title: 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: BACKGROUND
  Patient 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.
  
  
  METHODS
  Semi-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.
  
  
  RESULTS
  We 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).
  
  
  CONCLUSIONS
  Those 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.
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Louise
authors.initials: L
authors.lastname: Dudley
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
authors.affiliation: NIHR Clinical Research Network: Children, Coordinating Centre, University of Liverpool, Department of Women's and Children's Health, Liverpool, United Kingdom.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Preston
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Deborah
authors.initials: D
authors.lastname: Buck
authors.affiliation: TwoCan Associates, Brighton, United Kingdom.
authors.forename: Bec
authors.initials: B
authors.lastname: Hanley
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
authors.affiliation: Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
mesh_terms: D015331:Cohort Studies; D006040:Goals; D006801:Humans; D010358:Patient Participation; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic; D012108:Research Personnel