Non-pharmacological interventions in the management of dementia-related psychosis.

BACKGROUND: It is estimated 20-70% of those living with a dementia diagnosis experience dementia-related psychosis (D-RP). D-RP results in decreased quality of life, increased carer burden, increased rapid cognitive decline, increased need for primary care support, and earlier care/nursing home admission, all which come at a considerable cost to the NHS. Antipsychotic medications prescribed by primary care services are typically used as treatment but have short-term efficacy and dangerous side effects. Effective management with the use of non-pharmacological interventions could safely improve the quality of life of those living with dementia, as well as reduce burden on primary care services and GPs. AIM: To evaluate the effectiveness of non-pharmacological interventions in the management of D-RP. Studies that measure the effect of non-pharmacological interventions on patient or caregiver quality of life or determine the cost-effectiveness and safety of non-pharmacological interventions against antipsychotic medications will also be included. METHOD: A global systematic literature review was conducted in Medline, Embase, PsychInfo, CINAHL, Web of Science, and CENTRAL. Included studies were analysed using meta-analysis and narrative synthesis. The protocol is registered with PROSPERO (ID: CRD42022294750). RESULTS: Data extraction of 18 included papers revealed 4 interventions to show evidence of efficacy in improving D-RP in older adults. Person-centred care, robot pets, cognitive rehabilitation, and music therapy significantly decreased psychosis in care homes and in participants living at home. These results are discussed, and implications noted. CONCLUSION: Future RCTs should focus on specifically improving D-RP, as this was not the primary aim for many interventions.

Goal setting as part of a holistic intervention to promote independence in older people with mild frailty: a process evaluation alongside a randomised controlled trial.

BACKGROUND: Frailty is a condition resulting from a decline in physiological reserves caused by an accumulation of several deficits, which progressively impairs the ability to recover from health adverse events. Following a promising feasibility study, the HomeHealth trial assessed a holistic tailored intervention for older adults with mild frailty to promote independence in their own homes, compared with usual care. We aimed to understand how goal setting worked among older people with mild frailty. METHODS: This study was a process evaluation alongside the HomeHealth randomised trial in older adults with mild frailty. The intervention was delivered at participants' homes, either in person or by telephone or videoconferencing. We carried out semi-structured interviews with older participants who had received the intervention (between three and six appointments), on average 233 days (range 68-465) after their last appointment, purposively sampled according to age, gender, number of sessions attended, adverse events, ethnicity, Index of Multiple Deprivation, Montreal Cognitive Assessment (MoCA) and Barthel scores, research site, and HomeHealth worker. We also conducted interviews with HomeHealth workers who delivered the intervention (n=7). Interviews explored the experience and process of goal setting, benefits and challenges, perceived progress, and behaviour change maintenance after the service had finished. Ethics approval was obtained, and all participants gave informed consent. Interviews were thematically analysed. HomeHealth workers kept formal records of goals set and assessed progress towards goals (0-2 rating scale) during six monthly-sessions, which were descriptively summarised. FINDINGS: 56 interviews were completed between July 15, 2022, and May 18, 2023. Study participants (n=49) had a mean age of 80 years (range 66-94), including 32 (65%) women and 17 (35%) men. Participants self-identified as White (n=42), Asian (n=3), Black (n=2), Mixed (n=1), and other ethnic (n=1) backgrounds. Findings suggested goal setting could be both a challenge and a motivator for older participants with mild frailty. Goal setting worked well when the older person could identify a clear need and set realistic goals linked to functioning, which led to a positive sense of achievement. Challenges occurred when older people were already accessing multiple resources and health services, or where the terminology of "goals" was off-putting due to work or school connotations. Average progress towards goals was 1·15/2. Most participants set goals around improving mobility (or a combination of mobility and another goal type such as socialising), and there was evidence of participants sustaining these behaviour changes after the intervention. INTERPRETATION: Older people with mild frailty can engage well with goal setting to promote independence. The lapse between receiving the intervention and being interviewed limited recall for some participants. However, the acceptability and adherence to the intervention for older people with mild frailty, and their moderate progress towards goals, should encourage further tailored and person-centred practices to promote their independence. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment.

Enabling health and maintaining independence for older people at home (HomeHealth trial): a multicentre randomised controlled trial.

BACKGROUND: NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual. METHODS: In this single-blind multicentre randomised controlled trial, we recruited community-dwelling older people aged 65 years or older with mild frailty from 27 general practices, community groups and sheltered housing in London, Yorkshire, and Hertfordshire. Participants were randomly assigned (1:1) to receive either HomeHealth monthly for 6 months or treatment as usual (usual GP and outpatient care, no specific frailty services). Our primary outcome was independence in activities of daily living, measured by blinded outcome assessors using the modified Barthel Index, and analysed using linear mixed models, including 6-month and 12-month data and controlling for baseline Barthel score and site. The study was approved by the Social Care Research Ethics Committee, and all participants provided written or orally recorded informed consent. This study is registered with the ISRCTN registry, ISRCTN54268283. FINDINGS: This trial took place between Jan 18, 2021, and July 4, 2023. We recruited 388 participants (mean age 81·4 years; 64% female [n=250], 94% White British/European [n=364], 2·5% Asian [n=10], 1·5% Black [n=6], 2·0% other [n=8]). We achieved high retention for 6-month follow-up (89%, 345/388), 12-month follow-up (86%, 334/388), and medical notes data (89%, 347/388). 182 (93%) of 195 participants in the intervention group completed the intervention, attending a mean of 5·6 appointments. HomeHealth had no effect on Barthel Index scores at 12 months (mean difference 0·250, 95% CI -0·932 to 1·432). At 6 months, there was a small reduction in psychological distress (-1·237, -2·127 to -0·348) and frailty (-0·124, -0·232 to -0·017), and at 12 months, we found small positive effects on wellbeing (1·449, 0·124 to 2·775) in those receiving HomeHealth. Other outcomes in analysis to date showed no significant difference. Health economic outcomes (including quality of life, capability, health services use and care needs or burden) are pending. INTERPRETATION: This high-quality trial showed that HomeHealth did not maintain independence in older people with mild frailty, and had limited effects upon secondary outcomes. Future studies need to explore different ways to promote health in this population. FUNDING: National Institute for Health and Care Research Health Technology Assessment (NIHR HTA).

Type of goals set and progress towards these goals, as part of a behaviour change intervention, in people with mild cognitive impairment: a secondary analysis.

BACKGROUND: Mild cognitive impairment (MCI) affects 5-20% of older people in the UK, but often goes undiagnosed and is associated with increased risk of dementia. Targeting risk factors such as physical inactivity and social isolation through behaviour-change interventions could reduce this risk. However, it is unclear how MCI impacts engagement with these interventions. We aimed to explore how MCI affects goal-setting priorities and progress towards these goals in a behaviour-change intervention (HomeHealth). METHODS: This was a secondary analysis of a completed randomised controlled trial, HomeHealth, which started in January 2021 and recruited 386 participants aged 65 years and older with mild frailty according to the Clinical Frailty Scale from general practices and the community in England. Participants were randomly assigned (1:1) to receive either the HomeHealth intervention (n=195) or treatment as usual (n=191) for 6 months. An evidence-based behaviour change intervention supported older people to work on goals to maintain independence, addressing factors affecting capability, opportunity, and motivation. Goal setting and progress information was available for 167 (86%) of 195 participants who received the intervention. The type of goal set and goal progress (scale 0-2) were compared between participants with healthy cognition, those with potential MCI, and those with probable dementia (rated with Montreal Cognitive Assessment [MoCA]). Qualitative semi-structured interviews were conducted between Aug 16, 2022, and May 18, 2023, with 29 people with MCI who received the intervention, to explore the perceived impact of MCI on goal setting, progress, and maintenance. Data were analysed using codebook thematic analysis. FINDINGS: The mean age of participants was 80·8 years, 105 (63%) of 167 were women and 158 (95%) were white. 54 (32%) of 167 participants had healthy cognition, 94 (56%) had potential MCI, and 19 (11%) probable dementia. Distribution of goal type was similar across the three groups, with most participants setting mobility goals. Progress towards goals (scale 0-2) was similar in people with healthy cognition and potential MCI (1·24 and 1·18, respectively) but lower in those with probable dementia (0·76). However, all met the moderate progress cutoff (0·66-1·32). People with MCI recognised their cognition was getting worse but did not feel the HomeHealth intervention could help. Rather than setting new goals, people with MCI built on existing behaviours. Many did not initially understand the intervention and felt they would have benefitted from contact in between sessions or from more sessions to help goal progress. Once the sessions ended, less than a quarter of participants maintained the goal progress. INTERPRETATION: Interventions to help older adults age well can be successfully delivered in people with MCI, to help them set and make progress towards goals. However, to maintain changes, more intense support is needed. FUNDING: National Institute for Health and Care Research (NIHR) School for Primary Care Research, NIHR Health Technology Assessment.

Health inequalities for older people from minority ethnic groups receiving palliative care and end of life care: A scoping review protocol.

OBJECTIVE: The proposed scoping review aims to explore international literature on how older people from minority ethnic groups engage with and utilise palliative and end of life care, investigate the barriers and facilitators, and compare how this varies between ethnicities and health conditions. INTRODUCTION: Minority ethnic groups make up substantial parts of the populations of many countries around the world. Research has found that there are disparities in access to palliative care and end of life care among minority ethnic groups. Language barriers, cultural values, and socio-demographic factors have been cited as preventing access to quality palliative and end of life care. However, it is unclear how these barriers and inequalities differ across different minority ethnic groups in different countries, and across different health conditions within these groups. INCLUSION CRITERIA: The population will be older people of different minority ethnic groups who are receiving palliative or end of life care, family caregivers, and health and social care professionals. The sources of information will include quantitative, qualitative and mixed methods research, and sources that focus on minority ethnic groups' interactions with palliative and end of life care. METHODS: A scoping review guided by the Joanna Briggs Institute Manual for Evidence Synthesis. Searches of MEDLINE, Embase, PsycInfo, CINAHL, Scopus, Web of Science, Assia, and the Cochrane Library will be conducted. Citation tracking, reference list checking and grey literature searches will be undertaken. Data will be extracted, charted and summarised descriptively. IMPLICATIONS: This review will highlight the health inequalities present in palliative and end of life care, the research gaps in understudied minority ethnic populations, locations where further study is required, and how barriers and facilitators differ across different ethnic groups and health conditions. The results of this review will be shared with stakeholders and will provide evidence-based recommendations for inclusive palliative and end of life care.

Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty ('HomeHealth') compared to treatment as usual: study protocol for a randomised controlled trial.

BACKGROUND: Frailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness. Previously, we co-designed a new behaviour change health promotion intervention ("HomeHealth") to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes. AIM: To test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU). METHODS: Single-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65 + , with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted. DISCUSSION: This trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective. TRIAL REGISTRATION: ISRCTN, ISRCTN54268283 . Registered 06/04/2020.

Implementing post diagnostic dementia care in primary care: a mixed-methods systematic review.

OBJECTIVES: Concentrating post-diagnostic dementia care in primary care may lead to better and more cost-effective care closer to home. We aimed to assess which intervention components and contextual factors may contribute to the successful delivery and implementation of primary care-led post-diagnostic dementia care. METHODS: Mixed-methods systematic review. We searched five databases (inception-March 2019) with reference list screening and citation tracking. We included studies evaluating post-diagnostic dementia care interventions where primary care had a significant role in dementia care, which assessed one or more implementation elements (acceptability, feasibility, adoption, sustainability, reach, costs, appropriateness or fidelity). Two authors independently critically appraised studies. RESULTS: Out of 4528 unique references, we screened 380 full texts and included 49 evaluations of services collecting implementation process data. Most services had high acceptability ratings. The most acceptable components were information provision, social and emotional support and links to community organisations. Feasibility was chiefly influenced by provider engagement and leadership, building dementia care capacity, sufficient resources/funding and collaboration. Care quality was maximised through adding capacity from a dementia-specific health professional. On the basis of limited data, costs for various primary care-led models did not substantially differ from each other. CONCLUSION: A range of primary care-led dementia care models appear feasible and acceptable. Future services should: add dementia-focussed health professionals into primary care, develop primary care leadership and provide sufficient funding and collaboration opportunities. Information, community service links and social and ongoing support should be part of services. Further exploration of service reach and formalised fidelity assessment are needed.

What works in managing complex conditions in older people in primary and community care? A state-of-the-art review.

The number of older people living with complex health conditions is increasing, with the majority of these managed in primary and community settings. Many models of care have been developed to support them, however, there is mixed evidence on their value and they include multiple overlapping components. We aimed to synthesise the evidence to learn what works for managing complex conditions in older people in primary and community care. We carried out a state-of-the-art review of systematic reviews. We searched three databases (January 2009 to July 2019) for models of primary and community care for long-term conditions, frailty, multimorbidity and complex neurological conditions common to older people such as dementia. We narratively synthesised review findings to summarise the evidence for each model type and identify components which influenced effectiveness. Out of 2,129 unique titles and abstracts, 178 full texts were reviewed and 54 systematic reviews were included. We found that the models of care were more likely to improve depressive symptoms and mental health outcomes than physical health or service use outcomes. Interventions including self-management, patient education, assessment with follow-up care procedures, and structured care processes or pathways had greater evidence of effectiveness. The level of healthcare service integration appeared to be more important than inclusion of specific professional types within a team. However, more experienced and qualified nurses were associated with better outcomes. These conclusions are limited by the overlap between reviews, reliance on vote counting within some included reviews and the quality of study reports. In conclusion, primary and community care interventions for complex conditions in older people should include: (a) clear intervention targets; (b) explicit theoretical underpinnings; and (c) elements of self-management and patient education, structured collaboration between healthcare professionals and professional support. Further work needs to determine the optimal intensity, length, team composition and role of technology in interventions.

Effectiveness of different post-diagnostic dementia care models delivered by primary care: a systematic review.

BACKGROUND: Global policy recommendations suggest a task-shifted model of post-diagnostic dementia care, moving towards primary and community-based care. It is unclear how this may best be delivered. AIM: To assess the effectiveness and cost-effectiveness of primary care-based models of post-diagnostic dementia care. DESIGN AND SETTING: A systematic review of trials and economic evaluations of post-diagnostic dementia care interventions where primary care was substantially involved in care plan decision making. METHOD: Searches were undertaken of MEDLINE, PsychINFO, EMBASE, Web of Science, and CINAHL (from inception to March 2019). Two authors independently critically appraised studies and inductively classified interventions into types of care models. Random effects meta-analysis or narrative synthesis was conducted for each model where appropriate. RESULTS: From 4506 unique references and 357 full texts, 23 papers were included from 10 trials of nine interventions, delivered in four countries. Four types of care models were identified. Primary care provider (PCP)-led care (n = 1) led to better caregiver mental health and reduced hospital and memory clinic costs compared with memory clinics. PCP-led care with specialist consulting support (n = 2) did not have additional effects on clinical outcomes or costs over usual primary care. PCP-case management partnership models (n = 6) offered the most promise, with impact on neuropsychiatric symptoms, caregiver burden, distress and mastery, and healthcare costs. Integrated primary care memory clinics (n = 1) had limited evidence for improved quality of life and cost-effectiveness compared with memory clinics. CONCLUSION: Partnership models may impact on some clinical outcomes and healthcare costs. More rigorous evaluation of promising primary care-led care models is needed.

Health promotion for mild frailty based on behaviour change: Perceptions of older people and service providers.

Mild frailty is common among older people, but it is potentially reversible with health promotion interventions. Behaviour change may be a key to preventing progression of frailty; however, we know little about what interventions work best and how a behaviour change approach would be perceived by this group. The aim of this study was to explore how mildly frail older people perceive health promotion based on behaviour change and what factors affect engagement with this approach. We conducted semi-structured interviews with 16 older people with mild frailty who received a pilot home-based behaviour change health promotion service, including a dyad of older person/family carer, and two service providers delivering the service in two diverse areas of South England. Interviews were audio-recorded, transcribed and thematically analysed. The concept of goal setting was acceptable to most participants, though the process of goal setting needed time and consideration. Goals on maintaining independence, monitoring of progress and receiving feedback were reported to increase motivation. Physical/mental capability and knowledge/perception of own needs were main determinants of the type of goals chosen by participants as well as the approach used by the project workers. Older people with complex needs benefited from care coordination, with a combination of goal setting and elements of social, practical and emotional support in varying proportions. Mildly frail older people responded well to a behaviour change approach to promote health and well-being. Further consideration is needed of the most effective strategies based on complexity of needs, and how to overcome barriers among people with cognitive impairment.

Moving upstream in health promoting policies for older people with early frailty in England? A policy analysis.

Objectives Globally, populations are rapidly ageing and countries have developed health promotion and wellbeing strategies to address increasing demand for health care and old-age support. The older population is not homogeneous however, and includes a large group in transition between being active and healthy to being frail, i.e. with early frailty. This review explores the extent to which policy in England has addressed this group with a view to supporting independence and preventing further progression towards frailty. Methods A narrative review was conducted of 157 health and social care policy documents current in 2014-2017 at three levels of the health and social care system in England. Findings We report the policy problem analysis, the shifts over time in language from health promotion to illness prevention, the shift in target populations to mid-life and those most at risk of adverse outcomes through frailty, and changes to delivery mechanisms to incentivize attention to the frailest rather than those with early frailty. We found that older people in general were not identified as a specific population in many of these policies. While this may reflect a welcome lack of age discrimination, it could equally represent omission through ageism. Only at local level did we identify some limited attention to preventative actions with people with early frailty. Conclusion The lack of policy attention to older people with early frailty is a missed opportunity to address some of the demands on health and social care services. Addressing the individual and societal consequences of adverse experiences of those with the greatest frailty should not distract from a more distinct public health perspective which argues for a refocusing upstream to health promotion and illness prevention for those with early frailty.

Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT.

BACKGROUND: Mild frailty or pre-frailty is common and yet is potentially reversible. Preventing progression to worsening frailty may benefit individuals and lower health/social care costs. However, we know little about effective approaches to preventing frailty progression. OBJECTIVES: (1) To develop an evidence- and theory-based home-based health promotion intervention for older people with mild frailty. (2) To assess feasibility, costs and acceptability of (i) the intervention and (ii) a full-scale clinical effectiveness and cost-effectiveness randomised controlled trial (RCT). DESIGN: Evidence reviews, qualitative studies, intervention development and a feasibility RCT with process evaluation. INTERVENTION DEVELOPMENT: Two systematic reviews (including systematic searches of 14 databases and registries, 1990-2016 and 1980-2014), a state-of-the-art review (from inception to 2015) and policy review identified effective components for our intervention. We collected data on health priorities and potential intervention components from semistructured interviews and focus groups with older people (aged 65-94 years) (n = 44), carers (n = 12) and health/social care professionals (n = 27). These data, and our evidence reviews, fed into development of the 'HomeHealth' intervention in collaboration with older people and multidisciplinary stakeholders. 'HomeHealth' comprised 3-6 sessions with a support worker trained in behaviour change techniques, communication skills, exercise, nutrition and mood. Participants addressed self-directed independence and well-being goals, supported through education, skills training, enabling individuals to overcome barriers, providing feedback, maximising motivation and promoting habit formation. FEASIBILITY RCT: Single-blind RCT, individually randomised to 'HomeHealth' or treatment as usual (TAU). SETTING: Community settings in London and Hertfordshire, UK. PARTICIPANTS: A total of 51 community-dwelling adults aged ≥ 65 years with mild frailty. MAIN OUTCOME MEASURES: Feasibility - recruitment, retention, acceptability and intervention costs. Clinical and health economic outcome data at 6 months included functioning, frailty status, well-being, psychological distress, quality of life, capability and NHS and societal service utilisation/costs. RESULTS: We successfully recruited to target, with good 6-month retention (94%). Trial procedures were acceptable with minimal missing data. Individual randomisation was feasible. The intervention was acceptable, with good fidelity and modest delivery costs (£307 per patient). A total of 96% of participants identified at least one goal, which were mostly exercise related (73%). We found significantly better functioning (Barthel Index +1.68; p = 0.004), better grip strength (+6.48 kg; p = 0.02), reduced psychological distress (12-item General Health Questionnaire -3.92; p = 0.01) and increased capability-adjusted life-years [+0.017; 95% confidence interval (CI) 0.001 to 0.031] at 6 months in the intervention arm than the TAU arm, with no differences in other outcomes. NHS and carer support costs were variable but, overall, were lower in the intervention arm than the TAU arm. The main limitation was difficulty maintaining outcome assessor blinding. CONCLUSIONS: Evidence is lacking to inform frailty prevention service design, with no large-scale trials of multidomain interventions. From stakeholder/public perspectives, new frailty prevention services should be personalised and encompass multiple domains, particularly socialising and mobility, and can be delivered by trained non-specialists. Our multicomponent health promotion intervention was acceptable and delivered at modest cost. Our small study shows promise for improving clinical outcomes, including functioning and independence. A full-scale individually RCT is feasible. FUTURE WORK: A large, definitive RCT of the HomeHealth service is warranted. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010370 and Current Controlled Trials ISRCTN11986672. 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. 73. See the NIHR Journals Library website for further project information.

What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures.

OBJECTIVE: To systematically review methods for measuring adherence used in home-based rehabilitation trials and to evaluate their validity, reliability, and acceptability. DATA SOURCES: In phase 1 we searched the CENTRAL database, NHS Economic Evaluation Database, and Health Technology Assessment Database (January 2000 to April 2013) to identify adherence measures used in randomized controlled trials of allied health professional home-based rehabilitation interventions. In phase 2 we searched the databases of MEDLINE, Embase, CINAHL, Allied and Complementary Medicine Database, PsycINFO, CENTRAL, ProQuest Nursing and Allied Health, and Web of Science (inception to April 2015) for measurement property assessments for each measure. STUDY SELECTION: Studies assessing the validity, reliability, or acceptability of adherence measures. DATA EXTRACTION: Two reviewers independently extracted data on participant and measure characteristics, measurement properties evaluated, evaluation methods, and outcome statistics and assessed study quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. DATA SYNTHESIS: In phase 1 we included 8 adherence measures (56 trials). In phase 2, from the 222 measurement property assessments identified in 109 studies, 22 high-quality measurement property assessments were narratively synthesized. Low-quality studies were used as supporting data. StepWatch Activity Monitor validly and acceptably measured short-term step count adherence. The Problematic Experiences of Therapy Scale validly and reliably assessed adherence to vestibular rehabilitation exercises. Adherence diaries had moderately high validity and acceptability across limited populations. The Borg 6 to 20 scale, Bassett and Prapavessis scale, and Yamax CW series had insufficient validity. Low-quality evidence supported use of the Joint Protection Behaviour Assessment. Polar A1 series heart monitors were considered acceptable by 1 study. CONCLUSIONS: Current rehabilitation adherence measures are limited. Some possess promising validity and acceptability for certain parameters of adherence, situations, and populations and should be used in these situations. Rigorous evaluation of adherence measures in a broader range of populations is needed.

Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used.

BACKGROUND: Many complex intervention trials fail to show an intervention effect. Although this may be due to genuine ineffectiveness, it may also be the result of sub-optimal intervention design, implementation failure or a combination of these. Given current financial constraints and the pressure to reduce waste and increase value in health services research, pre-trial strategies are needed to reduce the likelihood of design or implementation failure and to maximise the intervention's potential for effectiveness. In this scoping review, we aimed to identify and synthesise the available evidence relating to the strategies and methods used to 'optimise' complex interventions at the pre-trial stage. METHODS: We searched MEDLINE, CINAHL, AMED, PsycINFO and ProQuest Nursing & Allied Health Source for papers published between January 2000 and March 2015. We included intervention development and optimisation studies that explored potential intervention weaknesses and limitations before moving to a definitive randomised controlled trial (RCT). Two reviewers independently applied selection criteria and systematically extracted information relating to the following: study characteristics; intervention under development; framework used to guide the development process; areas of focus of the optimisation process, methods used and outcomes of the optimisation process. Data were tabulated and summarised in a narrative format. RESULTS: We screened 3968 titles and 231 abstracts for eligibility. Eighty-nine full-text papers were retrieved; 27 studies met our selection criteria. Optimisation strategies were used for a range of reasons: to explore the feasibility and acceptability of the intervention to patients and healthcare professionals; to estimate the effectiveness and cost-effectiveness of different combinations of intervention components; and to identify potential barriers to implementation. Methods varied widely across studies, from interviews and focus groups to economic modelling and probability analysis. CONCLUSIONS: The review identifies a range of optimisation strategies currently used. Although a preliminary classification of these strategies can be proposed, a series of questions remain as to which methods to use for different interventions and how to determine when the intervention is ready or 'optimised enough' to be tested in a RCT. Future research should explore potential answers to the questions raised, to guide researchers in the development and evaluation of more effective interventions.