2024
Assessing readiness to use electronic health record data for outcome ascertainment in clinical trials – A case study
Esserman D, Greene E, Latham N, Kane M, Lu C, Peduzzi P, Gill T, Ganz D. Assessing readiness to use electronic health record data for outcome ascertainment in clinical trials – A case study. Contemporary Clinical Trials 2024, 142: 107572. PMID: 38740298, DOI: 10.1016/j.cct.2024.107572.Peer-Reviewed Original ResearchElectronic health record dataElectronic health recordsOutcome ascertainmentDevelop Confidence in EldersElectronic health record platformsClinical sitesPrimary care practicesHealth record dataMulti-site trialMulti-site clinical trialCare practicesHealth recordsAssess readinessAcute clinical outcomesHealthcare systemRecord dataClinical trialsReduce injuriesData qualityData comprehensionChecklistStudy dataClinical trial sitesVariable data qualityAscertainment
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
2019
Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study
Ganz DA, Siu AL, Magaziner J, Latham NK, Travison TG, Lorenze NP, Lu C, Wang R, Greene EJ, Stowe CL, Harvin LN, Araujo KLB, Gurwitz JH, Agrawal Y, Correa-De-Araujo R, Peduzzi P, Gill TM. Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study. Injury Epidemiology 2019, 6: 14. PMID: 31245263, PMCID: PMC6582694, DOI: 10.1186/s40621-019-0190-2.Peer-Reviewed Original ResearchSerious fall injuriesPrimary care providersFall injuriesPrimary outcomeMedical recordsMedical attentionFull-text medical recordsMulticenter pragmatic clinical trialHealth systemAdministrative dataMedical record reviewIndividualized care plansPragmatic clinical trialsPrimary care practicesMedical record dataParticipant's primary care providerUnderlying riskUS health systemOvernight hospitalizationRecord reviewHead injuryElders StudyClinical trialsEvent adjudicationJoint dislocation