2019
Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals
Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone G, Ross JS, Krumholz HM. Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals. Circulation 2019, 140: 379-389. PMID: 31177811, PMCID: PMC8416048, DOI: 10.1161/circulationaha.119.040214.Peer-Reviewed Original ResearchConceptsNoninferiority marginNoninferiority trialCardiovascular trialsAllocation concealmentLower riskOpen labelHazard ratioRelative riskMethodological qualityProportion of trialsIndependent reviewersRisk differenceNew England JournalNoninferiorityHigh-impact journalsNew interventionsTrialsCohortDiscrepant resultsProtocol analysisTime trendsRiskTreatInterventionFactors
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugs
2015
Trajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study
Dharmarajan K, Hsieh AF, Kulkarni VT, Lin Z, Ross JS, Horwitz LI, Kim N, Suter LG, Lin H, Normand SL, Krumholz HM. Trajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study. The BMJ 2015, 350: h411. PMID: 25656852, PMCID: PMC4353309, DOI: 10.1136/bmj.h411.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionRetrospective cohort studyHeart failureRisk of deathMyocardial infarctionFirst readmissionAbsolute riskOlder patientsCohort studyRelative riskMedicare feeService beneficiariesRisk of readmissionGeneral elderly populationGeneral older populationRisk trajectoriesHigh-risk periodHospital dischargeHospital admissionDischarge diagnosisAdverse outcomesReadmissionHospitalizationTrajectories of riskElderly population