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
2020
D‐CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System–Based Versus Community‐Based Dementia Care Versus Usual Dementia Care
Reuben DB, Gill TM, Stevens A, Williamson J, Volpi E, Lichtenstein M, Jennings LA, Tan Z, Evertson L, Bass D, Weitzman L, Carnie M, Wilson N, Araujo K, Charpentier P, Meng C, Greene EJ, Dziura J, Liu J, Unger E, Yang M, Currie K, Lenoir KM, Green A, Abraham S, Vernon A, Samper‐Ternent R, Raji M, Hirst RM, Galloway R, Finney GR, Ladd I, Rahm AK, Borek P, Peduzzi P. D‐CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System–Based Versus Community‐Based Dementia Care Versus Usual Dementia Care. Journal Of The American Geriatrics Society 2020, 68: 2492-2499. PMID: 32949145, PMCID: PMC8086629, DOI: 10.1111/jgs.16862.Peer-Reviewed Original ResearchConceptsCommunity-based dementia careUsual careClinical trial sitesDementia careHealth systemCaregiver unmet needsNursing home placement ratesClinical health systemsDementia care specialistsUnit of randomizationQuality of lifeCost effectivenessDementia Care StudyPrimary outcomeClinical benefitSuperiority trialFunctional statusPragmatic trialCaregiver dyadsCare specialistsComprehensive careCaregiver distressCare studiesMedicare claimsNurse practitionersA Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries
Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. New England Journal Of Medicine 2020, 383: 129-140. PMID: 32640131, PMCID: PMC7421468, DOI: 10.1056/nejmoa2002183.Peer-Reviewed Original ResearchConceptsSerious fall injuriesFall injuriesIntervention groupControl groupUsual careMultifactorial interventionRate of hospitalizationPrimary care practicesCluster-randomized trialCommunity-dwelling adultsFirst-event analysisYears of ageHealth care systemRate of fallElectronic health recordsBaseline characteristicsPrimary outcomeRandomized trialsMean ageEfficacy trialsIndividualized planCare practicesInjuryMultifactorial strategyEvent rates