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 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 criteriaNeurodevelopmental outcome descriptions in cohorts of extremely preterm children
Ding S, Mew E, Chee-A-Tow A, Offringa M, Butcher N, Moore G. Neurodevelopmental outcome descriptions in cohorts of extremely preterm children. Archives Of Disease In Childhood Fetal & Neonatal 2020, 105: fetalneonatal-2019-318144. PMID: 31932362, DOI: 10.1136/archdischild-2019-318144.Peer-Reviewed Original ResearchConceptsCohort studyCerebral palsyCognitive functionNeurodevelopmental outcomesOutcome selectionProspective cohort studyLong-term followOutcome descriptionsCompleteness of outcomeCompleteness of reportingOutcome assessorsPreterm infantsPreterm birthOutcome definitionsPreterm childrenOutcome reportingPalsyOutcomesInfantsChildrenReportingPretermStudy resultsCohortFollow