2022
Guidelines for Reporting Outcomes in Trial Protocols
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 Protocols. JAMA 2022, 328: 2345-2356. PMID: 36512367, DOI: 10.1001/jama.2022.21243.Peer-Reviewed Original Research
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 waste
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 outcomesGuidance for reporting outcomes in clinical trials: scoping review protocol
Butcher NJ, Mew EJ, Saeed L, Monsour A, Chee-A-Tow A, Chan AW, Moher D, Offringa M. Guidance for reporting outcomes in clinical trials: scoping review protocol. BMJ Open 2019, 9: e023001. PMID: 30782872, PMCID: PMC6377514, DOI: 10.1136/bmjopen-2018-023001.Peer-Reviewed Original Research