Patient and public involvement in randomised clinical trials:a mixed-methods study of a clinical trials unit to identify good practice, barriers and facilitators

Abstract Background While patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)’s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU’s role in PPI. Methods A mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors. Results (1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors (n=8), TMs (n=5), chief investigators (n=3), PPI coordinators (n=2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10–50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI. Conclusions While highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported

High levels of childhood obesity observed among 3- to 7-year-old New Zealand Pacific children is a public health concern.

This cross-sectional, community-based survey was designed to assess attained growth and body composition of 3- to 7-y-old Pacific children (n = 21 boys and 20 girls) living in Dunedin, New Zealand, and to examine nondietary factors associated with the percentage of body fat. Fat mass, lean tissue mass and the percentage of body fat were measured using dual energy X-ray absorptiometry. One trained anthropometrist also measured height, weight, skinfolds (triceps, subscapular) and circumferences (mid-upper arm, chest, waist, calf). Compared with the National Center for Health Statistics and National Health and Examination Surveys I and II reference data, these Pacific children were tall and heavy for their age with high arm-muscle-area-for-height. Median (quartiles) Z-scores for height and BMI-for-age and arm-muscle-area-for-height were 1.33 (0.60, 2.15), 1.20 (0.74, 4.43) and 1.09 (0.63, 1.85), respectively. Their median (quartile) percentage of body fat was 21.8% (15.0, 35.5) of which 38.5% was located in the trunk. The estimated percentage of children classified as obese ranged from 34 to 49% depending on the criterion used. Over 60% of the children had levels of trunk fat above 1 SD of reported age- and sex-specific Z-scores for New Zealand children. The nondietary factors examined (hours of television viewing and hours playing organized sports, as reported by parents) were not associated with variations in the percentage of body fat, after adjusting for age, sex and birth weight. These extremely high levels of obesity and truncal fat among very young New Zealand children will have major public health implications as these children age

Process evaluation of a community-based adolescent obesity prevention project in Tonga

<p>Abstract</p> <p>Background</p> <p>The rising burden of obesity in Tonga is alarming. The promotion of healthy behaviours and environments requires immediate urgent action and a multi-sectoral approach. A three-year community based study titled the Ma'alahi Youth Project (MYP) conducted in Tonga from 2005-2008 aimed to increase the capacity of the whole community (schools, churches, parents and adolescents) to promote healthy eating and regular physical activity and to reduce the prevalence of overweight and obesity amongst youth and their families. This paper reflects on the process evaluation for MYP, against a set of Best Practice Principles for community-based obesity prevention.</p> <p>Methods</p> <p>MYP was managed by the Fiji School of Medicine. A team of five staff in Tonga were committed to planning, implementation and evaluation of a strategic plan, the key planks of which were developed during a two day community workshop. Intervention activities were delivered in villages, churches and schools, on the main island of Tongatapu. Process evaluation data covering the resource utilisation associated with all intervention activities were collected, and analysed by dose, frequency and reach for specific strategies. The action plan included three standard objectives around capacity building, social marketing and evaluation; four nutrition; two physical activity objectives; and one around championing key people as role models.</p> <p>Results</p> <p>While the interventions included a wide mix of activities straddling across all of these objectives and in both school and village settings, there was a major focus on the social marketing and physical activity objectives. The intervention reach, frequency and dose varied widely across all activities, and showed no consistent patterns.</p> <p>Conclusions</p> <p>The adolescent obesity interventions implemented as part of the MYP program comprised a wide range of activities conducted in multiple settings, touched a broad spectrum of the population (wider than the target group), but the dose and frequency of activities were generally insufficient and not sustained. Also the project confirmed that, while the MYP resulted in increased community awareness of healthy behaviours, Tonga is still in its infancy in terms of conducting public health research and lacks research infrastructure and capacity.</p

Associations of body mass index and waist circumference with: energy intake and percentage energy from macronutrients, in a cohort of australian children

Background: It is evident from previous research that the role of dietary composition in relation to the development of childhood obesity remains inconclusive. Several studies investigating the relationship between body mass index (BMI), waist circumference (WC) and/or skin fold measurements with energy intake have suggested that the macronutrient composition of the diet (protein, carbohydrate, fat) may play an important contributing role to obesity in childhood as it does in adults. This study investigated the possible relationship between BMI and WC with energy intake and percentage energy intake from macronutrients in Australian children and adolescents

Systematic review: a resource that allows for the incorporation of evidence into nursing practice

A revisão sistemática é um recurso importante da prática baseada em evidências, que consiste em uma forma de síntese dos resultados de pesquisas relacionados com um problema específico. O presente artigo tem como objetivo oferecer subsídios que proporcionem reflexões para a construção e/ou aplicação de revisões sistemáticas no cenário da enfermagem. Fundamentados na literatura, apresentamos as fases que compõem uma revisão sistemática e aspectos relevantes a serem considerados para a utilização desse recurso.La revisión sistemática es un recurso importante de la práctica basada en evidencias, que consiste en una forma de síntesis de los resultados de las investigaciones relacionadas con un determinado problema. El presente artículo tiene como objetivo ofrecer elementos que permitan reflexionar sobre la construcción y/o aplicación de revisiones sistemáticas en el ámbito de la enfermería. Basados en la literatura, presentamos las etapas que componen una revisión sistemática y los aspectos relevantes que deben ser considerados para la utilización de este recurso.Systematic review is an important resource in evidence-based practice, which consists in a form of synthesizing the research results related to a specific problem. This article aimed to offer subsidies for reflections with a view to the construction and/or application of systematic reviews in the nursing environment. Based on the literature, authors presented the phases comprising a systematic review and the relevant aspects that must be considered for using this resource

Feminism

Event presented by the Friends of the University of Adelaide Library, held in the Ira Raymond Room, 18th June, 2015

F. N. C. V. Excursion to Cann River District 26 Dec 1907 - 3 Jan 1971

Volume: 88Start Page: 120End Page: 13