2024
The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID
Krumholz H, Sawano M, Bhattacharjee B, Caraballo C, Khera R, Li S, Herrin J, Coppi A, Holub J, Henriquez Y, Johnson M, Goddard T, Rocco E, Hummel A, Al Mouslmani M, Putrino D, Carr K, Carvajal-Gonzalez S, Charnas L, De Jesus M, Ziegler F, Iwasaki A. The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID. The American Journal Of Medicine 2024 PMID: 38735354, DOI: 10.1016/j.amjmed.2024.04.030.Peer-Reviewed Original ResearchLC trialPROMIS-29Participants' homesTargeting viral persistencePlacebo-controlled trialDouble-blind studyElectronic health recordsCore Outcome MeasuresLong COVIDEQ-5D-5LRepeated measures analysisEvidence-based treatmentsPhase 2Double-blindParticipant-centred approachStudy drugPrimary endpointSecondary endpointsCommunity-dwellingHealth recordsHealthcare utilizationContiguous US statesViral persistencePatient groupDrug treatment
2019
Development and Testing of Improved Models to Predict Payment Using Centers for Medicare & Medicaid Services Claims Data
Krumholz HM, Warner F, Coppi A, Triche EW, Li SX, Mahajan S, Li Y, Bernheim SM, Grady J, Dorsey K, Desai NR, Lin Z, Normand ST. Development and Testing of Improved Models to Predict Payment Using Centers for Medicare & Medicaid Services Claims Data. JAMA Network Open 2019, 2: e198406. PMID: 31411709, PMCID: PMC6694388, DOI: 10.1001/jamanetworkopen.2019.8406.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionHeart failurePopulation-based programsPOA codesSingle diagnostic codeDiagnostic codesComparative effectiveness research studyPublic reportingIndex admission diagnosisDays of hospitalizationClinical Modification codesService claims dataAcute care hospitalsMultiple care settingsPatient-level modelsAdmission diagnosisTotal hospitalizationsCare hospitalPrevious diagnosisNinth RevisionMyocardial infarctionCandidate variablesCare settingsClaims dataMAIN OUTCOMEComparative Effectiveness of New Approaches to Improve Mortality Risk Models From Medicare Claims Data
Krumholz HM, Coppi AC, Warner F, Triche EW, Li SX, Mahajan S, Li Y, Bernheim SM, Grady J, Dorsey K, Lin Z, Normand ST. Comparative Effectiveness of New Approaches to Improve Mortality Risk Models From Medicare Claims Data. JAMA Network Open 2019, 2: e197314. PMID: 31314120, PMCID: PMC6647547, DOI: 10.1001/jamanetworkopen.2019.7314.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionICD-9-CM codesMortality risk modelHeart failureHospital admissionC-statisticMAIN OUTCOMEMortality rateRisk-standardized mortality ratesHospital risk-standardized mortality ratesIndex admission diagnosisPatients 65 yearsDays of hospitalizationComparative effectiveness studiesClaims-based dataHospital-level performance measuresMedicare claims dataPatient-level modelsCMS modelRisk-adjustment modelsRisk modelHospital performance measuresAdmission diagnosisNinth RevisionMyocardial infarction
2018
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICD
2017
Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results
Huang C, Dhruva SS, Coppi AC, Warner F, Li S, Lin H, Nasir K, Krumholz HM. Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results. Journal Of The American Heart Association 2017, 6: e007509. PMID: 29133522, PMCID: PMC5721802, DOI: 10.1161/jaha.117.007509.Peer-Reviewed Original ResearchConceptsSystolic blood pressure responseBlood pressure responseTreatment groupsCause deathVisit variabilityDiscordant trialsBlood pressure trialStandard treatment groupPressure responseACCORD participantsPressure trialSBP responseHeart failureMean SBPPrimary outcomeSBPDiscordant resultsMean differenceSimilar interventionsTrial resultsTrialsSimilar mean differencesTreatment effectsSignificant differencesStrokeHeterogeneity in Early Responses in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial)
Dhruva SS, Huang C, Spatz ES, Coppi AC, Warner F, Li SX, Lin H, Xu X, Furberg CD, Davis BR, Pressel SL, Coifman RR, Krumholz HM. Heterogeneity in Early Responses in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). Hypertension 2017, 70: 94-102. PMID: 28559399, DOI: 10.1161/hypertensionaha.117.09221.Peer-Reviewed Original ResearchConceptsAntihypertensive therapySystolic blood pressure responseAdverse cardiovascular eventsFavorable initial responseBlood pressure responseHigher hazard ratioCardiovascular eventsCardiovascular outcomesHazard ratioMultivariable adjustmentHeart failureAverage SBPRandomized trialsOdds ratioCardiovascular diseaseSBPStudy participantsRespondersMonthsPressure responseImmediate respondersALLHATEarly responseInitial responseSuperior discriminationDiscovery of temporal and disease association patterns in condition-specific hospital utilization rates
Haimovich JS, Venkatesh AK, Shojaee A, Coppi A, Warner F, Li SX, Krumholz HM. Discovery of temporal and disease association patterns in condition-specific hospital utilization rates. PLOS ONE 2017, 12: e0172049. PMID: 28355219, PMCID: PMC5371293, DOI: 10.1371/journal.pone.0172049.Peer-Reviewed Original Research