To undertake a mixed-methodology implementation study to improve the well-being of men with gastrointestinal late effects following radical radiotherapy for prostate cancer. All men completed a validated screening tool for late bowel effects (ALERT-B) and the Gastrointestinal Symptom Rating Score (GSRS); men with a positive score on ALERT-B were offered management following a peer reviewed algorithm for pelvic radiation disease (PRD). Health-related quality of life (HRQoL) at baseline, 6 and 12 months; and healthcare resource usage (HRU) and patient, support-giver, staff experience and acceptability of staff training (qualitative analysis) were assessed. Two nurse- and one doctor-led gastroenterology services were set up in three UK cancer centres. Men (n = 339) who had had radical radiotherapy for prostate cancer at least 6 months previously, were recruited; of which 91/339 were eligible to participate; 58/91 men (63.7%) accepted the referral. Diagnoses included: radiation proctopathy (n = 18); bile acid malabsorption (n = 15); fructose or lactose intolerance and/or small intestinal bacterial overgrowth (n = 20); vitamin B12/D deficiency (n = 20). Increases in quality of life, sexual activity and/or sexual function, and decrease in specific symptoms (e.g. bowel-related or urinary) between 6 and 12 months were observed. Limited HRU modelling suggested staff costs were £117-£185, depending on the service model; total costs averaged £2,243 per patient. Both staff and patients welcomed the new service although there was concern about long-term funding and sustainability beyond the timeframe of the study (qualitative). PRD is increasingly recognised worldwide as an ongoing consequence of curative pelvic radiotherapy, despite widespread implementation of advanced radiotherapy techniques. Specialised services following national guidelines are required.

Background In the UK, over 100,000 people have a stroke annually. Over 1.3 million live with the effects of stroke, including problems with mobility, communication, cognition, anxiety, depression and fatigue. Previous research has tested single interventions to improve stroke outcomes in separate, fixed design, parallel-group trials. Evidence generation has been slow and inefficient. Adaptive trial designs are required, to better understand multiple treatments, targeting multiple questions simultaneously. We undertook to develop the first efficient adaptive platform trial protocol, aligned with national research priorities for ‘Life After Stroke’. Methods We embedded PPI activities throughout the platform development and co-developed resources to maximise equality, diversity, and inclusion. We established an inclusive multidisciplinary collaboration to inform design choices and future UK-wide platform delivery. We scrutinised existing research to identify candidate interventions and relevant outcomes; agreeing these with collaborators and PPI. We undertook detailed simulations to inform choice of platform design (adaptive elements, allocation, numbers of interventions, decision criteria for dropping/adding arms, interim analyses timing/frequency; intermediate outcomes choice). We explored barriers to trial and intervention participation through in-person and virtual meetings. To facilitate rapid trial set-up, we engaged with stroke research leaders and data providers; reviewed platform randomisation requirements; and widely disseminated our learning. Results We developed an efficient, adaptive trial protocol, which is feasible, inclusive and acceptable to stroke survivors and services and submitted a funding application for a platform trial testing at least five pre-determined non-pharmacological interventions for post-stroke emotional difficulties, the top research priority for ‘Life After Stroke’. Conclusions The complex and inclusive platform trial design has only been possible through UK-wide multidisciplinary collaboration with stroke researchers, trialists, clinicians, methodologists, third sector, and patient and public contributors. Such a trial would be a step-change in trial design, reducing research waste and accelerating evidence generation to inform improved stroke service provision world-wide.

Background Sustaining independence is important for older people, but there is insufficient guidance about which community health and care services to implement. Objectives To synthesise evidence of the effectiveness of community services to sustain independence for older people grouped according to their intervention components, and to examine if frailty moderates the effect. Review design Systematic review and network meta-analysis. Eligibility criteria Studies: Randomised controlled trials or cluster-randomised controlled trials. Participants: Older people (mean age 65+) living at home. Interventions: community-based complex interventions for sustaining independence. Comparators: usual care, placebo or another complex intervention. Main outcomes Living at home, instrumental activities of daily living, personal activities of daily living, care-home placement and service/economic outcomes at 1 year. Data sources We searched MEDLINE (1946–), Embase (1947–), CINAHL (1972–), PsycINFO (1806–), CENTRAL and trial registries from inception to August 2021, without restrictions, and scanned reference lists. Review methods Interventions were coded, summarised and grouped. Study populations were classified by frailty. A random-effects network meta-analysis was used. We assessed trial-result risk of bias (Cochrane RoB 2), network meta-analysis inconsistency and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation for network meta-analysis). Results We included 129 studies (74,946 participants). Nineteen intervention components, including ‘multifactorial-action’ (multidomain assessment and management/individualised care planning), were identified in 63 combinations. The following results were of low certainty unless otherwise stated. For living at home, compared to no intervention/placebo, evidence favoured: multifactorial-action and review with medication-review (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty) multifactorial-action with medication-review (odds ratio 2.55, 95% confidence interval 0.61 to 10.60) cognitive training, medication-review, nutrition and exercise (odds ratio 1.93, 95% confidence interval 0.79 to 4.77) and activities of daily living training, nutrition and exercise (odds ratio 1.79, 95% confidence interval 0.67 to 4.76). Four intervention combinations may reduce living at home. For instrumental activities of daily living, evidence favoured multifactorial-action and review with medication-review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living. For personal activities of daily living, evidence favoured exercise, multifactorial-action and review with medication-review and self-management (standardised mean difference 0.16, 95% confidence interval −0.51 to 0.82). For homecare recipients, evidence favoured the addition of multifactorial-action and review with medication-review (standardised mean difference 0.60, 95% confidence interval 0.32 to 0.88). Care-home placement and service/economic findings were inconclusive. Limitations High risk of bias in most results and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. Studies were diverse; findings may not apply to all contexts. Conclusions Findings for the many intervention combinations evaluated were largely small and uncertain. However, the combinations most likely to sustain independence include multifactorial-action, medication-review and ongoing review of patients. Some combinations may reduce independence. Future work Further research is required to explore mechanisms of action and interaction with context. Different methods for evidence synthesis may illuminate further. Study registration This study is registered as PROSPERO CRD42019162195. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR128862) and is published in full in Health Technology Assessment; Vol. 28, No. 48. See the NIHR Funding and Awards website for further award information.

OBJECTIVE To synthesise evidence of the effectiveness of community based complex interventions, grouped according to their intervention components, to sustain independence for older people. DESIGN Systematic review and network meta -analysis. DATA SOURCES Medline, Embase, CINAHL, PsycINFO, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to 9 August 2021 and reference lists of included studies. ELIGIBILITY CRITERIA Randomised controlled trials or cluster randomised controlled trials with >= 24 weeks' follow-up studying community based complex interventions for sustaining independence in older people (mean age >= 65 years) living at home, with usual care, placebo, or another complex intervention as comparators. MAIN OUTCOMES Living at home, activities of daily living (personal/ instrumental), care home placement, and service/ economic outcomes at 12 months. DATA SYNTHESIS Interventions were grouped according to a specifically developed typology. Random effects network meta -analysis estimated comparative effects; Cochrane's revised tool (RoB 2) structured risk of bias assessment. Grading of recommendations assessment, development and evaluation (GRADE) network meta-analysis structured certainty assessment. RESULTS The review included 129 studies (74 946 participants). Nineteen intervention components, including "multifactorial action from individualised care planning" (a process of multidomain assessment and management leading to tailored actions), were identified in 63 combinations. For living at home, compared with no intervention/placebo, evidence favoured multifactorial action from individualised care planning including medication review and regular follow-ups (routine review) (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty); multifactorial action from individualised care planning including medication review without regular follow-ups (2.55, 0.61 to 10.60; low certainty); combined cognitive training, medication review, nutritional support, and exercise (1.93, 0.79 to 4.77; low certainty); and combined activities of daily living training, nutritional support, and exercise (1.79, 0.67 to 4.76; low certainty). Risk screening or the addition of education and self-management strategies to multifactorial action from individualised care planning and routine review with medication review may reduce odds of living at home. For instrumental activities of daily living, evidence favoured multifactorial action from individualised care planning and routine review with medication review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living: combined activities of daily living training, aids, and exercise; and combined activities of daily living training, aids, education, exercise, and multifactorial action from individualised care planning and routine review with medication review and self-management strategies. For personal activities of daily living, evidence favoured combined exercise, multifactorial action from individualised care planning, and routine review with medication review and self-management strategies (0.16, -0.51 to 0.82; low certainty). For homecare recipients, evidence favoured addition of multifactorial action from individualised care planning and routine review with medication review (0.60, 0.32 to 0.88; low certainty). High risk of bias and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. CONCLUSIONS The intervention most likely to sustain independence is individualised care planning including medicines optimisation and regular follow-up reviews resulting in multifactorial action. Homecare recipients may particularly benefit from this intervention. Unexpectedly, some combinations may reduce independence. Further research is needed to investigate which combinations of interventions work best for different participants and contexts.

INTRODUCTION:Maintaining independence is a primary goal of community health and care services for older people, but there is currently insufficient guidance about which services to implement. Therefore, we aim to synthesise evidence on the effectiveness of community-based complex interventions to sustain independence for older people, including the effect of frailty, and group interventions to identify the best configurations. METHODS AND ANALYSIS:Systematic review and network meta-analysis (NMA). We will include randomised controlled trials (RCTs) and cluster RCTs of community-based complex interventions to sustain independence for older people living at home (mean age ≥65 years), compared with usual care or another complex intervention. We will search MEDLINE (1946 to September 2020), Embase (1947 to September 2020), CINAHL (1981 to September 2020), PsycINFO (1806 to September 2020), CENTRAL and clinical trial registries from inception to September 2020, without date/language restrictions, and scan included papers' reference lists. Main outcomes were: living at home, activities of daily living (basic/instrumental), home-care services usage, hospitalisation, care home admission, costs and cost effectiveness. Additional outcomes were: health status, depression, loneliness, falls and mortality. Interventions will be coded, summarised and grouped. An NMA using a multivariate random-effects model for each outcome separately will determine the relative effects of different complex interventions. For each outcome, we will produce summary effect estimates for each pair of treatments in the network, with 95% CI, ranking plots and measures, and the borrowing of strength statistic. Inconsistency will be examined using a 'design-by-treatment interaction' model. We will assess risk of bias (Cochrane tool V.2) and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation for NMA approach. ETHICS AND DISSEMINATION:This research will use aggregated, anonymised, published data. Findings will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. They will be disseminated to policy-makers, commissioners and providers, and via conferences and scientific journals. PROSPERO REGISTRATION NUMBER:CRD42019162195.

Review undertaken to identify and explore suitable strategies and interventions for managing or reducing the impact of pain for community-dwelling older people with frailty from the evidence in a broader population. Thirty-one randomised controlled trials (RCTs) that collectively evaluated 16 pain management programmes and 17 psychological therapies were identified. The common mechanisms of change proposed in the studies were enhancing self-efficacy, using positive psychological skills or refocusing attention to improve responses to pain, and practising physical exercises to improve physiological well-being and reduce restrictions from pain. All the evaluated interventions appeared to show potential benefits to older people that may be transferable to those with frailty. Persistent pain is common in older people and people living with frailty. Pain or the impact of pain on everyday life is potentially modifiable. We sought to map research evidence and information from randomised controlled trials (RCTs) of pain management programmes and psychological therapies targeting community-dwelling older people, and explore appropriate strategies and interventions for managing or reducing the negative impact of pain for older people, particularly those with frailty. A mapping review of pain management programmes and psychological therapies for community-dwelling older people living with chronic pain. We searched for systematic reviews of randomised controlled trials and for individual randomised controlled trials and extracted data from eligible studies. Searches resulted in 3419 systematic review records and 746 RCT records from which there were 33 eligible interventions identified in 31 eligible RCTs (48 reports). Broad aims of the interventions were to: improve physical, psychological, or social functioning; adjust the effects or sensation of pain psychologically; enhance self-care with self-management skills or knowledge. Common mechanisms of change proposed were self-efficacy enhanced by self-management tasks and skills, using positive psychological skills or refocusing attention to improve responses to pain, and practising physical exercises to improve physiological well-being and reduce restrictions from pain. Content of interventions included: skills training and activity management, education, and physical exercise. Interventions were delivered in person or remotely to individuals or in groups, typically in 1–2 sessions weekly over 5–12 weeks. All the evaluated interventions appeared to show potential to provide some benefits to older people. None of the included studies assessed frailty. However, some of the included interventions appear appropriate for community-dwelling older people living with both frailty and pain.

Aims To understand factors related to safety across UK endoscopy in line with the Joint Advisory Group on GI Endoscopy (JAG) ‘Improving Safety and Reducing Error in Endoscopy’ (ISREE) strategy.

Background: Care home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required. Design and setting: Cluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n= 5) or UC only (n= 7). Participants: Permanent residents aged >= 65 years. Intervention: MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents. Objectives and measurements: Feasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants' physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation. Results: 300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was <75%; at 9 months, 65.6% of residents provided valid accelerometer data; two CHs fully, two partially and one failed to implement the intervention. There were no safety concerns. Conclusions: Recruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.

Background Delirium is a distressing, common and serious condition in older people in hospital. Evidence suggests that it could be prevented in about one-third of patients using multicomponent interventions targeting delirium risk factors, but these interventions are not yet routinely available in the NHS. Objective The objective was to improve delirium prevention for older people admitted to the NHS. Design Project 1 comprised case studies employing qualitative methods (observation, interviews, workshops) in three NHS hospitals to develop the Prevention of Delirium system of care. Project 2 comprised case studies using mixed methods in five NHS hospitals to test the Prevention of Delirium implementation, feasibility and acceptability, and to modify the Prevention of Delirium system of care. Project 3 comprised a multicentre, cluster randomised, controlled, pragmatic feasibility study in eight hospitals, with embedded economic evaluation, to investigate the potential clinical effectiveness and cost-effectiveness of the Prevention of Delirium system of care, compared with standard care, among older patients admitted to hospital for emergency care. The primary objectives related to gathering information to design a definitive trial. Criteria for progression to a definitive trial were as follows: a minimum of six wards (75%) completing the Prevention of Delirium manual milestone checklist and an overall recruitment rate of at least 10% of the potential recruitment pool. Setting This study was set in NHS general hospitals. Participants In project 1, participants were staff, volunteers, and patient and carer representatives. In project 2, participants were staff, volunteers, patients and carers. In project 3, participants were older patients admitted to elderly care and orthopaedic trauma wards. Intervention The developed intervention (i.e. the Prevention of Delirium system of care). Main outcome measures For the feasibility study (project 3), the primary outcome measure was the Confusion Assessment Method. The secondary outcome measures were the Nottingham Extended Activities of Daily Living scale, the Clinical Anxiety Scale and the Geriatric Depression Scale Short Form. Results Project 1: understanding of delirium prevention was poor. Drawing on evidence, and working with ward teams, we developed the Prevention of Delirium system of care, which targeted 10 delirium risk factors. This multicomponent intervention incorporated systems and mechanisms to introduce and embed delirium prevention into routine ward practices. Project 2: five out of six wards implemented or partially implemented the Prevention of Delirium intervention. A prominent role for hospital volunteers was intended, but most wards were unable to recruit or sustain the numbers needed. We identified four conditions necessary to implement and deliver the Prevention of Delirium intervention: (1) commitment of senior nurse, (2) a named person to drive implementation forward, (3) dedicated time (1 day per week) of an experienced nurse to lead implementation and (4) adequate ward staffing levels. Overall, the intervention was acceptable to staff, volunteers, patients and carers, and did not increase nursing staff workload. In the light of these findings, the Prevention of Delirium system of care was modified for use in project 3. Project 3: 16 wards in eight hospitals (two wards per hospital) were recruited. Out of 4449 patients screened, 3274 (73.6%) were eligible and 713 were registered, resulting in a recruitment rate of 16.0%. Thirty-three (4.6%) participants withdrew. The screened and registered participants were similar, but some between-treatment group imbalances were noted among those registered to the trial. All eight wards allocated to the intervention group completed the Prevention of Delirium manual milestone checklist and delivered the Prevention of Delirium intervention (median time 18.6 weeks for implementation). Overall, fidelity to the intervention was assessed as being high in two wards, medium in five wards and low in one ward. Of the expected 5645 Confusion Assessment Method delirium assessments, 5065 (89.7%) were completed during the first 10 days of admission. The rates of return of the patient-reported questionnaire booklets were 98.0% at baseline, 81.8% at 30 days and 70.5% at 3 months. The return rate of the EuroQol-5 Dimensions questionnaire was 98.6% at baseline, 77.5% at 1 month and 65.3% at 3 months (94–98% fully completed). The completion rate of the resource use questionnaire was lower (48.7%). The number of people with new-onset delirium at 10 days was 24 (7.0%) in the Prevention of Delirium group and 33 (8.9%) in the control group. Multilevel logistic regression analysis showed that participants in the Prevention of Delirium group had non-significant lower odds of developing delirium (odds ratio 0.68, 95% confidence interval 0.37 to 1.26; p = 0.2225). The average cost of the Prevention of Delirium intervention was estimated as £10.98 per patient and the mean costs for the Prevention of Delirium and usual-care groups were £5332 and £4412, respectively, with negligible between-group differences in quality-adjusted life-years. There was conflicting evidence from the trial- and model-based analyses relating to the cost-effectiveness of the Prevention of Delirium intervention. Given this, and in view of issues with the data (e.g. high levels of missingness), the results from the economic evaluation are highly uncertain. The criteria for continuation to a future definitive randomised controlled trial were met. Such a trial would need to recruit 5200 patients in 26 hospital clusters (200 patients per cluster). Conclusions The Prevention of Delirium system of care was successfully developed, and a multicentre feasibility study showed that the intervention is capable of implementation and delivery in routine care, with acceptable intervention fidelity and preliminary estimate of effectiveness. Limitations A prominent role for volunteers was originally intended in the Prevention of Delirium system of care, but only three of the eight wards allocated to the trial intervention group involved volunteers. Future work The findings indicate that a definitive multicentre evaluation of the Prevention of Delirium system of care should be designed and conducted to obtain robust estimates of clinical effectiveness and cost-effectiveness. Trial registration Current Controlled Trials ISRCTN28213290 (project 1), ISRCTN65924234 (project 2) and ISRCTN01187372 (project 3). Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research ; Vol. 9, No. 4. See the NIHR Journals Library website for further project information.