The PRECIS-2 tool: designing trials that are fit for purpose

Abstract

This paper presents PRECIS-2-a validated, improved version of the tool-together with guidance for how to use it PRECIS-2 has nine domains including three new ones (recruitment, setting, and organisation), each scored on a 5-point Likert continuum (from 1=very explanatory "ideal conditions" to 5=very pragmatic "usual care conditions") so that trialists, clinicians, and policymakers can more easily consider whether design decisions match their intended purpose on 2 August