2020
Secondary prevention of cardiovascular disease in China
Lu J, Zhang L, Lu Y, Su M, Li X, Liu J, Zhang H, Nasir K, Masoudi F, Krumholz H, Li J, Zheng X. Secondary prevention of cardiovascular disease in China. Heart 2020, 106: 1349-1356. PMID: 31980439, DOI: 10.1136/heartjnl-2019-315884.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAlcohol DrinkingCardiovascular DiseasesChinaFemaleHealthy LifestyleHeart Disease Risk FactorsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedPlatelet Aggregation InhibitorsRisk AssessmentRisk Reduction BehaviorSecondary PreventionSex FactorsSmoking CessationTime FactorsTreatment OutcomeConceptsSecondary prevention drugsIschemic heart diseaseCardiovascular diseasePrevention drugsIschemic strokeSecondary preventionAntiplatelet drugsCardiac Events Million Persons ProjectHistory of IHDMillion Persons ProjectSecondary prevention therapiesPopulation subgroupsMultivariable mixed modelsPublic health programsCommunities of ChinaCurrent smokersCurrent useMedication usePrevention therapyMultivariable analysisChina PatientHeart diseaseCurrent drinkersHealth programsDrugs
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
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewersPostapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers
2016
Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study
Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. The BMJ 2016, 354: i4189. PMID: 27540015, PMCID: PMC4989280, DOI: 10.1136/bmj.i4189.Peer-Reviewed Original ResearchConceptsHospital referral regionsOral anticoagulantsReferral regionsDiabetes drugsDrug classesGreater prescribingMedicare Part D beneficiariesAdditional daysPart D beneficiariesMedicare Part D prescriptionsCross-sectional analysisSectional ecological studyMedicare Part DPart D prescriptionsManufacturers of pharmaceuticalsPrescribingAnticoagulantsPhysiciansDrugsPart DEducational materialsSectional analysisStudy limitationsConsulting feesAssociationDespite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged
Chen SI, Fox ER, Hall MK, Ross JS, Bucholz EM, Krumholz HM, Venkatesh AK. Despite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged. Health Affairs 2016, 35: 798-804. PMID: 27140985, PMCID: PMC6712565, DOI: 10.1377/hlthaff.2015.1157.Peer-Reviewed Original ResearchConceptsCare drugsNational drug shortageDrug information servicesDrug shortagesAcute unscheduled careAcute care settingShortage of drugsUtah Drug Information ServiceIll patientsEmergency departmentUnscheduled careDrug Administration SafetyCare settingsAdministration safetyStudy periodDrugsDrug supplyCareEarly evidenceTotal numberPatients
2012
State Medicaid Programs Did Not Make Use Of Prior Authorization To Promote Safer Prescribing After Rosiglitazone Warning
Ross JS, Jackevicius C, Krumholz HM, Ridgeway J, Montori VM, Alexander GC, Zerzan J, Fan J, Shah ND. State Medicaid Programs Did Not Make Use Of Prior Authorization To Promote Safer Prescribing After Rosiglitazone Warning. Health Affairs 2012, 31: 188-198. PMID: 22232110, PMCID: PMC3319744, DOI: 10.1377/hlthaff.2011.1068.Peer-Reviewed Original ResearchConceptsState Medicaid programsPreferred drugDrug listPrior authorizationMedicaid programSafety warningsPrior authorization programHigh-cost drugsDiabetes medicationsPrescribing ratesEffective prescribingSafe prescribingMedicaid beneficiariesDiabetes drugsPrescribingState MedicaidHeart attackRosiglitazoneDrug availabilityDrugsAuthorization programPrescriptionMinimal changesMedicationsProviders
2006
Door-to-drug and door-to-balloon times: Where can we improve? Time to reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI)
Bradley EH, Herrin J, Wang Y, McNamara RL, Radford MJ, Magid DJ, Canto JG, Blaney M, Krumholz HM. Door-to-drug and door-to-balloon times: Where can we improve? Time to reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI). American Heart Journal 2006, 151: 1281-1287. PMID: 16781237, DOI: 10.1016/j.ahj.2005.07.015.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionPatients' clinical characteristicsBalloon timeClinical characteristicsDrug timeMyocardial infarctionProportion of patientsElevation myocardial infarctionHospital-level variationTreatment of patientsCross-sectional analysisHigh performing hospitalsReperfusion therapyNational registryHospitalPatientsRegression modelingECGDrugsInfarctionHierarchical regression modelingHospital performanceImportant quality indicatorMinutesGeometric mean
2005
The Complexity and Cost of Drug Regimens of Older Patients Hospitalized With Heart Failure in the United States, 1998-2001
Masoudi FA, Baillie CA, Wang Y, Bradford WD, Steiner JF, Havranek EP, Foody JM, Krumholz HM. The Complexity and Cost of Drug Regimens of Older Patients Hospitalized With Heart Failure in the United States, 1998-2001. JAMA Internal Medicine 2005, 165: 2069-2076. PMID: 16216996, DOI: 10.1001/archinte.165.18.2069.Peer-Reviewed Original ResearchConceptsHeart failureOlder patientsNumber of drugsDrug regimensComplex drug regimensPatients 65 yearsChronic lung diseaseNumber of dosesPrior revascularizationConcurrent prescriptionsMultiple comorbiditiesChronic medicationsElderly patientsHospital dischargeMultiple medicationsMedical therapyLung diseaseMultivariable modelDrug treatmentWhite raceMore drugsPatientsYounger ageDrugsUtilization measures