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

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dc.contributor.authorKearney, Patricia M.
dc.contributor.authorMcCarthy, Megan
dc.contributor.authorRengarajan, Sandhya
dc.contributor.authorO’Keeffe, Linda M.
dc.contributor.authorAvery, Kerry
dc.contributor.authorChan, An Wen
dc.contributor.authorDevane, Declan
dc.contributor.authorDavies, Gwyneth
dc.contributor.authorGale, Chris
dc.contributor.authorHemkens, Lars G.
dc.contributor.authorJuszczak, Edmund
dc.contributor.authorKwakkenbos, Linda
dc.contributor.authorLangan, Sinéad M.
dc.contributor.authorLugg-Widger, Fiona
dc.contributor.authorMoher, David
dc.contributor.authorSchmidt, Morten
dc.contributor.authorThabane, Lehana
dc.contributor.authorThombs, Brett D.
dc.contributor.authorToader, Alice Maria
dc.contributor.authorWatkins, Alan
dc.contributor.authorFarrin, Amanda J.
dc.contributor.authorZwarenstein, Merrick
dc.contributor.authorSydes, Matthew R.
dc.contributor.authorWilliamson, Paula R.
dc.contributor.authorMarkham, Sarah
dc.date.accessioned2026-09-11T13:08:23Z
dc.date.available2026-09-11T13:08:23Z
dc.date.issued2026-06-12
dc.description.abstractRandomised 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.en
dc.description.sponsorshipHealth Research Board|HRB-TMRN-2017-1|Trials Methodology
dc.description.sponsorshipUK Research and Innovation|MR/T041285/1|Future Leaders Fellowship
dc.description.sponsorshipGovernment of Canada
dc.description.versionPublished Version
dc.format.extent20
dc.format.mimetypeapplication/pdfen
dc.identifier.articleide087095
dc.identifier.authororcidKearney, Patricia M.§0000-0001-9599-3540
dc.identifier.authororcidMcCarthy, Megan
dc.identifier.authororcidRengarajan, Sandhya§0009-0009-8043-7280
dc.identifier.authororcidO’Keeffe, Linda M.
dc.identifier.authororcidAvery, Kerry
dc.identifier.authororcidChan, An Wen
dc.identifier.authororcidDevane, Declan
dc.identifier.authororcidDavies, Gwyneth
dc.identifier.authororcidGale, Chris
dc.identifier.authororcidHemkens, Lars G.
dc.identifier.authororcidJuszczak, Edmund
dc.identifier.authororcidKwakkenbos, Linda
dc.identifier.authororcidLangan, Sinéad M.
dc.identifier.authororcidLugg-Widger, Fiona
dc.identifier.authororcidMoher, David
dc.identifier.authororcidSchmidt, Morten
dc.identifier.authororcidThabane, Lehana
dc.identifier.authororcidThombs, Brett D.
dc.identifier.authororcidToader, Alice Maria
dc.identifier.authororcidWatkins, Alan
dc.identifier.authororcidFarrin, Amanda J.
dc.identifier.authororcidZwarenstein, Merrick
dc.identifier.authororcidSydes, Matthew R.
dc.identifier.authororcidWilliamson, Paula R.
dc.identifier.authororcidMarkham, Sarah
dc.identifier.citationKearney, P M, McCarthy, M, Rengarajan, S, O’Keeffe, L M, Avery, K, Chan, A W, Devane, D, Davies, G, Gale, C, Hemkens, L G, Juszczak, E, Kwakkenbos, L, Langan, S M, Lugg-Widger, F, Moher, D, Schmidt, M, Thabane, L, Thombs, B D, Toader, A M, Watkins, A, Farrin, A J, Zwarenstein, M, Sydes, M R, Williamson, P R & Markham, S 2026, 'Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration', BMJ, vol. 393, e087095, pp. 1-20. https://doi.org/10.1136/bmj-2025-087095
dc.identifier.doi10.1136/bmj-2025-087095
dc.identifier.endpage20
dc.identifier.issn0959-8146
dc.identifier.journaltitleBMJ
dc.identifier.otherORCID: /0009-0009-8043-7280/work/226487271
dc.identifier.otherORCID: /0000-0001-9599-3540/work/226487282
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/19238
dc.identifier.volume393
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.relation.urihttps://www.scopus.com/pages/publications/105041874609
dc.rights© 2026, authors. BMJ published by BMJ Publishing Group Ltd. 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. http://creativecommons.org/licenses/by-nc/4.0/
dc.rights.accessrightsopen access
dc.rights.licensenameAttribution-NonCommercial 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.statusPeer reviewed
dc.subjectTrials
dc.subjectTrial protocols
dc.subjectReporting protocols
dc.subjectNon-randomised trials
dc.subject[Insight]
dc.subject[PublicHealth]
dc.titleReporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaborationen
dc.typeArticle (peer-reviewed)
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