BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative spinal condition in older adults associated with disability, diminished quality of life, and substantial healthcare costs. Individual symptoms and needs vary. With sparse and sometimes inconsistent evidence to guide clinical decision-making, variable clinical care may lead to unsatisfactory patient outcomes and inefficient use of healthcare resources. METHODS: a three-phase modified Delphi study comprising four consensus rounds was conducted on behalf of the International Taskforce for the Diagnosis and Management of LSS to develop a treatment algorithm based on multi-professional international expert consensus. Participants with expertise in the assessment and management of people with LSS were invited using an international distribution process used for two previous Delphi studies led by the Taskforce. Separate treatment pathways for patients with different symptom types and severity were developed and incorporated into a proposed treatment algorithm through consensus rounds 1 to 3. Agreement with the proposed algorithm was evaluated in the final consensus round. RESULTS: the final algorithm combines stratified and stepped approaches. When indicated, immediate investigation and surgery is advocated. Otherwise, a stepped approach is suggested when self-directed care is unsatisfactory. This starts with tailored rehabilitation, then more complex multidisciplinary care, investigations and surgery options if needed. Treatment options in each step depend on clinical phenotype and symptom severity. Treatment response guides pathway entrance and exit points. of 397 study participants, 86% rated their agreement ≥ 4 for the proposed algorithm on a 0-6 scale, of which 22% completely agreed. Only 7% disagreed. Over 70% of participants felt that the algorithm would be useful for clinicians in public healthcare (both primary care and specialist settings) and in private healthcare settings, and that a simplified version would help patients in shared decision-making. CONCLUSIONS: International and multi-professional agreement was achieved for a proposed LSS treatment algorithm developed through expert consensus. The algorithm advocates different pathway options depending on clinical indications. It is not intended as a treatment protocol and will require evaluation against current care for clinical and cost-effectiveness. It may, however, serve as a clinical guide until evidence is sufficient to inform a fully stratified care model.

OBJECTIVES: the aim of this study is to develop and validate two models to predict 2-year risk of self-reported mobility decline among community-dwelling older adults. STUDY DESIGN AND SETTING: We used data from a prospective cohort study of people aged 65 years and over in England. Mobility status was assessed using the EQ-5D-5L mobility question. The models were based on the outcome: Model 1, any mobility decline at 2 years; Model 2, new onset of persistent mobility problems over 2 years. Least absolute shrinkage and selection operator logistic regression was used to select predictors. Model performance was assessed using C-statistics, calibration plot, Brier scores, and decision curve analyses. Models were internally validated using bootstrapping. RESULTS: over 18% of participants who could walk reported mobility decline at year 2 (Model 1), and 7.1% with no mobility problems at baseline, reported new onset of mobility problems after 2 years (Model 2). Thirteen and 6 out of 31 variables were selected as predictors in Models 1 and 2, respectively. Models 1 and 2 had a C-statistic of 0.740 and 0.765 (optimism < 0.013), and Brier score = 0.136 and 0.069, respectively. CONCLUSION: Two prediction models for mobility decline were developed and internally validated. They are based on self-reported variables and could serve as simple assessments in primary care after external validation.

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.

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

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.

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).

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.

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.

Background: in both the United Kingdom (UK) and Brazil, women undergoing mastectomy should be offered breast reconstruction. Patients may benefit from physical therapy to prevent and treat muscular deficits. However, there are uncertainties regarding which physical therapy program to recommend. Objective: the aim was to investigate the clinical practice of physical therapists for patients undergoing breast reconstruction for breast cancer. A secondary aim was to compare physical therapy practice between UK and Brazil. Methods: Online survey with physical therapists in both countries. We asked about physical therapists’ clinical practice. Results: 181 physical therapists completed the survey, the majority were from Brazil (77%). Respondents reported that only half of women having breast reconstruction were routinely referred to physical therapy postoperatively. Contact with patients varied widely between countries, the mean number of postoperative sessions was 5.7 in the UK and 15.1 in Brazil. The exercise programs were similar for different reconstruction operations. Therapists described a progressive loading structure over time: range of motion (ROM) was restricted to 90° of arm elevation in the first two postoperative weeks; by 2–4 weeks ROM was unrestricted; at 1–3 months muscle strengthening was initiated, and after three months the focus was on sports-specific activities. Conclusion: Only half of patients having a breast reconstruction are routinely referred to physical therapy. Patients in Brazil have more intensive follow-up, with up to three times more face-to-face contact with a physical therapist than in the UK. Current practice broadly follows programs for mastectomy care rather than being specific to reconstruction surgery.

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.

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.

OBJECTIVES: to explore the experiences of women with breast cancer taking part in an early physiotherapy-led exercise intervention compared with the experiences of those receiving usual care. To understand physiotherapists' experience of delivering the trial intervention. To explore acceptability of the intervention and issues related to the implementation of the Prevention of Shoulder Problems (PROSPER) programme from participant and physiotherapist perspective. DESIGN: Qualitative semistructured interviews with thematic analysis. SETTING: UK National Health Service. PARTICIPANTS: Twenty participants at high risk of shoulder problems after breast cancer surgery recruited to the UK PROSPER trial (10 each from the intervention arm and control arm), and 11 physiotherapists who delivered the intervention. Trial participants were sampled using convenience sampling. Physiotherapists were purposively sampled from high and low recruiting sites. RESULTS: Participants described that the PROSPER exercise intervention helped them feel confident in what their body could do and helped them regain a sense of control in the context of cancer treatment, which was largely disempowering. Control arm participants expressed less of a sense of control over their well-being. Physiotherapists found the exercise intervention enjoyable to deliver and felt it was valuable to their patients. The extra time allocated for appointments during intervention delivery made physiotherapists feel they were providing optimal care, being the 'perfect physio'. Lessons were learnt about the implementation of a complex exercise intervention for women with breast cancer, and the issues raised will inform the development of a future implementation strategy. CONCLUSIONS: a physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies helped women at risk of shoulder problems following breast cancer treatment to feel more confident in their ability to mobilise their arm post-surgery. A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies may address the sense of powerlessness that many women experience during breast cancer treatment.Trial registration number ISRCTN35358984.

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.

We aimed to evaluate the evidence reported to underpin exercise dose in randomised controlled trials (RCTs) using strengthening exercise in RA. We searched six different databases between 1 January 2000 and 3 April 2019. We included RCTs, where a main component of the intervention and/or control used strengthening exercise. Evidence sources cited to underpin dose were judged for their quality, consistency and applicability. Thirty-two RCTs were reviewed. Four (12.5%) piloted the intervention without using dose-escalation designs to determine optimal dose-response. Twenty (62.5%) reported no evidence underpinning dose. Where reported, quality, consistency and applicability of the underpinning evidence was a cause for methodological concern. The majority of RCTs did not report the evidence underpinning dose. When reported, the evidence was often not applicable to the clinical population. Frequently, the dose used differed to the dose reported/recommended by the underpinning evidence. Our findings illustrate exercise dose may not be optimised for use with clinical populations prior to evaluation by RCT.

Background: Bayesian adaptive designs can be more efficient than traditional methods for multi-arm randomised controlled trials. The aim of this work was to demonstrate how Bayesian adaptive designs can be constructed for multi-arm phase III clinical trials and assess potential benefits that these designs offer. Methods: We constructed several alternative Bayesian adaptive designs for the Collaborative Ankle Support Trial (CAST), which was a randomised controlled trial that compared four treatments for severe ankle sprain. These designs incorporated response adaptive randomisation (RAR), arm dropping, and early stopping for efficacy or futility. We studied the operating characteristics of the Bayesian designs via simulation. We then virtually re-executed the trial by implementing the Bayesian adaptive designs using patient data sampled from the CAST study to demonstrate the practical applicability of the designs. Results: We constructed five Bayesian adaptive designs, each of which had high power and recruited fewer patients on average than the original designs target sample size. The virtual executions showed that most of the Bayesian designs would have led to trials that declared superiority of one of the interventions over the control. Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis. Similar estimates and conclusions were obtained from the Bayesian adaptive designs as from the original trial. Conclusions: Using CAST as an example, this case study shows how Bayesian adaptive designs can be constructed for phase III multi-arm trials using clinically relevant decision criteria. These designs demonstrated that they can potentially generate earlier results and allocate more patients to better performing arms. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. Trial registration: CAST study registration ISRCTN, ISRCTN37807450. Retrospectively registered on 25 April 2003.

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.

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.

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.

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.

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.

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.

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.

INTRODUCTION: Musculoskeletal pain is a prevalent health challenge for all age groups worldwide, but most notably in older adults. Social isolation is the consequence of a decrease in social network size with a reduction in the number of social contacts. Loneliness is the psychological embodiment of social isolation and represents an individual's perception of dissatisfaction in the quality or quantity of their social contacts. This study aims to determine whether a relationship exists between musculoskeletal pain and social isolation and loneliness. METHODS: a cross-sectional analysis of the English Longitudinal Study of Ageing (ELSA) cohort was undertaken. ELSA is a nationally representative sample of the non-institutionalised population of individuals aged 50 years and over based in England. Data were gathered on social isolation through the ELSA Social Isolation Index, loneliness through the University of California, Los Angeles (UCLA) Loneliness Scale and musculoskeletal pain. Data for covariates included physical activity, depression score, socioeconomic status, access to transport and demographic characteristics. Logistic regression analyses were undertaken to determine the relationship between social isolation and loneliness with pain and the additional covariates. RESULTS: a total of 9299 participants were included in the analysis. This included 4125 (44.4%) males, with a mean age of 65.8 years. There was a significant association where social isolation was lower for those in pain (odd ratio (OR): 0.87; 95% confidence intervals (CI): 0.75 to 0.99), whereas the converse occurred for loneliness where this was higher for those in pain (OR: 1.15; 95% CI: 1.01 to 1.31). Age, occupation, physical activity and depression were all associated with increased social isolation and loneliness. CONCLUSION: People who experience chronic musculoskeletal pain are at greater risk of being lonely, but at less risk of being socially isolated. Health professionals should consider the wider implications of musculoskeletal pain on individuals, to reduce the risk of negative health implications associated with loneliness from impacting on individual's health and well-being.

Introduction: International clinical guidelines for Complex Regional Pain Syndrome recommend a wide range and variation of rehabilitation therapies as the core treatment. It is likely that most therapists employ a range of approaches when managing people with Complex Regional Pain Syndrome but a recent Cochrane review identified little evidence relating to the effectiveness of multi-modal rehabilitation. There is need for up to date trials of rehabilitation for Complex Regional Pain Syndrome, but in order to develop a clear model of best practice that can be rigorously evaluated we need to understand current practice. Method: an electronic survey was disseminated internationally to clinicians involved in the rehabilitation of individuals with Complex Regional Pain Syndrome. The survey aimed to establish which criteria are used for diagnosis and which modalities clinicians use to treat Complex Regional Pain Syndrome and which they consider ineffective or harmful. Results: 132 valid responses were received. A third of participants did not use any established criteria to diagnose Complex Regional Pain Syndrome. Current practice commonly included patient education, encouragement of self-management, and physical exercises. Cortically directed treatments such as graded motor imagery and psychological approaches were often incorporated into treatment whereas pain provocative therapies, splinting, contrast bathing, and cold and heat therapy were rarely used in the acute or chronic phase of Complex Regional Pain Syndrome. Conclusion: a broad range of modalities are currently used in Complex Regional Pain Syndrome rehabilitation. Practice appears to be characterized by educational and exercise based interventions delivered in a pain-contingent manner which largely echoes recommendations in international clinical guidelines.Implications for Rehabilitation: Patients with Complex Regional Pain Syndrome suffer from a painful and disabling condition for which we still do not know the best treatment options. From our survey sample most clinicians use treatments recommended in the international guidelines. A large proportion of clinicians from our survey sample are not using internationally recognized diagnostic criteria and we therefore recommend that clinicians become familiar with these criteria and use them for all suspected Complex Regional Pain Syndrome cases.

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.

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.

Background: Rehabilitation approaches for people with rheumatoid arthritis include joint protection, exercises and self-management strategies. Health interventions delivered via the web have the potential to improve access to health services overcoming time constraints, physical limitations, and socioeconomic and geographic barriers. The objective of this review is to determine the effects of web-based rehabilitation interventions in adults with rheumatoid arthritis. Methods: Randomised controlled trials that compared web-based rehabilitation interventions with usual care, waiting list, no treatment or another web-based intervention in adults with rheumatoid arthritis were included. The outcomes were pain, function, quality of life, self-efficacy, rheumatoid arthritis knowledge, physical activity and adverse effects. Methodological quality was assessed using the Cochrane Risk of Bias tool and quality of evidence with the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Six source documents from four trials (n = 567) focusing on self-management, health information or physical activity were identified. The effects of web-based rehabilitation interventions on pain, function, quality of life, self-efficacy, rheumatoid arthritis knowledge and physical activity are uncertain because of the very low quality of evidence mostly from small single trials. Adverse effects were not reported. Conclusion: Large, well-designed trials are needed to evaluate the clinical and cost-effectiveness of web-based rehabilitation interventions in rheumatoid arthritis.

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.

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.

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.

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.

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.

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.

Introduction Healthcare researchers designing strength-based exercise interventions must choose an appropriate dose to test before evaluating its effect using a definitive/ phase-III randomised controlled trial (RCT). Compared with early phase testing employed by pharmaceutical trials, it is questionable whether exercise-based trials employ the same rigour for establishing tolerated dosage. Consequently, it is unclear if participants are initially prescribed optimal doses of exercise, which may potentially impact on study outcomes. Using trials of strength-based exercise interventions in adults with rheumatoid arthritis (RA) as an exemplar, the aims of this review are to (1) identify the proportion of RCTs that use phase I/II trials with dose escalation methodology for setting prescription parameters, (2) determine type and level of evidence used to justify prescription parameters of strength-based exercise interventions evaluated by RCTs, (3) explore consistency and applicability of the evidence underpinning prescription parameters in RCTs and (4) explore if a relationship exists between risk of bias for RCTs evaluating strength-based interventions and the level of evidence used to underpin prescription parameters. Methods and analysis Focusing on RCT’s evaluating strength-based exercise interventions in adults with RA published after 2000, the following databases will be searched: Allied and Complementary Medicine Database, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica Database, Medline and Physiotherapy Evidence Database. For each RCT, we will identify the evidence used to underpin prescription parameters. Both trial and underpinning evidence will have key information about the intervention extracted using the template for intervention description and replication checklist. Risk of bias will be assessed according to Cochrane. Levels of evidence will be assessed against the Oxford Centre for Evidence-Based Medicine and relationships between RCT and underpinning evidence explored and described narratively. Two independent assessors will be involved throughout data selection and extraction with recourse to a third reviewer should agreement not be reached. Ethics and dissemination No ethical issues are identified. Dissemination will be via publication. PrOsPErO registration number CRD42018090963.

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.

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.

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.

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.

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.

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).

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.

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.

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

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.

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.

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.

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.

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-.

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.

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.

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].

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.

PURPOSE: the objective of this study was to evaluate the reproducibility of the cervical range of motion device when measuring both active and passive range of motion in a group of individuals with sub-acute Whiplash Associated Disorders (WAD). METHODS: Participants were recruited as part of a large multi-centre Randomised Controlled Trial from UK emergency departments. Experienced research physiotherapists measured active and passive cervical spine movements in all directions. Both intra- and inter-observer reliability and agreement were assessed using the intra-class correlation coefficient, standard error of measurement and limits of agreement methods. RESULTS: Different groups of 39 and 19 subjects were included in the intra and inter-observer studies, respectively. The CROM device demonstrated substantial intra- and inter-observer reliability and agreement for all the active and passive half-cycle movements (ICC range 0.82-0.99) with the exception of one (passive right lateral flexion for inter-observer; ICC 0.77). CONCLUSIONS: the CROM device has proven to be a reproducible measurement method for a symptomatic WAD population using the measurement protocol described and can be used with confidence to differentiate individuals according to a single measurement.

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.

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.

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.

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.

This study aimed to identify current NHS physiotherapy practice following first time lumbar discectomy in the United Kingdom (UK) in order to inform future research priorities and design. Descriptive survey methodology was utilised employing a postal questionnaire. A total population sample was identified and questionnaires were posted to 87 NHS physiotherapy departments throughout the UK. Participants were senior physiotherapists working with spinal surgery patients. In the inpatient phase, the majority of patients receive physiotherapy. Management focused on mobility and education to facilitate early discharge with most patients being given exercises. However, there was a wide variation in the actual exercises prescribed. There was more variation in the provision of outpatient physiotherapy treatment. Not all patients have access to physiotherapy treatment post discharge in the UK and when treatment was available the content and amount was variable. There is evidence to support rehabilitation classes to assist early improvements in function and return to work but such classes are only available in around half of the centres involved in this study. Regarding the content of exercise classes and individual treatment sessions, a wide range of clinical practice was evident. This study raises many research questions and highlights the need for future research to optimise patient rehabilitation following first time lumbar discectomy.

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.

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.