2025
FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program
Kadakia K, Dhruva S, Ross J, Burke J, Johnston J, Ramachandran R, Krumholz H, Rathi V. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Internal Medicine 2025, 185: 996-1004. PMID: 40587167, PMCID: PMC12210143, DOI: 10.1001/jamainternmed.2025.2235.Peer-Reviewed Original ResearchConceptsFood and Drug AdministrationFDA review timesFood and Drug Administration authorityFood and Drug Administration dataShort follow-up durationUS Food and Drug AdministrationFollow-up durationDevice programmingEffectiveness end pointCross-sectional studyHigh-risk devicesSurrogate measureTarget timeframePostmarketing studiesMain OutcomesEnd pointsPatient accessDrug AdministrationHigh riskClass IStudy characteristicsTherapeutic devicesClinical testingSurrogate measures of effectivenessMeasures of effectivenessTrends and Key Factors Associated With Racial and Ethnic Differences in Life’s Essential 8 Scores
Yang H, Huang C, Sawano M, Herrin J, Faridi K, Li Z, Spatz E, Krumholz H, Lu Y. Trends and Key Factors Associated With Racial and Ethnic Differences in Life’s Essential 8 Scores. JAMA Network Open 2025, 8: e2516663. PMID: 40531529, PMCID: PMC12177675, DOI: 10.1001/jamanetworkopen.2025.16663.Peer-Reviewed Original ResearchConceptsLife's Essential 8 scoreLife's Essential 8Cross-sectional studyWhite differencesEthnic differencesNational Health and Nutrition Examination SurveyHealth and Nutrition Examination SurveySleep health scoreNutrition Examination SurveyGroup-specific interventionsPrimary positive factorPhysical activityExamination SurveyHealth scoresBlack adultsWhite adultsMain OutcomesAsian adultsOverall scoreEvaluate trendsNicotine exposureEssential 8Blood lipidsAdultsEthnic groups
2024
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study
Vazquez E, Ross J, Gross C, Childers K, Bamford S, Ritchie J, Waldstreicher J, Krumholz H, Wallach J. Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study. Clinical Trials 2024, 22: 279-288. PMID: 40396503, PMCID: PMC12095927, DOI: 10.1177/17407745241304355.Peer-Reviewed Original ResearchRacial and Ethnic Disparities in Age-Specific All-Cause Mortality During the COVID-19 Pandemic
Faust J, Renton B, Bongiovanni T, Chen A, Sheares K, Du C, Essien U, Fuentes-Afflick E, Haywood T, Khera R, King T, Li S, Lin Z, Lu Y, Marshall A, Ndumele C, Opara I, Loarte-Rodriguez T, Sawano M, Taparra K, Taylor H, Watson K, Yancy C, Krumholz H. Racial and Ethnic Disparities in Age-Specific All-Cause Mortality During the COVID-19 Pandemic. JAMA Network Open 2024, 7: e2438918. PMID: 39392630, PMCID: PMC11581672, DOI: 10.1001/jamanetworkopen.2024.38918.Peer-Reviewed Original ResearchConceptsCOVID-19 public health emergencyNon-HispanicPublic health emergencyOther Pacific IslanderExcess mortalityAlaska NativesUS populationExcess deathsRates of excess mortalityCross-sectional study analyzed dataYears of potential lifeMortality relative riskNon-Hispanic whitesCross-sectional studyPacific IslandersStudy analyzed dataAll-Cause MortalityEthnic groupsMortality disparitiesMortality ratioTotal populationDeath certificatesEthnic disparitiesMain OutcomesDecedent ageClass I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketingCardiovascular Disease Risk Factor Control Following Release From Carceral Facilities: A Cross-Sectional Study.
Aminawung J, Puglisi L, Roy B, Horton N, Elumn J, Lin H, Bibbins-Domingo K, Krumholz H, Wang E. Cardiovascular Disease Risk Factor Control Following Release From Carceral Facilities: A Cross-Sectional Study. Journal Of The American Heart Association 2024, 13: ejaha2024035683t. PMID: 39248257, PMCID: PMC11935634, DOI: 10.1161/jaha.124.035683.Peer-Reviewed Original ResearchConceptsUncontrolled CVD risk factorsCardiovascular disease risk factor controlCVD risk factorsRisk factor controlFactor controlRisk factorsSocial determinant of cardiovascular healthCardiovascular diseaseProspective cohort study of individualsDeterminants of cardiovascular healthPublic health prevention effortsCardiovascular disease risk factorsCohort study of individualsHealth prevention effortsCross-sectional studyProspective cohort studyCarceral facilitiesCorrectional facilitiesSocial determinantsTailored interventionsTraditional risk factorsStudy of individualsAdversity scorePerceived stressCardiovascular healthCause-Specific Mortality Rates Among the US Black Population
Arun A, Caraballo C, Sawano M, Lu Y, Khera R, Yancy C, Krumholz H. Cause-Specific Mortality Rates Among the US Black Population. JAMA Network Open 2024, 7: e2436402. PMID: 39348122, PMCID: PMC11443349, DOI: 10.1001/jamanetworkopen.2024.36402.Commentaries, Editorials and LettersBenchmarking Emergency Physician EHR Time per Encounter Based on Patient and Clinical Factors
Iscoe M, Venkatesh A, Holland M, Krumholz H, Sheares K, Melnick E. Benchmarking Emergency Physician EHR Time per Encounter Based on Patient and Clinical Factors. JAMA Network Open 2024, 7: e2427389. PMID: 39136949, PMCID: PMC11322841, DOI: 10.1001/jamanetworkopen.2024.27389.Peer-Reviewed Original ResearchInternal Tremors and Vibrations in Long COVID: A Cross-Sectional Study
Zhou T, Sawano M, Arun A, Caraballo C, Michelsen T, McAlpine L, Bhattacharjee B, Lu Y, Khera R, Huang C, Warner F, Herrin J, Iwasaki A, Krumholz H. Internal Tremors and Vibrations in Long COVID: A Cross-Sectional Study. The American Journal Of Medicine 2024, 138: 1010-1018.e14. PMID: 39069199, PMCID: PMC12023347, DOI: 10.1016/j.amjmed.2024.07.008.Peer-Reviewed Original ResearchNew-onset conditionsInternal tremorLong COVID symptomsCOVID symptomsNon-Hispanic whitesCross-sectional studyQuality of lifeVisual analogue scaleWorse healthHealth statusStudy participantsDemographic characteristicsAnalogue scaleOutcome variablesNeurological conditionsLong COVIDMast cell disordersTreatment experienceHealthComorbiditiesSymptomsMedian agePeopleCell disordersFactors Associated With Long COVID: Insights From Two Nationwide Surveys
Wu Y, Sawano M, Wu Y, Shah R, Bishop P, Iwasaki A, Krumholz H. Factors Associated With Long COVID: Insights From Two Nationwide Surveys. The American Journal Of Medicine 2024, 137: 515-519. PMID: 38490304, DOI: 10.1016/j.amjmed.2024.02.032.Peer-Reviewed Original ResearchBehavioral Risk Factor Surveillance SystemNational Health Interview SurveyAssociated with long COVIDNational Health Interview Survey cohortRisk Factor Surveillance SystemNon-Hispanic white individualsLong COVIDFactors associated with Long COVIDHealth Interview SurveyCross-sectional studyPositive COVID-19 testNon-HispanicInterview SurveyDoctor's diagnosisWhite individualsCOVID-19 testingCollege degreeCOVID-19 infectionFemale sexSurveillance systemBlack AmericansNationwide surveySeverity of acute COVID-19 infectionAcute COVID-19 infectionCohortBurden of Ischemic and Hemorrhagic Stroke Across the US From 1990 to 2019
Renedo D, Acosta J, Leasure A, Sharma R, Krumholz H, de Havenon A, Alahdab F, Aravkin A, Aryan Z, Bärnighausen T, Basu S, Burkart K, Coberly K, Criqui M, Dai X, Desai R, Dharmaratne S, Doshi R, Elgendy I, Feigin V, Filip I, Gad M, Ghozy S, Hafezi-Nejad N, Kalani R, Karaye I, Kisa A, Krishnamoorthy V, Lo W, Mestrovic T, Miller T, Misganaw A, Mokdad A, Murray C, Natto Z, Radfar A, Ram P, Roth G, Seylani A, Shah N, Sharma P, Sheikh A, Singh J, Song S, Sotoudeh H, Vervoort D, Wang C, Xiao H, Xu S, Zand R, Falcone G, Sheth K. Burden of Ischemic and Hemorrhagic Stroke Across the US From 1990 to 2019. JAMA Neurology 2024, 81: 394-404. PMID: 38436973, PMCID: PMC10913004, DOI: 10.1001/jamaneurol.2024.0190.Peer-Reviewed Original ResearchBurden of strokeHemorrhagic strokeBurden trendsGlobal burdenGlobal Burden of Disease StudyBurden of Disease StudyAge-standardized ratesAge-standardized estimatesPublic health policiesStroke-related outcomesIschemic strokeCross-sectional studyPublic health challengeCross-sectional analysisStroke mortalityStroke burdenHealth policyOlder adultsMain OutcomesStroke incidenceStroke casesIntracerebral hemorrhageEscalating burdenHealth challengesSignificant disparities
2023
National Trends in Racial and Ethnic Disparities in Use of Recommended Therapies in Adults with Atherosclerotic Cardiovascular Disease, 1999-2020
Lu Y, Liu Y, Dhingra L, Caraballo C, Mahajan S, Massey D, Spatz E, Sharma R, Rodriguez F, Watson K, Masoudi F, Krumholz H. National Trends in Racial and Ethnic Disparities in Use of Recommended Therapies in Adults with Atherosclerotic Cardiovascular Disease, 1999-2020. JAMA Network Open 2023, 6: e2345964. PMID: 38039001, PMCID: PMC10692850, DOI: 10.1001/jamanetworkopen.2023.45964.Peer-Reviewed Original ResearchConceptsAtherosclerotic cardiovascular diseaseHistory of ASCVDCross-sectional studyLifestyle modificationPharmacological medicationsOptimal careCurrent careUS adultsEthnic differencesWhite individualsGuideline-recommended therapiesTotal cholesterol controlNon-Hispanic white individualsNutrition Examination SurveyLatino individualsQuality of careSelf-reported raceStatin useRecommended TherapiesSecondary preventionCholesterol controlOptimal regimensSmoking cessationEligible participantsExamination SurveyRace and Ethnicity and Emergency Department Discharge Against Medical Advice
Tsai J, Janke A, Krumholz H, Khidir H, Venkatesh A. Race and Ethnicity and Emergency Department Discharge Against Medical Advice. JAMA Network Open 2023, 6: e2345437. PMID: 38015503, PMCID: PMC10685883, DOI: 10.1001/jamanetworkopen.2023.45437.Peer-Reviewed Original ResearchConceptsWhite patientsHispanic patientsEmergency departmentCross-sectional studyED visitsBlack patientsDAMA rateMedical adviceMAIN OUTCOMEEthnic disparitiesNationwide Emergency Department SampleNational cross-sectional studyHospital ED visitsEmergency department dischargeHospital-level variationEmergency Department SampleMetropolitan teaching hospitalHealth care resourcesMedian ageGreater morbidityHospital variationUnadjusted analysesTeaching hospitalAdditional adjustmentLower oddsDistinguishing features of long COVID identified through immune profiling
Klein J, Wood J, Jaycox J, Dhodapkar R, Lu P, Gehlhausen J, Tabachnikova A, Greene K, Tabacof L, Malik A, Silva Monteiro V, Silva J, Kamath K, Zhang M, Dhal A, Ott I, Valle G, Peña-Hernández M, Mao T, Bhattacharjee B, Takahashi T, Lucas C, Song E, McCarthy D, Breyman E, Tosto-Mancuso J, Dai Y, Perotti E, Akduman K, Tzeng T, Xu L, Geraghty A, Monje M, Yildirim I, Shon J, Medzhitov R, Lutchmansingh D, Possick J, Kaminski N, Omer S, Krumholz H, Guan L, Dela Cruz C, van Dijk D, Ring A, Putrino D, Iwasaki A. Distinguishing features of long COVID identified through immune profiling. Nature 2023, 623: 139-148. PMID: 37748514, PMCID: PMC10620090, DOI: 10.1038/s41586-023-06651-y.Peer-Reviewed Original ResearchConceptsLong COVIDSARS-CoV-2Infection syndromeExaggerated humoral responseSoluble immune mediatorsEpstein-Barr virusPost-exertional malaiseCross-sectional studyHigher antibody responseImmune mediatorsImmune phenotypingImmune profilingHumoral responseAntibody responseLymphocyte populationsCOVID statusUnbiased machineCortisol levelsLC statusRelevant biomarkersViral pathogensSyndromeCOVIDFuture studiesBiological featuresClinical 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 ResearchRelationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure
Wang Y, Eldridge N, Metersky M, Rodrick D, Eckenrode S, Mathew J, Galusha D, Peterson A, Hunt D, Normand S, Krumholz H. Relationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure. Circulation Cardiovascular Quality And Outcomes 2023, 16: e009573. PMID: 37463255, PMCID: PMC10351904, DOI: 10.1161/circoutcomes.122.009573.Peer-Reviewed Original ResearchConceptsMore adverse eventsAdverse eventsHeart failureCause mortalityReadmission ratesHigh riskMedicare Patient Safety Monitoring SystemHospital-acquired adverse eventsIn-Hospital Adverse EventsHospital adverse eventsRate of patientsPatient Safety DatabasePerformance categoriesAdverse event dataCross-sectional studyUnited States CentersHospital performanceHospital characteristicsReadmission dataPatient riskMAIN OUTCOMEPatientsWorst hospitalsHospitalHigh mortalityUse of Wearable Devices in Individuals With or at Risk for Cardiovascular Disease in the US, 2019 to 2020
Dhingra L, Aminorroaya A, Oikonomou E, Nargesi A, Wilson F, Krumholz H, Khera R. Use of Wearable Devices in Individuals With or at Risk for Cardiovascular Disease in the US, 2019 to 2020. JAMA Network Open 2023, 6: e2316634. PMID: 37285157, PMCID: PMC10248745, DOI: 10.1001/jamanetworkopen.2023.16634.Peer-Reviewed Original ResearchConceptsHealth Information National Trends SurveyUS adultsExacerbate disparitiesWearable device usersCardiovascular diseaseCardiovascular healthPopulation-based cross-sectional studySelf-reported cardiovascular diseaseCardiovascular disease risk factorsNational Trends SurveyOverall US adult populationCardiovascular risk factor profileSelf-reported accessAssociated with lower useUse of wearable devicesImprove cardiovascular healthLower household incomeLower educational attainmentUS adult populationRisk factor profileNationally Representative SampleCross-sectional studyProportion of adultsTrends SurveyWearable device dataExcess Mortality and Years of Potential Life Lost Among the Black Population in the US, 1999-2020
Caraballo C, Massey D, Ndumele C, Haywood T, Kaleem S, King T, Liu Y, Lu Y, Nunez-Smith M, Taylor H, Watson K, Herrin J, Yancy C, Faust J, Krumholz H. Excess Mortality and Years of Potential Life Lost Among the Black Population in the US, 1999-2020. JAMA 2023, 329: 1662-1670. PMID: 37191702, PMCID: PMC10189563, DOI: 10.1001/jama.2023.7022.Peer-Reviewed Original ResearchConceptsExcess mortality ratesExcess deathsMortality ratePotential lifeWhite populationExcess mortalitySerial cross-sectional studyHighest excess mortality ratesBlack populationCause-specific mortalityCross-sectional studyHigh mortality rateNon-Hispanic whitesYears of lifeUS national dataMiddle-aged adultsCause mortalityHeart diseaseDeath certificatesNon-Hispanic black populationMAIN OUTCOMEAge groupsDisease controlMortalityBlack malesPrimary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study
Group C, Zhou T, Wang Y, Zhang H, Wu C, Tian N, Cui J, Bai X, Yang Y, Zhang X, Lu Y, Spatz E, Ross J, Krumholz H, Lu J, Li X, Hu S. Primary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study. The Lancet Global Health 2023, 11: e83-e94. PMID: 36521957, DOI: 10.1016/s2214-109x(22)00428-4.Peer-Reviewed Original ResearchConceptsProportion of participantsPrimary care institutionsHypertension awarenessPrimary care systemBlood pressureCare institutionsCardiac Events Million Persons ProjectAverage diastolic blood pressureMedical Sciences (CAMS) Innovation FundAverage systolic blood pressureCare systemMillion Persons ProjectHistory of hypertensionDiastolic blood pressurePrimary care surveySystolic blood pressureCardiovascular disease riskBlood pressure measurementsCross-sectional studyParticipant-level dataProportion of physiciansRoutine service deliveryPrimary care roleHealth Care SurveyPublic health services
2022
Trends in Racial and Ethnic Disparities in Barriers to Timely Medical Care Among Adults in the US, 1999 to 2018
Caraballo C, Ndumele CD, Roy B, Lu Y, Riley C, Herrin J, Krumholz HM. Trends in Racial and Ethnic Disparities in Barriers to Timely Medical Care Among Adults in the US, 1999 to 2018. JAMA Health Forum 2022, 3: e223856. PMID: 36306118, PMCID: PMC9617175, DOI: 10.1001/jamahealthforum.2022.3856.Peer-Reviewed Original ResearchConceptsTimely medical careSerial cross-sectional studyNational Health Interview SurveyCross-sectional studyHealth Interview SurveyMedical careLack of transportationEthnic disparitiesHispanics/LatinosWhite individualsEthnicity groupsInterview SurveyCost of careSelf-reported raceStudy cohortClinic hoursMAIN OUTCOMEMedical officesCarePrevalenceLatino individualsBlack individualsSignificant differencesSignificant increasePopulation groups
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