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Background: Public involvement is health research policy in the UK and internationally. There is a need to establish a robust evidence base on the impact of public involvement on research processes and outcomes. Purpose: To review examples of public involvement in the design and conduct of clinical trials, to synthesise the contributions of the public, as well as the identified tensions and facilitating strategies. Method: Systematic literature search and narrative review. Results: Nine papers were identified, covering the following topics: breast-feeding, antiretroviral and nutrition interventions; paediatric resuscitation; exercise and cognitive behavioural therapy; breast cancer; stroke; chronic suppurative otitis media; Paget's disease; and shared decision-making in patient consultations. Six papers reported on public involvement at the trial design stage, while three reported on public involvement at the design and conduct stages of clinical trials. It was found that the public contributed at the consultation, collaboration and publicly-led levels of involvement. Four main public contributions to trial design were identified: review of consent procedures and patient information sheets; suggestion of additional trial outcomes; review of trial data collection procedures; and recommendations on the timing and location of follow-up data collection. Two main contributions that the public made to the conduct of trials were identified: scrutiny of the conduct of the trial through membership of the Trial Steering Committee; and delivering the trial protocol after completing relevant training. Numerous tensions and facilitating strategies were identified. Limitations: Papers on public involvement in the design and conduct of clinical trials may have been overlooked due to the difficulty of searching for, and identifying, papers in this area. Only English publications were searched for and the review focused on evidence in peer-reviewed journal articles only. Conclusions: The issues raised here should assist researchers in developing and conducting clinical trials with the involvement of the public. [ABSTRACT FROM AUTHOR]

This paper considers the assessment of the impact of a community-based randomized controlled trial to reduce repeat deliberate self-harm. It considers the drawbacks in simplistic applications of conventional significance testing procedures, as well as possible failures regarding the statistical assumptions underlying such tests. Instead, the paper considers how relevant prior information might be incorporated within a fully Bayesian-model-based assessment procedure. The model includes a latent trait approach to patient morbidity; controlling for morbidity and other patient characteristics enhances the impact of the intervention (measured by a hazard rate ratio). If allowance is made for external information (e.g. ethical approval of the treatment), the weight of evidence shifts towards a positive intervention effect. [ABSTRACT FROM AUTHOR]

Background: There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement.Methods/design: The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1:1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes depending on whether the outcome is time-to-event or continuous.Discussion: The START trial is a pragmatic national trial of sufficient size to evaluate multisystemic therapy, to inform policymakers, service commissioners, professionals, service users and their families about its potential in the UK. It will also provide data on the clinical and cost-effectiveness of usual services provided to youth with serious antisocial behaviour problems.Trial Registration: ISRCTN77132214. [ABSTRACT FROM AUTHOR]

Background: Although physical inactivity has been linked with numerous chronic health conditions and overall mortality, the majority of English adults report doing insufficient physical activity. To increase population physical activity levels, researchers have called for more community-level interventions. To evaluate these complex public health interventions, innovative study designs are required. This study protocol describes Devon Active Villages, a community-level intervention providing physical activity opportunities to 128 rural villages in southwest England, and the methods used to evaluate its effectiveness in increasing physical activity levels. Methods/Design: A stepped wedge cluster randomised trial will be used to evaluate whether Devon Active Villages leads to increased physical activity levels in rural communities. Community engagement will help tailor activity programmes for each village; communities will then be supported for a further twelve months. The intervention will be delivered over four periods, each lasting twelve weeks. Data collection consists of a postal survey of a random sample of adults aged 18 years and over, at baseline and after each of the four intervention periods. The questionnaire includes questions on participant demographics, physical activity behaviour, local environment characteristics, awareness of local activity programmes, and psychosocial factors. Based on detecting an increase in the proportion of people who meet physical activity guidelines (from 25% to 30%), at least ten respondents are needed from each of the 128 villages at each stage (80% power at the 5% level of significance). Anticipating a 20% response rate, 6,400 questionnaires will be sent out at each stage (i.e., 50 surveys to each village). Using data from all five periods, a comparison of study outcomes between intervention and control arms will be performed, allowing for time period (as a fixed effect) and the random effect induced by correlation of outcomes (clustering) within villages. Discussion: This paper describes the use of a stepped wedge cluster randomised trial to evaluate a complex, community-level physical activity intervention in an under-studied population of adults in rural communities in southwest England. The study addresses gaps in the current literature by providing new insights into physical activity levels in this population. Trial Registration Number: Current Controlled Trials ISRCTN37321160 [ABSTRACT FROM AUTHOR]

Although the need for psychoanalytic research is increasingly acknowledged, many psychoanalysts remain resistant to the performance and findings of this research. Objections to research include a continuing mistrust of research tools and approaches, combined with a belief in the effectiveness of psychoanalytic treatments based on clinical lore and individual experience. Furthermore, as psychoanalytic literature continues to function within its own separate domain, even well-read psychoanalysts can be sequestered from central scientific conversations occurring in the larger literature about mental health. In part due to these factors, few adequate studies of psychoanalytic treatment approaches have been performed. The lack of efficacy research has added to the marginalization of psychoanalytic treatments. Fortunately, in recent years groups of clinicians and researchers have begun to study psychoanalytic treatments, particularly approaches to specific disorders. In this context, this issue provides a welcome addition to the literature in the trailblazing work and papers of Lemma, Target, & Fonagy and Gelman, McKay, & Marks. They have developed an exportable and specific psychoanalytic psychotherapy, which has been employed in the UK's National Health Service Improving Access to Psychological Therapies (IAPT) programme. Work on manualized treatments, such as the Dynamic Interpersonal Therapy of Lemma et al., has allowed psychoanalysts to better clarify and illustrate their treatment approaches. Thus psychoanalytic research, in addition to assessing efficacy, can potentially lead to the development of more effective and rapid relief of symptoms, in a broader population of patients. [ABSTRACT FROM AUTHOR]

Background: To date, no school-based intervention has been proven to be effective in preventing adolescent smoking, despite continuing concern about smoking levels amongst young people in the United Kingdom. Although formal teacher-led smoking prevention interventions are considered unlikely to be effective, peer-led approaches to reducing smoking have been proposed as potentially valuable. Methods/design: ASSIST (A Stop Smoking in Schools Trial) is a comprehensive, large-scale evaluation to rigorously test whether peer supporters in Year 8 (age 11-12) can be recruited and trained to effect a reduction in smoking uptake among their fellow students. The evaluation is employing a cluster randomised controlled trial (RCT) design with secondary school as the unit of randomisation, and is being undertaken in 59 schools in South East Wales and the West of England. Embedded within the trial are an economic evaluation of the intervention costs, a process evaluation to provide detailed information on how the intervention was delivered and received, and an analysis of social networks to consider whether such a peer group intervention could work amongst schoolchildren in this age group. Schools were randomised to either continue with normal smoking education (n = 29 schools, 5562 students), or to do so and additionally receive the ASSIST intervention (n = 30 schools, 5481 students). No schools withdrew once the trial had started, and the intervention was successfully implemented in all 30 schools, with excellent participation rates from the peer supporters. The primary outcome is regular (weekly) smoking, validated by salivary cotinine, and this outcome has been obtained for 94.4%, 91.0% and 95.6% of eligible students at baseline, immediate post-intervention, and one-year follow-up respectively. Discussion: Comprehensive evaluations of complex public health interventions of this scale and nature are rare in the United Kingdom. This paper demonstrates the feasibility of conducting cluster RCTs of complex public health interventions in schools, and how the rigour of such designs can be maximised both by thorough implementation of the protocol and by broadening the scope of questions addressed in the trial by including additional evaluative components. [ABSTRACT FROM AUTHOR]