title: Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.
abstract: 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.
authors: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors: Carrol
authors: C
authors: Gamble
authors: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors: Louise
authors: L
authors: Dudley
authors: Patient and Public Advisory Group member, York, UK.
authors: Alison
authors: A
authors: Allam
authors: Patient and Public Advisory Group member, Amlwch, UK.
authors: Philip
authors: P
authors: Bell
authors: Patient and Public Advisory Group member, Edinburgh, UK.
authors: Heather
authors: H
authors: Goodare
authors: Patient and Public Advisory Group member, Hurstpierpoint, Hassocks, England.
authors: Bec
authors: B
authors: Hanley
authors: Medicines for Children Research Network Coordinating Centre, University of Liverpool, Liverpool, UK.
authors: Jennifer
authors: J
authors: Preston
authors: Patient and Public Advisory Group member, Edinburgh, UK.
authors: Alison
authors: A
authors: Walker
authors: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors: Paula
authors: P
authors: Williamson
authors: Department of Psychological Sciences, University of Liverpool, Liverpool, UK.
authors: Bridget
authors: B
authors: Young
mesh_terms: D000328:Adult; D002648:Child; D015331:Cohort Studies; D003256:Community Participation / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D010358:Patient Participation / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*
keywords: Consumer participation; HEALTH SERVICES ADMINISTRATION & MANAGEMENT; STATISTICS & RESEARCH METHODS