What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials

Abstract

BackgroundPatient and public involvement (PPI) is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.MethodsSemi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.ResultsWe interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups) and managerial (e.g. trial management groups) roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees).ConclusionThose seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

Is it worth it? Patient and public views on the impact of their involvement in health research and its assessment: a UK‐based qualitative interview study

“…This is consistent with the finding of a recent UK consensus study that the majority of public participants felt that PPI leads to research of greater quality and relevance – a view only shared by a minority of academics . In keeping with a qualitative study of PPI in clinical trials, none of the participants reported negative impacts of PPI on research, although some expressed uncertainty about the impact of their own involvement. In our study, this seemed to be in part because of a lack of individual feedback on impact within specific research projects.…”

“…Many different terms are used internationally to describe patients and members of the public involved in research, such as ‘lay representative’, ‘patient partner’ and ‘public adviser’. In this study, we adopt the term ‘PPI contributor’ to avoid implying either that the small number of individuals typically involved in research can represent the diversity of perspectives among patients and the public or that the role of PPI contributors can always be described as a partnership …”

Perceptions of Research Bronchoscopy in Malawian Adults with Pulmonary Tuberculosis: A Cross-Sectional Study

“…Engaging patients or public in research prior to study implementation is therefore seen to address their concerns, enhance trust, and can improve informed consent, mutual learning, recruitment and retention of research participants [9]. Patient and public involvement (PPI) is increasingly being advocated in health research to prevent harm to participants, improve the relevance of information sheets and the quality of informed consent [10, 11]. Boulanger (2013) however argues that little attention has been given to community engagement or PPI in TB research and this paper contributes to this knowledge gap [12].…”

Including qualitative research in Randomized Controlled Trials: Opportunities for nursing researchers

“…It also is advantageous as it reinforces the ongoing nature of health care and can be a very important aspect of identifying paths to impact from a study (Dudley et al, 2015). It also is advantageous as it reinforces the ongoing nature of health care and can be a very important aspect of identifying paths to impact from a study (Dudley et al, 2015).…”