2024
Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson A, Amstutz A, Bertolaccini L, Bruno V, Devane D, Faria C, Gilbert P, Harris R, Lassere M, Marinelli L, Markham S, Powers J, Rezaei Y, Richert L, Schwendicke F, Tereshchenko L, Thoma A, Turan A, Worrall A, Christensen R, Collins G, Ross J, Taylor R, Ciani O. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078524. PMID: 38981645, PMCID: PMC11231881, DOI: 10.1136/bmj-2023-078524.Peer-Reviewed Original ResearchConceptsRandomised controlled trial reportsTrial reportsRandomised controlled trialsControlled trial reportsIntervention treatment effectsResearch wasteTrial findingsTreatment effectsControlled trialsTarget outcomesChecklistAdequate informationSurrogate endpointsInterventionCONSORTItemsTrialsImprove transparencyHarmReportsGuidelinesOutcomesEndpoint
2022
Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE
Manyara AM, Davies P, Stewart D, Weir CJ, Young A, Butcher NJ, Bujkiewicz S, Chan AW, Collins GS, Dawoud D, Offringa M, Ouwens M, Ross JS, Taylor RS, Ciani O. Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open 2022, 12: e064304. PMID: 36220321, PMCID: PMC9557267, DOI: 10.1136/bmjopen-2022-064304.Peer-Reviewed Original ResearchConceptsSurrogate endpointsPeer-reviewed publicationsSurrogate primary endpointOpen-access peer-reviewed publicationPATIENTS/PARTICIPANTSCompleteness of reportingTranslation of effectsPhase 1Primary endpointPrimary outcomeTrial findingsEthical approvalCONSORT extensionSuch trialsEthics CommitteeEndpointHealth benefitsTrialsPhase 3Final outcomePhase 2Transparent reportingOutcomesPhase 4Additional items