2024
Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
Yap C, Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck A, Gilbert A, Gnanasakthy A, Greystoke A, Hansen A, Kamudoni P, Kholmanskikh O, King-Kallimanis B, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell K, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour L, Weber H, Wilson R, Calvert M, Peipert J. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine 2024, 76: 102838. PMID: 39386161, PMCID: PMC11462221, DOI: 10.1016/j.eclinm.2024.102838.Peer-Reviewed Original ResearchEarly phase trialsPatient-reported outcomesPhase trialsInvestigator-reported adverse eventsEarly phase clinical trialsTolerability assessmentsPhase clinical trialsIntegration of patient-reported outcomesAdverse eventsClinical trialsPatient-centred careDosing decisionsDiverse clinical areasTherapy risksLaboratory assessmentPatientsTrialsPatient advocatesClinical areasOutcomesSafety alertsPharmaceutical representativesVirtual roundtableRiskIllusory generalizability of clinical prediction models
Chekroud A, Hawrilenko M, Loho H, Bondar J, Gueorguieva R, Hasan A, Kambeitz J, Corlett P, Koutsouleris N, Krumholz H, Krystal J, Paulus M. Illusory generalizability of clinical prediction models. Science 2024, 383: 164-167. PMID: 38207039, DOI: 10.1126/science.adg8538.Peer-Reviewed Original Research
2023
Clinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation
Hurley N, Dhruva S, Desai N, Ross J, Ngufor C, Masoudi F, Krumholz H, Mortazavi B. Clinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation. ACM Transactions On Computing For Healthcare 2023, 4: 1-18. PMID: 37908872, PMCID: PMC10613929, DOI: 10.1145/3616021.Peer-Reviewed Original ResearchImpact of Marital Stress on 1‐Year Health Outcomes Among Young Adults With Acute Myocardial Infarction
Zhu C, Dreyer R, Li F, Spatz E, Caraballo‐Cordovez C, Mahajan S, Raparelli V, Leifheit E, Lu Y, Krumholz H, Spertus J, D'Onofrio G, Pilote L, Lichtman J. Impact of Marital Stress on 1‐Year Health Outcomes Among Young Adults With Acute Myocardial Infarction. Journal Of The American Heart Association 2023, 12: e030031. PMID: 37589125, PMCID: PMC10547344, DOI: 10.1161/jaha.123.030031.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionCardiac-specific qualityGeneric health statusMyocardial infarctionBaseline healthMarital stressHealth outcomesHealth statusWorse patient-reported outcomesMental healthYoung adultsObservational cohort studyPatient-reported outcomesSocioeconomic factorsWorse mental healthReadmission 1Cause readmissionCohort studyYounger patientsRoutine screeningDepressive symptomsGreater oddsAnginaMale participantsOutcomesClinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models
Rowhani-Farid A, Grewal M, Solar S, Eghrari A, Zhang A, Gross C, Krumholz H, Ross J. Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models. Scientific Data 2023, 10: 529. PMID: 37553403, PMCID: PMC10409750, DOI: 10.1038/s41597-023-02436-0.Peer-Reviewed Original ResearchSex Difference in Outcomes of Acute Myocardial Infarction in Young Patients
Sawano M, Lu Y, Caraballo C, Mahajan S, Dreyer R, Lichtman J, D'Onofrio G, Spatz E, Khera R, Onuma O, Murugiah K, Spertus J, Krumholz H. Sex Difference in Outcomes of Acute Myocardial Infarction in Young Patients. Journal Of The American College Of Cardiology 2023, 81: 1797-1806. PMID: 37137590, DOI: 10.1016/j.jacc.2023.03.383.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionNoncardiac hospitalizationsSubdistribution HRYounger patientsMyocardial infarctionSex differencesYoung womenCause-specific hospitalizationsCause of hospitalizationWorse health statusSignificant sex disparityNoncardiovascular hospitalizationsVIRGO StudyIndex episodeAdverse outcomesIncidence rateHospitalizationHigh riskSex disparitiesHealth statusPatientsU.S. hospitalsWomenInfarctionOutcomes
2022
12th Korea Healthcare Congress 2021; 김치국부터 마시지 말라; The Time for Digital Health is Almost Here
Krumholz HM. 12th Korea Healthcare Congress 2021; 김치국부터 마시지 말라; The Time for Digital Health is Almost Here. Yonsei Medical Journal 2022, 63: 493-498. PMID: 35512753, PMCID: PMC9086693, DOI: 10.3349/ymj.2022.63.5.493.Peer-Reviewed Original ResearchHealth status outcomes after spontaneous coronary artery dissection and comparison with other acute myocardial infarction: The VIRGO experience
Murugiah K, Chen L, Dreyer RP, Bouras G, Safdar B, Khera R, Lu Y, Spatz ES, Ng VG, Gupta A, Bueno H, Tweet MS, Spertus JA, Hayes SN, Lansky A, Krumholz HM. Health status outcomes after spontaneous coronary artery dissection and comparison with other acute myocardial infarction: The VIRGO experience. PLOS ONE 2022, 17: e0265624. PMID: 35320296, PMCID: PMC8942215, DOI: 10.1371/journal.pone.0265624.Peer-Reviewed Original ResearchConceptsSpontaneous coronary artery dissectionAcute myocardial infarctionAMI patientsCoronary artery dissectionYoung AMI patientsHealth status outcomesHealth status instrumentsSCAD patientsArtery dissectionMyocardial infarctionStatus outcomesPatientsOutcomesHousehold incomeCollege educationInfarction
2021
The association of neighborhood walkability with health outcomes in older adults after acute myocardial infarction: The SILVER-AMI study
Roy B, Hajduk AM, Tsang S, Geda M, Riley C, Krumholz HM, Chaudhry SI. The association of neighborhood walkability with health outcomes in older adults after acute myocardial infarction: The SILVER-AMI study. Preventive Medicine Reports 2021, 23: 101391. PMID: 34040930, PMCID: PMC8141908, DOI: 10.1016/j.pmedr.2021.101391.Peer-Reviewed Original ResearchAcute myocardial infarctionSILVER-AMI StudyPhysical activityMental healthMyocardial infarctionNeighborhood walkabilityOlder adultsHealth outcomesSocial supportCommunity-Living AdultsSecondary outcomesCoronary diseasePrimary outcomeSF-12Longitudinal cohortPhysical therapyAdjusted modelSurvival timeBetter outcomesGreater walkabilitySurvival analysisMobility limitationsPhysical healthOutcomesAdults
2020
Frequency, trends and institutional variation in 30‐day all‐cause mortality and unplanned readmissions following hospitalisation for heart failure in Australia and New Zealand
Labrosciano C, Horton D, Air T, Tavella R, Beltrame JF, Zeitz CJ, Krumholz HM, Adams R, Scott IA, Gallagher M, Hossain S, Hariharaputhiran S, Ranasinghe I. Frequency, trends and institutional variation in 30‐day all‐cause mortality and unplanned readmissions following hospitalisation for heart failure in Australia and New Zealand. European Journal Of Heart Failure 2020, 23: 31-40. PMID: 33094886, DOI: 10.1002/ejhf.2030.Peer-Reviewed Original ResearchConceptsHF hospitalisationUnplanned readmissionReadmission ratesHeart failure hospitalisationUnplanned readmission rateMortality cohortReadmission cohortCause mortalityHeart failurePrimary outcomeHospitalisationReadmissionSeparate cohortMortality rateHospitalPatientsMortalityCare qualityPrivate hospitalsStudy periodCohortModest declineNational averageOutcomesDaysNewly diagnosed diabetes and outcomes after acute myocardial infarction in young adults
Ding Q, Spatz ES, Lipska KJ, Lin H, Spertus JA, Dreyer RP, Whittemore R, Funk M, Bueno H, Krumholz HM. Newly diagnosed diabetes and outcomes after acute myocardial infarction in young adults. Heart 2020, 107: 657-666. PMID: 33082173, PMCID: PMC8005796, DOI: 10.1136/heartjnl-2020-317101.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionHealth statusDischarge diagnosisPharmacological treatmentMyocardial infarctionShort-term health statusYoung AMI Patients (VIRGO) studyDisease-specific health statusYoung adultsQuality of lifeHospital complicationsHospital mortalityMedication initiationBaseline characteristicsClinical outcomesDiabetesPatientsDiagnosisPatient studiesMonthsComplicationsInfarctionSignificant differencesOutcomesMortalityNon-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersInterventionQuality of informed consent documents among US. hospitals: a cross-sectional study
Spatz ES, Bao H, Herrin J, Desai V, Ramanan S, Lines L, Dendy R, Bernheim SM, Krumholz HM, Lin Z, Suter LG. Quality of informed consent documents among US. hospitals: a cross-sectional study. BMJ Open 2020, 10: e033299. PMID: 32434934, PMCID: PMC7247389, DOI: 10.1136/bmjopen-2019-033299.Peer-Reviewed Original ResearchConceptsInformed consent documentsHOSPITAL scoreUS hospitalsMean hospital scoresRetrospective observational studyConsent documentsCross-sectional studyEight-item instrumentService patientsElective proceduresProcedure typeObservational studySurgical proceduresMedicare feeHospitalHospital qualityMeasure scoresInformed consentMost hospitalsSpearman correlationScoresFace validityIndependent ratersOutcomesStakeholder feedbackRelevance of Cardiac Surgery Outcome Reporting 3 Years Later in a New York and California Statewide Analysis
Mori M, Shahian DM, Suter LG, Geirsson A, Lin Z, Krumholz HM. Relevance of Cardiac Surgery Outcome Reporting 3 Years Later in a New York and California Statewide Analysis. JAMA Surgery 2020, 155: 442-444. PMID: 32129801, PMCID: PMC7057169, DOI: 10.1001/jamasurg.2019.6367.Peer-Reviewed Original ResearchReadmission and Mortality After Hospitalization for Myocardial Infarction and Heart Failure
Ko DT, Khera R, Lau G, Qiu F, Wang Y, Austin PC, Koh M, Lin Z, Lee DS, Wijeysundera HC, Krumholz HM. Readmission and Mortality After Hospitalization for Myocardial Infarction and Heart Failure. Journal Of The American College Of Cardiology 2020, 75: 736-746. PMID: 32081282, DOI: 10.1016/j.jacc.2019.12.026.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionPost-discharge mortalityHospital mortalityReadmission ratesHospitalization ratesMyocardial infarctionMortality rateRisk-adjusted mortality ratesHospital Readmissions Reduction ProgramHF hospitalization ratesHeart failure hospitalizationPatients 65 yearsReadmissions Reduction ProgramFailure hospitalizationHF patientsSecondary outcomesHospital readmissionPrimary outcomeReadmissionMortalityAMI hospitalization ratesStudy periodPattern of outcomesHospitalizationOutcomes
2019
Digoxin Use and Associated Adverse Events Among Older Adults
Angraal S, Nuti SV, Masoudi FA, Freeman JV, Murugiah K, Shah ND, Desai NR, Ranasinghe I, Wang Y, Krumholz HM. Digoxin Use and Associated Adverse Events Among Older Adults. The American Journal Of Medicine 2019, 132: 1191-1198. PMID: 31077654, DOI: 10.1016/j.amjmed.2019.04.022.Peer-Reviewed Original ResearchConceptsRate of hospitalizationDigoxin useDigoxin toxicityNational Prescription AuditMedicare feeService beneficiariesDigoxin prescriptionAssociated adverse eventsAdverse eventsCohort studyAdverse outcomesSecondary diagnosisNational cohortPrescription auditPrescription trendsClinical guidelinesHospitalizationMortality rateClinical practiceOlder adultsSubsequent outcomesOutcomesToxicityPrescriptionNational-level trendsSubmissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation
Jackevicius CA, An J, Ko DT, Ross JS, Angraal S, Wallach JD, Koh M, Song J, Krumholz HM. Submissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation. BMJ Open 2019, 9: e025936. PMID: 30904868, PMCID: PMC6475140, DOI: 10.1136/bmjopen-2018-025936.Peer-Reviewed Original ResearchConceptsRisk prediction toolsCross-sectional evaluationClinical risk predictionClinical performanceCardiovascular disease historyClinical risk scoreHigh-risk patientsLow-risk patientsClinical prediction toolRisk predictionEfficacy outcomesC-statisticDisease historyInclusion criteriaIndependent reviewersRisk scoreExternal validationPatientsPrediction toolsEfficacyOutcomesSame outcome
2018
Sex and Race Differences in the Utilization and Outcomes of Coronary Artery Bypass Grafting Among Medicare Beneficiaries, 1999–2014
Angraal S, Khera R, Wang Y, Lu Y, Jean R, Dreyer RP, Geirsson A, Desai NR, Krumholz HM. Sex and Race Differences in the Utilization and Outcomes of Coronary Artery Bypass Grafting Among Medicare Beneficiaries, 1999–2014. Journal Of The American Heart Association 2018, 7: e009014. PMID: 30005557, PMCID: PMC6064835, DOI: 10.1161/jaha.118.009014.Peer-Reviewed Original ResearchConceptsCoronary artery bypassCABG utilizationArtery bypassUse of CABGService Medicare beneficiariesCalendar year trendsCABG mortalityUnderwent CABGReadmission ratesCABG proceduresWhite patientsBlack patientsPatient groupMedicare beneficiariesMedicare feeMortality rateCABGAnnual declineWomenRacial subgroupsRacial differencesGreater declineOutcomesPatientsSexIs Posthospital Syndrome a Result of Hospitalization-Induced Allostatic Overload?
Goldwater DS, Dharmarajan K, McEwan BS, Krumholz HM. Is Posthospital Syndrome a Result of Hospitalization-Induced Allostatic Overload? Journal Of Hospital Medicine 2018, 13 PMID: 29813141, DOI: 10.12788/jhm.2986.Peer-Reviewed Original ResearchConceptsPosthospital syndromeAllostatic overloadAutonomic nervous systemMultiple organ systemsHospital dischargeInflammatory markersAdverse eventsHospital readmissionAdrenal axisAdverse outcomesPlausible etiologyPathophysiologic consequencesElevated riskNervous systemNarrative reviewOrgan systemsEnhanced vulnerabilityElevated levelsHospital environmentTraditional hospital environmentSyndromeMaladaptive statesOverloadOutcomesPossible mechanism
2017
Trends in acute pericarditis hospitalizations and outcomes among the elderly in the USA, 1999–2012
Mody P, Bikdeli B, Wang Y, Imazio M, Krumholz HM. Trends in acute pericarditis hospitalizations and outcomes among the elderly in the USA, 1999–2012. European Heart Journal - Quality Of Care And Clinical Outcomes 2017, 4: 98-105. PMID: 29106473, PMCID: PMC6279101, DOI: 10.1093/ehjqcco/qcx040.Peer-Reviewed Original ResearchConceptsLength of stayHospitalization ratesMortality rateReadmission ratesStudy periodCause readmission rateCause mortality ratesLong-term outcomesPrincipal discharge diagnosisRisk of pericarditisHealth care expendituresAcute pericarditisCardiac surgeryRenal diseaseDischarge diagnosisPericarditisHigh riskMedicare beneficiariesHospitalizationOlder adultsCare expendituresStayOutcomesRiskCause