Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation

Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed

Development of the ACTIVE framework to describe stakeholder involvement in systematic reviews

Objectives Involvement of patients, health professionals, and the wider public (‘stakeholders’) is seen to be beneficial to the quality, relevance and impact of research and may enhance the usefulness and uptake of systematic reviews. However, there is a lack of evidence and resources to guide researchers in how to actively involve stakeholders in systematic reviews. In this paper we report the development of the ACTIVE framework to describe how stakeholders are involved in systematic reviews. Methods We developed a framework using methods previously described in the development of conceptual frameworks relating to other areas of public involvement, including: literature searching, data extraction, analysis, and categorisation. A draft ACTIVE framework was developed and then refined after presentation at a conference workshop, before being applied to a series of example systematic reviews. Data extracted from 32 systematic reviews, identified in a systematic scoping review, were categorised against pre-defined constructs, including: who was involved, how stakeholder were recruited, the mode of involvement, at what stage there was involvement and the level of control or influence. Results The final ACTIVE framework described whether patients, carers and/or families, and/or other stakeholders (including health professionals, health decision makers and funders) were involved. We defined: recruitment as either open or closed; the approach to involvement as either onetime, continuous or combined; and the method of involvement as either direct or indirect. The stage of involvement in reviews was defined using the Cochrane Ecosystem stages of a review. The level of control or influence was defined according to the roles and activities of stakeholders in the review process, and described as the ACTIVE continuum of involvement. Conclusions The ACTIVE framework provides a structure with which to describe key components of stakeholder involvement within a systematic review, and we have used this to summarise how stakeholders have been involved in a subset of varied systematic reviews. The ACTIVE continuum of involvement provides a new model that uses tasks and roles to detail the level of stakeholder involvement. This work has contributed to the development of learning resources aimed at supporting systematic review authors and editors to involve stakeholders in their systematic reviews. This framework may support the decision-making of systematic review authors in planning how to involve stakeholders in future review

Collaborating with consumer and community representatives in health and medical research in Australia: results from an evaluation

<p>Abstract</p> <p>Objective</p> <p>To collaborate with consumer and community representatives in the <it>Alcohol and Pregnancy Project </it>from 2006-2008 <url>http://www.ichr.uwa.edu.au/alcoholandpregnancy</url> and evaluate researchers' and consumer and community representatives' perceptions of the process, context and impact of consumer and community participation in the project.</p> <p>Methods</p> <p>We formed two reference groups and sought consumer and community representatives' perspectives on all aspects of the project over a three year period. We developed an evaluation framework and asked consumer and community representatives and researchers to complete a self-administered questionnaire at the end of the project.</p> <p>Results</p> <p>Fifteen researchers (93.8%) and seven (53.8%) consumer and community representatives completed a questionnaire. Most consumer and community representatives agreed that the process and context measures of their participation had been achieved. Both researchers and consumer and community representatives identified areas for improvement and offered suggestions how these could be improved for future research. Researchers thought consumer and community participation contributed to project outputs and outcomes by enhancing scientific and ethical standards, providing legitimacy and authority, and increasing the project's credibility and participation. They saw it was fundamental to the research process and acknowledged consumer and community representatives for their excellent contribution. Consumer and community representatives were able to directly influence decisions about the research. They thought that consumer and community participation had significant influence on the success of project outputs and outcomes.</p> <p>Conclusions</p> <p>Consumer and community participation is an essential component of good research practice and contributed to the <it>Alcohol and Pregnancy Project </it>by enhancing research processes, outputs and outcomes, and this participation was valued by community and consumer representatives and researchers. The National Health and Medical Research Council in Australia expects researchers to work in partnership and involve consumer and community representatives in health and medical research, and to evaluate community and consumer participation. It is important to demonstrate whether consumer and community participation makes a difference to health and medical research.</p