2024
Artificial Intelligence in Cardiovascular Clinical Trials
Cunningham J, Abraham W, Bhatt A, Dunn J, Felker G, Jain S, Lindsell C, Mace M, Martyn T, Shah R, Tison G, Fakhouri T, Psotka M, Krumholz H, Fiuzat M, O’Connor C, Solomon S, Collaboratory H. Artificial Intelligence in Cardiovascular Clinical Trials. Journal Of The American College Of Cardiology 2024, 84: 2051-2062. PMID: 39505413, DOI: 10.1016/j.jacc.2024.08.069.Peer-Reviewed Original ResearchMeSH KeywordsArtificial IntelligenceCardiovascular DiseasesClinical Trials as TopicHumansRandomized Controlled Trials as TopicConceptsArtificial intelligenceIntegrate AIPatient privacyClinical trialsRandomized clinical trialsClinical event outcomesCardiovascular clinical trialsIntelligenceInaccurate resultsRandomized trialsInterpreting imagesCardiovascular therapyMedical decision makingDecision makingGold standardValidity of trial resultsClinical trial operationsPrivacyWhen Direct Oral Anticoagulants Should Not Be Standard Treatment JACC State-of-the-Art Review
Bejjani A, Khairani C, Assi A, Piazza G, Sadeghipour P, Talasaz A, Fanikos J, Connors J, Siegal D, Barnes G, Martin K, Angiolillo D, Kleindorfer D, Monreal M, Jimenez D, Middeldorp S, Elkind M, Ruff C, Goldhaber S, Krumholz H, Mehran R, Cushman M, Eikelboom J, Lip G, Weitz J, Lopes R, Bikdeli B. When Direct Oral Anticoagulants Should Not Be Standard Treatment JACC State-of-the-Art Review. Journal Of The American College Of Cardiology 2024, 83: 444-465. PMID: 38233019, DOI: 10.1016/j.jacc.2023.10.038.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAnticoagulantsAtrial FibrillationHumansRandomized Controlled Trials as TopicThrombosisVenous ThromboembolismVenous ThrombosisVitamin KConceptsDirect oral anticoagulantsStandard of careRandomized controlled trialsOral anticoagulantsAtrial fibrillationCatheter-associated deep vein thrombosisCerebral venous sinus thrombosisControlled trialsVitamin K antagonistsThrombotic antiphospholipid syndromeEnd-stage renal diseaseLeft ventricular thrombusVenous thromboembolism treatmentVenous sinus thrombosisDeep vein thrombosisRheumatic heart diseaseReview of randomized controlled trialsEvidence-based reviewK antagonistsAntiphospholipid syndromeSinus thrombosisVentricular thrombusVein thrombosisThromboembolism treatmentVenous thrombosis
2022
Direct Oral Anticoagulants vs Vitamin K Antagonists in Patients With Antiphospholipid Syndromes Meta-Analysis of Randomized Trials
Khairani C, Bejjani A, Piazza G, Jimenez D, Monreal M, Chatterjee S, Pengo V, Woller S, Cortes-Hernandez J, Connors J, Kanthi Y, Krumholz H, Middeldorp S, Falanga A, Cushman M, Goldhaber S, Garcia D, Bikdeli B. Direct Oral Anticoagulants vs Vitamin K Antagonists in Patients With Antiphospholipid Syndromes Meta-Analysis of Randomized Trials. Journal Of The American College Of Cardiology 2022, 81: 16-30. PMID: 36328154, PMCID: PMC9812926, DOI: 10.1016/j.jacc.2022.10.008.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAnticoagulantsAntiphospholipid SyndromeFibrinolytic AgentsHemorrhageHumansRandomized Controlled Trials as TopicThrombosisVenous ThromboembolismVitamin KConceptsDirect oral anticoagulantsVitamin K antagonistsVenous thromboembolic eventsArterial thrombotic eventsSubsequent venous thromboembolic eventsThrombotic antiphospholipid syndromeMajor bleedingThrombotic eventsK antagonistsOral anticoagulantsAntiphospholipid syndromeUse of DOACsMain efficacy outcomeMain safety outcomeCochrane Central RegisterAdequate allocation concealmentRandom-effects modelRandom sequence generationThromboembolic eventsCentral RegisterEfficacy outcomesArterial thrombosisControlled TrialsRandomized trialsAllocation concealmentEffectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial
Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials 2022, 23: 412. PMID: 35578345, PMCID: PMC9109449, DOI: 10.1186/s13063-022-06374-x.Peer-Reviewed Original ResearchMeSH KeywordsAntihypertensive AgentsBlood PressureDecision Support Systems, ClinicalHumansHypertensionPrimary Health CareRandomized Controlled Trials as TopicConceptsHypertension managementPrimary carePrimary outcomeDual antihypertensive therapyHypertension Treatment TrialBlood pressure managementGuideline-based treatmentPrimary care sitesCluster-randomized trialUnit of randomizationGuideline-based decision support systemClinical decision support systemAntihypertensive regimensAntihypertensive treatmentUsual careGuideline adherenceBlood pressureMiddle-income countriesTreatment trialsManagement visitsStudy protocolCare sitesPatientsTrialsPressure managementWomen's representation in venous thromboembolism randomized trials and registries: The illustrative example of direct oral anticoagulants for acute treatment
Bikdeli B, Khairani CD, Barns BM, Rosovsky RP, Jimenez D, Monreal M, Sylvester KW, Middeldorp S, Bates SM, Krumholz HM, Goldhaber SZ, Hunt BJ, Piazza G. Women's representation in venous thromboembolism randomized trials and registries: The illustrative example of direct oral anticoagulants for acute treatment. Contemporary Clinical Trials 2022, 115: 106714. PMID: 35202841, DOI: 10.1016/j.cct.2022.106714.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAnticoagulantsFemaleHumansRandomized Controlled Trials as TopicRegistriesVenous ThromboembolismData-Driven Individualized Surgical Decision-making
Mori M, Spertus JA, Krumholz HM. Data-Driven Individualized Surgical Decision-making. JAMA Surgery 2022, 157: 93-94. PMID: 34817547, DOI: 10.1001/jamasurg.2021.5614.Peer-Reviewed Original ResearchClinical Decision-MakingHumansRandomized Controlled Trials as TopicSurgical Procedures, OperativeUnited States
2021
Investigating Lipid-Modulating Agents for Prevention or Treatment of COVID-19 JACC State-of-the-Art Review
Talasaz AH, Sadeghipour P, Aghakouchakzadeh M, Dreyfus I, Kakavand H, Ariannejad H, Gupta A, Madhavan MV, Van Tassell BW, Jimenez D, Monreal M, Vaduganathan M, Fanikos J, Dixon DL, Piazza G, Parikh SA, Bhatt DL, Lip GYH, Stone GW, Krumholz HM, Libby P, Goldhaber SZ, Bikdeli B. Investigating Lipid-Modulating Agents for Prevention or Treatment of COVID-19 JACC State-of-the-Art Review. Journal Of The American College Of Cardiology 2021, 78: 1635-1654. PMID: 34649702, PMCID: PMC8504484, DOI: 10.1016/j.jacc.2021.08.021.Peer-Reviewed Original ResearchMeSH KeywordsAmidesCOVID-19COVID-19 Drug TreatmentEstersFatty Acids, Omega-3Fibric AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLipid Regulating AgentsNiacinRandomized Controlled Trials as TopicSulfhydryl CompoundsConceptsLipid-modulating agentsEndothelial activationLow high-density lipoprotein cholesterolCOVID-19High-density lipoprotein cholesterolLipid modulating agentsHigh triglyceride levelsMultiorgan manifestationsStatin trialsLipoprotein cholesterolSystemic inflammationTriglyceride levelsJACC StateWorse outcomesInflammatory responsePatient managementRCTsCoronavirus diseaseViral entrySystematic searchLipid raft disruptionTrialsPatientsRaft disruptionPreventionRecent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19 JACC State-of-the-Art Review
Talasaz AH, Sadeghipour P, Kakavand H, Aghakouchakzadeh M, Kordzadeh-Kermani E, Van Tassell BW, Gheymati A, Ariannejad H, Hosseini SH, Jamalkhani S, Sholzberg M, Monreal M, Jimenez D, Piazza G, Parikh SA, Kirtane AJ, Eikelboom JW, Connors JM, Hunt BJ, Konstantinides SV, Cushman M, Weitz JI, Stone GW, Krumholz HM, Lip GYH, Goldhaber SZ, Bikdeli B. Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19 JACC State-of-the-Art Review. Journal Of The American College Of Cardiology 2021, 77: 1903-1921. PMID: 33741176, PMCID: PMC7963001, DOI: 10.1016/j.jacc.2021.02.035.Peer-Reviewed Original ResearchMeSH KeywordsCOVID-19COVID-19 Drug TreatmentFibrinolytic AgentsHumansRandomized Controlled Trials as TopicThromboembolismConceptsCOVID-19Recent randomized trialsCommon pathophysiological featuresDuration of therapyClinical trial enterpriseMacrovascular thrombosisThromboprophylactic regimensAntithrombotic therapyAntithrombotic strategiesEndothelial injuryFuture RCTsMedical wardsIllness severityRandomized trialsPathophysiological featuresJACC StateAntithrombotic agentsCoronavirus diseasePatientsRCTsTherapyTrialsRegimensThrombosisOutpatients
2020
Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials.
Madhavan M, Bikdeli B, Redfors B, Biondi-Zoccai G, Varunok N, Burton J, Crowley A, Francese D, Gupta A, DER Nigoghossian C, Chatterjee S, Palmerini T, Benedetto U, You S, Ohman E, Kastrati A, Steg P, Gibson C, Angiolillo D, Krumholz H, Stone G. Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials. Minerva Cardioangiologica 2020, 69: 398-407. PMID: 33258563, DOI: 10.23736/s2724-5683.20.05353-0.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeHumansNetwork Meta-AnalysisPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsRandomized Controlled Trials as TopicConceptsAcute coronary syndromeNetwork meta-analysisIncidence rate ratiosReceptor inhibitorsRandom-effects methodMeta-analysisCoronary syndromeMonths of follow-up timePatients of advanced ageControlled trialsBackground of aspirinEfficacy of prasugrelST-elevation myocardial infarctionCochrane Central Register of Controlled TrialsCentral Register of Controlled TrialsFollow-up timeFrequentist network meta-analysisManagement of patientsRegister of Controlled TrialsShort-term outcomesLong-term outcomesCochrane Central RegisterRandomized controlled trialsHemorrhagic outcomesAntiplatelet strategiesAntiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials
Madhavan MV, Bikdeli B, Redfors B, Biondi-Zoccai G, Varunok NJ, Burton JR, Crowley A, Francese DP, Gupta A, Der Nigoghossian C, Chatterjee S, Palmerini T, Benedetto U, You S, Ohman M, Kastrati A, Steg PG, Gibson C, Angiolillo DJ, Krumholz HM, Stone GW. Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials. Minerva Cardioangiologica 2020 DOI: 10.23736/s0026-4725.20.05353-0.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeHumansNetwork Meta-AnalysisPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsRandomized Controlled Trials as TopicSulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials
Bikdeli B, Chatterjee S, Kirtane AJ, Parikh SA, Andreozzi GM, Desai NR, Francese DP, Gibson CM, Piazza G, Goldhaber SZ, Eikelboom JW, Krumholz HM, Stone GW. Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials. Seminars In Thrombosis And Hemostasis 2020, 46: 908-918. PMID: 33086402, DOI: 10.1055/s-0040-1716874.Peer-Reviewed Original ResearchMeSH KeywordsAnticoagulantsGlycosaminoglycansHemorrhageHumansRandomized Controlled Trials as TopicRisk FactorsThrombosisConceptsDeep vein thrombosisUse of sulodexideCause mortalityCardiovascular mortalityReduced oddsPulmonary embolismOdds ratioOdds of VTESafety of sulodexideCardiovascular risk factorsCochrane Central RegisterPeripheral arterial diseaseHistory of MIThrombotic cardiovascular diseasesRandom-effects modelCardiovascular efficacyOral glycosaminoglycansCardiovascular outcomesHemorrhagic eventsCentral RegisterVein thrombosisControlled TrialsArterial diseaseRandomized trialsRisk factorsIntermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies
Bikdeli B, Talasaz AH, Rashidi F, Sharif-Kashani B, Farrokhpour M, Bakhshandeh H, Sezavar H, Dabbagh A, Beigmohammadi MT, Payandemehr P, Yadollahzadeh M, Riahi T, Khalili H, Jamalkhani S, Rezaeifar P, Abedini A, Lookzadeh S, Shahmirzaei S, Tahamtan O, Matin S, Amin A, Parhizgar SE, Jimenez D, Gupta A, Madhavan MV, Parikh SA, Monreal M, Hadavand N, Hajighasemi A, Maleki M, Sadeghian S, Mohebbi B, Piazza G, Kirtane AJ, Lip GYH, Krumholz HM, Goldhaber SZ, Sadeghipour P. Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies. Thrombosis Research 2020, 196: 382-394. PMID: 32992075, PMCID: PMC7513771, DOI: 10.1016/j.thromres.2020.09.027.Peer-Reviewed Original ResearchConceptsStandard-dose prophylactic anticoagulationKey safety endpointIll patientsProphylactic anticoagulationVenous thromboembolismMajor bleedingSafety endpointCOVID-19Bleeding Academic Research Consortium definitionAcademic Research Consortium definitionsTimes upper normal limitAcute arterial thrombosisExuberant immune responseMacrovascular thrombotic eventsPrespecified secondary analysisCritically Ill PatientsKey secondary endpointVentilator-free daysExtracorporeal membrane oxygenationUpper normal limitNon-inferiority marginReverse transcription-polymerase chain reactionCoronavirus disease 2019Transcription-polymerase chain reactionAtorvastatin 20Large-scale evidence generation and evaluation across a network of databases (LEGEND): assessing validity using hypertension as a case study
Schuemie MJ, Ryan PB, Pratt N, Chen R, You SC, Krumholz HM, Madigan D, Hripcsak G, Suchard MA. Large-scale evidence generation and evaluation across a network of databases (LEGEND): assessing validity using hypertension as a case study. Journal Of The American Medical Informatics Association 2020, 27: 1268-1277. PMID: 32827027, PMCID: PMC7481033, DOI: 10.1093/jamia/ocaa124.Peer-Reviewed Original ResearchMeSH KeywordsAntihypertensive AgentsComputer Communication NetworksConfidence IntervalsDatabases, FactualHumansHypertensionMeta-Analysis as TopicObservationPropensity ScoreRandomized Controlled Trials as TopicTreatment OutcomeConceptsLarge-scale Evidence GenerationPrinciples of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND)
Schuemie MJ, Ryan PB, Pratt N, Chen R, You SC, Krumholz HM, Madigan D, Hripcsak G, Suchard MA. Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND). Journal Of The American Medical Informatics Association 2020, 27: 1331-1337. PMID: 32909033, PMCID: PMC7481029, DOI: 10.1093/jamia/ocaa103.Peer-Reviewed Original ResearchConceptsNetwork of databasesLarge-scale Evidence GenerationObservational Health Data SciencesObservational health care databasesHealth Data SciencesHealth care dataElectronic health recordsData sciencePublication biasPatient-level informationGeneric overviewHealth recordsMethods addressAforementioned concernsHealth care databasesAnalytic codeNetworkNew paradigmSuch dataHackingEvidence generationDissemination of evidenceHypertension treatmentResidual confoundingAdministrative claimsUpdating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. The BMJ 2020, 368: l7078. PMID: 32024657, PMCID: PMC7190063, DOI: 10.1136/bmj.l7078.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesHumansHypoglycemic AgentsInformation DisseminationRandomized Controlled Trials as TopicRisk FactorsRosiglitazoneConceptsIndividual patient-level dataCardiovascular related deathsCardiovascular riskMyocardial infarctionRelated deathsSummary-level dataHeart failureOdds ratioSystematic reviewIncreased cardiovascular riskMore myocardial infarctionsHeart failure eventsCochrane Central RegistryAcute myocardial infarctionMyocardial infarction eventsPatient-level dataRandom-effects modelWeb of ScienceAnalysis of trialsEligible trialsComposite outcomeAdverse eventsContinuity correctionControlled TrialsRosiglitazone treatment
2019
Submissions 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 ResearchMeSH KeywordsBlood PressureCross-Sectional StudiesData AnalysisData CollectionHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRisk AssessmentConceptsRisk 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
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 ResearchMeSH KeywordsCross-Sectional StudiesJournal Impact FactorPublishingRandomized Controlled Trials as TopicResearch DesignTime FactorsConceptsClinical 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 resultsTrialsAccurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population
Warner F, Dhruva SS, Ross JS, Dey P, Murugiah K, Krumholz HM. Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population. BMJ Open 2018, 8: e021685. PMID: 30037874, PMCID: PMC6059296, DOI: 10.1136/bmjopen-2018-021685.Peer-Reviewed Original ResearchMeSH KeywordsAntihypertensive AgentsBlood Pressure DeterminationCardiovascular DiseasesHumansHypertensionRandomized Controlled Trials as TopicSystoleConceptsSystolic Blood Pressure Intervention TrialFramingham risk scoreCardiovascular riskRisk scoreStudy populationStudy participantsNon-diabetic adultsTotal study populationHigh-risk populationClinical trial dataClinical trial sitesTrial populationIntervention trialsRisk populationsNew England JournalIndependent investigatorsTrial dataSecondary analysisSPRINT trialSPRINT dataTrialsRiskScoresParticipantsPopulation
2017
Time for a New Approach to Studying Older People with Ischemic Heart Disease
Dodson JA, Chaudhry SI, Krumholz HM. Time for a New Approach to Studying Older People with Ischemic Heart Disease. Journal Of The American Geriatrics Society 2017, 65: 2349-2351. PMID: 28493548, PMCID: PMC5681380, DOI: 10.1111/jgs.14923.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overHumansMyocardial IschemiaRandomized Controlled Trials as TopicConceptsIschemic heart diseaseReevaluating the Efficacy and Predictability of Antidepressant Treatments: A Symptom Clustering Approach
Chekroud AM, Gueorguieva R, Krumholz HM, Trivedi MH, Krystal JH, McCarthy G. Reevaluating the Efficacy and Predictability of Antidepressant Treatments: A Symptom Clustering Approach. JAMA Psychiatry 2017, 74: 370-378. PMID: 28241180, PMCID: PMC5863470, DOI: 10.1001/jamapsychiatry.2017.0025.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAffectAgedAntidepressive AgentsBupropionCitalopramCluster AnalysisDepressive Disorder, MajorDose-Response Relationship, DrugDrug Therapy, CombinationDuloxetine HydrochlorideFemaleHumansMaleMianserinMiddle AgedMirtazapineRandomized Controlled Trials as TopicSleepSyndromeTreatment OutcomeVenlafaxine HydrochlorideYoung AdultConceptsCore emotional symptomsDepressive severitySymptom clustersHamilton Depression Rating ScaleDepression Outcomes trialDifferent antidepressant medicationsHAM-D scaleHigh-dose duloxetinePhase 3 trialEmotional symptomsPatient-reported dataDepression Rating ScaleSequenced Treatment AlternativesGroup of symptomsCluster of symptomsDepressive symptom checklistMixed-effects regression analysisDepressive Symptomatology ScaleAntidepressant therapyAntidepressant treatmentAntidepressant medicationOutcome trialsCombining MedicationsAtypical symptomsAdditional placebo