Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation

Abstract

BackgroundRandomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions.ObjectiveTo increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders.MethodsDocumentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006–2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded.Results110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI.ConclusionsIncorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed.

An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study

“…The trial and participant characteristics restricted to these 90 trials are summarised elsewhere. 69 Of these 90 outline applications, 49 (54%) provided some level of detail on PPI. Table 5 summarises the stage of initiating PPI and role of PPI across the trials.…”

“…73,74 However, the funding available is often small and inaccessible to those working within the tight timescales of a typical funding call. 69 Increasing the availability and scale of resource to provide an infrastructure to support researchers and contributors to initiate PPI at the pre-funding stage would help to facilitate earlier implementation.…”

“…The survey responses cannot be taken as a fixed or true point from which to assess the adequacy of our interview sample. 69 In their interviews participants described their experiences in detail and we were able to consider how they talked about PPI, as well as what they said about it. In this context, it is notable that, while all of the CIs in the survey reported some impact from PPI, the interview accounts of CIs told a rather different story, with one-third describing PPI as having no impact.…”

Crowdfunding: from startup businesses to startup science

“…5 The most commonly cited challenges, a recent review of the literature indicated, were to do with logistics (extra time and funding needed for patient and public involvement) and, the main worry, a tokenistic approach. 6 Two examples of patient and public involvement initiatives, the Nano-dialogue and Wellbeing dialogue projects, supported by Sciencewise.co.uk, had a total cost of more than half a million pounds in 2007.…”

Implementation and trial evidence: a plea for fore-thought

“…[40][41][42] Reasons for better outcomes include the type of language used in patient-facing information, insights into appropriate or least burdensome study designs, and awareness of patient involvement improving the willingness to be involved. 43 PPI should be carefully planned before research design, incorporating an iterative process where appropriate with clear guidance about roles.…”