2020
Impact of left ventricular assist devices and heart transplants on acute myocardial infarction and heart failure mortality and readmission measures
Brandt EJ, Ross JS, Grady JN, Ahmad T, Pawar S, Bernheim SM, Desai NR. Impact of left ventricular assist devices and heart transplants on acute myocardial infarction and heart failure mortality and readmission measures. PLOS ONE 2020, 15: e0230734. PMID: 32214363, PMCID: PMC7098556, DOI: 10.1371/journal.pone.0230734.Peer-Reviewed Original ResearchConceptsLeft ventricular assist deviceHeart transplantation patientsRisk-standardized mortalityHeart transplantationTransplantation patientsAMI cohortReadmission cohortHF cohortVentricular assist deviceAMI mortalityAssist deviceHeart failure mortalityAcute myocardial infarctionHF mortalityLVAD indicationHF patientsLVAD patientsReadmission ratesHeart transplantMyocardial infarctionPrimary diagnosisReadmission measuresMedicare feeChronic supportPatientsVibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk
Chu L, Ioannidis JPA, Egilman AC, Vasiliou V, Ross JS, Wallach JD. Vibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk. International Journal Of Epidemiology 2020, 49: 608-618. PMID: 31967637, PMCID: PMC7266551, DOI: 10.1093/ije/dyz271.Peer-Reviewed Original ResearchConceptsObservational studyRelative effect estimatesImpact of alcoholEffect estimatesExposure definitionAlcohol-breast cancer relationshipDifferent exposure definitionsBreast cancer riskVibration of effectsRelative risk estimatesMost observational studiesAdjustment covariatesCancer relationshipEligible studiesBreast cancerStudy populationEpidemiologic studiesCancer riskSmaller effect estimatesAlcohol consumptionRisk estimatesContrast levelsSame associationStability of findingsOne-third
2017
Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologics
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2014
Innovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe’s Personal Genome Service
Downing NS, Ross JS. Innovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe’s Personal Genome Service. JAMA 2014, 311: 793-794. PMID: 24474248, DOI: 10.1001/jama.2014.148.Commentaries, Editorials and Letters
2011
Switching From Rosiglitazone: Thinking Outside the Class
Lipska KJ, Ross JS. Switching From Rosiglitazone: Thinking Outside the Class. JAMA 2011, 305: 820-821. PMID: 21304068, DOI: 10.1001/jama.2011.193.Commentaries, Editorials and Letters
2010
National Patterns of Risk-Standardized Mortality and Readmission for Acute Myocardial Infarction and Heart Failure
Bernheim SM, Grady JN, Lin Z, Wang Y, Wang Y, Savage SV, Bhat KR, Ross JS, Desai MM, Merrill AR, Han LF, Rapp MT, Drye EE, Normand SL, Krumholz HM. National Patterns of Risk-Standardized Mortality and Readmission for Acute Myocardial Infarction and Heart Failure. Circulation Cardiovascular Quality And Outcomes 2010, 3: 459-467. PMID: 20736442, PMCID: PMC3027304, DOI: 10.1161/circoutcomes.110.957613.Peer-Reviewed Original Research
2009
Reduction in Acute Myocardial Infarction Mortality in the United States: Risk-Standardized Mortality Rates From 1995-2006
Krumholz HM, Wang Y, Chen J, Drye EE, Spertus JA, Ross JS, Curtis JP, Nallamothu BK, Lichtman JH, Havranek EP, Masoudi FA, Radford MJ, Han LF, Rapp MT, Straube BM, Normand SL. Reduction in Acute Myocardial Infarction Mortality in the United States: Risk-Standardized Mortality Rates From 1995-2006. JAMA 2009, 302: 767-773. PMID: 19690309, PMCID: PMC3349070, DOI: 10.1001/jama.2009.1178.Peer-Reviewed Original ResearchConceptsRisk-standardized mortality ratesAcute myocardial infarctionShort-term mortality rateMortality rateHospital variationNonfederal acute care hospitalsAcute myocardial infarction mortalityHospital mortality rateDay of admissionRisk standardized mortality ratesAcute care hospitalsMyocardial infarction mortalityHealth care professionalsIndex hospitalizationCare hospitalMyocardial infarctionNational averagePatient levelMedicare patientsObservational studyMedical adviceHospital varianceMAIN OUTCOMECare professionalsPatients