Background Depression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. Objectives The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. The specific objectives were to confirm methods for practice recruitment and the ability to recruit patients via the proposed approaches; to determine the acceptability of the study interventions and outcome measures; to assess contamination; to confirm the randomisation method for main trial and the level of participant attrition; and to check the robustness of data collection systems. Design An adaptive, parallel, two-group multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation. Both individual- and cluster (general practice)-level were was used in the pilot phase to assign participants to intervention or control groups. Setting General practices in England and Wales. Participants Individuals were included who were aged ≥ 18 years, scored ≥ 14 on the Beck Depression Inventory II and self-identified as having debt worries. The main exclusion criteria were being actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; having a severe addiction to alcohol/illicit drugs; being unable/unwilling to give written informed consent; currently participating in other research including follow-up phases; having received Citizens Advice Bureau (CAB) debt advice in the past year; and not wanting debt advice via a general practice. Interventions The participants in the intervention group were given debt advice provided by the CAB and shared biopsychosocial assessment, in addition to treatment as usual (TAU) and two debt advice leaflets. The participants in the control group were given advice leaflets provided by the general practitioner and TAU only. Main outcome measures (1) Outcomes of the pilot trial – the proportion of eligible patients who consented, the number of participants recruited compared with target, assessment of contamination, and assessment of patient satisfaction with intervention and outcome measures. (2) Participant outcomes – primary – Beck Depression Inventory II; secondary – psychological well-being, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties, and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and at 4 months post randomisation. Other data sources – qualitative interviews were conducted with participants, clinicians and CAB advisors. Results Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 in the intervention group and 29 in the control group). All participants provided baseline outcomes and 52 provided the primary outcome at 4 months’ follow-up (14.7% dropout). Seventeen participants allocated to the intervention saw a CAB advisor. Descriptive statistics are reported for participants with complete outcomes at baseline and 4 months’ follow-up. Our qualitative findings suggest that the relationship between debt and depression is complex, and the impact of each on the other is compounded by other psychological, social and contextual influences. Conclusions As a result of low recruitment, this trial was terminated at the internal pilot phase and was too small for inferential statistical analysis. We recommend ways to reduce this risk when conducting complex trials among vulnerable populations recruited in community settings. These cover trial design, the design and delivery of interventions, recruitment strategies and support for sites. Trial registration Current Controlled Trials ISRCTN79705874. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 35. See the NIHR Journals Library website for further project information. Mark Gabbay and Adele Ring are part-funded by NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) North West Coast and Richard Byng and Rod S Taylor, Vashti Berry and Elizabeth Shaw part-funded by NIHR CLAHRC South West Peninsula.

Background The NHS policy of constructing multispecialty community providers (MCPs) rests on a complex set of assumptions about how health systems can replace hospital use with enhanced primary care for people with complex, chronic or multiple health problems, while contributing savings to health-care budgets. Objectives To use policy-makers’ assumptions to elicit an initial programme theory (IPT) of how MCPs can achieve their outcomes and to compare this with published secondary evidence and revise the programme theory accordingly. Design Realist synthesis with a three-stage method: (1) for policy documents, elicit the IPT underlying the MCP policy, (2) review and synthesise secondary evidence relevant to those assumptions and (3) compare the programme theory with the secondary evidence and, when necessary, reformulate the programme theory in a more evidence-based way. Data sources Systematic searches and data extraction using (1) the Health Management Information Consortium (HMIC) database for policy statements and (2) topically appropriate databases, including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Applied Social Sciences Index and Abstracts (ASSIA). A total of 1319 titles and abstracts were reviewed in two rounds and 116 were selected for full-text data extraction. We extracted data using a formal data extraction tool and synthesised them using a framework reflecting the main policy assumptions. Results The IPT of MCPs contained 28 interconnected context–mechanism–outcome relationships. Few policy statements specified what contexts the policy mechanisms required. We found strong evidence supporting the IPT assumptions concerning organisational culture, interorganisational network management, multidisciplinary teams (MDTs), the uses and effects of health information technology (HIT) in MCP-like settings, planned referral networks, care planning for individual patients and the diversion of patients from inpatient to primary care. The evidence was weaker, or mixed (supporting some of the constituent assumptions but not others), concerning voluntary sector involvement, the effects of preventative care on hospital admissions and patient experience, planned referral networks and demand management systems. The evidence about the effects of referral reductions on costs was equivocal. We found no studies confirming that the development of preventative care would reduce demands on inpatient services. The IPT had overlooked certain mechanisms relevant to MCPs, mostly concerning MDTs and the uses of HITs. Limitations The studies reviewed were limited to Organisation for Economic Co-operation and Development countries and, because of the large amount of published material, the period 2014–16, assuming that later studies, especially systematic reviews, already include important earlier findings. No empirical studies of MCPs yet existed. Conclusions Multidisciplinary teams are a central mechanism by which MCPs (and equivalent networks and organisations) work, provided that the teams include the relevant professions (hence, organisations) and, for care planning, individual patients. Further primary research would be required to test elements of the revised logic model, in particular about (1) how MDTs and enhanced general practice compare and interact, or can be combined, in managing referral networks and (2) under what circumstances diverting patients from in-patient to primary care reduces NHS costs and improves the quality of patient experience. Study registration This study is registered as PROSPERO CRD42016038900. Funding The National Institute for Health Research (NIHR) Health Services and Delivery Research programme and supported by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

ObjectivesThere is currently no widely accepted estimate of the proportion of people in England that self-identifies as lesbian, gay or bisexual (LGB), which is needed if we are to compare health inequality between different population groups. Using systematic review methods, this study identified all national social surveys with a question on sexual orientation and pooled those which represented the overall population of England. LGB proportions were synthesized into an aggregated mean estimate using weights based on sample size, response rate and missing data. The modelled estimate was stratified by socio-demographic and geographical variables.ResultsTwenty-two national surveys were identified of which 15 were suitable for pooling. Synthesis resulted in a weighted mean estimate of 2.50% of the adult population of England identifying as LGB or ‘other’. The proportion was highest in men, people below 45 years of age and the London region. The (theoretical) upper limit was 5.89% if all non-responders were assumed to identify as LGB. The reported 2.50% presents a minimum and may be influenced by respondents’ perceptions of confidentiality and social acceptance. It is however the most robust estimate currently available and can be used as baseline to understand health and wellbeing needs of different groups.Electronic supplementary materialThe online version of this article (10.1186/s13104-017-2921-1) contains supplementary material, which is available to authorized users.

Realist evaluation has become widespread partly because of its sensitivity to the influence of contexts on policy implementation. In many such evaluations, the range of contexts considered relevant nevertheless remains disparate and under-conceptualised. This article uses findings from a realist evaluation of English Patient Safety Collaboratives during 2015–2018 to develop a realist taxonomy of contexts, differentiating contexts according to how they affect the corresponding policy mechanism. By analysing the main context-mechanism-outcome configurations that made up the English Patient Safety Collaboratives, we derive a taxonomy of the contexts that affected implementation and outcomes. The categories of context were structural (network, hierarchy, market and organisational contexts); resource-based (actors, material, financial); motivational (receptivity, outcome headroom), and temporal (continuity, history and convergence). To the categories found in previous studies, this study adds the three temporal contexts.

No abstract