Reporting of cohort and routinely collected data in randomised controlled trial protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Randomised controlled trials that use cohorts or health-and-care systems data, often known as routinely collected data—such as electronic health records, registries, or administrative claims—are becoming increasingly common. These trials have the potential to streamline recruitment, intervention delivery, follow-up (within trial and long term), and to lower costs. The lack of clear information governance pathways, heterogeneous data quality, delays in data recording and acquisition, and regulatory or ethical complexities undermine reproducibility and bias assessment when routinely collected data are used in trials. We introduce the SPIRIT-ROUTINE extension to the SPIRIT 2025 guideline: a checklist and explanation designed to improve the reporting of trial protocols that rely on cohorts or routinely collected data sources. Investigators, funders, ethics committees, journal editors, and peer reviewers can use the SPIRIT-ROUTINE extension to enhance completeness, transparency, and usability of such protocols to support better research, healthcare decisions, and patient outcomes.
Date Issued
2026-06-12
Date Acceptance
2026-02-25
Citation
The BMJ, 2026, 393
ISSN
0959-8146
Publisher
BMJ Publishing Group
Journal / Book Title
The BMJ
Volume
393
Copyright Statement
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/42285568
Publication Status
Published
Coverage Spatial
England
Article Number
e087095
Date Publish Online
2026-06-12