Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process

Abstract

BackgroundDespite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials.ObjectiveTo identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.DesignA modified Delphi process including a two round online survey and a stakeholder consensus meeting.ParticipantsIn total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty‐seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting.ResultsRound 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants.ConclusionsThe prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Hope, disappointment and perseverance: Reflections of people with Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Multiple Sclerosis participating in biomedical research. A qualitative focus group study

“…Various research approaches have been used to elicit patient views on research priorities including focus groups, PPI consultation workshops and expert panels, as well as structured consensus seeking methodologies such as the Delphi technique . In this study, the use of focus groups permitted us not only to explore patient views on research priorities, but also to shed light on some of the emotional and experiential reasons behind these priorities, helping to inform our understanding of this complex topic.…”

Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians

“…However, the methods of Delphi studies do vary as noted in a systematic review conducted by Boulkedid and colleagues [ 10 ] and the “The RAND/UCLA Appropriateness Method User's Manual” [ 13 ]. Based on currently used cut-off values, we used a scoring of 1–9 for the importance of the different items with median scores of 7–9 being considered high enough to reach consensus [ 10 , 14 , 15 ].…”

PPI in research: a reflection from early stage researchers

“…As a number of ESRs pointed to uncertainty about how to implement PPI in research future learning opportunities could look specifically at ways of implementation such as coproduction, we note such guidance already exists for PPI in primary research [40]. More investigation is also needed on training PPI contributors receive in methodological research to improve the current practice [41].…”