2020
Association of Ticagrelor vs Clopidogrel With Net Adverse Clinical Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
You SC, Rho Y, Bikdeli B, Kim J, Siapos A, Weaver J, Londhe A, Cho J, Park J, Schuemie M, Suchard MA, Madigan D, Hripcsak G, Gupta A, Reich CG, Ryan PB, Park RW, Krumholz HM. Association of Ticagrelor vs Clopidogrel With Net Adverse Clinical Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. JAMA 2020, 324: 1640-1650. PMID: 33107944, PMCID: PMC7592033, DOI: 10.1001/jama.2020.16167.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAdultAgedAged, 80 and overAlgorithmsAspirinCase-Control StudiesCause of DeathClopidogrelDatabases, FactualDyspneaFemaleHemorrhageHumansIschemiaMaleMiddle AgedMyocardial InfarctionNetwork Meta-AnalysisPercutaneous Coronary InterventionPropensity ScorePurinergic P2Y Receptor AntagonistsRecurrenceRepublic of KoreaRetrospective StudiesStrokeTicagrelorUnited StatesConceptsNet adverse clinical eventsAcute coronary syndromePercutaneous coronary interventionAdverse clinical eventsHemorrhagic eventsIschemic eventsHazard ratioCause mortalityCoronary syndromeCoronary interventionClinical eventsRisk of NACEClinical practiceLarge randomized clinical trialsPrimary end pointRetrospective cohort studyPropensity-matched pairsSummary hazard ratioRandomized clinical trialsRoutine clinical practiceSignificant differencesP2Y12 platelet inhibitorsTicagrelor groupCohort studySecondary outcomesAssessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approval
2019
Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease
Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease. Circulation Cardiovascular Quality And Outcomes 2019, 12: e005616. PMID: 30998400, DOI: 10.1161/circoutcomes.119.005616.Peer-Reviewed Original ResearchMeSH KeywordsAgedAsian PeopleBlood PressureChinaCoronary DiseaseCulturally Competent CareFemaleHealth Knowledge, Attitudes, PracticeHumansMaleMiddle AgedPatient Education as TopicRisk AssessmentRisk FactorsSecondary PreventionSingle-Blind MethodTelemedicineText MessagingTime FactorsTreatment OutcomeConceptsCoronary heart diseaseSystolic blood pressureBody mass indexBlood pressureHeart diseaseSecondary preventionIntervention groupPhysical activityEnd pointSmoking statusMass indexControl groupPrimary end pointRisk factor controlSecondary end pointsRisk factor managementLDL-C levelsDisease-specific knowledgeMobile phone textMobile health technologyUsual careDiabetes mellitusMedication adherenceRisk factorsFactor management
2018
Age of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrials
2014
Place of Residence and Outcomes of Patients With Heart Failure
Bikdeli B, Wayda B, Bao H, Ross JS, Xu X, Chaudhry SI, Spertus JA, Bernheim SM, Lindenauer PK, Krumholz HM. Place of Residence and Outcomes of Patients With Heart Failure. Circulation Cardiovascular Quality And Outcomes 2014, 7: 749-756. PMID: 25074375, PMCID: PMC5323058, DOI: 10.1161/circoutcomes.113.000911.Peer-Reviewed Original ResearchConceptsNeighborhood socioeconomic statusIndividual socioeconomic statusOutcomes of patientsHeart failureHigher SES neighborhoodsSocioeconomic statusClinical factorsHeart Failure Outcomes trialPrimary end pointPatient-level factorsUS internal medicineCause mortalityCause readmissionMultivariable adjustmentOutcome trialsMedical chartsPatient interviewsLow-SES neighborhoodsCardiology practiceMortality ratePatientsPlace of residenceInternal medicineReadmissionEnd point
2010
Telemonitoring in Patients with Heart Failure
Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in Patients with Heart Failure. New England Journal Of Medicine 2010, 363: 2301-2309. PMID: 21080835, PMCID: PMC3237394, DOI: 10.1056/nejmoa1010029.Peer-Reviewed Original ResearchConceptsPrimary end pointUsual care groupSecondary end pointsHeart failureEnd pointHeart failure outcomesNumber of hospitalizationsTelephone-based interactive voice response systemUsual careAdverse eventsPatient's clinicianMedian ageCare groupLarge trialsInteractive voice response systemPatientsSmall studyVoice response systemNumber of daysHospitalizationReadmissionTelemonitoringSignificant differencesCliniciansDeath
2006
Impact of Chronic Kidney Disease on Health-Related Quality-of-Life Improvement After Coronary Artery Bypass Surgery
Parikh CR, Coca SG, Smith GL, Vaccarino V, Krumholz HM. Impact of Chronic Kidney Disease on Health-Related Quality-of-Life Improvement After Coronary Artery Bypass Surgery. JAMA Internal Medicine 2006, 166: 2014-2019. PMID: 17030836, DOI: 10.1001/archinte.166.18.2014.Peer-Reviewed Original ResearchConceptsSevere chronic kidney diseaseChronic kidney diseasePhysical functionMH scorePF scoresKidney diseaseMedical Outcomes Trust Short FormAdvanced chronic kidney diseaseCoronary artery bypass surgeryLife outcomesCoronary artery bypassPrimary end pointArtery bypass surgeryHealth-related qualityCoronary artery diseaseMH subscalesArtery bypassCKD stageBypass surgeryArtery diseaseHealth SurveyMean changeStage 0Mean decreaseCABGPrediction of medical morbidity and mortality after acute myocardial infarction in patients at increased psychosocial risk in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) study
Jaffe AS, Krumholz HM, Catellier DJ, Freedland KE, Bittner V, Blumenthal JA, Calvin JE, Norman J, Sequeira R, O'Connor C, Rich MW, Sheps D, Wu C, Investigators F. Prediction of medical morbidity and mortality after acute myocardial infarction in patients at increased psychosocial risk in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) study. American Heart Journal 2006, 152: 126-135. PMID: 16824842, DOI: 10.1016/j.ahj.2005.10.004.Peer-Reviewed Original ResearchConceptsPost-MI patientsAcute myocardial infarctionMyocardial infarctionLow social supportCardiovascular mortalityEnd pointNonfatal myocardial infarctionPrimary end pointSecondary end pointsLong-term mortalityPrior myocardial infarctionSignificant multivariable predictorsProportional hazards modelSocial supportKillip classCause mortalityElevated creatinineRecurrent infarctionAdverse eventsBaseline characteristicsBypass surgeryEjection fractionHeart failureMedical morbidityMedical predictors
2002
Sex-Based Differences in the Effect of Digoxin for the Treatment of Heart Failure
Rathore SS, Wang Y, Krumholz HM. Sex-Based Differences in the Effect of Digoxin for the Treatment of Heart Failure. New England Journal Of Medicine 2002, 347: 1403-1411. PMID: 12409542, DOI: 10.1056/nejmoa021266.Peer-Reviewed Original ResearchConceptsEffect of digoxinDepressed left ventricular systolic functionLeft ventricular systolic functionVentricular systolic functionSex-based differencesRate of deathDigoxin therapyHeart failureSystolic functionMultivariable Cox proportional hazards modelsDigitalis Investigation Group (DIG) studyDigitalis Investigation Group trialCox proportional hazards modelHeart failure variesPrimary end pointRisk of deathProportional hazards modelMantel-Haenszel testOverall mortalityTherapy differsEpidemiologic featuresMultivariable analysisClinical variablesSubgroup analysisGroup trialsβ-Blocker Therapy in Heart Failure: Scientific Review
Foody JM, Farrell MH, Krumholz HM. β-Blocker Therapy in Heart Failure: Scientific Review. JAMA 2002, 287: 883-889. PMID: 11851582, DOI: 10.1001/jama.287.7.883.Peer-Reviewed Original ResearchConceptsHeart failure patientsHeart failureClinical trialsFailure patientsClinical outcomesClass IIDrug Administration indicationsBeta-blocker usePrimary end pointΒ-blocker therapyScientific rationaleTreatment of patientsCare of patientsEnglish-language articlesPotential physiologic roleBasic science studiesClass of agentsSystolic dysfunctionMortality benefitPlacebo treatmentDATA EXTRACTIONClinical guidelinesSTUDY SELECTIONCurrent recommendationsPatients