SummaryBackgroundEvidence 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.MethodsIn 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.FindingsBetween 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)....

BackgroundDiabetes peer support, where one person with diabetes helps guide and support others, has been proposed as a way to improve diabetes management. We have tested whether different diabetes peer support strategies can improve metabolic and/or psychological outcomes.MethodsPeople with type 2 diabetes (n = 1,299) were invited to participate as either ‘peer’ or ‘peer support facilitator’ (PSF) in a 2x2 factorial randomised cluster controlled trial across rural communities (130 clusters) in England. Peer support was delivered over 8–12 months by trained PSFs, supported by monthly meetings with a diabetes educator. Primary end point was HbA1c. Secondary outcomes included quality of life, diabetes distress, blood pressure, waist, total cholesterol and weight. Outcome assessors and investigators were masked to arm allocation. Main factors were 1:1 or group intervention. Analysis was by intention-to-treat adjusting for baseline.ResultsThe 4 arms were well matched (Group n = 330, 1:1(individual) n = 325, combined n = 322, control n = 322); 1035 (79•7%) completed the mid-point postal questionnaire and 1064 (81•9%) had a final HbA1c. A limitation was that although 92.6% PSFs and peers were in telephone contact, only 61.4% of intervention participants attended a face to face session. Mean baseline HbA1c was 57 mmol/mol (7•4%), with no significant change across arms. Follow up systolic blood pressure was 2•3mm Hg (0.6 to 4.0) lower among those allocated group peer-support and 3•0mm Hg (1.1 to 5.0) lower if the group support was attended at least once. There was no impact on other outcomes by intention to treat or significant differences between arms in self-reported adherence or medication.ConclusionsGroup diabetes peer support over 8–12 months was associated with a small improvement in blood pressure but no other significant outcomes. Long term benefits should be investigated.Trial RegistrationISRCTN.com ISRCTN6696362166963621

Seventy six senior academics from 11 countries invite The BMJ’s editors to reconsider their policy of rejecting qualitative research on the grounds of low priority. They challenge the journal to develop a proactive, scholarly, and pluralist approach to research that aligns with its stated mission

The shift of health care burden from acute to chronic conditions is strongly linked to lifestyle and behaviour. As a consequence, health services are attempting to develop strategies and interventions that can attend to the complex interactions of social and biological factors that shape both. In this paper we trace one of the most influential incarnations of this 'turn to the complex': the Medical Research Council (MRC) guidance on developing and evaluating complex interventions. Through an analysis of the key publications, and drawing on social scientific approaches to what might constitute complexity in this context, we suggest that such initiatives need to adjust their conceptualisation of 'the complex'. We argue that complexity needs to be understood as a dynamic, ecological system rather than a stable, albeit complicated, arrangement of individual elements. Crucially, in contrast to the experimental logic embedded in the MRC guidance, we question whether the Randomised Controlled Trial (RCT) is the most appropriate method through which to engage with complexity and establish reliable evidence of the effectiveness of complex interventions.

The concept of health behaviour has become ubiquitous in health-related research and intervention studies, as well as among policymakers. Developed from psychology, it is based on a number of key underlying assumptions that enable it to be integrated in an existing health research paradigm. However, by conceiving individual health behaviour as discrete, stable, homogeneous and measurable, many other aspects of health-related activities, in particular those relating to power and sociality, are excluded. As a consequence, any genuine contribution from medical sociology or related disciplines is, at best, limited. To counter this, it is proposed that reconceptualising what people do in terms of health practices, rather than health behaviour, captures the emergent and contingent properties of people's activities in particular situations. Rather than serving as a direct replacement term, and thus reproducing the same epistemological assumptions, it is argued that its very flexibility and capacity to articulate different theoretical orientations is likely to be its major strength.

AimsTo determine whether the introduction of the Universal Form of Treatment Options (the UFTO), as an alternative approach to Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) orders, reduces harms in patients in whom a decision not to attempt cardiopulmonary resuscitation (CPR) was made, and to understand the mechanism for any observed change.MethodsA mixed-methods before-and-after study with contemporaneous case controls was conducted in an acute hospital. We examined DNACPR (103 patients with DNACPR orders in 530 admissions) and UFTO (118 decisions not to attempt resuscitation in 560 admissions) practice. The Global Trigger Tool was used to quantify harms. Qualitative interviews and observations were used to understand mechanisms and effects.ResultsRate of harms in patients for whom there was a documented decision not to attempt CPR was reduced: Rate difference per 1000 patient-days was 12.9 (95% CI: 2.6–23.2, p-value = 0.01). There was a difference in the proportion of harms contributing to patient death in the two periods (23/71 in the DNACPR period to 4/44 in the UFTO period (95% CI 7.8–36.1, p-value = 0.006). Significant differences were maintained after adjustment for known confounders. No significant change was seen on contemporaneous case control wards. Interviews with clinicians and observation of ward practice revealed the UFTO helped provide clarity of goals of care and reduced negative associations with resuscitation decisions.ConclusionsIntroducing the UFTO was associated with a significant reduction in harmful events in patients in whom a decision not to attempt CPR had been made. Coupled with supportive qualitative evidence, this indicates the UFTO improved care for this vulnerable group.Trial RegistrationControlled-Trials.com ISRCTN85474986 UK Comprehensive Research Network Portfolio 7932

The concept of health behaviour has become ubiquitous in health-related research and intervention studies, as well as among policymakers. Developed from psychology, it is based on a number of key underlying assumptions that enable it to be integrated in an existing health research paradigm. However, by conceiving individual health behaviour as discrete, stable, homogeneous and measurable, many other aspects of health-related activities, in particular those relating to power and sociality, are excluded. As a consequence, any genuine contribution from medical sociology or related disciplines is, at best, limited. To counter this, it is proposed that reconceptualising what people do in terms of health practices, rather than health behaviour, captures the emergent and contingent properties of people's activities in particular situations. Rather than serving as a direct replacement term, and thus reproducing the same epistemological assumptions, it is argued that its very flexibility and capacity to articulate different theoretical orientations is likely to be its major strength.

BackgroundThe UK government has encouraged NHS services to obtain patient feedback to support the further development of patient-centred care. In 2009, the English GP Patient Survey included a sample of 5.5 million, but little is known about its potential utility in informing developments aimed at improving the quality of patients' experiences of primary care. AimTo investigate primary care providers' response to feedback on patient experience from a national survey. Design and settingQualitative interview study in 10 general practices from four primary care trusts in England. MethodSemi-structured interviews were conducted with GPs, practice nurses, and practice managers (n = 37). Transcripts were analysed thematically. ResultsAlthough some participants reported making changes to their practice in response to the survey data, many expressed doubts about the credibility of the results. Key issues included: concerns about practical aspects of the survey, such as the response rate and representativeness of the sample; the view that it gave insufficient detail to facilitate change and failed to address some salient issues; and unease about the influence of political influences underpinning its introduction and use. ConclusionAlthough, in general, primary care professionals have positive attitudes towards patient feedback, this study suggests a mismatch between the conventional demonstration of the objectivity of a questionnaire survey and the attitudes and experiences of those receiving the data. This is likely to prevent doctors from engaging constructively with the survey. These concerns may well militate against the potential of the survey to act as a simple means of capturing, and effectively using, feedback from patients. Keywordsprimary healthcare; qualitative research; reliability and validity; surveys.