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
Development of an international standard set of patient-centred outcome measures for overall paediatric health: a consensus process
Algurén B, Ramirez J, Salt M, Sillett N, Myers S, Alvarez-Cote A, Butcher N, Caneo L, Cespedes J, Chaplin J, Ng K, García-García J, Hazelzet J, Klassen A, Turquetto A, Mew E, Morris M, Offringa M, O'Meara M, Papp J, Rodrigo C, Switaj T, Mayer C, Jenkins K. Development of an international standard set of patient-centred outcome measures for overall paediatric health: a consensus process. Archives Of Disease In Childhood 2020, 106: 868-876. PMID: 33310707, PMCID: PMC8380885, DOI: 10.1136/archdischild-2020-320345.Peer-Reviewed Original ResearchConceptsOutcome measuresPatient-centered outcome measuresDelphi processHealth Professional SurveyPatient-reported outcomesCase-mix variablesClinician-reported measuresField of pediatricsHealth Outcomes MeasurementAdolescent physical healthWorking GroupInternational Working GroupClinical trialsPediatric healthcare deliveryProxy-reported outcomesHealth SurveyPediatric healthInternational standard setOutcome measurementsPatient advisorsBiopsychosocial aspectsPatient validationPhysical healthHealth conditionsFamily medicineOutcome 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 wasteSystematic scoping review identifies heterogeneity in outcomes measured in adolescent depression clinical trials
Mew E, Monsour A, Saeed L, Santos L, Patel S, Courtney D, Watson P, Szatmari P, Offringa M, Monga S, Butcher N. Systematic scoping review identifies heterogeneity in outcomes measured in adolescent depression clinical trials. Journal Of Clinical Epidemiology 2020, 126: 71-79. PMID: 32561367, DOI: 10.1016/j.jclinepi.2020.06.013.Peer-Reviewed Original ResearchConceptsOutcome measurement instrumentsOutcome heterogeneityMajor depressive disorder trialsMajor depressive disorderDepressive symptom severityOutcome termsSingle trialDepression clinical trialPrimary outcomeClinical trialsDepressive disorderDepression trialsSymptom severityLife impactStudy designIdentified outcomesTrial resultsTrialsOutcomesIdentifies heterogeneityDescriptive analysisMeasurement instrumentsTherapySeverityPrimary 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 outcomesOutcomes reported in randomised clinical trials of major depressive disorder treatments in adolescents: a systematic scoping review protocol
Monsour A, Mew EJ, Szatmari P, Patel S, Saeed L, Offringa M, Butcher NJ. Outcomes reported in randomised clinical trials of major depressive disorder treatments in adolescents: a systematic scoping review protocol. BMJ Open 2019, 9: bmjopen-2018-024191. PMID: 30782729, PMCID: PMC6340428, DOI: 10.1136/bmjopen-2018-024191.Peer-Reviewed Original ResearchConceptsAdolescent major depressive disorderCore outcome setsMajor depressive disorderClinical trialsMajor depressive disorder treatmentCommon mental health conditionsDepressive disorder treatmentBest treatment practicesMental health conditionsElectronic bibliographic database searchJoanna Briggs InstituteReview methods manualFull-text screeningEfficacy of interventionsSystematic scoping review protocolScoping review protocolSystematic scoping reviewDepressive disorderEligible studiesBibliographic database searchOutcome setsTreatment interventionsDisorder treatmentOutcome selectionRCTs