse events, or health resource use measures. CONCLUSIONS: Informal caregivers who receive training to facilitate the recovery of older people discharged from the hospital following stroke may have a lower burden and reduced anxiety at 12 months compared with those who do not. However, the evidence was moderate to low quality. Further study is warranted to explore whether caregiver interventions can be modified for nonstroke populations such as those with hip fracture. J Am Geriatr Soc 67:1960–1969, 2019.
Abstract.
Zhou B, Zhang J, Zhao Y, Li X, Anderson CS, Xie B, Wang N, Zhang Y, Tang X, Prvu Bettger J, et al (2019). Caregiver-Delivered Stroke Rehabilitation in Rural China: the RECOVER Randomized Controlled Trial.
Stroke,
50(7), 1825-1830.
Abstract:
Caregiver-Delivered Stroke Rehabilitation in Rural China: the RECOVER Randomized Controlled Trial
Background and Purpose-Stroke disability is a major health burden in rural China where rehabilitation services are inadequate. We aimed to determine the effectiveness of a novel nurse-led, caregiver-delivered model of stroke rehabilitation in rural China. Methods-A multicenter prospective, randomized open, blinded outcome assessed, controlled trial was conducted in 3 rural county hospitals in China: Zhangwu, Liaoning Province (Northeast); Qingtongxia, Ningxia Hui Autonomous Region (Northwest); and Dianjiang, Chongqing Municipality (Southwest). Adult patients (age 18-79 years) with residual disability (Barthel Index score ≤80/100) after a recent acute stroke were randomized to a new service model or usual care. The new intervention was multifaceted and was based on a task-shifting/training-the-trainers model, supported by a custom-designed smartphone application, where patients and caregivers received evidence-based in-hospital education and stroke rehabilitation training (focus on mobility, self-care, and toileting), delivered by trained nurses before hospital discharge, and 3 postdischarge support telephone calls. Outcome assessments were undertaken before hospital discharge and at 3 and 6 months. Primary outcome was physical functioning (Barthel Index scores) at 6 months, assessed by research staff blind to treatment allocation, adjusted for baseline covariates in an intention-to-treat analysis. Secondary outcomes included measures of mobility, health-related quality of life, mood, and caregiver burden. The study included a process evaluation that assessed intervention fidelity. Results-From November 2014 to December 2016, 246 stroke patients were randomized to intervention (n=118) or control (n=128) groups. There was no statistically significant difference in adjusted 6-month Barthel Index scores between groups (70.1 versus 74.1, mean difference,-4.0 [95% CI,-10.0 to 2.9]), nor any differences across the other outcome measures. Process evaluation interviews revealed that the intervention was desirable and positively accepted by nurses, caregivers, and patients but was considered too complex despite efforts to simplify materials for the rural context. Key strategies identified for future studies included the use of community health workers, smartphone application enhancement, and simpler and more frequent training for nurses, caregivers, and patients. Conclusions-A novel nurse-led, digital supported, caregiver-delivered stroke rehabilitation program did not improve patient physical functioning after stroke in rural China. Further stroke rehabilitation research suitable for resource-poor settings is required, with several components being suggested through stakeholder interviews in our study.
Abstract.
Griffin J, Lall R, Bruce J, Withers E, Finnegan S, Lamb SE, Underwood M, Martin F, Yardley L, Skelton D, et al (2019). Comparison of alternative falls data collection methods in the Prevention of Falls Injury Trial (PreFIT).
Journal of Clinical Epidemiology,
106, 32-40.
Abstract:
Comparison of alternative falls data collection methods in the Prevention of Falls Injury Trial (PreFIT)
Background and Objectives: Prospective, monthly diaries are recommended for collecting falls data but are burdensome and expensive. The aim of the article was to compare characteristics of fallers and estimates of fall rates by method of data collection. Study Design and Setting: a methodology study nested within a large cluster randomized controlled trial. We randomized 9,803 older adults from 63 general practices across England to receive one of three fall prevention interventions. Participants provided a retrospective report of falls in postal questionnaires mailed every 4 months. A separate randomization allocated participants to receive prospective monthly falls diaries for one simultaneous 4-month period. Results: Falls diaries were returned by 7,762 of 9,375 (83%); of which 6,306 (67%) participants reported the same number of falls on both data sources. Diary nonresponders were older and had poorer levels of physical and mental health. Analysis of time points where both data sources were available showed the falls rate on diaries was consistently higher than on the questionnaire (mean rate: 0.16 vs. 0.12 falls per person-month observation). Diary allocation was associated with a higher rate of withdrawal from the main trial. Conclusion: Diary completion was associated with sample attrition. We found on average a 32% difference in falls rates between the two data sources. Retrospective and prospective falls data are not consistently reported when collected simultaneously.
Abstract.
Jayakumar P, Teunis T, Vranceanu A-M, Lamb S, Williams M, Ring D, Gwilym S (2019). Construct Validity and Precision of Different Patient-reported Outcome Measures During Recovery After Upper Extremity Fractures.
Clin Orthop Relat Res,
477(11), 2521-2530.
Abstract:
Construct Validity and Precision of Different Patient-reported Outcome Measures During Recovery After Upper Extremity Fractures.
BACKGROUND: Patient perceptions of their limitations after illness and injury can be quantified using patient-reported outcome measures (PROMs). Few studies have assessed construct validity (using correlations and factor analysis) and precision (floor and ceiling effects) of a range of frequently used PROMs longitudinally in a population of patients recovering from common upper extremity fractures according to area (general health, region-specific, or joint-specific measures) and mode of administration (fixed-scale or computer adaptive test). QUESTIONS/PURPOSES: (1) What is the strength of the correlation between different PROMs within 1 week, 2 to 4 weeks and 6 to 9 months after shoulder, elbow, and wrist fractures? (2) Using a factor analysis, what underlying constructs are being measured by these PROMs? (3) Are there strong floor and ceiling effects with these instruments? METHODS: Between January 2016 and August 2016, 734 patients recovering from an isolated shoulder, elbow, or wrist fracture completed physical-limitation PROMs at baseline (the initial office visit after diagnosis in the emergency department), 2 to 4 weeks after injury, and at the final assessment 6 to 9 months after injury. In all, 775 patients were originally approached; 31 patients (4%) declined to participate due to time constraints, four patients died of unrelated illness, and six patients were lost to follow-up. The PROMs included the PROMIS Physical Function (PF, a computer adaptive, general measure of physical function), the PROMIS Upper Extremity (UE, a computer adaptive measure of upper extremity physical function), the QuickDASH (a fixed-scale, region-specific measure), the Oxford Shoulder Score (OSS), the Oxford Elbow Score (OES) and the Patient-rated Wrist Evaluation (PRWE) (a fixed-scale, joint-specific measure), and the EQ-5D-3L (a fixed-scale measure of general health). PROMs were evaluated during recovery for construct validity (using correlations and factor analysis) and precision (using floor and ceiling effects). RESULTS: Physical-limitation PROMs were intercorrelated at all time points, and the correlation strengthened over time (for example, PROMIS UE and QuickDASH at 1 week, r = -0.4665; at 2 to 4 weeks, r = -0.7763; at 6 to 9 months, r = -0.8326; p < 0.001). Factor analysis generated two factors or groupings of PROMs that could be described as capability (perceived ability to perform or engage in activities), and quality of life (an overall sense of health and wellbeing) that varied by time point and fracture type, Joint-specific and general-health PROMs demonstrated high ceiling effects 6 to 9 months after injury and PROMIS PF, PROMIS UE and QuickDASH had no floor or ceiling effects at any time points. CONCLUSIONS: There is a substantial correlation between PROMs that assess physical limitations (based on anatomic region) and general health after upper extremity fractures, and these relationships strengthen during recovery. Regardless of the delivery mode or area of focus, PROMs largely appear to represent two underlying constructs: capability and quality of life. Computer adaptive tests may be favored over fixed-scale measures for their efficiency and limited censoring. LEVEL OF EVIDENCE: Level II, therapeutic study.
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Author URL.
Petrou S, Parker B, Masters J, Achten J, Bruce J, Lamb SE, Parsons N, Costa ML, WOLLF Trial Collaborators (2019). Cost-effectiveness of negative-pressure wound therapy in adults with severe open fractures of the lower limb: evidence from the WOLLF randomized controlled trial.
Bone Joint J,
101-B(11), 1392-1401.
Abstract:
Cost-effectiveness of negative-pressure wound therapy in adults with severe open fractures of the lower limb: evidence from the WOLLF randomized controlled trial.
AIMS: the aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb. PATIENTS AND METHODS: an economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation. RESULTS: the base case analysis produced an incremental cost-effectiveness ratio of £267 910 per QALY gained, reflecting higher costs on average (£678; 95% confidence interval (CI) -£1082 to £2438) and only marginally higher QALYS (0.002; 95% CI -0.054 to 0.059) in the NPWT group. The probability that NPWT is cost-effective in this patient population did not exceed 27% regardless of the value of the cost-effectiveness threshold. This result remained robust to several sensitivity and subgroup analyses. CONCLUSION: This trial-based economic evaluation suggests that NPWT is unlikely to be a cost-effective strategy for improving outcomes in adult patients with severe open fractures of the lower limb. Cite this article: Bone Joint J 2019;101-B:1392-1401.
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Author URL.
Ward L, Williamson E, Hansen Z, French DP, Boniface G, Rogers D, Lamb SE (2019). Development and delivery of the BOOST (Better Outcomes for Older adults with Spinal Trouble)intervention for older adults with neurogenic claudication.
Physiotherapy (United Kingdom),
105(2), 262-274.
Abstract:
Development and delivery of the BOOST (Better Outcomes for Older adults with Spinal Trouble)intervention for older adults with neurogenic claudication
Neurogenic claudication due to spinal stenosis is a common cause of disability in older adults. Conservative treatments are a favourable treatment option. This paper describes the development and delivery of the BOOST (Better Outcomes for Older adults with Spinal Trouble)intervention, a physiotherapist-delivered physical and psychological intervention for the management of neurogenic claudication in older adults. The BOOST intervention is being tested in a multi-centre, randomised controlled trial in UK National Health Service Trusts; delivered by physiotherapists registered with the Health and Care Professionals Council. Participants are aged 65 years or older, registered with a primary care practice, and report symptoms consistent with neurogenic claudication. Intervention content and delivery was initially informed by clinical and patient experts, research evidence, and behaviour change guidelines; and refined following an intervention development day attended by researchers, health professionals, and Patient and Public Involvement representatives. The BOOST intervention comprises 12 group sessions, promoting sustained adherence with a long term home and physical activity programme. Each session includes education and group discussion, individually tailored exercises, and walking. Initial exercise levels are set at a one-to-one assessment. Continued home exercise adherence and increased physical activity following completion of the sessions is facilitated through support telephone calls. Trial registration ISRCTN12698674.
Abstract.
Khan I, Petrou S, Khan K, Mistry D, Lall R, Sheehan B, Lamb S, DAPA Trial Group (2019). Does Structured Exercise Improve Cognitive Impairment in People with Mild to Moderate Dementia? a Cost-Effectiveness Analysis from a Confirmatory Randomised Controlled Trial: the Dementia and Physical Activity (DAPA) Trial.
Pharmacoecon Open,
3(2), 215-227.
Abstract:
Does Structured Exercise Improve Cognitive Impairment in People with Mild to Moderate Dementia? a Cost-Effectiveness Analysis from a Confirmatory Randomised Controlled Trial: the Dementia and Physical Activity (DAPA) Trial.
BACKGROUND: Previous studies suggest that physical exercise could slow dementia progression. However, evidence for the cost effectiveness of structured exercise is conflicting and based on small trials. OBJECTIVES: the objective of this study was to compare the cost effectiveness of a tailored, structured, moderate- to high-intensity exercise programme versus usual care in people with mild to moderate dementia. METHODS: an economic evaluation was conducted from the UK National Health Service and personal social services perspective, based on data from a large randomised controlled trial. The primary clinical outcome was the participant reported ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale) at 12 months. Costs (£; 2014-2015 prices) were collected prospectively over a 12-month follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted with the view to estimating the incremental cost per QALY gained and the incremental net monetary benefit (INMB) associated with the exercise programme plus usual care versus usual care. Sensitivity analyses were undertaken to assess the impact of uncertainty surrounding aspects of the economic evaluation, and pre-specified subgroup analyses explored heterogeneity in the cost-effectiveness results. RESULTS: Participants (n = 494) were randomised to exercise plus usual care or usual care only. By 12 months the mean ADAS-Cog score had worsened slightly to 25.2 (standard deviation [SD] 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care: difference - 1.4, 95% confidence interval (CI) - 2.6 to - 0.2 (p = 0.03). The mean (standard error [SE]) costs over 12 months for experimental versus control was £5945 (US$7856) versus £4597 (US$6574), respectively; (difference: £1347 [$1926]; p = 0.0426). Mean (SE) QALY estimates were 0.787 (0.012) versus 0.826 (0.019), respectively (p = 0.090). The probability that the exercise programme is cost effective was
Abstract.
Author URL.
Copsey B, Buchanan J, Fitzpatrick R, Lamb SE, Dutton SJ, Cook JA (2019). Duration of Treatment Effect Should be Considered in the Design and Interpretation of Clinical Trials: Results of a Discrete Choice Experiment.
Medical Decision Making,
39(4), 461-473.
Abstract:
Duration of Treatment Effect Should be Considered in the Design and Interpretation of Clinical Trials: Results of a Discrete Choice Experiment
Objective. This study examined whether duration of treatment effect should be considered in a benefit-risk assessment using a case study of osteoarthritis medications. Study Design and Setting. A discrete choice experiment was completed by 300 residents of the United Kingdom with hip and/or knee osteoarthritis. In 16 choice tasks, participants selected their preferred option from 2 medications. Medications were described in terms of effect on pain, stiffness, and function; duration of treatment effect; and risk of heart attack and stomach ulcer bleeding. The analysis used mixed-effects logistic regression. Results. Pain, disease severity, and duration of treatment effect had the greatest influence on medication preferences, whereas stiffness did not significantly affect medication choice. Participants were willing to accept an increase in the risk of heart attack of 2.6% (95% confidence interval: 2.0% to 3.2%) to increase the duration of treatment effect from 1 month to 12 months. Reducing pain from moderate to mild was valued the same as increasing duration of effect from 1 month to 3 months; both were seen as equivalent to an absolute reduction of 1.2% in the risk of heart attack in the next year. Subgroup analysis suggested disease severity influenced patient preferences. Conclusions. Along with treatment benefits and risks, the results suggest that duration of treatment effect is an important factor in the medication choices of people with osteoarthritis. This could have implications for the design and interpretation of clinical trials, for example, incorporating longer-term surveillance of trial participants and accounting for duration of treatment effect in risk-benefit assessments. Future research is needed to assess whether these findings are generalizable to other samples, disease areas, and levels of duration of effect.
Abstract.
Thompson JY, Williamson EM, Williams MA, Heine PJ, Lamb SE (2019). Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis.
Physiotherapy (United Kingdom),
105(2), 214-234.
Abstract:
Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis
Study design: Systematic review and meta-analysis. Objective: to assess the effectiveness of scoliosis-specific exercises (SSE) on adolescent idiopathic scoliosis (AIS) compared with other non-surgical interventions. Background: AIS is a complex deformity of the spine that develops between the age of 10 years and skeletal maturity. SSE are prescribed to patients to reduce or slow curve progression, although their effectiveness is unknown. Methods: Electronic databases were searched for relevant studies. Randomised controlled trials were eligible if they compared SSE with non-surgical interventions for individuals with AIS. Three authors independently extracted data, evaluated methodological quality and assessed the quality of evidence. Meta-analysis was performed where possible; otherwise, descriptive syntheses are reported. Results: Nine randomised controlled trials were included. Four had a high risk of bias, three had an unclear risk and two had a low risk. Very-low-quality evidence indicated that SSE improved some measures of spinal deformity, function, pain and overall health-related quality of life (HRQoL). Very-low-quality evidence suggested that SSE had no effect on self-image and mental health. Very-low-quality evidence showed that bracing was more effective than SSE on measures of spinal deformity. However, SSE showed greater improvements in function, HRQoL, self-image, mental health and patient satisfaction with treatment. No differences were found for pain or trunk rotation. Conclusions: SSE may be effective for improving measures of spinal deformity for people with AIS, but the evidence is of very low quality. Future studies should evaluate relevant clinical measures and cost-effectiveness using rigorous methods and reporting standards.
Abstract.
Clemson L, Stark S, Pighills AC, Torgerson DJ, Sherrington C, Lamb SE (2019). Environmental interventions for preventing falls in older people living in the community.
Cochrane Database of Systematic Reviews,
2019(2).
Abstract:
Environmental interventions for preventing falls in older people living in the community
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: to assess the effects (benefits and harms) of environmental interventions (such as assistive devices, and reduction of fall hazards in home, outdoors, and public places) for preventing falls in older people living in the community.
Abstract.
Jayakumar P, Overbeek CL, Lamb S, Williams M, Funes CJ, Gwilym S, Ring D, Vranceanu AM (2019). Erratum: What factors are associated with disability after upper extremity injuries? a systematic review (Clinical Orthopaedics and Related Research DOI: 10.1097/CORR.0000000000000427).
Clinical Orthopaedics and Related Research,
477(5).
Abstract:
Erratum: What factors are associated with disability after upper extremity injuries? a systematic review (Clinical Orthopaedics and Related Research DOI: 10.1097/CORR.0000000000000427)
The published study, "What Factors Are Associated with Disability After Upper Extremity Injuries? a Systematic Review" did not include the middle initial of coauthor Christopher Funes MS. In the author list, he should be listed as Christopher J. Funes MS. The authors apologize for the error.
Abstract.
Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE (2019). Exercise for preventing falls in older people living in the community.
The Cochrane database of systematic reviews,
1Abstract:
Exercise for preventing falls in older people living in the community
BACKGROUND: at least one-third of community-dwelling people over 65 years of age fall each year. Exercises that target balance, gait and muscle strength have been found to prevent falls in these people. An up-to-date synthesis of the evidence is important given the major long-term consequences associated with falls and fall-related injuries OBJECTIVES: to assess the effects (benefits and harms) of exercise interventions for preventing falls in older people living in the community. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, three other databases and two trial registers up to 2 May 2018, together with reference checking and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effects of any form of exercise as a single intervention on falls in people aged 60+ years living in the community. We excluded trials focused on particular conditions, such as stroke. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was rate of falls. MAIN RESULTS: We included 108 RCTs with 23,407 participants living in the community in 25 countries. There were nine cluster-RCTs. On average, participants were 76 years old and 77% were women. Most trials had unclear or high risk of bias for one or more items. Results from four trials focusing on people who had been recently discharged from hospital and from comparisons of different exercises are not described here.Exercise (all types) versus control Eighty-one trials (19,684 participants) compared exercise (all types) with control intervention (one not thought to reduce falls). Exercise reduces the rate of falls by 23% (rate ratio (RaR) 0.77, 95% confidence interval (CI) 0.71 to 0.83; 12,981 participants, 59 studies; high-certainty evidence). Based on an illustrative risk of 850 falls in 1000 people followed over one year (data based on control group risk data from the 59 studies), this equates to 195 (95% CI 144 to 246) fewer falls in the exercise group. Exercise also reduces the number of people experiencing one or more falls by 15% (risk ratio (RR) 0.85, 95% CI 0.81 to 0.89; 13,518 participants, 63 studies; high-certainty evidence). Based on an illustrative risk of 480 fallers in 1000 people followed over one year (data based on control group risk data from the 63 studies), this equates to 72 (95% CI 52 to 91) fewer fallers in the exercise group. Subgroup analyses showed no evidence of a difference in effect on both falls outcomes according to whether trials selected participants at increased risk of falling or not.The findings for other outcomes are less certain, reflecting in part the relatively low number of studies and participants. Exercise may reduce the number of people experiencing one or more fall-related fractures (RR 0.73, 95% CI 0.56 to 0.95; 4047 participants, 10 studies; low-certainty evidence) and the number of people experiencing one or more falls requiring medical attention (RR 0.61, 95% CI 0.47 to 0.79; 1019 participants, 5 studies; low-certainty evidence). The effect of exercise on the number of people who experience one or more falls requiring hospital admission is unclear (RR 0.78, 95% CI 0.51 to 1.18; 1705 participants, 2 studies, very low-certainty evidence). Exercise may make little important difference to health-related quality of life: conversion of the pooled result (standardised mean difference (SMD) -0.03, 95% CI -0.10 to 0.04; 3172 participants, 15 studies; low-certainty evidence) to the EQ-5D and SF-36 scores showed the respective 95% CIs were much smaller than minimally important differences for both scales.Adverse events were reported to some degree in 27 trials (6019 participants) but were monitored closely in both exercise and control groups in only one trial. Fourteen trials reported no adverse events. Aside from two serious adverse events (one pelvic stress fracture and one inguinal hernia surgery) reported in one trial, the remainder were non-serious adverse events, primarily of a musculoskeletal nature. There was a median of three events (range 1 to 26) in the exercise groups.Different exercise types versus controlDifferent forms of exercise had different impacts on falls (test for subgroup differences, rate of falls: P = 0.004, I² = 71%). Compared with control, balance and functional exercises reduce the rate of falls by 24% (RaR 0.76, 95% CI 0.70 to 0.81; 7920 participants, 39 studies; high-certainty evidence) and the number of people experiencing one or more falls by 13% (RR 0.87, 95% CI 0.82 to 0.91; 8288 participants, 37 studies; high-certainty evidence). Multiple types of exercise (most commonly balance and functional exercises plus resistance exercises) probably reduce the rate of falls by 34% (RaR 0.66, 95% CI 0.50 to 0.88; 1374 participants, 11 studies; moderate-certainty evidence) and the number of people experiencing one or more falls by 22% (RR 0.78, 95% CI 0.64 to 0.96; 1623 participants, 17 studies; moderate-certainty evidence). Tai Chi may reduce the rate of falls by 19% (RaR 0.81, 95% CI 0.67 to 0.99; 2655 participants, 7 studies; low-certainty evidence) as well as reducing the number of people who experience falls by 20% (RR 0.80, 95% CI 0.70 to 0.91; 2677 participants, 8 studies; high-certainty evidence). We are uncertain of the effects of programmes that are primarily resistance training, or dance or walking programmes on the rate of falls and the number of people who experience falls. No trials compared flexibility or endurance exercise versus control. AUTHORS' CONCLUSIONS: Exercise programmes reduce the rate of falls and the number of people experiencing falls in older people living in the community (high-certainty evidence). The effects of such exercise programmes are uncertain for other non-falls outcomes. Where reported, adverse events were predominantly non-serious.Exercise programmes that reduce falls primarily involve balance and functional exercises, while programmes that probably reduce falls include multiple exercise categories (typically balance and functional exercises plus resistance exercises). Tai Chi may also prevent falls but we are uncertain of the effect of resistance exercise (without balance and functional exercises), dance, or walking on the rate of falls.
Abstract.
Barker KL, Newman M, Stallard N, Leal J, Minns Lowe C, Javaid MK, Noufaily A, Adhikari A, Hughes T, Smith DJ, et al (2019). Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT.
Health Technol Assess,
23(44), 1-318.
Abstract:
Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT.
BACKGROUND: a total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role. OBJECTIVE: the objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session. DESIGN: This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies. SETTING: This trial was based in 21 NHS physiotherapy departments. PARTICIPANTS: the participants were people with symptomatic OVF. INTERVENTIONS: Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT). MAIN OUTCOME MEASURES: Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version. RESULTS: a total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference -0.23 points, 95% confidence interval (CI) -3.20 to 1.59 points; p = 1.000; and TLS test, difference 5.77 seconds, 95% CI -4.85 to 20.46 seconds; p = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI -1.76 to 2.93 points; p = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds; p = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged
Abstract.
Author URL.
Ashburn A, Pickering R, McIntosh E, Hulbert S, Rochester L, Roberts HC, Nieuwboer A, Kunkel D, Goodwin VA, Lamb SE, et al (2019). Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.
Health Technol Assess,
23(36), 1-150.
Abstract:
Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.
BACKGROUND: People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life. OBJECTIVE: to estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease. DESIGN: a multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses. SETTING: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions. PARTICIPANTS: a total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50. INTERVENTIONS: all participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE. MAIN OUTCOME MEASURES: the primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire. RESULTS: PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG. LIMITATIONS: all participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding. CONCLUSIONS: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation. FUTURE WORK: Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48152791. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria a Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.
Abstract.
Author URL.
Jayakumar P, Teunis T, Williams M, Lamb SE, Ring D, Gwilym S (2019). Factors associated with the magnitude of limitations during recovery from a fracture of the proximal humerus.
Bone and Joint Journal,
B101(6), 715-723.
Abstract:
Factors associated with the magnitude of limitations during recovery from a fracture of the proximal humerus
Aims the purpose of this study was to identify factors associated with limitations in function, measured by patient-reported outcome measures (PROMs), six to nine months after a proximal humeral fracture, from a range of demographic, injury, psychological, and social variables measured within a week and two to four weeks after injury. Patients and Methods We enrolled 177 adult patients who sustained an isolated proximal humeral fracture into the study and invited them to complete PROMs at their initial outpatient visit within one week of injury, between two and four weeks, and between six to nine months after injury. There were 128 women and 49 men; the mean age was 66 years (sd 16; 18 to 95). In all, 173 patients completed the final assessment. Bivariate analysis was performed followed by multivariable regression analysis accounting for multicollinearity using partial R2, correlation matrices, and variable inflation factor. Results Many variables within a week of injury and between two and four weeks after injury correlated with six- to nine-month PROMs in bivariate analysis. Kinesiophobia measured within a week of injury (Tampa Scale for Kinesiophobia-11: partial R2 = 0.14; p = 0.000) and self-efficacy measured between two and four weeks (Pain Self-efficacy Questionnaire-2: partial R2 = 0.266; p < 0.001) were the strongest predictors of limitations (measured by Patient Reported Outcome Measurement Information System Upper Extremity Physical Function Computer Adaptive Test (PROMIS UE)) at six to nine months in multivariable analysis. Similar findings were observed with other types of PROM. Regression models accounted for a substantial amount of variance in all PROMs at both timepoints (e.g. 66% of the overall variance within one week, and 70% within two to four weeks for PROMIS UE at six to nine months). Conclusion Recovery from a proximal humeral fracture appears to be enhanced by overcoming fears of movement or reinjury within a week after injury and greater self-efficacy (developing resilience and more effective coping strategies) within a month. Such factors are modifiable using enhanced communication skills and cognitive behavioural treatments. These findings could be a catalyst for the routine assessment and treatment of psychological and social factors in the management of patients with fractures.
Abstract.
Webster RK, Howick J, Hoffmann T, Macdonald H, Collins GS, Rees JL, Napadow V, Madigan C, Price A, Lamb SE, et al (2019). Inadequate description of placebo and sham controls in a systematic review of recent trials.
Eur J Clin Invest,
49(11).
Abstract:
Inadequate description of placebo and sham controls in a systematic review of recent trials.
BACKGROUND: Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known. MATERIALS AND METHODS: We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS: We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention. CONCLUSIONS: Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.
Abstract.
Author URL.
Lee H, Herbert RD, Lamb SE, Moseley AM, McAuley JH (2019). Investigating causal mechanisms in randomised controlled trials.
Trials,
20(1).
Abstract:
Investigating causal mechanisms in randomised controlled trials.
INTRODUCTION: in some randomised trials, the primary interest is in the mechanisms by which an intervention exerts its effects on health outcomes. That is, clinicians and policy-makers may be interested in how the intervention works (or why it does not work) through hypothesised causal mechanisms. In this article, we highlight the value of understanding causal mechanisms in randomised trials by applying causal mediation analysis to two randomised trials of complex interventions. MAIN BODY: in the first example, we examine a potential mechanism by which an exercise programme for rheumatoid arthritis of the hand could improve hand function. In the second example, we explore why a rehabilitation programme for ankle fractures failed to improve lower-limb function through hypothesised mechanisms. We outline critical assumptions that are required for making valid causal inferences from these analyses, and provide results of sensitivity analyses that are used to assess the degree to which the estimated causal mediation effects could have been biased by residual confounding. CONCLUSION: This paper demonstrates how the application of causal mediation analyses to randomised trials can identify the mechanisms by which complex interventions exert their effects. We discuss methodological issues and assumptions that should be considered when mediation analyses of randomised trials are used to inform clinical practice and policy decisions.
Abstract.
Author URL.
Hopewell S, Copsey B, Nicolson P, Adedire B, Boniface G, Lamb S (2019). Multifactorial interventions for preventing falls in older people living in the community: a systematic review and meta-analysis of 41 trials and almost 20 000 participants.
British Journal of Sports MedicineAbstract:
Multifactorial interventions for preventing falls in older people living in the community: a systematic review and meta-analysis of 41 trials and almost 20 000 participants
Objective: to assess the longer term effects of multifactorial interventions for preventing falls in older people living in the community, and to explore whether prespecific trial-level characteristics are associated with greater fall prevention effects. Design: Systematic review with meta-analysis and meta-regression. Data sources: MEDLINE, EMBASE, CINHAL, CENTRAL and trial registries were searched up to 25 July 2018. Study selection: We included randomised controlled trials (≥12 months' follow-up) evaluating the effects of multifactorial interventions on falls in older people aged 65 years and over, living in the community, compared with either usual care or usual care plus advice. Review methods: Two authors independently verified studies for inclusion, assessed risk of bias and extracted data. Rate ratios (RaR) with 95% CIs were calculated for rate of falls, risk ratios (RR) for dichotomous outcomes and standardised mean difference for continuous outcomes. Data were pooled using a random effects model. The Grading of Recommendations, Assessment, Development and Evaluation was used to assess the quality of the evidence. Results: We included 41 trials totalling 19 369 participants; mean age 72-85 years. Exercise was the most common prespecified component of the multifactorial interventions (85%; n=35/41). Most trials were judged at unclear or high risk of bias in ≥1 domain. Twenty trials provided data on rate of falls and showed multifactorial interventions may reduce the rate at which people fall compared with the comparator (RaR 0.79, 95% CI 0.70 to 0.88; 20 trials; 10 116 participants; I2=90%; low-quality evidence). Multifactorial interventions may also slightly lower the risk of people sustaining one or more falls (RR 0.95, 95% CI 0.90 to 1.00; 30 trials; 13 817 participants; I2=56%; moderate-quality evidence) and recurrent falls (RR 0.88, 95% CI 0.78 to 1.00; 15 trials; 7277 participants; I2=46%; moderate-quality evidence). However, there may be little or no difference in other fall-related outcomes, such as fall-related fractures, falls requiring hospital admission or medical attention and health-related quality of life. Very few trials (n=3) reported on adverse events related to the intervention. Prespecified subgroup analyses showed that the effect on rate of falls may be smaller when compared with usual care plus advice as opposed to usual care only. Overall, heterogeneity remained high and was not explained by the prespecified characteristics included in the meta-regression. Conclusion: Multifactorial interventions (most of which include exercise prescription) may reduce the rate of falls and slightly reduce risk of older people sustaining one or more falls and recurrent falls (defined as two or more falls within a specified time period). Trial registration number: CRD42018102549.
Abstract.
Costa ML, Achten J, Rangan A, Lamb SE, Parsons NR (2019). Percutaneous fixation with Kirschner wires versus volar locking-plate fixation in adults with dorsally displaced fracture of distal radius: Five-year follow-up of a randomized controlled trial.
Bone and Joint Journal,
101 B(8), 978-983.
Abstract:
Percutaneous fixation with Kirschner wires versus volar locking-plate fixation in adults with dorsally displaced fracture of distal radius: Five-year follow-up of a randomized controlled trial
Aims the aim of this study was to compare the clinical effectiveness of Kirschner wire (K-wire) fixation with locking-plate fixation for patients with a dorsally displaced fracture of the distal radius in the five years after injury. Patients and Methods We report the five-year follow-up of a multicentre, two-arm, parallel-group randomized controlled trial. A total of 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation were recruited from 18 trauma centres in the United Kingdom. Patients were excluded if the surface of the wrist joint was so badly displaced it required open reduction. In all, 448 patients were randomized to receive either K-wire fixation or locking-plate fixation. In the K-wire group, there were 179 female and 38 male patients with a mean age of 59.1 years (19 to 89). In the locking-plate group, there were 194 female and 37 male patients with a mean age of 58.3 years (20 to 89). The primary outcome measure was the patient-rated wrist evaluation (PRWE). Secondary outcomes were health-related quality of life using the EuroQol five-dimension three-level (EQ-5D-3L) assessment, and further surgery related to the index fracture. Results at 12 months, 402/448 participants (90%) recruited into the main study provided PRWE scores. At year two, 294 participants (66%) provided scores; at year five, 198 participants (44%) provided scores. There was no clinically relevant difference in the PRWE at any point during the five-year follow-up; at five years, the PRWE score was 8.3 (12.5) in the wire group and 11.3 (15.6) in the plate group (95% confidence interval -6.99 to 0.99; p = 0.139). Nor was there a clinically relevant difference in health-related quality of life. Only three participants had further surgery in the five years after their injury (one in the wire group and two in the plate group). Conclusion This follow-up study continues to show no evidence of a difference in wrist pain, wrist function, or quality of life for patients treated with wires versus locking plates in the five years following a dorsally displaced fracture of the distal radius.
Abstract.
Keene DJ, Alsousou J, Harrison P, Hulley P, Wagland S, Parsons SR, Thompson JY, O’Connor HM, Schlüssel MM, Dutton SJ, et al (2019). Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial.
BMJ, l6132-l6132.
Abstract:
Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial
Abstract
.
. Objective
. To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture.
.
.
. Design
. Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial.
.
.
. Setting
. Secondary care trauma units across 19 hospitals in the United Kingdom’s health service.
.
.
. Participants
. Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions.
.
.
. Interventions
. Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy).
.
.
. Main outcomes and measures
. Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat.
.
.
. Results
.
. Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%)
. v
. 38.5% (22.8%); adjusted mean difference −3.9% (95% confidence interval −10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings.
.
.
.
. Conclusions
. There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit.
.
.
. Trial registration
. ISRCTN54992179.
.
Abstract.
Alsousou J, Keene DJ, Harrison P, Hulley P, Wagland S, Thompson JY, Parsons SR, Byrne C, Schlüssel MM, O’Connor HM, et al (2019). Platelet-rich plasma injection for adults with acute Achilles tendon rupture: the PATH-2 RCT.
Efficacy and Mechanism Evaluation,
6(12), 1-98.
Abstract:
Platelet-rich plasma injection for adults with acute Achilles tendon rupture: the PATH-2 RCT
BackgroundAchilles tendon rupture (ATR) has a long healing period, which is challenging for patients and clinicians. Platelet-rich plasma (PRP) is an autologous concentration of platelets thought to improve tendon function recovery. Although preliminary research has indicated positive effects, there is, as yet, no evidence of clinical efficacy from adequately powered robust clinical trials.ObjectivesThe objectives were to determine the clinical efficacy of PRP in patients with acute ATR using an objective mechanical muscle–tendon function measure and patient-reported outcome measures (PROMs), and to determine which PRP components contribute to its mechanism.DesignThis was a multicentre, parallel-group, participant- and outcome assessor-blinded randomised controlled trial (RCT) comparing PRP with placebo. Two embedded substudies investigated the PRP’s quality and composition and its effects on healing tendon tissues.SettingThis trial was set in trauma and orthopaedic surgery departments in 19 NHS hospitals in England and Wales.ParticipantsAdults with acute ATR presenting within 12 days of injury to be treated non-surgically were eligible. Patients with platelet dysfunction or leg functional deficiency were excluded.InterventionsParticipants were randomised 1 : 1 to the PRP injection group or the placebo group (dry needle in the rupture gap) by central computer-based randomisation using minimisation, stratified by centre and age.Main outcome measuresThe primary outcome measure was the Limb Symmetry Index (LSI) of work during the heel-rise endurance test at 24 weeks. Secondary outcomes measures, collected at 4, 7, 13 and 24 weeks, were repetitions, maximum heel-rise height, Achilles tendon Total Rupture Score (ATRS), quality of life (as measured using the Short Form questionnaire-12 items version 2), pain and participant goal attainment. Needle biopsies of the affected tendon zone were taken under ultrasound guidance at 6 weeks from 16 participants from one centre. Whole blood was analysed for cell count. PRP was analysed for cell count, platelet activation and growth factor concentration. The primary analysis was intention to treat.ResultsA total of 230 participants were randomised: 114 to the PRP group (103 treated) and 116 to the placebo group (all treated). One participant withdrew after randomisation but before the intervention. At 24 weeks, 201 out of 230 participants (87.4%) completed the primary outcome and 216 out of 230 participants (93.9%) completed the PROMs. The treatment groups had similar participant characteristics. At 24 weeks, there was no difference in work LSI (mean difference –3.872; 95% confidence interval –10.454 to 2.710;p = 0.231), ATRS, pain or goal attainment between PRP- and placebo-injected participants. There were no differences between the groups in any PROM at any time point or in complication rates, including re-rupture and deep-vein thrombosis. There was no correlation between work LSI and platelet activation in PRP, or erythrocyte, leucocyte or platelet counts in whole blood or PRP. Biopsies showed similar cellularity and vascularity between groups.ConclusionsThis trial design and standardised PRP preparation gives the first robust RCT evidence about PRP’s role in managing ATR, which suggests that PRP offers no patient benefit. Equally robust evidence to investigate PRP application in tendon and soft tissue injuries is required. The 24-month follow-up will be completed in April 2020.Trial registrationCurrent Controlled Trials ISRCTN54992179.FundingThis project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. The trial was supported by the NIHR Biomedical Research Centre, Oxford, and the NIHR Fellowship programme.
Abstract.
Keene DJ, Vadher K, Willett K, Mistry D, Costa ML, Collins GS, Lamb SE (2019). Predicting patient-reported and objectively measured functional outcome 6 months after ankle fracture in people aged 60 years or over in the UK: Prognostic model development and internal validation.
BMJ Open,
9(7).
Abstract:
Predicting patient-reported and objectively measured functional outcome 6 months after ankle fracture in people aged 60 years or over in the UK: Prognostic model development and internal validation
Objective to predict functional outcomes 6 months after ankle fracture in people aged ≥60 years using post-treatment and 6-week follow-up data to inform anticipated recovery, and identify people who may benefit from additional monitoring or rehabilitation. Design Prognostic model development and internal validation. Setting 24 National Health Service hospitals, UK. Methods Participants were the Ankle Injury Management clinical trial cohort (n=618) (ISRCTN04180738), aged 60-96 years, 459/618 (74%) female, treated surgically or conservatively for unstable ankle fracture. Predictors were injury and sociodemographic variables collected at baseline (acute hospital setting) and 6-week follow-up (clinic). Outcome measures were 6-month postinjury (primary) self-reported ankle function, using the Olerud and Molander Ankle Score (OMAS), and (secondary) Timed up and Go (TUG) test by blinded assessor. Missing data were managed with single imputation. Multivariable linear regression models were built to predict OMAS or TUG, using baseline variables or baseline and 6-week follow-up variables. Models were internally validated using bootstrapping. Results the OMAS baseline data model included: alcohol per week (units), postinjury EQ-5D-3L visual analogue scale (VAS), sex, preinjury walking distance and walking aid use, smoking status and perceived health status. The baseline/6-week data model included the same baseline variables, minus EQ-5D-3L VAS, plus five 6-week predictors: radiological malalignment, injured ankle dorsiflexion and plantarflexion range of motion, and 6-week OMAS and EQ-5D-3L. The models explained approximately 23% and 26% of the outcome variation, respectively. Similar baseline and baseline/6 week data models to predict TUG explained around 30% and 32% of the outcome variation, respectively. Conclusions Predictive accuracy of the prognostic models using commonly recorded clinical data to predict self-reported or objectively measured ankle function was relatively low and therefore unlikely to be beneficial for clinical practice and counselling of patients. Other potential predictors (eg, psychological factors such as catastrophising and fear avoidance) should be investigated to improve predictive accuracy. Trial registration number ISRCTN04180738; Post-results.
Abstract.
Copsey B, Thompson JY, Vadher K, Ali U, Dutton SJ, Fitzpatrick R, Lamb SE, Cook JA (2019). Problems persist in reporting of methods and results for the WOMAC measure in hip and knee osteoarthritis trials.
Qual Life Res,
28(2), 335-343.
Abstract:
Problems persist in reporting of methods and results for the WOMAC measure in hip and knee osteoarthritis trials.
PURPOSE: the Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a commonly used outcome measure for osteoarthritis. There are different versions of the WOMAC (Likert, visual analogue or numeric scales). A previous review of trials published before 2010 found poor reporting and inconsistency in how the WOMAC was used. This review explores whether these problems persist. METHODS: This systematic review included randomised trials of hip and/or knee osteoarthritis published in 2016 that used the WOMAC. Data were extracted on the version used, score range, analysis and results of the WOMAC, and whether these details were clearly reported. RESULTS: This review included 62 trials and 41 reported the WOMAC total score. The version used and item range for the WOMAC total score were unclear in 44% (n = 18/41) and 24% (n = 10/41) of trials, respectively. The smallest total score range was 0-10 (calculated by averaging 24 items scored 0-10); the largest was 0-2400 (calculated by summing 24 items scored 0-100). All trials reported the statistical analysis methods but only 29% reported the between-group mean difference and 95% confidence interval. CONCLUSION: Details on the use and scoring of the WOMAC were often not reported. We recommend that trials report the version of the WOMAC and the score range used. The between-group treatment effect and corresponding confidence interval should be reported. If all the items of the WOMAC are collected, the total score and individual subscale scores should be presented. Better reporting would facilitate the interpretation, comparison and synthesis of the WOMAC score in trials.
Abstract.
Author URL.
Ribeiro DC, Abbott JH, Sharma S, Lamb SE (2019). Process evaluation of complex interventions tested in randomised controlled trials in musculoskeletal disorders: a systematic review protocol.
BMJ Open,
9(5).
Abstract:
Process evaluation of complex interventions tested in randomised controlled trials in musculoskeletal disorders: a systematic review protocol
Introduction the effectiveness of complex interventions for the management of musculoskeletal disorders has been estimated in many randomised clinical trials (RCTs). These trials inform which interventions are the most effective, however they do not always inform how an intervention achieved its clinical outcomes, nor how and what elements of an intervention were delivered to patients. Such information is useful for translating findings into clinical practice. A few process evaluation studies have been conducted alongside RCTs and a variety of methods have been used. To gain a better understanding of current practices of process evaluation in RCTs in musculoskeletal disorders, this systematic review is designed to answer the following research question: How are process evaluation of complex interventions tested in RCTs in musculoskeletal disorders being conducted? Methods and analysis We will systematically search seven electronic databases (MEDLINE, SCOPUS, CINAHL, PsycINFO, EMBASE, Web of Science and Cochrane database) from the date of inception to August 2018 for studies on process evaluation of RCTs on non-surgical and non-pharmacological management of musculoskeletal disorders. We will include qualitative and quantitative studies conducted alongside RCTs, reported with the RCTs or separate studies that assessed interventions for musculoskeletal disorders. Two reviewers will screen abstracts and apply prespecified inclusion criteria to identify relevant studies, extract the data and assess the risk of bias within included studies. We will follow recommendations from the Cochrane Qualitative and Implementation Methods Group Guidance Series' when assessing methodological strengths and limitations of included studies. We will use a narrative synthesis to describe findings. Ethics and dissemination Ethical approval is not required as this review will not collect original data. Findings from this systematic review will be presented at a scientific conference and published in a peer reviewed journal. PROSPERO registration number CRD42018109600
Abstract.
Keene DJ, Costa ML, Tutton E, Hopewell S, Barber VS, Dutton SJ, Redmond AC, Willett K, Lamb SE (2019). Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.
BMJ Open,
9(11).
Abstract:
Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.
INTRODUCTION: Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up. METHODS AND ANALYSIS: a multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group. ETHICS AND DISSEMINATION: Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018. TRIAL REGISTRATION NUMBER: ISRCTN16612336.
Abstract.
Author URL.
Perkins GD, Mistry D, Lall R, Gao-Smith F, Snelson C, Hart N, Camporota L, Varley J, Carle C, Paramasivam E, et al (2019). Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT.
Health Technol Assess,
23(48), 1-114.
Abstract:
Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT.
BACKGROUND: Invasive mechanical ventilation (IMV) is a life-saving intervention. Following resolution of the condition that necessitated IMV, a spontaneous breathing trial (SBT) is used to determine patient readiness for IMV discontinuation. In patients who fail one or more SBTs, there is uncertainty as to the optimum management strategy. OBJECTIVE: to evaluate the clinical effectiveness and cost-effectiveness of using non-invasive ventilation (NIV) as an intermediate step in the protocolised weaning of patients from IMV. DESIGN: Pragmatic, open-label, parallel-group randomised controlled trial, with cost-effectiveness analysis. SETTING: a total of 51 critical care units across the UK. PARTICIPANTS: Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT. INTERVENTIONS: Control group (invasive weaning): patients continued to receive IMV with daily SBTs. A weaning protocol was used to wean pressure support based on the patient's condition. Intervention group (non-invasive weaning): patients were extubated to NIV. A weaning protocol was used to wean inspiratory positive airway pressure, based on the patient's condition. MAIN OUTCOME MEASURES: the primary outcome measure was time to liberation from ventilation. Secondary outcome measures included mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life. RESULTS: a total of 364 patients (invasive weaning, n = 182; non-invasive weaning, n = 182) were randomised. Groups were well matched at baseline. There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p = 0.352}. There was also no difference in mortality between groups at any time point. Patients in the non-invasive weaning group had fewer IMV days [invasive weaning 4 days (IQR 2-11 days) vs. non-invasive weaning 1 day (IQR 0-7 days); adjusted mean difference -3.1 days, 95% CI -5.75 to -0.51 days]. In addition, fewer non-invasive weaning patients required antibiotics for a respiratory infection [odds ratio (OR) 0.60, 95% CI 0.41 to 1.00; p = 0.048]. A higher proportion of non-invasive weaning patients required reintubation than those in the invasive weaning group (OR 2.00, 95% CI 1.27 to 3.24). The within-trial economic evaluation showed that NIV was associated with a lower net cost and a higher net effect, and was dominant in health economic terms. The probability that NIV was cost-effective was estimated at 0.58 at a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. CONCLUSIONS: a protocolised non-invasive weaning strategy did not reduce time to liberation from ventilation. However, patients who underwent non-invasive weaning had fewer days requiring IMV and required fewer antibiotics for respiratory infections. FUTURE WORK: in patients who fail a SBT, which factors predict an adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV? TRIAL REGISTRATION: Current Controlled Trials ISRCTN15635197. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 48. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Jayakumar P, Teunis T, Vranceanu AM, Moore MG, Williams M, Lamb S, Ring D, Gwilym S (2019). Psychosocial factors affecting variation in patient-reported outcomes after elbow fractures.
Journal of Shoulder and Elbow Surgery,
28(8), 1431-1440.
Abstract:
Psychosocial factors affecting variation in patient-reported outcomes after elbow fractures
Background: the purpose of this study was to identify factors associated with limitations in function measured by patient-reported outcome measures (PROMs) 6-9 months after elbow fractures in adults from a range of demographic, injury, psychological, and social variables measured within a week and 2-4 weeks after injury. Methods: We enrolled 191 adult patients sustaining an isolated elbow fracture and invited them to complete PROMs at their initial visit to the orthopedic outpatient clinic (within a maximum of 1 week after fracture), between 2 and 4 weeks, and between 6 and 9 months after injury; 183 patients completed the final assessment. Bivariate analysis was performed, followed by multivariable regression analysis accounting for multicollinearity. This was evaluated using partial R2, correlation matrices, and variable inflation factor assessment. Results: There was a correlation between multiple variables within a week of injury and 2-4 weeks after injury with PROMs 6-9 months after injury in bivariate analysis. Kinesiophobia measured within a week of injury and self-efficacy measured at 2-4 weeks were the strongest predictors of limitations 6-9 months after injury in multivariable regression. Regression models accounted for substantial variance in all PROMs at both time points. Conclusions: Developing effective coping strategies to overcome fears related to movement and reinjury and finding ways of persevering with activity despite pain within a month of injury may enhance recovery after elbow fractures. Heightened fears around movement and suboptimal coping ability are modifiable using evidence-based behavioral treatments.
Abstract.
Jayakumar P, Teunis T, Vranceanu A-M, Lamb S, Ring D, Gwilym S (2019). Relationship Between Magnitude of Limitations and Patient Experience During Recovery from Upper-Extremity Fracture.
JB JS Open Access,
4(3).
Abstract:
Relationship Between Magnitude of Limitations and Patient Experience During Recovery from Upper-Extremity Fracture.
UNLABELLED: the relationship between the magnitude of limitations (measured by patient-reported outcome measures, or PROMs) and satisfaction with care providers and hospital services (measured by patient-reported experience measures, or PREMs) over the course of recovery after injury is unclear. The purpose of this study was to assess the relationship between a range of PROMs and 2 PREMs at 3 time points (initial office visit within a week, 2 to 4 weeks, and 6 to 9 months) after shoulder, elbow, and wrist fractures. METHODS: We enrolled 744 adult patients with an isolated shoulder, elbow, or wrist fracture and invited them to complete PROMs (the Patient-Reported Outcomes Measurement Information System Upper Extremity Physical Function computer adaptive test [PROMIS UE], PROMIS Physical Function (PROMIS PF) scale, Quick Disabilities of the Arm, Shoulder and Hand [QuickDASH] questionnaire, EuroQol 5-Dimensions 3-Level Index [EQ-5D-3L], and Oxford Shoulder Score [OSS], Oxford Elbow Score [OES], or Patient-Rated Wrist Evaluation [PRWE]) and PREMs (Numerical Rating Scale [NRS] for satisfaction with care providers [NRS-C] and for satisfaction with hospital services [NRS-S]) at their initial visit at the outpatient surgical practice (maximum, 1 week after the fracture), between 2 and 4 weeks after the injury, and between 6 and 9 months after the injury. Correlational analysis was performed at each time point. RESULTS: There was moderate correlation between the PROMIS UE and the NRS-C (r = 0.56) and NRS-S (r = 0.59) at 6 to 9 months after injury, which was stronger than the correlation at the 2 to 4-week mark (NRS-C, r = 0.34; NRS-S, r = 0.36) and at the evaluation that took place within a week after the injury (NRS-C, r = 0.18; NRS-S, r = 0.16). These correlational trends were observed with all forms of PROMs. Patients reporting greater limitations after injury were also less satisfied with their care and services. CONCLUSIONS: the increasing alignment of PROMs and PREMs over the course of recovery after an upper-extremity fracture suggests that restored physical function may improve perceptions of satisfaction with care providers and hospital services over time. Future studies should assess factors that could be addressed to improve patient satisfaction and their limitations during recovery after fracture in order to maximize patient outcomes. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Abstract.
Author URL.
Taraldsen K, Thingstad P, Døhl Ø, Follestad T, Helbostad JL, Lamb SE, Saltvedt I, Sletvold O, Halsteinli V (2019). Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-HIP randomised controlled trial.
PLoS ONE,
14(11).
Abstract:
Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-HIP randomised controlled trial
The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p
Abstract.
Knight R, Poulton L, Strickland LH, Hamilton TW, Beard D, Cook J, Dutton SJ, Leal J, Lamb S, Cooper C, et al (2019). Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine.
Trials,
20(1).
Abstract:
Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine.
BACKGROUND: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia; however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. METHODS: SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0-10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. DISCUSSION: the clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. TRIAL REGISTRATION: ISRCTN registry, ISRCTN54191675. Registered on 14 November 2017.
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Author URL.
Achten J, Sones W, Dias J, Hedley H, Cook JA, Dritsaki M, Png ME, Gray A, Lamb SE, Costa ML, et al (2019). Surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: Protocol for Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT 2).
BMJ Open,
9(3).
Abstract:
Surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: Protocol for Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT 2)
Introduction Optimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures. Methods and analysis Adult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-Articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either 'manipulation and surgical fixation with K-wires' or 'manipulation and plaster casting'. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications. Ethics and Dissemination the National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462). The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. Trial registration number ISRCTN11980540; Pre-results.
Abstract.
Soutakbar H, Lamb SE, Silman AJ (2019). The different influence of high levels of physical activity on the incidence of knee OA in overweight and obese men and women-a gender specific analysis.
Osteoarthritis Cartilage,
27(10), 1430-1436.
Abstract:
The different influence of high levels of physical activity on the incidence of knee OA in overweight and obese men and women-a gender specific analysis.
OBJECTIVE: to investigate the influence of physical activity on incidence of knee osteoarthritis (OA) in overweight and obese men and women. DESIGN: Data were extracted from the Osteoarthritis Initiative cohort on 1,667 participants without symptomatic knee OA at baseline. We used logistic regression and marginal effect models to estimate the effect of body mass index (BMI) and reported physical activity score, together with the interaction between them, on the development of radiographic knee OA, symptomatic knee OA and joint space narrowing (JSN) after 96-months. RESULTS: Men in the most active quartile had almost double the likelihood of knee OA, independent of OA definition [e.g. odds ratio (OR) 2.4 (95%CI: 1.2-4.5) for radiographic knee OA]. Interaction analyses showed statistically significant interactions between physical activity and BMI on developing knee OA (i) radiographic OA interaction(P = 0.039), (ii) symptomatic OA interaction(P = 0.022), (iii) JSN interactionP = 0.012). The margin plots in men also demonstrated that the effect of physical activity on different measures of knee OA were modified by high levels of BMI. These effects were not mirrored in women where at all BMI levels, the level of reported physical activity did not influence likelihood of knee OA independent of OA definition. CONCLUSIONS: in overweight and obese men, there appears to be a threshold above which increasing levels of physical activity are associated with higher risk of knee OA. This is absent in women.
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Author URL.
Rees JL, Shah A, Edwards K, Sanchez-Santos MT, Robinson DE, Delmestri A, Carr A, Arden N, Lamb SE, Rangan A, et al (2019). Treatment of first-time traumatic anterior shoulder dislocation: the uk tash-d cohort study.
Health Technology Assessment,
23(18), 1-103.
Abstract:
Treatment of first-time traumatic anterior shoulder dislocation: the uk tash-d cohort study
Background: Shoulder dislocations are the most common joint dislocations seen in emergency departments. Most traumatic cases are anterior and cause recurrent dislocations. Management options include surgical and conservative treatments. There is a lack of evidence about which method is most effective after the first traumatic anterior shoulder dislocation (TASD). Objectives: to produce UK age- and sex-specific incidence rates for TASD. To assess whether or not surgery within 6 months of a first-time TASD decreases re-dislocation rates compared with no surgery. To identify clinical predictors of recurrent dislocation. Design: a population-based cohort study of first-time TASD patients in the UK. An initial validation study and subsequent propensity-score-matched analysis to compare re-dislocation rates between surgery and no surgery after a first-time TASD. Prediction modelling was used to identify potential predictors ofrecurrent dislocation. Setting: UK primary and secondary care data. Participants: Patients with a first-time TASD between 1997 and 2015. Interventions: Stabilisation surgery within 6 months of a first-time TASD (compared with no surgery). Stabilisation surgery within 12 months of a first-time TASD was also carried out as a sensitivity analysis. Main outcome measure: Re-dislocation rate up to 2 years after the first TASD. Methods: Eligible patients were identified from the Clinical Practice Research Datalink (CPRD) (1997–2015). Accuracy of shoulder dislocation coding was internally validated using the CPRD General Practitioner questionnaire service. UK age- and sex-specific incidence rates for TASD were externally validated against rates from the USA and Canada. A propensity-score-matched analysis using linked CPRD and Hospital Episode Statistics (HES) data compared re-dislocation rates for patients aged 16–35 years, comparing surgery with no surgery. Multivariable Cox regression models for predicting re-dislocation were developed for the surgical and non-surgical cohorts. Results: Shoulder dislocation was coded correctly for 89% of cases in the CPRD [95% confidence interval (CI) 83% to 95%], with a ‘primary’ dislocation confirmed for 76% of cases (95% CI 67% to 85%). Far fewer patients than expected received stabilisation surgery within 6 months of a first TASD, leading to an underpowered study. Around 20% of re-dislocation rates were observed for both surgical and non-surgical patients. The sensitivity analysis at 12 months also showed little difference in re-dislocation rates. Missing data on risk factors limited the value of the prediction modelling; however, younger age, epilepsy and sex (male) were identified as statistically significant predictors of re-dislocation. Limitations: Far fewer than the expected number of patients had surgery after a first-time TASD, resulting in an underpowered study. This and residual confounding from missing risk factors mean that it is not possible to draw valid conclusions. Conclusions: This study provides, for the first time, UK data on the age- and sex-specific incidence rates for TASD. Most TASD occurs in men, but an unexpected increased incidence was observed in women aged > 50 years. Surgery after a first-time TASD is uncommon in the NHS. Re-dislocation rates for patients receiving surgery after their first TASD are higher than previously expected; however, important residual confounding risk factors were not recorded in NHS primary and secondary care databases, thus preventing useful recommendations. Future work: the high incidence of TASD justifies investigation into preventative measures for young men participating in contact sports, as well as investigating the risk factors in women aged > 50 years. A randomised controlled trial would account for key confounders missing from CPRD and HES data. A national TASD registry would allow for a more relevant data capture for this patient group. Study registration: Independent Scientific Advisory Committee (ISAC) for the Medicines and Healthcare Products Regulatory Agency (ISAC protocol 15_0260).
Abstract.
Ryan EG, Bruce J, Metcalfe AJ, Stallard N, Lamb SE, Viele K, Young D, Gates S (2019). Using Bayesian adaptive designs to improve phase III trials: a respiratory care example.
BMC Medical Research Methodology,
19(1).
Abstract:
Using Bayesian adaptive designs to improve phase III trials: a respiratory care example
Background: Bayesian adaptive designs can improve the efficiency of trials, and lead to trials that can produce high quality evidence more quickly, with fewer patients and lower costs than traditional methods. The aim of this work was to determine how Bayesian adaptive designs can be constructed for phase III clinical trials in critical care, and to assess the influence that Bayesian designs would have on trial efficiency and study results. Methods: We re-designed the High Frequency OSCillation in Acute Respiratory distress syndrome (OSCAR) trial using Bayesian adaptive design methods, to allow for the possibility of early stopping for success or futility. We constructed several alternative designs and studied their operating characteristics via simulation. We then performed virtual re-executions by applying the Bayesian adaptive designs using the OSCAR data to demonstrate the practical applicability of the designs. Results: We constructed five alternative Bayesian adaptive designs and identified a preferred design based on the simulated operating characteristics, which had similar power to the original design but recruited fewer patients on average. The virtual re-executions showed the Bayesian sequential approach and original OSCAR trial yielded similar trial conclusions. However, using a Bayesian sequential design could have led to a reduced sample size and earlier completion of the trial. Conclusions: Using the OSCAR trial as an example, this case study found that Bayesian adaptive designs can be constructed for phase III critical care trials. If the OSCAR trial had been run using one of the proposed Bayesian adaptive designs, it would have terminated at a smaller sample size with fewer deaths in the trial, whilst reaching the same conclusions. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. Trial registration: OSCAR Trial registration ISRCTN, ISRCTN10416500. Retrospectively registered 13 June 2007.
Abstract.
Metcalfe D, Costa ML, Parsons NR, Achten J, Masters J, Png ME, Lamb SE, Griffin XL (2019). Validation of a prospective cohort study of older adults with hip fractures.
Bone and Joint Journal,
101 B(6), 708-714.
Abstract:
Validation of a prospective cohort study of older adults with hip fractures
Aims This study sought to determine the proportion of older adults with hip fractures captured by a multicentre prospective cohort, the World Hip Trauma Evaluation (WHiTE), whether there was evidence of selection bias during WHiTE recruitment, and the extent to which the WHiTE cohort is representative of the broader population of older adults with hip fractures. Patients and Methods the characteristics of patients recruited into the WHiTE cohort study were compared with those treated at WHiTE hospitals during the same timeframe and submitted to the National Hip Fracture Database (NHFD). Results Patients recruited to WHiTE were more likely to be admitted from their own home (83.5% vs 80.2%; p < 0.001) and to have a higher median Abbreviated Mental Test Score (AMTS) (9 (interquartile range (IQR) 6 to 10) vs 9 (IQR 5 to 10); p < 0.001) than those who were not recruited. In terms of WHiTE cohort generalizability, participating hospitals included a greater proportion of Major Trauma Centres (47.8% vs 7.8%) and large hospitals (997 (IQR 873 to 1290) vs 707 (459 to 903) beds) with high-volume Emergency Departments (median annual attendances of 43 981 (IQR 37 147 to 54 385) vs 35 964 (IQR 26 229 to 50 551)). However, there were few differences in baseline characteristics between patients in the WHiTE cohort and those recorded in the NHFD. Conclusion There is evidence of a weak selection bias towards recruiting fitter patients within the WHiTE cohort, which will help to put into context the findings of future studies. We conclude that the patients within the WHiTE cohort are representative of the national population of older adults with hip fractures throughout England, Wales, and Northern Ireland.
Abstract.
Maredza M, Petrou S, Dritsaki M, Achten J, Griffin J, Lamb SE, Parsons NR, Costa ML (2018). A comparison of the cost-effectiveness of intramedullary nail fixation and locking plate fixation in the treatment of adult patients with an extra-articular fracture of the distal tibia: economic evaluation based on the FixDT trial.
Bone Joint J,
100-B(5), 624-633.
Abstract:
A comparison of the cost-effectiveness of intramedullary nail fixation and locking plate fixation in the treatment of adult patients with an extra-articular fracture of the distal tibia: economic evaluation based on the FixDT trial.
AIMS: the aim of this study was to compare the cost-effectiveness of intramedullary nail fixation and 'locking' plate fixation in the treatment of extra-articular fractures of the distal tibia. PATIENTS AND METHODS: an economic evaluation was conducted from the perspective of the United Kingdom National Health Service (NHS) and personal social services (PSS), based on evidence from the Fixation of Distal Tibia Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients were available for analysis. Costs were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality adjusted life year (QALY) gained, and net monetary benefit. Sensitivity analyses were conducted to test the robustness of cost-effectiveness estimates. RESULTS: Mean NHS and PSS costs were significantly lower for patients treated with an intramedullary nail than for those treated with a locking plate (-£970, 95% confidence interval (CI) -1685 to -256; p = 0.05). There was a small increase in QALYs gained in the nail fixation group (0.01, 95% CI -0.03 to 0.06; p = 0.52). The probability of cost-effectiveness for nail fixation exceeded 90% at cost-effectiveness thresholds as low as £15 000 per additional QALY. The cost-effectiveness results remained robust to several sensitivity analyses. CONCLUSION: This trial-based economic evaluation suggests that nail fixation is a cost-effective alternative to locking plate fixation. Cite this article: Bone Joint J 2018;100-B:624-33.
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Author URL.
Rodgers S, Sbizzera I, Cockayne S, Fairhurst C, Lamb SE, Vernon W, Watson J, Hewitt C, Torgerson D (2018). A nested randomised controlled trial of a newsletter and Post-it® note did not increase postal questionnaire response rates in a falls prevention trial.
F1000Research,
7Abstract:
A nested randomised controlled trial of a newsletter and Post-it® note did not increase postal questionnaire response rates in a falls prevention trial
Background: Attrition (i.e. when participants do not return the questionnaires) is a problem for many randomised controlled trials. The resultant loss of data leads to a reduction in statistical power and can lead to bias. The aim of this study was to assess whether a pre-notification newsletter and/or a handwritten or printed Post-it® note sticker, as a reminder, increased postal questionnaire response rates for participants of randomised controlled trials. Method: This study was a factorial trial embedded within a trial of a falls-prevention intervention among men and women aged ≥65 years under podiatric care. Participants were randomised into one of six groups: newsletter plus handwritten Post-it®; newsletter plus printed Post-it®; newsletter only; handwritten Post-it® only; printed Post-it® only; or no newsletter or Post-it®. The results were combined with those from previous embedded randomised controlled trials in a meta-analysis. Results: the 12-month response rate was 803/826 (97.2%) (newsletter 95.1%, no newsletter 99.3%, printed Post-it® 97.5%, handwritten Post-it® 97.1%, no Post-it® 97.1%). Pre-notification with a newsletter had a detrimental effect on response rates (adjusted odds ratio (OR), 0.14; 95% CI, 0.04 to 0.48; p
Abstract.
Tutton E, Achten J, Lamb SE, Willett K, Costa ML (2018). A qualitative study of patient experience of an open fracture of the lower limb during acute care.
Bone Joint J,
100-B(4), 522-526.
Abstract:
A qualitative study of patient experience of an open fracture of the lower limb during acute care.
AIMS: the aim of this study was to explore the patients' experience of recovery from open fracture of the lower limb in acute care. PATIENTS AND METHODS: a purposeful sample of 20 participants with a mean age of 40 years (20 to 82) (16 males, four females) were interviewed a mean of 12 days (five to 35) after their first surgical intervention took place between July 2012 and July 2013 in two National Health Service (NHS) trusts in England, United Kingdom. The qualitative interviews drew on phenomenology and analysis identified codes, which were drawn together into categories and themes. RESULTS: the findings identify the vulnerability of the patients expressed through three themes; being emotionally fragile, being injured and living with injury. The participants felt a closeness to death and continued uncertainty regarding loss of their limb. They experienced strong emotions while also trying to contain their emotions for the benefit of others. Their sense of self changed as they became a person with visible wounds, needed intimate help, and endured pain. When ready, they imagined what it would be like to live with injury. CONCLUSION: Recovery activities require an increased focus on emotional wellbeing. Surgeons are aware of the need for clinical expertise and for adequate pain relief but may not be as aware that their patients require support regarding their body image and help to imagine their future life. Cite this article: Bone Joint J 2018;100-B:522-6.
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Lamb SE, Mistry D, Alleyne S, Atherton N, Brown D, Copsey B, Dosanjh S, Finnegan S, Fordham B, Griffiths F, et al (2018). Aerobic and strength training exercise programme for cognitive impairment in people with mild to moderate dementia: the DAPA RCT.
Health Technol Assess,
22(28), 1-202.
Abstract:
Aerobic and strength training exercise programme for cognitive impairment in people with mild to moderate dementia: the DAPA RCT.
BACKGROUND: Approximately 670,000 people in the UK have dementia. Previous literature suggests that physical exercise could slow dementia symptom progression. OBJECTIVES: to estimate the clinical effectiveness and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD) and carer burden and HRQoL. DESIGN: Intervention development, systematic review, multicentred, randomised controlled trial (RCT) with a parallel economic evaluation and qualitative study. SETTING: 15 English regions. PARTICIPANTS: People with MMD living in the community. INTERVENTION: a 4-month moderate- to high-intensity, structured exercise programme designed specifically for people with MMD, with support to continue unsupervised physical activity thereafter. Exercises were individually prescribed and progressed, and participants were supervised in groups. The comparator was usual practice. MAIN OUTCOME MEASURES: the primary outcome was the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). The secondary outcomes were function [as measured using the Bristol Activities of Daily Living Scale (BADLS)], generic HRQoL [as measured using the EuroQol-5 Dimensions, three-level version (EQ-5D-3L)], dementia-related QoL [as measured using the Quality of Life in Alzheimer's Disease (QoL-AD) scale], behavioural symptoms [as measured using the Neuropsychiatric Inventory (NPI)], falls and fractures, physical fitness (as measured using the 6-minute walk test) and muscle strength. Carer outcomes were HRQoL (Quality of Life in Alzheimer's Disease) (as measured using the EQ-5D-3L) and carer burden (as measured using the Zarit Burden Interview). The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained from a NHS and Personal Social Services perspective. We measured health and social care use with the Client Services Receipt Inventory. Participants were followed up for 12 months. RESULTS: Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care and 329 to the intervention. The mean age of participants was 77 years [standard deviation (SD) 7.9 years], 39% (193/494) were female and the mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates, with 65% (214/329) attending between 75% and 100% of sessions. Outcome data were obtained for 85% (418/494) of participants at 12 months, at which point a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), with a mean difference of -1.4 [95% confidence interval (CI) -2.62 to -0.17]. There were no treatment effects for any of the other secondary outcome measures for participants or carers: for the BADLS there was a mean difference of -0.6 (95% CI -2.05 to 0.78), for the EQ-5D-3L a mean difference of -0.002 (95% CI -0.04 to 0.04), for the QoL-AD scale a mean difference of 0.7 (95% CI -0.21 to 1.65) and for the NPI a mean difference of -2.1 (95% CI -4.83 to 0.65). Four serious adverse events were reported. The exercise intervention was dominated in health economic terms. LIMITATIONS: in the absence of definitive guidance and rationale, we used a mixed exercise programme. Neither intervention providers nor participants could be masked to treatment allocation. CONCLUSIONS: This is a large well-conducted RCT, with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function or HRQoL in people with dementia or on carer burden. FUTURE WORK: Future work should concentrate on approaches other than exercise to influence cognitive impairment in dementia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32612072. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full programme and will be published in full in Health Technology Assessment Vol. 22, No. 28. See the NIHR Journals Library website for further project information. Additional funding was provided by the Oxford NIHR Biomedical Research Centre and the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care.
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Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE (2018). An online hand exercise intervention for adults with rheumatoid arthritis (mySARAH): Design, development, and usability testing.
Journal of Medical Internet Research,
20(6).
Abstract:
An online hand exercise intervention for adults with rheumatoid arthritis (mySARAH): Design, development, and usability testing
Background: the Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, progressive 12-week exercise program for people with hand problems due to rheumatoid arthritis. The program was shown to be clinically and cost-effective in a large clinical trial and is recommended by the UK National Institute for Health and Care Excellence (NICE) guidelines for rheumatoid arthritis in adults. Objective: We have developed an online version of the SARAH program (mySARAH) to make the SARAH program widely accessible to people with rheumatoid arthritis. The purposes of this study were to develop mySARAH and to evaluate and address its usability issues. Methods: We developed mySARAH using a three-step process and gaining feedback from patient contributors. After initial development, mySARAH was tested in two iterative usability cycles in nine participants using a simplified think-aloud protocol and self-reported questionnaires. We also evaluated if participants executed the SARAH exercises correctly after watching the exercise videos included on the website. Results: a preliminary version of mySARAH consisting of six sessions over a 12-week period and delivered via text, exercise videos, images, exercise plan form, exercise calendar, and links to additional information on rheumatoid arthritis was developed. Five participants (1 male; 4 females; median age 64 years) and four participants (four females; median age 64.5 years) took part in the first and second usability testing cycles respectively. Usability issues identified from Cycle 1 such as having a navigation tutorial video and individualised feedback on pain levels were addressed prior to Cycle 2. The need for more instructions to complete the mySARAH patient forms was identified in Cycle 2 and was rectified. Self-reports from both cycles indicated that participants found the program useful and easy to use and were confident in performing the SARAH exercises themselves. Eight of the nine participants correctly demonstrated all the exercises. Conclusions: mySARAH is the first online hand exercise intervention for people with rheumatoid arthritis. We actively involved target users in the development and usability evaluation and ensured mySARAH met their needs and preferences.
Abstract.
Nanchahal J, Ball C, Davidson D, Williams L, Sones W, McCann FE, Cabrita M, Swettenham J, Cahoon NJ, Copsey B, et al (2018). Anti-Tumour Necrosis Factor Therapy for Dupuytren's Disease: a Randomised Dose Response Proof of Concept Phase 2a Clinical Trial.
EBioMedicine,
33, 282-288.
Abstract:
Anti-Tumour Necrosis Factor Therapy for Dupuytren's Disease: a Randomised Dose Response Proof of Concept Phase 2a Clinical Trial.
BACKGROUND: Dupuytren's disease is a common fibrotic condition of the hand that causes irreversible flexion contractures of the fingers, with no approved therapy for early stage disease. Our previous analysis of surgically-excised tissue defined tumour necrosis factor (TNF) as a potential therapeutic target. Here we assessed the efficacy of injecting nodules of Dupuytren's disease with a TNF inhibitor. METHODS: Patients were randomised to receive adalimumab on one occasion in dose cohorts of 15 mg in 0.3 ml, 35 mg in 0.7 ml, or 40 mg in 0.4 ml, or an equivalent volume of placebo in a 3:1 ratio. Two weeks later the injected tissue was surgically excised and analysed. The primary outcome measure was levels of mRNA expression for α-smooth muscle actin (ACTA2). Secondary outcomes included levels of α-SMA and collagen proteins. The trial was registered with ClinicalTrial.gov (NCT03180957) and the EudraCT (2015-001780-40). FINDINGS: We recruited 28 patients, 8 assigned to the 15 mg, 12 to the 35 mg and 8 to the 40 mg adalimumab cohorts. There was no change in mRNA levels for ACTA2, COL1A1, COL3A1 and CDH11. Levels of α-SMA protein expression in patients treated with 40 mg adalimumab (1.09 ± 0.09 ng per μg of total protein) were significantly lower (p = 0.006) compared to placebo treated patients (1.51 ± 0.09 ng/μg). The levels of procollagen type I protein expression were also significantly lower (p
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Williamson E, Ward L, Vadher K, Dutton SJ, Parker B, Petrou S, Hutchinson CE, Gagen R, Arden NK, Barker K, et al (2018). Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol.
BMJ Open,
8(10).
Abstract:
Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol.
INTRODUCTION: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. METHODS AND ANALYSIS: This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by 'intention to treat'. There is a parallel health economic evaluation and qualitative study. ETHICS AND DISSEMINATION: Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. TRIAL REGISTRATION NUMBER: ISRCTN12698674; Pre-results.
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Cockayne S, Pighills A, Adamson J, Fairhurst C, Drummond A, Hewitt C, Rodgers S, Ronaldson SJ, Lamb SE, Crossland S, et al (2018). Can occupational therapist-led home environmental assessment prevent falls in older people? a modified cohort randomised controlled trial protocol.
BMJ Open,
8(9).
Abstract:
Can occupational therapist-led home environmental assessment prevent falls in older people? a modified cohort randomised controlled trial protocol
Introduction Falls and fall-related injuries are a serious cause of morbidity and cost to society. Environmental hazards are implicated as a major contributor to falls among older people. A recent Cochrane review found an environmental assessment, undertaken by an occupational therapist, to be an effective approach to reducing falls. However, none of the trials included a cost-effectiveness evaluation in the UK setting. This protocol describes a large multicentre trial investigating the clinical and cost-effectiveness of environmental assessment and modification within the home with the aim of preventing falls in older people. Methods and analysis a two-arm, modified cohort randomised controlled trial, conducted within England, with 1299 community-dwelling participants aged 65 years and above, who are at an increased risk of falls. Participants will be randomised 2:1 to receive either usual care or home assessment and modification. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by monthly patient self-report falls calendars. Secondary self-reported outcome measures include: the proportion of single and multiple fallers, time to first fall over a 12-month period, quality of life (EuroQoL EQ-5D-5L) and health service utilisation at 4, 8 and 12 months. A nested qualitative study will examine the feasibility of providing the intervention and explore barriers, facilitators, workload implications and readiness to employ these interventions into routine practice. An economic evaluation will assess value for money in terms of cost per fall averted. Ethics and dissemination This study protocol (including the original application and subsequent amendments) received a favourable ethical opinion from National Health Service West of Scotland REC 3. The trial results will be published in peer-reviewed journals and at conference presentations. A summary of the findings will be sent to participants.
Abstract.
Corbacho B, Cockayne S, Fairhurst C, Hewitt CE, Hicks K, Kenan A-M, Lamb SE, MacIntosh C, Menz HB, Redmond AC, et al (2018). Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: the REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings.
Gerontology,
64(5), 503-512.
Abstract:
Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: the REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings.
BACKGROUND: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. OBJECTIVE: to evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. METHODS: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet (n = 517). PRIMARY OUTCOME: incidence of falls per participant in the 12 months following randomisation. SECONDARY OUTCOMES: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. RESULTS: There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73-1.05, p = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI -0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP -69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. CONCLUSION: the benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.
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Author URL.
Dritsaki M, Gray A, Petrou S, Dutton S, Lamb SE, Thorn JC (2018). Current UK Practices on Health Economics Analysis Plans (HEAPs): Are We Using Heaps of Them?.
Pharmacoeconomics,
36(2), 253-257.
Author URL.
Lamb SE, Sheehan B, Atherton N, Nichols V, Collins H, Mistry D, Dosanjh S, Slowther AM, Khan I, Petrou S, et al (2018). Dementia and Physical Activity (DAPA) trial of moderate to high intensity exercise training for people with dementia: randomised controlled trial.
BMJ,
361Abstract:
Dementia and Physical Activity (DAPA) trial of moderate to high intensity exercise training for people with dementia: randomised controlled trial.
OBJECTIVE: to estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia. DESIGN: Multicentre, pragmatic, investigator masked, randomised controlled trial. SETTING: National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions. PARTICIPANTS: 494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm. INTERVENTIONS: Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises. MAIN OUTCOME MEASURES: the primary outcome was score on the Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention. RESULTS: the average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference -1.4, 95% confidence interval -2.6 to -0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer's disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m). CONCLUSION: a moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10416500.
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Author URL.
Finnegan S, Bruce J, Skelton DA, Withers EJ, Lamb SE, PreFIT Study Group (2018). Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT).
Physiotherapy,
104(1), 72-79.
Abstract:
Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT).
OBJECTIVE: This paper describes the development and implementation of an exercise intervention to prevent falls within the Prevention of Fall Injury Trial (PreFIT), which is a large multi-centred randomised controlled trial based in the UK National Health Service (NHS). DESIGN: Using the template for intervention description and replication (TIDieR) checklist, to describe the rationale and processes for treatment selection and delivery of the PreFIT exercise intervention. PARTICIPANTS: Based on the results of a validated falls and balance survey, participants were eligible for the exercise intervention if they were at moderate or high risk of falling. INTERVENTIONS: Intervention development was informed using the current evidence base, published guidelines, and pre-existing surveys of clinical practice, a pilot study and consensus work with therapists and practitioners. The exercise programme targets lower limb strength and balance, which are known, modifiable risk factors for falling. Treatment was individually tailored and progressive, with seven recommended contacts over a six-month period. Clinical Trials Registry (ISCTRN 71002650).
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Author URL.
Schlussel MM, Keene DJ, Collins GS, Bostock J, Byrne C, Goodacre S, Gwilym S, Hagan DA, Haywood K, Thompson J, et al (2018). Development and prospective external validation of a tool to predict poor recovery at 9 months after acute ankle sprain in UK emergency departments: the SPRAINED prognostic model.
BMJ Open,
8(11).
Abstract:
Development and prospective external validation of a tool to predict poor recovery at 9 months after acute ankle sprain in UK emergency departments: the SPRAINED prognostic model.
OBJECTIVES: to develop and externally validate a prognostic model for poor recovery after ankle sprain. SETTING AND PARTICIPANTS: Model development used secondary data analysis of 584 participants from a UK multicentre randomised clinical trial. External validation used data from 682 participants recruited in 10 UK emergency departments for a prospective observational cohort. OUTCOME AND ANALYSIS: Poor recovery was defined as presence of pain, functional difficulty or lack of confidence in the ankle at 9 months after injury. Twenty-three baseline candidate predictors were included together in a multivariable logistic regression model to identify the best predictors of poor recovery. Relationships between continuous variables and the outcome were modelled using fractional polynomials. Regression parameters were combined over 50 imputed data sets using Rubin's rule. To minimise overfitting, regression coefficients were multiplied by a heuristic shrinkage factor and the intercept re-estimated. Incremental value of candidate predictors assessed at 4 weeks after injury was explored using decision curve analysis and the baseline model updated. The final models included predictors selected based on the Akaike information criterion (p
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Richmond H, Lait C, Srikesavan C, Williamson E, Moser J, Newman M, Betteley L, Fordham B, Rees S, Lamb SE, et al (2018). Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER).
BMC Health Serv Res,
18(1).
Abstract:
Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER).
BACKGROUND: Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER). METHODS: a pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres. DISCUSSION: the PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN 35358984.
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Author URL.
Ali UM, Judge A, Foster C, Brooke A, James K, Marriott T, Lamb SE (2018). Do portable nursing stations within bays of hospital wards reduce the rate of inpatient falls? an interrupted time-series analysis.
Age Ageing,
47(6), 818-824.
Abstract:
Do portable nursing stations within bays of hospital wards reduce the rate of inpatient falls? an interrupted time-series analysis.
BACKGROUND: falls can negatively affect patients, resulting in loss of independence and functional decline and have substantial healthcare costs. Hospitals are a high-risk falls environment and regularly introduce, but seldom evaluate, policies to reduce inpatient falls. This study evaluated whether introducing portable nursing stations in ward bays to maximise nurse-patient contact time reduced inpatient falls. METHODS: inpatient falls data from local hospital incident reporting software (Datix) were collected monthly (April 2014-December 2017) from 17 wards in Stoke Mandeville and Wycombe General Hospitals, the UK. Portable nursing stations were introduced in bays on these wards from April 2016. We used a natural experimental study design and interrupted time series analysis to evaluate changes in fall rates, measured by the monthly rate of falls per 1000 occupied bed days (OBDs). RESULTS: the wards reported 2875 falls (April 2014-December 2017). The fallers' mean age was 78 (SD = 13) and 58% (1624/2817) were men. Most falls, 99.41% (2858/2875), resulted in none, low or moderate harm, 0.45% (13/2875) in severe harm and 0.14% (4/2875) in death. The monthly falls rate increased by 0.119 per 1000 OBDs (95% CI: 0.045, 0.194; P = 0.002) before April 2016, then decreased by 0.222 per 1000 OBDs (95% CI: -0.350, -0.093; P = 0.001) until December 2017. At 12 months post-intervention, the absolute difference between the estimated post-intervention trend and pre-intervention projected estimate was 2.84 falls per 1000 OBDs, a relative reduction of 26.71%. CONCLUSION: portable nursing stations were associated with lower monthly falls rates and could reduce inpatient falls across the NHS.
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Author URL.
Costa ML, Achten J, Bruce J, Tutton E, Petrou S, Lamb SE, Parsons NR, UK WOLLF Collaboration (2018). Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults with Severe Open Fracture of the Lower Limb: the WOLLF Randomized Clinical Trial.
JAMA,
319(22), 2280-2288.
Abstract:
Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults with Severe Open Fracture of the Lower Limb: the WOLLF Randomized Clinical Trial.
IMPORTANCE: Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing. OBJECTIVES: to assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires. INTERVENTIONS: NPWT (n = 226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (n = 234). MAIN OUTCOMES AND MEASURES: Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to -0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months. RESULTS: Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patients' Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, -3.9 [95% CI, -8.9 to 1.2]; P = .13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0% [95% CI, -4.2% to 6.3%]; P = .64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, -0.05 to 0.08]; Short Form-12 Physical Component Score, 0.5 [95% CI, -3.1 to 4.1] and Mental Health Component Score, -0.4 [95% CI, -2.2 to 1.4]). CONCLUSIONS AND RELEVANCE: Among patients with severe open fracture of the lower limb, use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months. The findings do not support this treatment for severe open fractures. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN33756652.
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Perkins GD, Mistry D, Gates S, Gao F, Snelson C, Hart N, Camporota L, Varley J, Carle C, Paramasivam E, et al (2018). Effect of Protocolized Weaning with Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation from Mechanical Ventilation Among Patients with Respiratory Failure: the Breathe Randomized Clinical Trial.
JAMA,
320(18), 1881-1888.
Abstract:
Effect of Protocolized Weaning with Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation from Mechanical Ventilation Among Patients with Respiratory Failure: the Breathe Randomized Clinical Trial.
IMPORTANCE: in adults in whom weaning from invasive mechanical ventilation is difficult, noninvasive ventilation may facilitate early liberation, but there is uncertainty about its effectiveness in a general intensive care patient population. OBJECTIVE: to investigate among patients with difficulty weaning the effects of protocolized weaning with early extubation to noninvasive ventilation on time to liberation from ventilation compared with protocolized invasive weaning. DESIGN, SETTING, AND PARTICIPANTS: Randomized, allocation-concealed, open-label, multicenter clinical trial enrolling patients between March 2013 and October 2016 from 41 intensive care units in the UK National Health Service. Follow-up continued until April 2017. Adults who received invasive mechanical ventilation for more than 48 hours and in whom a spontaneous breathing trial failed were enrolled. INTERVENTIONS: Patients were randomized to receive either protocolized weaning via early extubation to noninvasive ventilation (n = 182) or protocolized standard weaning (continued invasive ventilation until successful spontaneous breathing trial, followed by extubation) (n = 182). MAIN OUTCOMES AND MEASURES: Primary outcome was time from randomization to successful liberation from all forms of mechanical ventilation among survivors, measured in days, with the minimal clinically important difference defined as 1 day. Secondary outcomes were duration of invasive and total ventilation (days), reintubation or tracheostomy rates, and survival. RESULTS: Among 364 randomized patients (mean age, 63.1 [SD, 14.8] years; 50.5% male), 319 were evaluable for the primary effectiveness outcome (41 died before liberation, 2 withdrew, and 2 were discharged with ongoing ventilation). The median time to liberation was 4.3 days in the noninvasive group vs 4.5 days in the invasive group (adjusted hazard ratio, 1.1; 95% CI, 0.89-1.40). Competing risk analysis accounting for deaths had a similar result (adjusted hazard ratio, 1.1; 95% CI, 0.86-1.34). The noninvasive group received less invasive ventilation (median, 1 day vs 4 days; incidence rate ratio, 0.6; 95% CI, 0.47-0.87) and fewer total ventilator days (median, 3 days vs 4 days; incidence rate ratio, 0.8; 95% CI, 0.62-1.0). There was no significant difference in reintubation, tracheostomy rates, or survival. Adverse events occurred in 45 patients (24.7%) in the noninvasive group compared with 47 (25.8%) in the invasive group. CONCLUSIONS AND RELEVANCE: Among patients requiring mechanical ventilation in whom a spontaneous breathing trial had failed, early extubation to noninvasive ventilation did not shorten time to liberation from any ventilation. TRIAL REGISTRATION: ISRCTN Identifier: ISRCTN15635197.
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Fordham B, Sugavanam T, Hopewell S, Hemming K, Howick J, Kirtley S, das Nair R, Hamer-Hunt J, Lamb SE (2018). Effectiveness of cognitive-behavioural therapy: a protocol for an overview of systematic reviews and meta-analyses.
BMJ Open,
8(12).
Abstract:
Effectiveness of cognitive-behavioural therapy: a protocol for an overview of systematic reviews and meta-analyses.
INTRODUCTION: Cognitive-behavioural therapy (CBT) is a psychological therapy that has been used to improve patient well-being across multiple mental and physical health problems. Its effectiveness has been examined in thousands of randomised control trials that have been synthesised into hundreds of systematic reviews. The aim of this overview is to map, synthesise and assess the reliability of evidence generated from these systematic reviews of the effectiveness of CBT across all health conditions, patient groups and settings. METHODS AND ANALYSIS: We will run our search strategy, to identify systematic reviews of CBT, within the Database of Abstracts of Reviews of Effects, the Cochrane Library of Systematic Reviews, MEDLINE, Embase, PsycInfo, CINAHL, Child Development and Adolescent Studies, and OpenGrey between January 1992 and 25 April 2018. Independent reviewers will sift, perform data extraction in duplicate and assess the quality of the reviews using the Assessing the Methodological Quality of Systematic Reviews (V.2) tool. The outcomes of interest include: health-related quality of life, depression, anxiety, psychosis and physical/physiological outcomes prioritised in the individual reviews. The evidence will be mapped and synthesised where appropriate by health problem, patient subgroups, intervention type, context and outcome. ETHICS AND DISSEMINATION: Ethical approval is not required as this is an overview of published systematic reviews. We plan to publish results in peer-reviewed journals and present at international and national academic, clinical and patient conferences. TRIAL REGISTRATION NUMBER: CRD42017078690.
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Author URL.
Williams MA, Srikesavan C, Heine PJ, Bruce J, Brosseau L, Hoxey-Thomas N, Lamb SE (2018). Exercise for rheumatoid arthritis of the hand.
Cochrane Database Syst Rev,
7(7).
Abstract:
Exercise for rheumatoid arthritis of the hand.
BACKGROUND: Rheumatoid arthritis is an inflammatory polyarthritis that frequently affects the hands and wrists. Hand exercises are prescribed to improve mobility and strength, and thereby hand function. OBJECTIVES: to determine the benefits and harms of hand exercise in adults with rheumatoid arthritis. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, Embase, CINAHL, AMED, Physiotherapy Evidence Database (PEDro), OTseeker, Web of Science, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) up to July 2017. SELECTION CRITERIA: We considered all randomised or quasi-randomised controlled trials that compared hand exercise with any non-exercise therapy. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as outlined by the Cochrane Musculoskeletal Group. MAIN RESULTS: We included seven studies involving 841 people (aged 20 to 94 years) in the review. Most studies used validated diagnostic criteria and involved home programmes.Very low-quality evidence (due to risk of bias and imprecision) from one study indicated uncertainty about whether exercise improves hand function in the short term (< 3 months). On a 0 to 80 points hand function test (higher scores mean better function), the exercise group (n = 11) scored 76.1 points and control group (n = 13) scored 75 points.Moderate-quality evidence (due to risk of bias) from one study indicated that exercise compared to usual care probably slightly improves hand function (mean difference (MD) 4.5, 95% confidence interval (CI) 1.58 to 7.42; n = 449) in the medium term (3 to 11 months) and in the long term (12 months or beyond) (MD 4.3, 95% CI 0.86 to 7.74; n = 438). The absolute change on a 0-to-100 hand function scale (higher scores mean better function) and number needed to treat for an additional beneficial outcome (NNTB) were 5% (95% CI 2% to 7%); 8 (95% CI 5 to 20) and 4% (95% CI 1% to 8%); 9 (95% CI 6 to 27), respectively. A 4% to 5% improvement indicates a minimal clinical benefit.Very low-quality evidence (due to risk of bias and imprecision) from two studies indicated uncertainty about whether exercise compared to no treatment improved pain (MD -27.98, 95% CI -48.93 to -7.03; n = 124) in the short term. The absolute change on a 0-to-100-millimetre scale (higher scores mean more pain) was -28% (95% CI -49% to -7%) and NNTB 2 (95% CI 2 to 11).Moderate-quality evidence (due to risk of bias) from one study indicated that there is probably little or no difference between exercise and usual care on pain in the medium (MD -2.8, 95% CI - 6.96 to 1.36; n = 445) and long term (MD -3.7, 95% CI -8.1 to 0.7; n = 437). On a 0-to-100 scale, the absolute changes were -3% (95% CI -7% to 2%) and -4% (95% CI -8% to 1%), respectively.Very low-quality evidence (due to risk of bias and imprecision) from three studies (n = 141) indicated uncertainty about whether exercise compared to no treatment improved grip strength in the short term. The standardised mean difference for the left hand was 0.44 (95% CI 0.11 to 0.78), re-expressed as 3.5 kg (95% CI 0.87 to 6.1); and for the right hand 0.46 (95% CI 0.13 to 0.8), re-expressed as 4 kg (95% CI 1.13 to 7).High-quality evidence from one study showed that exercise compared to usual care has little or no benefit on mean grip strength (in kg) of both hands in the medium term (MD 1.4, 95% CI -0.27 to 3.07; n = 400), relative change 11% (95% CI -2% to 13%); and in the long term (MD 1.2, 95% CI -0.62 to 3.02; n = 355), relative change 9% (95% CI -5% to 23%).Very low-quality evidence (due to risk of bias and imprecision) from two studies (n = 120) indicated uncertainty about whether exercise compared to no treatment improved pinch strength (in kg) in the short term. The MD and relative change for the left and right hands were 0.51 (95% CI 0.13 to 0.9) and 44% (95% CI 11% to 78%); and 0.82 (95% CI 0.43 to 1.21) and 68% (95% CI 36% to 101%).High-quality evidence from one study showed that exercise compared to usual care has little or no benefit on mean pinch strength of both hands in the medium (MD 0.3, 95% CI -0.14 to 0.74; n = 396) and long term (MD 0.4, 95% CI -0.08 to 0.88; n = 351). The relative changes were 8% (95% CI -4% to 19%) and 10% (95% CI -2% to 22%).No study evaluated the American College of Rheumatology 50 criteria.Moderate-quality evidence (due to risk of bias) from one study indicated that people who also received exercise with strategies for adherence were probably more adherent than those who received routine care alone in the medium term (risk ratio 1.31, 95% CI 1.15 to 1.48; n = 438) and NNTB 6 (95% CI 4 to 10). In the long term, the risk ratio was 1.09 (95% CI 0.93 to 1.28; n = 422).Moderate-quality evidence (due to risk of bias) from one study (n = 246) indicated no adverse events with exercising. The other six studies did not report adverse events. AUTHORS' CONCLUSIONS: it is uncertain whether exercise improves hand function or pain in the short term. It probably slightly improves function but has little or no difference on pain in the medium and long term. It is uncertain whether exercise improves grip and pinch strength in the short term, and probably has little or no difference in the medium and long term. The ACR50 response is unknown. People who received exercise with adherence strategies were probably more adherent in the medium term than who did not receive exercise, but with little or no difference in the long term. Hand exercise probably does not lead to adverse events. Future research should consider hand and wrist function as their primary outcome, describe exercise following the TIDieR guidelines, and evaluate behavioural strategies.
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Author URL.
Richmond H, Hall AM, Hansen Z, Williamson E, Davies D, Lamb SE (2018). Exploring physiotherapists' experiences of implementing a cognitive behavioural approach for managing low back pain and identifying barriers to long-term implementation.
Physiotherapy,
104(1), 107-115.
Abstract:
Exploring physiotherapists' experiences of implementing a cognitive behavioural approach for managing low back pain and identifying barriers to long-term implementation.
OBJECTIVES: Our objectives were two-fold: (i) to describe physiotherapists' experiences of implementing a cognitive behavioural approach (CBA) for managing low back pain (LBP) after completing an extensive online training course (iBeST), and (ii) to identify how iBeST could be enhanced to support long-term implementation before scale up for widespread use. DESIGN: We conducted semi-structured interviews with 11 physiotherapists from six National Health Service departments in the Midlands, Oxfordshire and Derbyshire. Questions centred on (i) using iBeST to support implementation, (ii) what barriers they encountered to implementation and (iii) what of information or resources they required to support sustained implementation. Interviews were transcribed and thematically analysed using NVivo. Themes were categorised using the Theoretical Domains Framework (TDF). Evidence-based techniques were identified using the behaviour change technique taxonomy to target relevant TDF domains. RESULTS: Three themes emerged from interviews: anxieties about using a CBA, experiences of implementing a CBA, and sustainability for future implementation of a CBA. Themes crossed multiple TDF domains and indicated concerns with knowledge, beliefs about capabilities and consequences, social and professional roles, social influences, emotion, and environmental context and resources. We identified evidence-based strategies that may support sustainable implementation of a CBA for LBP in a physiotherapy setting. CONCLUSIONS: This study highlighted potential challenges for physiotherapists in the provision of evidence-based LBP care within the current UK NHS. Using the TDF provided the foundation to develop a tailored, evidence-based, implementation intervention to support long term use of a CBA by physiotherapists managing LBP within UK NHS outpatient departments.
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Author URL.
Maredza M, Petrou S, Dritsaki M, Achten J, Griffin J, Lamb SE, Parsons NR, Costa ML (2018). Infographic: Economic justification for intramedullary nail fixation over locking plate fixation for extra-articular distal tibial fractures.
Bone Joint J,
100-B(5), 622-623.
Author URL.
Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, Maredza M, Dritsaki M, Wood T, Masters J, et al (2018). Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT.
Health Technol Assess,
22(25), 1-148.
Abstract:
Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT.
BACKGROUND: the best treatment for fractures of the distal tibia remains controversial. Most of these fractures require surgical fixation, but the outcomes are unpredictable and complications are common. OBJECTIVES: to assess disability, quality of life, complications and resource use in patients treated with intramedullary (IM) nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia. DESIGN: This was a multicentre randomised trial. SETTING: the trial was conducted in 28 UK acute trauma centres from April 2013 to final follow-up in February 2017. PARTICIPANTS: in total, 321 adult patients were recruited. Participants were excluded if they had open fractures, fractures involving the ankle joint, contraindication to nailing or inability to complete questionnaires. INTERVENTIONS: IM nail fixation (n = 161), in which a metal rod is inserted into the hollow centre of the tibia, versus locking plate fixation (n = 160), in which a plate is attached to the surface of the tibia with fixed-angle screws. MAIN OUTCOME MEASURES: the primary outcome measure was the Disability Rating Index (DRI) score, which ranges from 0 points (no disability) to 100 points (complete disability), at 6 months with a minimum clinically important difference of 8 points. The DRI score was also collected at 3 and 12 months. The secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life as measured using EuroQol-5 Dimensions (EQ-5D), complications such as infection, and further surgery. Resource use was collected to inform the health economic evaluation. RESULTS: Participants had a mean age of 45 years (standard deviation 16.2 years), were predominantly male (61%, 197/321) and had experienced traumatic injury after a fall (69%, 223/321). There was no statistically significant difference in DRI score at 6 months [IM nail fixation group, mean 29.8 points, 95% confidence interval (CI) 26.1 to 33.7 points; locking plate group, mean 33.8 points, 95% CI 29.7 to 37.9 points; adjusted difference, 4.0 points, 95% CI -1.0 to 9.0 points; p = 0.11]. There was a statistically significant difference in DRI score at 3 months in favour of IM nail fixation (IM nail fixation group, mean 44.2 points, 95% CI 40.8 to 47.6 points; locking plate group, mean 52.6 points, 95% CI 49.3 to 55.9 points; adjusted difference 8.8 points, 95% CI 4.3 to 13.2 points; p
Abstract.
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Zadro JR, Shirley D, Ferreira M, Carvalho Silva AP, Lamb SE, Cooper C, Ferreira PH (2018). Is Vitamin D Supplementation Effective for Low Back Pain? a Systematic Review and Meta-Analysis.
Pain Physician,
21(2), 121-145.
Abstract:
Is Vitamin D Supplementation Effective for Low Back Pain? a Systematic Review and Meta-Analysis.
BACKGROUND: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Current intervention strategies are failing to reduce the enormous global burden of LBP and are prompting researchers to investigate alternative management strategies, such as vitamin D supplementation. Vitamin D supplementation appears to down regulate pro-inflammatory cytokines which lead to pain and up regulate anti-inflammatory cytokines that reduce inflammation. These mechanisms might explain the increasing interest in the use of vitamin D supplementation for LBP. OBJECTIVES: to determine whether vitamin D supplementation improves pain more than a control intervention for individuals with LBP. STUDY DESIGN: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. METHODS: We performed searches in numerous electronic databases combining key words relating to "vitamin D" and "LBP" until March 2017. Studies were included if they investigated vitamin D supplementation in participants with LBP, provided there was a comparison intervention. There was no restriction on the type of LBP, the intervention parameters investigated, or the type of clinical trial (e.g. randomized, non-randomized). Two reviewers independently performed the selection of studies, extracted data, rated the methodological quality of the included studies, and evaluated the overall quality of the evidence using the Grading of Recommendations Assessment, Delevopment, and Evaulation (GRADE) approach. RESULTS: After screening 3,534 articles, 8 clinical trials were included in this systematic review. There is very low quality evidence (based on the GRADE approach) that vitamin D supplementation is not more effective than any intervention (including placebo, no intervention, and other conservative/pharmacological interventions) (continuous pain measures [0-100]: mean difference [MD] = -2.65, 95% confidence interval [CI]: -10.42 to 5.12, P = 0.504, n = 5; self-reported reduction in pain: pooled odds ratio [OR] = 1.07, 95% CI: 0.35 to 3.26, P = 0.906, n = 5) or placebo/no intervention for individuals with LBP (continuous pain measures: MD = 1.29, 95% CI: -3.81 to 6.39, P = 0.620, n = 4; self-reported reduction in pain: pooled OR = 1.53, 95% CI: 0.38 to 6.20, P = 0.550, n = 4), where 'n' is the number of studies included in the meta-analysis. These results did not change when we stratified the meta-analyses by the type of vitamin supplementation (vitamin D3 vs. alfacalcidol) or the type of LBP (non-specific vs. LBP resulting from osteoporosis or vertebral fractures). LIMITATIONS: the overall quality of evidence was "very low" due to the poor methodological quality and small sample sizes of the included studies. CONCLUSIONS: Vitamin D supplementation is not more effective than placebo, no intervention, or other conservative/pharmacological interventions for LBP (based on very low quality evidence). These results are consistent, regardless of the type of LBP or vitamin D supplementation. Until well-designed and adequately powered clinical trials suggest otherwise, the prescription of vitamin D for LBP cannot be recommended. PROSPERO Registration No: CRD42016046874. www.crd.york.ac.uk/PROSPERO/display_record.asp?ID = CRD42016046874. KEY WORDS: Vitamin D, low back pain, chronic low back pain, alfacalcidol, osteoporosis, vertebral fractures, serum 25-hydroxyvitamin D, systematic review.
Abstract.
Author URL.
Parsons N, Griffin XL, Achten J, Chesser TJ, Lamb SE, Costa ML (2018). Modelling and estimation of health-related quality of life after hip fracture a RE-ANALYSIS OF DATA FROM a PROSPECTIVE COHORT STUDY.
BONE & JOINT RESEARCH,
7(1), 1-5.
Author URL.
Parsons N, Griffin XL, Achten J, Chesser TJ, Lamb SE, Costa ML (2018). Modelling and estimation of health-related quality of life after hip fracture: a re-analysis of data from a prospective cohort study.
Bone Joint Res,
7(1), 1-5.
Abstract:
Modelling and estimation of health-related quality of life after hip fracture: a re-analysis of data from a prospective cohort study.
OBJECTIVES: This study investigates the reporting of health-related quality of life (HRQoL) in patients following hip fracture. We compare the relative merits and make recommendations for the use for two methods of measuring HRQoL; (i) including patients who died during follow-up and (ii) including survivors only. METHODS: the World Hip Trauma Evaluation has previously reported changes in HRQoL using EuroQol-5D for patients with hip fractures. We performed additional analysis to investigate the effect of including or excluding those patients who died during the first four months of the follow-up period. RESULTS: the dataset included 503 patients, 25 of whom died between 30 days and four months of injury. There was a statistically significant difference in 30-day HRQoL between those alive (mean 0.331 and standard deviation (sd) 0.360) and those dead (mean 0.156 and sd 0.421) by four months (independent-samples t-test; p 0.022). The estimated difference of 0.175 in HRQoL (95% confidence interval 0.025 to 0.325) was also highly clinically significant. CONCLUSION: When reporting HRQoL for patients after a hip fracture, excluding patients who die during follow-up leads to an overestimate of the effects of the intervention or treatment pathway. We would recommend that death-adjusted estimates should be used routinely when reporting HRQoL in this population.Cite this article: N. Parsons, X. L. Griffin, J. Achten, T. J. Chesser, S. E. Lamb, M. L. Costa. Modelling and estimation of health-related quality of life after hip fracture: a re-analysis of data from a prospective cohort study. Bone Joint Res 2018;7:1-5.
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Author URL.
Hopewell S, Adedire O, Copsey BJ, Boniface GJ, Sherrington C, Clemson L, Close JC, Lamb SE (2018). Multifactorial and multiple component interventions for preventing falls in older people living in the community.
Cochrane Database Syst Rev,
7(7).
Abstract:
Multifactorial and multiple component interventions for preventing falls in older people living in the community.
BACKGROUND: Falls and fall-related injuries are common, particularly in those aged over 65, with around one-third of older people living in the community falling at least once a year. Falls prevention interventions may comprise single component interventions (e.g. exercise), or involve combinations of two or more different types of intervention (e.g. exercise and medication review). Their delivery can broadly be divided into two main groups: 1) multifactorial interventions where component interventions differ based on individual assessment of risk; or 2) multiple component interventions where the same component interventions are provided to all people. OBJECTIVES: to assess the effects (benefits and harms) of multifactorial interventions and multiple component interventions for preventing falls in older people living in the community. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature, trial registers and reference lists. Date of search: 12 June 2017. SELECTION CRITERIA: Randomised controlled trials, individual or cluster, that evaluated the effects of multifactorial and multiple component interventions on falls in older people living in the community, compared with control (i.e. usual care (no change in usual activities) or attention control (social visits)) or exercise as a single intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risks of bias and extracted data. We calculated the rate ratio (RaR) with 95% confidence intervals (CIs) for rate of falls. For dichotomous outcomes we used risk ratios (RRs) and 95% CIs. For continuous outcomes, we used the standardised mean difference (SMD) with 95% CIs. We pooled data using the random-effects model. We used the GRADE approach to assess the quality of the evidence. MAIN RESULTS: We included 62 trials involving 19,935 older people living in the community. The median trial size was 248 participants. Most trials included more women than men. The mean ages in trials ranged from 62 to 85 years (median 77 years). Most trials (43 trials) reported follow-up of 12 months or over. We assessed most trials at unclear or high risk of bias in one or more domains.Forty-four trials assessed multifactorial interventions and 18 assessed multiple component interventions. (I2 not reported if = 0%).Multifactorial interventions versus usual care or attention controlThis comparison was made in 43 trials. Commonly-applied or recommended interventions after assessment of each participant's risk profile were exercise, environment or assistive technologies, medication review and psychological interventions. Multifactorial interventions may reduce the rate of falls compared with control: rate ratio (RaR) 0.77, 95% CI 0.67 to 0.87; 19 trials; 5853 participants; I2 = 88%; low-quality evidence. Thus if 1000 people were followed over one year, the number of falls may be 1784 (95% CI 1553 to 2016) after multifactorial intervention versus 2317 after usual care or attention control. There was low-quality evidence of little or no difference in the risks of: falling (i.e. people sustaining one or more fall) (RR 0.96, 95% CI 0.90 to 1.03; 29 trials; 9637 participants; I2 = 60%); recurrent falls (RR 0.87, 95% CI 0.74 to 1.03; 12 trials; 3368 participants; I2 = 53%); fall-related hospital admission (RR 1.00, 95% CI 0.92 to 1.07; 15 trials; 5227 participants); requiring medical attention (RR 0.91, 95% CI 0.75 to 1.10; 8 trials; 3078 participants). There is low-quality evidence that multifactorial interventions may reduce the risk of fall-related fractures (RR 0.73, 95% CI 0.53 to 1.01; 9 trials; 2850 participants) and may slightly improve health-related quality of life but not noticeably (SMD 0.19, 95% CI 0.03 to 0.35; 9 trials; 2373 participants; I2 = 70%). of three trials reporting on adverse events, one found none, and two reported 12 participants with self-limiting musculoskeletal symptoms in total.Multifactorial interventions versus exerciseVery low-quality evidence from one small trial of 51 recently-discharged orthopaedic patients means that we are uncertain of the effects on rate of falls or risk of falling of multifactorial interventions versus exercise alone. Other fall-related outcomes were not assessed.Multiple component interventions versus usual care or attention controlThe 17 trials that make this comparison usually included exercise and another component, commonly education or home-hazard assessment. There is moderate-quality evidence that multiple interventions probably reduce the rate of falls (RaR 0.74, 95% CI 0.60 to 0.91; 6 trials; 1085 participants; I2 = 45%) and risk of falls (RR 0.82, 95% CI 0.74 to 0.90; 11 trials; 1980 participants). There is low-quality evidence that multiple interventions may reduce the risk of recurrent falls, although a small increase cannot be ruled out (RR 0.81, 95% CI 0.63 to 1.05; 4 trials; 662 participants). Very low-quality evidence means that we are uncertain of the effects of multiple component interventions on the risk of fall-related fractures (2 trials) or fall-related hospital admission (1 trial). There is low-quality evidence that multiple interventions may have little or no effect on the risk of requiring medical attention (RR 0.95, 95% CI 0.67 to 1.35; 1 trial; 291 participants); conversely they may slightly improve health-related quality of life (SMD 0.77, 95% CI 0.16 to 1.39; 4 trials; 391 participants; I2 = 88%). of seven trials reporting on adverse events, five found none, and six minor adverse events were reported in two.Multiple component interventions versus exerciseThis comparison was tested in five trials. There is low-quality evidence of little or no difference between the two interventions in rate of falls (1 trial) and risk of falling (RR 0.93, 95% CI 0.78 to 1.10; 3 trials; 863 participants) and very low-quality evidence, meaning we are uncertain of the effects on hospital admission (1 trial). One trial reported two cases of minor joint pain. Other falls outcomes were not reported. AUTHORS' CONCLUSIONS: Multifactorial interventions may reduce the rate of falls compared with usual care or attention control. However, there may be little or no effect on other fall-related outcomes. Multiple component interventions, usually including exercise, may reduce the rate of falls and risk of falling compared with usual care or attention control.
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Author URL.
Costa ML, Achten J, Bruce J, Davis S, Hennings S, Willett K, Petrou S, Jeffery S, Griffin D, Parker B, et al (2018). Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture: the WOLLF RCT.
Health Technol Assess,
22(73), 1-162.
Abstract:
Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture: the WOLLF RCT.
BACKGROUND: Open fractures of the lower limb occur when a broken bone penetrates the skin and is exposed to the outside environment. These are life-changing injuries. The risk of deep infection may be as high as 27%. The type of dressing applied after surgical debridement could potentially reduce the risk of infection in the open-fracture wound. OBJECTIVES: to assess the disability, rate of deep infection, quality of life and resource use in patients with severe open fracture of the lower limb treated with negative-pressure wound therapy (NPWT) versus standard wound management after the first surgical debridement of the wound. DESIGN: a pragmatic, multicentre randomised controlled trial. SETTING: Twenty-four specialist trauma hospitals in the UK Major Trauma Network. PARTICIPANTS: a total of 460 patients aged ≥ 16 years with a severe open fracture of the lower limb were recruited from July 2012 through to December 2015. Patients were excluded if they presented more than 72 hours after their injury or were unable to complete questionnaires. INTERVENTIONS: Negative-pressure wound therapy (n = 226) where an 'open-cell' solid foam or gauze was placed over the surface of the wound and connected to a suction pump which created a partial vacuum over the dressing versus standard dressings not involving negative pressure (n = 234). MAIN OUTCOME MEASURES: Disability Rating Index (DRI) - a score of 0 (no disability) to 100 (completely disabled) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. The secondary outcomes were deep infection, quality of life and resource use collected at 3, 6, 9 and 12 months post randomisaton. RESULTS: There was no evidence of a difference in the patients' DRI at 12 months. The mean DRI in the NPWT group was 45.5 points [standard deviation (SD) 28.0 points] versus 42.4 points (SD 24.2 points) in the standard dressing group, giving a difference of -3.9 points (95% confidence interval -8.9 to 1.2 points) in favour of standard dressings (p = 0.132). There was no difference in HRQoL and no difference in the number of surgical site infections or other complications at any point in the 12 months after surgery. NPWT did not reduce the cost of treatment and it was associated with a low probability of cost-effectiveness. LIMITATIONS: Owing to the emergency nature of the interventions, we anticipated that some patients who were randomised into the trial would subsequently be unable or unwilling to take part. Such post-randomisation withdrawal of patients could have posed a risk to the external validity of the trial. However, the great majority of these patients (85%) were found to be ineligible after randomisation. Therefore, we can be confident that the patients who took part were representative of the population with severe open fractures of the lower limb. CONCLUSIONS: Contrary to the existing literature and current clinical guidelines, NPWT dressings do not provide a clinical or an economic benefit for patients with an open fracture of the lower limb. FUTURE WORK: Future work should investigate alternative strategies to reduce the incidence of infection and improve outcomes for patients with an open fracture of the lower limb. Two specific areas of potentially great benefit are (1) the use of topical antibiotic preparations in the open-fracture wound and (2) the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33756652 and UKCRN Portfolio ID 11783. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 73. See the NIHR Journals Library website for further project information.
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Author URL.
Vollam S, Dutton S, Lamb S, Petrinic T, Young JD, Watkinson P (2018). Out-of-hours discharge from intensive care, in-hospital mortality and intensive care readmission rates: a systematic review and meta-analysis.
Intensive Care Medicine,
44(7), 1115-1129.
Abstract:
Out-of-hours discharge from intensive care, in-hospital mortality and intensive care readmission rates: a systematic review and meta-analysis
Purpose: Discharge from an intensive care unit (ICU) out of hours is common. We undertook a systematic review and meta-analysis to explore the association between time of discharge and mortality/ICU readmission. Methods: We searched Medline, Embase, Web of Knowledge, CINAHL, the Cochrane Library and OpenGrey to June 2017. We included studies reporting in-hospital mortality and/or ICU readmission rates by ICU discharge “out-of-hours” and “in-hours”. Inclusion was limited to patients aged ≥ 16 years discharged alive from a non-specialist ICU to a lower level of hospital care. Studies restricted to specific diseases were excluded. We assessed study quality using the Newcastle Ottowa Scale. We extracted published data, summarising using a random-effects meta-analysis. Results: Our searches identified 1961 studies. We included unadjusted data from 1,191,178 patients from 18 cohort studies (presenting data from 1994 to 2014). “Out of hours” had multiple definitions, beginning between 16:00 and 22:00 and ending between 05:59 and 09:00. Patients discharged out of hours had higher in-hospital mortality [relative risk (95% CI) 1.39 (1.24, 1.57) p < 0.0001] and readmission rates [1·30 (1.19, 1.42), p < 0.001] than patients discharged in hours. Heterogeneity was high (I2 90.1% for mortality and 90.2% for readmission), resulting from differences in effect size rather than the presence of an effect. Conclusions: Out-of-hours discharge from an ICU is strongly associated with both in-hospital death and ICU readmission. These effects persisted across all definitions of “out of hours” and across healthcare systems in different geographical locations. Whether these increases in mortality and readmission result from patient differences, differences in care, or a combination remains unclear.
Abstract.
Tutton E, Achten J, Lamb SE, Willett K, Costa ML, UK WOLLF Research Collaborators (2018). Participation in a trial in the emergency situation: a qualitative study of patient experience in the UK WOLLF trial.
Trials,
19(1).
Abstract:
Participation in a trial in the emergency situation: a qualitative study of patient experience in the UK WOLLF trial.
BACKGROUND: Patients can struggle to make sense of trials in emergency situations. This study examines patient experience of participating in the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) study, a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT). METHODS: the aim of the study was to understand the patient's lived experience of taking part in a trial of wound dressings. Interviews drawing on Phenomenology were undertaken with a purposive sample of 20 patients, on average 12 days into their hospital stay from July 2012-July 2013. RESULTS: the participants were vulnerable due to the emotional and physical impact of injury. They expressed their trial experience through the theme of being compromised identified in categories of being dependent, being trusting, being grateful and being without experience. Participants felt dependent on and trusted the team to make the right decisions for them and not cause them harm. Their hopes for future recovery were also invested within the expertise of the team. Despite often not being well enough to consent to the study prior to surgery, they wished to be involved as much as possible. In agreeing to take part they expressed gratitude for their care, wanted to be helpful to others and considered the trial interventions to be a small component in relation to the enormity of their injury and broader treatment. In making sense of the trial they felt they could not understand the interventions without experience of them but if they received NPWT they developed a strong technological preference for this intervention. CONCLUSIONS: Patients prefer to be involved in studies within the limits of their capacity, despite not being able to provide informed consent. A variety of sources of knowledge may enable participants to feel that they have a better understanding of the interventions. Professional staff need to be aware of the situated nature of decision making where participants invest their hopes for recovery in the team. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN33756652. Registered on 24 February 2012.
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Hall A, Richmond H, Copsey B, Hansen Z, Williamson E, Jones G, Fordham B, Cooper Z, Lamb S (2018). Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? a systematic review.
Disabil Rehabil,
40(1), 1-9.
Abstract:
Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? a systematic review.
PURPOSE: to determine if physiotherapist-led cognitive-behavioural (CB) interventions are effective for low back pain (LBP) and described sufficiently for replication. METHOD: Randomised controlled trials (RCTs) of patients with LBP treated by physiotherapists using a CB intervention were included. Outcomes of disability, pain, and quality of life were assessed using the GRADE approach. Intervention reporting was assessed using the Template for Intervention Description and Replication. RESULTS: of 1898 titles, 5 RCTs (n = 1390) were identified. Compared to education and/or exercise interventions, we found high-quality evidence that CB had a greater effect (SMD; 95% CI) on reducing disability (-0.19; -0.32, -0.07), pain (-0.21; -0.33, -0.09); and moderate-quality evidence of little difference in quality of life (-0.06; -0.18 to 0.07). Sufficient information was provided on dose, setting, and provider; but not content and procedural information. Studies tended to report the type of CB component used (e.g. challenging unhelpful thoughts) with little detail on how it was operationalised. Moreover, access to treatment manuals, patient materials and provider training was lacking. CONCLUSIONS: with additional training, physiotherapists can deliver effective CB interventions. However, without training or resources, successful translation and implementation remains unlikely. Researchers should improve reporting of procedural information, provide relevant materials, and offer accessible provider training. Implications for Rehabilitation Previous reviews have established that traditional biomedical-based treatments (e.g. acupuncture, manual therapy, massage, and specific exercise programmes) that focus only on physical symptoms do provide short-term benefits but the sustained effect is questionable. A cognitive-behavioural (CB) approach includes techniques to target both physical and psychosocial symptoms related to pain and provides patients with long-lasting skills to manage these symptoms on their own. This combined method has been used in a variety of settings delivered by different health care professionals and has been shown to produce long-term effects on patient outcomes. What has been unclear is if these programmes are effective when delivered by physiotherapists in routine physiotherapy settings. Our study synthesises the evidence for this context. We have confirmed with high-quality evidence that with additional training, physiotherapists can deliver CB interventions that are effective for patients with back pain. Physiotherapists who are considering enhancing their treatment for patients with low back pain should consider undertaking some additional training in how to incorporate CB techniques into their practice to optimise treatment benefits and help patients receive long-lasting treatment effects. Importantly, our results indicate that using a CB approach, including a variety of CB techniques that could be easily adopted in a physical therapy setting, provides greater benefits for patient outcomes compared to brief education, exercise or physical techniques (such as manual therapy) alone. This provides further support that a combined treatment approach is likely better than one based on physical techniques alone. Notably, we identified a significant barrier to adopting any of these CB interventions in practice. This is because no study provided a description of the intervention or accessible training materials that would allow for accurate replication. Without access to provider training and/or resources, we cannot expect this evidence to be implemented in practice with optimal effects. Thus, we would urge physiotherapists to directly contact authors of the studies for more information on how to incorporate their interventions into their settings.
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Schlüssel MM, Keene DJ, Wagland S, Alsousou J, Lamb SE, Willett K, Dutton SJ, PATH-2 Trial Study Group (2018). Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial.
Trials,
19(1).
Abstract:
Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial.
BACKGROUND: There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) trial. METHODS: PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function. Patients are identified in the orthopaedic/trauma outpatient clinic. The primary outcome is muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules), at 24 weeks post randomisation. Multivariate linear regression adjusting for the stratification factors (centre and age) and additional prognostic factors will be used to investigate the adjusted effect of the intervention. The analysis will be by modified intention-to-treat. Sensitivity analysis will assess the internal validity of the trial results by performing a per-protocol analysis. Safety will be summarised by treatment arm for all patients who started treatment. Secondary patient-reported outcome measures will be analysed using linear mixed effects models to allow all data collected at all follow-up points to be considered. Missing data will be summarised and reported by treatment arm. Missing data imputation will be performed, if appropriate. DISCUSSION: the PATH-2 trial will be reported in accordance with the CONSORT statement. This SAP publication will avoid bias arising from prior knowledge of the study results. Any changes or deviations from the current SAP will be described and justified in the final report. TRIAL REGISTRATION: ISRCTN registry: ISRCTN54992179 , assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.
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Sharma S, Mueller C, Stewart R, Veronese N, Vancampfort D, Koyanagi A, Lamb SE, Perera G, Stubbs B (2018). Predictors of Falls and Fractures Leading to Hospitalization in People with Dementia: a Representative Cohort Study.
J Am Med Dir Assoc,
19(7), 607-612.
Abstract:
Predictors of Falls and Fractures Leading to Hospitalization in People with Dementia: a Representative Cohort Study.
OBJECTIVES: Investigate predictors of falls and fractures leading to hospitalization in a large cohort of people with dementia. DESIGN: a retrospective cohort study. SETTING AND PARTICIPANTS: People with diagnosed dementia between January 2007 and March 2013, aged >65 years, were assembled using data from the Maudsley Biomedical Research Centre Case Register, from 4 boroughs in London serving a population of 1.3 million people. MEASURES: Falls and/or fractures leading to hospitalization were ascertained from linked national records. Demographic data, cognitive test scores, medications, and symptom and functioning scores from Health of the Nation Outcome Scales (HoNOS65+) were modeled in multivariate survival analyses to identify predictors of falls and fractures. RESULTS: of 8036 people with dementia (63.9% female), 2500 (31.1%, incidence rate 125.5 per 1000 person-years) had a fall during a mean follow-up of 2.5 years and 1437 (17.7%, incidence rate 65.5 per 1000 person-years) had a fracture. In multivariable models, significant predictors of falls were increased age, female gender, physical health problems, previous fall or fracture, vascular dementia vs Alzheimer's disease, higher neighborhood deprivation, noncohabiting status, and problems with living conditions. Ethnic minority status was protective of falls (eg, Caribbean/Asian ethnicity). Medications (including psychotropic and antipsychotics), neuropsychiatric symptoms, cognitive (Mini-Mental State Examination scores), or functional problems did not predict hospitalized falls. Predictors of fractures were similar to those predicting falls. IMPLICATIONS: over an average of 2.5 years, a third of people with dementia had a fall leading to hospitalization, necessitating action in clinical practice. Clinicians should consider that besides established demographic and physical health-related factors, the risk of hospitalization due to a fall or fractures in dementia is largely determined by environmental and socioeconomic factors. Interestingly, our data suggest that neuropsychiatric symptoms, cognitive status, functioning, or pharmacotherapy were not associated with falls/fractures.
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Stubbs B, Mueller C, Gaughran F, Lally J, Vancampfort D, Lamb SE, Koyanagi A, Sharma S, Stewart R, Perera G, et al (2018). Predictors of falls and fractures leading to hospitalization in people with schizophrenia spectrum disorder: a large representative cohort study.
Schizophr Res,
201, 70-78.
Abstract:
Predictors of falls and fractures leading to hospitalization in people with schizophrenia spectrum disorder: a large representative cohort study.
AIM: to investigate predictors of falls/fractures leading to hospitalisation in people with schizophrenia-spectrum disorders. METHODS: a historical cohort of people with schizophrenia-spectrum disorders (ICD F20-29) from 01/2006-12/2012 was assembled using data from the South London and Maudsley NHS Biomedical Research Centre Case Register. Falls/fractures were ascertained from a linkage to national hospitalisation data. Separate multivariate Cox regression analyses were employed to identify predictors of falls and fractures. RESULTS: of 11,567 people with schizophrenia-spectrum disorders (mean age 42.6 years, 43% female), 579 (incidence rate 12.79 per 1000 person-years) and 528 (11.65 per 1000 person-years) had at least one reported hospital admission due to a fall or fracture respectively and 822 patients had at least either a recorded fall or a fracture during this period (i.e. 7.1% of sample). Overall, 6.69 and 10.74 years of inpatient hospital stay per 1000-person years of follow-up occurred due to a fall and fracture respectively. 14(0.12%) and 28(0.24%) died due to a fall and fracture respectively. In Multivariable analysis, increasing age, white ethnicity, analgesics, cardiovascular disease, hypertension, diseases of the genitourinary system, visual disturbance and syncope were significant risk factor for both falls and fractures. A previous fracture (HR 2.05, 95% CI 1.53-2.73) and osteoporosis (HR 6.79, 95% CI 4.71-9.78) were strong risk factors for consequent fractures. CONCLUSION: Comorbid physical health conditions and analgesic medication prescription were associated with higher risk of falls and fractures. Osteoporosis and previous fracture were strong predictors for subsequent fractures. Interventions targeting bone health and falls/fractures need to be developed and evaluated in these populations.
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Keene DJ, Schlüssel MM, Thompson J, Hagan DA, Williams MA, Byrne C, Goodacre S, Cooke M, Gwilym S, Hormbrey P, et al (2018). Prognostic models for identifying risk of poor outcome in people with acute ankle sprains: the SPRAINED development and external validation study.
Health Technol Assess,
22(64), 1-112.
Abstract:
Prognostic models for identifying risk of poor outcome in people with acute ankle sprains: the SPRAINED development and external validation study.
BACKGROUND: Ankle sprains are very common injuries. Although recovery can occur within weeks, around one-third of patients have longer-term problems. OBJECTIVES: to develop and externally validate a prognostic model for identifying people at increased risk of poor outcome after an acute ankle sprain. DESIGN: Development of a prognostic model in a clinical trial cohort data set and external validation in a prospective cohort study. SETTING: Emergency departments (EDs) in the UK. PARTICIPANTS: Adults with an acute ankle sprain (within 7 days of injury). SAMPLE SIZE: There were 584 clinical trial participants in the development data set and 682 recruited for the external validation study. PREDICTORS: Candidate predictor variables were chosen based on availability in the clinical data set, clinical consensus, face validity, a systematic review of the literature, data quality and plausibility of predictiveness of the outcomes. MAIN OUTCOME MEASURES: Models were developed to predict two composite outcomes representing poor outcome. Outcome 1 was the presence of at least one of the following symptoms at 9 months after injury: persistent pain, functional difficulty or lack of confidence. Outcome 2 included the same symptoms as outcome 1, with the addition of recurrence of injury. Rates of poor outcome in the external data set were lower than in the development data set, 7% versus 20% for outcome 1 and 16% versus 24% for outcome 2. ANALYSIS: Multiple imputation was used to handle missing data. Logistic regression models, together with multivariable fractional polynomials, were used to select variables and identify transformations of continuous predictors that best predicted the outcome based on a nominal alpha of 0.157, chosen to minimise overfitting. Predictive accuracy was evaluated by assessing model discrimination (c-statistic) and calibration (flexible calibration plot). RESULTS: (1) Performance of the prognostic models in development data set - the combined c-statistic for the outcome 1 model across the 50 imputed data sets was 0.74 [95% confidence interval (CI) 0.70 to 0.79], with good model calibration across the imputed data sets. The combined c-statistic for the outcome 2 model across the 50 imputed data sets was 0.70 (95% CI 0.65 to 0.74), with good model calibration across the imputed data sets. Updating these models, which used baseline data collected at the ED, with an additional variable at 4 weeks post injury (pain when bearing weight on the ankle) improved the discriminatory ability (c-statistic 0.77, 95% CI 0.73 to 0.82, for outcome 1 and 0.75, 95% CI 0.71 to 0.80, for outcome 2) and calibration of both models. (2) Performance of the models in the external data set - the combined c-statistic for the outcome 1 model across the 50 imputed data sets was 0.73 (95% CI 0.66 to 0.79), with a calibration plot intercept of -0.91 (95% CI -0.98 to 0.44) and slope of 1.13 (95% CI 0.76 to 1.50). The combined c-statistic for the outcome 2 model across the 50 imputed data sets was 0.63 (95% CI 0.58 to 0.69), with a calibration plot intercept of -0.25 (95% CI -0.27 to 0.11) and slope of 1.03 (95% CI 0.65 to 1.42). The updated models with the additional pain variable at 4 weeks had improved discriminatory ability over the baseline models but not better calibration. CONCLUSIONS: the SPRAINED (Synthesising a clinical Prognostic Rule for Ankle Injuries in the Emergency Department) prognostic models performed reasonably well, and showed benefit compared with not using any model; therefore, the models may assist clinical decision-making when managing and advising ankle sprain patients in the ED setting. The models use predictors that are simple to obtain. LIMITATIONS: the data used were from a randomised controlled trial and so were not originally intended to fulfil the aim of developing prognostic models. However, the data set was the best available, including data on the symptoms and clinical events of interest. FUTURE WORK: Further model refinement, including recalibration or identifying additional predictors, may be required. The effect of implementing and using either model in clinical practice, in terms of acceptability and uptake by clinicians and on patient outcomes, should be investigated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12726986. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 64. See the NIHR Journals Library website for further project information. Funding was also recieved from the NIHR Collaboration for Leadership in Applied Health Research, Care Oxford at Oxford Health NHS Foundation Trust, NIHR Biomedical Research Centre, Oxford, and the NIHR Fellowship programme.
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Bruce J, Williamson E, Lait C, Richmond H, Betteley L, Lall R, Petrou S, Rees S, Withers EJ, Lamb SE, et al (2018). Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER).
BMJ Open,
8(3).
Abstract:
Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER).
UNLABELLED: Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. METHODS: This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions. DISCUSSION: the PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. PROTOCOL VERSION: Version 2.1; dated 11 January 2017 TRIAL REGISTRATION NUMBER: ISRCTN35358984; Pre-results.
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Lee H, Lamb SE, Bagg MK, Toomey E, Cashin AG, Moseley GL (2018). Reproducible and replicable pain research: a critical review.
Pain,
159(9), 1683-1689.
Author URL.
Copsey B, Thompson JY, Vadher K, Ali U, Dutton SJ, Fitzpatrick R, Lamb SE, Cook JA (2018). Sample size calculations are poorly conducted and reported in many randomized trials of hip and knee osteoarthritis: results of a systematic review.
J Clin Epidemiol,
104, 52-61.
Abstract:
Sample size calculations are poorly conducted and reported in many randomized trials of hip and knee osteoarthritis: results of a systematic review.
OBJECTIVES: to review the methodology and reporting of sample size calculations in a contemporary sample of trials in osteoarthritis. STUDY DESIGN AND SETTING: Randomized trials in hip and/or knee osteoarthritis published in 2016 were identified by searching MEDLINE, Cochrane library, CINAHL, EMBASE, PsycINFO, PEDro, and AMED until March 31, 2017. Data were extracted on study characteristics, methods used to calculate the sample size, and the reporting and justification of components used in the sample size calculation. We attempted to replicate the sample size calculation using the reported information. RESULTS: This review included 116 trials. Seventy-eight (67%, n = 78/116) reported a power calculation. Less than a quarter reported all core components of the sample size calculation (21%, n = 16/78). The sample size calculation was only reproducible in 53% of the trials that reported a power calculation (n = 41/78). The replicated calculation produced a sample size over 10% larger than the reported value in 12% of trials (n = 9/78). Insufficient information was reported to allow the sample size calculation to be replicated in a quarter of trials (27%, n = 21/78). CONCLUSION: Sample size calculations in trials of hip and knee osteoarthritis are not adequately reported, and the calculation frequently cannot be reproduced.
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Jayakumar P, Overbeek C, Vranceanu AM, Williams M, Lamb S, Ring D, Gwilym S (2018). The use of computer adaptive tests in outcome assessments following upper limb trauma: a systematic review.
Bone and Joint Journal,
100B(6), 693-702.
Abstract:
The use of computer adaptive tests in outcome assessments following upper limb trauma: a systematic review
Aims Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods a search of multiple electronic databases was undertaken on 1 January 2017 with terms related to “CATs”, “orthopaedics”, “trauma”, and “anatomical regions”. Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and registered (PROSPERO: CRD42016053886). Results a total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures.
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Keene DJ, Lamb SE, Mistry D, Tutton E, Lall R, Handley R, Willett K, Ankle Injury Management (AIM) Trial Collaborators (2018). Three-Year Follow-up of a Trial of Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults.
JAMA,
319(12), 1274-1276.
Abstract:
Three-Year Follow-up of a Trial of Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults.
This study reports 3-year outcomes of a randomized trial that compared close contact casting vs the usual surgery for unstable ankle fractures in older adults and that found equivalent ankle function outcomes at 6 months.
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Jayakumar P, Overbeek CL, Lamb S, Williams M, Funes C, Gwilym S, Ring D, Vranceanu AM (2018). What factors are associated with disability after upper extremity injuries? a systematic review.
Clinical Orthopaedics and Related Research,
476(11), 2190-2215.
Abstract:
What factors are associated with disability after upper extremity injuries? a systematic review
Background Psychosocial factors are key determinants of health after upper extremity injuries. However, a systematic review is needed to understand which psychosocial factors are most consistently associated with disability and how the language, conceptualization, and types of measures used to assess disability impact these associations in upper extremity injuries. Questions/purposes (1) What factors are most consistently associated with disability after upper extremity injuries in adults? (2) What are the trends in types of outcome measures and conceptualization of disability in patients' upper extremity injuries? Methods We searched multiple electronic databases (PubMED, OVIDSP, PsycInfo, Google Scholar, ISI Web of Science) between January 1, 1996, and December 31, 2016, using terms related to the "upper extremity", "outcome measurement", and "impairment, psychological, social or symptomatic" variables. We included all studies involving adult patients with any musculoskeletal injury and excluded those that did not use patient-reported outcome measures. We identified and screened 9339 studies. of these, we retained 41 studies that involved conditions ranging from fractures to soft tissue injuries in various regions of the arm. We conducted quality assessment using a 10-item validated checklist and a five-tier strength of evidence assessment. We used the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) criteria and registered the review before performing our search (PROSPERO: CRD42017054048). None of the authors received any funding to perform this work. Results Disability after upper extremity injury was most consistently associated with depression (21 cohorts), catastrophic thinking (13 cohorts), anxiety (11 cohorts), pain self-efficacy (eight cohorts), and pain interference (seven cohorts). Social and demographic factors were also associated with disability. Measures of impairment such as ROM and injury severity were least associated with disability. There has been a gradual increase in use of region or condition-specific patient-reported outcome measures and measures of psychological, social, and symptomatic factors over a period since the introduction of the World Health Organization (WHO) International Classification of Functioning, Disability and Health (ICF) around 2000. Approximately 17% of studies (n = 454 of 2628) had instances of unclear, conflicting, or inappropriate terminology and 11% of studies (n = 257 of 2628) involved misrepresentations of outcome measures related to disability. Conclusions Psychologic and social factors are most consistently associated with disability than factors related to impairment. Further research involving the assessment of depression, anxiety, and coping strategies in cohorts with specific injuries may support decision-making regarding the provision of emotional support and psychologic therapies during recovery. Using the WHO ICF framework to conceptualize disability is key in increasing strength of evidence and allowing accurate comparisons of research in this field. Level of Evidence Level IV, therapeutic study.
Abstract.
Jayakumar P, Williams M, Ring D, Lamb S, Gwilym S (2017). A Systematic Review of Outcome Measures Assessing Disability Following Upper Extremity Trauma.
J Am Acad Orthop Surg Glob Res Rev,
1(4).
Abstract:
A Systematic Review of Outcome Measures Assessing Disability Following Upper Extremity Trauma.
OBJECTIVES: to define upper extremity outcome measures focusing on trauma and level of initial psychometric evaluation and to assess methodological quality of relevant patient-reported outcome (PRO) measures. DATA SOURCES: a broad search strategy using PubMed, OVID, CINAHL, and PsycINFO was deployed and reported using PRISMA (PROSPERO: CRD42016046243). STUDY SELECTION EXTRACTION SYNTHESIS: PRO measures involving orthopedic trauma in their original development were selected and original publications assessed, including psychometric evaluations. Extraction, synthesis, and quality assessment were performed using COSMIN. RESULTS: of 144 upper extremity outcome measures, the majority were designed for the shoulder, wrist, and hand; 20% (n = 29/144) involved trauma conditions in their initial development, PRO measurements, and psychometric evaluation on introduction. Methodological quality was highly variable. CONCLUSION: a few PRO measures were originally designed for use in upper extremity trauma. Methodological quality and psychometric evaluation need to improve. This review aims to highlight strengths and weaknesses and guide decision making in this field.
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Srikesavan CS, Williamson E, Eldridge L, Heine P, Adams J, Cranston T, Lamb SE (2017). A Web-Based Training Resource for Therapists to Deliver an Evidence-Based Exercise Program for Rheumatoid Arthritis of the Hand (iSARAH): Design, Development, and Usability Testing.
J Med Internet Res,
19(12).
Abstract:
A Web-Based Training Resource for Therapists to Deliver an Evidence-Based Exercise Program for Rheumatoid Arthritis of the Hand (iSARAH): Design, Development, and Usability Testing.
BACKGROUND: the Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) is a tailored, progressive exercise program for people having difficulties with wrist and hand function due to rheumatoid arthritis (RA). The program was evaluated in a large-scale clinical trial and was found to improve hand function, was safe to deliver, and was cost-effective. These findings led to the SARAH program being recommended in the UK National Institute for Health and Care Excellence guidelines for the management of adults with RA. To facilitate the uptake of this evidence-based program by clinicians, we proposed a Web-based training program for SARAH (iSARAH) to educate and train physiotherapists and occupational therapists on delivering the SARAH program in their practice. The overall iSARAH implementation project was guided by the 5 phases of the analysis, design, development, implementation, and evaluation (ADDIE) system design model. OBJECTIVE: the objective of our study was to conduct the first 3 phases of the model in the development of the iSARAH project. METHODS: Following publication of the trial, the SARAH program materials were made available to therapists to download from the trial website for use in clinical practice. A total of 35 therapists who downloaded these materials completed an online survey to provide feedback on practice trends in prescribing hand exercises for people with RA, perceived barriers and facilitators to using the SARAH program in clinical practice, and their preferences for the content and Web features of iSARAH. The development and design of iSARAH were further guided by a team of multidisciplinary health professionals (n=17) who took part in a half-day development meeting. We developed the preliminary version of iSARAH and tested it among therapists (n=10) to identify and rectify usability issues and to produce the final version. RESULTS: the major recommendations made by therapists and the multidisciplinary team were having a simple Web design and layout, clear exercise pictures and videos, and compatibility of iSARAH on various browsers and devices. We rectified all usability issues in the preliminary version to develop the final version of iSARAH, which included 4 short modules and additional sections on self-assessment, frequently asked questions, and a resource library. CONCLUSIONS: the use of the ADDIE design model and engagement of end users in the development and evaluation phases have rendered iSARAH a convenient, easy-to-use, and effective Web-based learning resource for therapists on how to deliver the SARAH program. There is also huge potential for adapting iSARAH across different cultures and languages, thus opening more opportunities for wider uptake and application of the SARAH program into practice.
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Nichols VP, Williamson E, Toye F, Lamb SE (2017). A longitudinal, qualitative study exploring sustained adherence to a hand exercise programme for rheumatoid arthritis evaluated in the SARAH trial.
Disabil Rehabil,
39(18), 1856-1863.
Abstract:
A longitudinal, qualitative study exploring sustained adherence to a hand exercise programme for rheumatoid arthritis evaluated in the SARAH trial.
PURPOSE: This study explores the experience of participants taking part in a hand exercise programme for people with rheumatoid arthritis with a focus on adherence. The exercise programme was tested in a randomised controlled trial. This parallel qualitative study will inform future implementation into clinical practice. METHOD: Twenty-seven semi-structured interviews from 14 participants were undertaken at two time points (4 and 12 months after randomisation). We collected data of participants' experiences over time. This was guided by an interview schedule. Interview data were analysed using interpretative phenomenological analysis which is informed by phenomenological and hermeneutic theory. We recruited participants from National Health Service rheumatology and therapy departments. RESULTS: at 4 months, 11/14 participants reported continuing with the exercises. By 12 months, 7/13 participants still reported exercising. The ability to establish a routine determined whether participants adhered to the exercise programme. This was sometimes influenced by practical issues. We also identified facilitators and barriers to regular exercise in the themes of the following: the therapeutic encounter, perceived benefit of exercises, attitude of mind, confidence, and unpredictability. CONCLUSIONS: Establishing a routine was an important step towards participants being able to exercise independently. Therapists provided participants with skills to continue to exercise while dealing with changes in symptoms and schedules. Potential barriers to long-term exercise adherence need to be taken into account and addressed for successful implementation of this programme. Implications for Rehabilitation Behavioural change components such as the use of an exercise planner (stating intentions of where, when and how), daily diary sheets, and joint goal setting enhance adherence to a hand exercise programme for RA by helping to establish routines. Exercise routines need to be flexible enough to fit in with life and symptom changes whilst delivering a sufficient dosage. Therapists facilitate this process by using behavioural components alongside more commonly used aspects of care (assessment, education, advice, and encouragement) to enable people with RA to become independent exercisers.
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Lyle S, Williamson E, Darton F, Griffiths F, Lamb SE (2017). A qualitative study of older people's experience of living with neurogenic claudication to inform the development of a physiotherapy intervention.
Disabil Rehabil,
39(10), 1009-1017.
Abstract:
A qualitative study of older people's experience of living with neurogenic claudication to inform the development of a physiotherapy intervention.
PURPOSE: the aim of this study was to explore older people's experiences of living with neurogenic claudication (NC), their preferences for physiotherapy treatment provision and associated outcomes in order to inform an intervention to be tested in a clinical trial. METHOD: Patients with a diagnosis of NC and/or lumbar spinal stenosis were recruited through a UK NHS tertiary care center. Semi-structured interviews and self-report questionnaires were used to obtain data. A thematic analysis was conducted. RESULTS: 15 participants were recruited; half were classed as frail older adults. Pain and the threat of pain was a prominent feature of participants' experience of NC. This led to a loss of engagement in meaningful activities and sense of self. Discourses of ageing influenced experiences as well as treatment preferences, particularly the acceptability of walking aids. A combination of one-to-one and group setting for treatment was preferred. Outcome preferences related to re-engagement in meaningful activities and pain reduction. Limitations relate to generalisability of the findings for NC patients not under physiotherapy treatment. CONCLUSION: We have obtained important findings about older people's experiences of living with NC and preferences for physiotherapy treatment and outcomes. These will be incorporated into an evidence-based intervention and evaluated in a randomized controlled trial. Implications for rehabilitation Older people living with NC want to get back to meaningful activities and learn how to live with the threat of pain. Allied health professionals (AHPs) should be sensitive to the complex and ambiguous ways in which older people live with ageing and age-related decline. AHPs are in a position to support patients' successful transition to the use of walking aids thereby reducing stigmatizing effects and increasing activity. AHPs should consider a mixture of one-to-one and group classes to enable rehabilitation for older NC patients.
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Richmond H, Copsey B, Hall AM, Davies D, Lamb SE (2017). A systematic review and meta-analysis of online versus alternative methods for training licensed health care professionals to deliver clinical interventions.
BMC Med Educ,
17(1).
Abstract:
A systematic review and meta-analysis of online versus alternative methods for training licensed health care professionals to deliver clinical interventions.
BACKGROUND: Online training is growing in popularity and yet its effectiveness for training licensed health professionals (HCPs) in clinical interventions is not clear. We aimed to systematically review the literature on the effectiveness of online versus alternative training methods in clinical interventions for licensed Health Care Professionals (HCPs) on outcomes of knowledge acquisition, practical skills, clinical behaviour, self-efficacy and satisfaction. METHODS: Seven databases were searched for randomised controlled trials (RCTs) from January 2000 to June 2015. Two independent reviewers rated trial quality and extracted trial data. Comparative effects were summarised as standardised mean differences (SMD) and 95% confidence intervals. Pooled effect sizes were calculated using a random-effects model for three contrasts of online versus (i) interactive workshops (ii) taught lectures and (iii) written/electronic manuals. RESULTS: We included 14 studies with a total of 1089 participants. Most trials studied medical professionals, used a workshop or lecture comparison, were of high risk of bias and had small sample sizes (range 21-183). Using the GRADE approach, we found low quality evidence that there was no difference between online training and an interactive workshop for clinical behaviour SMD 0.12 (95% CI -0.13 to 0.37). We found very low quality evidence of no difference between online methods and both a workshop and lecture for knowledge (workshop: SMD 0.04 (95% CI -0.28 to 0.36); lecture: SMD 0.22 (95% CI: -0.08, 0.51)). Lastly, compared to a manual (n = 3/14), we found very low quality evidence that online methods were superior for knowledge SMD 0.99 (95% CI 0.02 to 1.96). There were too few studies to draw any conclusions on the effects of online training for practical skills, self-efficacy, and satisfaction across all contrasts. CONCLUSIONS: it is likely that online methods may be as effective as alternative methods for training HCPs in clinical interventions for the outcomes of knowledge and clinical behaviour. However, the low quality of the evidence precludes drawing firm conclusions on the relative effectiveness of these training methods. Moreover, the confidence intervals around our effect sizes were large and could encompass important differences in effectiveness. More robust, adequately powered RCTs are needed.
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Lee H, Lamb SE (2017). Advancing Physical Therapist Interventions by Investigating Causal Mechanisms.
Phys Ther,
97(12), 1119-1121.
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Dritsaki M, Petrou S, Williams M, Lamb SE (2017). An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand.
Health Qual Life Outcomes,
15(1).
Abstract:
An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand.
BACKGROUND: the aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D (utility)), Short Form 12 Dimensions (SF-12), SF-6D and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand. METHODS: the empirical investigation was based upon data from a randomised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the hands and/or wrists. Participants completed the EQ-5D, SF-12 and MHQ at baseline and at 4 and 12 months follow up. Acceptability was measured using completion rates over time; construct validity using the "known groups" approach, based on pain troublesomeness; convergent validity using spearman's rho correlation (ρ); reliability using internal consistency (Cronbach's alpha); interpretability using minimal important differences (MID); and responsiveness using effect sizes and standardised response means (SRM) stratified by level of self-rated improvement in hand and wrist function or level of self-rated benefit and satisfaction from trial treatments. RESULTS: at baseline, the study population had a mean age of 62.4 years, a mean MHQ score of 52.1 and included 76% women. The EQ-5D (utility) had the highest completion rates across time points. All instruments discriminated between pre-specified groups based on pain troublesomeness. Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D (ρ = 0.65) and SF-6D (ρ = 0.63) utility scores. The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months, whilst minimal important differences varied considerably across PROMs. CONCLUSIONS: the instruments evaluated in this study displayed varying psychometric properties in the context of RA of the hand. The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.
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Cockayne S, Fairhurst C, Adamson J, Hewitt C, Hull R, Hicks K, Keenan A-M, Lamb SE, Green L, McIntosh C, et al (2017). An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.
Trials,
18(1).
Abstract:
An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.
BACKGROUND: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. METHODS: a three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. RESULTS: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). CONCLUSIONS: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461. Registered on 01 July 2011.
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Barbour V, Bhui K, Chescheir N, Clavien PA, Diener MK, Glasziou P, Golub RM, Grimshaw JM, Groves T, Hopewell S, et al (2017). CONSORT Statement for randomized Trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic Trial Abstracts.
Annals of Internal Medicine,
167(1), 40-47.
Abstract:
CONSORT Statement for randomized Trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic Trial Abstracts
Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidencebased reporting guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists. Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.
Abstract.
Madan J, Khan KA, Petrou S, Lamb SE (2017). Can Mapping Algorithms Based on Raw Scores Overestimate QALYs Gained by Treatment? a Comparison of Mappings Between the Roland-Morris Disability Questionnaire and the EQ-5D-3L Based on Raw and Differenced Score Data.
Pharmacoeconomics,
35(5), 549-559.
Abstract:
Can Mapping Algorithms Based on Raw Scores Overestimate QALYs Gained by Treatment? a Comparison of Mappings Between the Roland-Morris Disability Questionnaire and the EQ-5D-3L Based on Raw and Differenced Score Data.
INTRODUCTION: Mapping algorithms are increasingly being used to predict health-utility values based on responses or scores from non-preference-based measures, thereby informing economic evaluations. OBJECTIVES: We explored whether predictions in the EuroQol 5-dimension 3-level instrument (EQ-5D-3L) health-utility gains from mapping algorithms might differ if estimated using differenced versus raw scores, using the Roland-Morris Disability Questionnaire (RMQ), a widely used health status measure for low back pain, as an example. METHODS: We estimated algorithms mapping within-person changes in RMQ scores to changes in EQ-5D-3L health utilities using data from two clinical trials with repeated observations. We also used logistic regression models to estimate response mapping algorithms from these data to predict within-person changes in responses to each EQ-5D-3L dimension from changes in RMQ scores. Predicted health-utility gains from these mappings were compared with predictions based on raw RMQ data. RESULTS: Using differenced scores reduced the predicted health-utility gain from a unit decrease in RMQ score from 0.037 (standard error [SE] 0.001) to 0.020 (SE 0.002). Analysis of response mapping data suggests that the use of differenced data reduces the predicted impact of reducing RMQ scores across EQ-5D-3L dimensions and that patients can experience health-utility gains on the EQ-5D-3L 'usual activity' dimension independent from improvements captured by the RMQ. CONCLUSION: Mappings based on raw RMQ data overestimate the EQ-5D-3L health utility gains from interventions that reduce RMQ scores. Where possible, mapping algorithms should reflect within-person changes in health outcome and be estimated from datasets containing repeated observations if they are to be used to estimate incremental health-utility gains.
Abstract.
Author URL.
Achten J, Parsons NR, Kearney RL, Maia Schlüssel M, Liew AS, Dutton S, Petrou S, Ollivere B, Lamb SE, Costa ML, et al (2017). Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial.
BMJ Open,
7(10).
Abstract:
Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial.
INTRODUCTION: Achilles tendon rupture affects over 11 000 people yearly in the UK, and the incidence is increasing. Controversy remains with regard to the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture. METHODS AND ANALYSIS: all adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population. Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the National Health Service. Standardised protocols will be followed, and details of plaster material and brace will be as per the site's usual practice.A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Total Rupture Score at 9 months. Quality of life and resource use will be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The results of the trial-based economic evaluation will be expressed in terms of incremental cost per quality-adjusted life-year gained. ETHICS AND DISSEMINATION: the National Research Ethic Committee approved this study on 18 March 2016 (16/SC/0109).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial (summer 2019). The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. This study has been registered on the International Standard Randomised Controlled Trial Number registry with reference no ISRCTN62639639.
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Author URL.
Hopewell S, Keene DJ, Maia Schlüssel M, Dritsaki M, Dutton S, Carr A, Hamilton W, Hansen Z, Jaggi A, Littlewood C, et al (2017). Clinical and cost-effectiveness of progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: protocol for a 2x2 factorial randomised controlled trial (the GRASP trial).
BMJ Open,
7(7).
Abstract:
Clinical and cost-effectiveness of progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: protocol for a 2x2 factorial randomised controlled trial (the GRASP trial).
INTRODUCTION: Shoulder pain is very common, with around 70% of cases due to disorders of the rotator cuff. Despite widespread provision of physiotherapy, there is uncertainty about which type of exercise and delivery mechanisms are associated with best outcomes. There is also uncertainty around the long-term benefits and harms of corticosteroid injection therapy, which is often used in addition to physiotherapy. The Getting it Right: Addressing Shoulder Pain trial will assess the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. METHODS AND ANALYSIS: We are conducting a large multicentre randomised controlled trial (2×2 factorial design). We will recruit adults ≥18 years with a new episode of shoulder pain attributable to a rotator cuff disorder as per British Elbow and Shoulder Society guidelines, not currently receiving physiotherapy or being considered for surgery, from at least eight UK National Health Service primary care-based musculoskeletal and related physiotherapy services. Participants (n=704) will be randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (≤6 physiotherapy sessions); (2) best practice advice (one physiotherapy session); (3) corticosteroid injection then progressive exercise (≤6 sessions) or (4) corticosteroid injection then best practice advice (one session). The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score at 12 months. Secondary outcomes are: pain and function SPADI subdomains; health-related quality of life (Five-Level version of the EuroQol EQ-5D-5L); sleep disturbance; return to activity; global impression of change; health resource use; out-of-pocket expenses; work disability. A parallel within-trial economic evaluation will be conducted. The primary analysis will be intention to treat. ETHICS AND DISSEMINATION: Research Ethics Committee approval (REC: 16/SC/0508) has been obtained. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN16539266; EudraCT number: 2016-002991-28.
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Author URL.
Cockayne S, Rodgers S, Green L, Fairhurst C, Adamson J, Scantlebury A, Corbacho B, Hewitt CE, Hicks K, Hull R, et al (2017). Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial).
Health Technol Assess,
21(24), 1-198.
Abstract:
Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial).
BACKGROUND: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness. OBJECTIVES: to determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care. DESIGN: a pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study. SETTING: Nine NHS trusts in the UK and one site in Ireland. PARTICIPANTS: in total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible. INTERVENTIONS: all participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises. MAIN OUTCOME MEASURES: the primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness. RESULTS: the primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants. LIMITATIONS: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care. CONCLUSIONS: the intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective. FUTURE WORK: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68240461. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Cockayne S, Adamson J, Clarke A, Corbacho B, Fairhurst C, Green L, Hewitt CE, Hicks K, Kenan A-M, Lamb SE, et al (2017). Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).
PLoS One,
12(1).
Abstract:
Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).
BACKGROUND: Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. DESIGN: Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. RESULTS: in the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. CONCLUSION: There was a small reduction in falls. The intervention may be cost-effective. TRIAL REGISTRATION: ISRCTN ISRCTN68240461.
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Author URL.
Webster L, Groskreutz D, Grinbergs-Saull A, Howard R, O'Brien JT, Mountain G, Banerjee S, Woods B, Perneczky R, Lafortune L, et al (2017). Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: Systematic review and consensus recommendations.
PLoS One,
12(6).
Abstract:
Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: Systematic review and consensus recommendations.
BACKGROUND: There are no disease-modifying treatments for dementia. There is also no consensus on disease modifying outcomes. We aimed to produce the first evidence-based consensus on core outcome measures for trials of disease modification in mild-to-moderate dementia. METHODS AND FINDINGS: We defined disease-modification interventions as those aiming to change the underlying pathology. We systematically searched electronic databases and previous systematic reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate dementia. We included 149/22,918 of the references found; with 81 outcome measures from 125 trials. Trials involved participants with Alzheimer's disease (AD) alone (n = 111), or AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric symptoms, quality of life, global). We calculated the number of trials and of participants using each outcome. We detailed psychometric properties of each outcome. We sought the views of people living with dementia and family carers in three cities through Alzheimer's society focus groups. Attendees at a consensus conference (experts in dementia research, disease-modification and harmonisation measures) decided on the core set of outcomes using these results. Recommended core outcomes were cognition as the fundamental deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition should be measured by Mini Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made recommendations for measuring important, but non-core domains which may not change despite disease modification. LIMITATIONS: Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties. INTERPRETATION: This is the first review to identify the 81 outcome measures the research community uses for disease-modifying trials in mild-to-moderate dementia. Our recommendations will facilitate designing, comparing and meta-analysing disease modification trials in mild-to-moderate dementia, increasing their value. TRIAL REGISTRATION: PROSPERO no. CRD42015027346.
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Author URL.
Copsey B, Dutton S, Fitzpatrick R, Lamb SE, Cook JA (2017). Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review.
Trials,
18(1).
Abstract:
Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review.
BACKGROUND: a key aspect of the design of randomised controlled trials (RCTs) is determining the sample size. It is important that the trial sample size is appropriately calculated. The required sample size will differ by clinical area, for instance, due to the prevalence of the condition and the choice of primary outcome. Additionally, it will depend upon the choice of target difference assumed in the calculation. Focussing upon the hip and knee osteoarthritis population, this study aims to systematically review how the trial size was determined for trials of osteoarthritis, on what basis, and how well these aspects are reported. METHODS: Several electronic databases (Medline, Cochrane library, CINAHL, EMBASE, PsycINFO, PEDro and AMED) will be searched to identify articles on RCTs of hip and knee osteoarthritis published in 2016. Articles will be screened for eligibility and data extracted independently by two reviewers. Data will be extracted on study characteristics (design, population, intervention and control treatments), primary outcome, chosen sample size and justification, parameters used to calculate the sample size (including treatment effect in control arm, level of variability in primary outcome, loss to follow-up rates). Data will be summarised across the studies using appropriate summary statistics (e.g. n and %, median and interquartile range). The proportion of studies which report each key component of the sample size calculation will be presented. The reproducibility of the sample size calculation will be tested. DISCUSSION: the findings of this systematic review will summarise the current practice for sample size calculation in trials of hip and knee osteoarthritis. It will also provide evidence on the completeness of the reporting of the sample size calculation, reproducibility of the chosen sample size and the basis for the values used in the calculation. TRIAL REGISTRATION: As this review was not eligible to be registered on PROSPERO, the summary information was uploaded to Figshare to make it publicly accessible in order to avoid unnecessary duplication amongst other benefits ( https://doi.org/10.6084/m9.figshare.5009027.v1) ; Registered January 17, 2017.
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Author URL.
Keene DJ, Schlüssel MM, Hagan D, Thompson J, Williams MA, Byrne C, Gwilym SE, Goodacre S, Cooke MW, Hormbrey P, et al (2017). Development and external validation of a prognostic model for predicting poor outcome in patients with acute ankle sprains. Physiotherapy, 103, e32-e33.
Webster L, Groskreutz D, Grinbergs-Saull A, Howard R, O'Brien JT, Mountain G, Banerjee S, Woods B, Perneczky R, Lafortune L, et al (2017). Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations.
Health Technol Assess,
21(26), 1-192.
Abstract:
Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations.
BACKGROUND: There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials. OBJECTIVES: to agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI). DATA SOURCES: We included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches. REVIEW METHODS: the project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes. RESULTS: We included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally. LIMITATIONS: Most of the trials included participants with Alzheimer's disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer's Society Research Network. CONCLUSIONS: Cognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants. FUTURE WORK: We envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog. STUDY REGISTRATION: the project was registered with Core Outcome Measures in Effectiveness Trials [ www.comet-initiative.org/studies/details/819?result=true (accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346. FUNDING: the National Institute for Health Research Health Technology Assessment programme.
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Author URL.
Costa ML, Achten J, Griffin J, Petrou S, Pallister I, Lamb SE, Parsons NR, FixDT Trial Investigators (2017). Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults with Displaced Fracture of the Distal Tibia: the UK FixDT Randomized Clinical Trial.
JAMA,
318(18), 1767-1776.
Abstract:
Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults with Displaced Fracture of the Distal Tibia: the UK FixDT Randomized Clinical Trial.
IMPORTANCE: the best treatment for fractures of the distal tibia remains controversial. Most such fractures require surgical fixation but outcomes are unpredictable and complications are common. OBJECTIVE: to assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation. DESIGN, SETTING, AND PARTICIPANTS: a multicenter randomized trial recruiting 321 patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia from April 2013 through April 2016 with final follow-up in February 2017. Exclusion criteria included open fractures, fractures involving the ankle joint, contraindication to nailing, or inability to complete questionnaires. INTERVENTIONS: Intramedullary nail fixation (nail group; n = 161), a metal rod inserted into the hollow center of the tibia, vs locking plate fixation (plate group; n = 160), a plate attached to the surface of the tibia with fixed-angle screws. MAIN OUTCOMES AND MEASURES: Disability Rating Index (DRI; score range, 0 [no disability] to 100 [complete disability]) at 6 months was the primary outcome measure, with a minimal clinically important difference of 8 points. DRI measurement was also collected at 3 and 12 months. Secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life, and complications (such as infection and further surgery). RESULTS: Among 321 randomized patients (mean age, 45 years [SD, 16.2]; men, 197 [61%]; had experienced traumatic injury after a fall, 223 [69%]), 258 completed the study. There was no statistically significant difference in the DRI score at 6 months between groups (mean score, 29.8 in the nail group vs 33.8 in the plate group; adjusted difference, 4.0 [95% CI, -1.0 to 9.0], P = .11). There was a statistically significant difference in the DRI score at 3 months in favor of nail fixation (mean score, 44.2 in the nail group and 52.6 in the plate group; adjusted difference, 8.8 [95% CI, 4.3 to 13.2], P
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Author URL.
Fordham B, Ji C, Hansen Z, Lall R, Lamb SE (2017). Explaining How Cognitive Behavioral Approaches Work for Low Back Pain: Mediation Analysis of the Back Skills Training Trial.
Spine (Phila Pa 1976),
42(17), E1031-E1039.
Abstract:
Explaining How Cognitive Behavioral Approaches Work for Low Back Pain: Mediation Analysis of the Back Skills Training Trial.
STUDY DESIGN: This is secondary research examining the longitudinal mediation effect within a structural equation model. OBJECTIVE: to identify possible mechanisms that mediate the effects of a cognitive behavioral approach upon disability and pain in low back pain patients. SUMMARY OF BACKGROUND DATA: Cognitive behavioral interventions (CBIs) can improve pain and disability in low back pain (LBP) but the mechanisms of action are unclear. We used data from a large randomized controlled trial to investigate mediators of the treatment effect of CBI. METHODS: Pain self-efficacy, fear avoidance, and physical and mental functioning were selected as candidate mediators based on the theoretical rationale of the intervention. The primary treatment outcomes were the Roland Morris Questionnaire (RMDQ) and the modified Von Korff scale (MVK pain and disability) at 12 months. We used structural equation models to estimate the contribution of mediators. All models were tested for goodness-of-fit using χ , Root Mean Square Error of Approximation, Adjusted Goodness of Fit Index, and Bentler Comparative Fit Index. RESULTS: We included 701 adults with LBP. The average RMDQ score at baseline for those on the intervention arm was 8.8 (Standard Deviation 5.0). The intervention was effective in reducing disability and pain at 12 months. Change in mental functioning was not a significant mediator. Changes to pain self-efficacy, fear avoidance, and physical functioning were causal mediators of the treatment effect at 12 months (RMDQ b= -0.149, P
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Author URL.
Lamb SE, Mistry D, Lall R, Khan I, Dosanjh S, Petrou S, Sheehan B (2017). HIGH INTENSITY EXERCISE DOES NOT DELAY COGNITIVE DECLINE IN MILD TO MODERATE DEMENTIA: RCT.
Innovation in aging,
1(Suppl 1), 908-908.
Abstract:
HIGH INTENSITY EXERCISE DOES NOT DELAY COGNITIVE DECLINE IN MILD TO MODERATE DEMENTIA: RCT
Abstract Several small trials suggest exercise may delay cognitive decline in people with Alzheimer’s, Vascular or Mixed dementia. In a multicentre trial (registration ISRCTN10416500,15 centres), we randomly assigned 494 people with mild or moderate dementia to either a 4-month supervised high intensity exercise training regime and on-going supported physical activity programme or usual care. All participants had a standardised Mini-Mental State Examination (sMMSE) score greater than 10. The primary outcome was the Alzheimer’s Disease Assessment Scale-cognitive (ADAS-cog) score at 12 months. Secondary outcomes were physical fitness, ADLs, neuropsychiatric symptoms, quality of life and health service resource use. We undertook pre-specified sub-group analyses and investigated impact on carers Baseline sample means were ADAS-cog 21 (SD 8.2); age 77 (SD 7.7) and 60% were men. Compliance with exercise classes was high and physical fitness improved. By 12 months, mean ADAS-cog was 25 (SD12.3) in the exercise group and 24 (SD 10.4) in the usual care group (adjusted between group difference -1.4 (95% CI -2.62,-0.17, p 0.026 higher score indicates worse cognition). Pre-randomisation disease type, sMMSE, physical status and gender were not significant sub-group factors. There were no significant differences in secondary or carer outcomes between groups. The exercise intervention was not cost effective. In this large, well conducted trial, high intensity exercise training did not reduce decline in cognition in mild to moderate dementia. Although physical fitness improved, the impacts on other important clinical outcomes was null and the intervention was not cost effective from a UK Health care perspective.
Abstract.
Williamson E, McConkey C, Heine P, Dosanjh S, Williams M, Lamb SE (2017). Hand exercises for patients with rheumatoid arthritis: an extended follow-up of the SARAH randomised controlled trial.
BMJ Open,
7(4).
Abstract:
Hand exercises for patients with rheumatoid arthritis: an extended follow-up of the SARAH randomised controlled trial.
OBJECTIVES: the Stretching and strengthening for Rheumatoid Arthritis of the Hand (SARAH) randomised controlled trial evaluated the effectiveness of a hand exercise programme and demonstrated it was clinically effective and cost-effective at 12
months. The aim of this extended follow-up was to evaluate the effects of the SARAH programme beyond 12
months. METHODS: Using postal questionnaires, we collected the Michigan Hand Questionnaire hand function (primary outcome), activities of daily living and work subscales, pain troublesomeness, self-efficacy and health-related quality of life. All participants were asked how often they performed hand exercises for their rheumatoid arthritis. Mean difference in hand function scores were analysed by a linear model, adjusted for baseline score. RESULTS: Two-thirds (n=328/490, 67%) of the original cohort provided data for the extended follow-up. The mean follow-up time was 26
months (range 19-40
months).There was no difference in change in hand function scores between the two groups at extended follow-up (mean difference (95% CI) 1.52 (-1.71 to 4.76)). However, exercise group participants were still significantly improved compared with baseline (p=0.0014) unlike the best practice usual care group (p=0.1122). Self-reported performance of hand exercises had reduced substantially. CONCLUSIONS: Participants undertaking the SARAH exercise programme had improved hand function compared with baseline >2
years after randomisation. This was not the case for the control group. However, scores were no longer statistically different between the groups indicating the effect of the programme had diminished over time. This reduction in hand function compared with earlier follow-up points coincided with a reduction in self-reported performance of hand exercises. Further intervention to promote long-term adherence may be warranted. TRIAL REGISTRATION NUMBER: ISRCTN89936343; Results.
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Shah A, Judge A, Delmestri A, Edwards K, Arden NK, Prieto-Alhambra D, Holt TA, Pinedo-Villanueva RA, Hopewell S, Lamb SE, et al (2017). Incidence of shoulder dislocations in the UK, 1995-2015: a population-based cohort study.
BMJ Open,
7(11).
Abstract:
Incidence of shoulder dislocations in the UK, 1995-2015: a population-based cohort study.
OBJECTIVE: This cohort study evaluates the unknown age-specific and gender-specific incidence of primary shoulder dislocations in the UK. SETTING: UK primary care data from the Clinical Practice Research Datalink (CPRD) were used to identify patients aged 16-70 years with a shoulder dislocation during 1995-2015. Coding of primary shoulder dislocations was validated using the CPRD general practitioner questionnaire service. PARTICIPANTS: a cohort of 16 763 patients with shoulder dislocation aged 16-70 years during 1995-2015 were identified. PRIMARY OUTCOME MEASURE: Incidence rates per 100 000 person-years and 95% CIs were calculated. RESULTS: Correct coding of shoulder dislocation within CPRD was 89% (95% CI 83% to 95%), and confirmation that the dislocation was a 'primary' was 76% (95% CI 67% to 85%). Seventy-two percent of shoulder dislocations occurred in men. The overall incidence rate in men was 40.4 per 100 000 person-years (95% CI 40.4 to 40.4), and in women was 15.5 per 100 000 person-years (95% CI 15.5 to 15.5). The highest incidence was observed in men aged 16-20 years (80.5 per 100 000 person-years; 95% CI 80.5 to 80.6). Incidence in women increased with age to a peak of 28.6 per 100 000 person-years among those aged 61-70 years. CONCLUSIONS: This is the first time the incidence of shoulder dislocations has been studied using primary care data from a national database, and the first time the results for the UK have been produced. While most primary dislocations occurred in young men, an unexpected finding was that the incidence increased in women aged over 50 years, but not in men. The reasons for this are unknown. Further work is commissioned by the National Institute for Health Research to examine treatments and predictors for recurrent shoulder dislocation. STUDY REGISTRATION: the design of this study was approved by the Independent Scientific Advisory Committee (15_260) for the Medicines & Healthcare products Regulatory Agency.
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Avery KNL, Williamson PR, Gamble C, Francischetto EOC, Metcalfe C, Davidson P, Williams H, Blazeby JM, Blencowe N, Bugge C, et al (2017). Informing efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studies.
BMJ Open,
7(2).
Abstract:
Informing efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studies
Objectives: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. Design: a structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. Results: There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decisionmaking process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. Conclusions: Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials.
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Byrne C, Keene DJ, Lamb SE, Willett K (2017). Intrarater reliability and agreement of linear encoder derived heel-rise endurance test outcome measures in healthy adults.
J Electromyogr Kinesiol,
36, 34-39.
Abstract:
Intrarater reliability and agreement of linear encoder derived heel-rise endurance test outcome measures in healthy adults.
A linear encoder measuring vertical displacement during the heel-rise endurance test (HRET) enables the assessment of work and maximum height in addition to the traditional repetitions measure. We aimed to compare the test-retest reliability and agreement of these three outcome measures. Thirty-eight healthy participants (20 females, 18 males) performed the HRET on two occasions separated by a minimum of seven days. Reliability was assessed by the intraclass correlation coefficient (ICC) and agreement by a range of measures including the standard error of measurement (SEM), coefficient of variation (CV), and 95% limits of agreement (LoA). Reliability for repetitions (ICC=0.77 (0.66, 0.85)) was equivalent to work (ICC=0.84 (95% CI 0.76, 0.89)) and maximum height (ICC=0.85 (0.77, 0.90)). Agreement for repetitions (SEM=6.7 (5.8, 7.9); CV=13.9% (11.9, 16.8%); LoA=-1.9±37.2%) was equivalent to work (SEM=419J (361, 499J); CV=13.1% (11.2, 15.8%); LoA=0.1±34.8%) with maximum height superior (SEM=0.8cm (0.6, 1.0cm); CV=6.6% (5.7, 7.9%); LoA=1.3±17.1%). Work and maximum height demonstrated acceptable reliability and agreement that was at least equivalent to the traditional repetitions measure.
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Zadro J, Shirley D, Ferreira M, Carvalho-Silva AP, Lamb SE, Cooper C, Ferreira PH (2017). Mapping the Association between Vitamin D and Low Back Pain: a Systematic Review and Meta-Analysis of Observational Studies.
Pain Physician,
20(7), 611-640.
Abstract:
Mapping the Association between Vitamin D and Low Back Pain: a Systematic Review and Meta-Analysis of Observational Studies.
BACKGROUND: Low back pain (LBP) is the highest contributor to disability worldwide, with current intervention strategies only providing small to moderate analgesic effects. The use of vitamin D supplementation for LBP has gained interest due to its proposed anti-inflammatory and neuromodulatory properties. However, it is still unclear whether vitamin D levels differ between those with and without LBP or if vitamin D levels are associated with pain intensity. OBJECTIVES: We aim to investigate the association between vitamin D levels and LBP and to determine if vitamin D levels correlate with pain intensity in individuals with LBP. STUDY DESIGN: This study was conducted in accordance with the guidelines for performing a Meta-analysis and Systematic Review of Observational Studies in Epidemiology (MOOSE). METHODS: We performed electronic database searches combined keywords relating to vitamin D and LBP in MEDLINE, CINAHL, EMBASE, AMED, WEB OF SCIENCE, and SCOPUS from the earliest record to March 2017. Studies were included if they reported any quantitative measure of vitamin D, such as serum 25-hydroxyvitamin D [25(OH)D], with adequate data in patients with and without LBP or adequate data on pain intensity in patients with LBP. No restriction on the type or duration of LBP, nor the age and gender of patients was applied. Two reviewers independently performed the selection of studies, extracted data, and assessed the methodological quality of the included studies using a modified 15-item Downs and Black checklist. RESULTS: After the removal of duplicates and the screening of titles and abstracts, 105 full texts were evaluated. There were 29 articles included in this systemic review (22 entered into a meta-analysis), including 19 cross-sectional studies, 9 case-control studies, and one single-arm surgical trial where the pre-operative data were used in our analyses. The pooled results from 19 studies showed that individuals with LBP were more likely to have vitamin D deficiency (pooled OR = 1.60, 95% CI: 1.20 - 2.12, P = 0.001, n = 19), severe deficiency (pooled OR = 2.08, 95% CI: 1.19 - 3.64, P = 0.010, n = 7), and lower serum concentrations of 25(OH)D (weighted MD = 3.86, 95% CI: 0.20 - 7.52, P = 0.039, n = 12) compared to those without LBP (where "n" is the number of studies). The association between vitamin D deficiency (pooled OR = 1.83, 95% CI: 1.26 - 2.66, P = 0.002, n = 9) or serum 25(OH)D (weighted MD = 7.64, 95% CI: 4.02 - 11.26, P < 0.001, n = 4) and LBP was stronger for women but failed to be statistically significant for men (pooled OR = 1.06, 95% CI: 0.62 - 1.81, P = 0.213, n = 3). In addition, there were strong associations between vitamin D deficiency and LBP in patients < 60 years old (particularly women). We found minimal evidence to support an association between vitamin D levels and pain intensity in patients with LBP. LIMITATIONS: We were unable to investigate whether vitamin D deficiency increases the risk of developing LBP as there were no longitudinal studies included in this review. CONCLUSION: Vitamin D deficiency is associated with LBP, with stronger associations observed in younger women and those with severe levels of deficiency. The association between vitamin D levels and pain intensity is inconsistent. These results may guide the implementation of future studies on vitamin D supplementation for LBP. PROSPERO Registration No: CRD42016046874. KEY WORDS: Vitamin D, low back pain, deficiency, pain intensity, serum 25-hydroxyvitamin D, supplementation, cross-sectional study, case-control study.
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Author URL.
Lamb SE, Keene DJ (2017). Measuring physical capacity and performance in older people.
Best Pract Res Clin Rheumatol,
31(2), 243-254.
Abstract:
Measuring physical capacity and performance in older people.
We highlight the important differences between the concepts of capacity and performance and highlight the development of measures and their application in common conditions encountered in health care practice with older people. A number of expert consensus projects have concluded that mobility, balance, muscle strength and dexterity are core domains for capacity measurement in older people. Instruments with evidence of adequate psychometric properties for the evaluation of capacity in response to intervention programmes include the Short Physical Performance Battery, hand grip strength, mini-BEST and 9-hole pegboard test. Measures that can track individual change and convey information that can be used to inform clinical decision-making, individual prognosis or prediction of events require greater precision. However, few such measures are available. Performance measurement usually focuses on basic or instrumental (advanced) Activities of Daily Living performed by people in their usual environments. Finally, we discuss the limitations of physical performance and capacity measures and future developments that may enhance the use of these measures in health and clinical care.
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Hall AM, Copsey B, Williams M, Srikesavan C, Lamb SE, Sarah Trial Team (2017). Mediating Effect of Changes in Hand Impairments on Hand Function in Patients with Rheumatoid Arthritis: Exploring the Mechanisms of an Effective Exercise Program.
Arthritis Care Res (Hoboken),
69(7), 982-988.
Abstract:
Mediating Effect of Changes in Hand Impairments on Hand Function in Patients with Rheumatoid Arthritis: Exploring the Mechanisms of an Effective Exercise Program.
OBJECTIVE: to determine whether the effect of the Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) exercise program on hand function was mediated by changes in the proposed active ingredients: strength, dexterity, and/or range of motion. METHODS: the SARAH intervention included exercises hypothesized to improve potential mediators of grip strength, pinch strength, wrist flexion, wrist extension, finger flexion, finger extension, thumb opposition, and dexterity, which would theoretically improve self-reported hand function. All variables were measured at baseline and at 4 and 12 months. Structural equation modeling was used to assess mediation on change in hand function via change in potential mediators. RESULTS: Change in grip strength partially mediated change in hand function. Grip strength mediated 19.4% (95% confidence interval 0.9%, 37.8%) of the treatment effect. CONCLUSION: Improvements in grip strength at 4 months are likely to mediate improved hand function at 12 months. The role of joint mobility exercises is less clear and is likely influenced by the choice of measurement tools for both mobility and function outcomes. More robust measurements of wrist and hand mobility for patients with rheumatoid arthritis may be necessary to determine the relationship between this variable and self-reported hand function. Using a large trial data set, we have demonstrated that techniques used to target grip strength are key active ingredients of the SARAH exercise program and mediate its effect.
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Lamb S (2017). PHYSICAL IMPAIRMENTS AFTER HIP FRACTURE.
Innovation in aging,
1(Suppl 1), 616-617.
Abstract:
PHYSICAL IMPAIRMENTS AFTER HIP FRACTURE
Abstract Modern surgical management of hip fractures leads, in most instances, to successful restoration of skeletal integrity of the femur and the possibility for resumption of weight bearing and early locomotion. However, studies of other organs involved in locomotion reveal substantial impairments that may not recover completely, or take much longer to recover and impact many essential facets of locomotion, including ability and speed of walking, chair standing, and stair climbing. This presentation will use data collected between 1 and 3 months after hip fracture surgery, including muscle force generating characteristics of injured and uninjured limbs, postural sway, functional balance capabilities, and pain to characterise recovery of locomotion and the pathway between organ impairments, functional limitation, and disability in older people with hip fracture. The presentation will highlight potential avenues for new effective adjuncts to hip fracture management and consider both research and practice implications.
Abstract.
Alsousou J, Keene DJ, Hulley PA, Harrison P, Wagland S, Byrne C, Schlüssel MM, Dutton SJ, Lamb SE, Willett K, et al (2017). Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture.
BMJ Open,
7(11).
Abstract:
Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture.
BACKGROUND: Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies. METHODS AND DESIGN: This is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle-tendon function, quality of life, pain and overall patient's functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations. ETHICS AND DISSEMINATION: the protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: ISRCTN: 54992179, assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.
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Gates S, Lall R, Quinn T, Deakin CD, Cooke MW, Horton J, Lamb SE, Slowther A-M, Woollard M, Carson A, et al (2017). Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation.
Health Technol Assess,
21(11), 1-176.
Abstract:
Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation.
BACKGROUND: Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). OBJECTIVE: Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. DESIGN: Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. SETTING: Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. PARTICIPANTS: Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged
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Thompson J, Byrne C, Williams M, Keene D, Schlussel M, Lamb S, Group SS (2017). Prognostic factors for outcome following acute lateral ankle ligament sprain: a systematic review. Physiotherapy, 103, e44-e45.
Thompson JY, Byrne C, Williams MA, Keene DJ, Schlussel MM, Lamb SE (2017). Prognostic factors for recovery following acute lateral ankle ligament sprain: a systematic review.
BMC Musculoskelet Disord,
18(1).
Abstract:
Prognostic factors for recovery following acute lateral ankle ligament sprain: a systematic review.
BACKGROUND: One-third of individuals who sustain an acute lateral ankle ligament sprain suffer significant disability due to pain, functional instability, mechanical instability or recurrent sprain after recovery plateaus at 1 to 5 years post injury. The identification of early prognostic factors associated with poor recovery may provide an opportunity for early-targeted intervention and improve outcome. METHODS: We performed a comprehensive search of AMED, EMBASE, Psych Info, CINAHL, SportDiscus, PubMed, CENTRAL, PEDro, OpenGrey, abstracts and conference proceedings from inception to September 2016. Prospective studies investigating the association between baseline prognostic factors and recovery over time were included. Two independent assessors performed the study selection, data extraction and quality assessment of the studies. A narrative synthesis is presented due to inability to meta-analyse results due to clinical and statistical heterogeneity. RESULTS: the search strategy yielded 3396 titles/abstracts after duplicates were removed. Thirty-six full text articles were then assessed, nine of which met the study inclusion criteria. Six were prospective cohorts, and three were secondary analyses of randomised controlled trials. Results are presented for nine studies that presented baseline prognostic factors for recovery after an acute ankle sprain. Age, female gender, swelling, restricted range of motion, limited weight bearing ability, pain (at the medial joint line and on weight-bearing dorsi-flexion at 4 weeks, and pain at rest at 3 months), higher injury severity rating, palpation/stress score, non-inversion mechanism injury, lower self-reported recovery, re-sprain within 3 months, MRI determined number of sprained ligaments, severity and bone bruise were found to be independent predictors of poor recovery. Age was one prognostic factor that demonstrated a consistent association with outcome in three studies, however cautious interpretation is advised. CONCLUSIONS: the associations between prognostic factors and poor recovery after an acute lateral ankle sprain are largely inconclusive. At present, there is insufficient evidence to recommend any factor as an independent predictor of outcome. There is a need for well-conducted prospective cohort studies with adequate sample size and long-term follow-up to provide robust evidence on prognostic factors of recovery following an acute lateral ankle sprain. TRIAL REGISTRATION: Prospero registration: CRD42014014471.
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Veronese N, Stubbs B, Crepaldi G, Solmi M, Cooper C, Harvey NC, Reginster J-Y, Rizzoli R, Civitelli R, Schofield P, et al (2017). Relationship Between Low Bone Mineral Density and Fractures with Incident Cardiovascular Disease: a Systematic Review and Meta-Analysis.
J Bone Miner Res,
32(5), 1126-1135.
Abstract:
Relationship Between Low Bone Mineral Density and Fractures with Incident Cardiovascular Disease: a Systematic Review and Meta-Analysis.
An increasing evidence base suggests that low bone mineral density (BMD) and fractures are associated with cardiovascular disease (CVD). We conducted a systematic review and meta-analysis summarizing the evidence of low BMD and fractures as risk factors for future CVD. Two independent authors searched major databases from inception to August 1, 2016, for longitudinal studies reporting data on CVD incidence (overall and specific CVD) and BMD status and fractures. The association between low BMD, fractures, and CVD across longitudinal studies was explored by calculating pooled adjusted hazard ratios (HRs) ±95% confidence intervals (CIs) with a random-effects meta-analysis. Twenty-eight studies (18 regarding BMD and 10 fractures) followed a total of 1,107,885 participants for a median of 5 years. Taking those with higher BMD as the reference, people with low BMD were at increased risk of developing CVD during follow-up (11 studies; HR = 1.33; 95%CI, 1.27 to 1.38; I2 = 53%), after adjusting for a median of eight confounders. This finding was confirmed using a decrease in one standard deviation of baseline BMD (9 studies; HR = 1.16; 95% CI, 1.09 to 1.24; I2 = 69%). The presence of fractures at baseline was associated with an increased risk of developing CVD (HR = 1.20; 95% CI, 1.06 to 1.37; I2 = 91%). Regarding specific CVDs, low BMD was associated with an increased risk of developing coronary artery disease, cerebrovascular conditions, and CVD-associated death. Fractures at baseline was associated with an increased risk of cerebrovascular conditions and death due to CVD. In conclusion, low BMD and fractures are associated with a small, but significant increased risk of CVD risk and possibly death. © 2017 American Society for Bone and Mineral Research.
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Reuben DB, Gill TM, Lamb S (2017). STRIDE: a PRAGMATIC TRIAL OF a MULTIFACTORIAL APPROACH TO REDUCE SERIOUS FALLS INJURIES.
Innovation in aging,
1(Suppl 1), 1007-1007.
Abstract:
STRIDE: a PRAGMATIC TRIAL OF a MULTIFACTORIAL APPROACH TO REDUCE SERIOUS FALLS INJURIES
Abstract Among older adults, falls are the leading cause of both fatal and nonfatal injuries. In 2014, the Patient-Centered Outcomes Research Institute (PCORI) and the National Institute on Aging (NIA) funded a pragmatic trial to develop and test an intervention that would be integrated into the provision of clinical care in 10 US health care systems with the aim of reducing serious falls-related injuries. Within the 10 health systems, 86 practices (43 intervention and 43 control) and 707 primary care physicians (348 intervention and 359 control) are participating. Both central and clinic-based screening are being utilized followed by centralized recruitment. By Spring 2017, STRIDE will have recruited 5322 participants aged 73 years or older and will follow them for an average of 2.5 years. The STRIDE intervention is patient-centered and based on identification and co-management of up to 8 personal risk factors (medications, postural hypotension, feet and footwear, vision, vitamin D, osteoporosis, home safety, and strength, gait, and balance impairment) by a registered nurse. Interventions for specific risk factors are evidence-based and can be implemented within health care systems and community-based organizations. Several approaches, including self-report, electronic health care records, and claims data, are being used to ascertain and verify the primary and several secondary outcomes. At each step, barriers to conducting the study have surfaced and solutions to overcoming these barriers have been implemented. These study barriers and their solutions provide lessons for conducting pragmatic trials in older persons, implementing interventions, ascertaining outcomes, and diffusing research findings into clinical care.
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Meade MO, Young D, Hanna S, Zhou Q, Bachman TE, Bollen C, Slutsky AS, Lamb SE, Adhikari NKJ, Mentzelopoulos SD, et al (2017). Severity of Hypoxemia and Effect of High-Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome.
Am J Respir Crit Care Med,
196(6), 727-733.
Abstract:
Severity of Hypoxemia and Effect of High-Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome.
RATIONALE: High-frequency oscillatory ventilation (HFOV) is theoretically beneficial for lung protection, but the results of clinical trials are inconsistent, with study-level meta-analyses suggesting no significant effect on mortality. OBJECTIVES: the aim of this individual patient data meta-analysis was to identify acute respiratory distress syndrome (ARDS) patient subgroups with differential outcomes from HFOV. METHODS: After a comprehensive search for trials, two reviewers independently identified randomized trials comparing HFOV with conventional ventilation for adults with ARDS. Prespecified effect modifiers were tested using multivariable hierarchical logistic regression models, adjusting for important prognostic factors and clustering effects. MEASUREMENTS AND MAIN RESULTS: Data from 1,552 patients in four trials were analyzed, applying uniform definitions for study variables and outcomes. Patients had a mean baseline PaO2/FiO2 of 114 ± 39 mm Hg; 40% had severe ARDS (PaO2/FiO2
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Bruce J, Ralhan S, Sheridan R, Westacott K, Withers E, Finnegan S, Davison J, Martin FC, Lamb SE (2017). The design and development of a complex multifactorial falls assessment intervention for falls prevention: the Prevention of Falls Injury Trial (PreFIT).
BMC Geriatrics,
17(1).
Abstract:
The design and development of a complex multifactorial falls assessment intervention for falls prevention: the Prevention of Falls Injury Trial (PreFIT)
Background: This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). Methods: a complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Results: Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of ‘red flags’; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. Conclusion: This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and fractures, will be reported at the conclusion of the trial.
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Brealey S, Armstrong AL, Brooksbank A, Carr AJ, Charalambous CP, Cooper C, Corbacho B, Dias J, Donnelly I, Goodchild L, et al (2017). United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.
Trials,
18(1).
Abstract:
United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.
BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. METHODS: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. DISCUSSION: the three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014.
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Bruce J, Lall R, Withers EJ, Finnegan S, Underwood M, Hulme C, Sheridan R, Skelton DA, Martin F, Lamb SE, et al (2016). A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: Protocol for the prevention of falls injury trial (PreFIT).
BMJ Open,
6(1).
Abstract:
A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: Protocol for the prevention of falls injury trial (PreFIT)
Introduction: Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. Methods and analysis: a three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. Ethics and dissemination: the study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/ 2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties.
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Yan LL, Chen S, Zhou B, Zhang J, Xie B, Luo R, Wang N, Lindley R, Zhang Y, Zhao Y, et al (2016). A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.
Int J Stroke,
11(7), 823-830.
Abstract:
A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.
RATIONALE: Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. AIM: This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. METHODS AND DESIGN: This 2-year randomized controlled trial is being conducted in 2-3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. STUDY OUTCOME: the primary outcome is patients' Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. DISCUSSION: the results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care.
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Byrne C, Faure C, Keene DJ, Lamb SE (2016). Ageing, Muscle Power and Physical Function: a Systematic Review and Implications for Pragmatic Training Interventions.
Sports Med,
46(9), 1311-1332.
Abstract:
Ageing, Muscle Power and Physical Function: a Systematic Review and Implications for Pragmatic Training Interventions.
BACKGROUND: the physiological impairments most strongly associated with functional performance in older people are logically the most efficient therapeutic targets for exercise training interventions aimed at improving function and maintaining independence in later life. OBJECTIVES: the objectives of this review were to (1) systematically review the relationship between muscle power and functional performance in older people; (2) systematically review the effect of power training (PT) interventions on functional performance in older people; and (3) identify components of successful PT interventions relevant to pragmatic trials by scoping the literature. METHODS: Our approach involved three stages. First, we systematically reviewed evidence on the relationship between muscle power, muscle strength and functional performance and, second, we systematically reviewed PT intervention studies that included both muscle power and at least one index of functional performance as outcome measures. Finally, taking a strong pragmatic perspective, we conducted a scoping review of the PT evidence to identify the successful components of training interventions needed to provide a minimally effective training dose to improve physical function. RESULTS: Evidence from 44 studies revealed a positive association between muscle power and indices of physical function, and that muscle power is a marginally superior predictor of functional performance than muscle strength. Nine studies revealed maximal angular velocity of movement, an important component of muscle power, to be positively associated with functional performance and a better predictor of functional performance than muscle strength. We identified 31 PT studies, characterised by small sample sizes and incomplete reporting of interventions, resulting in less than one-in-five studies judged as having a low risk of bias. Thirteen studies compared traditional resistance training with PT, with ten studies reporting the superiority of PT for either muscle power or functional performance. Further studies demonstrated the efficacy of various methods of resistance and functional task PT on muscle power and functional performance, including low-load PT and low-volume interventions. CONCLUSIONS: Maximal intended movement velocity, low training load, simple training methods, low-volume training and low-frequency training were revealed as components offering potential for the development of a pragmatic intervention. Additionally, the research area is dominated by short-term interventions producing short-term gains with little consideration of the long-term maintenance of functional performance. We believe the area would benefit from larger and higher-quality studies and consideration of optimal long-term strategies to develop and maintain muscle power and physical function over years rather than weeks.
Abstract.
Author URL.
Copsey B, Hopewell S, Becker C, Cameron ID, Lamb SE (2016). Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention.
Trials,
17(1).
Abstract:
Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention.
BACKGROUND: Many researchers and professional bodies are seeking consensus for core outcomes for clinical trials. The Prevention of Falls Network Europe (ProFaNE) developed a common outcome data set for fall injury prevention trials 10 years ago. This study assesses the impact of these recommendations. METHODS: a systematic search (up to 16 January 2015) was performed using Web of Science, Scopus and PubMed for articles citing the ProFaNE recommendations. Randomised trials on fall prevention in older people were selected for further analysis. Data were extracted on study characteristics and adherence to the key domains recommended by the ProFaNE consensus: falls, fall injury, physical activity, psychological consequences and health-related quality of life. Details of non-recommended outcome measures used were also recorded. RESULTS: the ProFaNE recommendations were cited in a total of 464 published articles, of which 34 were randomised trials on fall prevention in older people. Only one study (3 %) reported on all core domains. Most of the trials reported on falls (n = 32/34, 94 %) as a core outcome measure. Most of the recommendations within the falls domain were well-followed. Around half of the trials reported on fall-related injury (n = 16/34, 47 %). However, none reported the number of radiologically confirmed peripheral fracture events, which is the recommended outcome measure for injury. The other key domains (quality of life, physical activity and psychological consequences) were less frequently reported on, with a lack of consistency in the outcome measures used. CONCLUSIONS: the ProFaNE recommendations had a limited effect on standardising the reporting of outcomes in randomised trials on fall injury prevention in older people during the search period. Authors of consensus guidelines should consider maximising buy-in by including a diversity of geographic areas and academic disciplines at the development stage and using a solid dissemination strategy.
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Author URL.
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA, Altman D, Bretz F, Campbell M, et al (2016). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. The BMJ, 355
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA, O'Cathain A, Altman D, Bretz F, et al (2016). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials.
Pilot and Feasibility Studies,
2(1).
Abstract:
CONSORT 2010 statement: Extension to randomised pilot and feasibility trials
The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor's note: in order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.
Abstract.
Barker KL, Beard D, Price A, Toye F, Underwood M, Drummond A, Collins G, Dutton S, Campbell H, Kenealy N, et al (2016). COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial.
Trials,
17(1).
Abstract:
COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial.
BACKGROUND: the number of knee arthroplasties performed each year is steadily increasing. Although the outcome is generally favourable, up to 15 % fail to achieve a satisfactory clinical outcome which may indicate that the existing model of rehabilitation after surgery may not be the most efficacious. Given the increasing number of knee arthroplasties, the relative limited physiotherapy resources available and the increasing age and frailty of patients receiving arthroplasty surgery, it is important that we concentrate our rehabilitation resources on those patients who most need help to achieve a good outcome. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of a community-based multidisciplinary rehabilitation intervention in comparison to usual care. METHODS/DESIGN: the trial is designed as a prospective, single-blind, two-arm randomised controlled trial (RCT). A bespoke algorithm to predict which patients are at risk of poor outcome will be developed to screen patients for inclusion into a RCT using existing datasets. Six hundred and twenty patients undergoing knee arthroplasty, and assessed as being at risk of poor outcome using this algorithm, will be recruited and randomly allocated to one of two rehabilitation strategies: usual care or an individually tailored community-based rehabilitation package. The primary outcome is the Late Life Function and Disability Instrument measured at 1 year after surgery. Secondary outcomes include the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EQ-5D-5L and physical function measured by three performance-based tests: figure of eight, sit to stand and single-leg stand. A nested qualitative study will explore patient experience and perceptions and a health economic analysis will assess whether a home-based multidisciplinary individually tailored rehabilitation package represents good value for money when compared to usual care. DISCUSSION: There is lack of consensus about what constitutes the optimum package of rehabilitation after knee arthroplasty surgery. There is also a need to tailor rehabilitation to the needs of those predicted to do least well by focussing on interventions that target the elderly and frailer population receiving arthroplasty surgery. TRIAL REGISTRATION: ISRCTN 13517704 , registered on 12 February 2015.
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Author URL.
Willett K, Keene DJ, Mistry D, Nam J, Tutton E, Handley R, Morgan L, Roberts E, Briggs A, Lall R, et al (2016). Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults: a Randomized Clinical Trial.
JAMA,
316(14), 1455-1463.
Abstract:
Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults: a Randomized Clinical Trial.
IMPORTANCE: Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications. OBJECTIVE: to determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use. DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment. INTERVENTIONS: Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon. MAIN OUTCOMES AND MEASURES: the primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction. RESULTS: Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P for equivalence = .001). Infection and wound breakdown were more common with surgery (29/298 [10%] vs 4/275 [1%]; odds ratio [OR], 7.3 [95% CI, 2.6-20.2]), as were additional operating room procedures (18/298 [6%] for surgery and 3/275 [1%] for casting; OR, 5.8 [95% CI, 1.8-18.7]). Radiologic malunion was more common in the casting group (38/249 [15%] vs 8/274 [3%] for surgery; OR, 6.0 [95% CI, 2.8-12.9]). Casting required less operating room time compared with surgery (mean difference [minutes/participant], -54 [95% CI, -58 to -50]). There were no significant differences in other secondary outcomes: quality of life, pain, ankle motion, mobility, and patient satisfaction. CONCLUSIONS AND RELEVANCE: Among older adults with unstable ankle fracture, the use of close contact casting compared with surgery resulted in similar functional outcomes at 6 months. Close contact casting may be an appropriate treatment for such patients. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN04180738.
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Author URL.
Atherton N, Bridle C, Brown D, Collins H, Dosanjh S, Griffiths F, Hennings S, Khan K, Lall R, Lyle S, et al (2016). Dementia and Physical Activity (DAPA) - an exercise intervention to improve cognition in people with mild to moderate dementia: study protocol for a randomized controlled trial.
Trials,
17Abstract:
Dementia and Physical Activity (DAPA) - an exercise intervention to improve cognition in people with mild to moderate dementia: study protocol for a randomized controlled trial.
BACKGROUND: Dementia is more common in older than in younger people, and as a result of the ageing of the population in developed countries, it is becoming more prevalent. Drug treatments for dementia are limited, and the main support offered to people with dementia and their families is generally services to mitigate against loss of function. Physical exercise is a candidate non-pharmacological treatment for dementia. METHODS/DESIGN: DAPA is a randomised controlled trial funded by the National Institute for Health Research Health Technology Assessment programme to estimate the effect of a 4-month, moderate- to hard-intensity exercise training programme and subsequent advice to remain active, on cognition (primary outcome) at 12 months in people with mild to moderate dementia. Community-dwelling participants (with their carers where possible), who are able to walk 3 metres without human assistance, able to undertake an exercise programme and do not have any unstable or terminal illness are recruited. Participants are then randomised by an independent statistician using a computerised random number generator to usual care or exercise at a 2:1 ratio in favour of exercise. The exercise intervention comprises 29, 1-hour-long exercise classes, run twice weekly at suitable venues such as leisure centres, which include aerobic exercise (on static bikes) and resistance exercise (using weights). Goals for independent exercise are set while the classes are still running, and supported thereafter with phone calls. The primary outcome is measured using ADAS-cog. Secondary outcome measures include behavioural symptoms, functional ability, quality of life and carer burden. Primary and secondary outcomes will be measured at baseline and at 6 and 12 months after randomisation, by researchers masked to participant randomisation in the participants' own homes. An economic evaluation will be carried out in parallel to the RCT, as will a qualitative study capturing the experiences of participants, carers and staff delivering the intervention. DISCUSSION: the DAPA study will be the first large, randomised trial of the cognitive effects of exercise on people with dementia. The intervention is designed to be capable of being delivered within the constraints of NHS service provision, and the economic evaluation will allow assessment of its cost-effectiveness. TRIAL REGISTRATION: DAPA was registered with the ISRCTN database on 29 July 2011, registration number ISRCTN32612072.
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Author URL.
Pink J, Petrou S, Williamson E, Williams M, Lamb SE (2016). Economic and Health-Related Quality of Life Outcomes of Whiplash Associated Disorders.
Spine (Phila Pa 1976),
41(17), 1378-1386.
Abstract:
Economic and Health-Related Quality of Life Outcomes of Whiplash Associated Disorders.
STUDY DESIGN: This study examines the links between severity of whiplash associated disorder and costs and health outcomes. OBJECTIVE: the study aims to estimate the economic costs and health-state utilities associated with disability levels and recovery trajectories after acute whiplash injury. SUMMARY OF BACKGROUND DATA: Data used were from the Managing Injuries of the Neck Trial, which collected information on 3851 people over a 12-month period after acute whiplash injury. METHODS: Effects of whiplash associated disorder severity on economic costs (measured from a societal perspective and separately from a health and personal social services perspective) were estimated using two-part regression models, comprising probability of incurring a cost and the total cost, given one was incurred. Effects on health-state utilities (measured using the EQ-5D and SF-6D) were estimated using ordinary least squares regression, and two-part models as for costs. RESULTS: There was a direct relationship between severity of disability after acute whiplash injury and economic costs. Between baseline and 4 months, average societal costs for those with no disability were £99.55 (UK£, 2009 prices), increasing to £668.53 for those with complete disability. Average societal costs for the whole sample were £234.15 over the first 4 months, decreasing to £127.51 between 8 and 12 months. Conversely, utility scores decreased with increased disability. The average EQ-5D utility score was 0.934 at 4 months for those with no disability, decreasing to 0.033 for those with complete disability. The average EQ-5D utility score for the whole sample increased from 0.587 immediately post-injury to 0.817 at 12 months. Relative costs and disutilities generated by the multivariate models are also presented by disability level and recovery trajectory. CONCLUSION: These results provide estimates of the costs and health-state utilities associated with disability levels and recovery trajectories after acute whiplash injury. They can be used to inform estimates of the cost-effectiveness of interventions targeting whiplash-associated disorders. LEVEL OF EVIDENCE: 3.
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Author URL.
Sherrington C, Tiedemann A, Fairhall NJ, Hopewell S, Michaleff ZA, Howard K, Clemson L, Lamb SE (2016). Exercise for preventing falls in older people living in the community.
Cochrane Database of Systematic Reviews,
2016(11).
Abstract:
Exercise for preventing falls in older people living in the community
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: to assess the effects (benefits and harms) of exercise interventions for preventing falls in older people living in the community.
Abstract.
Patel S, Hee SW, Mistry D, Jordan J, Brown S, Dritsaki M, Ellard DR, Friede T, Lamb SE, Lord J, et al (2016). Identifying back pain subgroups: developing and applying approaches using individual patient data collected within clinical trials.
Abstract:
Identifying back pain subgroups: developing and applying approaches using individual patient data collected within clinical trials
BackgroundThere is good evidence that therapist-delivered interventions have modest beneficial effects for people with low back pain (LBP). Identification of subgroups of people with LBP who may benefit from these different treatment approaches is an important research priority.Aim and objectivesTo improve the clinical effectiveness and cost-effectiveness of LBP treatment by providing patients, their clinical advisors and health-service purchasers with better information about which participants are most likely to benefit from which treatment choices. Our objectives were to synthesise what is already known about the validity, reliability and predictive value of possible treatment moderators (patient factors that predict response to treatment) for therapist-delivered interventions; develop a repository of individual participant data from randomised controlled trials (RCTs) testing therapist-delivered interventions for LBP; determine which participant characteristics, if any, predict clinical response to different treatments for LBP; and determine which participant characteristics, if any, predict the most cost-effective treatments for LBP. Achieving these objectives required substantial methodological work, including the development and evaluation of some novel statistical approaches. This programme of work was not designed to analyse the main effect of interventions and no such interpretations should be made.MethodsFirst, we reviewed the literature on treatment moderators and subgroups. We initially invited investigators of trials of therapist-delivered interventions for LBP with > 179 participants to share their data with us; some further smaller trials that were offered to us were also included. Using these trials we developed a repository of individual participant data of therapist-delivered interventions for LBP. Using this data set we sought to identify which participant characteristics, if any, predict response to different treatments (moderators) for clinical effectiveness and cost-effectiveness outcomes. We undertook an analysis of covariance to identify potential moderators to apply in our main analyses. Subsequently, we developed and applied three methods of subgroup identification: recursive partitioning (interaction trees and subgroup identification based on a differential effect search); adaptive risk group refinement; and an individual participant data indirect network meta-analysis (NWMA) to identify subgroups defined by multiple parameters.ResultsWe included data from 19 RCTs with 9328 participants (mean age 49 years, 57% females). Our prespecified analyses using recursive partitioning and adaptive risk group refinement performed well and allowed us to identify some subgroups. The differences in the effect size in the different subgroups were typically small and unlikely to be clinically meaningful. Increasing baseline severity on the outcome of interest was the strongest driver of subgroup identification that we identified. Additionally, we explored the application of Bayesian indirect NWMA. This method produced varying probabilities that a particular treatment choice would be most likely to be effective for a specific patient profile.ConclusionsThese data lack clinical effectiveness or cost-effectiveness justification for the use of baseline characteristics in the development of subgroups for back pain. The methodological developments from this work have the potential to be applied in other clinical areas. The pooled repository database will serve as a valuable resource to the LBP research community.FundingThe National Institute for Health Research Programme Grants for Applied Research programme. This project benefited from facilities funded through Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands (AWM) and the Wolfson Foundation.
Abstract.
Keene DJ, Williams MA, Segar AH, Byrne C, Lamb SE (2016). Immobilisation versus early ankle movement for treating acute lateral ankle ligament injuries in adults.
Cochrane Database of Systematic Reviews,
2016(2).
Abstract:
Immobilisation versus early ankle movement for treating acute lateral ankle ligament injuries in adults
This is the protocol for a review and there is no abstract. The objectives are as follows: to assess the effects (benefits and harms) of immobilisation compared with early movement protocols for acute lateral ankle ligament injuries.
Abstract.
Tian M, Gong X, Rath S, Wei J, Yan LL, Lamb SE, Lindley RI, Sherrington C, Willett K, Norton R, et al (2016). Management of hip fractures in older people in Beijing: a retrospective audit and comparison with evidence-based guidelines and practice in the UK.
Osteoporos Int,
27(2), 677-681.
Abstract:
Management of hip fractures in older people in Beijing: a retrospective audit and comparison with evidence-based guidelines and practice in the UK.
UNLABELLED: Despite the high burden of hip fracture in China, there is limited information on its management. This study investigated the management of hip fractures in a Beijing tertiary hospital and compared practice with that in 180 hospitals in the UK. The findings show a significant gap exists between the countries. INTRODUCTION: the purpose of this study was to determine if the management of older people with hip fractures in a Beijing tertiary hospital is comparable with the UK best practice guidelines for hip fracture management and the UK National Hip Fracture Database 2012, obtained from 180 hospitals. METHODS: a retrospective audit was undertaken in a large tertiary care hospital in Beijing. Data were compared with the National Hip Fracture Database 2012 collected in 180 hospitals in the UK on the proportion of patients managed according to the UK Blue Book standards. RESULTS: Sixty-six percent of patients were admitted to an orthopaedic ward within 24 h of fracture, while 100 % of patients in the UK were admitted to an orthopaedic ward within 24 h of arrival to an accident and emergency department. Only 8 % of patients received surgery within 48 h of admission compared with 83 % in the UK; 10 % received no surgery compared with 2.5 % in the UK; and 27 % received orthogeriatrician assessment compared with 70 % in the UK. New pressure ulcers developed in 2 % of patients compared with 3.7 % of those in the UK; whereas, 0.3 % of patients were assessed for osteoporosis treatment and 3.8 % received falls assessment, and comparable figures for the UK were 94 and 92 %, respectively. CONCLUSIONS: Significant gaps exist in hip fracture management in the Beijing hospital compared with the best practice achieved in 180 UK hospitals, highlighting the need to implement and evaluate proactive strategies to increase the uptake of best practice hip fracture care in China.
Abstract.
Author URL.
Hopewell S, Adedire O, Copsey BJ, Sherrington C, Clemson LM, Close JCT, Lamb SE (2016). Multifactorial and multiple component interventions for preventing falls in older people living in the community.
Cochrane Database of Systematic Reviews,
2016(6).
Abstract:
Multifactorial and multiple component interventions for preventing falls in older people living in the community
This is the protocol for a review and there is no abstract. The objectives are as follows: to assess the effects (benefits and harms) of multifactorial interventions and multiple component interventions for preventing falls in older people living in the community.
Abstract.
Marti J, Hall P, Hamilton P, Lamb S, McCabe C, Lall R, Darbyshire J, Young D, Hulme C (2016). One-year resource utilisation, costs and quality of life in patients with acute respiratory distress syndrome (ARDS): secondary analysis of a randomised controlled trial.
J Intensive Care,
4Abstract:
One-year resource utilisation, costs and quality of life in patients with acute respiratory distress syndrome (ARDS): secondary analysis of a randomised controlled trial.
BACKGROUND: the long-term economic and quality-of-life outcomes of patients admitted to intensive care unit (ICU) with acute respiratory distress syndrome are not well understood. In this study, we investigate 1-year costs, survival and quality of life following ICU admission in patients who required mechanical ventilation for acute respiratory distress syndrome. METHODS: Economic analysis of data collected alongside a UK-based multi-centre randomised, controlled trial, aimed at comparing high-frequency oscillatory ventilation with conventional mechanical ventilation. The study included 795 critically ill patients admitted to ICU. Hospital costs were assessed using daily data. Post-hospital healthcare costs, patient out-of-pocket expenses, lost earnings of survivors and their carers and health-related quality of life were assessed using follow-up surveys. RESULTS: the mean cost of initial ICU stay was £26,857 (95 % CI £25,222-£28,491), and the average daily cost in ICU was £1738 (CI £1667-£1810). Following hospital discharge, the average 1-year cost among survivors was £7523 (CI £5692-£9354). The mean societal cost at 1 year was £44,077 (£41,168-£46,985), and the total societal cost divided by the number of 1-year survivors was £90,206. Survivors reported significantly lower health-related quality of life than the age- and sex-matched reference population, and this difference was more marked in younger patients. CONCLUSIONS: Given the high costs and low health-related quality of life identified, there is significant scope for further research aimed at improving care in this in-need patient group. TRIAL REGISTRATION: ISRCTN10416500.
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Author URL.
Perkins GD, Quinn T, Deakin CD, Nolan JP, Lall R, Slowther A-M, Cooke M, Lamb SE, Petrou S, Achana F, et al (2016). Pre-hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration in Cardiac arrest (PARAMEDIC-2): Trial protocol.
Resuscitation,
108, 75-81.
Abstract:
Pre-hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration in Cardiac arrest (PARAMEDIC-2): Trial protocol.
Despite its use since the 1960s, the safety or effectiveness of adrenaline as a treatment for cardiac arrest has never been comprehensively evaluated in a clinical trial. Although most studies have found that adrenaline increases the chance of return of spontaneous circulation for short periods, many studies found harmful effects on the brain and raise concern that adrenaline may reduce overall survival and/or good neurological outcome. The PARAMEDIC-2 trial seeks to determine if adrenaline is safe and effective in out-of-hospital cardiac arrest. This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. Participants will be eligible if they are in cardiac arrest in the out-of-hospital environment and advanced life support is initiated. Exclusions are cardiac arrest as a result of anaphylaxis or life threatening asthma, and patient known or appearing to be under 16 or pregnant. 8000 participants treated by 5 UK ambulance services will be randomised between December 2014 and August 2017 to adrenaline (intervention) or placebo (control) through opening pre-randomised drug packs. Clinical outcomes are survival to 30 days (primary outcome), hospital discharge, 3, 6 and 12 months, health related quality of life, and neurological and cognitive outcomes (secondary outcomes). Trial registration (ISRCTN73485024).
Abstract.
Author URL.
Keene DJ, Mistry D, Nam J, Tutton E, Handley R, Morgan L, Roberts E, Gray B, Briggs A, Lall R, et al (2016). The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years.
Health Technol Assess,
20(75), 1-158.
Abstract:
The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years.
BACKGROUND: Close contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults. OBJECTIVES: We aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences. DESIGN: a pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study. SETTING: Trauma and orthopaedic departments of 24 NHS hospitals. PARTICIPANTS: Adults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded. INTERVENTIONS: CCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern. MAIN OUTCOME MEASURES: Follow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud-Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol. RESULTS: We recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference -0.65 points, 95% confidence interval (CI) -3.98 to 2.68 points; standardised effect size -0.04, 95% CI -0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%); p
Abstract.
Author URL.
Keene DJ, Willett K, Lamb SE (2016). The Immediate Effects of Different Types of Ankle Support Introduced 6 Weeks After Surgical Internal Fixation for Ankle Fracture on Gait and Pain: a Randomized Crossover Trial.
J Orthop Sports Phys Ther,
46(3), 157-167.
Abstract:
The Immediate Effects of Different Types of Ankle Support Introduced 6 Weeks After Surgical Internal Fixation for Ankle Fracture on Gait and Pain: a Randomized Crossover Trial.
STUDY DESIGN: Randomized 3-treatment, 3-period crossover trial. BACKGROUND: There is variation in clinical practice regarding the type of ankle support used to aid recovery after ankle fracture internal fixation surgery. OBJECTIVE: to determine the immediate effects of different ankle supports commonly issued to patients 6 weeks after surgery. METHODS: Participants were 18 adults, 6 weeks after internal fixation for transsyndesmotic/infrasyndesmotic fracture, in a major trauma center in the UK. Interventions were a stirrup brace and walker boot compared with Tubigrip. Outcomes were (1) step-length and single-limb support time asymmetry (percentage comparing injured and uninjured limbs), (2) step width, (3) gait velocity, and (4) pain during walking (visual analog scale, 0-100). RESULTS: Participants (mean ± SD age, 47 ± 14 years) included 8 women and 10 men, 6 weeks after surgical internal fixation for ankle fracture. Single-limb support time asymmetry reduced by 3% (95% confidence interval [CI]: 0%, 6%; P =. 02) in the stirrup brace and by 5% (95% CI: 2%, 7%; P =. 001) in the walker boot compared with Tubigrip. Step width was 1.2 cm (95% CI: 0.6, 1.7; P
Abstract.
Author URL.
Keene DJ, Moe-Nilssen R, Lamb SE (2016). The application of multilevel modelling to account for the influence of walking speed in gait analysis.
Gait Posture,
43, 216-219.
Abstract:
The application of multilevel modelling to account for the influence of walking speed in gait analysis.
Differences in gait performance can be explained by variations in walking speed, which is a major analytical problem. Some investigators have standardised speed during testing, but this can result in an unnatural control of gait characteristics. Other investigators have developed test procedures where participants walking at their self-selected slow, preferred and fast speeds, with computation of gait characteristics at a standardised speed. However, this analysis is dependent upon an overlap in the ranges of gait speed observed within and between participants, and this is difficult to achieve under self-selected conditions. In this report a statistical analysis procedure is introduced that utilises multilevel modelling to analyse data from walking tests at self-selected speeds, without requiring an overlap in the range of speeds observed or the routine use of data transformations.
Abstract.
Author URL.
Thingstad P, Taraldsen K, Saltvedt I, Sletvold O, Vereijken B, Lamb SE, Helbostad JL (2016). The long-term effect of comprehensive geriatric care on gait after hip fracture: the Trondheim Hip Fracture Trial--a randomised controlled trial.
Osteoporos Int,
27(3), 933-942.
Abstract:
The long-term effect of comprehensive geriatric care on gait after hip fracture: the Trondheim Hip Fracture Trial--a randomised controlled trial.
SUMMARY: at present, most hip fracture patients are treated in orthopaedic wards. This study showed that a relatively short hospital intervention based on principles of comprehensive geriatric assessment resulted in safer and more efficient gait as long as 1 year following the fracture as compared to conventional orthopaedic treatment. INTRODUCTION: Hip fracture patients are frail, and the fracture is usually followed by substantial decline in gait function. Few studies have assessed gait characteristics other than gait speed and knowledge about the effect of early intervention on long-term gait outcome is sparse. The purpose of this study was to evaluate the long-term effect of pre- and post-surgery Comprehensive Geriatric Care (CGC) on ability to walk, self-reported mobility and gait characteristics in hip fracture patients. METHODS: Two armed, parallel group randomised controlled trial comparing CGC to conventional Orthopaedic Care (OC) in pre- and early post-surgery phase. Hip fracture patients (n = 397), community-dwelling, age >70 years and able to walk at time of the fracture were included. Spatial and temporal gait characteristics were collected using an instrumented walkway (GAITRite® system) 4 and 12 months post-surgery. RESULTS: Participants who received CGC had significantly higher gait speed, less asymmetry, better gait control and more efficient gait patterns, more participants were able to walk and participants reported better mobility 4 and 12 months following the fracture as compared to participants receiving OC. CONCLUSIONS: Pre- and post-surgery CGC showed an effect on gait as long as 1 year after hip fracture. These findings underscore the importance of targeting the vulnerability of these patients at an early stage to prevent gait decline in the long run. As presently, most hip fracture patients are treated in orthopaedic wards with larger focus on the fracture than on frailty, these results are important to inform new models for hip fracture care.
Abstract.
Author URL.
Richmond H, Hall AM, Hansen Z, Williamson E, Davies D, Lamb SE (2016). Using mixed methods evaluation to assess the feasibility of online clinical training in evidence based interventions: a case study of cognitive behavioural treatment for low back pain.
BMC Med Educ,
16Abstract:
Using mixed methods evaluation to assess the feasibility of online clinical training in evidence based interventions: a case study of cognitive behavioural treatment for low back pain.
BACKGROUND: Cognitive behavioural (CB) approaches are effective in the management of non-specific low back pain (LBP). We developed the CB Back Skills Training programme (BeST) and previously provided evidence of clinical and cost effectiveness in a large pragmatic trial. However, practice change is challenged by a lack of treatment guidance and training for clinicians. We aimed to explore the feasibility and acceptability of an online programme (iBeST) for providing training in a CB approach. METHODS: This mixed methods study comprised an individually randomised controlled trial of 35 physiotherapists and an interview study of 8 physiotherapists. Participants were recruited from 8 National Health Service departments in England and allocated by a computer generated randomisation list to receive iBeST (n = 16) or a face-to-face workshop (n = 19). Knowledge (of a CB approach), clinical skills (unblinded assessment of CB skills in practice), self-efficacy (reported confidence in using new skills), attitudes (towards LBP management), and satisfaction were assessed after training. Engagement with iBeST was assessed with user analytics. Interviews explored acceptability and experiences with iBeST. Data sets were analysed independently and jointly interpreted. RESULTS: Fifteen (94 %) participants in the iBeST group and 16 (84 %) participants in the workshop group provided data immediately after training. We observed similar scores on knowledge (MD (95 % CI): 0.97 (-1.33, 3.26)), and self-efficacy to deliver the majority of the programme (MD (95 % CI) 0.25 (-1.7; 0.7)). However, the workshop group showed greater reduction in biomedical attitudes to LBP management (MD (95 % CI): -7.43 (-10.97, -3.89)). Clinical skills were assessed in 5 (33 %) iBeST participants and 7 (38 %) workshop participants within 6 months of training and were similar between groups (MD (95 % CI): 0.17(-0.2; 0.54)). Interviews highlighted that while initially sceptical, participants found iBeST acceptable. A number of strategies were identified to enhance future versions of iBeST such as including more skills practice. CONCLUSIONS: Combined quantitative and qualitative data indicated that online training was an acceptable and promising method for providing training in an evidence based complex intervention. With future enhancement, the potential reach of this training method may facilitate evidence-based practice through large scale upskilling of the workforce. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82203145 (registered prospectively on 03.09.2012).
Abstract.
Author URL.
Toye F, Williamson E, Williams MA, Fairbank J, Lamb SE (2016). What Value can Qualitative Research Add to Quantitative Research Design? an Example from an Adolescent Idiopathic Scoliosis Trial Feasibility Study.
Qual Health Res,
26(13), 1838-1850.
Abstract:
What Value can Qualitative Research Add to Quantitative Research Design? an Example from an Adolescent Idiopathic Scoliosis Trial Feasibility Study.
Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan.
Abstract.
Author URL.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, et al (2016). [Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide].
Gesundheitswesen,
78(3).
Author URL.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, et al (2016). [Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide].
Gesundheitswesen,
78(3), 175-188.
Abstract:
[Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide].
Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face-to-face panel meeting. The resultant 12-item TIDieR checklist (brief name, why, what (materials), what (procedure), who intervened, how, where, when and how much, tailoring, modifications, how well (planned), how well (actually carried out)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with a detailed explanation of each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure the accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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Author URL.
Williamson E, Nichols V, Lamb SE (2015). "If I can get over that, I can get over anything"--understanding how individuals with acute whiplash disorders form beliefs about pain and recovery: a qualitative study.
Physiotherapy,
101(2), 178-186.
Abstract:
"If I can get over that, I can get over anything"--understanding how individuals with acute whiplash disorders form beliefs about pain and recovery: a qualitative study.
OBJECTIVES: Beliefs held by patients have been shown to influence outcomes in acute whiplash associated disorders (WAD). The aim was to identify beliefs about pain and recovery present in the narratives of individuals with WAD and to understand how and why individuals' came to hold these beliefs. DESIGN: a qualitative study. Interpretative Phenomenological Analysis of semi-structured interviews. PARTICIPANTS: Participants (n=20) were enrolled in a large, pragmatic randomised controlled trial of physiotherapy for acute WAD. Participants were interviewed after they completed their treatment. RESULTS: a range of beliefs were evident. These included beliefs about exercise and activity, ability to self-manage symptoms, expectations of recovery and competing priorities. Some beliefs appeared to be barriers to recovery despite all participants having consulted several health professionals. Health professionals were highly influential over how individuals' thought about and managed their injury. The pain experienced influenced how individuals thought and behaved as did past experiences of injury and illness. Competing priorities were a potential barrier to engaging with treatment. We identified examples of how beliefs and behaviour changed in response to information from health professionals and the pain they experienced. CONCLUSION: People with WAD hold a range of beliefs about pain and recovery and some appear unhelpful to recovery. Health professionals can influence these beliefs and encourage behaviours that aid recovery. Understanding how patients form beliefs may help health professionals to address unhelpful beliefs. It is important that advice and education provided is in line with the current evidenced based understanding of pain and recovery.
Abstract.
Author URL.
Goodwin VA, Pickering R, Ballinger C, Roberts H, McIntosh E, Lamb S, Nieuwboer A, Rochester L, Ashburn A, PDSAFE Protocol Development Group, et al (2015). A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol.
BMC Neurol,
15Abstract:
A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol.
BACKGROUND: Falls amongst people with Parkinson's (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effectiveness and cost-effectiveness of a novel, home-based physiotherapy programme, compared with usual care, on falls amongst PwP. METHODS/DESIGN: a UK multi-centre, community-based, single blind, randomised controlled trial with twelve month follow-up, and nested economic evaluation and qualitative studies will be undertaken. Six hundred PwP who live in their own home, have had one or more falls in the previous year and an MMSE score of ≥24 will be recruited. Those living in care homes and those needing assistance from another person to walk indoors will not be eligible. The intervention is a physiotherapist delivered, individually tailored and progressive, home-based programme (PDSAFE) comprising task orientated movement strategy training, functional lower limb strengthening and balance training, of six months duration. Unsupervised daily home exercises and strategies will be practised and supported using technology. Control participants will receive usual care. Data collection will include falls, cognitive state, balance and mobility, fear of falling, freezing of gait, mood, quality of life, carer quality of life and resource use. Data will be collected at baseline, three, six and twelve months. Longitudinal semi-structured interviews will be undertaken with forty participants to explore the expectations and experiences of participants. The primary outcome is risk of repeat falling at six months post-randomisation. DISCUSSION: the aims of this trial are to establish the effectiveness and cost-effectiveness of a novel, home-delivered physiotherapy intervention (PDSAFE) compared with usual care on risk of falling for PwP who have a history of falling. PDSAFE is a novel intervention that builds upon the existing literature and targeting known risk factors, being the first study that uses a novel delivery modus (technology) in conjunction with traditional physiotherapeutic approaches. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48152791.
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Author URL.
Lall R, Hamilton P, Young D, Hulme C, Hall P, Shah S, MacKenzie I, Tunnicliffe W, Rowan K, Cuthbertson B, et al (2015). A randomised controlled trial and cost-effectiveness analysis of high-frequency oscillatory ventilation against conventional artificial ventilation for adults with acute respiratory distress syndrome. The OSCAR (OSCillation in ARDS) study.
Health Technol Assess,
19(23), 1-vii.
Abstract:
A randomised controlled trial and cost-effectiveness analysis of high-frequency oscillatory ventilation against conventional artificial ventilation for adults with acute respiratory distress syndrome. The OSCAR (OSCillation in ARDS) study.
BACKGROUND: Patients with the acute respiratory distress syndrome (ARDS) require artificial ventilation but this treatment may produce secondary lung damage. High-frequency oscillatory ventilation (HFOV) may reduce this damage. OBJECTIVES: to determine the clinical benefit and cost-effectiveness of HFOV in patients with ARDS compared with standard mechanical ventilation. DESIGN: a parallel, randomised, unblinded clinical trial. SETTING: UK intensive care units. PARTICIPANTS: Mechanically ventilated patients with a partial pressure of oxygen in arterial blood/fractional concentration of inspired oxygen (P : F) ratio of 26.7 kPa (200 mmHg) or less and an expected duration of ventilation of at least 2 days at recruitment. INTERVENTIONS: Treatment arm HFOV using a Novalung R100(®) ventilator (Metran Co. Ltd, Saitama, Japan) ventilator until the start of weaning. Control arm Conventional mechanical ventilation using the devices available in the participating centres. MAIN OUTCOME MEASURES: the primary clinical outcome was all-cause mortality at 30 days after randomisation. The primary health economic outcome was the cost per quality-adjusted life-year (QALY) gained. RESULTS: One hundred and sixty-six of 398 patients (41.7%) randomised to the HFOV group and 163 of 397 patients (41.1%) randomised to the conventional mechanical ventilation group died within 30 days of randomisation (p = 0.85), for an absolute difference of 0.6% [95% confidence interval (CI) -6.1% to 7.5%]. After adjustment for study centre, sex, Acute Physiology and Chronic Health Evaluation II score, and the initial P : F ratio, the odds ratio for survival in the conventional ventilation group was 1.03 (95% CI 0.75 to 1.40; p = 0.87 logistic regression). Survival analysis showed no difference in the probability of survival up to 12 months after randomisation. The average QALY at 1 year in the HFOV group was 0.302 compared to 0.246. This gives an incremental cost-effectiveness ratio (ICER) for the cost to society per QALY of £88,790 and an ICER for the cost to the NHS per QALY of £ 78,260. CONCLUSIONS: the use of HFOV had no effect on 30-day mortality in adult patients undergoing mechanical ventilation for ARDS and no economic advantage. We suggest that further research into avoiding ventilator-induced lung injury should concentrate on ventilatory strategies other than HFOV. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10416500.
Abstract.
Author URL.
Williams MA, Heine PJ, Williamson EM, Toye F, Dritsaki M, Petrou S, Crossman R, Lall R, Barker KL, Fairbank J, et al (2015). Active Treatment for Idiopathic Adolescent Scoliosis (ACTIvATeS): a feasibility study.
Health Technol Assess,
19(55), 1-242.
Abstract:
Active Treatment for Idiopathic Adolescent Scoliosis (ACTIvATeS): a feasibility study.
BACKGROUND: the feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain. OBJECTIVES: the aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS; (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise; (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites; (4) develop, document and assess acceptability and adherence of interventions; (5) assess and describe training requirements of physiotherapists; and (6) gain user input in all relevant stages of treatment and protocol design. DESIGN: Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial. SETTING: the randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS. PARTICIPANTS: the randomised feasibility study recruited people aged 10-16 years with mild AIS (Cobb angle of
Abstract.
Author URL.
Lamb SE, Lamb JE (2015). Better balance, fewer falls.
BMJ,
351 Author URL.
Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, et al (2015). Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial.
Lancet,
385(9978), 1623-1633.
Abstract:
Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial.
BACKGROUND: Most patients with hip fractures are characterised by older age (>70 years), frailty, and functional deterioration, and their long-term outcomes are poor with increased costs. We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care. METHODS: We did a prospective, single-centre, randomised, parallel-group, controlled trial. Between April 18, 2008, and Dec 30, 2010, we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture, to either comprehensive geriatric care or orthopaedic care in the emergency department, to achieve the required sample of 400 patients. Randomisation was achieved via a web-based, computer-generated, block method with unknown block sizes. The primary outcome, analysed by intention to treat, was mobility measured with the Short Physical Performance Battery (SPPB) 4 months after surgery for the fracture. The type of treatment was not concealed from the patients or staff delivering the care, and assessors were only partly masked to the treatment during follow-up. This trial is registered with ClinicalTrials.gov, number NCT00667914. FINDINGS: We assessed 1077 patients for eligibility, and excluded 680, mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years. of the remaining patients, we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care. At 4 months, 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group; the main reason for dropout was death. Mean SPPB scores at 4 months were 5·12 (SE 0·20) for comprehensive geriatric care and 4·38 (SE 0·20) for orthopaedic care (between-group difference 0·74, 95% CI 0·18-1·30, p=0·010). INTERPRETATION: Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months, compared with the usual orthopaedic care. The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care. FUNDING: Norwegian Research Council, Central Norway Regional Health Authority, St Olav Hospital Trust and Fund for Research and Innovation, Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology, the Department of Neuroscience at the Norwegian University of Science and Technology, Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology (SINTEF), and the Municipality of Trondheim.
Abstract.
Author URL.
Tubeuf S, Yu G, Achten J, Parsons NR, Rangan A, Lamb SE, Costa ML (2015). Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius: analysis from the DRAFFT trial.
Bone Joint J,
97-B(8), 1082-1089.
Abstract:
Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius: analysis from the DRAFFT trial.
We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare the relative cost effectiveness of percutaneous Kirschner wire (K-wire) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius. The cost effectiveness analysis (cost per quality-adjusted life year; QALY) was derived from a multi-centre, two-arm, parallel group, assessor-blind, randomised controlled trial which took place in 18 trauma centres in the United Kingdom. Data from 460 patients were available for analysis, which includes both a National Health Service cost perspective including costs of surgery, implants and healthcare resource use over a 12-month period after surgery, and a societal perspective, which includes the cost of time off work and the need for additional private care. There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires. At a mean additional cost of £714 (95% confidence interval 588 to 865) per patient, locking-plate fixation presented an incremental cost effectiveness ratio (ICER) of £89,322 per QALY within the first 12 months of treatment. Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires. These were greater than £30,000. Compared with locking-plate fixation, K-wire fixation is a 'cost saving' intervention, with similar health benefits.
Abstract.
Author URL.
Brown D, Spanjers K, Atherton N, Lowe J, Stonehewer L, Bridle C, Sheehan B, Lamb SE (2015). Development of an exercise intervention to improve cognition in people with mild to moderate dementia: Dementia and Physical Activity (DAPA) Trial, registration ISRCTN32612072.
Physiotherapy,
101(2), 126-134.
Abstract:
Development of an exercise intervention to improve cognition in people with mild to moderate dementia: Dementia and Physical Activity (DAPA) Trial, registration ISRCTN32612072.
More than 800000 people in the UK have dementia, and it is a government priority to improve dementia care. Drug treatment options are relatively limited. The Dementia and Physical Activity (DAPA) study is a randomised trial which targets cognition in people with dementia, using an exercise programme. There is evidence to suggest that both aerobic and resistance exercise may be useful in improving cognition. Hence the intervention comprises a supervised part of twice-weekly exercise classes of one hour duration for 4 months, including aerobic exercise at moderate intensity on static bicycles, and resistance (weight training) exercise using weight vests, weight belts and dumbbells. Thereafter participants progress to unsupervised, independent exercise. Aids to behaviour modification have been incorporated into the intervention. The DAPA intervention has been designed to maximise likelihood of effectiveness and cost-effectiveness, and for delivery in the UK National Health Service.
Abstract.
Author URL.
Lamb SE, Williamson EM, Heine PJ, Adams J, Dosanjh S, Dritsaki M, Glover MJ, Lord J, McConkey C, Nichols V, et al (2015). Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial.
Lancet,
385(9966), 421-429.
Abstract:
Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial.
BACKGROUND: Disease-modifying biological agents and other drug regimens have substantially improved control of disease activity and joint damage in people with rheumatoid arthritis of the hand. However, commensurate changes in function and quality of life are not always noted. Tailored hand exercises might provide additional improvements, but evidence is lacking. We estimated the effectiveness and cost-effectiveness of tailored hand exercises in addition to usual care during 12 months. METHODS: in this pragmatic, multicentre, parallel-group trial, at 17 National Health Service sites across the UK we randomly assigned 490 adults with rheumatoid arthritis who had pain and dysfunction of the hands and had been on a stable drug regimen for at least 3 months, to either usual care or usual care plus a tailored strengthening and stretching hand exercise programme. Participants were randomly assigned with stratification by centre. Allocation was computer generated and unmasked to participants and therapists delivering treatment after randomisation. Outcome assessors and all investigators were masked to allocation. Physiotherapists or occupational therapists gave the treatments. The primary outcome was the Michigan Hand Outcomes Questionnaire overall hand function score at 12 months. The analysis was by intention to treat. We calculated cost per quality-adjusted life-year. This trial is registered as ISRCTN 89936343. FINDINGS: Between Oct 5, 2009, and May 10, 2011, we screened 1606 people, of whom 490 were randomly assigned to usual care (n=244) or tailored exercises (n=246). 438 of 490 participants (89%) provided 12 month follow-up data. Improvements in overall hand function were 3·6 points (95% CI 1·5-5·7) in the usual care group and 7·9 points (6·0-9·9) in the exercise group (mean difference between groups 4·3, 95% CI 1·5-7·1; p=0·0028). Pain, drug regimens, and health-care resource use were stable for 12 months, with no difference between the groups. No serious adverse events associated with the treatment were recorded. The cost of tailored hand exercise was £156 per person; cost per quality-adjusted life-year was £9549 with the EQ-5D (£17,941 with imputation for missing data). INTERPRETATION: We have shown that a tailored hand exercise programme is a worthwhile, low-cost intervention to provide as an adjunct to various drug regimens. Maximisation of the benefits of biological and DMARD regimens in terms of function, disability, and health-related quality of life should be an important treatment aim. FUNDING: UK National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 07/32/05.
Abstract.
Author URL.
Richmond H, Hansen Z, Davies D, Williamson E, Lamb S (2015). Implementation of the best intervention: a group cognitive behavioural approach for patients with low back pain. Physiotherapy, 101, e815-e816.
Blencowe NS, Brown JM, Cook JA, Metcalfe C, Morton DG, Nicholl J, Sharples LD, Treweek S, Blazeby JM, Bach S, et al (2015). Interventions in randomised controlled trials in surgery: Issues to consider during trial design.
Trials,
16(1).
Abstract:
Interventions in randomised controlled trials in surgery: Issues to consider during trial design
Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.
Abstract.
Perkins GD, Lall R, Quinn T, Deakin CD, Cooke MW, Horton J, Lamb SE, Slowther A-M, Woollard M, Carson A, et al (2015). Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial.
Lancet,
385(9972), 947-955.
Abstract:
Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial.
BACKGROUND: Mechanical chest compression devices have the potential to help maintain high-quality cardiopulmonary resuscitation (CPR), but despite their increasing use, little evidence exists for their effectiveness. We aimed to study whether the introduction of LUCAS-2 mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest. METHODS: the pre-hospital randomised assessment of a mechanical compression device in cardiac arrest (PARAMEDIC) trial was a pragmatic, cluster-randomised open-label trial including adults with non-traumatic, out-of-hospital cardiac arrest from four UK Ambulance Services (West Midlands, North East England, Wales, South Central). 91 urban and semi-urban ambulance stations were selected for participation. Clusters were ambulance service vehicles, which were randomly assigned (1:2) to LUCAS-2 or manual CPR. Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene. The primary outcome was survival at 30 days following cardiac arrest and was analysed by intention to treat. Ambulance dispatch staff and those collecting the primary outcome were masked to treatment allocation. Masking of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. The study is registered with Current Controlled Trials, number ISRCTN08233942. FINDINGS: We enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 group, 2819 assigned to the control group) between April 15, 2010 and June 10, 2013. 985 (60%) patients in the LUCAS-2 group received mechanical chest compression, and 11 (
Abstract.
Author URL.
Griffin D, Parsons N, Shaw E, Kulikov Y, Hutchinson C, Thorogood M, Lamb SE, Investigato UKHFT (2015). Operative Care Did Not Benefit Closed, Displaced, Intra-Articular Calcaneal Fractures.
JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME,
97A(4), 341-341.
Author URL.
Nichols VP, Griffiths FE, Patel S, Lamb SE (2015). Patterns of interaction between factors that enhance or inhibit recovery from chronic low back pain.
Disabil Rehabil,
37(3), 194-206.
Abstract:
Patterns of interaction between factors that enhance or inhibit recovery from chronic low back pain.
PURPOSE: This interview study aimed to capture an account of change in low back pain over time and understand the interaction of known bio-psychosocial risk factors. METHODS: Thirty-four participants from the Back Skills Training (BeST) U.K. trial, evaluating a cognitive behavioural approach intervention for LBP, gave 61 interviews. Semi-structured interviews taken once or twice post intervention explored participants' experiences of LBP and the intervention received. Initial thematic analysis of the data gave themes, which participants spoke about in an integrated way. Rereading of whole transcripts identified interactions between themes, which we classified as helpful or unhelpful to recovery. The team also explored whether there were correlations with Roland and Morris Disability Questionnaire (RMDQ) scores from the main trial. RESULTS: Web diagrams gave a graphic representation of the interactions between factors, which were highly individual and time specific. We identified three categories of webs; dense web (mostly unhelpful), open web (helpful and unhelpful) and sparse web (mostly helpful). These categories correlated with (RMDQ) scores. CONCLUSIONS: Facilitators as well as potential barriers to recovery give added insight when considering psychosocial risk factors. Web categories highlight patterns of interaction between psychosocial factors, which underlie levels of disability. These patterns of interaction may help to guide clinicians in their choice of treatment approaches.
Abstract.
Author URL.
Finnegan S, Bruce J, Lamb SE, Griffiths F (2015). Predictors of attendance to group exercise: a cohort study of older adults in long-term care facilities.
BMC Geriatr,
15Abstract:
Predictors of attendance to group exercise: a cohort study of older adults in long-term care facilities.
BACKGROUND: the benefits of regular exercise and physical activity are well known. Those living in long-term care are often frail, but have the potential to benefit from physical activity; yet are less likely to be offered exercise. Promoting exercise within residential and nursing homes may reduce health risks associated with inactivity in this population. The aim of this cohort study is to identify predictors of attendance at physiotherapy led exercise groups offered to older adults residing in long-term care in the United Kingdom. METHODS: One thousand and twenty three older adults residing in residential and nursing homes, were recruited to the Older People's Exercise in Residential and nursing Accommodation (OPERA) cluster randomised controlled trial. Secondary analysis of 428 adults (aged 75 to 107) randomised to twice-weekly physiotherapy-led group exercise sessions for 12 months was undertaken. Using attendance data, linear regression analysis was utilised to separately identify individual and home-level factors predictive of attendance at exercise in the residential and nursing homes. RESULTS: of 428 older adults, 326 lived in residential homes and 102 in nursing homes. Mean age of the sample was 88.0 years and the majority of residents were female (324/428, 76%). Pre-intervention assessment suggested that most residents had moderate cognitive impairment; median (range) Mini Mental State Examination scores in residential homes were 19 (0-30) and 14 (0-29) in nursing homes. Median Geriatric Depression Scale (GDS-15) scores were 3 (0-13) and 5 (0-13) respectively, indicating low levels of depressive symptoms. Over a 12-month period, 3191 exercise groups were delivered. Mean number of groups in the residential homes was 82 and 78 in the nursing homes. Number of attendances at group exercise was 11,534/21,292 (54.2%) and 3295/6436 (51.2%) respectively. Linear regression analysis revealed that depression, social engagement, and socio-economic characteristics were significantly associated with participant attendance at exercise groups in the residential homes, but none of these factors predicted attendance at group exercise in nursing homes. CONCLUSIONS: Older people living in long-term care are receptive to participating in exercise programmes, but there are individual and home-level reasons for attendance and non-attendance.
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Author URL.
Achten J, Parsons NR, Bruce J, Petrou S, Tutton E, Willett K, Lamb SE, Costa ML (2015). Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Lower Limb Fractures (UK WOLLF).
BMJ Open,
5(9).
Abstract:
Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Lower Limb Fractures (UK WOLLF).
INTRODUCTION: Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures. METHODS AND ANALYSIS: all adult patients presenting with an open lower limb fracture, with a Gustilo and Anderson (G&A) grade 2/3, will be considered for inclusion. 460 consented patients will provide 90% power to detect a difference of eight points in the Disability Rating Index (DRI) score at 12
months, at the 5% level. A randomisation sequence, stratified by trial centre and G&A grade, will be produced and administered by a secure web-based service. A qualitative substudy will assess patients' experience of giving consent for the trial, and acceptability of trial procedures to patients and staff. Patients will have clinical follow-up in a fracture clinic up to a minimum of 12
months as per standard National Health Service (NHS) practice. Functional and quality of life outcome data will be collected using the DRI, SF12 and EQ-5D questionnaires at 3, 6, 9 and 12
months postoperatively. In addition, information will be requested with regards to resource use and any late complications or surgical interventions related to their injury. The main analysis will investigate differences in the DRI score at 1
year after injury, between the two treatment groups on an intention-to-treat basis. Tests will be two sided and considered to provide evidence for a significant difference if p values are less than 0.05. ETHICS AND DISSEMINATION: Ethical approval was given by NRES Committee West Midlands-Coventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences. TRIAL REGISTRATION NUMBER: ISRCTN33756652.
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Author URL.
Shipman A, Alsousou J, Keene DJ, Dyson IN, Lamb SE, Willett KM, Thompson MS (2015). Quantitative biomechanical comparison of ankle fracture casting methods.
Biomed Tech (Berl),
60(3), 263-267.
Abstract:
Quantitative biomechanical comparison of ankle fracture casting methods.
The incidence of ankle fractures is increasing rapidly due to the ageing demographic. In older patients with compromised distal circulation, conservative treatment of fractures may be indicated. High rates of malunion and complications due to skin fragility motivate the design of novel casting systems, but biomechanical stability requirements are poorly defined. This article presents the first quantitative study of ankle cast stability and hypothesises that a newly proposed close contact cast (CCC) system provides similar biomechanical stability to standard casts (SC). Two adult mannequin legs transected at the malleoli, one incorporating an inflatable model of tissue swelling, were stabilised with casts applied by an experienced surgeon. They were cyclically loaded in torsion, measuring applied rotation angle and resulting torque. CCC stiffness was equal to or greater than that of SC in two measures of ankle cast resistance to torsion. The effect of swelling reduction at the ankle site was significantly greater on CCC than on SC. The data support the hypothesis that CCC provides similar biomechanical stability to SC and therefore also the clinical use of CCC. They suggest that more frequent re-application of CCC is likely required to maintain stability following resolution of swelling at the injury site.
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Author URL.
Sibley KM, Howe T, Lamb SE, Lord SR, Maki BE, Rose DJ, Scott V, Stathokostas L, Straus SE, Jaglal SB, et al (2015). Recommendations for a core outcome set for measuring standing balance in adult populations: a consensus-based approach.
PLoS One,
10(3).
Abstract:
Recommendations for a core outcome set for measuring standing balance in adult populations: a consensus-based approach.
BACKGROUND: Standing balance is imperative for mobility and avoiding falls. Use of an excessive number of standing balance measures has limited the synthesis of balance intervention data and hampered consistent clinical practice. OBJECTIVE: to develop recommendations for a core outcome set (COS) of standing balance measures for research and practice among adults. METHODOLOGY: a combination of scoping reviews, literature appraisal, anonymous voting and face-to-face meetings with fourteen invited experts from a range of disciplines with international recognition in balance measurement and falls prevention. Consensus was sought over three rounds using pre-established criteria. DATA SOURCES: the scoping review identified 56 existing standing balance measures validated in adult populations with evidence of use in the past five years, and these were considered for inclusion in the COS. RESULTS: Fifteen measures were excluded after the first round of scoring and a further 36 after round two. Five measures were considered in round three. Two measures reached consensus for recommendation, and the expert panel recommended that at a minimum, either the Berg Balance Scale or Mini Balance Evaluation Systems Test be used when measuring standing balance in adult populations. LIMITATIONS: Inclusion of two measures in the COS may increase the feasibility of potential uptake, but poses challenges for data synthesis. Adoption of the standing balance COS does not constitute a comprehensive balance assessment for any population, and users should include additional validated measures as appropriate. CONCLUSIONS: the absence of a gold standard for measuring standing balance has contributed to the proliferation of outcome measures. These recommendations represent an important first step towards greater standardization in the assessment and measurement of this critical skill and will inform clinical research and practice internationally.
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Author URL.
Williamson E, Williams MA, Gates S, Lamb SE (2015). Risk factors for chronic disability in a cohort of patients with acute whiplash associated disorders seeking physiotherapy treatment for persisting symptoms.
Physiotherapy,
101(1), 34-43.
Abstract:
Risk factors for chronic disability in a cohort of patients with acute whiplash associated disorders seeking physiotherapy treatment for persisting symptoms.
OBJECTIVES: (1) to identify risk factors for chronic disability in people with acute whiplash associated disorders (WAD). (2) to estimate the impact of the numbers of risk factors present. DESIGN: Prospective cohort study. Data were collected, on average, 32 days after injury (SD=10.9) and 12 months later. Baseline measures of pain, disability, neck movement, psychological and behavioural factors were independent variables and chronic disability at 12 months was the dependent variable in a multivariable logistic regression analysis. SETTING: National Health Service physiotherapy departments. PARTICIPANTS: Participants (n=599) with symptoms 3 weeks after injury, self-referred to physiotherapy as part of a randomised controlled trial. 430 (72%) participants provided complete data for this analysis. MAIN OUTCOME MEASURES: Chronic disability based on Neck Disability Index scores. RESULTS: 136 (30%) participants developed chronic disability. High baseline disability (OR 3.3, 95% CI 1.97 to 5.55), longer predicted recovery time (OR 2.4, 95% CI 1.45 to 3.87), psychological distress (OR 1.9, 95%CI 1.05 to 3.51), passive coping (OR 1.8, 95% CI 1.07 to 2.97) and greater number of symptoms (OR 1.7, 95% CI 1.07 to 2.78) were associated with chronic disability. One risk factor resulted in 3.5 times the risk (95% CI 1.04 to 11.45) of chronic disability but this risk increased to 16 times (95%CI 5.36 to 49.27) in those with four or five risk factors. CONCLUSION: Baseline disability had the strongest association with chronic disability but psychological and behavioural factors were also important. Treatment strategies should reflect this which may require a change to current physiotherapy approaches for acute WAD. The number of risk factors present should be considered when evaluating potential for poor outcome.
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Author URL.
Williams MA, Williamson EM, Heine PJ, Nichols V, Glover MJ, Dritsaki M, Adams J, Dosanjh S, Underwood M, Rahman A, et al (2015). Strengthening and stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation.
Health Technol Assess,
19(19), 1-222.
Abstract:
Strengthening and stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation.
BACKGROUND: the effectiveness of exercise for improving hand and wrist function in people with rheumatoid arthritis (RA) is uncertain. OBJECTIVES: the study aims were (1) to estimate the clinical effectiveness and cost-effectiveness of adding an optimised exercise programme for hands and upper limbs to standard care for patients with RA; and (2) to qualitatively describe the experience of participants in the trial with a particular emphasis on acceptability of the intervention, exercise behaviours and reasons for adherence/non-adherence. DESIGN: a pragmatic, multicentred, individually randomised controlled trial with an embedded qualitative study. Outcome assessors were blind to group assignment and independent of treatment delivery. SETTING: Seventeen NHS trusts in England comprising 21 rheumatology and therapy departments. PARTICIPANTS: Adults with RA who had pain and dysfunction of the hands and/or wrists and had been on stable medication for at least 3 months. Patients were excluded if they were under 18 years old, had undergone upper limb surgery/fracture in the last 6 months, were on a waiting list for upper limb surgery or were pregnant. INTERVENTIONS: Usual care or usual care plus an individualised exercise programme. Usual care consisted of joint protection education, general exercise advice and functional splinting if required. The exercise programme consisted of six sessions of strengthening and stretching exercises with a hand therapist, daily home exercises and strategies to maximise adherence. MAIN OUTCOME MEASURES: the primary outcome was the Michigan Hand Outcome Questionnaire (MHQ) overall hand function subscale score at 12 months. Secondary outcome measures included the full MHQ, pain, health-related quality of life (Short Form questionnaire-12 items), impairment (grip strength, dexterity and range of motion) and self-efficacy. European Quality of Life-5 Dimensions, medication and health-care use were collected for the health economics evaluation. Follow-up was at 4 and 12 months post randomisation. Analysis was performed on an intention-to-treat basis. RESULTS: We randomised 490 patients (244 to usual care, 246 to exercise programme). Compliance with the treatments was very good (93% of usual care participants and 75% of exercise programme participants completed treatment). Outcomes were obtained for 89% of participants at 12 months (222 for usual care, 216 for exercise programme). There was a statistically significant difference in favour of the exercise programme for the primary outcome at 4 and 12 months [mean difference 4.6 points, 95% confidence interval (CI) 2.2 to 7.0 points; and mean difference 4.4 points, 95% CI 1.6 to 7.1 points, respectively]. There were no significant differences in pain scores or adverse events. The estimated difference in mean quality-adjusted life-years (QALYs) accrued over 12 months was 0.01 greater (95% CI -0.03 to 0.05) in the exercise programme group. Imputed analysis produced incremental cost-effectiveness ratio estimates of £17,941 (0.59 probability of cost-effectiveness at willingness-to-pay threshold of £30,000 per QALY). The qualitative study found the exercise programme to be acceptable and highlighted the importance of the therapist in enabling patients to establish a routine and incorporate the exercises into their lives. CONCLUSIONS: the results of the Strengthening and stretching for Rheumatoid Arthritis of the Hand trial suggest that the addition of an exercise programme for RA hands/wrists to usual care is clinically effective and cost-effective when compared with usual care alone. No adverse effects were associated with the exercise programme. The economic analysis suggests that the intervention is likely to be cost-effective. STUDY REGISTRATION: Current Controlled Trials ISRCTN 89936343.
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Author URL.
Richmond H, Hall AM, Copsey B, Hansen Z, Williamson E, Hoxey-Thomas N, Cooper Z, Lamb SE (2015). The Effectiveness of Cognitive Behavioural Treatment for Non-Specific Low Back Pain: a Systematic Review and Meta-Analysis.
PLoS One,
10(8).
Abstract:
The Effectiveness of Cognitive Behavioural Treatment for Non-Specific Low Back Pain: a Systematic Review and Meta-Analysis.
OBJECTIVES: to assess whether cognitive behavioural (CB) approaches improve disability, pain, quality of life and/or work disability for patients with low back pain (LBP) of any duration and of any age. METHODS: Nine databases were searched for randomised controlled trials (RCTs) from inception to November 2014. Two independent reviewers rated trial quality and extracted trial data. Standardised mean differences (SMD) and 95% confidence intervals were calculated for individual trials. Pooled effect sizes were calculated using a random-effects model for two contrasts: CB versus no treatment (including wait-list and usual care (WL/UC)), and CB versus other guideline-based active treatment (GAT). RESULTS: the review included 23 studies with a total of 3359 participants. of these, the majority studied patients with persistent LBP (>6 weeks; n=20). At long term follow-up, the pooled SMD for the WL/UC comparison was -0.19 (-0.38, 0.01) for disability, and -0.23 (-0.43, -0.04) for pain, in favour of CB. For the GAT comparison, at long term the pooled SMD was -0.83 (-1.46, -0.19) for disability and -0.48 (-0.93, -0.04) for pain, in favour of CB. While trials varied considerably in methodological quality, and in intervention factors such as provider, mode of delivery, dose, duration, and pragmatism, there were several examples of lower intensity, low cost interventions that were effective. CONCLUSION: CB interventions yield long-term improvements in pain, disability and quality of life in comparison to no treatment and other guideline-based active treatments for patients with LBP of any duration and of any age. SYSTEMATIC REVIEW REGISTRATION: PROSPERO protocol registration number: CRD42014010536.
Abstract.
Author URL.
Lamb SE (2015). The case for stepped-wedge studies: a trial of falls prevention.
Lancet,
385(9987), 2556-2557.
Author URL.
Keene DJ, Willett K, Lamb SE (2015). The effects of ankle supports on gait in adults: a randomized cross-over study.
J Electromyogr Kinesiol,
25(6), 973-981.
Abstract:
The effects of ankle supports on gait in adults: a randomized cross-over study.
We aimed to compare the effects of different ankle supports used after ankle injury/surgery on temporo-spatial gait characteristics. We conducted a randomized cross-over study including adult participants with no previous lower limb or neurological pathology, who underwent gait analysis on an electronic walkway in three different ankle supports, Tubigrip(®), a stirrup brace and a walker boot. The 18 participants were an average age of 42 (SD 13, range 24-62) years and 14 (88%) were female. Compared to Tubigrip(®), gait in the walker boot was slower (-0.19 m/s, 95%CI -0.23 to -0.16, P < 0.001), step length asymmetry was 10% (95%CI 9-12, P < 0.001) worse, single support time asymmetry was 5% (95%CI 3-7, P < 0.001) worse and participants also adopted a wider step width (4.1 cm, 95%CI 3.7-4.5, P < 0.001). There were no important differences in gait between the Tubigrip(®) and stirrup brace. The findings of this study suggest that there is a limit to the degree of normal walking characteristics in a walker boot in the absence of lower limb impairment. Further research is required to directly compare the effects of these ankle supports in clinical populations.
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Cockayne S, Adamson J, Bower P, Corbacho B, Fairhurst C, Farndon L, Hicks K, Keenan A-M, Knapp P, Lamb S, et al (2015). The reform patient information sheet sub study - an embedded trial evaluating the enhancement of patient information sheets to improve recruitment. Trials, 16(Suppl 2), P87-P87.
Cockayne S, Adamson J, Corbacho B, Fairhurst C, Farndon L, Hicks K, Keenan A-M, Lamb S, Loughrey L, McIntosh C, et al (2015). The reform study: a case study of embedded trials. Trials, 16(Suppl 2), P174-P174.
Costa ML, Achten J, Plant C, Parsons NR, Rangan A, Tubeuf S, Yu G, Lamb SE (2015). UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius.
Health Technol Assess,
19(17), 1-vi.
Abstract:
UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius.
BACKGROUND: in high-income countries, 6% of all women will have sustained a fracture of the wrist (distal radius) by the age of 80 years and 9% by the age of 90 years. Advances in orthopaedic surgery have improved the outcome for patients: many such fractures can be treated in a plaster cast alone, but others require surgical fixation to hold the bone in place while they heal. The existing evidence suggests that modern locking-plate fixation provides improved functional outcomes, but costs more than traditional wire fixation. METHODS: in this multicentre trial, we randomly assigned 461 adult patients having surgery for an acute dorsally displaced fracture of the distal radius to either percutaneous Kirschner-wire fixation or locking-plate fixation. The primary outcome measure was the Patient-Rated Wrist Evaluation© (PRWE) questionnaire at 12 months after the fracture. In this surgical trial, neither the patients nor the surgeons could be blind to the intervention. We also collected information on complications and combined costs and quality-adjusted life-years (QALYs) to assess cost-effectiveness. RESULTS: the baseline characteristics of the two groups were well balanced and over 90% of patients completed follow-up. Both groups of patients recovered wrist function by 12 months. There was no clinically relevant difference in the PRWE questionnaire score at 3 months, 6 months or 12 months [difference at 12 months: -1.3; 95% confidence interval (CI) -4.5 to 1.8; p=0.398]. There was no difference in the number of complications in each group and small differences in QALY gains (0.008; 95% CI -0.001 to 0.018); Kirschner-wire fixation represents a cost-saving intervention (-£727; 95% CI -£588 to -£865), particularly in younger patients. CONCLUSIONS: Contrary to the existing literature, and against the increasing use of locking-plate fixation, this trial shows that there is no difference between Kirschner wires and volar locking plates for patients with dorsally displaced fractures of the distal radius. A Kirschner-wire fixation is less expensive and quicker to perform. TRIAL REGISTRATION: Current Controlled Trials ISRCTN31379280. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 17. See the NIHR Journals Library website for further project information.
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Achten J, Parsons NR, McGuinness KR, Petrou S, Lamb SE, Costa ML (2015). UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of 'locking' plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia.
BMJ Open,
5(9).
Abstract:
UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of 'locking' plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia.
INTRODUCTION: the treatment of displaced, extra-articular fractures of the distal tibia remains controversial. These injuries are difficult to manage due to limited soft tissue cover, poor vascularity of the area and proximity to the ankle joint. Surgical treatment options are expanding and include locked intramedullary nails, plate and screw fixation and external fixator systems. The nail and plate options are most commonly used in the UK, but controversy exists over which treatment is most clinically and cost-effective. In this multicentre randomised controlled trial we aim to assess ratings of disability 6
months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation. METHODS AND ANALYSIS: Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6
months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6-8
weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12
months postoperatively. The main analysis will investigate differences in DRI 6
months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are
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Author URL.
Willett K, Keene DJ, Morgan L, Gray B, Handley R, Chesser T, Pallister I, Tutton E, Knox C, Lall R, et al (2014). Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years.
BMC Musculoskelet Disord,
15Abstract:
Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years.
BACKGROUND: Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery. METHODS/DESIGN: This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment. DISCUSSION: This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04180738.
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Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, et al (2014). Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.
BMJ,
348Abstract:
Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.
Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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Keene DJ, Williamson E, Bruce J, Willett K, Lamb SE (2014). Early ankle movement versus immobilization in the postoperative management of ankle fracture in adults: a systematic review and meta-analysis.
J Orthop Sports Phys Ther,
44(9), 690-C7.
Abstract:
Early ankle movement versus immobilization in the postoperative management of ankle fracture in adults: a systematic review and meta-analysis.
STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: to compare early ankle movement versus ankle immobilization after surgery for ankle fracture on clinical and patient-reported outcomes. BACKGROUND: a significant proportion of patients undergoing surgery for ankle fracture experience postoperative complications and delayed return to function. The risks and benefits of movement of the ankle in the first 6 weeks after surgery are not known, and clinical practice varies widely. METHODS: We searched bibliographic databases and reference lists to identify eligible trials. Two independent reviewers conducted data extraction and risk-of-bias assessments. RESULTS: Fourteen trials (705 participants) were included in the review, 11 of which were included in the meta-analysis. The quality of the trials was universally poor. The pooled effect of early ankle movement on function at 9 to 12 weeks after surgery compared to immobilization was inconclusive (standardized mean difference, 0.46; 95% confidence interval: -0.02, 0.93; P =. 06; I(2) = 72%), and no differences were observed between groups at 1 year. The odds of venous thromboembolism were significantly lower with early ankle movement compared to immobilization (Peto odds ratio = 0.12; 95% confidence interval: 0.02, 0.71; P =. 02; I(2) = 0%). Deep surgical site infection (Peto odds ratio = 7.08; 95% confidence interval: 1.39, 35.99; P =. 02; I(2) = 0%), superficial surgical site infection, fixation failure, and reoperation to remove metalwork were more common after early ankle movement compared to immobilization. CONCLUSION: the quality of evidence is poor. The effects of early movement after ankle surgery on short-term functional outcomes are unclear, but there is no observable difference in the longer term. There is a small reduction in risk of postoperative thromboembolism with early ankle movement. Current evidence suggests that deep and superficial surgical site infections, fixation failure, and the need to remove metalwork are more common after early ankle movement. Level of Evidence Therapy, level 1a-.
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Patel KV, Phelan EA, Leveille SG, Lamb SE, Missikpode C, Wallace RB, Guralnik JM, Turk DC (2014). High prevalence of falls, fear of falling, and impaired balance in older adults with pain in the United States: findings from the 2011 National Health and Aging Trends Study.
J Am Geriatr Soc,
62(10), 1844-1852.
Abstract:
High prevalence of falls, fear of falling, and impaired balance in older adults with pain in the United States: findings from the 2011 National Health and Aging Trends Study.
OBJECTIVES: to determine the prevalence of clinically relevant falls-related outcomes according to pain status in older adults in the United States. DESIGN: Cross-sectional analysis of the 2011 National Health and Aging Trends Study, a sample of Medicare enrollees aged 65 and older (response rate 71.0%). SETTING: In-person assessments were conducted in the home or residential care facility of the sampled study participant. PARTICIPANTS: Individuals aged 65 and older (n = 7,601, representing 35.3 million Medicare beneficiaries). MEASUREMENTS: Participants were asked whether they had been "bothered by pain" and the location of pain, as well as questions about balance and coordination, fear of falling, and falls. RESULTS: Fifty-three percent of the participants reported bothersome pain. The prevalence of recurrent falls in the past year (≥ 2 falls) was 19.5% in participants with pain and 7.4% in those without (age- and sex-adjusted prevalence ratio (PR) = 2.63, 95% confidence interval (CI) = 2.28-3.05). The prevalence of fear of falling that limits activity was 18.0% in those with pain and 4.4% in those without (adjusted PR = 3.98, 95% CI = 3.24-4.87). Prevalence of balance and falls outcomes increased with number of pain sites. For example, prevalence of problems with balance and coordination that limited activity was 6.6% in participants with no pain, 11.6% in those with one site of pain, 17.7% in those with two sites, 25.0% in those with three sites, and 41.4% in those with four or more sites (P <. 001 for trend). Associations were robust to adjustment for several potential confounders, including cognitive and physical performance. CONCLUSION: Falls-related outcomes were substantially more common in older adults with pain than in those without. Accordingly, pain management strategies should be developed and evaluated for falls prevention.
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Author URL.
Khan KA, Madan J, Petrou S, Lamb SE (2014). Mapping between the Roland Morris Questionnaire and generic preference-based measures.
Value Health,
17(6), 686-695.
Abstract:
Mapping between the Roland Morris Questionnaire and generic preference-based measures.
OBJECTIVES: the Roland Morris Questionnaire (RMQ) is a widely used health status measure for low back pain (LBP). It is not preference-based, and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures. Using data from randomized controlled trials of treatment for LBP, we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire (EQ-5D) or the six-dimensional health state short form (derived from Medical Outcomes Study 36-Item Short-Form Health Survey) (SF-6D). METHODS: This study is based on data from the Back Skills Training Trial in which data were collected from 701 patients at baseline and subsequently at 3, 6, and 12 months postrandomization using a range of outcome measures, including the RMQ, the EQ-5D, and the Short Form 12 item Health Survey (SF-12) (from which SF-6D utilities can be derived). We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-5D and SF-6D health utilities and dimension responses. A multistage model selection process was used to assess the predictive accuracy of the models. We then explored different techniques and mapping models that made use of repeated follow-up observations in the data. The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial. RESULTS: a number of models were developed that accurately predict health utilities in this context. The best performing model for RMQ to EQ-5D mapping was a beta regression with Bayesian quasi-likelihood estimation that included 24 dummy variables for RMQ responses, age, and sex as covariates (mean squared error 0.0380) based on repeated data. The model selected for RMQ to SF-6D mapping was a finite mixture model that included the overall RMQ score, age, sex, RMQ score squared, age squared, and an interaction term for age and RMQ score as covariates (mean squared error 0.0114) based on repeated data. CONCLUSIONS: it is possible to reasonably predict EQ-5D and SF-6D health utilities from RMQ scores and responses using regression methods. Our regression equations provide an empirical basis for estimating health utilities when EQ-5D or SF-6D data are not available. They can be used to inform future economic evaluations of interventions targeting LBP.
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Author URL.
Barons MJ, Griffiths FE, Parsons N, Alba A, Thorogood M, Medley GF, Lamb SE (2014). Matching patients to an intervention for back pain: classifying patients using a latent class approach.
J Eval Clin Pract,
20(4), 544-550.
Abstract:
Matching patients to an intervention for back pain: classifying patients using a latent class approach.
RATIONALE, AIMS AND OBJECTIVES: Classification of patients with back pain in order to inform treatments is a long-standing aim in medicine. We used latent class analysis (LCA) to classify patients with low back pain and investigate whether different classes responded differently to a cognitive behavioural intervention. The objective was to provide additional guidance on the use of cognitive behavioural therapy to both patients and clinicians. METHOD: We used data from 407 participants from the full study population of 701 with complete data at baseline for the variables the intervention was designed to affect and complete data at 12 months for important outcomes. Patients were classified using LCA, and a link between class membership and outcome was investigated. For comparison, the latent class partition was compared with a commonly used classification system called Subgroups for Targeted Treatment (STarT). RESULTS: of the relatively parsimonious models tested for association between class membership and outcome, an association was only found with one model which had three classes. For the trial participants who received the intervention, there was an association between class membership and outcome, but not for those who did not receive the intervention. However, we were unable to detect an effect on outcome from interaction between class membership and the intervention. The results from the comparative classification system were similar. CONCLUSION: We were able to classify the trial participants based on psychosocial baseline scores relevant to the intervention. An association between class membership and outcome was identified for those people receiving the intervention, but not those in the control group. However, we were not able to identify outcome associations for individual classes and so predict outcome in order to aid clinical decision making. For this cohort of patients, the STarT system was as successful, but not superior.
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Author URL.
Griffin D, Parsons N, Shaw E, Kulikov Y, Hutchinson C, Thorogood M, Lamb SE, UK Heel Fracture Trial Investigators (2014). Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.
BMJ,
349Abstract:
Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.
OBJECTIVE: to investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures. DESIGN: Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial). SETTING: 22 tertiary referral hospitals, United Kingdom. PARTICIPANTS: 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment. MAIN OUTCOME MEASURES: the primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat. RESULTS: 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference -7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8). CONCLUSIONS: Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.
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Author URL.
Costa ML, Achten J, Parsons NR, Rangan A, Griffin D, Tubeuf S, Lamb SE, DRAFFT Study Group (2014). Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial.
BMJ,
349Abstract:
Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial.
OBJECTIVES: to compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius. DESIGN: a multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation. SETTING: 18 trauma centres in the United Kingdom. PARTICIPANTS: 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction. INTERVENTIONS: Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws. PRIMARY OUTCOME MEASURE: validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient's experience of pain and disability to give a score out of 100. SECONDARY OUTCOMES: disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery. RESULTS: the baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was -1.3, 95% confidence interval -4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group. CONCLUSIONS: Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform. TRIAL REGISTRATION: Current Controlled Trials ISCRTN 31379280. UKCRN 8956.
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Barker KL, Javaid MK, Newman M, Minns Lowe C, Stallard N, Campbell H, Gandhi V, Lamb S (2014). Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): Study protocol for a randomised controlled trial.
Trials,
15(1).
Abstract:
Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): Study protocol for a randomised controlled trial
Background: Osteoporosis and vertebral fracture can have a considerable impact on an individual's quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care.Methods/Design: Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year.Discussion: There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown.Trial registration: Reference number ISRCTN49117867. © 2014 Barker et al.; licensee BioMed Central Ltd.
Abstract.
Pink J, Petrou S, Williamson E, Williams M, Lamb SE (2014). Properties of patient-reported outcome measures in individuals following acute whiplash injury.
Health Qual Life Outcomes,
12Abstract:
Properties of patient-reported outcome measures in individuals following acute whiplash injury.
BACKGROUND: the aim of this study was to assess the acceptability, reliability, validity and responsiveness of the Short-Form Health Survey (SF-12) and its preference-based derivative (SF-6D), the EQ-5D and the Neck Disability Index (NDI) in patients recovering from acute whiplash injury. METHODS: Data from the Managing Injuries of the Neck Trial of 3,851 patients with acute whiplash injury formed the basis of this empirical investigation. The EQ-5D and SF-12 were collected at baseline, and all three outcome measures were then collected at 4 months, 8 months and 12 months post-randomisation. The measures were assessed for their acceptability (response rates), internal consistency, validity (known groups validity and discriminant validity) and their internal and external responsiveness. RESULTS: Response rates were broadly similar across the measures, with evidence of a floor effect for the NDI and a ceiling effect for the EQ-5D utility measure. All measures had Cronbach's α statistics of greater than 0.7, indicating acceptable internal consistency. The NDI and EQ-5D utility score correlated more strongly with the physical component scale of the SF-12 than the mental component scale, whilst this was reversed for the SF-6D utility score. The smaller standard deviations in SF-6D utility scores meant there were larger effect sizes for differences in utility score between patients with different injury severity at baseline than for the EQ-5D utility measure. However, the EQ-5D utility measure and NDI were both more responsive to longitudinal changes in health status than the SF-6D. CONCLUSIONS: There was no evidence of differences between the EQ-5D utility measure and NDI in terms of their construct validity, discriminant validity or responsiveness in patients with acute whiplash injury. However, both demonstrated superior responsiveness to longitudinal health changes than the SF-6D.
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Author URL.
Perkins GD, Gates S, Park D, Gao F, Knox C, Holloway B, McAuley DF, Ryan J, Marzouk J, Cooke MW, et al (2014). The Beta Agonist Lung Injury Trial Prevention.
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE,
189(6), 674-683.
Author URL.
Cockayne S, Adamson J, Corbacho Martin B, Fairhurst C, Hewitt C, Hicks K, Hull R, Keenan AM, Lamb SE, Loughrey L, et al (2014). The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people.
BMJ Open,
4(12).
Abstract:
The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people.
INTRODUCTION: Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. METHODS AND ANALYSIS: This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. ETHICS AND DISSEMINATION: the trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN68240461 assigned 01/07/2011.
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Chesser T, Fox R, Harding K, Greenwood R, Javaid K, Barnfield S, Halliday R, Willett K, Lamb S (2014). The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a protocol for a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment (FRACTT).
BMJ Open,
4(1).
Abstract:
The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a protocol for a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment (FRACTT)
Introduction: Pertrochanteric hip fractures occur in an elderly population and cause considerable morbidity and loss of functional ability as the fracture heals. Recently, parathyroid hormone (PTH), which is licensed for the treatment of osteoporosis, has been shown to potentially accelerate bone healing in animal and human studies. If its administration could allow a faster functional recovery after pertrochanteric hip fracture, then a patient's hospital stay may be reduced and rehabilitation could be potentially accelerated. PTH can currently only be administered by subcutaneous injection. The acceptability of this intervention is unknown in this elderly population. The aim of this pilot study is to inform the design of a future powered study comparing the functional recovery after pertrochanteric hip fracture in patients undergoing standard care versus those who undergo administration of subcutaneous injection of PTH. Methods and analysis: the study is an open label, prospective, randomised, comparative pilot study with blinded outcomes assessment to establish feasibility of the trial design. Patients will be randomised to receive a 6-week course of PTH or usual treatment. Functional outcomes will be assessed at 6 weeks and 12 weeks. Blinded assessment will be used to minimise the effect of bias of an open label study design. A nested qualitative study will investigate the patient experience of, and expectations following, hip fracture and the patient important aspects of recovery compared with the outcome measures proposed. Results: Results will be analysed to establish the potential recruitment, compliance and retention rates using 95% CIs, and trial outcomes quoted with SDs and 95% CIs for the effect size. Ethics and dissemination: the study has been approved by the South West 2 Research Ethics committee (reference 10/H0206/34). The findings of this study will be disseminated to the medical community via presentations to orthopaedic, orthogeriatric and osteoporosis societies, and their relevant specialist journals.
Abstract.
Perkins GD, Gates S, Park D, Gao F, Knox C, Holloway B, McAuley DF, Ryan J, Marzouk J, Cooke MW, et al (2014). The beta agonist lung injury trial prevention. A randomized controlled trial.
Am J Respir Crit Care Med,
189(6), 674-683.
Abstract:
The beta agonist lung injury trial prevention. A randomized controlled trial.
RATIONALE: Experimental studies suggest that pretreatment with β-agonists might prevent acute lung injury (ALI). OBJECTIVES: to determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled β-agonists effects the development of early ALI. METHODS: We conducted a randomized placebo-controlled trial in 12 UK centers (2008-2011). Adult patients undergoing elective esophagectomy were allocated to prerandomized, sequentially numbered treatment packs containing inhaled salmeterol (100 μg twice daily) or a matching placebo. Patients, clinicians, and researchers were masked to treatment allocation. The primary outcome was development of ALI within 72 hours of surgery. Secondary outcomes were ALI within 28 days, organ failure, adverse events, survival, and health-related quality of life. An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury. MEASUREMENTS AND MAIN RESULTS: a total of 179 patients were randomized to salmeterol and 183 to placebo. Baseline characteristics were similar. Treatment with salmeterol did not prevent early lung injury (32 [19.2%] of 168 vs. 27 [16.0%] of 170; odds ratio [OR], 1.25; 95% confidence interval [CI], 0.71-2.22). There was no difference in organ failure, survival, or health-related quality of life. Adverse events were less frequent in the salmeterol group (55 vs. 70; OR, 0.63; 95% CI, 0.39-0.99), predominantly because of a lower number of pneumonia (7 vs. 17; OR, 0.39; 95% CI, 0.16-0.96). Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury. CONCLUSION: Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI. Clinical trial registered with International Standard Randomized Controlled Trial Register (ISRCTN47481946) and European Union database of randomized Controlled Trials (EudraCT 2007-004096-19).
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Author URL.
Knox CR, Lall R, Hansen Z, Lamb SE (2014). Treatment compliance and effectiveness of a cognitive behavioural intervention for low back pain: a complier average causal effect approach to the BeST data set.
BMC Musculoskelet Disord,
15Abstract:
Treatment compliance and effectiveness of a cognitive behavioural intervention for low back pain: a complier average causal effect approach to the BeST data set.
BACKGROUND: Group cognitive behavioural intervention (CBI) is effective in reducing low-back pain and disability in comparison to advice in primary care. The aim of this analysis was to investigate the impact of compliance on estimates of treatment effect and to identify factors associated with compliance. METHODS: in this multicentre trial, 701 adults with troublesome sub-acute or chronic low-back pain were recruited from 56 general practices. Participants were randomised to advice (control n = 233) or advice plus CBI (n = 468). Compliance was specified a priori as attending a minimum of three group sessions and the individual assessment. We estimated the complier average causal effect (CACE) of treatment. RESULTS: Comparison of the CACE estimate of the mean treatment difference to the intention-to-treat (ITT) estimate at 12 months showed a greater benefit of CBI amongst participants compliant with treatment on the Roland Morris Questionnaire (CACE: 1.6 points, 95% CI 0.51 to 2.74; ITT: 1.3 points, 95% CI 0.55 to 2.07), the Modified Von Korff disability score (CACE: 12.1 points, 95% CI 6.07 to 18.17; ITT: 8.6 points, 95% CI 4.58 to 12.64) and the Modified von Korff pain score (CACE: 10.4 points, 95% CI 4.64 to 16.10; ITT: 7.0 points, 95% CI 3.26 to 10.74). People who were non-compliant were younger and had higher pain scores at randomisation. CONCLUSIONS: Treatment compliance is important in the effectiveness of group CBI. Younger people and those with more pain are at greater risk of non-compliance. TRIAL REGISTRATION: Current Controlled Trials ISRCTN54717854.
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Author URL.
Underwood M, Lamb S, Sheehan B, Ellard DR, Taylor SJ (2013). Authors' reply. The Lancet, 382(9901).
Gates S, Perkins GD, Lamb SE, Kelly C, Thickett DR, Young JD, McAuley DF, Snaith C, McCabe C, Hulme CT, et al (2013). Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome.
Health Technol Assess,
17(38), v-87.
Abstract:
Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome.
BACKGROUND: Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care patients and lacks effective treatments. A previous randomised controlled Phase II trial suggested that an intravenous (i.v.) infusion of salbutamol may be beneficial, as it reduced extravascular lung water and plateau airway pressure. The Beta-Agonist Lung injury TrIal-2 (BALTI-2) was initiated to evaluate the effects of this intervention on mortality in patients with ARDS. OBJECTIVES: to evaluate whether or not, in patients with ARDS, an i.v. infusion of salbutamol given at 15 μg/kg ideal body weight (IBW)/hour for up to 7 days, compared with a placebo (0.9% sodium chloride) infusion, reduces 28-day all-cause mortality and other clinical outcomes. To evaluate salbutamol's clinical effectiveness and its cost-effectiveness in subgroups of patients. DESIGN: a multicentre, randomised, placebo-controlled trial. SETTING: Forty-six intensive care units (ICUs) in the UK. PARTICIPANTS: Patients were eligible if they (1) were intubated and mechanically ventilated patients in participating ICUs; (2) were within 72 hours of onset of ARDS; (3) fulfilled American-European Consensus Conference definition for ARDS {acute-onset, severe hypoxaemic respiratory failure [partial pressure of oxygen in arterial blood/fraction of inspired oxygen ≤ 26.7 kPa (200 mmHg)] and bilateral infiltrates on the chest radiograph in the absence of clinical evidence of left atrial hypertension}; and (4) were aged ≥ 16 years. INTERVENTIONS: Intravenous infusion of salbutamol (15 μg/kg IBW/hour) or placebo (0.9% saline) for up to 7 days. MAIN OUTCOME MEASURES: All-cause mortality 28 days after randomisation, mortality at (first) discharge from ICU, mortality at (first) discharge from hospital, number of ventilator-free days, number of organ failure-free days, mortality at 12 months post randomisation, side effects (tachycardia/new arrhythmia/lactic acidosis) sufficient to stop treatment with trial drug, health-related quality of life (European Quality of Life-5 Dimensions and Short Form questionnaire-12 items at 6 and 12 months after randomisation), length of stay in critical care unit and length of stay in hospital. RESULTS: Forty-six ICUs recruited patients to the trial. A total of 326 patients were randomised; 162 were allocated to salbutamol and 164 to placebo. One patient in each group withdrew consent. Recruitment was stopped after the second interim analysis because of safety concerns. Salbutamol increased 28-day mortality: 55 (34%) of 161 patients died in the salbutamol group compared with 38 (23%) of 163 in the placebo group (risk ratio 1.47, 95% confidence interval 1.03 to 2.08). CONCLUSIONS: Treatment with i.v. salbutamol early in the course of ARDS was poorly tolerated, is unlikely to be beneficial and could worsen outcomes. Further trials of β-agonists in patients with ARDS are unlikely to be conducted. Some questions remain, such as whether or not there may be benefit at a different dose or in specific populations, but any studies investigating these would require a very strong rationale. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38366450. FUNDING: the National Institute for Health Research Health Technology Assessment programme.
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Author URL.
Helbostad JL, Oedegaard M, Lamb SE, Delbaere K, Lord SR, Sletvold O (2013). Change in vision, visual disability, and health after cataract surgery.
Optom Vis Sci,
90(4), 392-399.
Abstract:
Change in vision, visual disability, and health after cataract surgery.
PURPOSE: Cataract surgery improves vision and visual functioning; the effect on general health is not established. We investigated if vision, visual functioning, and general health follow the same trajectory of change the year after cataract surgery and if changes in vision explain changes in visual disability and general health. METHODS: One-hundred forty-eight persons, with a mean (SD) age of 78.9 (5.0) years (70% bilateral surgery), were assessed before and 6 weeks and 12 months after surgery. Visual disability and general health were assessed by the CatQuest-9SF and the Short Formular-36. RESULTS: Corrected binocular visual acuity, visual field, stereo acuity, and contrast vision improved (P < 0.001) from before to 6 weeks after surgery, with further improvements of visual acuity evident up to 12 months (P = 0.034). Cataract surgery had an effect on visual disability 1 year later (P < 0.001). Physical and mental health improved after surgery (P < 0.01) but had returned to presurgery level after 12 months. Vision changes did not explain visual disability and general health 6 weeks after surgery. CONCLUSIONS: Vision improved and visual disability decreased in the year after surgery, whereas changes in general health and visual functioning were short-term effects. Lack of associations between changes in vision and self-reported disability and general health suggests that the degree of vision changes and self-reported health do not have a linear relationship.
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Author URL.
Lamb SE, Gates S, Williams MA, Williamson EM, Mt-Isa S, Withers EJ, Castelnuovo E, Smith J, Ashby D, Cooke MW, et al (2013). Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial.
Lancet,
381(9866), 546-556.
Abstract:
Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial.
BACKGROUND: Little is known about the effectiveness of treatments for acute whiplash injury. We aimed to estimate whether training of staff in emergency departments to provide active management consultations was more effective than usual consultations (Step 1) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms (Step 2). METHODS: Step 1 was a pragmatic, cluster randomised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grades I-III. The hospitals were randomised by clusters to either active management or usual care consultations. In Step 2, we used a nested individually randomised trial. Patients were randomly assigned to receive either a package of up to six physiotherapy sessions or a single advice session. Randomisation in Step 2 was stratified by centre. Investigator-masked outcomes were obtained at 4, 8, and 12 months. Masking of clinicians and patients was not possible in all steps of the trial. The primary outcome was the Neck Disability Index (NDI). Analysis was intention to treat, and included an economic evaluation. The study is registered ISRCTN33302125. FINDINGS: Recruitment ran from Dec 5, 2005 to Nov 30, 2007. Follow-up was completed on Dec 19, 2008. In Step 1, 12 NHS Trusts were randomised, and 3851 of 6952 eligible patients agreed to participate (1598 patients were assigned to usual care and 2253 patients were assigned to active management). 2704 (70%) of 3851 patients provided data at 12 months. NDI score did not differ between active management and usual care consultations (difference at 12 months 0·5, 95% CI -1·5 to 2·5). In Step 2, 599 patients were randomly assigned to receive either advice (299 patients) or a physiotherapy package (300 patients). 479 (80%) patients provided data at 12 months. The physiotherapy package at 4 months showed a modest benefit compared to advice (NDI difference -3·7, -6·1 to -1·3), but not at 8 or 12 months. Active management consultations and the physiotherapy package were more expensive than usual care and single advice session. No treatment-related serious adverse events or deaths were noted. INTERPRETATION: Provision of active management consultation did not show additional benefit. A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective. Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended. FUNDING: NIHR Health Technology Assessment programme.
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Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther A, Spencer A, Thorogood M, Atherton N, Bremner SA, Devine A, et al (2013). Exercise for depression in care home residents: a randomised controlled trial with cost-effectiveness analysis (OPERA). Health Technol Assess, 17(18).
Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther A, Spencer AE, Thorogood M, Atherton N, Bremner SA, Devine A, et al (2013). Exercise for depression in care home residents: a randomised controlled trial with cost-effectiveness analysis (OPERA). Health Technol Assess, 17(18), 1-1.
Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther A-M, Spencer A, Thorogood M, Atherton N, Bremner SA, Devine A, et al (2013). Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial. The Lancet
Keene D, James G, Lamb SE, Walton J, Gray B, Coleman D, Handley R, Handa A, Willett K (2013). Factors associated with mobility outcomes in older people post-ankle fracture: an observational cohort study focussing on peripheral vessel function.
Injury,
44(7), 987-993.
Abstract:
Factors associated with mobility outcomes in older people post-ankle fracture: an observational cohort study focussing on peripheral vessel function.
INTRODUCTION: There are increasing numbers of older persons sustaining ankle fractures. This injury often results in a degree of functional limitation, particularly in older patients. There is currently limited research into factors associated with mobility outcomes. DESIGN: Observational cohort study. SETTING: Hospital Trauma Department, UK. PARTICIPANTS: Persons aged 60 years or over who sustained an unstable ankle fracture with no established peripheral arterial disease pre-injury. METHODS: This study investigated the association between ankle-brachial pressure index (ABPI) and extended timed 'up and go' (TUG) measures. Associations between TUG outcomes and age, pre-morbid functional mobility (Olerud-Molander Ankle Score) and fracture severity (number of malleoli injured) were also explored. ANALYSIS: Complete cases (n=76; 84% of cohort) were entered into univariate and multivariate linear regression. RESULTS: No association was found between ABPI and TUG at 6 months in unadjusted and adjusted analyses. Pre-morbid functional mobility (B=-0.34, 95% confidence interval (CI) -0.45 to -0.23, p
Abstract.
Author URL.
Young D, Lamb SE, Shah S, MacKenzie I, Tunnicliffe W, Lall R, Rowan K, Cuthbertson BH, OSCAR Study Group (2013). High-frequency oscillation for acute respiratory distress syndrome.
N Engl J Med,
368(9), 806-813.
Abstract:
High-frequency oscillation for acute respiratory distress syndrome.
BACKGROUND: Patients with the acute respiratory distress syndrome (ARDS) require mechanical ventilation to maintain arterial oxygenation, but this treatment may produce secondary lung injury. High-frequency oscillatory ventilation (HFOV) may reduce this secondary damage. METHODS: in a multicenter study, we randomly assigned adults requiring mechanical ventilation for ARDS to undergo either HFOV with a Novalung R100 ventilator (Metran) or usual ventilatory care. All the patients had a ratio of the partial pressure of arterial oxygen (PaO) to the fraction of inspired oxygen (FiO) of 200 mm Hg (26.7 kPa) or less and an expected duration of ventilation of at least 2 days. The primary outcome was all-cause mortality 30 days after randomization. RESULTS: There was no significant between-group difference in the primary outcome, which occurred in 166 of 398 patients (41.7%) in the HFOV group and 163 of 397 patients (41.1%) in the conventional-ventilation group (P=0.85 by the chi-square test). After adjustment for study center, sex, score on the Acute Physiology and Chronic Health Evaluation (APACHE) II, and the initial PaO:FiO ratio, the odds ratio for survival in the conventional-ventilation group was 1.03 (95% confidence interval, 0.75 to 1.40; P=0.87 by logistic regression). CONCLUSIONS: the use of HFOV had no significant effect on 30-day mortality in patients undergoing mechanical ventilation for ARDS. (Funded by the National Institute for Health Research Health Technology Assessment Programme; OSCAR Current Controlled Trials number, ISRCTN10416500.).
Abstract.
Author URL.
Cockayne S, Adamson J, Hewitt C, Hull R, Keenan A-M, Redmond A, Lamb S, McIntosh C, Menz H, Vernon W, et al (2013). The reform study: a cohort multiple randomised controlled trial. Trials, 14(S1).
Lamb SE (2012). A multidisciplinary evaluation of the elderly with history of multiple falls reduces the risk of supplementary falls. Kinesitherapie, 12(127), 18-19.
Kearney RS, Achten J, Lamb SE, Plant C, Costa ML (2012). A systematic review of patient-reported outcome measures used to assess Achilles tendon rupture management: what's being used and should we be using it?.
Br J Sports Med,
46(16), 1102-1109.
Abstract:
A systematic review of patient-reported outcome measures used to assess Achilles tendon rupture management: what's being used and should we be using it?
BACKGROUND: Currently, there is no consensus regarding the optimal management for patients following an Achilles tendon rupture. To allow comparisons between different treatments, a universally accepted outcome measure is required. However, there are currently a range of these reported within the literature. OBJECTIVE: to recommend the most suitable patient-reported outcome measure for the assessment of patients following an Achilles tendon rupture, based on a systematic review of first what is currently used and second evidence of validity. METHODS: the electronic databases MEDLINE, EMBASE and AMED were searched up to September 2010. Predefined inclusion and exclusion criteria were applied to identify what outcome measures are reported in the literature. Aspects of validity were defined and a checklist used to determine which aspects have been evaluated. RESULTS: Twenty-one outcome measures in 50 research papers were identified. The most commonly used was the American Orthopaedic Foot and Ankle Society hind-foot score. of the 21 outcome measures, only 4 cited independent validation data. of these four, only the 'Achilles tendon Total Rupture Score' reported evidence to support multiple facets of validity, as defined by a predetermined criteria checklist. CONCLUSIONS: the Achilles tendon Total Rupture Score was identified as the only outcome measure which has demonstrated multiple facets of validity for use in this patient group. However, even this tool has limitations. Researchers should be aware of the limitations of the available outcome measurement tools and check on their validity before use in clinical research.
Abstract.
Author URL.
Smith FG, Perkins GD, Gates S, Lamb SE (2012). Author's reply. The Lancet, 379(9829).
Heine PJ, Williams MA, Williamson E, Bridle C, Adams J, O'Brien A, Evans D, Lamb SE, SARAH Team (2012). Development and delivery of an exercise intervention for rheumatoid arthritis: strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial.
Physiotherapy,
98(2), 121-130.
Abstract:
Development and delivery of an exercise intervention for rheumatoid arthritis: strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial.
This paper describes the development and implementation of a hand exercise intervention for rheumatoid arthritis (RA) as part of a large multi-centred randomised controlled trial in a U.K. National Health Service (NHS) setting. Participants are eligible if diagnosed with RA according to American College of Rheumatology criteria, have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. The intervention development was informed by the current evidence base, published guidelines, clinician and expert opinion, and a pilot study. The exercise programme targets known, potentially modifiable physical impairments of the hand with 5 exercise sessions and a home exercise component over a 12 week period. The intervention will be provided to 240 participants along with usual care. A further 240 will receive usual care only as part of the control arm. Specific details of the treatments delivered are described. [ISRCTN no: 89936343].
Abstract.
Author URL.
Bridle C, Spanjers K, Patel S, Atherton NM, Lamb SE (2012). Effect of exercise on depression severity in older people: systematic review and meta-analysis of randomised controlled trials.
Br J Psychiatry,
201(3), 180-185.
Abstract:
Effect of exercise on depression severity in older people: systematic review and meta-analysis of randomised controlled trials.
BACKGROUND: the prevalence of depression in older people is high, treatment is inadequate, it creates a substantial burden and is a public health priority for which exercise has been proposed as a therapeutic strategy. AIMS: to estimate the effect of exercise on depressive symptoms among older people, and assess whether treatment effect varies depending on the depression criteria used to determine participant eligibility. METHOD: Systematic review and meta-analysis of randomised controlled trials of exercise for depression in older people. RESULTS: Nine trials met the inclusion criteria and seven were meta-analysed. Exercise was associated with significantly lower depression severity (standardised mean difference (SMD) = -0.34, 95% CI -0.52 to -0.17), irrespective of whether participant eligibility was determined by clinical diagnosis (SMD = -0.38, 95% CI -0.67 to -0.10) or symptom checklist (SMD = -0.34, 95% CI -0.62 to -0.06). Results remained significant in sensitivity analyses. CONCLUSIONS: Our findings suggest that, for older people who present with clinically meaningful symptoms of depression, prescribing structured exercise tailored to individual ability will reduce depression severity.
Abstract.
Author URL.
Gao Smith F, Perkins GD, Gates S, Young D, McAuley DF, Tunnicliffe W, Khan Z, Lamb SE, BALTI-2 study investigators (2012). Effect of intravenous β-2 agonist treatment on clinical outcomes in acute respiratory distress syndrome (BALTI-2): a multicentre, randomised controlled trial.
Lancet,
379(9812), 229-235.
Abstract:
Effect of intravenous β-2 agonist treatment on clinical outcomes in acute respiratory distress syndrome (BALTI-2): a multicentre, randomised controlled trial.
BACKGROUND: in a previous randomised controlled phase 2 trial, intravenous infusion of salbutamol for up to 7 days in patients with acute respiratory distress syndrome (ARDS) reduced extravascular lung water and plateau airway pressure. We assessed the effects of this intervention on mortality in patients with ARDS. METHODS: We did a multicentre, placebo-controlled, parallel-group, randomised trial at 46 UK intensive-care units between December, 2006, and March, 2010. Intubated and mechanically ventilated patients (aged ≥16 years) within 72 h of ARDS onset were randomly assigned to receive either salbutamol (15 μg/kg ideal bodyweight per h) or placebo for up to 7 days. Randomisation was done by a central telephone or web-based randomisation service with minmisation by centre, pressure of arterial oxygen to fractional inspired oxygen concentration (PaO(2)/F(I)O(2)) ratio, and age. All participants, caregivers, and investigators were masked to group allocation. The primary outcome was death within 28 days of randomisation. Analysis was by intention-to-treat. This trial is registered, ISRCTN38366450 and EudraCT number 2006-002647-86. FINDINGS: We randomly assigned 162 patients to the salbutamol group and 164 to the placebo group. One patient in each group withdrew consent. Recruitment was stopped after the second interim analysis because of safety concerns. Salbutamol increased 28-day mortality (55 [34%] of 161 patients died in the salbutamol group vs 38 (23%) of 163 in the placebo group; risk ratio [RR] 1·47, 95% CI 1·03-2·08). INTERPRETATION: Treatment with intravenous salbutamol early in the course of ARDS was poorly tolerated. Treatment is unlikely to be beneficial, and could worsen outcomes. Routine use of β-2 agonist treatment in ventilated patients with this disorder cannot be recommended. FUNDING: UK Medical Research Council, UK Department of Health, UK Intensive Care Foundation.
Abstract.
Author URL.
Lamb SE, Mistry D, Lall R, Hansen Z, Evans D, Withers EJ, Underwood MR, Back Skills Training Trial Group. (2012). Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854).
Pain,
153(2), 494-501.
Abstract:
Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854).
Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12-month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow-up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health-related quality of life. The time of extended follow-up ranged between 20 and 50 months (mean 34 months). Fifty-six percent (395 of 701) of the original cohort provided extended follow-up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between-group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer-term recovery of disability remains substantially less.
Abstract.
Author URL.
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE (2012). Interventions for preventing falls in older people living in the community.
Cochrane Database Syst Rev,
2012(9).
Abstract:
Interventions for preventing falls in older people living in the community.
BACKGROUND: Approximately 30% of people over 65 years of age living in the community fall each year. This is an update of a Cochrane review first published in 2009. OBJECTIVES: to assess the effects of interventions designed to reduce the incidence of falls in older people living in the community. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (February 2012), CENTRAL (The Cochrane Library 2012, Issue 3), MEDLINE (1946 to March 2012), EMBASE (1947 to March 2012), CINAHL (1982 to February 2012), and online trial registers. SELECTION CRITERIA: Randomised trials of interventions to reduce falls in community-dwelling older people. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person year) between intervention and control groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of people falling (fallers) in each group. We pooled data where appropriate. MAIN RESULTS: We included 159 trials with 79,193 participants. Most trials compared a fall prevention intervention with no intervention or an intervention not expected to reduce falls. The most common interventions tested were exercise as a single intervention (59 trials) and multifactorial programmes (40 trials). Sixty-two per cent (99/159) of trials were at low risk of bias for sequence generation, 60% for attrition bias for falls (66/110), 73% for attrition bias for fallers (96/131), and only 38% (60/159) for allocation concealment.Multiple-component group exercise significantly reduced rate of falls (RaR 0.71, 95% CI 0.63 to 0.82; 16 trials; 3622 participants) and risk of falling (RR 0.85, 95% CI 0.76 to 0.96; 22 trials; 5333 participants), as did multiple-component home-based exercise (RaR 0.68, 95% CI 0.58 to 0.80; seven trials; 951 participants and RR 0.78, 95% CI 0.64 to 0.94; six trials; 714 participants). For Tai Chi, the reduction in rate of falls bordered on statistical significance (RaR 0.72, 95% CI 0.52 to 1.00; five trials; 1563 participants) but Tai Chi did significantly reduce risk of falling (RR 0.71, 95% CI 0.57 to 0.87; six trials; 1625 participants).Multifactorial interventions, which include individual risk assessment, reduced rate of falls (RaR 0.76, 95% CI 0.67 to 0.86; 19 trials; 9503 participants), but not risk of falling (RR 0.93, 95% CI 0.86 to 1.02; 34 trials; 13,617 participants).Overall, vitamin D did not reduce rate of falls (RaR 1.00, 95% CI 0.90 to 1.11; seven trials; 9324 participants) or risk of falling (RR 0.96, 95% CI 0.89 to 1.03; 13 trials; 26,747 participants), but may do so in people with lower vitamin D levels before treatment.Home safety assessment and modification interventions were effective in reducing rate of falls (RR 0.81, 95% CI 0.68 to 0.97; six trials; 4208 participants) and risk of falling (RR 0.88, 95% CI 0.80 to 0.96; seven trials; 4051 participants). These interventions were more effective in people at higher risk of falling, including those with severe visual impairment. Home safety interventions appear to be more effective when delivered by an occupational therapist.An intervention to treat vision problems (616 participants) resulted in a significant increase in the rate of falls (RaR 1.57, 95% CI 1.19 to 2.06) and risk of falling (RR 1.54, 95% CI 1.24 to 1.91). When regular wearers of multifocal glasses (597 participants) were given single lens glasses, all falls and outside falls were significantly reduced in the subgroup that regularly took part in outside activities. Conversely, there was a significant increase in outside falls in intervention group participants who took part in little outside activity.Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity (RaR 0.73, 95% CI 0.57 to 0.93; three trials; 349 participants) but not risk of falling. First eye cataract surgery in women reduced rate of falls (RaR 0.66, 95% CI 0.45 to 0.95; one trial; 306 participants), but second eye cataract surgery did not.Gradual withdrawal of psychotropic medication reduced rate of falls (RaR 0.34, 95% CI 0.16 to 0.73; one trial; 93 participants), but not risk of falling. A prescribing modification programme for primary care physicians significantly reduced risk of falling (RR 0.61, 95% CI 0.41 to 0.91; one trial; 659 participants).An anti-slip shoe device reduced rate of falls in icy conditions (RaR 0.42, 95% CI 0.22 to 0.78; one trial; 109 participants). One trial (305 participants) comparing multifaceted podiatry including foot and ankle exercises with standard podiatry in people with disabling foot pain significantly reduced the rate of falls (RaR 0.64, 95% CI 0.45 to 0.91) but not the risk of falling.There is no evidence of effect for cognitive behavioural interventions on rate of falls (RaR 1.00, 95% CI 0.37 to 2.72; one trial; 120 participants) or risk of falling (RR 1.11, 95% CI 0.80 to 1.54; two trials; 350 participants).Trials testing interventions to increase knowledge/educate about fall prevention alone did not significantly reduce the rate of falls (RaR 0.33, 95% CI 0.09 to 1.20; one trial; 45 participants) or risk of falling (RR 0.88, 95% CI 0.75 to 1.03; four trials; 2555 participants).No conclusions can be drawn from the 47 trials reporting fall-related fractures.Thirteen trials provided a comprehensive economic evaluation. Three of these indicated cost savings for their interventions during the trial period: home-based exercise in over 80-year-olds, home safety assessment and modification in those with a previous fall, and one multifactorial programme targeting eight specific risk factors. AUTHORS' CONCLUSIONS: Group and home-based exercise programmes, and home safety interventions reduce rate of falls and risk of falling.Multifactorial assessment and intervention programmes reduce rate of falls but not risk of falling; Tai Chi reduces risk of falling.Overall, vitamin D supplementation does not appear to reduce falls but may be effective in people who have lower vitamin D levels before treatment.
Abstract.
Author URL.
Smith FG, Perkins GD, Gates S, Lamb SE (2012). Intravenous salbutamol in ARDS and increased mortality – Authors' reply. The Lancet, 379(9829).
Lamb SE, Williams MA, Williamson EM, Gates S, Withers EJ, Mt-Isa S, Ashby D, Castelnuovo E, Underwood M, Cooke MW, et al (2012). Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.
Health Technol Assess,
16(49), iii-141.
Abstract:
Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.
OBJECTIVES: to examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). DESIGN: Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or the Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. SETTING: Twelve NHS trusts in England comprising 15 EDs. PARTICIPANTS: People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. INTERVENTIONS: in Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. MAIN OUTCOME: the primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. RESULTS: a total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were randomised to WBA/active management. Outcome data were obtained at 12 months for 70% and 80% of participants at Step 1 and Step 2, respectively. The majority of people recovered from the injury. Eighteen per cent of the Step 1 cohort had late whiplash syndrome. There was no statistically or clinically significant difference observed in any of the outcomes for participants attending EDs randomised to UCA or active management advice [difference in NDI 0.5, 95% confidence interval (CI) -1.8 to 2.8]. In Step 2 the physiotherapy package resulted in improvements in neck disability at 4 months compared with a single advice session, but these effects were small at the population level (difference in NDI -3.2, 95% CI -5.8 to -0.7). The physiotherapy package was accompanied by a significant reduction in the number of work days lost at 4-month follow-up (difference -40.2, 95% CI -44.3 to -35.8). CONCLUSIONS: MINT suggests that enhanced psycho-educational interventions in EDs are no more effective than UCA in reducing the burden of acute whiplash injuries. A physiotherapy package provided to people who have persisting symptoms within the first 6 weeks of injury produced additional short-term benefits in neck disability compared with a single physiotherapy advice session. However, from a health-care perspective, the physiotherapy package was not cost-effective at current levels of willingness to pay. Both experimental treatments were associated with increased cost with no discernible gain in health-related quality of life. However, an important benefit of the physiotherapy package was a reduction in work days lost; consequently, the intervention may prove cost-effective at the societal level. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33302125. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 49. See the HTA programme website for further project information.
Abstract.
Author URL.
Sarah Trial Team, Adams J, Bridle C, Dosanjh S, Heine P, Lamb SE, Lord J, McConkey C, Nichols V, Toye F, et al (2012). Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention--ISRCTN89936343.
BMC Musculoskelet Disord,
13Abstract:
Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention--ISRCTN89936343.
BACKGROUND: Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. METHODS/DESIGN: 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. DISCUSSION: This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.
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Author URL.
Lall R, Mistry D, Bridle C, Lamb SE (2012). Telephone interviews can be used to collect follow-up data subsequent to no response to postal questionnaires in clinical trials.
J Clin Epidemiol,
65(1), 90-99.
Abstract:
Telephone interviews can be used to collect follow-up data subsequent to no response to postal questionnaires in clinical trials.
OBJECTIVE: Follow-up data were collected using postal questionnaires and if participants did not respond, then data was collected using telephone interviews. The objectives of this study were to examine, for the two methods, how respondents differed in characteristics and whether the observed treatment difference varied. STUDY DESIGN AND SETTING: a large clinical trial of lower back pain. RESULTS: About 60% (98/163) of the nonresponders to postal questionnaire provided data by telephone, which increased the overall response rate by 14% (from 71% to 85%). A consistent treatment difference was found across the methods for the outcome measures at 12 months, implying that the observed treatment effect had not been modified. There were some differences between the participants: responders of postal questionnaire were older, likely to be female, white (ethnic origin), not working, with less disability of back pain, compared with those who responded by a telephone interview. At 12 months, there was greater improvement in back pain, disability, and general health for those who responded by postal questionnaires. CONCLUSION: Researchers should consider the use of more than one method of collecting data as this increases response rate, participant representativeness, and enhances precision of effect estimates.
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Author URL.
Kearney RS, Achten J, Lamb SE, Parsons N, Costa ML (2012). The Achilles tendon total rupture score: a study of responsiveness, internal consistency and convergent validity on patients with acute Achilles tendon ruptures.
Health Qual Life Outcomes,
10Abstract:
The Achilles tendon total rupture score: a study of responsiveness, internal consistency and convergent validity on patients with acute Achilles tendon ruptures.
BACKGROUND: the Achilles tendon Total Rupture Score was developed by a research group in 2007 in response to the need for a patient reported outcome measure for this patient population. Beyond this original development paper, no further validation studies have been published.Consequently the purpose of this study was to evaluate internal consistency, convergent validity and responsiveness of this newly developed patient reported outcome measure within patients who have sustained an isolated acute Achilles tendon rupture. METHODS: Sixty-four eligible patients with an acute rupture of their Achilles tendon completed the Achilles tendon Total Rupture Score alongside two further patient reported outcome measures (Disability Rating Index and EQ 5D). These were completed at baseline, six weeks, three months, six months and nine months post injury. The Achilles tendon Total Rupture Score was evaluated for internal consistency, using Cronbach's alpha, convergent validity, through correlation analysis and responsiveness, by analysing floor and ceiling effects and calculating its relative efficiency in comparison to the Disability Rating Index and EQ 5D scores. RESULTS: the Achilles tendon Total Rupture Score demonstrated high internal consistency (Cronbachs alpha > 0.8) and correlated significantly (p < 0.001) with the Disability Rating Index at five time points (pre-injury, six weeks, three, six and nine months) with correlation coefficients between -0.5 and -0.9. However, the confidence intervals were wide. Furthermore, the ability of the new score to detect clinically important changes over time (responsiveness) was shown to be greater than the Disability Rating Index and EQ 5D. CONCLUSIONS: a universally accepted outcome measure is imperative to allow comparisons to be made across practice. This is the first study to evaluate aspects of validity of this newly developed outcome measure, outside of the developing centre. The ATRS demonstrated high internal consistency and responsiveness, with limited convergent validity. This research provides further support for the use of this outcome measure, however further research is required to advocate its universal use in patients with acute Achilles tendon ruptures. Such areas include inter-rater reliability and research to determine the minimally clinically important difference between scores.All authors have read and concur with the content of this manuscript. The material presented has not been and will not be submitted for publication elsewhere, except as an abstract. All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content and (3) final approval of the submitted version. This research has been funded by Arthritis Research UK, no conflicts of interests have been declared by the authors.
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Author URL.
Shokoohi A, Stanworth S, Mistry D, Lamb S, Staves J, Murphy MF (2012). The risks of red cell transfusion for hip fracture surgery in the elderly.
Vox Sanguinis,
103(3), 223-230.
Abstract:
The risks of red cell transfusion for hip fracture surgery in the elderly
Background and Objectives the benefits and indications for blood transfusion among surgical patients are controversial. There is evidence which suggests that blood transfusion is associated with poor clinical outcomes and risks of infection, but there are few data in the elderly population. Materials and Methods Data were collected on haemoglobin concentrations and transfusions in 919 patients undergoing hip fracture repair at a university hospital over a 2-year period. 28-day and 180-day mortality were specified as primary outcomes. A composite infection outcome (chest infections, urinary tract infections and wound infections) was the main secondary outcome. Preoperative, operative and/or postoperative transfusions were the main exposure variable. Regression analyses were used to explore the associations between transfusion and outcomes, adjusting for pre-defined preoperative variables. Results 300 patients (32·6%) were transfused at least once during their admission. There was no evidence of a significant difference in either 28-day survival or 180-day survival between transfused and non-transfused hip fracture patients. The transfused group had higher adjusted composite infection rate (HR, 1·91; 95% CI, 1·41-2·59, P
Abstract.
Hauer K, Lord SR, Lindemann U, Lamb SE, Aminian K, Schwenk M (2011). Assessment of physical activity in older people with and without cognitive impairment.
J Aging Phys Act,
19(4), 347-372.
Abstract:
Assessment of physical activity in older people with and without cognitive impairment.
The purpose of this study was to validate a new interview-administered physical activity questionnaire (Assessment of Physical Activity in Frail Older People; APAFOP) in older people with and without cognitive impairment. The authors assessed feasibility, validity, and test-retest reliability in 168 people (n = 78 with, n = 88 without cognitive impairment). Concurrent validity was assessed against an inertia-based motion sensor and an established questionnaire. Sensitivity to change was tested in an ongoing study in patients with mild to moderate dementia (n = 81). Assessment of physical activity by the APAFOP and the motion sensor correlated well in the total sample (TS; p =. 705), as well as in the subsamples with cognitive impairment (CI; p =. 585) and without CI (p =. 787). Excellent feasibility with an acceptance rate of 100%, test-retest reliability (intraclass correlation coefficients ranging from. 973 (TS) to. 975 (CI) to. 966 (no CI), and sensitivity to change (effect sizes: 0.35-1.47) were found in both subsamples.
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Author URL.
Perkins GD, Gates S, Lamb SE, McCabe C, Young D, Gao F (2011). Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: a randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome.
Trials,
12Abstract:
Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: a randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome.
BACKGROUND: the acute respiratory distress syndrome (ARDS) is a common cause of respiratory failure in critically ill patients. Experimental studies suggest that treatment with beta agonists may be helpful in ARDS. The Beta Agonist Lung Injury TrIal (BALTI-2) is a multicentre, pragmatic, randomised, double-blind, placebo-controlled clinical trial which aims to determine if sustained treatment with intravenous (IV) salbutamol will improve survival in ARDS. METHODS/DESIGN: Patients fulfilling the American-European Consensus Conference Definition of ARDS will be randomised in a 1:1 ratio to receive an IV infusion either of salbutamol (15 μg kg ideal body weight-1 hr-1) or placebo (0.9% sodium chloride solution), for a maximum of seven days. Allocation to randomised groups will use minimisation to ensure balance with respect to hospital of recruitment, age group (85 years) and PaO2/FiO2 ratio (≤6.7, 6.8- 13.2, ≥13.3 kPa). Data will be recorded by participating ICUs until hospital discharge, and all surviving patients will be followed up by post at six and twelve months post randomisation. The primary outcome is mortality at 28 days after randomisation; secondary outcomes are mortality in ICU, mortality in hospital, number of ventilator-free days, number of organ failure-free days, mortality at twelve months post-randomisation, quality of life at six and twelve months, length of stay in ICU, length of stay in hospital, adverse effects (tachycardia, arrhythmia or other side effects sufficient to stop treatment drug). 1,334 patients will be recruited from about fifty ICUs in the UK. An economic evaluation will be conducted alongside the trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38366450.
Abstract.
Author URL.
Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Prestmo A, Lamb SE, Aamodt A, Johnsen R, Magnussen J, Saltvedt I, et al (2011). Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial.
BMC Geriatr,
11Abstract:
Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial.
BACKGROUND: Hip fractures in older people are associated with high morbidity, mortality, disability and reduction in quality of life. Traditionally people with hip fracture are cared for in orthopaedic departments without additional geriatric assessment. However, studies of postoperative rehabilitation indicate improved efficiency of multidisciplinary geriatric rehabilitation as compared to traditional care. This randomized controlled trial (RCT) aims to investigate whether an additional comprehensive geriatric assessment of hip fracture patients in a special orthogeriatric unit during the acute in-hospital phase may improve outcomes as compared to treatment as usual in an orthopaedic unit. METHODS/DESIGN: the intervention of interest, a comprehensive geriatric assessment is compared with traditional care in an orthopaedic ward. The study includes 401 home-dwelling older persons >70 years of age, previously able to walk 10 meters and now treated for hip fracture at St. Olav Hospital, Trondheim, Norway. The participants are enrolled and randomised during the stay in the Emergency Department. Primary outcome measure is mobility measured by the Short Physical Performance Battery (SPPB) at 4 months after surgery. Secondary outcomes measured at 1, 4 and 12 months postoperatively are place of residence, activities of daily living, balance and gait, falls and fear of falling, quality of life and depressive symptoms, as well as use of health care resources and survival. DISCUSSION: We believe that the design of the study, the randomisation procedure and outcome measurements will be of sufficient strength and quality to evaluate the impact of comprehensive geriatric assessment on mobility and other relevant outcomes in hip fracture patients. TRIALS REGISTRATION: ClinicalTrials.gov, NCT00667914.
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Author URL.
Nichols VP, Griffiths FE, McCarthy CJ, Lamb SE (2011). Exploring the use of the 'Adapted Miracle Question' in the assessment of low back pain.
Physiotherapy,
97(3), 203-208.
Abstract:
Exploring the use of the 'Adapted Miracle Question' in the assessment of low back pain.
BACKGROUND: Low back pain is a complex condition, often recurring or chronic, which has proved difficult to characterise. To explore an alternative approach to assessing low back pain, an expert panel adapted the 'Miracle Question' from Solution-Focused Brief Therapy. This asks about a forward scenario of waking without the problems that the client had presented with. The question was adapted to: What would you do if you did not have back pain? OBJECTIVES: to explore the use of the Adapted Miracle Question (AMQ) within an interview study of patients with low back pain. DESIGN, SETTING AND PARTICIPANTS: the AMQ was used in an interview study of 34 participants recruited from the UK Back Skills Training (BeST) trial, assessing the effectiveness of a cognitive behavioural approach intervention for the management of low back pain. Responses to the AMQ were analysed thematically and then case by case. RESULTS: Interviewees talked about details of their activities and ability to function that would be different, and about change to their quality of life. Some talked about work. Five interviewees said that it would make no difference to them. When considered overall, the responses could be categorised as: no change; some change in activity/function; a return to their pre-back pain state; and life would be transformed. CONCLUSION: the AMQ was straightforward to ask and prompted a breadth of responses which may be useful in tailoring treatment. This question warrants further evaluation in the clinical setting.
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Author URL.
Kearney RS, Lamb SE, Achten J, Parsons NR, Costa ML (2011). In-shoe plantar pressures within ankle-foot orthoses: implications for the management of achilles tendon ruptures.
Am J Sports Med,
39(12), 2679-2685.
Abstract:
In-shoe plantar pressures within ankle-foot orthoses: implications for the management of achilles tendon ruptures.
BACKGROUND: Advances in the management of Achilles tendon rupture have led to the development of immediate weightbearing protocols. These vary regarding which ankle-foot orthoses (AFOs) are used and the number of inserted heel wedges used within them. PURPOSE: This study was conducted to evaluate plantar pressure measurements and temporal gait parameters within different AFOs, using different numbers of heel wedges. STUDY DESIGN: Controlled laboratory study. METHODS: Fifteen healthy participants were evaluated using 3 different AFOs, with 4 different levels of inserted heel wedges. Therefore, a total of 12 conditions were evaluated, in a sequence that was randomly allocated to each participant. Pressure and temporal gait parameters were measured using an in-shoe F-Scan pressure system, and range of movement was measured using an electrogoniometer. RESULTS: Ankle-foot orthoses that were restrictive in design, combined with a higher number of inserted heel wedges, reduced forefoot pressures, increased heel pressures, and decreased the amount of time spent in the terminal stance and preswing phase of the gait cycle (P =. 029. 002, and. 001). CONCLUSION: the choice of AFO design and the number of inserted heel wedges have a significant effect on plantar pressure measurements and temporal gait parameters. The implications of these changes need to be applied to the clinical management of acute Achilles tendon ruptures. This clinical management requires a balance between protected weightbearing and functional loading, requiring further research within a clinical context. CLINICAL RELEVANCE: the biomechanical data from this research imply that a carbon-fiber AFO, with 1 heel raise, protects against excessive dorsiflexion while facilitating the restoration of near-normal gait parameters. This could lead to an accelerated return to function, avoiding the effects of disuse atrophy. This is in contrast to the rigid rocker-bottom AFO design with a greater number of heel-wedge inserts. However, research within a clinical context would be required to ascertain if these biomechanical advantages translate into a functional benefit for patients. The results should also be considered in relation to the amount of force a healing Achilles tendon can withstand.
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Ftouh S, Morga A, Swift C, Guideline Development Group (2011). Management of hip fracture in adults: summary of NICE guidance.
BMJ,
342 Author URL.
Underwood M, Mistry D, Lall R, Lamb S (2011). Predicting response to a cognitive-behavioral approach to treating low back pain: Secondary analysis of the BeST data set.
Arthritis Care and Research,
63(9), 1271-1279.
Abstract:
Predicting response to a cognitive-behavioral approach to treating low back pain: Secondary analysis of the BeST data set
Objective Identifying factors that predict who is likely to gain the greatest benefit from different treatments for low back pain is an important research priority. Here we report moderator analyses of the Back Skills Training Trial (BeST) that tested a cognitive-behavioral approach for low back pain. Methods We recruited 701 participants ages ≥18 years with at least moderately troublesome low back pain present for >6 weeks from 56 general practices in 7 localities across England to a trial adding a group cognitive-behavioral approach to active management advice. The cognitive-behavioral package had a moderate effect on primary outcomes (Roland Morris Disability Questionnaire [RMDQ] and modified Von Korff scales). At 12-month followup, we tested for interaction between randomized groups on 2 prespecified baseline variables (troublesomeness and fear avoidance) and 10 post hoc (exploratory) variables identified from previous studies. Results Neither troublesomeness nor fear avoidance moderated treatment effect on any of our primary outcomes. In the final model, the only moderation by baseline variables of the effect of randomization was on the RMDQ outcome. Being younger and currently working both moderated treatment effect, resulting in larger improvements as a response to treatment. Conclusion Although BeST is one of the larger trials of back pain treatment, it is still too small to reliably detect moderation if it exists. Since the significant moderation effects were only observed for 1 outcome measure in 3 of 10 post-hoc analyses, we cannot conclude that these are true moderation effects. Copyright © 2011 by the American College of Rheumatology.
Abstract.
Lamb SE, Becker C, Gillespie LD, Smith JL, Finnegan S, Potter R, Pfeiffer K, Taxonomy Investigators (2011). Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions.
Trials,
12Abstract:
Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions.
BACKGROUND: Interventions for preventing falls in older people often involve several components, multidisciplinary teams, and implementation in a variety of settings. We have developed a classification system (taxonomy) to describe interventions used to prevent falls in older people, with the aim of improving the design and reporting of clinical trials of fall-prevention interventions, and synthesis of evidence from these trials. METHODS: Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus. Robust techniques were used including literature reviews, expert presentations, and structured consensus workshops moderated by experienced facilitators. The taxonomy was refined using an international test panel of five health care practitioners. We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 randomly selected published papers describing a variety of fall-prevention interventions. RESULTS: the taxonomy consists of four domains, summarized as the "Approach", "Base", "Components" and "Descriptors" of an intervention. Sub-domains include; where participants are identified; the theoretical approach of the intervention; clinical targeting criteria; details on assessments; descriptions of the nature and intensity of interventions. Chance corrected agreement of the final version of the taxonomy was good to excellent for all items. Further independent evaluation of the taxonomy is required. CONCLUSIONS: the taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention. Investigators are encouraged to use the taxonomy to report their interventions.
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Author URL.
Lamb S (2011). Sarcopenia and some simple approaches to modifying the consequence of ageing. Clinical Medicine, Journal of the Royal College of Physicians of London, 11(2), 170-172.
Kenny RAM, Rubenstein LZ, Tinetti ME, Brewer K, Cameron KA, Capezuti EA, John DP, Lamb S, Martin F, Rockey PH, et al (2011). Summary of the Updated American Geriatrics Society/British Geriatrics Society Clinical Practice Guideline for Prevention of Falls in Older Persons.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
59(1), 148-157.
Author URL.
Perkins GD, Park D, Alderson D, Cooke MW, Gao F, Gates S, Lamb SE, Mistry D, Thickett DR (2011). The Beta Agonist Lung Injury TrIal (BALTI)--prevention trial protocol.
Trials,
12Abstract:
The Beta Agonist Lung Injury TrIal (BALTI)--prevention trial protocol.
BACKGROUND: Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decreasing inflammatory cell infiltration, activation and inflammatory cytokine release, enhancing basal alveolar fluid clearance and improving alveolar capillary barrier function. METHODS/DESIGN: the Beta Agonist Lung Injury TrIal (prevention) is a multi-centre, randomised, double blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesphagectomy, if treatment with inhaled salmeterol 100 mcg twice daily started at induction of anaesthesia and continued for 72 hours thereafter compared to placebo affect the incidence of early acute lung injury and other clinical, resource and patient focused outcomes. The primary outcome will be the development of acute lung injury within 72 hours of oesophagectomy. The trial secondary outcomes are the development of acute lung injury during the first 28 days post operatively; PaO2: FiO2 ratio; the number of ventilator and organ failure free days, 28 and 90 day survival; health related quality of life and resource utilisation. The study aims to recruit 360 patients from 10 UK centres. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN47481946.
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Underwood M, Eldridge S, Lamb S, Potter R, Sheehan B, Slowther AM, Taylor S, Thorogood M, Weich S (2011). The OPERA trial: Protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation.
Trials,
12Abstract:
The OPERA trial: Protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation
Background: Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents.Method: OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months. Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or. Control group: a depression awareness training session for care home staff.Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs.Discussion: Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. © 2011 Underwood et al; licensee BioMed Central Ltd.
Abstract.
Costa ML, Achten J, Parsons NR, Rangan A, Edlin RP, Brown J, Lamb SE (2011). UK DRAFFT - a randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius.
BMC Musculoskelet Disord,
12Abstract:
UK DRAFFT - a randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius.
BACKGROUND: Fractures of the distal radius are extremely common injuries in adults. However, the optimal management remains controversial. In general, fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic. However, if this is not possible, then operative fixation is required. There are several operative options but the two most common in the UK, are Kirschner-wire fixation (K-wires) and volar plate fixation using fixed-angle screws (locking-plates). The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius. METHODS/DESIGN: all adult patients with an acute, dorsally-displaced fracture of the distal radius, requiring operative fixation are potentially eligible to take part in this study. A total of 390 consenting patients will be randomly allocated to either K-wire fixation or locking-plate fixation. The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon. Data regarding wrist function, quality of life, complications and costs will be collected at six weeks and three, six and twelve months following the injury. The primary outcome measure will be wrist function with a parallel economic analysis. DISCUSSION: This pragmatic, multi-centre trial is due to deliver results in December 2013. TRIAL REGISTRATION: Current Controlled Trials ISRCTN31379280 UKCRN portfolio ID 8956.
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Hansen Z, Daykin A, Lamb SE (2010). A cognitive-behavioural programme for the management of low back pain in primary care: a description and justification of the intervention used in the Back Skills Training Trial (BeST; ISRCTN 54717854).
Physiotherapy,
96(2), 87-94.
Abstract:
A cognitive-behavioural programme for the management of low back pain in primary care: a description and justification of the intervention used in the Back Skills Training Trial (BeST; ISRCTN 54717854).
A multicentre randomised controlled trial has been commissioned to evaluate cognitive-behavioural (CB) approaches in the management of subacute and chronic low back pain in primary care. This paper describes the development of the CB intervention based on best-available evidence. Several methods were used to design the intervention. Risk factors for the development of chronic low back pain were identified from the literature to provide targets for treatment, essential components of a CB intervention were considered using the CB treatment model, and the optimal delivery method was used to balance clinical effectiveness and cost-effectiveness within primary care.
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Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A, Underwood M, et al (2010). A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial.
Health Technol Assess,
14(41), 1-iv.
Abstract:
A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial.
OBJECTIVES: to estimate the clinical effectiveness of active management (AM) in general practice versus AM plus a group-based, professionally led cognitive behavioural approach (CBA) for subacute and chronic low back pain (LBP) and to measure the cost of each strategy over a period of 12 months and estimate cost-effectiveness. DESIGN: Pragmatic multicentred randomised controlled trial with investigator-blinded assessment of outcomes. SETTING: Fifty-six general practices from seven English regions. PARTICIPANTS: People with subacute and chronic LBP who were experiencing symptoms that were at least moderately troublesome. INTERVENTIONS: Participants were randomised (in a ratio of 2:1) to receive either AM+CBA or AM alone. MAIN OUTCOME MEASURES: Primary outcomes were the Roland Morris Disability Questionnaire (RMQ) and the Modified Von Korff Scale (MVK), which measure LBP and disability. Secondary outcomes included mental and physical health-related quality of life (Short Form 12-item health survey), health status, fear avoidance beliefs and pain self-efficacy. Cost-utility of CBA was considered from both the UK NHS perspective and a broader health-care perspective, including both NHS costs and costs of privately purchased goods and services related to LBP. Quality-adjusted life-years (QALYs) were calculated from the five-item EuroQoL. RESULTS: Between April 2005 and April 2007, 701 participants were randomised: 233 to AM and 468 to AM+CBA. of these, 420 were female. The mean age of participants was 54 years and mean baseline RMQ was 8.7. Outcome data were obtained for 85% of participants at 12 months. Benefits were seen across a range of outcome measures in favour of CBA with no evidence of group or therapist effects. CBA resulted in at least twice as much improvement as AM. Mean additional improvement in the CBA arm was 1.1 [95% confidence interval (CI) 0.4 to 1.7], 1.4 (95% CI 0.7 to 2.1) and 1.3 (95% CI 0.6 to 2.1) change points in the RMQ at 3, 6 and 12 months respectively. Additional improvement in MVK pain was 6.8 (95% CI 3.5 to 10.2), 8.0 (95% CI 4.3 to 11.7) and 7.0 (95% CI 3.2 to 10.7) points, and in MVK disability was 4.3 (95% CI 0.4 to 8.2), 8.1 (95% CI 4.1 to 12.0) and 8.4 (95% CI 4.4 to 12.4) points at 3, 6 and 12 months respectively. At 12 months, 60% of the AM+CBA arm and 31% of the AM arm reported some or complete recovery. Mean cost of attending a CBA course was 187 pounds per participant with an additional benefit in QALYs of 0.099 and an additional cost of 178.06 pounds. Incremental cost-effectiveness ratio was 1786.00 pounds. Probability of CBA being cost-effective reached 90% at about 3000 pounds and remained at that level or above; at a cost-effectiveness threshold of 20,000 pounds the CBA group had an almost 100% probability of being considered cost-effective. User perspectives on the acceptability of group treatments were sought through semi-structured interviews. Most were familiar with key messages of AM; most who had attended any group sessions had retained key messages from the sessions and two-thirds talked about a reduction in fear avoidance and changes in their behaviour. Group sessions appeared to provide reassurance, lessen isolation and enable participants to learn strategies from each other. CONCLUSIONS: Long-term effectiveness and cost-effectiveness of CBA in treating subacute and chronic LBP was shown, making this intervention attractive to patients, clinicians and purchasers. Short-term (3-month) clinical effects were similar to those found in high-quality studies of other therapies and benefits were maintained and increased over the long term (12 months). Cost per QALY was about half that of competing interventions for LBP and because the intervention can be delivered by existing NHS staff following brief training, the back skills training programme could be implemented within the NHS with relative ease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37807450. FUNDING: the National Institute for Health Research Health Technology Assessment programme.
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Griffiths F, Borkan J, Byrne D, Crabtree BF, Dowrick C, Gunn J, Kokanovic R, Lamb S, Lindenmeyer A, Parchman M, et al (2010). Developing evidence for how to tailor medical interventions for the individual patient.
Qualitative Health Research,
20(12), 1629-1641.
Abstract:
Developing evidence for how to tailor medical interventions for the individual patient
We aim to answer the question: How can we develop an evidence base that will assist tailoring health interventions to individual patients? Using social theory and interview data from people living with chronic illness, we developed a new approach to analysis. Individuals were considered as emergent complex systems, adjusting and adapting within their environment and sometimes transforming. The notion of illness trajectory brought our attention to data in the interviews about the "emergent present," the current period of time when all domains of life, from across time, have expression. We summarized patterns of adjustment and adaptation within the emergent present for people living with chronic back pain, depression, and diabetes. We considered the potential of this analysis approach to inform medical decision making. Our analysis approach is the first step in developing a categorization of individuals that might be useful in tailoring health care interventions to the individual. © 2010 the Author(s).
Abstract.
Rapp K, Lamb SE, Erhardt-Beer L, Lindemann U, Rissmann U, Klenk J, Becker C (2010). Effect of a statewide fall prevention program on incidence of femoral fractures in residents of long-term care facilities.
J Am Geriatr Soc,
58(1), 70-75.
Abstract:
Effect of a statewide fall prevention program on incidence of femoral fractures in residents of long-term care facilities.
OBJECTIVES: to evaluate the effect of a statewide dissemination of a modified evidence-based fall prevention program on incidence of femoral fractures in nursing homes. DESIGN: Observational study of a staged implementation of a successful fall prevention program. SETTING: One thousand three hundred fifty-nine nursing homes in two federal states in the south of Germany. PARTICIPANTS: Nine thousand seventy-seven residents in the intervention homes and 43,583 residents in control homes from the same and a different federal state. INTERVENTION: Staff education on fall prevention, advice on environmental adaptations, and progressive strength and balance training over at least 1 year. MEASUREMENTS: Incident femoral fractures. RESULTS: One thousand five hundred eighteen femoral fractures occurred in the total study population during the intervention period. The crude incidence rate of femoral fractures was 39.5/1,000 person-years in residents from the intervention homes and 40.9 and 39.7/1,000 person-years in residents from two sets of control homes. In a multivariate model, there was no evidence of an effect of the fall prevention program on incidence of femoral fracture when compared with control homes from the same federal state (adjusted hazard ratio (AHR)=0.96, 95% confidence interval (CI)=0.83-1.11) or from a different federal state (AHR=1.00, 95% CI=0.86-1.16). CONCLUSION: the statewide dissemination of a multifactorial fall prevention program did not appear to reduce the burden of femoral fractures in residents of nursing homes.
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Author URL.
Lamb SE, Hansen Z, Lall R, Castelnuova E, Withers E, Nichols V, Potter R (2010). Group cognitive behavioral intervention in primary care in low back pain: a randomized, controlled study and analysis of cost-effectiveness.
Osteopathische Medizin,
11(2), 24-26.
Abstract:
Group cognitive behavioral intervention in primary care in low back pain: a randomized, controlled study and analysis of cost-effectiveness
Background: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. Methods: in this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computergenerated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. Findings: 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p
Abstract.
Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR, Back Skills Training Trial investigators (2010). Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.
Lancet,
375(9718), 916-923.
Abstract:
Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.
BACKGROUND: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS: in this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. FINDINGS: 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p
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Author URL.
Perkins GD, Woollard M, Cooke MW, Deakin C, Horton J, Lall R, Lamb SE, McCabe C, Quinn T, Slowther A, et al (2010). Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol.
Scand J Trauma Resusc Emerg Med,
18Abstract:
Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol.
BACKGROUND: Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. METHODS/DESIGN: the primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. METHODS: Ambulance service vehicles will be randomised to either manual compression (control) or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. CONCLUSION: the trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. TRIAL REGISTRATION: the trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942).
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Author URL.
Barker KL, Lamb SE, Simpson HRW (2010). Recovery of muscle strength and power after limb-lengthening surgery.
Arch Phys Med Rehabil,
91(3), 384-388.
Abstract:
Recovery of muscle strength and power after limb-lengthening surgery.
OBJECTIVE: to report muscle strength, power, and function after limb-lengthening surgery performed by using the Ilizarov technique. DESIGN: Prospective, longitudinal observational study of a cohort of consecutive patients who underwent limb-lengthening distraction followed up for 2 years after surgery. SETTING: National Health Service hospital specializing in orthopedic surgery. PARTICIPANTS: Patients (N=16) who had undergone limb-lengthening surgery performed by using the Ilizarov method (11 men, 5 women; mean age=27 y; range, 13-56 y). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Muscle strength and power were assessed by using 2 validated measures: isokinetic concentric strength of the quadriceps and hamstrings measured by using a dynamometer and leg extensor power. Measures were recorded preoperatively and at 6, 12, and 24 months after the completion of lengthening. Function was measured by 2 timed tests of functional performance: stair climbing and sit-to-stand. RESULTS: Overall results were good with high reports of function and satisfactory clinical examination. Both concentric muscle strength and leg power showed a clear pattern of decreased muscle strength at 6 months after frame removal, improving throughout the study period until it was within 3% of the preoperative value at 2 years. By 2 years, self-reported function and ability to complete timed functional tests had returned to or improved on the preoperative values. Muscle strength remained slightly below the preoperative value; this was more pronounced in the quadriceps than the hamstrings. There was no association between muscle strength and the amount of lengthening that had been undertaken. CONCLUSIONS: This study suggests that there is a small residual decrease in muscle strength and power after limb-lengthening surgery but that these do not adversely impact on a patients' ability to perform everyday functional activities.
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Lamb SE, Cooke MW, Hutton JL, Marsh JL, Team CAST (2009). 10-day below-knee cast for management of severe ankle sprains Authors' reply.
LANCET,
373(9675), 1602-1603.
Author URL.
Lamb SE, Williams MA, Withers E, Perry J, Gates S, Williamson E, Underwood M, Cooke M (2009). A national survey of clinical practice for the management of whiplash-associated disorders in UK emergency departments.
Emerg Med J,
26(9), 644-647.
Abstract:
A national survey of clinical practice for the management of whiplash-associated disorders in UK emergency departments.
OBJECTIVE: to undertake a national survey to determine current practice for the management of whiplash injuries in UK emergency departments (ED). METHODS: Postal questionnaire survey. 316 lead consultants from all UK ED with annual new attendances of over 50 000 people were asked to indicate the use of a range of treatments and the frequency with which these treatments were used. Samples of written advice were requested and content analysis was conducted and compared with survey responses. RESULTS: the response rate was 79% (251/316). The intervention most frequently used was verbal advice to exercise, reported by 84% of respondents for most or all cases, and advice against the use of a collar (83%). Other treatments reported as being used frequently were written advice and anti-inflammatory medication. 106 consultants (42%) provided a sample of written materials. Reference to expected recovery and encouragement for early return to activities were included in less than 6%. Nearly 50% of written materials contained information on how to use a soft collar and 61% contained information on solicitors and pursuing a personal injury claim. There were important differences between reported verbal behaviours and written advice. CONCLUSION: Verbal advice is the primary method for managing whiplash injuries in ED and is usually supplemented by written advice. Within individual hospitals there is a lack of consistency between verbal and written advice. The promotion of personal injury claims is a common feature of written advice. Research is required to develop effective and consistent models of advice.
Abstract.
Author URL.
Williamson E, Williams M, Hansen Z, Joseph S, Lamb SE (2009). Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: the Managing Injuries of Neck Trial (MINT) Intervention.
Physiotherapy,
95(1), 15-23.
Abstract:
Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: the Managing Injuries of Neck Trial (MINT) Intervention.
This paper describes the development and implementation of a physiotherapy intervention for a large multicentred randomised controlled trial of the early management of whiplash injuries in a National Health Service setting. Participants were eligible if they were classified as having whiplash-associated disorder grades I to III and self-referred for treatment within 6 weeks of injury. The intervention development was informed through a variety of methods including the current evidence base, published guidelines, clinician opinion, a pilot study and expert opinion. The intervention was targeted at known, potentially modifiable risk factors for poor recovery, and utilised manual therapy, exercises and psychological strategies. The treatment was individually tailored, with a maximum of six treatments allowed within the trial protocol over an 8-week period. The intervention was delivered to 300 participants. The amount and types of treatments delivered are described.
Abstract.
Author URL.
Gates S, Williams MA, Withers E, Williamson E, Mt-Isa S, Lamb SE (2009). Does a monetary incentive improve the response to a postal questionnaire in a randomised controlled trial? the MINT incentive study.
Trials,
10Abstract:
Does a monetary incentive improve the response to a postal questionnaire in a randomised controlled trial? the MINT incentive study.
BACKGROUND: Sending a monetary incentive with postal questionnaires has been found to improve the proportion of responders, in research in non-healthcare settings. However, there is little research on use of incentives to improve follow-up rates in clinical trials, and existing studies are inconclusive. We conducted a randomised trial among participants in the Managing Injuries of the Neck Trial (MINT) to investigate the effects on the proportion of questionnaires returned and overall non-response of sending a 5 pounds gift voucher with a follow-up questionnaire. METHODS: Participants in MINT were randomised to receive either: (a) a 5 POUNDSgift voucher (incentive group) or (b) no gift voucher (no incentive group), with their 4 month or 8 month follow-up questionnaire. We recorded, for each group, the number of questionnaires returned, the number returned without any chasing from the study office, the overall number of non-responders (after all chasing efforts by the study office), and the costs of following up each group. RESULTS: 2144 participants were randomised, 1070 to the incentive group and 1074 to the no incentive group. The proportion of questionnaires returned (RR 1.10 (95% CI 1.05, 1.16)) and the proportion returned without chasing (RR 1.14 (95% CI 1.05, 1.24) were higher in the incentive group, and the overall non-response rate was lower (RR 0.68 (95% CI 0.53, 0.87)). Adjustment for injury severity and hospital of recruitment to MINT made no difference to these results, and there were no differences in results between the 4-month and 8-month follow up questionnaires. Analysis of costs suggested a cost of 67.29 POUNDS per additional questionnaire returned. CONCLUSION: Monetary incentives may be an effective way to increase the proportion of postal questionnaires returned and minimise loss to follow-up in clinical trials. TRIAL REGISTRATION NUMBER: ISRCTN61305297.
Abstract.
Author URL.
Rapp K, Lamb SE, Klenk J, Kleiner A, Heinrich S, König H-H, Nikolaus T, Becker C (2009). Fractures after nursing home admission: incidence and potential consequences.
Osteoporos Int,
20(10), 1775-1783.
Abstract:
Fractures after nursing home admission: incidence and potential consequences.
SUMMARY: Fracture rates were examined in residents newly admitted to nursing homes. The risk of a fracture was highest during the first months after admission and declined thereafter. This risk pattern was observed independently of fracture site, gender or degree of care need. INTRODUCTION AND HYPOTHESIS: Residents of nursing homes are a high-risk group for fractures. The aim of the study was to analyse fracture rates as a function of time from admission to nursing home. METHODS: Fractures of the upper limb, femur, pelvis and lower leg, time to first and subsequent fractures, age, gender and care needs at admission were measured in 93,424 women and men aged 65 years and over and newly admitted to nursing homes in Bavaria between 2001 and 2006. RESULTS: Fracture incidence was highest during the first months after admission to nursing homes and declined thereafter. This pattern was observed for all fracture sites, in women and men and in residents with different care needs. For example, fracture rates of the upper limb declined from 30.0 to 13.5/1,000 person-years in the first 9 months after admission and for all fracture sites from 135.3 to 69.4/1,000 person-years in a corresponding time period. CONCLUSION: Newly admitted residents have the highest fracture risk. The pattern of risk is similar across all fractures, suggesting a generic causal pathway. Implementation of effective fracture prevention efforts should be a priority at the time of admission to nursing homes.
Abstract.
Author URL.
Lamb SE, Pepper J, Lall R, Jørstad-Stein EC, Clark MD, Hill L, Fereday-Smith J (2009). Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.
BMC Womens Health,
9Abstract:
Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.
BACKGROUND: the aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. METHODS: a pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. RESULTS: the majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference 52.91 pounds 95%, confidence interval ( 25.82 pounds- 80.00 pounds)). CONCLUSION: Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. TRIAL REGISTRATION NUMBER: ISRCTN 16772662.
Abstract.
Author URL.
Griffiths F, Pepper J, Jørstad-Stein EC, Smith JF, Hill L, Lamb SE (2009). Group versus individual sessions delivered by a physiotherapist for female urinary incontinence: an interview study with women attending group sessions nested within a randomised controlled trial.
BMC Women's Health,
9Abstract:
Group versus individual sessions delivered by a physiotherapist for female urinary incontinence: an interview study with women attending group sessions nested within a randomised controlled trial
Background: the aim was to explore the concerns and expectations of women invited to attend group physiotherapy sessions for the management of female urinary incontinence and whether the experience changed their views; and to gather recommendations from women attending group sessions on the design and delivery of these sessions. Methods: an interview study nested within a randomised controlled trial in five British NHS physiotherapy departments, including 22 women who had expressed a preference for an individual physiotherapy session but were randomised to, and attended, group sessions. Results: Embarrassment was woven throughout women's accounts of experiencing urinary incontinence and seeking health care. Uncertainty about the nature of group sessions was a source of concern. Attending the first session was seen as a big hurdle by many women. However, a sense of relief was common once the session started, with most women describing some benefit from attendance. Recommendations for design and delivery of the sessions from women focused on reducing embarrassment and uncertainty prior to attendance. Conclusion: Taking account of women's embarrassment and providing detailed information about the content of group sessions will enable women to benefit from group physiotherapy sessions for the management of female urinary incontinence. © 2009 Griffiths et al; licensee BioMed Central Ltd.
Abstract.
Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH (2009). Interventions for preventing falls in older people living in the community.
Cochrane Database Syst Rev(2).
Abstract:
Interventions for preventing falls in older people living in the community.
BACKGROUND: Approximately 30% of people over 65 years of age living in the community fall each year. OBJECTIVES: to assess the effects of interventions to reduce the incidence of falls in older people living in the community. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (The Cochrane Library 2008, Issue 2), MEDLINE, EMBASE, CINAHL, and Current Controlled Trials (all to May 2008). SELECTION CRITERIA: Randomised trials of interventions to reduce falls in community-dwelling older people. Primary outcomes were rate of falls and risk of falling. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Data were pooled where appropriate. MAIN RESULTS: We included 111 trials (55,303 participants).Multiple-component group exercise reduced rate of falls and risk of falling (rate ratio (RaR) 0.78, 95%CI 0.71 to 0.86; risk ratio (RR) 0.83, 95%CI 0.72 to 0.97), as did Tai Chi (RaR 0.63, 95%CI 0.52 to 0.78; RR 0.65, 95%CI 0.51 to 0.82), and individually prescribed multiple-component home-based exercise (RaR 0.66, 95%CI 0.53 to 0.82; RR 0.77, 95%CI 0.61 to 0.97).Assessment and multifactorial intervention reduced rate of falls (RaR 0.75, 95%CI 0.65 to 0.86), but not risk of falling.Overall, vitamin D did not reduce falls (RaR 0.95, 95%CI 0.80 to 1.14; RR 0.96, 95%CI 0.92 to 1.01), but may do so in people with lower vitamin D levels. Overall, home safety interventions did not reduce falls (RaR 0.90, 95%CI 0.79 to 1.03); RR 0.89, 95%CI 0.80 to 1.00), but were effective in people with severe visual impairment, and in others at higher risk of falling. An anti-slip shoe device reduced rate of falls in icy conditions (RaR 0.42, 95%CI 0.22 to 0.78).Gradual withdrawal of psychotropic medication reduced rate of falls (RaR 0.34, 95%CI 0.16 to 0.73), but not risk of falling. A prescribing modification programme for primary care physicians significantly reduced risk of falling (RR 0.61, 95%CI 0.41 to 0.91).Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity (RaR 0.42, 95%CI 0.23 to 0.75). First eye cataract surgery reduced rate of falls (RaR 0.66, 95%CI 0.45 to 0.95).There is some evidence that falls prevention strategies can be cost saving. AUTHORS' CONCLUSIONS: Exercise interventions reduce risk and rate of falls. Research is needed to confirm the contexts in which multifactorial assessment and intervention, home safety interventions, vitamin D supplementation, and other interventions are effective.
Abstract.
Author URL.
Lamb SE, Marsh JL, Hutton JL, Nakash R, Cooke MW, Collaborative Ankle Support Trial (CAST Group) (2009). Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.
Lancet,
373(9663), 575-581.
Abstract:
Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.
BACKGROUND: Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. METHODS: We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. RESULTS: Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2.4-15.0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1.8-14.2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). INTERPRETATION: a short period of immobilisation in a below-knee cast or Aircast results in faster recovery than if the patient is only given tubular compression bandage. We recommend below-knee casts because they show the widest range of benefit. FUNDING: National Co-ordinating Centre for Health Technology Assessment.
Abstract.
Author URL.
Lamb SE (2009). Multidisciplinary assessment of elderly people with a history of multiple falls reduces the risk of further falls. Australian Journal of Physiotherapy, 55(2), 136-136.
Lamb SE (2009). Multidisciplinary assessment of elderly people with a history of multiple falls reduces the risk of further falls.
Aust J Physiother,
55(2).
Abstract:
Multidisciplinary assessment of elderly people with a history of multiple falls reduces the risk of further falls.
QUESTION: Does assessment by a multidisciplinary team, or assessment by a community nurse with the ability to refer to other professionals, reduce further falls in recurrent fallers? DESIGN: Cluster-randomised, controlled trial. SETTING: 18 general practices in the UK. PARTICIPANTS: Adults aged at least 65 years, living in the community, who had experienced 2 or more falls in the past year, and who did not present to an emergency department for their most recent fall. Inability to participate for one year, abbreviated mental test score less than 7, and nursing home placement were exclusion criteria. Randomisation of 516 participants allotted 213 to care by the multidisciplinary team (secondary care), 141 to care by the community nurse (primary care), and 162 to usual care. INTERVENTIONS: Participants allocated to secondary care attended a multidisciplinary clinic (comprising a doctor, nurse, physiotherapist, and occupational therapist) with referral for investigations, interventions, (including Homecheck), and follow-up if necessary. Participants allocated to primary care were assessed by a community nurse who identified risk factors for falls and could refer to other professionals. Participants in the usual care group were assessed by their usual primary care physicians, who provided management at their own discretion. OUTCOME MEASURES: the primary outcome was the proportion of participants in each group who had at least one fall during the follow-up period of 12 months. Other outcomes were death, move to institutional care, change in Barthel score, change in the timed Get up and Go score, fall-related fractures, and hospitalisations. Participants lost to follow-up were assumed to have had an adverse outcome. RESULTS: 466 participants contributed data to the primary outcome, with an adverse outcome assumed for a further 39 participants on falls and other dichotomous outcomes. At 12 months, 75% of the secondary care group, 87% of the primary care group, and 84% of the usual care group had fallen. Secondary care prevented significantly more falls than usual care (adjusted odds ratio 0.52, 95% Ci 0.35 to 0.79). the secondary care group also had a significantly more positive Barthel index than the usual care group. the groups did not significantly differ on the other outcomes. The data were also analysed without imputing adverse outcomes for participants who were lost to follow-up. Compared to the usual care group, the secondary care group had significantly fewer falls, fractures, hospitalisations, and deaths. CONCLUSION: Multidisciplinary assessment of elderly, recurrent fallers reduces the risk of further falls compared to usual care. Assessment of risk factors for falls by a community nurse with the potential to refer to other professionals did not have the same benefit.
Abstract.
Author URL.
Chorti AG, Chortis AG, Strimpakos N, McCarthy CJ, Lamb SE (2009). The prognostic value of symptom responses in the conservative management of spinal pain: a systematic review.
Spine (Phila Pa 1976),
34(24), 2686-2699.
Abstract:
The prognostic value of symptom responses in the conservative management of spinal pain: a systematic review.
STUDY DESIGN: Systematic review. OBJECTIVE: to investigate the prognostic value of clinically induced changes in spinal symptoms (i.e. symptom response) in the conservative management of spinal pain. SUMMARY OF BACKGROUND DATA: Symptom response is used by clinicians to inform management decisions. Understanding the prognostic value of symptom response can aid in this decision-making process. METHODS: a search of Ovid-Medline, Ovid-Embase, Ovid-Cinahl, Ovid-Amed, reference lists and citation tracking was performed. Methodologic quality was assessed independently by 2 raters. RESULTS: We included 22 articles reporting 18 different cohorts. The evidence was limited and mainly involved low back pain. We found no association between most symptom responses and clinical outcomes. Only for changes in pain location and/or intensity with repeated spinal movement testing or as a response to treatment did the data provide support for use of symptom response to inform management. Further work is needed to confirm these findings. Limited evidence of an association with disability was found for the prone instability test in low back pain patients attending a stabilization program. The evidence for neurodynamic testing was conflicting for low back pain. The strength of identified associations and the extent of confounding between investigated prognostic factors remain uncertain. CONCLUSION: Further investigation of symptom responses in spinal pain is needed before their use can be recommended.
Abstract.
Author URL.
Cooke MW, Marsh JL, Clark M, Nakash R, Jarvis RM, Hutton JL, Szczepura A, Wilson S, Lamb SE, CAST trial group, et al (2009). Treatment of severe ankle sprain: a pragmatic randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of three types of mechanical ankle support with tubular bandage. The CAST trial.
Health Technol Assess,
13(13), iii-121.
Abstract:
Treatment of severe ankle sprain: a pragmatic randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of three types of mechanical ankle support with tubular bandage. The CAST trial.
OBJECTIVE: to estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN: a randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING: Eight emergency departments in England. PARTICIPANTS: Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS: 584 participants were randomised to one of four treatment arms: tubular bandage, below knee cast, Aircast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES: Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS: When adjusted for age, sex and baseline scores, the below knee cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the Aircast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the Aircast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the Aircast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS: the below knee cast and the Aircast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.
Abstract.
Author URL.
Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH (2009). WITHDRAWN: Interventions for preventing falls in elderly people.
Cochrane Database Syst Rev(2).
Abstract:
WITHDRAWN: Interventions for preventing falls in elderly people.
BACKGROUND: Approximately 30 per cent of people over 65 years of age and living in the community fall each year; the number is higher in institutions. Although less than one fall in 10 results in a fracture, a fifth of fall incidents require medical attention. OBJECTIVES: to assess the effects of interventions designed to reduce the incidence of falls in elderly people (living in the community, or in institutional or hospital care). SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2003), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003), MEDLINE (1966 to February 2003), EMBASE (1988 to 2003 Week 19), CINAHL (1982 to April 2003), the National Research Register, Issue 2, 2003, Current Controlled Trials (www.controlled-trials.com accessed 11 July 2003) and reference lists of articles. No language restrictions were applied. Further trials were identified by contact with researchers in the field. SELECTION CRITERIA: Randomised trials of interventions designed to minimise the effect of, or exposure to, risk factors for falling in elderly people. Main outcomes of interest were the number of fallers, or falls. Trials reporting only intermediate outcomes were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Data were pooled using the fixed effect model where appropriate. MAIN RESULTS: Sixty two trials involving 21,668 people were included.Interventions likely to be beneficial:Multidisciplinary, multifactorial, health/environmental risk factor screening/intervention programmes in the community both for an unselected population of older people (4 trials, 1651 participants, pooled RR 0.73, 95%CI 0.63 to 0.85), and for older people with a history of falling or selected because of known risk factors (5 trials, 1176 participants, pooled RR 0.86, 95%CI 0.76 to 0.98), and in residential care facilities (1 trial, 439 participants, cluster-adjusted incidence rate ratio 0.60, 95%CI 0.50 to 0.73) a programme of muscle strengthening and balance retraining, individually prescribed at home by a trained health professional (3 trials, 566 participants, pooled relative risk (RR) 0.80, 95% confidence interval (95%CI) 0.66 to 0.98) Home hazard assessment and modification that is professionally prescribed for older people with a history of falling (3 trials, 374 participants, RR 0.66, 95% CI 0.54 to 0.81) Withdrawal of psychotropic medication (1 trial, 93 participants, relative hazard 0.34, 95%CI 0.16 to 0.74) Cardiac pacing for fallers with cardioinhibitory carotid sinus hypersensitivity (1 trial, 175 participants, WMD -5.20, 95%CI -9.40 to -1.00) a 15 week Tai Chi group exercise intervention (1 trial, 200 participants, risk ratio 0.51, 95%CI 0.36 to 0.73). Interventions of unknown effectiveness:Group-delivered exercise interventions (9 trials, 1387 participants) Individual lower limb strength training (1 trial, 222 participants) Nutritional supplementation (1 trial, 46 participants) Vitamin D supplementation, with or without calcium (3 trials, 461 participants) Home hazard modification in association with advice on optimising medication (1 trial, 658 participants), or in association with an education package on exercise and reducing fall risk (1 trial, 3182 participants) Pharmacological therapy (raubasine-dihydroergocristine, 1 trial, 95 participants) Interventions using a cognitive/behavioural approach alone (2 trials, 145 participants) Home hazard modification for older people without a history of falling (1 trial, 530 participants) Hormone replacement therapy (1 trial, 116 participants) Correction of visual deficiency (1 trial, 276 participants).Interventions unlikely to be beneficial:Brisk walking in women with an upper limb fracture in the previous two years (1 trial, 165 participants). AUTHORS' CONCLUSIONS: Interventions to prevent falls that are likely to be effective are now available; less is known about their effectiveness in preventing fall-related injuries. Costs per fall prevented have been established for four of the interventions and careful economic modelling in the context of the local healthcare system is important. Some potential interventions are of unknown effectiveness and further research is indicated.
Abstract.
Author URL.
Lamb SE, Fisher JD, Gates S, Potter R, Cooke MW, Carter YH (2008). A national survey of services for the prevention and management of falls in the UK.
BMC Health Serv Res,
8Abstract:
A national survey of services for the prevention and management of falls in the UK.
BACKGROUND: the National Health Service (NHS) was tasked in 2001 with developing service provision to prevent falls in older people. We carried out a national survey to provide a description of health and social care funded UK fallers services, and to benchmark progress against current practice guidelines. METHODS: Cascade approach to sampling, followed by telephone survey with senior member of the fall service. Characteristics of the service were assessed using an internationally agreed taxonomy. Reported service provision was compared against benchmarks set by the National Institute for Health and Clinical Excellence (NICE). RESULTS: We identified 303 clinics across the UK. 231 (76%) were willing to participate. The majority of services were based in acute or community hospitals, with only a few in primary care or emergency departments. Access to services was, in the majority of cases, by health professional referral. Most services undertook a multi-factorial assessment. The content and quality of these assessments varied substantially. Services varied extensively in the way that interventions were delivered, and particular concern is raised about interventions for vision, home hazard modification, medication review and bone health. CONCLUSION: the most common type of service provision was a multi-factorial assessment and intervention. There were a wide range of service models, but for a substantial number of services, delivery appears to fall below recommended NICE guidance.
Abstract.
Author URL.
Williamson E, Williams M, Gates S, Lamb SE (2008). A systematic literature review of psychological factors and the development of late whiplash syndrome.
PAIN,
135(1-2), 20-30.
Author URL.
Lamb SE, Toye F, Barker KL (2008). Chronic disease management programme in people with severe knee osteoarthritis: efficacy and moderators of response.
CLINICAL REHABILITATION,
22(2), 169-178.
Author URL.
Haywood KL, Garratt AM, Lall R, Smith JF, Lamb SE (2008). EuroQol EQ-5D and condition-specific measures of health outcome in women with urinary incontinence: reliability, validity and responsiveness.
QUALITY OF LIFE RESEARCH,
17(3), 475-483.
Author URL.
Rapp K, Becker C, Lamb SE, Icks A, Klenk J (2008). Hip Fractures in Institutionalized Elderly People: Incidence Rates and Excess Mortality.
JOURNAL OF BONE AND MINERAL RESEARCH,
23(11), 1825-1831.
Author URL.
Gillespie LD, Robertson MC, Gillespie WJ, Lamb S, Gates S, Cumming RG, Rowe BH (2008). Interventions for preventing falls in older people living in the community. Cochrane Database of Systematic Reviews(2).
Portegijs E, Sipila S, Rantanen T, Lamb SE (2008). Leg extension power deficit and mobility limitation in women recovering from hip fracture.
AMERICAN JOURNAL OF PHYSICAL MEDICINE & REHABILITATION,
87(5), 363-370.
Author URL.
Gates S, Fisher JD, Cooke MW, Carter YH, Lamb SE (2008). Multifactorial assessment and targeted intervention for preventing falls and injuries among older people in community and emergency care settings: systematic review and meta-analysis.
BRITISH MEDICAL JOURNAL,
336(7636), 130-133.
Author URL.
Rapp K, Lamb SE, Buechele G, Lall R, Lindemann U, Becker C (2008). Prevention of falls in nursing homes: Subgroup analyses of a randomized fall prevention trial.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
56(6), 1092-1097.
Author URL.
Nakash RA, Hutton JL, Lamb SE, Gates S, Fisher J (2008). Response and non-response to postal questionnaire follow-up in a clinical trial - a qualitative study of the patient's perspective.
JOURNAL OF EVALUATION IN CLINICAL PRACTICE,
14(2), 226-235.
Author URL.
Frost H, Lamb SE, Stewart-Brown S (2008). Responsiveness of a Patient Specific Outcome Measure Compared with the Oswestry Disability Index v2.1 and Roland and Morris Disability Questionnaire for Patients with Subacute and Chronic Low Back Pain.
SPINE,
33(22), 2450-2457.
Author URL.
Gates S, Smith LA, Fisher JD, Lamb SE (2008). Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults.
J Rehabil Res Dev,
45(8), 1105-1116.
Abstract:
Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults.
The objective of this study was to summarize the evidence on the accuracy of screening tools for predicting falling risk in community-living older adults. This study was designed as a systematic review. Prospective studies of clinical fall risk prediction tools that provided data on the number of participants who sustained falls during follow-up were included. We searched six electronic databases and reference lists of studies and review articles. Data were extracted by two reviewers independently, and methodological quality assessment was performed with a modified version of the Quality Assessment of Diagnostic Accuracy Studies checklist. Twenty-five studies were included. These studies evaluated 29 different screening tools, but only 6 of the tools were evaluated by more than one study. Methodological quality was variable, and many studies were small. No meta-analyses were performed because of heterogeneity. Most tools discriminated poorly between fallers and nonfallers. We found that existing studies are methodologically variable and the results are inconsistent. Insufficient evidence exists that any screening instrument is adequate for predicting falls.
Abstract.
Author URL.
McCarthy C, Keating JL, Kent PM, Lall R, Lamb SE, Strimpakos N (2008). Targeted manual therapy for non-specific low-back pain. Cochrane Database of Systematic Reviews(2).
Lamb SE, McCabe C, Becker C, Fried LP, Guralnik JM (2008). The Optimal Sequence and Selection of Screening Test Items to Predict Fall Risk in Older Disabled Women: the Women's Health and Aging Study.
JOURNALS OF GERONTOLOGY SERIES A-BIOLOGICAL SCIENCES AND MEDICAL SCIENCES,
63(10), 1082-1088.
Author URL.
Williams M, Williamson E, Gates S, Lamb S, Cooke M (2007). A systematic literature review of physical prognostic factors for the development of Late Whiplash Syndrome.
Spine,
32(25).
Abstract:
A systematic literature review of physical prognostic factors for the development of Late Whiplash Syndrome
STUDY DESIGN. Systematic Review. OBJECTIVE. To summarize evidence concerning physical prognostic factors for development of Late Whiplash Syndrome (LWS). SUMMARY OF BACKGROUND DATA. There have been 3 previous systematic reviews of prognosis of whiplash with conflicting findings. The Quebec Task Force concluded that high priority should be given to determining prognostic factors. Subsequently their review was updated by Cote et al (Spine 2001;26:E445-58) and most recently by Scholten-Peeters et al (Pain 2003;104:303-22). METHODS. We searched electronic databases from their inception to August 2006 using a prespecified search strategy. We included prospective cohort and case control studies that studied physical prognostic factors at baseline. Two independent reviewers selected articles, extracted data, and assessed quality. Meta-analysis was not performed due to the heterogeneity between studies. Instead, levels of evidence were generated by grouping similar findings from cohorts. RESULTS. Thirty-eight articles from 26 cohorts were reviewed. The majority of articles (25 of 38) were rated as low quality. No studies were rated as high quality. Only a minority of studies used validated prognostic measures and/or outcome measures. High initial neck pain intensity, neck pain related disability, and cold hyperalgesia all had moderate evidence for an association with the development of LWS. No factor was rated as having strong evidence. CONCLUSION. Pain has a central role to play as a prognostic factor for the development of LWS. Other physical factors commonly used in the clinical setting showed inconclusive evidence for their influence on prognosis. There is a need for improved quality of studies with consistent use of validated measures of all categories of prognostic factors and outcome. This may then provide a clearer understanding of prognosis of Whiplash Associated Disorders and therefore facilitate effective management of this costly problem. © 2007 Lippincott Williams & Wilkins, Inc.
Abstract.
Toye F, Barlow J, Wright C, Lamb SE (2007). A validation study of the new Zealand score for hip and knee surgery.
CLINICAL ORTHOPAEDICS AND RELATED RESEARCH(464), 190-195.
Author URL.
Lamb SE, Lall R, Hansen Z, Withers EJ, Griffiths FE, Szczepura A, Barlow J, Underwood MR, Back Skills Training Trial (BeST) Team (2007). Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial.
BMC Musculoskelet Disord,
8Abstract:
Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial.
BACKGROUND: Low back pain (LBP) is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion. METHODS/DESIGN: This randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6-8 participants. A parallel qualitative study will aid the evaluation of the intervention. DISCUSSION: in this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.
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Lamb SE, Gates S, Underwood MR, Cooke MW, Ashby D, Szczepura A, Williams MA, Williamson EM, Withers EJ, Mt Isa S, et al (2007). Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders.
BMC Musculoskelet Disord,
8Abstract:
Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders.
BACKGROUND: a substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of the Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. METHODS: Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. CONCLUSION: This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.
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Skelton DA, Hauer K, Lamb S (2007). Re: 'Falls definition validation' [10]. Age and Ageing, 36(1), 111-112.
Portegijs E, Sipila S, Pajala S, Lamb SE, Alen M, Kaprio J, Koskenvuo M, Rantanen T (2006). Asymmetrical lower extremity power deficit as a risk factor for injurious falls in healthy older women.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
54(3), 551-553.
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Lamb SE, Becker C (2006). Cognitive function may be important for fall injury prevention trials - a response letter to Drs. Hausdorff and Yogev.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
54(5), 865-866.
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Rivero-Arias O, Gray A, Frost H, Lamb SE, Stewart-Brown S (2006). Cost-utility analysis of physiotherapy treatment compared with physiotherapy advice in low back pain.
SPINE,
31(12), 1381-1387.
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Nakash RA, Hutton JL, Jørstad-Stein EC, Gates S, Lamb SE (2006). Maximising response to postal questionnaires--a systematic review of randomised trials in health research.
BMC Med Res Methodol,
6Abstract:
Maximising response to postal questionnaires--a systematic review of randomised trials in health research.
BACKGROUND: Postal self-completion questionnaires offer one of the least expensive modes of collecting patient based outcomes in health care research. The purpose of this review is to assess the efficacy of methods of increasing response to postal questionnaires in health care studies on patient populations. METHODS: the following databases were searched: Medline, Embase, CENTRAL, CDSR, PsycINFO, NRR and ZETOC. Reference lists of relevant reviews and relevant journals were hand searched. Inclusion criteria were randomised trials of strategies to improve questionnaire response in health care research on patient populations. Response rate was defined as the percentage of questionnaires returned after all follow-up efforts. Study quality was assessed by two independent reviewers. The Mantel-Haenszel method was used to calculate the pooled odds ratios. RESULTS: Thirteen studies reporting fifteen trials were included. Implementation of reminder letters and telephone contact had the most significant effect on response rates (odds ratio 3.7, 95% confidence interval 2.30 to 5.97 p = or
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Toye FM, Barlow J, Wright C, Lamb SE (2006). Personal meanings in the construction of need for total knee replacement surgery.
SOCIAL SCIENCE & MEDICINE,
63(1), 43-53.
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Hauer K, Lamb SE, Jorstad EC, Todd C, Becker C, PROFANE-Grp (2006). Systematic review of definitions and methods of measuring falls in randomised controlled fall prevention trials.
AGE AND AGEING,
35(1), 5-10.
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Frost H, Lamb SE (2005). A critical appraisal and defence of the Oxfordshire low back pain trial.
PHYSIOTHERAPY,
91(1), 1-2.
Author URL.
Lamb SE, Nakash RA, Withers EJ, Clark M, Marsh JL, Wilson S, Hutton JL, Szczepura A, Dale JR, Cooke MW, et al (2005). Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450].
BMC Musculoskelet Disord,
6Abstract:
Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450].
BACKGROUND: the optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast brace and Bledsoe boot) in comparison to Tubigrip, and (2) to compare the cost of each strategy, including subsequent health care costs. METHODS/DESIGN: Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. DISCUSSION: This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.
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Lamb SE, Jørstad-Stein EC, Hauer K, Becker C, Prevention of Falls Network Europe and Outcomes Consensus Group (2005). Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus.
J Am Geriatr Soc,
53(9), 1618-1622.
Abstract:
Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus.
The prevention of injury associated with falls in older people is a public health target in many countries around the world. Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls, the effect on serious injury rates is unclear. Historically, trials have not been adequately powered to detect injury endpoints, and variations in case definition across trials have hindered meta-analysis. It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in populations who are at a higher risk of injury. Further research is required to determine whether fall-prevention interventions can reduce serious injuries. Prevention of Falls Network Europe (ProFaNE) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice (www.profane.eu.org). The European Commission funds the network, which links clinicians, members of the public, and researchers worldwide. The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity, including clinical trials, comparative research, and prospective meta-analysis. Work is being undertaken in a 4-year program. As a first step, the development of a common set of outcome definitions and measures for future trials or meta-analysis was considered.
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Jacob-Lloyd HA, Dunn OM, Brain ND, Lamb SE (2005). Effective measurement of the functional progress of stroke clients.
British Journal of Occupational Therapy,
68(6), 253-259.
Abstract:
Effective measurement of the functional progress of stroke clients
There is a need for occupational therapists to establish a range of outcome measures that can measure change effectively. The aim of this study was to identify effective methods of measuring the functional performance of individuals who had experienced a stroke and had been discharged from a rehabilitation ward. Measures with recorded validity and reliability and in clinical use were selected. The measures were the Barthel Index (Shah version), Nottingham Extended Activities of Daily Living scale, Motricity Index (Upper and Lower Limb), Rivermead Mobility Index and Nine-Hole Peg Test. Assessments were carried out at the point of discharge from hospital and 6 months later. Responsiveness was analysed using effect size and relative efficiency statistics. The practicality (feasibility) was established by comparing completion rates. The Nottingham Extended Activities of Daily Living scale and the Rivermead Mobility Index were found to be more responsive than the Barthel Index and Lower Limb Motricity Index respectively and to be practical after discharge from hospital. The Nine-Hole Peg Test was found to be more responsive than the Upper Limb Motricity Index but less practical. The analysis suggested that some measures are more suitable than others for tracking change in function after discharge from hospital for a wide case mix of people who have experienced a stroke.
Abstract.
Jørstad EC, Hauer K, Becker C, Lamb SE, ProFaNE Group (2005). Measuring the psychological outcomes of falling: a systematic review.
J Am Geriatr Soc,
53(3), 501-510.
Abstract:
Measuring the psychological outcomes of falling: a systematic review.
The objectives were to identify fall-related psychological outcome measures and to undertake a systematic quality assessment of their key measurement properties. A Cochrane review of fall-prevention interventions in older adults was used to identify fall-related psychological measurements. PubMed, CINAHL, and PsycINFO were systematically searched to identify instruments not used in trials and papers reporting the methodological quality of relevant measures. Reference lists of articles were searched for additional literature, and researchers were contacted. Two reviewers undertook quality extraction relating to content, population, reliability, validity, responsiveness, practicality, and feasibility. Twenty-five relevant papers were identified. Twenty-three measures met the inclusion criteria: six single-item questions, Falls Efficacy Scale (FES), revised FES, modified FES, FES-UK, Activities-specific Balance and Confidence Scale (ABC), ABC-UK, Confidence in maintaining Balance Scale, Mobility Efficacy Scale, adapted FES, amended FES, Survey of Activities and Fear of Falling in the Elderly (SAFFE), University of Illinois at Chicago Fear of Falling Measure, Concern about Falling Scale, Falls Handicap Inventory, modified SAFFE, Consequences of Falling Scale, and Concern about the Consequences of Falling Scale. There is limited evidence about the measurement properties of single-item measures. Several multiitem measures obtained acceptable reliability and validity, but there is less evidence regarding responsiveness, practicality, and feasibility. Researchers should select measures based on the constructs they intend to study. Further research is needed to establish and compare the instruments' measurement properties.
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Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S (2005). Physical therapy adds little to back pain treatment.
CLEVELAND CLINIC JOURNAL OF MEDICINE,
72(1), 17-17.
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Jorstad-Stein EC, Hauer K, Becker C, Bonnefoy M, Nakash RA, Skelton DA, Lamb SE (2005). Suitability of physical activity questionnaires for older adults in fall prevention trials: a systematic review.
JOURNAL OF AGING AND PHYSICAL ACTIVITY,
13(4), 461-481.
Author URL.
Barker K, Lamb SE, Toye F, Jackson S, Barrington S (2004). Association between radiographic joint space narrowing, function, pain and muscle power in severe osteoarthritis of the knee.
Clin Rehabil,
18(7), 793-800.
Abstract:
Association between radiographic joint space narrowing, function, pain and muscle power in severe osteoarthritis of the knee.
OBJECTIVE: to examine the association between radiographic classification of severe knee osteoarthritis and measurements of function, pain and power. DESIGN: Cross-sectional study. SETTING: Specialist orthopaedic hospital. SUBJECTS: One hundred and twenty-three patients on the waiting list for elective knee arthroplasty. OUTCOME MEASURES: Weight-bearing antero-posterior radiographs scored for severity of osteoarthritis using the Kellgren and Lawrence scale. Function measured using the function subscale of the WOMAC (Western Ontario and McMaster Universities) index, timed tests of walking speed and sit-to-stand. Pain measured using the pain subscale of the WOMAC index and a visual analogue scale. Extensor strength of the lower limb measured with the leg extensor power rig. RESULTS: Within any radiographic grade there was considerable variation in function: WOMAC function for patients with grade 2 mean 64 (47-86), grade 3 mean 47 (12-89) grade 4 mean 45 (2-92). There was poor correlation between radiographic score function, pain or muscle power, with no statistically significant associations. A wide range of scores was also seen within patients with the same radiographic grade. CONCLUSIONS: Radiographic score was not found to be closely associated with function. Amongst patients with the same radiographic score there was considerable variation in function, pain and power.
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Simpson AHRW, Lamb S, Roberts PJ, Gardner TN, Evans JG (2004). Does the type of flooring affect the risk of hip fracture?.
Age and Ageing,
33(3), 242-246.
Abstract:
Does the type of flooring affect the risk of hip fracture?
Background: the number of hip fractures occurring worldwide in 1990 was estimated at 1.7 million and is predicted to rise to 6.3 million by 2050. The vast majority occur as a result of simple falls and the impact of the femoral trochanter with the floor. Previous studies have addressed the problem from the patient's side of the impact. Little research has been carried out on the other surface involved in the impact, the floor. Study location: 34 residential care homes. Methods: (1) the mechanical properties of the floor were measured with force transducers. (2) the number and location of falls and fractures on the various floors were recorded prospectively for 2 years. The threshold for reporting falls in different care homes was assessed using a standardised set of scenarios. Results: a total of 6,641 falls and 222 fractures were recorded. Wooden carpeted floors were associated with the lowest number of fractures per 100 falls. The risk of fracture resulting from a fall was significantly lower compared to all other floor types (odds ratio 1.78, 95% CI 1.33-2.35). The mean impact force was significantly lower on wooden carpeted floors: 11.9 kN compared to the other floor types. Discussion: the possible implications of our findings are considerable. Residents of homes are typically frail and many have a propensity to falls. In designing safer environments for older people, the type of floor should be chosen to minimise the risk of fracture. This may result in a major reduction in fractures in the elderly. © British Geriatrics Society 2004; all rights reserved.
Abstract.
Barker KL, Lamb SE, Simpson AHRW (2004). Functional recovery in patients with nonunion treated with the Ilizarov technique.
JOURNAL OF BONE AND JOINT SURGERY-BRITISH VOLUME,
86B(1), 81-85.
Author URL.
Barker KL, Lamb SE, Simpson AHRW (2004). Functional recovery in patients with nonunion treated with the Ilizarov technique.
J Bone Joint Surg Br,
86(1), 81-85.
Abstract:
Functional recovery in patients with nonunion treated with the Ilizarov technique.
There are few reports on function after limb salvage surgery using the Ilizarov technique, and none that document the pattern of recovery or predict when maximum function returns. This prospective, longitudinal study documents the baseline functional abilities of 40 consecutive patients with nonunion of a fracture in the lower limb. Patients were studied for at least two and a half years following the completion of surgery. Function was measured by timed tests of functional performance and by the Toronto Extremity Salvage Score self-reported patient questionnaire. Recovery was slowest in the early stages after removal of the frame and greatest between six months and one year. Statistically significant improvement continued up to, but not beyond two years. This observation has important implications for the length of follow-up incorporated into the rehabilitation programmes for patients, predictions of patient status in regard to compensation and for the design of future studies to evaluate functional outcome.
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Haywood KL, Hargreaves J, Lamb SE (2004). Multi-item outcome measures for lateral ligament injury of the ankle: a structured review.
J Eval Clin Pract,
10(2), 339-352.
Abstract:
Multi-item outcome measures for lateral ligament injury of the ankle: a structured review.
OBJECTIVE: to identify and review evidence relating to the measurement properties of published multi-item outcome measures for the conservative management of lateral ligament injuries of the ankle. METHODS: Systematic literature searches were used to identify measures, which were then assessed against pre-defined criteria relating to development, item content, reliability, validity and responsiveness. RESULTS: Seven disease-specific measures of ankle status [Ankle Joint Functional Assessment Tool, Clinical Trauma Severity Score, Composite Inversion Injury Scale, Kaikkonen Functional Scale (KFS), Karlsson Ankle Function Score (KAFS), Olerud and Molander Ankle Score (OMAS), and the Point System] and two generic measures of health (McGill Pain Questionnaire, Sickness Impact Profile) met the review inclusion criteria. While all measures had been used in acute injuries, only two had also been applied during later stages of recovery (>6 months). The studies covered a comprehensive range of graded ligament injuries. Expert opinion dominated item generation for all measures. All measures lack evidence of test-retest or internal consistency reliability in patients with ankle sprain. Several measures were assessed for validity through comparison with other measures, but there was limited evidence of construct validity and no formal assessment of responsiveness for any measure. CONCLUSION: the disappointing lack of evidence for measurement properties suggests that any measure should be used with caution until appropriate evidence is provided. On the basis of limited evidence, the KFS offers the most promising approach to a combined clinician- and patient-assessment of ankle function, and the KAFS or OMAS if a patient-assessed evaluation of function is required.
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Skelton DA, Becker C, Lamb SE, Close JCT, Zijlstra W, Yardley L, Todd CJ (2004). Prevention of Falls Network Europe: a thematic network aimed at introducing good practice in effective falls prevention across Europe.
Eur J Ageing,
1(1), 89-94.
Abstract:
Prevention of Falls Network Europe: a thematic network aimed at introducing good practice in effective falls prevention across Europe.
The Prevention of Falls Network Europe (ProFaNE) aims to improve quality of life of the ageing population by focussing on a major cause of disability and distress: falls. The thematic network is funded by the European Commission and brings together scientists, clinicians and other health professionals from around Europe to focus on four main themes: taxonomy and coordination of trials, clinical assessment and management of falls, assessment of balance function, and psychological aspects of falling. There are 24 members across Europe as well as network associates who contribute expertise at workshops and meetings. ProFaNE, a 4-year project which started in January 2003, aims to improve and standardise health care processes, introducing and promoting good practice widely across Europe. ProFaNE undertakes workshops that bring together experts and observers around specific topics to exchange knowledge, expertise and resources on interventions that reduce falls. A key document for policy makers around Europe, written by ProFaNE members, was published by the World Health Organisation in March 2004. ProFaNE's website has both public and private areas with resources (web links to falls prevention, useful documents for policy makers, researchers and practitioners) and a discussion board to encourage informal networking between members and the public. The ultimate aim of ProFaNE is to submit a collaborative bid to undertake a multi-centre, randomised controlled trial of a multi-factorial fall prevention intervention with peripheral fracture as the primary outcome. The success of the networking and relationship building in the first year and a half of ProFaNE's work makes this an achievable goal.
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Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S (2004). Randomised controlled trial of physiotherapy compared with advice for low back pain.
BMJ,
329(7468).
Abstract:
Randomised controlled trial of physiotherapy compared with advice for low back pain.
OBJECTIVE: to measure the effectiveness of routine physiotherapy compared with an assessment session and advice from a physiotherapist for patients with low back pain. DESIGN: Pragmatic, multicentre, randomised controlled trial. SETTING: Seven British NHS physiotherapy departments. PARTICIPANTS: 286 patients with low back pain of more than six weeks' duration. INTERVENTION: Routine physiotherapy or advice on remaining active from a physiotherapist. Both groups received an advice book. MAIN OUTCOME MEASURES: Primary outcome was scores on the Oswestry disability index at 12 months. Secondary outcomes were scores on the Oswestry disability index (two and six months), scores on the Roland and Morris disability questionnaire and SF-36 (2, 6 and 12 months), and patient perceived benefit from treatment (2, 6, and 12 months). RESULTS: 200 of 286 patients (70%) provided follow up information at 12 months. Patients in the therapy group reported enhanced perceptions of benefit, but there was no evidence of a long term effect of physiotherapy in either disease specific or generic outcome measures (mean difference in change in Oswestry disability index scores at 12 months -1.0%, 95% confidence interval -3.7% to 1.6%). The most common treatments were low velocity spinal joint mobilisation techniques (72%, 104 of 144 patients) and lumbar spine mobility and abdominal strengthening exercises (94%, 136 patients). CONCLUSIONS: Routine physiotherapy seemed to be no more effective than one session of assessment and advice from a physiotherapist.
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Haywood KL, Hargreaves J, White R, Lamb SE (2004). Reviewing measures of outcome: reliability of data extraction.
J Eval Clin Pract,
10(2), 329-337.
Abstract:
Reviewing measures of outcome: reliability of data extraction.
RATIONALE, AIMS AND OBJECTIVES: Although there is wide acceptance of the necessary domains for the evaluation of measures of health outcome, there has been little development or evaluation of methods of data extraction, such as checklists. This study aimed to assess the inter-rater reliability of data extrac
