PT  - JOURNAL ARTICLE
AU  - Carrol Gamble
AU  - Louise Dudley
AU  - Alison Allam
AU  - Philip Bell
AU  - Heather Goodare
AU  - Bec Hanley
AU  - Jennifer Preston
AU  - Alison Walker
AU  - Paula Williamson
AU  - Bridget Young
TI  - Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation
AID  - 10.1136/bmjopen-2014-005234
DP  - 2014 Jul 01
TA  - BMJ Open
PG  - e005234
VI  - 4
IP  - 7
4099  - http://bmjopen.bmj.com/content/4/7/e005234.short
4100  - http://bmjopen.bmj.com/content/4/7/e005234.full
SO  - BMJ Open2014 Jul 01; 4
AB  - Background Randomised 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. Objective To 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. Methods Documentation 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. Results 110 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. Conclusions Incorporation 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.