2023
A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials
Ciani O, Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartssson 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. A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. EClinicalMedicine 2023, 65: 102283. PMID: 37877001, PMCID: PMC10590868, DOI: 10.1016/j.eclinm.2023.102283.Peer-Reviewed Original ResearchSurrogate endpointsInterventional trialsIntermediate outcomesHealth technology assessment expertsPrimary outcome measureMeasures of functionTreatment effectsE-Delphi studyOutcome measuresConsensus meetingBetter HealthTarget outcomesTrialsEndpointLack of consensusOutcomesPatientsFuture reportingCurrent definitionUrgent needSymptomsCliniciansSettingBiomarkers
2020
Evaluation of confounding in epidemiologic studies assessing alcohol consumption on the risk of ischemic heart disease
Wallach JD, Serghiou S, Chu L, Egilman AC, Vasiliou V, Ross JS, Ioannidis JPA. Evaluation of confounding in epidemiologic studies assessing alcohol consumption on the risk of ischemic heart disease. BMC Medical Research Methodology 2020, 20: 64. PMID: 32171256, PMCID: PMC7071725, DOI: 10.1186/s12874-020-0914-6.Peer-Reviewed Original ResearchConceptsIschemic heart disease riskHeart disease riskObservational studyImpact of alcoholPotential confoundersHeart diseaseDisease riskMultivariate modelIschemic heart diseaseResidual confoundingDisease relationshipsEpidemiologic studiesAlcohol consumptionConfoundersMultivariate analysisLack of consensusIndividual studiesStratification variablesDiseaseRiskSame exposureConfoundingDifferent studiesStudy findingsDifferent investigators