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From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials
  1. Deborah Buck1,
  2. Carrol Gamble1,
  3. Louise Dudley1,
  4. Jennifer Preston2,
  5. Bec Hanley3,
  6. Paula R Williamson1,
  7. Bridget Young4,
  8. The EPIC Patient Advisory Group
  1. 1Department of Biostatistics, University of Liverpool, Liverpool, UK
  2. 2Department of Women's and Children's Health, NIHR Clinical Research Network: Children, Coordinating Centre, University of Liverpool, Institute of Translational Medicine (Child Health), Alder Hey Children's NHS Foundation Trust, Liverpool, UK
  3. 3TwoCan Associates, Hassocks, UK
  4. 4Department of Psychological Sciences, University of Liverpool, Liverpool, UK
  1. Correspondence to Professor Bridget Young; byoung{at}liv.ac.uk

Abstract

Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited.

Objective Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams.

Methods We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers’ and PPI contributors’ interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique.

Results Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors’ lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding ‘the right’ PPI contributors, and advised caution when involving investigators’ current patients.

Conclusions Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised.

  • QUALITATIVE RESEARCH
  • patient and public involvement
  • patient and public engagement

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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