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A study protocol for the development of a SPIRIT...
Journal article

A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

Abstract

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data …

Authors

McCarthy M; O'Keeffe L; Williamson PR; Sydes MR; Farrin A; Lugg-Widger F; Davies G; Avery K; Chan A-W; Kwakkenbos L

Journal

HRB Open Research, Vol. 4, ,

Publisher

F1000Research

DOI

10.12688/hrbopenres.13314.1

ISSN

2515-4826