Background:Half of older people in hospital have frailty and are at increased risk of re-admission or death following discharge. Although short-term rehabilitation can reduce early re-admissions, benefits are attenuated over time. It is unknown whether extended rehabilitation for older people with frailty can improve outcomes. Trial design:Pragmatic, multicentre, individually randomised controlled parallel-group superiority trial with economic evaluation and embedded process evaluation. Methods:Participants: Eligible participants were 65 years or older with mild/moderate/severe frailty (score of 5-7 on Clinical Frailty Scale) admitted to hospital with acute illness or injury, then discharged home directly or from intermediate care (post-acute care) rehabilitation services. People with significant cognitive impairment and care home residents were among those ineligible. Recruitment took place from December 2017 to August 2021, with follow-up till August 2022. Interventions: Participants were randomly assigned (1.28 : 1) to the Home-based Older People's Exercise programme - a 24-week home-based manualised, progressive exercise intervention delivered by National Health Service therapists as extended rehabilitation, or usual care (control). Randomisation occurred after the participant had been discharged from hospital or intermediate care. Participants were not masked to allocation. Main outcome measures: The primary outcome was physical health-related quality of life, measured using the physical component score of the modified Short Form 36-item health questionnaire at 12 months. Secondary outcomes at 6 and 12 months included physical and mental health-related quality of life, functional independence, death, hospitalisations and care home admissions. Researchers involved in data collection were masked to allocation. Data sources: Primary and secondary outcomes were obtained via self-report questionnaire at 6 and 12 months. Hospitalisations and deaths were collected from routine healthcare data. Results:We randomised 740 participants (410 Home-based Older People's Exercise, 330 control) across 15 sites. Four hundred and seventy-nine (64.7%) participants completed 12-month follow-up. One hundred and eighty-eight Home-based Older People's Exercise participants (45.9%) completed 24 weeks of intervention delivery. Over half of participants completed more than 75% of prescribed exercises. Intention-to-treat analyses (258 Home-based Older People's Exercise participants, 208 control participants for primary outcome) showed no evidence that Home-based Older People's Exercise was superior to control for 12-month physical component score (adjusted mean difference -0.22, 95% confidence interval -1.47 to 1.03; p = 0.73). There was some evidence of a higher rate of all-cause hospitalisations in the control arm (incidence rate ratio 1.12, 95% confidence interval 1.00 to 1.25; p = 0.05), but no evidence of differences in other outcomes. The process evaluation found the intervention was largely delivered as intended and proved acceptable to most participants. The economic analysis showed incremental costs of Home-based Older People's Exercise plus usual care of GB£1401 (mean per participant), compared with usual care alone. There was a 0.024 quality-adjusted life-year improvement in Home-based Older People's Exercise compared to control. The incremental cost-effectiveness ratio was £58,375. Limitations:This trial was delivered during especially challenging circumstances that included the COVID-19 pandemic. We examined outcomes taking account of this but detected no difference in primary or secondary outcomes, providing reassurance that COVID-19 was unlikely to have influenced trial results. Conclusions:Based on our findings, we do not recommend routine commissioning of extended rehabilitation for older people with frailty after discharge home from hospital or intermediate care, following an acute admission with illness or injury. Future work:Future work should consider how existing core intermediate care and community rehabilitation services should be best organised and delivered to ensure that older people with frailty feel ready for discharge from rehabilitation, and are enabled to maintain their independence. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/43/07.

ObjectiveTo review the costs and cost-effectiveness of telerehabilitation training for upper limb function in people after stroke.Data SourcesMEDLINE, EconLit, and EMBASE databases were searched for studies published between 2013 and 16 March 2026.MethodsThe review included studies of technology-based rehabilitation programmes for individuals after stroke that evaluated costs or cost-effectiveness. Titles and abstracts were screened, and data were independently extracted by two researchers. Study quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. Findings were synthesised narratively.ResultsFifteen studies including 963 participants were included. Two studies conducted cost-effectiveness analyses, eight reported cost analyses, and six reported the use of a preference-based measure recommended for cost-effectiveness studies (all used the EQ-5D), with some studies contributing to more than one category. Evidence on costs and cost-effectiveness was mixed, but several studies suggested potential cost savings. Reporting of EQ-5D outcomes was inconsistent across studies.ConclusionsEvidence on the costs of telerehabilitation training for upper limb function primarily focused on therapist time and equipment costs. Few studies included costs associated with equipment maintenance, depreciation, or the need for internet-enabled devices. Reductions in therapist time could offset or exceed technology costs. Further research is needed to evaluate the longer-term costs and cost-effectiveness of telerehabilitation in this population.

Abstract Aims The Falls Management Exercise (FaME) programme, delivered over 24 weeks, reduces falls in randomised controlled trials and ‘real world’ delivery, but some services deliver shorter, adapted FaME programmes. We investigated the ‘real-world’ effectiveness of FaME delivered for 12 or 24 weeks across three UK regions. Methods Design: prospective cohort study. Participants: 1,601 FaME programme attendees (median age 79.5 years), of whom 873 had follow-up data recorded. Setting: 14 provider organisations in Greater Manchester, Devon and the East Midlands. Procedure: Participant data were collected by FaME providers at baseline and up to 24 weeks later. Outcomes: Timed up-and-go (TUG); Short Falls Efficacy Scale-International (Short FES-I); at least one self-reported fall, and number of self-reported falls, in the past 3 months. Analysis: Univariate before-and-after tests; multivariable multilevel logistic, linear, Poisson, negative binomial regression. Results At final follow-up (≤24 weeks), compared to baseline, the odds of a self-reported fall within 3 months (Odds ratio 0.16 [95% confidence interval [CI] 0.10 to 0.25], p <.001) and TUG time had decreased (difference-between-paired-medians -1.0 (95% CI -1.50 to -1.0), p <.001). Short FES-I scores had not significantly changed. Twenty-four- rather than 12-week programmes were associated with faster TUG times (mean difference -3.31 seconds [95% CI -5.97 to -0.65]) and reduced concerns about falling (mean Short FES-I difference -2.00 [95% CI -3.65 to -0.34], p = 0.018), but no significant difference in the odds of a self-reported fall or number of falls within 3 months. Conclusions FaME programmes of both 12 and 24-weeks were associated with improved functional mobility and reduced falls. Participants who attended 24-, rather than 12-week, programmes had significantly greater improvements in functional mobility and reduced concerns about falling. Due to follow-up data missingness, the study was not adequately powered to detect differences in falls risk or rate between 12 and 24-week programmes.

Objectives To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.Design Pilot cluster randomised controlled trial (c-RCT).Setting Community-based healthcare services across six UK sites representing primary and secondary care settings.Participants 31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.Interventions The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.Primary and secondary outcome measures Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.Results Recruitment occurred over an 8-month period (September 2023-April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.Conclusions The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.Trial registration number ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

Background The frequency of mammographic surveillance for women after diagnosis of breast cancer varies globally. The aim of this study was to evaluate whether less than annual mammography was non-inferior in terms of breast cancer-specific survival in women aged 50 years or older. Methods Mammo-50 was a multicentre, randomised, phase 3 trial of annual versus less frequent mammography (2-yearly after conservation surgery; 3-yearly after a mastectomy) for women aged 50 years or older at initial diagnosis of invasive or non-invasive breast cancer and who were recurrence free 3 years post curative surgery. The trial was conducted at 114 National Health Service hospitals in the UK. Participants were randomly assigned (1:1) to annual or less frequent mammograms at 3 years post curative surgery and were followed up for 6 years. The co-primary outcomes were breast cancer-specific survival and cost-effectiveness. The cost-effectiveness analysis will be reported elsewhere. Breast cancer-specific survival was assessed in the intention-to-treat population. Secondary outcomes were recurrence-free interval, overall survival, and referrals back to the hospital system. 5000 women provided 90% power to detect a 3% absolute non-inferiority margin for breast cancer-specific survival with 25% one-sided significance. The trial was registered with the ISRCTN registry, ISRCTN48534559; recruitment is complete but longer-term followup is ongoing. Findings Between April 22, 2014, and Sept 28, 2018, 5235 women were randomly assigned to annual mammography (n=2618) or less frequent mammography (n=2617). 3858 (736%) women were aged 60 years or older, 4202 (803%) had undergone conservation surgery, 4576 (874%) had invasive disease, 1159 (221%) had node positive disease, and 4330 (827%) had oestrogen receptor-positive tumours. With a median of 57 years follow-up (IQR 50-60; 87 years post curative surgery), 343 women died, including 116 who died of breast cancer (61 in the annual mammography group and 55 in the less frequent mammography group). 5-year breast cancer-specific survival was 981% (95% CI 975-986) in the annual mammography group and 983% (978-988) in the less frequent mammography group (hazard ratio 092, 95% CI 064-132), demonstrating non-inferiority of less frequent mammography at the pre- specified 3% margin (non-inferiority p<00001). 5-year recurrence-free interval was 941% (95% CI 931-949) in the annual mammography group and 945% (935-953) in the less frequent mammography group. Overall survival at 5 years was 947% (95% CI 938-955%) and 945% (935-953), respectively. 224 (649%) of 345 breast cancer events were detected from emergency admissions or symptomatic referrals back to the hospital system, including 108 (617%) of 175 in the annual mammography group and 116 (682%) of 170 in the less frequent mammography group. Interpretation For patients aged 50 years or older and at 3 years post diagnosis, less frequent mammograms were non-inferior compared with annual mammograms for breast cancer-specific survival, recurrence-free interval, and overall survival, and should be considered for this population.

Objectives To evaluate the feasibility, clinical effectiveness, and economic impact of the EvolvRehab MoveWell virtual therapy through an AI-based system and real-time feedback in community stroke rehabilitation services. Design The study was structured into 2 stages: an initial codesign phase and a feasibility clinical trial. The trial used a before-and-after 6-week longitudinal study design to assess the system's impact. Setting The research was conducted across 5 NHS community stroke services in England, supplemented by recruitment from stroke support groups and local charities. Participants Fifty-five people with chronic stroke (aged 63.5±16y) were recruited between May 2023 and February 2024, with 50 completing the outcome measures collection. Thirty-seven patients were recruited from 5 NHS community stroke services in England, and 18 participants were recruited from the communities, including stroke support groups and local charities. A total of N=15 participants were interviewed and provided feedback. Interventions Participants completed a 6-week virtual rehabilitation program. A certified physiotherapist assessed their performance at baseline and week 6. The system included a range of exercises and exergames designed to improve upper limb function through virtual therapy sessions. Main Outcome Measures Fugl-Meyer Assessment scores for upper extremity motor function, feasibility and acceptability of telerehabilitation method, and participant feedback. Results Clinical outcome: Fugl-Meyer Assessment results showed significant improvements in upper extremity motor function, with mean scores ± SD increasing from 22.54±6.69 at baseline to 24.78±6.78 at 6 weeks (P<.001). Feasibility: A high completion rate (91%) for outcome measure collection was achieved with an average of 17.6±18.4 sessions, an average of 1449±2108 repetitions executed, and average activity time of 211.2±320.9 minutes, indicating strong feasibility for future trials. Stakeholder Feedback: Interviews with patients, carers, and therapists identified both benefits, such as improved mobility and confidence, and challenges, including technical issues and setup difficulties. Conclusions The EvolvRehab MoveWell system shows potential for supporting stroke rehabilitation in community settings, demonstrating significant clinical improvements and high feasibility. However, further research is necessary to establish its long-term clinical and economic benefits. Disclosures none.

Introduction People living alone with neurodegenerative conditions face unique difficulties in maintaining independence and accessing appropriate health and social care support. Consolidating current understanding regarding these unique difficulties would better inform health and social care services and enable more tailored and appropriate service delivery. The proposed scoping review will summarise evidence from studies that provide evidence about people with dementia, Parkinson’s disease, Huntington’s disease or motor neurone disease who live alone. This protocol sets out the processes that will be followed in the subsequent scoping review to ensure that a transparent, rigorous and reproducible approach is used to identify, select and synthesise relevant evidence.Methods and analysis This scoping review protocol uses well-established methodology outlined by the Preferred Reporting Items for Systematic review and Meta-Analysis and the Joanna Briggs Institute. Relevant publications will be searched using PubMed, Web of Science Core Collection, CINAHL and AgeLine via EBSCOhost and EMBASE, PsycInfo and Social Policy and Practice via Ovid. Grey literature will be searched via Google looking specifically for pdf documents. As there was no previous review on the topic, no date restrictions will be applied to the searches. Piloting of the search strategy provided an estimate of the number of titles likely to require title and abstract screening, which, along with prior experience from a similar review approach, informed the feasibility of the proposed strategy. For research publications, a two-stage screening approach will be undertaken. The first stage will involve screening titles and abstracts for relevant literature on people with neurodegenerative conditions living alone in the community. The second stage will involve full text screening of selected articles. For grey literature, the first 20 PDFs per website identified in Google will be downloaded and screened. Summary data will be extracted from publications selected for inclusion. Data synthesis will involve tabulating study characteristics and findings and preparing narrative summaries to identify commonalities, gaps and areas for future research.Ethics and dissemination Ethical approval is not required for this review, as the information included is in the public domain and people with lived experience are consultees rather than research participants. Consultation with people with lived experience, stakeholders and experts linked with the National Institute for Health and Care Research Policy Research Unit in Dementia and Neurodegeneration University of Exeter will help to ensure the relevance and applicability of findings. Dissemination will include a policy report and peer-reviewed publications aimed at informing policy, practice and improving support services for people living alone with neurodegenerative conditions.

Background:Frailty is an especially significant consequence of ageing with resulting physical decline. Some studies suggest that exercise can reduce the deleterious effects of ageing and have a positive impact on functional ability and quality of life. Further research was required to determine the clinical effectiveness and cost-effectiveness of extended community-based rehabilitation for older people following acute illness or injury. The Home-based Extended Rehabilitation for Older people trial included an embedded process evaluation and compared provision of a home-based graded exercise programme plus usual care (the Home-based Older People's Exercise intervention) versus usual care alone for community-dwelling older people with frailty. Methods:Qualitative mixed-methods process evaluation incorporating non-participant observations, semistructured interviews and analysis of therapy records and participants' exercise diaries. Primary aims of the process evaluation were to explore fidelity and acceptability in intervention delivery. Data analysis was based on thematic analysis and was underpinned by Normalisation Process Theory. Results:Data were generated in 10 community services in England. Non-participant observations of 10 staff training sessions, 61 intervention delivery sessions and 8 staff trial update sessions were completed. Semistructured interviews were conducted with 10 therapy service managers, 19 therapists and 4 therapy assistants. Thirty-five interviews were conducted with intervention participants, with some including supporting carers, and 19 with usual care only participants. There was evidence of fidelity to the intervention protocol, with no significant variation between sites. Less experienced therapists were sometimes less confident in making judgements about what exercises could be adapted and tailored to the individual while maintaining intervention fidelity. Most therapists utilised planned behaviour change techniques to engage participants and sustain their involvement in the exercise programme. Intervention acceptability was generally good, with therapy staff and participants noting potential and actual benefits of the intervention and associated physical improvements for participants completing the 24-week intervention. Usual care only participant interviews provided no evidence of engagement with or perceived benefit from community-based programmes provided by the National Health Service or private providers which were equivalent to the Home-based Older People's Exercise intervention. Therapists and therapy service managers noted the value of the Home-based Older People's Exercise intervention as an addition to existing programmes that were designed to reduce the likelihood of older people with frailty requiring hospital admission. However, they felt that embedding the intervention in routine service provision would prove to be challenging within the existing resource allocation. Limitations:It was necessary to utilise convenience sampling for some of the data collection. It proved to be difficult to recruit family carers, as many participants lived alone. These issues may have impacted the extent to which participants were fully representative of the population targeted in the Home-based Extended Rehabilitation for Older people trial. Conclusions:Home-based Older People's Exercise was perceived to be an acceptable rehabilitation intervention, which could be utilised to extend existing home-based rehabilitation for older people living with frailty. With appropriate resource allocation, it could be delivered by therapists and appropriately trained and supervised therapy assistants in community-based rehabilitation settings. Future work:Research is needed to evaluate the effectiveness of structured, individually tailored, exercise interventions, like Home-based Older People's Exercise, within inpatient and community-based intermediate care settings, recognising the variation in delivery models across health services. Funding:This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/43/07.

BACKGROUND:People with dementia who have a fall can experience both physical and psychological effects, often leading to diminished independence. Falls impose economic costs on the healthcare system. Despite elevated fall risks in dementia populations, evidence supporting effective home-based interventions remains limited. METHODS:Multiple-methods process evaluation within a pilot cluster randomised controlled trial informed by a realist approach. Settings included six UK sites/clusters (three intervention, three control). Fidelity checks on routine data collection and fidelity observations of intervention sessions, multidisciplinary team meetings and supervision sessions were undertaken. Semi-structured interviews were conducted with people with dementia, caregivers and intervention therapists. RESULTS:The MAINTAIN intervention demonstrated high fidelity in home assessments and intervention delivery, with participants receiving a mean of 15 of the 22 available sessions with a range of 5-25 sessions. Qualitative findings revealed that regular home visits increased engagement and motivation. Multidisciplinary team support enhanced therapists' confidence, particularly with complex cases. While most participants achieved their functional goals and reported improved confidence, challenges included geographical disparities in service delivery, carer burden and varying effectiveness of referral pathways. Therapists' attitudes towards advanced dementia influenced intervention delivery. The paired approach, involving both the person living with dementia and their carer, supported activity engagement but occasionally added extra responsibilities for caregivers. CONCLUSIONS:MAINTAIN was both feasible and acceptable. Future studies should consider standardising multidisciplinary support, incorporating targeted falls-related anxiety support and establishing sustainable post-intervention maintenance strategies. Protocol adaptations, such as video consultations, showed promise in addressing workforce constraints.

There is limited evidence on the optimal frequency of mammogram surveillance. At 5-year follow-up, the Mammo-50 trial found that, in patients aged 50+ and 3 years post diagnosis, less frequent mammograms were non-inferior to annual mammograms for breast-cancer-specific-survival, recurrence-free interval and overall survival. A within-trial cost-effectiveness analysis compared annual versus less frequent mammogram surveillance over 5 years from healthcare and societal perspectives. Hospital Episodes Statistics captured hospital-based resource use. Health-related quality of life and other cost data were obtained via questionnaires at surveillance mammograms. A budget impact analysis estimated NHS savings. Less frequent surveillance led to cost savings of −£543.88 (−£1116; £26) and a small reduction in quality-adjusted life years (QALYs) of −0.02 (−0.095; 0.06) per patient. The incremental net monetary benefit at a £20,000/QALY threshold was £187 (−£1574; £2027). Including societal costs increased savings to £1543 per person (−£2416; −£669), and cost-effectiveness. Projected NHS savings were £185.87 million over 6 years. Less frequent mammogram surveillance is cost-effective. Uncertainty remains due to variability in costs and quality of life estimates, and missing data in the less frequent arm due to study design. Given the trial’s non-inferiority findings, this strategy is recommended from healthcare and societal perspectives.

When implementing multicomponent interventions, fidelity to the intervention is key for reproducible outcomes. This study investigates the main influences on the fidelity (implementation strategy fidelity and intervention delivery fidelity) of the community-based Falls Management Exercise (FaME) programmes in three different areas of England. FaME classes across Greater Manchester (GM), Devon and the East Midlands (EM) were studied between 2021 and 23 using a mixed-methodological approach. Data sources included interviews, observations of FaME classes, field notes, and communities of practice recordings. Forty interviews were conducted with stakeholders, providers and class attendees. Additionally, twenty-one class observations were conducted. Triangulated quantitative and qualitative data revealed issues with fidelity to the FaME programme, especially in sites with limited oversight roles/structures and limited funding. There was a lack of understanding and clarity of essential components which impacted both implementation strategy and intervention delivery fidelity. The conceptual map developed highlights the importance of mediators of fidelity in relation to implementation and delivery, including: economic influence, organisational influence, oversight roles, fidelity evaluation, participant responsiveness, essential components and knowledge, training and professionalism. Despite a recognised need for implementing evidence-based falls prevention programmes, a lack of sufficient funding, formalised oversight roles/structures and understanding of essential intervention components is associated with lower fidelity to the intervention. Unchecked by local monitoring, this can lead to an incremental migration of delivery away from the evidence base. We recommend: (i) providers have clarity on essential intervention components, (ii) standardised fidelity monitoring based on essential components, and (iii) effective local oversight roles and structures.

The finding that 40% of community-dwelling individuals with dementia in England live alone challenges still-prevalent assumptions about availability of informal carers. We conducted a scoping review to synthesise knowledge about their characteristics and needs and how best to support them, in consultation with people with lived experience and other stakeholders. Following PRISMA-ScR guidelines, we searched for English-language publications in seven databases without date restriction. After screening, 200 articles reporting on 161 discrete studies met inclusion criteria. Findings showed that people living alone with dementia are more likely to be female and older, with pre-existing social disadvantage, significant unmet needs, and varying levels of informal support. Although no different to those living with others in dementia symptoms or general health, people living alone are subject to inequalities in relation to diagnosis, provision of formal support, financial burden and transition to institutional care. They experience greater loneliness and isolation and more challenges in everyday life. Family members and professionals are primarily concerned with balancing risk and autonomy, but family members involved at a distance receive little support. Although people living alone have more unmet needs and different needs to those living with others, surprisingly few studies explored ways of addressing these needs or improving support. We conclude that living alone with dementia is a neglected source of inequality. We offer recommendations for policy and practice in four key areas: robust estimation of numbers, increasing service responsiveness, strengthening community support, and ensuring research is inclusive and focused on practical ways of improving support.

BACKGROUND:Frailty increases vulnerability to major health changes because of seemingly small health problems. It affects around 10% of people aged >65 years. Older adults with frailty frequently have multiple long-term conditions, personal challenges, and social problems. Personalised care planning (PCP) based on 'goal setting' and 'action planning' is a promising way to address the needs of older adults living with frailty. AIM:To identify and explore factors that influence the implementation of PCP-style interventions for older adults. DESIGN & SETTING:We conducted a scoping review and identified a small number of interventions that explicitly employed goal setting and action planning. METHOD:We used a range of sources to identify relevant material. We included all interventions inclusive of patients aged ≥65 years and reported in English. We excluded end-of-life care interventions, group education, and/or those that did not involve one-to-one engagement. We explored all related articles that described, examined, or discussed implementation. We constructed a thematic framework in NVivo (version 11). Findings were narratively synthesised. RESULTS:We identified 18 potentially relevant PCP-style interventions and 13 of these met the inclusion criteria. Within these, were seven main categories of potentially modifiable influences relevant to older adults with frailty related to the following: primary care engagement; delivery staff characteristics; training; patient engagement; collaborative working; organisation and management; and systems. CONCLUSION:Many modifiable factors can influence the implementation of PCP. We identified several influences that have informed the development and implementation of a novel intervention PeRsOnaliSed care Planning for oldER people with frailty (PROSPER).

PURPOSE A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self-efficacy, without increasing hospital admissions and visits. The aim of this study was to evaluate the cost-effectiveness of the eRAPID eHealth intervention compared with usual care for patients receiving systemic treatment for colorectal, breast, or gynecologic cancers in the United Kingdom. METHODS An embedded economic evaluation was conducted alongside the trial evaluating the effectiveness of eRAPID from health care provider and societal perspectives. Costs and quality-adjusted life-years (QALYs) of patients were compared over 18 weeks of the trial. Incremental cost-effectiveness ratios (ICERs) were estimated and compared with the National Institute for Health and Care Excellence cost-effectiveness threshold. Uncertainty around the ICER was explored using nonparametric bootstrapping and sensitivity analyses. Follow-up data were collected 12-months after random assignment for a subset of the study sample to conduct exploratory analysis of potential longer-term effects. RESULTS Patients in the eRAPID group had the highest QALY gain and lowest costs over 18 weeks. Although differences were small and not statistically significant, eRAPID had a 55%-58% probability of being more cost-effective than usual care. Patient out-of-pocket costs were lower in the eRAPID group, indicating eRAPID may help patients access support needed within the National Health Service. Exploratory 12-months analysis showed small differences in costs and QALYs, with higher QALY gains in the eRAPID group but also higher costs. Exploratory subgroup analysis by disease status indicated that the eRAPID intervention was cost-effective for patients with early-stage cancers but not for patients with metastatic disease. CONCLUSION Despite small differences in QALYs and costs, the analyses show potential cost-effectiveness of online symptom monitoring, when added to usual care, particularly during adjuvant systemic treatment for early-stage cancers.

Background The Falls Management Exercise (FaME) Programme is a group-based, face-to-face and home-based, six-month multi-component exercise intervention for older adults. It reduces falls and fear of falling, increases physical activity and improves confidence and balance. FaME is also cost effective. Despite this evidence, it is not widely available in the UK. Objective To study the spread, implementation, adherence, 'real world' outcomes and quality management of FaME in 14 organisations across three demographically diverse regions of the UK. Programme Description Using the Consolidated Framework for Implementation Research to map themes, we undertook a qualitative analysis of 40 Semi-structured interviews with FaME commissioners, providers and participants, 25 class observations and content analysis of management documents. To assess participant outcomes we analysed quantitative functional and self-reported fall outcomes from 1601 participants. Outcomes and Learnings Class availability tripled in one region, whilst delivery remained consistent in others. Factors influencing spread included FaME's evidence base, perceived fit with organisational values and the personal experiences and beliefs of decision-makers. Univariate pre/post analyses of routinely-collected outcomes showed significant improvements in confidence and balance (Confbal p<0.001), falls (in the previous 3 months, p<0.001) and Timed-Up-and-Go (p<0.001). Participants valued social opportunities as well as improvements in their physical abilities and reported wellbeing benefits beyond fall prevention. Newer programmes or those with quality assurance systems in place showed higher fidelity and quality. Programmes varied in duration and aspects of delivery but a national community of practice forum provided improvement opportunities and mechanisms. Implications Complex and interacting factors influence FaME's availability, delivery, uptake, participant adherence and outcomes. Findings could be extrapolated to other exercise interventions and have informed the production of an updated implementation toolkit to assist its high-quality implementation. Conclusions FaME is an evidence-based fall prevention programme but delivery is often inconsistent and there are areas without any provision in the UK. Awareness of its evidence-base is necessary but not sufficient for spread and measures to ensure continued fidelity, quality, outcomes and adherence need to be designed into contracted delivery.

Objectives During 2015–2018, a randomised controlled trial (RCT) evaluated eRAPID, an eHealth intervention designed to capture patient-reported symptoms online during cancer treatment. eRAPID provides patients with advice on when to self-manage or seek medical support. Clinicians accessed symptom reports within electronic patient records. 508 participants starting systemic cancer treatment were recruited and followed for 18 weeks. The intervention group (n=256) was asked to access eRAPID and complete weekly online symptom reports. Clinicians received training on accessing and interpreting symptom reports. Overall, eRAPID had a positive impact on patients’ symptoms, quality of life and self-efficacy, particularly early in treatment and for patients with early-stage disease. Using mixed methods, we aimed to gather insight from patients and clinicians on how eRAPID worked to facilitate the interpretation of RCT findings.Methods Following a concurrent triangulation design, patient experiences of eRAPID were gathered via end-of-study interviews (n=45) and questionnaires (n=186). Clinician experiences were obtained by end-of-study interviews (n=18) and completion, throughout the trial, of feedback questionnaires (n=787 from n=55 clinicians). Framework analysis was applied to examine qualitative data and close-ended questions were descriptively summarised. Findings were mapped against results from the RCT.Setting Medical oncology services, UK cancer centre.Results Patient feedback indicated eRAPID was easy to use. Adherence to weekly reporting was influenced by health status, reminders, perceived value and clinical use. Patient-reported benefits of eRAPID included an enhanced connection with the hospital, provision of practical advice and personal monitoring, which provided reassurance and empowerment. Clinicians were positive about the potential for online symptom monitoring but had mixed levels of direct experience with using eRAPID during the trial. Patients echoed this and recommended more explicit clinician use of symptom data.Conclusions The mixed-method approach to capturing patient and clinician opinions provided valuable insight into the eRAPID intervention and complementary information on how the intervention was received and functioned.

Background:Liaison mental health services provide mental health care to patients in acute hospital settings. Evaluation of liaison services is challenging due to their heterogeneous organisation and delivery, high case throughput and varied patient case mix. We aimed to link routinely collected National Health Service data from secondary care settings, chosen for their service characteristics, to data from primary care to evaluate hospital-based liaison mental health services in England. Methods:We planned to compare patients referred to hospital-based liaison services with comparable patients in the same hospital not referred to liaison services and comparable patients in hospitals without any liaison services. We designed and enacted a methodology to link data from: (1) Hospital Episode Statistics, a database controlled by the National Health Service Digital and (2) ResearchOne, a primary care database controlled by The Phoenix Partnership. Results:Obtaining approvals for the steps prespecified in the methodological protocol took 907 days. Enactment following approvals took 385 days. Data supplied from Hospital Episode Statistics contained 181,063 patients from 6 hospitals (mean = 30,177, standard deviation = 28,875.86) who matched the inclusion and exclusion criteria. Data supplied from ResearchOne contained 33,666 (18.6%) of these patients from the 6 hospitals (mean = 5611, standard deviation = 5206.59). Discussion:Time required for approvals and enactment was attributable to slowness of data handling processes within each data holder and to resolution of technical and organisational queries between them. Variation in number of patients for which data was supplied between databases and between hospitals was attributable to coding inconsistencies and to the limited intersection of patient populations between databases and variation in recording practices between hospitals. Conclusion:Although it is technically feasible to link primary and secondary care data, the current system is challenging, complicated, unnecessarily bureaucratic, time consuming and costly. This limits the number of studies that could be conducted with these rich data sources. Funding:This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 13/58/08.

Background Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic changes in health because of relatively small problems. Older people with frailty are at increased risk of adverse outcomes including disability, hospitalisation, and care home admission, with associated reduction in quality of life and increased NHS and social care costs. Personalised Care Planning offers an anticipatory, preventative approach to supporting older adults to live independently for longer, but it has not been robustly evaluated in a population of older adults with frailty. Methods Following an initial feasibility study, this multi-centre, individually randomised controlled trial aims to establish whether personalised care planning for older people improves health-related quality of life. It will recruit 1337 participants from general practices across Yorkshire and Humber and Mid-Mersey in the North of England. Eligible patients will be aged 65 and over with an electronic frailty index score of 0.21 or above, living in their own homes, without severe cognitive impairment and not in receipt of end-of-life care. Following confirmation of eligibility, informed consent and baseline data collection, participants will be individually randomised to the PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) intervention or usual care in a 2.6:1 allocation ratio. Participants will not be blinded to allocation, but data collection and analysis will be blinded. The intervention will be delivered over 12 weeks by a Personal Independence Co-ordinator worker based within a voluntary sector organisation, Age UK. The primary outcomes are health-related quality of life, measured using both the physical and mental components of the Short-Form 12 Item Health Questionnaire at 12 months after randomisation. Secondary outcomes comprise activities of daily living, self-management capabilities and loneliness, admission to care homes, hospitalisations, and health and social care resource use at 12 months post randomisation. Parallel cost-effectiveness and process evaluations will be conducted alongside the trial. Discussion The PROSPER study will evaluate the effectiveness and cost-effectiveness of a personalised care planning approach for older people with frailty and inform the process of its implementation. Trial registration mailto:ISRCTN16123291. Registered on 28 August 2020.

BACKGROUND:Approximately 1.5 million adults in the UK have a learning disability. The difference between age at death for this group and the general population is 26 years for females and 22 years for males. The NHS Long Term Plan (January 2019) recognises learning disabilities as a clinical priority area. People with a learning disability are often excluded from research by design or lack of reasonable adjustments, and self-reported health status/health-related quality of life questionnaires such as the EQ-5D are often not appropriate for this population. Here, we systematically examine the EQ-5D-3L (its wording, content, and format) using qualitative methods to inform the adaption of the measure for use with adults with mild to moderate learning disabilities.METHODS:Think-aloud interviews with carers/advocates of learning-disabled adults were undertaken to explore the difficulties with completing the EQ-5D-3L. Alternative wording, language, structure, and images were developed using focus groups, stakeholder reference groups, and an expert panel. Data analysis followed a framework method.RESULTS:The dimensions and levels within the EQ-5D-3L were deemed appropriate for adults with mild to moderate learning disabilities. Consensus on wording, structure, and images was reached through an iterative process, and an adapted version of the EQ-5D-3L was finalised.CONCLUSION:The EQ-5D-3L adapted for adults with mild to moderate intellectual/learning disabilities can facilitate measurement of self-reported health status. Research is underway to assess the potential use of the adaptation for economic evaluation.

Introduction Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.Method and analysis This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.Ethics and dissemination The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.Trial registration number ISRCTN16413728.