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Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration

Patricia M Kearney Orcid Logo, Megan McCarthy Orcid Logo, Sandhya Rengarajan Orcid Logo, Linda M O'Keeffe Orcid Logo, Kerry Avery Orcid Logo, An-Wen Chan Orcid Logo, Declan Devane Orcid Logo, Gwyneth Davies Orcid Logo, Chris Gale Orcid Logo, Lars G Hemkens Orcid Logo, Edmund Juszczak Orcid Logo, Linda Kwakkenbos Orcid Logo, Sinéad M Langan Orcid Logo, Fiona Lugg-Widger Orcid Logo, David Moher Orcid Logo, Morten Schmidt Orcid Logo, Lehana Thabane Orcid Logo, Brett D Thombs Orcid Logo, Alice-Maria Toader Orcid Logo, Alan Watkins Orcid Logo, Amanda J Farrin Orcid Logo, Merrick Zwarenstein Orcid Logo, Matthew R Sydes Orcid Logo, Paula R Williamson Orcid Logo, Sarah Markham Orcid Logo

The BMJ, Volume: 393, Start page: e087095

Swansea University Author: Alan Watkins Orcid Logo

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DOI (Published version): 10.1136/bmj-2025-087095

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 del...

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Published in: The BMJ
ISSN: 1756-1833
Published: BMJ Publishing Group Ltd. 2026
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URI: https://cronfa.swan.ac.uk/Record/cronfa72170
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spelling 2026-06-26T11:37:25.5688961 v2 72170 2026-06-26 Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false 2026-06-26 MEDS 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. Journal Article The BMJ 393 e087095 BMJ Publishing Group Ltd. 1756-1833 12 6 2026 2026-06-12 10.1136/bmj-2025-087095 Research Methods & Reporting COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee 2026-06-26T11:37:25.5688961 2026-06-26T11:26:39.7329141 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Patricia M Kearney 0000-0001-9599-3540 1 Megan McCarthy 0000-0002-1415-8461 2 Sandhya Rengarajan 0009-0009-8043-7280 3 Linda M O'Keeffe 0000-0002-0003-0774 4 Kerry Avery 0000-0001-5477-2418 5 An-Wen Chan 0000-0002-4498-3382 6 Declan Devane 0000-0002-9393-7075 7 Gwyneth Davies 0000-0001-7937-2728 8 Chris Gale 0000-0003-0707-876X 9 Lars G Hemkens 0000-0002-3444-1432 10 Edmund Juszczak 0000-0001-5500-2247 11 Linda Kwakkenbos 0000-0002-1573-4504 12 Sinéad M Langan 0000-0002-7022-7441 13 Fiona Lugg-Widger 0000-0003-0029-9703 14 David Moher 0000-0003-2434-4206 15 Morten Schmidt 0000-0002-4935-4059 16 Lehana Thabane 0000-0003-0355-9734 17 Brett D Thombs 0000-0002-5644-8432 18 Alice-Maria Toader 0000-0002-3801-3486 19 Alan Watkins 0000-0003-3804-1943 20 Amanda J Farrin 0000-0002-2876-0584 21 Merrick Zwarenstein 0000-0003-0162-7027 22 Matthew R Sydes 0000-0002-9323-1371 23 Paula R Williamson 0000-0001-9802-6636 24 Sarah Markham 0000-0002-8755-5935 25 72170__37058__7ee8851fb0a44861b6fb7cd48e135a8a.pdf 72170.VOR.pdf 2026-06-26T11:34:57.6040818 Output 424738 application/pdf Version of Record true © 2026, The Author(s). This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license. true eng http://creativecommons.org/licenses/by-nc/4.0/
title Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
spellingShingle Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
Alan Watkins
title_short Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
title_full Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
title_fullStr Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
title_full_unstemmed Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
title_sort Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration
author_id_str_mv 81fc05c9333d9df41b041157437bcc2f
author_id_fullname_str_mv 81fc05c9333d9df41b041157437bcc2f_***_Alan Watkins
author Alan Watkins
author2 Patricia M Kearney
Megan McCarthy
Sandhya Rengarajan
Linda M O'Keeffe
Kerry Avery
An-Wen Chan
Declan Devane
Gwyneth Davies
Chris Gale
Lars G Hemkens
Edmund Juszczak
Linda Kwakkenbos
Sinéad M Langan
Fiona Lugg-Widger
David Moher
Morten Schmidt
Lehana Thabane
Brett D Thombs
Alice-Maria Toader
Alan Watkins
Amanda J Farrin
Merrick Zwarenstein
Matthew R Sydes
Paula R Williamson
Sarah Markham
format Journal article
container_title The BMJ
container_volume 393
container_start_page e087095
publishDate 2026
institution Swansea University
issn 1756-1833
doi_str_mv 10.1136/bmj-2025-087095
publisher BMJ Publishing Group Ltd.
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description 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.
published_date 2026-06-12T05:42:37Z
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