Show simple item record

Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration

dc.rights.licenseopenen_US
dc.contributor.authorMANYARA, Anthony Muchai
dc.contributor.authorDAVIES, Philippa
dc.contributor.authorSTEWART, Derek
dc.contributor.authorWEIR, Christopher J
dc.contributor.authorYOUNG, Amber E
dc.contributor.authorBLAZEBY, Jane
dc.contributor.authorBUTCHER, Nancy J
dc.contributor.authorBUJKIEWICZ, Sylwia
dc.contributor.authorCHAN, An-Wen
dc.contributor.authorDAWOUD, Dalia
dc.contributor.authorOFFRINGA, Martin
dc.contributor.authorOUWENS, Mario
dc.contributor.authorHROBJARTSSSON, Asbjorn
dc.contributor.authorAMSTUTZ, Alain
dc.contributor.authorBERTOLACCINI, Luca
dc.contributor.authorBRUNO, Vito Domenico
dc.contributor.authorDEVANE, Declan
dc.contributor.authorFARIA, Christina D C M
dc.contributor.authorGILBERT, Peter B
dc.contributor.authorHARRIS, Ray
dc.contributor.authorLASSERE, Marissa
dc.contributor.authorMARINELLI, Lucio
dc.contributor.authorMARKHAM, Sarah
dc.contributor.authorPOWERS, John H
dc.contributor.authorREZAEI, Yousef
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorSCHWENDICKE, Falk
dc.contributor.authorTERESHCHENKO, Larisa G
dc.contributor.authorTHOMA, Achilles
dc.contributor.authorTURAN, Alparslan
dc.contributor.authorWORRALL, Andrew
dc.contributor.authorCHRISTENSEN, Robin
dc.contributor.authorCOLLINS, Gary S
dc.contributor.authorROSS, Joseph S
dc.contributor.authorTAYLOR, Rod S
dc.contributor.authorCIANI, Oriana
dc.date.accessioned2024-10-15T10:30:40Z
dc.date.available2024-10-15T10:30:40Z
dc.date.issued2024-07-09
dc.identifier.issn1756-1833en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/202506
dc.description.abstractEnRandomised controlled trials commonly use surrogate endpoints to substitute for a target outcome (outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve their efficiency (through shorter trial duration, reduced sample size, and thus lower research costs), or for ethical or practical reasons. But reliance on surrogate endpoints can increase the uncertainty of an intervention’s treatment effect and potential failure to provide adequate information on intervention harms, which has led to calls for improved reporting of trials using surrogate endpoints. This report presents a consensus driven reporting guideline for trials using surrogate endpoints as the primary outcomes—the CONSORT (Consolidated Standards of Reporting Trials) extension checklist: CONSORT-Surrogate. The extension includes nine items modified from the CONSORT 2010 checklist and two new items. Examples and explanations for each item are provided. We recommend that all stakeholders (including trial investigators and sponsors, journal editors and peer reviewers, research ethics reviewers, and funders) use this extension in reporting trial reports using surrogate endpoints. Use of this checklist will improve transparency, interpretation, and usefulness of trial findings, and ultimately reduce research waste.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enReporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
dc.title.alternativeBMJen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1136/bmj-2023-078524en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38981645en_US
bordeaux.journalBMJen_US
bordeaux.pagee078524en_US
bordeaux.volume386en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04738314
hal.version2
hal.date.transferred2024-10-15T23:04:46Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=BMJ&rft.date=2024-07-09&rft.volume=386&rft.spage=e078524&rft.epage=e078524&rft.eissn=1756-1833&rft.issn=1756-1833&rft.au=MANYARA,%20Anthony%20Muchai&DAVIES,%20Philippa&STEWART,%20Derek&WEIR,%20Christopher%20J&YOUNG,%20Amber%20E&rft.genre=article


Files in this item

Thumbnail
Name:
BPH_BMJ_2024_Manyara.pdf
Size:
326.2Kb
Format:
PDF
View/Open
Thumbnail
Name:
license_rdf
Size:
914bytes
Format:
application/rdf+xml
View/Open

This item appears in the following Collection(s)

Show simple item record