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Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were −3·26 kg (brief intervention), −4·75 kg (12-week programme), and −6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference −2·71 kg, 95% CI −3·86 to −1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (−2·14 kg, −3·05 to −1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

ObjectiveTo evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention.DesignA multicentre cluster randomised controlled trial.SettingClusters were 33 hospital wards within five hospitals in the UK.ParticipantsAll patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition.InterventionThe ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings.MeasurementsPrimary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS).ResultsIntervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention.LimitationsAdherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure.ConclusionsPatients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components.Trial registration numberISRCTN07689702; pre-results.

Uptake in the national colorectal cancer screening programme in England varies by socioeconomic status. We assessed four interventions aimed at reducing this gradient, with the intention of improving the health benefits of screening. All people eligible for screening (men and women aged 60–74 years) across England were included in four cluster-randomised trials. Randomisation was based on day of invitation. Each trial compared the standard information with the standard information plus the following supplementary interventions: trial 1 (November, 2012), a supplementary leaflet summarising the gist of the key information; trial 2 (March, 2012), a supplementary narrative leaflet describing people's stories; trial 3 (June, 2013), general practice endorsement of the programme on the invitation letter; and trial 4 (July–August, 2013) an enhanced reminder letter with a banner that reiterated the screening offer. Socioeconomic status was defined by the Index of Multiple Deprivation score for each home address. The primary outcome was the socioeconomic status gradient in uptake across deprivation quintiles. This study is registered, number ISRCTN74121020. As all four trials were embedded in the screening programme, loss to follow-up was minimal (less than 0·5%). Trials 1 (n=163 525) and 2 (n=150 417) showed no effects on the socioeconomic gradient of uptake or overall uptake. Trial 3 (n=265 434) showed no effect on the socioeconomic gradient but was associated with increased overall uptake (adjusted odds ratio [OR] 1·07, 95% CI 1·04–1·10, p<0·0001). In trial 4 (n=168 480) a significant interaction was seen with socioeconomic status gradient (p=0·005), with a stronger effect in the most deprived quintile (adjusted OR 1·11, 95% CI 1·04–1·20, p=0·003) than in the least deprived (1·00, 0·94–1·06, p=0·98). Overall uptake was also increased (1·07, 1·03–1·11, p=0·001). Of four evidence-based interventions, the enhanced reminder letter reduced the socioeconomic gradient in screening uptake, but further reducing inequalities in screening uptake through written materials alone will be challenging. National Institute for Health Research.

BackgroundThe ‘Productive Ward: Releasing Time to Care’ programme is a quality improvement (QI) intervention introduced in English acute hospitals a decade ago to: (1) Increase time nurses spend in direct patient care. (2) Improve safety and reliability of care. (3) Improve experience for staff and patients. (4) Make changes to physical environments to improve efficiency.ObjectiveTo explore how timing of adoption, local implementation strategies and processes of assimilation into day-to-day practice relate to one another and shape any sustained impact and wider legacies of a large-scale QI intervention.DesignMultiple methods within six hospitals including 88 interviews (with Productive Ward leads, ward staff, Patient and Public Involvement representatives and senior managers), 10 ward manager questionnaires and structured observations on 12 randomly selected wards.ResultsResource constraints and a managerial desire for standardisation meant that, over time, there was a shift away from the original vision of empowering ward staff to take ownership of Productive Ward towards a range of implementation ‘short cuts’. Nonetheless, material legacies (eg, displaying metrics data; storage systems) have remained in place for up to a decade after initial implementation as have some specific practices (eg, protected mealtimes). Variations in timing of adoption, local implementation strategies and contextual changes influenced assimilation into routine practice and subsequent legacies. Productive Ward has informed wider organisational QI strategies that remain in place today and developed lasting QI capabilities among those meaningfully involved in its implementation.ConclusionsAs an ongoing QI approach Productive Ward has not been sustained but has informed contemporary organisational QI practices and strategies. Judgements about the long-term sustainability of QI interventions should consider the evolutionary and adaptive nature of change processes.

Treatment guidelines identify few adequately powered trials to guide recommendations for anorexia nervosa. To evaluate the effectiveness of three readily available National Health Service treatments for adolescents (aged 12-18 years) with anorexia nervosa. Multicentre randomised controlled trial of 167 young people comparing in-patient, specialist out-patient and general child and adolescent mental health service (CAMHS) treatment. Each group made considerable progress at 1 year, with further improvement by 2 years. Full recovery rates were poor (33% at 2 years, 27% still with anorexia nervosa). Adherence to in-patient treatment was only 50%. Neither in-patient nor specialist out-patient therapy demonstrated advantages over general CAMHS treatment by intention to treat, although some CAMHS out-patients were subsequently admitted on clinical grounds. In-patient treatment (randomised or after out-patient transfer) predicted poor outcomes. First-line in-patient psychiatric treatment does not provide advantages over out-patient management. Out-patient treatment failures do very poorly on transfer to in-patient facilities.

BackgroundWe assessed impacts of a large, nationwide cardiovascular disease (CVD) risk assessment and management programme on sociodemographic group inequalities in (1) early identification of hypertension, type 2 diabetes (T2D) and chronic kidney disease (CKD); and (2) management of global CVD risk among high-risk individuals.MethodsWe obtained retrospective electronic medical records from the Clinical Practice Research Datalink for a randomly selected sample of 138 788 patients aged 40–74 years without known CVD or diabetes, who were registered with 462 practices between 2009 and 2013. We estimated programme impact using a difference-in-differences matching analysis that compared changes in outcome over time between attendees and non-attendees.ResultsNational Health Service Health Check attendance was 21.4% (29 672/138 788). A significantly greater number of hypertension and T2D incident cases were identified in men than women (eg, an additional 4.02%, 95% CI 3.65% to 4.39%, and 2.08%, 1.81% to 2.35% cases of hypertension in men and women, respectively). A significantly greater number of T2D incident cases were identified among attendees living in the most deprived areas, but no differences were found for hypertension and CKD across socioeconomic groups. No major differences in CVD risk management were observed between sociodemographic subgroups (eg, programme impact on 10-year CVD risk score was −1.13%, −1.48% to −0.78% in male and −1.53%, −2.36% to −0.71% in female attendees).ConclusionDuring 2009–2013, the programme had low attendance and small overall impacts on early identification of disease and risk management. The age, sex and socioeconomic subgroups appeared to have derived similar level of benefits, leaving existing inequalities unchanged. These findings highlight the importance of population-wide interventions to address inequalities in CVD outcomes.

Background Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including but not exclusively, dementia and/or delirium and/or cognitive impairment(s)) before, during or after acute admissions. Older people experiencing hip fracture and confusion risk serious complications, linked to delayed recovery and higher mortality post-operatively. Specific care pathways acknowledging the differences in patient presentation and care needs are proposed to improve clinical and process outcomes. Methods This protocol describes a multi-centre, feasibility, cluster-randomised, controlled trial (CRCT) to be undertaken across ten National Health Service hospital trusts in the UK. The trial will explore the feasibility of undertaking a CRCT comparing the multicomponent PERFECTED enhanced recovery intervention (PERFECT-ER), which acknowledges the differences in care needs of confused older patients experiencing hip fracture, with standard care. The trial will also have an integrated process evaluation to explore how PERFECT-ER is implemented and interacts with the local context. The study will recruit 400 hip fracture patients identified as experiencing confusion and will also recruit “suitable informants” (individuals in regular contact with participants who will complete proxy measures). We will also recruit NHS professionals for the process evaluation. This mixed methods design will produce data to inform a definitive evaluation of the intervention via a large-scale pragmatic randomised controlled trial (RCT). Discussion The trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt. Trial registration ISRCTN, 99336264 . Registered on 5 September 2016.

Background Across sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation. Methods We will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN. Discussion SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up. Trial registration ClinicalTrials.gov NCT04088656 (registered 09/13/2019; https://clinicaltrials.gov/ct2/show/NCT04088656 ).

Background Older people living in care homes in England have complex health needs due to a range of medical conditions, mental health needs and frailty. Despite an increasing policy expectation that professionals should operate in an integrated way across organisational boundaries, there is a lack of understanding between care homes and the National Health Service (NHS) about how the two sectors should work together, meaning that residents can experience a poor \"fit\" between their needs, and services they can access. This paper describes a survey to establish the current extent of integrated working that exists between care homes and primary and community health and social services. Methods A self-completion, online questionnaire was designed by the research team. Items on the different dimensions of integration (funding, administrative, organisational, service delivery, clinical care) were included. The survey was sent to a random sample of residential care homes with more than 25 beds (n = 621) in England in 2009. Responses were analysed using quantitative and qualitative methods. Results The survey achieved an overall response rate of 15.8%. Most care homes (78.7%) worked with more than one general practice. Respondents indicated that a mean of 14.1 professionals/ services (other than GPs) had visited the care homes in the last six months (SD 5.11, median 14); a mean of .39 (SD.163) professionals/services per bed. The most frequent services visiting were district nursing, chiropody and community psychiatric nurses. Many (60%) managers considered that they worked with the NHS in an integrated way, including sharing documents, engaging in integrated care planning and joint learning and training. However, some care home managers cited working practices dictated by NHS methods of service delivery and priorities for care, rather than those of the care home or residents, a lack of willingness by NHS professionals to share information, and low levels of respect for the experience and knowledge of care home staff. Conclusions Care homes are a hub for a wide range of NHS activity, but this is ad hoc with no recognised way to support working together. Integration between care homes and local health services is only really evident at the level of individual working relationships and reflects patterns of collaborative working rather than integration. More integrated working between care homes and primary health services has the potential to improve quality of care in a cost- effective manner, but strategic decisions to create more formal arrangements are required to bring this about. Commissioners of services for older people need to capitalise on good working relationships and address idiosyncratic patterns of provision to care homes.The low response rate is indicative of the difficulty of undertaking research in care homes.