INITIAL: Involving patients and the public In sTatistIcal Analysis pLans

INITIAL: Involving patients and the public In sTatistIcal Analysis pLans

Improving relationships and communication between trialists and public partners has been identified as the number one priority for methodological research in patient and public involvement (PPI) in trials, which aims to enhance research by improving relevance, increasing transparency and public trust. However, PPI often remains tokenistic. Our recent work has evidenced that the public believes patient and public involvement in numerical aspects of clinical trials is important, but trialists find involving patients challenging. Statistical analysis plans contain many important analytical choices, but patients are rarely involved in these, which may undermine the relevance of the results of trials. Failing to actively communicate with and involve patients or the public in these decisions can ultimately lead to research waste, for example by answering non-relevant (to patients) research questions. The current project proposes a first step to address this gap by: 1) develop Plain English Summaries to define and describe relevant items in statistical analysis plans, using a creative workshop methodology; 2) identify the most important items of statistical analysis plans to involve patients and the public in, through a Delphi consensus study.

CI: Beatriz Goulao

Co-investigators include Dr Katie Gillies and Prof Craig Ramsay (University of Aberdeen), Dr Tim Morris (University College London), Prof Jane Blazeby (University of Bristol), Prof Carrol Gamble (University of Liverpool), Nikki Totton (University of Sheffield), Derek Stewart (Public Partner), Lynn Laidlaw (Public Partner), Irene Soulsby (Public Partner).

Funder: Medical Research Council-National Institute for Health Research

Study participants can view the Participant Information Sheet here

To find out more about the statistical items discussed in INITIAL including lay summaries, please visit: