2025
Computational Phenomapping of Randomized Clinical Trial Participants to Enable Assessment of Their Real-World Representativeness and Personalized Inference
Thangaraj P, Oikonomou E, Dhingra L, Aminorroaya A, Jayaram R, Suchard M, Khera R. Computational Phenomapping of Randomized Clinical Trial Participants to Enable Assessment of Their Real-World Representativeness and Personalized Inference. Circulation Cardiovascular Quality And Outcomes 2025, 18: e011306. PMID: 40261065, PMCID: PMC12203226, DOI: 10.1161/circoutcomes.124.011306.Peer-Reviewed Original ResearchConceptsElectronic health record patientElectronic health recordsDistance metricRandomized clinical trialsElectronic health record dataMachine learning methodsYale New Haven Health SystemElectronic health record cohortRandomized clinical trial participantsLearning methodsHeart failureClinical trial participationTOPCAT participantsReal worldMultidimensional metricRCT participantsHealth recordsTreatment effectsHealth systemCharacteristics of patientsRandomized clinical trial cohortsTrial participantsMetricsUnited StatesNovel statistic
2021
Rationale and pathways forward in the implementation of coronary artery calcium-based enrichment of randomized trials
Cainzos-Achirica M, Anugula D, Mszar R, Grandhi G, Patel K, Bittencourt M, Blankstein R, Blaha M, Blumenthal R, Ray K, Bhatt D, Nasir K. Rationale and pathways forward in the implementation of coronary artery calcium-based enrichment of randomized trials. American Heart Journal 2021, 243: 54-65. PMID: 34587511, DOI: 10.1016/j.ahj.2021.09.006.Peer-Reviewed Original ResearchConceptsCoronary artery calciumRandomized Controlled TrialsPrognostic enrichmentCoronary artery calcium scoreCoronary artery calcium dataAdd-on therapyRisk reduction therapyFood and Drug AdministrationComputed tomography imagesArtery calciumCardiovascular riskRandomized trialsEnrichment paradigmDrug AdministrationPrimary preventionTomography imagesRCT participantsTherapyTrialsLogistical barriersRisk
2006
Does Random Treatment Assignment Cause Harm to Research Participants?
Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. Does Random Treatment Assignment Cause Harm to Research Participants? PLOS Medicine 2006, 3: e188. PMID: 16719548, PMCID: PMC1470665, DOI: 10.1371/journal.pmed.0030188.Peer-Reviewed Original ResearchConceptsClinical outcomesTreatment assignmentRCT participantsClinical trialsTrial participantsRandom treatment assignmentPrimary study outcomeMeeting eligibility criteriaImproved patient outcomesSimilar health statusSubstandard medical careBaseline characteristicsPatient groupPatient outcomesEligibility criteriaHealth outcomesHealth statusEligible manuscriptsMedical careSystematic reviewSame interventionClinical researchStudy outcomesOutcomesSignificant differences
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