What question did this study set out to answer?

This research aims to present the PRECIS-2 tool, an enhanced version designed to evaluate clinical trial designs effectively.

May 8, 2015Open Access

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

KLKirsty LoudonNatCen Social Research STShaun TreweekUniversity of Stirling FSFrank SullivanUniversity of St Andrews

Key Points

This research aims to present the PRECIS-2 tool, an enhanced version designed to evaluate clinical trial designs effectively.
Introduced PRECIS-2, featuring nine domains including three new ones: recruitment, setting, and organization.
Each domain is rated on a 5-point Likert scale from ideal to usual care conditions.
Provides guidance for trialists, clinicians, and policymakers on utilizing the tool.
PRECIS-2 assists in aligning trial designs with intended purposes.
It enhances understanding of how design choices affect trial applicability and relevance.

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

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