2022
Percutaneous Left Atrial Appendage Occlusion in Comparison to Non‐Vitamin K Antagonist Oral Anticoagulant Among Patients With Atrial Fibrillation
Noseworthy PA, Van Houten HK, Krumholz HM, Kent DM, Abraham NS, Graff‐Radford J, Alkhouli M, Henk HJ, Shah ND, Gersh BJ, Friedman PA, Holmes DR, Yao X. Percutaneous Left Atrial Appendage Occlusion in Comparison to Non‐Vitamin K Antagonist Oral Anticoagulant Among Patients With Atrial Fibrillation. Journal Of The American Heart Association 2022, 11: e027001. PMID: 36172961, PMCID: PMC9673739, DOI: 10.1161/jaha.121.027001.Peer-Reviewed Original ResearchConceptsComposite end pointAtrial appendage occlusionOral anticoagulantsAtrial fibrillationLower riskMajor bleedingSystemic embolismIntracranial bleedingAppendage occlusionNon-Vitamin K Antagonist Oral AnticoagulantsIschemic stroke/systemic embolismK Antagonist Oral AnticoagulantsPrimary composite end pointPropensity score overlap weightingStroke/systemic embolismEnd pointHigh bleeding riskSignificant differencesAntithrombotic regimensBleeding riskCause mortalityBaseline characteristicsComposite outcomeIschemic strokeSecondary outcomes
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
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
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 pointClinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2012
Role of Intensive Glucose Control in Development of Renal End Points in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis
Coca SG, Ismail-Beigi F, Haq N, Krumholz HM, Parikh CR. Role of Intensive Glucose Control in Development of Renal End Points in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis. JAMA Internal Medicine 2012, 172: 761-769. PMID: 22636820, PMCID: PMC3688081, DOI: 10.1001/archinternmed.2011.2230.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBlood GlucoseDiabetes Mellitus, Type 2Diabetic NephropathiesDisease ProgressionFemaleGlycated HemoglobinHumansHypoglycemic AgentsKidney Failure, ChronicKidney Function TestsMaleMiddle AgedMonitoring, PhysiologicPrognosisRandomized Controlled Trials as TopicRenal DialysisRisk AssessmentSeverity of Illness IndexConceptsIntensive glucose controlRenal end pointsSerum creatinine levelsConventional glucose controlGlucose controlType 2 diabetesRenal diseaseCreatinine levelsEnd pointGlycemic controlSystematic reviewType 2 diabetes mellitusAggressive glycemic controlClinical renal outcomesKidney-related outcomesIntensive glycemic controlRenal outcomesCumulative incidenceDiabetes mellitusRandomized trialsConventional therapyLanguage restrictionsMacroalbuminuriaMicroalbuminuriaType 2
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 differencesCliniciansDeathLicensing drugs for diabetes
Lehman R, Yudkin JS, Krumholz H. Licensing drugs for diabetes. The BMJ 2010, 341: c4805. PMID: 20819887, DOI: 10.1136/bmj.c4805.Peer-Reviewed Original Research
2006
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
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
2000
Pulse pressure and risk for myocardial infarction and heart failure in the elderly
Vaccarino V, Holford T, Krumholz H. Pulse pressure and risk for myocardial infarction and heart failure in the elderly. Journal Of The American College Of Cardiology 2000, 36: 130-138. PMID: 10898424, DOI: 10.1016/s0735-1097(00)00687-2.Peer-Reviewed Original ResearchConceptsCongestive heart failureCoronary heart diseaseSystolic blood pressureCardiovascular end pointsDiastolic blood pressurePulse pressureBlood pressureEnd pointHeart failureIndependent predictorsOverall mortalityIncidence of CHFIncidence of CHDEffect of PPElevated systolic blood pressureCurrent hypertension guidelinesIncident CHF eventsCHD risk factorsCurrent medication useIncident CHD eventsPowerful independent predictorBlood pressure parametersBlood pressure variablesElevated pulse pressureDiastolic hypertension