Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey.

ABSTRACT:

Background

Patient and public involvement (PPI) in trials aims to enhance research by improving its relevance and transparency. Planning for statistical analysis begins at the design stage of a trial within the protocol and is refined and detailed in a Statistical Analysis Plan (SAP). While PPI is common in design and protocol development it is less common within SAPs. This study aimed to reach consensus on the most important and relevant statistical analysis items within an SAP to involve patients and the public.

Methods

We developed a UK-based, two-round Delphi survey through an iterative consultation with public partners, statisticians, and trialists. The consultation process started with 55 items from international guidance for statistical analysis plans. We aimed to rec

SUBMITTER: Goulao B 

PROVIDER: S-EPMC10721002 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature