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Table 4 Recommendations: Enhancing patient and public involvement in trial oversight

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

Steps to maximise the benefit of PPIFacilitated by:
Agree PPI needs of trial with research team (early trial design stage)*
 • Define clear role/s and/or goals for PPI
 • Define trial stages that PPI needed – including trial design stage
 • Define demographic characteristics, skills and experience desired from public contributors
 • Identify optimal format for PPI (e.g. attendance at trial oversight committee(s), and/or separate PPI meetings, email/telephone) – negotiate this with public contributors recruited
 • Ensure PPI is costed properly to re-imburse for public contributors’ time and expenses, including carer support if appropriate
 • Ensure PPI plan is fully justified in both funding applications and trial protocols
 • Training for research team on the role PPI can play in trials and how to maximise meaningful input. Include opportunities for discussion.
 • Accessing useful PPI planning resources (e.g. PPI Toolkit for clinical trials [16]), and the NIHR INVOLVE public involvement cost calculator (https://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/involvement-cost-calculator/)
 • Consulting with existing patient or public panels may be useful at this early stage to help define PPI needs
 • Consider inviting public contributors to be co-applicants on grant applications
Recruit diverse public contributors
 • Consider effective routes to invite public contributors (e.g. local groups, national organisations, existing PPI groups, advertising) to allow for diversity
 • Recruit more than one public contributor, focusing on diversity of characteristics, skills and experience (e.g. some with research/committee experience and some without)
 • Drawing on insight of colleagues with previous experience of identifying and working with public contributors from target population, and existing relevant patient or public panels.
Engage public contributors in trial oversight
 • Provide an induction to the trial for public contributors including oversight processes
 • Ensure meeting Chairs have skills to engage public contributors
 • Provide on-going mentoring/support to public contributors in between oversight meetings, e.g. regular meetings/phone calls to foster relationship, answer queries, and provide training as deemed appropriate
 • Accommodate needs of the patient group to facilitate PPI attendance at meetings (e.g. shorter meetings/attendance for part of the meeting, care needs or caring responsibilities)
 • Adapt format of PPI to the emerging needs of the trial and public contributors
 • Accessing PPI training/support for trial team including meeting Chairs (e.g. UKCRC/NCRI PPI in research groups - Guidance for Chairs [41])
 • Identifying appropriate research team member to provide on-going support to public contributors, and allowing protected time for this within their role
 • Drawing on relevant resources provided in the PPI Toolkit for clinical trials [16] to familiarise public contributors with their role in the trial oversight committee, academic terminology and environment
 • Considering both academic and public contributors’ commitments
  1. PPI patient and public involvement
  2. *Relevant patients or lay members of the public should be involved in defining the PPI needs for a trial