2021
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
2019
Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke Database
2017
Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge
Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA 2017, 318: 270-278. PMID: 28719692, PMCID: PMC5817448, DOI: 10.1001/jama.2017.8444.Peer-Reviewed Original ResearchConceptsRisk-adjusted readmission ratesRisk-adjusted mortality ratesAcute myocardial infarctionHeart failureReadmission ratesMortality rateMyocardial infarctionMedicare feeService beneficiariesHospital readmission ratesMean hospitalHospital mortalityPostdischarge mortalityHospital dischargeHospital readmissionRetrospective studyAffordable Care ActReadmission reductionMAIN OUTCOMEPneumoniaHospitalSecondary analysisWeighted Pearson correlation coefficientMortalityCare Act
2015
Patterns of Use of Angiotensin‐Converting Enzyme Inhibitors/Angiotensin Receptor Blockers Among Patients With Acute Myocardial Infarction in China From 2001 to 2011: China PEACE‐Retrospective AMI Study
Liu J, Masoudi FA, Spertus JA, Wang Q, Murugiah K, Spatz ES, Li J, Li X, Ross JS, Krumholz HM, Jiang L, Group C. Patterns of Use of Angiotensin‐Converting Enzyme Inhibitors/Angiotensin Receptor Blockers Among Patients With Acute Myocardial Infarction in China From 2001 to 2011: China PEACE‐Retrospective AMI Study. Journal Of The American Heart Association 2015, 4: e001343. PMID: 25713293, PMCID: PMC4345866, DOI: 10.1161/jaha.114.001343.Peer-Reviewed Original ResearchConceptsACEI/ARB therapyAcute myocardial infarctionClass I indicationsARB therapyMyocardial infarctionMortality riskReceptor blockersAngiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor BlockersEnzyme inhibitors/angiotensin receptor blockersChina PEACE-Retrospective AMI StudyChinese AMI patientsClass IIa recommendationRates of therapyAbsence of contraindicationsAngiotensin receptor blockersHigher mortality riskCost-effective therapyIIa recommendationAMI patientsChina PatientRetrospective studyHigh riskPatterns of useChinese guidelinesPatients
2013
For-profit hospital ownership status and use of brachytherapy after breast-conserving surgery
Sen S, Soulos PR, Herrin J, Roberts KB, Yu JB, Lesnikoski BA, Ross JS, Krumholz HM, Gross CP. For-profit hospital ownership status and use of brachytherapy after breast-conserving surgery. Surgery 2013, 155: 776-788. PMID: 24787104, PMCID: PMC4008843, DOI: 10.1016/j.surg.2013.12.009.Peer-Reviewed Original ResearchConceptsHospital ownership statusBreast-conserving operationsBreast-conserving surgeryUse of brachytherapyRadiation therapyOperative careBreast cancerMedicare beneficiariesOverall useReceipt of brachytherapyAdjuvant radiation therapyInvasive breast cancerFemale Medicare beneficiariesGreater overall useYears of ageShort life expectancyRetrospective studyRT modalityProfit hospitalsExpensive modalityOlder womenBrachytherapy useBreast brachytherapyHospitalBrachytherapy