2022
Guidelines for Reporting Outcomes in Trial Reports
Butcher N, Monsour A, Mew E, Chan A, Moher D, Mayo-Wilson E, Terwee C, Chee-A-Tow A, Baba A, Gavin F, Grimshaw J, Kelly L, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson P, Szatmari P, Tugwell P, Golub R, Monga S, Vohra S, Marlin S, Ungar W, Offringa M. Guidelines for Reporting Outcomes in Trial Reports. JAMA 2022, 328: 2252-2264. PMID: 36511921, DOI: 10.1001/jama.2022.21022.Peer-Reviewed Original ResearchConceptsCONSORT 2010 statementClinical trialsConsensus meetingTrial reportsTrial outcomesReporting outcomesReporting Trials (CONSORT) 2010 statementTrial resultsElectronic database searchReporting of outcomesPerson consensus meetingCochrane Methodology RegisterGrey literature searchReference list searchesPrespecified analysisSecondary outcomesConsensus-based standardsDelphi survey processConsolidated StandardsDelphi votingTreatment groupsOutcome selectionFurther evaluationEvidence-informed decisionLiterature search
2020
Outcome reporting recommendations for clinical trial protocols and reports: a scoping review
Butcher N, Mew E, Monsour A, Chan A, Moher D, Offringa M. Outcome reporting recommendations for clinical trial protocols and reports: a scoping review. Trials 2020, 21: 620. PMID: 32641085, PMCID: PMC7341657, DOI: 10.1186/s13063-020-04440-w.Peer-Reviewed Original ResearchConceptsClinical trial protocolTrial protocolTrial outcomesStandard Protocol ItemsReporting of outcomesElectronic bibliographic database searchConsensus-based guidanceFull-text screeningGrey literature searchInterventional trialsResultsIn totalClinical trialsBibliographic database searchConsolidated StandardsProtocol ItemsCandidate itemsOutcome selectionAbstract screeningLiterature searchOutcomesResearch wastePrimary outcome reporting in adolescent depression clinical trials needs standardization
Monsour A, Mew E, Patel S, Chee-a-tow A, Saeed L, Santos L, Courtney D, Watson P, Monga S, Szatmari P, Offringa M, Butcher N. Primary outcome reporting in adolescent depression clinical trials needs standardization. BMC Medical Research Methodology 2020, 20: 129. PMID: 32450810, PMCID: PMC7247139, DOI: 10.1186/s12874-020-01019-6.Peer-Reviewed Original ResearchConceptsRandomized clinical trialsPrimary outcomeSingle primary outcomeClinical trialsOutcome assessmentDiagnosis of MDDChecklist itemsOutcome assessorsDepression clinical trialClinical guidelinesAdolescent MDDOutcome analysisRCT publicationsMost trialsTrial publicationsOutcome reportingReporting ItemsTreatment interventionsTrial outcomesOutcome informationTrialsHealth careOutcomesSignificant differencesMinimal criteria
2019
Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)
Butcher NJ, Monsour A, Mew EJ, Szatmari P, Pierro A, Kelly LE, Farid-Kapadia M, Chee-a-tow A, Saeed L, Monga S, Ungar W, Terwee CB, Vohra S, Fergusson D, Askie LM, Williamson PR, Chan AW, Moher D, Offringa M. Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT). Trials 2019, 20: 161. PMID: 30841935, PMCID: PMC6404348, DOI: 10.1186/s13063-019-3248-0.Peer-Reviewed Original ResearchConceptsClinical trialsTrial protocolTrial reportsExpert consensus meetingClinical trial reportsCONSORT reporting guidelinesIntegrated knowledge translation approachSystematic review authorsKnowledge translation approachReview authorsConsensus-based standardsPatient outcomesConsensus meetingDiverse disease areasInternational Delphi studyTrial designGuideline developersGuideline developmentCONSORT extensionDelphi studyTrial outcomesEQUATOR NetworkCandidate outcomesTrialsPoor quality outcomes