2020
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
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 20
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
2013
Centers for Cardiovascular Outcomes Research
Cook NL, Bonds DE, Kiefe CI, Curtis JP, Krumholz HM, Kressin NR, Peterson ED. Centers for Cardiovascular Outcomes Research. Circulation Cardiovascular Quality And Outcomes 2013, 6: 223-228. PMID: 23481526, PMCID: PMC3684990, DOI: 10.1161/circoutcomes.0b013e31828e8d5c.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesContinuity of Patient CareCooperative BehaviorHealth Care ReformHealth Services ResearchHealthcare DisparitiesHumansInterdisciplinary CommunicationInterinstitutional RelationsMulticenter Studies as TopicNational Heart, Lung, and Blood Institute (U.S.)Organizational ObjectivesOutcome Assessment, Health CareProgram DevelopmentProgram EvaluationQuality Indicators, Health CareQuality of LifeTreatment OutcomeUnited StatesConceptsCardiovascular Outcomes ResearchOutcomes research programsBlood InstituteNational HeartCardiovascular conditionsCross-program collaborationOutcomes researchAcute coronary syndromeBetter patient outcomesQuality of lifeCoronary syndromeVenous thromboembolismClinical eventsCare transitionsPatient outcomesDisparate careEarly-stage investigatorsClinical practiceTranslational gapLungNational InstituteHealthcare deliveryOutcomesHeartCare
2007
Acute Coronary Care in the Elderly, Part I
Alexander KP, Newby LK, Cannon CP, Armstrong PW, Gibler WB, Rich MW, Van de Werf F, White HD, Weaver WD, Naylor MD, Gore JM, Krumholz HM, Ohman EM. Acute Coronary Care in the Elderly, Part I. Circulation 2007, 115: 2549-2569. PMID: 17502590, DOI: 10.1161/circulationaha.107.182615.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAge FactorsAgedAged, 80 and overAngina, UnstableAngioplasty, Balloon, CoronaryAnticoagulantsCardiac CatheterizationClinical Trials as TopicComorbidityCreatinineDisease ManagementDisease SusceptibilityDose-Response Relationship, DrugEvidence-Based MedicineFemaleHospital MortalityHumansKidneyLife ExpectancyMaleMetabolic Clearance RateMulticenter Studies as TopicMyocardial InfarctionPlatelet Aggregation InhibitorsPractice Guidelines as TopicRegistriesRisk AssessmentRisk FactorsStentsTreatment OutcomeConceptsAcute coronary syndromeElderly patientsOlder patientsInvasive treatmentSegment elevation acute coronary syndromesAmerican Heart Association scientific statementST-segment elevation myocardial infarctionElevation acute coronary syndromeComplex health statusAcute coronary careSubset of patientsAcute cardiac diseaseAge subgroup analysisTreatment-related benefitsGuideline-based careTreatment-related risksOutcomes of importanceQuality of lifeLimited trial dataCommunity practiceBasis of ageApplication of evidenceHigher disease riskGeriatric perspectiveCoronary syndromeAcute Coronary Care in the Elderly, Part II
Alexander KP, Newby LK, Armstrong PW, Cannon CP, Gibler WB, Rich MW, Van de Werf F, White HD, Weaver WD, Naylor MD, Gore JM, Krumholz HM, Ohman EM. Acute Coronary Care in the Elderly, Part II. Circulation 2007, 115: 2570-2589. PMID: 17502591, DOI: 10.1161/circulationaha.107.182616.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAge FactorsAgedAged, 80 and overAngina, UnstableAngioplasty, Balloon, CoronaryCardiovascular AgentsClinical Trials as TopicCombined Modality TherapyDisease ManagementDisease SusceptibilityEvidence-Based MedicineFemaleFibrinolytic AgentsGeriatricsHumansMaleMiddle AgedMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationPatient RightsPractice Guidelines as TopicPrejudiceQuality of LifeRegistriesRisk FactorsStentsThrombolytic TherapyTreatment OutcomeConceptsST-segment elevation myocardial infarctionElderly patientsMyocardial infarctionInvasive treatmentAmerican Heart Association scientific statementOlder adultsComplex health statusGuideline-recommended careTreatment-associated risksAcute coronary syndromeAcute coronary careTreatment-related benefitsAge 85 yearsPatient-centered mannerQuality of lifeLimited trial dataCoronary syndromeReperfusion strategyAbsolute contraindicationAdjunctive therapyCardiovascular medicationsOlder patientsCoronary careGeriatric conditionsElderly subgroup
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
2004
Cancer Trial Enrollment After State-Mandated Reimbursement
Gross CP, Murthy V, Li Y, Kaluzny AD, Krumholz HM. Cancer Trial Enrollment After State-Mandated Reimbursement. Journal Of The National Cancer Institute 2004, 96: 1063-1069. PMID: 15265967, DOI: 10.1093/jnci/djh193.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicColorectal NeoplasmsFemaleGovernment RegulationHumansIncidenceLogistic ModelsLongitudinal StudiesLung NeoplasmsMaleMulticenter Studies as TopicNational Institutes of Health (U.S.)NeoplasmsPatient SelectionPoisson DistributionProstatic NeoplasmsReimbursement MechanismsRetrospective StudiesState GovernmentUnited StatesConceptsCancer trial enrollmentTrial enrollment ratesTrial enrollmentMultivariable analysisTrial participationOdds ratioTrial participantsCoverage policiesCancer trial participantsCooperative group trialsClinical trial enrollmentEarly phase trialsRecruitment of patientsCancer trial participationMedical care costsPhase II trial participantsCancer patientsPhase trialsCancer research studiesGroup trialsCare costsPoisson regressionCancer typesReimbursement policiesPhase II