Journal articles
Ball S, McAndrew A, Aylward A, Cockcroft E, Gordon E, Kerridge A, Morgan-Trimmer S, Powell R, Price A, Rhodes S, et al (In Press). Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard. lateral approach: HemiSPAIRE.
TrialsAbstract:
Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard. lateral approach: HemiSPAIRE
Background: the HemiSPAIRE trial is being conducted to determine whether a modified
muscle sparing technique (SPAIRE - “Save Piriformis and Internus, Repairing Externus”) in
hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in
adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes
the detailed statistical analysis plan for the trial.
Methods and design: HemiSPAIRE is a definitive, pragmatic, superiority, multicentre,
randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward
staff and all research staff involved in post-operative assessments are blinded to allocation.
This article describes in detail (1) the primary and secondary outcomes, (2) the statistical
analysis principles, including: a survivor average causal effect (SACE) method chosen
specifically to address the issue of potential bias from differential survival between trial arms,
which was seen from data review by the Trial Steering Committee; the participants that will be
included in each analysis; the covariates that will be included in each analysis, and how the
results will be presented, (3) planned main analysis of the primary outcome; (4) planned
analyses of the secondary outcomes, (5) planned additional analyses of the primary and
secondary outcomes.
Abstract.
Clare L, Kudlicka A, Oyebode JR, Jones RW, Bayer A, Leroi I, Kopelman M, James IA, Culverwell A, Pool J, et al (In Press). Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer’s and related dementias: a multi-centre single-blind randomised controlled Trial (GREAT). Health Technology Assessment
Chestnutt IG, Hutchings S, Playle R, Morgan-Trimmer SA, Fitzsimmons D, Aawar N, Angel L, Derrick S, Drew C, Hoddell C, et al (In Press). Seal or Varnish? a randomised controlled trial to determine the relative cost and effectiveness of pit and fissure sealant and fluoride varnish in preventing dental decay. Health Technology Assessment
Alzehr A, Hulme C, Spencer A, Morgan-Trimmer S (In Press). The Economic Impact of Cancer Diagnosis to Individuals and Their Families: a Systematic Review.
Supportive Care in CancerAbstract:
The Economic Impact of Cancer Diagnosis to Individuals and Their Families: a Systematic Review
Background: the effect of a cancer diagnosis is wide ranging with the potential to affect income, employment and risk of poverty. The aim of this systematic review is to identify the economic impact of a cancer diagnosis for patients and their families/caregivers.
Methods: the search covered peer-reviewed journals using MEDLINE, EMBASE, CINAHL, Cochrane Library, Epistemonikos and PsycINFO databases. Quality appraisal was undertaken using CASP tools. Monetary values were converted to US Dollars/2019 using a purchasing power parities (PPP) conversion factor. The review included articles up to and including January 2020, written in English language, for patients with cancer aged ≥18 years and focused on the costs up to five years following a cancer diagnosis.
Results: the search was run in January 2020 and updated in November 2021. of 7973 articles identified, 18 met the inclusion criteria. Studies were undertaken in the USA, Ireland, Canada, Australia, France, UK, Malaysia, Pakistan, China and Sri Lanka. The majority were cohort studies. Twelve reported out-of-pocket costs (range US$16–US$2,523/month per patient/caregiver) consisting of medical expenses (e.g. surgery, radiotherapy and chemotherapy) and non-medical expenses (e.g. travel, food and childcare). Fourteen studies reported patient/caregiver loss of income and lost productivity (range 14–57.8%).
Conclusions: a high percentage of cancer patients and their families/caregivers experience out-of-pocket expenditure, loss of income and lost productivity. Future research is needed to observe the effects of continuing changes to healthcare policies and social protections on the economic burden among cancer patients and their families/caregivers.
Abstract.
Poltawski L, Van Beurden S, Morgan-Trimmer S, Greaves C (In Press). The dynamics of decision-making in weight loss and maintenance: a qualitative enquiry. BMC Public Health
Raghuraman S, Richards E, Morgan-Trimmer S, Clare L, Anderson R, Goodwin V, Allan L (2023). 1354 USING REALIST PROGRAMME THEORY TO DESIGN a NEW INTERVENTION FOR IMPROVING RECOVERY AFTER DELIRIUM. Age and Ageing, 52(Supplement_1).
Allan L, O'Connell A, Raghuraman S, Bingham A, Laverick A, Chandler K, Connors J, Jones B, Um J, Morgan-Trimmer S, et al (2023). A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study.
Pilot Feasibility Stud,
9(1).
Abstract:
A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study.
BACKGROUND: Delirium affects over 20% of all hospitalised older adults. Delirium is associated with a number of adverse outcomes following hospital admission including cognitive decline, anxiety and depression, increased mortality and care needs. Previous research has addressed prevention of delirium in hospitals and care homes, and there are guidelines on short-term treatment of delirium during admission. However, no studies have addressed the problem of longer-term recovery after delirium and it is currently unknown whether interventions to improve recovery after delirium are effective and cost-effective. The primary objective of this feasibility study is to test a new, theory-informed rehabilitation intervention (RecoverED) in older adults delivered following a hospital admission complicated by delirium to determine whether (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible. METHODS: the study is a multi-centre, single-arm feasibility study of a rehabilitation intervention with an embedded process evaluation. Sixty participants with delirium (aged > 65 years old) and carer pairs will be recruited from six NHS acute hospitals across the UK. All pairs will be offered the intervention, with follow-up assessments conducted at 3 months and 6 months post-discharge home. The intervention will be delivered in participants' own homes by therapists and rehabilitation support workers for up to 10 intervention sessions over 12 weeks. The intervention will be tailored to individual needs, and the chosen intervention plan and goals will be discussed and agreed with participants and carers. Quantitative data on reach, retention, fidelity and dose will be collected and summarised using descriptive statistics. The feasibility outcomes that will be used to determine whether the study meets the criteria for progression to a definitive randomised controlled trial (RCT) include recruitment, delivery of the intervention, retention, data collection and acceptability of outcome measures. Acceptability of the intervention will be assessed using in-depth, semi-structured qualitative interviews with participants and healthcare professionals. DISCUSSION: Findings will inform the design of a pragmatic multi-centre RCT of the effectiveness and cost-effectiveness of the RecoverED intervention for helping the longer-term recovery of people with delirium compared to usual care. TRIAL REGISTRATION: the feasibility study was registered: ISRCTN15676570.
Abstract.
Author URL.
Wheat H, Weston L, Oh TM, Morgan-Trimmer S, Ingram W, Griffiths S, Sheaff R, Clarkson P, Medina-Lara A, Musicha C, et al (2023). Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.
BJGP Open,
7(3).
Abstract:
Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.
BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: a realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: the realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.
Abstract.
Author URL.
Whitfield E, Parnell Johnson S, Higgs P, Martin W, Morgan-Trimmer S, Burton A, Poppe M, Cooper C (2023). Nature as a 'Lifeline': the Power of Photography when Exploring the Experiences of Older Adults living with Memory Loss and Memory Concerns.
GerontologistAbstract:
Nature as a 'Lifeline': the Power of Photography when Exploring the Experiences of Older Adults living with Memory Loss and Memory Concerns.
The visual is an underutilised modality through which to investigate experiences of memory loss in older people. We describe a visual ethnography with older adults experiencing subjective or objective memory loss, receiving a cognitive wellbeing group intervention designed to prevent cognitive decline and dementia (APPLE-Tree programme). We aimed to explore lived experiences of people with memory concerns, how participants engaged with this photography and co-design project, and how collaboration with an artist/photographer enhanced this process. Nineteen participants shared photographs reflecting what they valued in their daily lives, their experiences of memory concerns, and the intervention. Fourteen participated in qualitative photo-elicitation interviews, and thirteen collaborated with a professional artist/photographer to co-create an exhibition, in individual meetings and workshops, during which a researcher took ethnographic field notes. Eight participants were re-interviewed after the exhibition launch. We contextualise images produced by participants in relation to discourses around the visual and ageing and highlight their relationship with themes developed through thematic analysis that interconnects photographic, observational and interview data. We present themes around the use of photographs to: (1) celebrate connections to nature as a lifeline; (2) anchor lives within the context of relationships with family; (3) reflect on self and identity, enduring through ageing, memory concerns, pandemic, and ageing stereotypes. We explore visual research as a powerful tool for eliciting meaningful accounts from older adults experiencing cognitive change and to connect the arts and social sciences within ageing studies.
Abstract.
Author URL.
Wheat H, Griffiths S, Gude A, Weston L, Quinn C, Morgan-Trimmer S, Oh TM, Musicha C, Greene L, Clark M, et al (2023). Practitioners’ ability to remotely develop understanding for personalised care and support planning: a thematic analysis of multiple data sources from the feasibility phase of the Dementia Personalised Care Team (D-PACT) intervention.
Dementia,
22(7), 1461-1486.
Abstract:
Practitioners’ ability to remotely develop understanding for personalised care and support planning: a thematic analysis of multiple data sources from the feasibility phase of the Dementia Personalised Care Team (D-PACT) intervention
Practitioner understanding of patients’ preferences, wishes and needs is essential for personalised health care i.e. focusing on ‘what matters’ to people based on their individual life situation. To develop such an understanding, dementia practitioners need to use communication practices that help people share their experiences, preferences, and priorities. Following the COVID-19 pandemic, dementia support is likely to continue to be delivered both remotely and in-person. This study analysed multiple sources of qualitative data to examine the views of practitioners, people living with dementia and carers, and researchers on how an understanding of what matters to people living with dementia can be developed remotely via telephone and video call. Access to environmental stimuli, the remote use of visual tools, peoples’ tendency to downplay or omit details about their troubles and carers’ ability to disclose privately were interpreted, through thematic analysis, to be factors affecting how practitioners sought to develop understanding remotely. Cumulatively, findings show that while remote support created unique challenges to practitioners’ ability to develop understanding for personalised care, practitioners developed adaptive strategies to overcome some of these challenges. Further research should examine how, when and for whom these adapted practices for remote personalised care work, informing the development of evidence-based guidance and training on how practitioners can remotely develop the understanding required for personalised care.
Abstract.
Alenezi S, Morgan-Trimmer S, Hulbert S, Young W, Goodwin VA (2023). “It's a lot more complicated than it seems”: physiotherapists' experiences of using compensation strategies in people with Parkinson's.
Frontiers in Rehabilitation Sciences,
4Abstract:
“It's a lot more complicated than it seems”: physiotherapists' experiences of using compensation strategies in people with Parkinson's
BackgroundGait disturbances often result in functional limitations in daily activities and negatively impact the quality of life in people with Parkinson's disease. Physiotherapists often employ compensation strategies in an attempt to improve patients' walking. However, little is known about physiotherapists' experiences in this regard. We evaluated how physiotherapists adopt compensation strategies and what they draw on to inform their clinical decision-making.MethodsWe carried out semi-structured online interviews with 13 physiotherapists with current or recent experience working with people with Parkinson's disease in the United Kingdom. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was utilized.ResultsTwo main themes were developed from the data. The first theme, optimizing compensation strategies through personalized care, shows how physiotherapists accounted for the individual needs and characteristics of people with Parkinson's, which resulted in them individually tailoring compensation strategies. The second theme, delivering compensation strategies effectively, considers the available support and perceived challenges with work settings and experience that impact physiotherapists' ability to deliver compensation strategies.DiscussionAlthough physiotherapists strived to optimize compensation strategies, there was a lack of formal training in this area, and their knowledge was primarily acquired from peers. Furthermore, a lack of specific knowledge on Parkinson's can impact physiotherapists’ confidence in maintaining person-centered rehabilitation. However, the question that remains to be answered is what accessible training could address the knowledge–practice gap to contribute to the delivery of better-personalized care for people with Parkinson's.
Abstract.
Wyman DL, Butler L, Bright P, Morgan-Trimmer S, Budgett J, Cooper C (2022). A systematic review of process evaluations for psychosocial interventions designed to improve the wellbeing and quality of life of community-dwelling people with dementia and their carers.
International Journal of Geriatric Psychiatry,
37(12).
Abstract:
A systematic review of process evaluations for psychosocial interventions designed to improve the wellbeing and quality of life of community-dwelling people with dementia and their carers
Background: Psychosocial interventions improve the wellbeing and quality of life of People Living with Dementia (PLWD) and their family carers; but due to their complexity it can be challenging to identify mechanisms of action. We reviewed process evaluations that have sought to elucidate how these interventions work, to inform their implementation. Method: We systematically reviewed process evaluations of studies evaluating psychosocial interventions for PLWD in their own home and/or their family carers. We rated study quality using the Mixed Methods Appraisal Tool. We described, with reference to Medical Research Council (2015) process evaluation guidance, how implementation, mechanisms of impact and contextual factors were investigated; and describe commonalities in the mechanisms of action identified across studies. Results: Twenty four included studies evaluated the processes of 22 interventions. These studies collectively applied five frameworks; almost all frameworks' advised evaluations were theory-based and used mixed-methods analyses, but only 5/24 evaluation designs were informed by the intervention theory and 8/24 used mixed methods. 8/24 evaluations considered contextual factors in their design, though 20/24 cited contextual factors in findings. Interventions were more successful where PLWD were motivated and aware of potential benefits, and when carers could support engagement and were themselves supported by the intervention. How the intervention aligned with participants' current needs and stage of dementia were key influencing factors. Conclusion: Knowing how interventions can influence change for community-dwelling people with dementia and their family carer's will improve translation of trial findings into practice. Robust, theory-driven process evaluations can enable this.
Abstract.
Griffiths S, Weston L, Morgan-Trimmer S, Wheat H, Gude A, Manger L, Oh TM, Clarkson P, Quinn C, Sheaff R, et al (2022). Engaging Stakeholders in Realist Programme Theory Building: Insights from the Prospective Phase of a Primary Care Dementia Support Study. International Journal of Qualitative Methods, 21
Wyman DL, Butler L, Cooper C, Bright P, Morgan-Trimmer S, Barber J (2022). Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol.
BMJ Open,
12(6).
Abstract:
Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol.
INTRODUCTION: New Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer's Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention's effectiveness. Findings will inform how the programme is implemented in practice. METHODS AND ANALYSIS: the process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level 'case studies', and a joint display for 'population' level analysis and interpretation. ETHICS AND DISSEMINATION: Ethical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer's Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy. TRIAL REGISTRATION NUMBER: ISRCTN11425138.
Abstract.
Author URL.
Poppe M, Duffy L, Marchant NL, Barber JA, Hunter R, Bass N, Minihane AM, Walters K, Higgs P, Rapaport P, et al (2022). The APPLE Tree programme: Active Prevention in People at risk of dementia through Lifestyle, bEhaviour change and Technology to build REsiliEnce—randomised controlled trial.
Trials,
23(1).
Abstract:
The APPLE Tree programme: Active Prevention in People at risk of dementia through Lifestyle, bEhaviour change and Technology to build REsiliEnce—randomised controlled trial
Abstract
. Background
. Large-scale trials of multidomain interventions show that modifying lifestyle and psychological risk factors can slow cognitive decline. We aim to determine if a lower intensity, personally tailored secondary dementia prevention programme for older people with subjective or mild objective memory decline, informed by behaviour change theory, reduces cognitive decline over 2 years.
.
. Methods
. A multi-site, single-blind randomised controlled trial recruiting 704 older adults at high dementia risk due to mild cognitive impairment (MCI) or subjective cognitive decline (SCD). Participants are randomised using 1:1 allocation ratio to the APPLE Tree intervention versus control arm (dementia prevention information), stratified by site. The intervention explores and implements strategies to promote healthy lifestyle, increase pleasurable activities and social connections and improve long-term condition self-management. Two facilitators trained and supervised by a clinical psychologist deliver ten, 1-h group video call sessions over 6 months (approximately every fortnight), video-call ‘tea breaks’ (less structured, facilitated social sessions) in intervening weeks and individual goal-setting phone calls every 2 weeks. From 6 to 12 months, participants meet monthly for ‘tea breaks’, with those not attending receiving monthly goal-setting phone calls. Participants receive a food delivery, pedometer and website access to cognitive training and information about lifestyle modification. Follow-ups for all outcome measures are at 12 and 24 months. The primary outcome is cognition (Neuropsychological Test Battery (NTB) score) at 24 months. Secondary outcomes are quality of life, cost per quality-adjusted life year (QALY) and wellbeing and lifestyle factors the intervention targets (diet, vascular risk, body weight, activity, sleep, anxiety, depression, social networks and loneliness, alcohol intake and smoking). Participants from purposively selected sites participate in qualitative process evaluation interviews, which will be analysed using thematic analytic methods.
.
. Discussion
. If effective, the intervention design, involving remote delivery and non-clinical facilitators, would facilitate intervention roll-out to older people with memory concerns.
.
. Trial registration
. ISRCTN17325135. Registration date 27 November 2019
.
Abstract.
Luscombe N, Morgan-Trimmer S, Savage S, Allan L (2021). Digital technologies to support people living with dementia in the care home setting to engage in meaningful occupations: protocol for a scoping review.
Syst Rev,
10(1).
Abstract:
Digital technologies to support people living with dementia in the care home setting to engage in meaningful occupations: protocol for a scoping review.
BACKGROUND: People living with all stages of dementia should have the opportunity to participate in meaningful occupations. For those living in care homes, this may not always occur and residents may spend significant parts of the day unengaged, especially those living with more advanced dementia. Digital technologies are increasingly being used in health care and could provide opportunities for people living with dementia (PLWD) in care homes to engage in meaningful occupations and support care staff to provide these activities. With technology advancing at a rapid rate, the objective of this scoping review is to provide an up-to-date systematic map of the research on the diverse range of digital technologies that support engagement in meaningful occupations. In particular, focus will be given to barriers and facilitators to inform future intervention design and implementation strategies, which have not yet been clearly mapped across the full range of these digital technologies. METHOD: a scoping review will be conducted to systematically search for published research using a comprehensive search strategy on thirteen databases. Published, peer-reviewed studies that focused on PLWD in the care home setting and assessed any form of digital technology that supported a meaningful occupation will be included. All methodologies which meet the criteria will be included. Data will be extracted and charted to report the range of digital technologies, underlying mechanisms of action, facilitators and barriers to implementation. DISCUSSION: Mapping the range of technologies to support PLWD to engage in meaningful occupations will identify gaps in research. The systematic search will include a diverse range of technologies such as software to enhance care planning, tablets devices, smartphones, communication robots and social media platforms, rather than focussing on a specific design or interface. This will enable comparison between mechanisms of action, barriers and facilitators to implementation which will be useful for future research and intervention design. TRIAL REGISTRATION: Open Science Framework https://doi.org/10.17605/OSF.IO/7UDM2.
Abstract.
Author URL.
Price A, Ball S, Rhodes S, Wickins R, Gordon E, Aylward A, Cockcroft E, Morgan-Trimmer S, Powell R, Timperley J, et al (2021). Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial.
BMJ Open,
11(6), e045652-e045652.
Abstract:
Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial
IntroductionCurrently National Institute for Health and Care Excellence clinical guidelines in the UK suggest that surgeons performing partial hip replacements (hemiarthroplasty) should consider using the lateral approach. Alternatively, a newer, modified posterior approach using a muscle sparing technique named ‘Save Piriformis and Internus, Repairing Externus’ (SPAIRE) can be used leaving the major muscles intact. This randomised controlled trial (RCT) aims to compare the SPAIRE approach to the standard lateral approach, to determine if it allows patients to mobilise better and experience improved function after surgery.Methods and analysisHemiSPAIRE is a two-arm, assessor-blinded, definitive pragmatic RCT with nested pilot and qualitative studies. Two hundred and twenty-eight participants with displaced intracapsular fractures requiring hip hemiarthroplasty will be individually randomised 1:1 to either the SPAIRE, or control (standard lateral approach) surgical procedure. Outcomes will be assessed at postoperative day 3 (POD3) and 120 (POD120). The primary outcome measure will be level of function and mobility using the Oxford Hip Score at POD120. Secondary outcomes include: De Morton Mobility Index (DEMMI), Cumulated Ambulatory Score and Numeric Pain Rating Scale (NPRS) at POD3; DEMMI, NPRS and EQ-5D-5L at POD120, complications, acute and total length of hospital stay, and mortality. Primary analysis will be on an intention-to-treat basis. Participant experiences of the impact of surgery and recovery period will be examined via up to 20 semi-structured telephone interviews.Ethics and disseminationThe protocol has been approved by Yorkshire and the Humber—Bradford Leeds Research Ethics Committee. Recruitment commenced in November 2019. Findings will be disseminated via research articles in peer-reviewed journals, presentations at conferences, public involvement events, patient groups and media releases. A summary of the trial findings will be shared with participants at the end of the study.Trial registration numberNCT04095611.
Abstract.
Morgan-Trimmer S, Kudlicka A, Warmoth K, Leroi I, Oyebode JR, Pool J, Woods R, Clare L (2021). Implementation processes in a cognitive rehabilitation intervention for people with dementia: a complexity-informed qualitative analysis.
BMJ Open,
11(10), e051255-e051255.
Abstract:
Implementation processes in a cognitive rehabilitation intervention for people with dementia: a complexity-informed qualitative analysis
ObjectivesHealthcare is often delivered through complex interventions. Understanding how to implement these successfully is important for optimising services. This article demonstrates how the complexity theory concept of ‘self-organisation’ can inform implementation, drawing on a process evaluation within a randomised controlled trial of the GREAT (Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer’s and related dementias: a multi-centre single-blind randomised controlled Trial) intervention which compared a cognitive rehabilitation intervention for people with dementia with usual treatment.DesignA process evaluation examined experiences of GREAT therapists and participants receiving the intervention, through thematic analysis of a focus group with therapists and interviews with participants and their carers. Therapy records of participants receiving the intervention were also analysed using adapted framework analysis. Analysis adopted a critical realist perspective and a deductive-inductive approach to identify patterns in how the intervention operated.SettingThe GREAT intervention was delivered through home visits by therapists, in eight regions in the UK.ParticipantsSix therapists took part in a focus group, interviews were conducted with 25 participants and 26 carers, and therapy logs for 50 participants were analysed.InterventionA 16-week cognitive rehabilitation programme for people with mild-to-moderate dementia.Results‘Self-organisation’ of the intervention occurred through adaptations made by therapists. Adaptations included simplifying the intervention for people with greater cognitive impairment, and extending it to meet additional needs. Relational work by therapists produced an emergent outcome of ‘social support’. Self-organised aspects of the intervention were less visible than formal components, but were important aspects of how it operated during the trial. This understanding can help to inform future implementation.ConclusionsResearchers are increasingly adopting complexity theory to understand interventions. This study extends the application of complexity theory by demonstrating how ‘self-organisation’ was a useful concept for understanding aspects of the intervention that would have been missed by focusing on formal intervention components. Analysis of self-organisation could enhance future process evaluations and implementation studies.Trial registration numberISRCTN21027481.
Abstract.
Cooper C, Mansour H, Carter C, Rapaport P, Morgan-Trimmer S, Marchant NL, Poppe M, Higgs P, Brierley J, Solomon N, et al (2021). Social connectedness and dementia prevention: Pilot of the APPLE-Tree video-call intervention during the Covid-19 pandemic.
Dementia (London),
20(8), 2779-2801.
Abstract:
Social connectedness and dementia prevention: Pilot of the APPLE-Tree video-call intervention during the Covid-19 pandemic.
BACKGROUND AND OBJECTIVES: the Covid-19 pandemic reduced access to social activities and routine health care that are central to dementia prevention. We developed a group-based, video-call, cognitive well-being intervention; and investigated its acceptability and feasibility; exploring through participants' accounts how the intervention was experienced and used in the pandemic context. RESEARCH DESIGN AND METHOD: We recruited adults aged 60+ years with memory concerns (without dementia). Participants completed baseline assessments and qualitative interviews/focus groups before and after the 10-week intervention. Qualitative interview data and facilitator notes were integrated in a thematic analysis. RESULTS: 12/17 participants approached completed baseline assessments, attended 100/120 (83.3%) intervention sessions and met 140/170 (82.4%) of goals set. Most had not used video calling before. In the thematic analysis, our overarching theme was social connectedness. Three sub-themes were as follows: Retaining independence and social connectedness: social connectedness could not be at the expense of independence; Adapting social connectedness in the pandemic: participants strived to compensate for previous social connectedness as the pandemic reduced support networks; Managing social connections within and through the intervention: although there were tensions, for example, between sharing of achievements feeling supportive and competitive, participants engaged with various lifestyle changes; social connections supported group attendance and implementation of lifestyle changes. DISCUSSION AND IMPLICATIONS: Our intervention was acceptable and feasible to deliver by group video-call. We argue that dementia prevention is both an individual and societal concern. For more vulnerable populations, messages that lifestyle change can help memory should be communicated alongside supportive, relational approaches to enabling lifestyle changes.
Abstract.
Author URL.
Poppe M, Mansour H, Rapaport P, Palomo M, Burton A, Morgan-Trimmer S, Carter C, Roche M, Higgs P, Walker Z, et al (2020). "Falling through the cracks"; Stakeholders' views around the concept and diagnosis of mild cognitive impairment and their understanding of dementia prevention.
Int J Geriatr Psychiatry,
35(11), 1349-1357.
Abstract:
"Falling through the cracks"; Stakeholders' views around the concept and diagnosis of mild cognitive impairment and their understanding of dementia prevention.
OBJECTIVES: Many people live with an awareness of mild cognitive changes that increase their dementia risk. Previous authors describe the uncertainties of this liminal state, between cognitive health and dementia, where being "at risk" can itself be an illness. We ask how services respond to people with memory concerns currently, and how a future, effective and inclusive dementia prevention intervention might be structured for people with memory concerns. METHODS/DESIGN: We conducted qualitative interviews with 18 people aged 60+ years with subjective or objective memory problems, six family members, 10 health and social care professionals and 11 third sector workers. Interviews were audio-recorded, transcribed and analysed using an inductive thematic approach. RESULTS: Three main themes were identified: (1) acknowledging the liminal state, compounded by current, discordant health service responses: medicalising memory concerns yet situating responsibilities for their management with patients and families; (2) enabling change in challenging contexts of physical and cognitive frailty and social disengagement and (3) building on existing values, cultures and routines. CONCLUSIONS: Effective dementia prevention must empower individuals to make lifestyle changes within challenging contexts. Programmes must be evidence based yet sufficiently flexible to allow new activities to be fitted into people's current lives; and mindful of the risks of pathologising memory concerns. Most current memory services are neither commissioned, financially or clinically resourced to support people with memory concerns without dementia. Effective, large scale dementia prevention will require a broad societal response.
Abstract.
Author URL.
Cooper C, Aguirre E, Barber JA, Bass N, Brodaty H, Burton A, Higgs P, Hunter R, Huntley J, Lang I, et al (2020). APPLE-Tree (Active Prevention in People at risk of dementia: Lifestyle, bEhaviour change and Technology to REducE cognitive and functional decline) programme: Protocol.
Int J Geriatr Psychiatry,
35(8), 811-819.
Abstract:
APPLE-Tree (Active Prevention in People at risk of dementia: Lifestyle, bEhaviour change and Technology to REducE cognitive and functional decline) programme: Protocol.
BACKGROUND: Observational studies indicate that approximately a third of dementia cases are attributable to modifiable cardiometabolic, physical and mental health, and social and lifestyle risk factors. There is evidence that intensive behaviour change interventions targeting these factors can reduce cognitive decline. [Figure: see text] METHODS AND ANALYSIS: We will design and test a low intensity, secondary dementia-prevention programme (Active Prevention in People at risk of dementia: Lifestyle, bEhaviour change and Technology to REducE cognitive and functional decline, "APPLE-Tree") to slow cognitive decline in people with subjective cognitive decline with or without objective cognitive impairment. We will embed our work within social science research to understand how dementia prevention is currently delivered and structured. We will carry out systematic reviews and around 50 qualitative interviews with stakeholders, using findings to coproduce the APPLE-Tree intervention. We plan a 10-session group intervention, involving personalised goal-setting, with individual sessions for those unable or unwilling to attend groups, delivered by psychology assistants who will be trained and supervised by clinical psychologists. The coproduction group (including public and patient involvement [PPI], academic and clinical/third-sector professional representatives) will use the Behaviour Change Wheel theoretical framework to develop it. We will recruit and randomly allocate 704 participants, 1:1 to the intervention: informational control group. This sample size is sufficient to detect a between-group difference at 2 years of 0.15 on the primary outcome (cognition: modified neuropsychological test battery; 90% power, 5% significance, effect size 0.25, SD 0.6). DISSEMINATION: We will work with Public Health England and third-sector partners to produce an effective national implementation approach, so that if our intervention works, it is used in practice.
Abstract.
Author URL.
Simpson SA, Matthews L, Pugmire J, McConnachie A, McIntosh E, Coulman E, Hughes K, Kelson M, Morgan-Trimmer S, Murphy S, et al (2020). An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.
Pilot Feasibility Stud,
6Abstract:
An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.
BACKGROUND: Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. METHODS: the intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet. RESULTS: One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count (p = 0.098; 1187 steps [- 180, 2555])) and sedentary time (p = 0.022; - 60.8 min [- 110.5, - 11.0]). However, these outcomes were poorly completed. CONCLUSIONS: the study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. TRIAL REGISTRATION: ISRCTN, ISRCTN85615983. Registered 25 September 2014.
Abstract.
Author URL.
Simpson SA, Matthews L, Pugmire J, McConnachie A, McIntosh E, Coulman E, Hughes K, Kelson M, Morgan-Trimmer S, Murphy S, et al (2020). An app-, web- and social support-based weight loss intervention for adults with obesity: the HelpMeDoIt! feasibility RCT.
Public Health Research,
8(3), 1-270.
Abstract:
An app-, web- and social support-based weight loss intervention for adults with obesity: the HelpMeDoIt! feasibility RCT
. Background
. Finding solutions to rising levels of obesity continues to be a major public health focus. Social support has an important role in successful weight loss, and digital interventions can reach a large proportion of the population at low cost.
.
.
. Objective
. To develop and assess the feasibility and acceptability of an application (app), web- and social support-based intervention in supporting adults with obesity to achieve weight loss goals.
.
.
. Design
. Stage 1 – intervention development phase involved three focus groups (n = 10) with users, and think-aloud interviews and field testing with another group (n = 28). Stage 2 – the intervention and evaluation methods were explored in a feasibility randomised controlled trial with economic and process evaluation.
.
.
. Setting
. Greater Glasgow and Clyde, UK.
.
.
. Participants
. Adults with a body mass index of ≥ 30kg/m2 who owned a smartphone and were interested in losing weight were randomised 2 : 1 (intervention : control) and followed up at 12 months. Recruitment took place in April–October 2016.
.
.
. Interventions
. The intervention group had access to HelpMeDoIt! for 12 months. This encouraged them to (1) set goals, (2) monitor progress and (3) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet.
.
.
. Main outcome measures
. Data from stage 1 informed the intervention design. Key measures in stage 2 assessed the feasibility and acceptability of the intervention and trial methods against prespecified progression criteria. Three primary outcomes were explored: body mass index, diet and physical activity. Secondary outcomes included weight, waist and hip circumference, social support, self-efficacy, motivation, mental health, health-related quality of life, NHS resource use, participant-borne costs and intervention costs. Qualitative interviews with participants (n = 26) and helpers (n = 9) explored the feasibility and acceptability of the trial methods and intervention.
.
.
. Results
. Stage 1 produced (1) a website that provided evidence-based information for lifestyle change and harnessing social support, and (2) an app that facilitated goal-setting, self-monitoring and supportive interaction between participants and their helper(s). Progression criteria were met, demonstrating that the intervention and trial methods were feasible and acceptable. A total of 109 participants (intervention, n = 73; control, n = 36) were recruited, with 84 participants (77%: intervention, 71%; control, 89%) followed up at 12 months. Data were successfully collected for most outcome measures (≥ 82% completion). Participants and helpers were generally positive, although helper engagement with the app was low. of the 54 (74%) participants who downloaded the app, 48 (89%) used it twice or more, 28 helpers enrolled via the app, and 19 (36%) participants interacted with their helper(s) via the app. Interview data indicated that HelpMeDoIt! prompted support from helpers that often occurred without the helpers using the app.
.
.
. Limitations
. Early technical problems meant that some participants and helpers had difficulty accessing the app. Ethical constraints meant that we were unable to contact helpers directly for interview.
.
.
. Conclusions
. The HelpMeDoIt! study demonstrated that a weight loss intervention delivered via an app and a website is feasible and acceptable. Progression criteria were met, supporting further evaluation of the intervention.
.
.
. Future work
. To further explore (1) the motivation and engagement of helpers, (2) the programme theory and (3) the effectiveness and cost-effectiveness of the intervention.
.
.
. Trial registration
. Current Controlled Trials ISRCTN85615983.
.
.
. Funding
. This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 3. See the NIHR Journals Library website for further project information.
.
Abstract.
Mansour H, Whitty E, Aguirre E, Palomo M, Charlesworth G, Ramjee S, Poppe M, Brodaty H, Kales HC, Morgan‐Trimmer S, et al (2020). Effectiveness of lifestyle and psychosocial interventions in reducing cognitive decline in older people: Systematic review. Alzheimer's & Dementia, 16(S7).
Whitty E, Mansour H, Aguirre E, Palomo M, Charlesworth G, Ramjee S, Poppe M, Brodaty H, Kales HC, Morgan-Trimmer S, et al (2020). Efficacy of lifestyle and psychosocial interventions in reducing cognitive decline in older people: Systematic review.
Ageing Res Rev,
62Abstract:
Efficacy of lifestyle and psychosocial interventions in reducing cognitive decline in older people: Systematic review.
It is unclear what non-pharmacological interventions to prevent cognitive decline should comprise. We systematically reviewed lifestyle and psychosocial interventions that aimed to reduce cognitive decline in healthy people aged 50+, and people of any age with Subjective Cognitive Decline or Mild Cognitive Impairment. We narratively synthesised evidence, prioritising results from studies rated as at lower Risk of Bias (ROB) and assigning Centre for Evidence Based Medicine grades. We included 64 papers, describing: psychosocial (n = 12), multi-domain (n = 10), exercise (n = 36), and dietary (n = 6) interventions. We found Grade a evidence that over 4+ months: aerobic exercise twice weekly had a moderate effect on global cognition in people with/ without MCI; and interventions that integrate cognitive and motor challenges (e.g. dance, dumb bell training) had small to moderate effects on memory or global cognition in people with MCI. We found Grade B evidence that 4+ months of creative art or story-telling groups in people with MCI; 6 months of resistance training in people with MCI and a two-year, dietary, exercise, cognitive training and social intervention in people with or without MCI had small, positive effects on global cognition. Effects for some intervention remained up to a year beyond facilitated sessions.
Abstract.
Author URL.
O’Rourke G, Parker D, Anderson R, Morgan-Trimmer S, Allan L (2020). Interventions to support recovery following an episode of delirium: a realist synthesis. Aging & Mental Health, 25(10), 1769-1785.
Warmoth K, Morgan-Trimmer S, Kudlicka A, Toms G, James IA, Woods B (2020). Reflections on a personalized cognitive rehabilitation intervention: Experiences of people living with dementia and their carers participating in the GREAT trial. Neuropsychological Rehabilitation, 32(2), 268-286.
Poppe M, Mansour H, Rapaport P, Palomo M, Burton A, Morgan‐Trimmer S, Carter C, Roche M, Higgs P, Walker Z, et al (2020). Stakeholders’ views around the concept and diagnosis of mild cognitive impairment and their understanding of dementia prevention: a qualitative study. Alzheimer's & Dementia, 16(S7).
Bleiker J, Knapp K, Morgan-Trimmer S, Hopkins S (2020). What Medical Imaging Professionals Talk About When They Talk About Compassion. Journal of Medical Imaging and Radiation Sciences, 51(4), S44-S52.
Borek AJ, Smith JR, Greaves CJ, Gillison F, Tarrant M, Morgan-Trimmer SA, McCabe R, Abraham SCS (2019). Developing and applying a framework to understand mechanisms of action in group-based, behaviour change interventions: the MAGI mixed-methods study.
Efficacy and Mechanism Evaluation,
6(3), 1-162.
Abstract:
Developing and applying a framework to understand mechanisms of action in group-based, behaviour change interventions: the MAGI mixed-methods study
Background
Theories and meta-analyses have elucidated individual-level mechanisms of action in behaviour change interventions. Although group-based interventions are commonly used to support health-related behaviour change, such interventions rarely consider theory and research (e.g. from social psychology) on how group-level mechanisms can also influence personal change.
Objectives
The aim was to enhance understanding of mechanisms of action in group-based behaviour change interventions. The objectives were to (1) develop a potentially generalisable framework of change processes in groups, (2) test the framework by analysing group session recordings to identify examples illustrating group processes and facilitation techniques and (3) explore links between group-level mechanisms and outcomes.
Data sources
In this mixed-methods study, the research team reviewed literature, conducted consultations and analysed secondary data (i.e. delivery materials and 46 audio-recordings of group sessions) from three group-based weight loss interventions targeting diet and physical activity: ‘Living Well Taking Control’ (LWTC), ‘Skills for weight loss Maintenance’ and ‘Waste the Waist’. Quantitative LWTC programme data on participant characteristics, attendance and outcomes (primarily weight loss) were also used.
Methods
Objectives were addressed in three stages. In stage 1, a framework of change processes in groups was developed by reviewing literature on groups (including theories, taxonomies of types of change techniques, qualitative studies and measures of group processes), analysing transcripts of 10 diverse group sessions and consulting with four group participants, four facilitators and 31 researchers. In stage 2, the framework was applied in analysing 28 further group sessions. In stage 3, group-level descriptive analyses of available quantitative data from 67 groups and in-depth qualitative analyses of two groups for which comprehensive quantitative and qualitative data were available were conducted to illustrate mixed-methods approaches for exploring links between group processes and outcomes.
Results
Stage 1 resulted in development of the ‘Mechanisms of Action in Group-based Interventions’ (MAGI) framework and definitions, encompassing group intervention design features, facilitation techniques, group dynamic and development processes, interpersonal change processes, selective intrapersonal change processes operating in groups, and contextual factors. In stage 2, a coding schema was developed, refined and applied to identify examples of framework components in group sessions, confirming the content validity of the framework for weight loss interventions. Stage 3 demonstrated considerable variability in group characteristics and outcomes and illustrated how the framework could be applied in integrating group-level qualitative and quantitative data to generate and test hypotheses about links between group mechanisms and outcomes (e.g. to identify features of more or less successful groups).
Limitations
The framework and examples were primarily derived from research on weight loss interventions, and may require adaptations/additions to ensure applicability to other types of groups. The mixed-methods analyses were limited by the availability and quality of the secondary data.
Conclusions
This study identified, defined, categorised into a framework and provided examples of group-level mechanisms that may influence behaviour change.
Future work
The framework and mixed-methods approaches developed provide a resource for designers, facilitators and evaluators to underpin future research on, and delivery of, group-based interventions.
Funding
This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership.
Abstract.
Borek AJ, Abraham SCS, Greaves CJ, Gillison F, Tarrant M, Morgan-Trimmer SA, McCabe R, Smith JR (2019). Identifying change processes in group-based health behaviour-change interventions: development of the mechanisms of action in group-based interventions (MAGI) framework.
Health Psychology ReviewAbstract:
Identifying change processes in group-based health behaviour-change interventions: development of the mechanisms of action in group-based interventions (MAGI) framework
Group-based interventions are widely used to promote health-related behaviour change. While processes operating in groups have been extensively described, it remains unclear how behaviour change is generated in group-based health-related behaviour-change interventions. Understanding how such interventions facilitate change is important to guide intervention design and process evaluations. We employed a mixed-methods approach to identify, map and define change processes operating in group-based behaviour-change interventions. We reviewed multidisciplinary literature on group dynamics, taxonomies of change technique categories, and measures of group processes. Using weight-loss groups as an exemplar, we also reviewed qualitative studies of participants’ experiences and coded transcripts of 38 group sessions from three weight-loss interventions. Finally, we consulted group participants, facilitators and researchers about our developing synthesis of findings. The resulting ‘Mechanisms of Action in Group-based Interventions’ (MAGI) framework comprises six overarching categories: (1) group intervention design features, (2) facilitation techniques, (3) group dynamic and development processes, (4) inter-personal change processes, (5) selective intra-personal change processes operating in groups, and (6) contextual influences. The framework provides theoretical explanations of how change occurs in group-based behaviour-change interventions and can be applied to optimise their design and delivery, and to guide evaluation, facilitator training and further research.
Abstract.
Bleiker J, Morgan-Trimmer S, Knapp K, Hopkins S (2019). Navigating the maze: Qualitative research methodologies and their philosophical foundations.
Radiography,
25, S4-S8.
Abstract:
Navigating the maze: Qualitative research methodologies and their philosophical foundations
Objectives: One of the three objectives of the Society and College of Radiographers is the promotion and dissemination of research in radiography and radiotherapy. This article aims to assist in the production of high standard research by explaining how transparency in reporting the underpinning philosophical basis of a qualitative study can be achieved in addition to the more customary descriptions of how data were collected and analysed. Key findings: Unlike their quantitative equivalent, qualitative research methodologies are less well understood and reported in radiography research, in particular the philosophical and epistemological assumptions which underpin the methods used. Conclusion: Demonstrating consistency between the philosophical position taken and the methods used within a study is an important aspect of research quality. Implications for practice: Qualitative research can offer valuable insights into the social, organisational, behavioural and interpersonal aspects of medical imaging practice. These may include wellbeing, attitudes, perceptions and beliefs, leadership, management practices, education, professionalism and a wide range of issues around patients' experiences during medical imaging. Patient care and outcomes can be positively impacted as a result of acquiring these insights.
Abstract.
Morgan-Trimmer S, Chadwick BL, Hutchings S, Scoble C, Lisles C, Drew CJ, Murphy S, Pickles T, Hood K, Chestnutt IG, et al (2019). The acceptability of fluoride varnish and fissure sealant treatments in children aged 6-9 delivered in a school setting.
Community Dent Health,
36(1), 33-38.
Abstract:
The acceptability of fluoride varnish and fissure sealant treatments in children aged 6-9 delivered in a school setting.
OBJECTIVE: to assess the acceptability of fluoride varnish and fissure sealant treatments for children. To investigate the acceptability of delivering this treatment in a school setting for children, parents, clinicians and school staff. BASIC RESEARCH DESIGN: Semi-structured interviews (with children, parents, clinicians and school staff) and a questionnaire (for school staff) as part of a two-arm, randomised clinical trial. PARTICIPANTS: Children aged 6-9, their parents, clinical staff and school staff. INTERVENTIONS: Fluoride varnish or fissure sealant was delivered to children from the ages of 6 to 9 years for 36 months, by a community dental service in a school setting. Fluoride varnish was re-applied every 6 months; fissure sealant was applied once to first permanent molars and re-applied as required. RESULTS: Interviews with children a few days after treatment indicated little difference in preference; acceptability at this point was driven by factors such as finding it fun to visit 'the van' (i.e. mobile dental unit) and receiving a "sticker" rather than specific treatment received. Interviews with parents, clinicians and school staff indicated high acceptability of delivering this type of intervention in a school setting; this may have been partly due to the service being delivered by a well-established, child-oriented community dental service which delivered the clinical trial. CONCLUSIONS: Preventive fluoride varnish and fissure sealant treatments in a school setting has high overall acceptability.
Abstract.
Author URL.
Bleiker J, Knapp KM, Morgan-Trimmer S, Hopkins SJ (2018). “It's what's behind the mask”: Psychological diversity in compassionate patient care.
Radiography,
24, S28-S32.
Abstract:
“It's what's behind the mask”: Psychological diversity in compassionate patient care
Introduction: the Francis Report recommended an increased focus on compassion in healthcare, and recognition and non-judgmental acceptance of diversity is fundamental in compassionate patient care. The aim of this study was to achieve a wider understanding of diversity that includes individual patient needs, expectations, perceptions and feelings during diagnostic imaging. Methods: Using thirty-four semi-structured interviews with individual patients, this qualitative study explored their experiences of undergoing diagnostic radiography examinations and asked what compassionate care meant to them and how it is perceived and manifested in the brief, task-focussed and highly technical diagnostic projection imaging encounter. Data were analysed using Thematic Analysis. Results: Four key themes were identified from the analysis; these were: feelings and vulnerability; hidden emotions; professionalism and valued qualities and communication. Conclusion: Diversity is defined not only in terms of socio-cultural differences but also psychological ones, i.e. individual emotional and attitudinal characteristics, some of which may be consciously or unconsciously concealed. In order that patients are treated equitably and all of their care needs met, recommendations include a broader focus in education and training to include adapting communication skills and techniques in perception and expression of non-verbal cues. Further research into the pressures specific to the time-pressured, task-focussed, highly technical and rapid turnover environment of projection imaging radiography and how this impacts upon compassionate patient care would make a useful contribution to the field.
Abstract.
Segrott J, Murphy S, Rothwell H, Scourfield J, Foxcroft D, Gillespie D, Holliday J, Hood K, Hurlow C, Morgan-Trimmer S, et al (2017). An application of Extended Normalisation Process Theory in a randomised controlled trial of a complex social intervention: Process evaluation of the Strengthening Families Programme (10–14) in Wales, UK. SSM - Population Health, 3, 255-265.
Chestnutt IG, Playle R, Hutchings S, Morgan-Trimmer S, Fitzsimmons D, Aawar N, Angel L, Derrick S, Drew C, Hoddell C, et al (2017). Fissure Seal or Fluoride Varnish? a Randomized Trial of Relative Effectiveness.
J Dent Res,
96(7), 754-761.
Abstract:
Fissure Seal or Fluoride Varnish? a Randomized Trial of Relative Effectiveness.
Fissure sealant (FS) and fluoride varnish (FV) are effective in preventing dental caries when compared with a no-treatment control. However, the relative clinical effectiveness of these interventions is uncertain. The objective of the study was to compare the clinical effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- to 7-y-olds. The study design was a randomized clinical trial, with 2 parallel arms. The setting was a targeted-population program that used mobile dental clinics in schools located within areas of high social and economic deprivation in South Wales. A total of 1,016 children were randomized 1:1 to receive either FS or FV. Resin-based FS was applied to caries-free FPMs and maintained at 6-mo intervals. FV was applied at baseline and at 6-mo intervals for 3 y. The main outcome measures were the proportion of children developing caries into dentine (D4-6MFT) on any 1 of up to 4 treated FPMs after 36 mo. At 36 mo, 835 (82%) children remained: 417 in the FS arm and 418 in the FV arm. A smaller proportion of children who received FV ( n = 73, 17.5%) versus FS ( n = 82, 19.6%) developed caries into dentine on at least 1 FPM (odds ratio [OR] = 0.84; 95% CI, 0.59 to 1.21; P = 0.35), a nonstatistically significant difference between FS and FV treatments. The results were similar when the number of newly decayed teeth (OR = 0.86; 95% CI, 0.60 to 1.22) and tooth surfaces (OR = 0.85; 95% CI, 0.59 to 1.21) were examined. In a community oral health program, semiannual application of FV resulted in caries prevention that was not significantly different from that obtained by applying and maintaining FS after 36 mo (EudraCT: 2010-023476-23; ISRCTN: ISRCTN17029222).
Abstract.
Author URL.
Chestnutt IG, Hutchings S, Playle R, Morgan-Trimmer S, Fitzsimmons D, Aawar N, Angel L, Derrick S, Drew C, Hoddell C, et al (2017). Seal or Varnish? a randomised controlled trial to determine the relative cost and effectiveness of pit and fissure sealant and fluoride varnish in preventing dental decay.
Health Technol Assess,
21(21), 1-256.
Abstract:
Seal or Varnish? a randomised controlled trial to determine the relative cost and effectiveness of pit and fissure sealant and fluoride varnish in preventing dental decay.
BACKGROUND: Fissure sealant (FS) and fluoride varnish (FV) have been shown to be effective in preventing dental caries when tested against a no-treatment control. However, the relative clinical effectiveness and cost-effectiveness of these interventions is unknown. OBJECTIVE: to compare the clinical effectiveness and cost-effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- and 7-year-olds and to determine their acceptability. DESIGN: a randomised controlled allocation-blinded clinical trial with two parallel arms. SETTING: a targeted population programme using mobile dental clinics (MDCs) in schools located in areas of high social and economic deprivation in South Wales. PARTICIPANTS: in total, 1016 children were randomised, but one parent subsequently withdrew permission and so the analysis was based on 1015 children. The randomisation of participants was stratified by school and balanced for sex and primary dentition baseline caries levels using minimisation in a 1 : 1 ratio for treatments. A random component was added to the minimisation algorithm, such that it was not completely deterministic. of the participants, 514 were randomised to receive FS and 502 were randomised to receive FV. INTERVENTIONS: Resin-based FS was applied to caries-free FPMs and maintained at 6-monthly intervals. FV was applied at baseline and at 6-month intervals over the course of 3 years. MAIN OUTCOME MEASURES: the proportion of children developing caries into dentine (decayed, missing, filled teeth in permanent dentition, i.e. D4-6MFT) on any one of up to four treated FPMs after 36 months. The assessors were blinded to treatment allocation; however, the presence or absence of FS at assessment would obviously indicate the probable treatment received. Economic measures established the costs and budget impact of FS and FV and the relative cost-effectiveness of these technologies. Qualitative interviews determined the acceptability of the interventions. RESULTS: at 36 months, 835 (82%) children remained in the trial: 417 in the FS arm and 418 in the FV arm. The proportion of children who developed caries into dentine on a least one FPM was lower in the FV arm (73; 17.5%) than in the FS arm (82, 19.6%) [odds ratio (OR) 0.84, 95% confidence interval (CI) 0.59 to 1.21; p = 0.35] but the difference was not statistically significant. The results were similar when the numbers of newly decayed teeth (OR 0.86, 95% CI 0.60 to 1.22) and tooth surfaces (OR 0.85, 95% CI 0.59 to 1.21) were examined. Trial fidelity was high: 95% of participants received five or six of the six scheduled treatments. Between 74% and 93% of sealants (upper and lower teeth) were intact at 36 months. The costs of the two technologies showed a small but statistically significant difference; the mean cost to the NHS (including intervention costs) per child was £500 for FS, compared with £432 for FV, a difference of £68.13 (95% CI £5.63 to £130.63; p = 0.033) in favour of FV. The budget impact analysis suggests that there is a cost saving of £68.13 (95% CI £5.63 to £130.63; p = 0.033) per child treated if using FV compared with the application of FS over this time period. An acceptability score completed by the children immediately after treatment and subsequent interviews demonstrated that both interventions were acceptable to the children. No adverse effects were reported. LIMITATIONS: There are no important limitations to this study. CONCLUSIONS: in a community oral health programme utilising MDCs and targeted at children with high caries risk, the twice-yearly application of FV resulted in caries prevention that is not significantly different from that obtained by applying and maintaining FSs after 36 months. FV proved less expensive. FUTURE WORK: the clinical effectiveness and cost-effectiveness of FS and FV following the cessation of active intervention merits investigation. TRIAL REGISTRATION: EudraCT number 2010-023476-23, Current Controlled Trials ISRCTN17029222 and UKCRN reference 9273. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 21. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Matthews L, Pugmire J, Moore L, Kelson M, McConnachie A, McIntosh E, Morgan-Trimmer S, Murphy S, Hughes K, Coulman E, et al (2017). Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.
BMJ Open,
7(10).
Abstract:
Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.
INTRODUCTION: HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). AIM: to test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. METHODS AND ANALYSIS: 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)> 30 kg/m2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention. ETHICS AND DISSEMINATION: the protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN85615983.
Abstract.
Author URL.
Morgan-Trimmer S, Wood F (2016). Ethnographic methods for process evaluations of complex health behaviour interventions.
Trials,
17(1).
Abstract:
Ethnographic methods for process evaluations of complex health behaviour interventions.
This article outlines the contribution that ethnography could make to process evaluations for trials of complex health-behaviour interventions. Process evaluations are increasingly used to examine how health-behaviour interventions operate to produce outcomes and often employ qualitative methods to do this. Ethnography shares commonalities with the qualitative methods currently used in health-behaviour evaluations but has a distinctive approach over and above these methods. It is an overlooked methodology in trials of complex health-behaviour interventions that has much to contribute to the understanding of how interventions work. These benefits are discussed here with respect to three strengths of ethnographic methodology: (1) producing valid data, (2) understanding data within social contexts, and (3) building theory productively. The limitations of ethnography within the context of process evaluations are also discussed.
Abstract.
Author URL.
Morgan-Trimmer S, Channon S, Gregory JW, Townson J, Lowes L (2016). Family preferences for home or hospital care at diagnosis for children with diabetes in the DECIDE study.
Diabet Med,
33(1), 119-124.
Abstract:
Family preferences for home or hospital care at diagnosis for children with diabetes in the DECIDE study.
AIMS: a diagnosis of Type 1 diabetes in childhood can be a difficult life event for children and families. For children who are not severely ill, initial home rather than hospital-based care at diagnosis is an option although there is little research on which is preferable. Practice varies widely, with long hospital stays in some countries and predominantly home-based care in others. This article reports on the comparative acceptability and experience of children with Type 1 diabetes and their parents taking part in the DECIDE study evaluating outcomes of home or hospital-based treatment from diagnosis in the UK. METHODS: Semi-structured interviews with 11 (pairs of) parents and seven children were conducted between 15 and 20 months post diagnosis. Interviewees were asked about adaptation to, management and impact of the diabetes diagnosis, and their experience of initial post-diagnosis treatment. RESULTS: There were no differences between trial arms in adaptation to, management of or impact of diabetes. Most interviewees wanted to be randomized to the 'home' arm initially but expressed a retrospective preference for whichever trial arm they had been in, and cited benefits relating to learning about diabetes management. CONCLUSIONS: the setting for early treatment did not appear to have a differential impact on families in the long term. However, the data presented here describe different experiences of early treatment settings from the perspective of children and their families, and factors that influenced how families felt initially about treatment setting. Further research could investigate the short-term benefits of both settings.
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Morgan-Trimmer S (2015). Improving Process Evaluations of Health Behavior Interventions: Learning from the Social Sciences.
Eval Health Prof,
38(3), 295-314.
Abstract:
Improving Process Evaluations of Health Behavior Interventions: Learning from the Social Sciences.
This article reflects on the current state of process evaluations of health behavior interventions and argues that evaluation practice in this area could be improved by drawing on the social science literature to a greater degree. While process evaluations of health behavior interventions have increasingly engaged with the social world and sociological aspects of interventions, there has been a lag in applying relevant and potentially useful approaches from the social sciences. This has limited the scope for health behavior process evaluations to address pertinent contextual issues and methodological challenges. Three aspects of process evaluations are discussed: the incorporation of contexts of interventions; engagement with the concept of "process" in process evaluation; and working with theory to understand interventions. Following on from this, the article also comments on the need for new methodologies and on the implications for addressing health inequalities.
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Morgan-Trimmer S (2015). People-centred Public Health.
SOCIOLOGY OF HEALTH & ILLNESS,
37(5), 799-800.
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Segrott J, Rothwell H, Murphy S, Morgan-Trimmer S, Scourfield J, Holliday J, Thomas C, Gillespie D, Roberts Z, Foxcroft D, et al (2014). Fidelity of implementation of the Strengthening Families Programme 10-14 UK in Wales UK: a mixed-method process evaluation within a randomised controlled trialLaurence Moore. European Journal of Public Health, 24(suppl_2).
Morgan-Trimmer S (2014). Policy is political; our ideas about knowledge translation must be too.
J Epidemiol Community Health,
68(11), 1010-1011.
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Morgan-Trimmer S (2013). 'It's who you know': community empowerment through network brokers. Community Development Journal, 49(3), 458-472.
Chestnutt IG, Chadwick BL, Hutchings S, Playle R, Pickles T, Lisles C, Kirkby N, Morgan MZ, Hunter L, Hodell C, et al (2012). Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay.
BMC Oral Health,
12Abstract:
Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay.
BACKGROUND: Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. METHODS/DESIGN: the trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6-7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars. DISCUSSION: the objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children. TRIAL REGISTRATIONS: ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273.
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