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.

Louise Dudley,Paula Williamson,Jennifer Preston,Carrol Gamble,Bec Hanley,Bridget Young,Deborah Buck,Ruth Jepson

doi:10.1371/journal.pone.0128817

Louise Dudley, Paula Williamson + Show 6 more

Open Access

https://doi.org/10.1371/journal.pone.0128817

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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.

Highlights

Patient and public involvement (PPI) or stakeholder engagement in research refers to the practice of patients, members of the public and researchers working together to prioritise, plan, conduct and disseminate research
We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials
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

Summary

Introduction

Patient and public involvement (PPI) or stakeholder engagement in research refers to the practice of patients, members of the public and researchers working together to prioritise, plan, conduct and disseminate research. While several different terms have been used to refer to the patients and members of the public who take on these roles, most commonly “PPI representative” or “research partner”, here we use the term “PPI contributor” This is 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. Health research funding bodies strongly encourage researchers to implement PPI at every stage of the research process[3,4,5,6,7] and to include PPI contributors on study steering committees[8,9]. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact

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