Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials.

Autor: Coulman KD; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK. Karen.Coulman@bristol.ac.uk., Nicholson A; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Shaw A; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Daykin A; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Selman LE; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Macefield R; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Shorter GW; Centre for Improving Health Related Quality of Life, School of Psychology, Queen's University Belfast, Belfast, BT9 5BN, UK., Cramer H; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Sydes MR; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, WC1J 6JL, UK.; MRC London Hub for Trial Methodology Research, London, UK., Gamble C; MRC North West Hub for Trials Methodology Research, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3BX, UK., Pick ME; Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Taylor G; Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Lane JA; MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2020 Jun 18; Vol. 21 (1), pp. 543. Date of Electronic Publication: 2020 Jun 18.
DOI: 10.1186/s13063-020-04495-9
Abstrakt: Background: Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. However, there is a lack of guidance on how to undertake PPI in trial oversight and tokenistic PPI remains an issue. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. This was part of a larger study investigating the role and function of oversight committees in trials facing challenges.
Methods: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including public contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight.
Results: Eight TSC and six TMG meetings from eight trials were observed, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three public contributors. PPI was reported as beneficial in trial oversight, with public members contributing a patient voice and fulfilling a patient advocacy role. However, public contributors were not always active at oversight meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI in trial oversight. To optimise PPI in trial oversight, the following areas were highlighted: the importance of planning effective strategies to recruit public contributors; considering the level of oversight and stage(s) of trial to include PPI; support for public contributors by the trial team between and during oversight meetings.
Conclusions: We present evidence-based recommendations to inform future PPI in trial oversight. Consideration should be given at trial design stage on how to recruit and involve public contributors within trial oversight, as well as support and mentorship for both public contributors and trialists (in how to undertake PPI effectively). Findings from this study further strengthen the evidence base on facilitating meaningful PPI within clinical trials.
Databáze: MEDLINE
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