2022
ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
Sarri G, Bennett D, Debray T, Deruaz‐Luyet A, Gabarró M, Largent JA, Li X, Liu W, Lund JL, Moga DC, Gokhale M, Rentsch CT, Wen X, Yanover C, Ye Y, Yun H, Zullo AR, Lin KJ. ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs. Clinical Pharmacology & Therapeutics 2022, 112: 990-999. PMID: 35170021, PMCID: PMC9087010, DOI: 10.1002/cpt.2560.Peer-Reviewed Original ResearchConceptsComparative effectiveness researchElectronic health recordsRoutine careCOVID-19Health recordsCoronavirus disease 2019 (COVID-19) pandemicLong-term treatment effectsEHR dataEffectiveness researchDisease 2019 pandemicRigorous study designsCOVID-19-related questionsAscertainment of outcomesVaccine effectivenessComplex patientsExposure statusHealthcare databasesTherapeutic interventionsOptimal managementHealthcare professionalsClinical researchStudy designTreatment effectsAppropriate statistical methodsInternational Society
2021
A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial
Esserman DA, Gill TM, Miller ME, Greene EJ, Dziura JD, Travison TG, Meng C, Peduzzi PN. A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial. Clinical Trials 2021, 18: 207-214. PMID: 33678038, PMCID: PMC8009806, DOI: 10.1177/1740774520980070.Peer-Reviewed Original ResearchConceptsPrimary outcome definitionUsual care armSerious fall injuriesMedical attentionOutcome definitionsFall injuriesElders trialCare armOvernight hospitalizationStudy powerCare managersIntervention effectsType 2 injuriesAscertainment biasAscertainment of outcomesInterim monitoring planUsual careHazard ratioPrimary outcomeIntervention armClinical trialsUnblinded observerClinical basisMulticomponent interventionAdditional fall
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