2021
Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway
Gyawali B, Ross JS, Kesselheim AS. Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway. JAMA Internal Medicine 2021, 181: 1275-1276. PMID: 34254981, DOI: 10.1001/jamainternmed.2021.4604.Commentaries, Editorials and Letters
2020
Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products
Dhruva SS, Shah ND, Ross JS. Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products. Mayo Clinic Proceedings 2020, 95: 2609-2611. PMID: 33289654, DOI: 10.1016/j.mayocp.2020.04.013.Commentaries, Editorials and LettersComparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation
Yao X, Inselman JW, Ross JS, Izem R, Graham DJ, Martin DB, Thompson AM, Ross Southworth M, Siontis KC, Ngufor CG, Nath KA, Desai NR, Nallamothu BK, Saran R, Shah ND, Noseworthy PA. Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006515. PMID: 33012172, PMCID: PMC7580213, DOI: 10.1161/circoutcomes.120.006515.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAnticoagulantsAntithrombinsAtrial FibrillationComparative Effectiveness ResearchDabigatranDatabases, FactualFactor Xa InhibitorsFemaleGlomerular Filtration RateHemorrhageHumansKidneyMaleMiddle AgedPyrazolesPyridonesRenal Insufficiency, ChronicRetrospective StudiesRisk AssessmentRisk FactorsRivaroxabanTime FactorsTreatment OutcomeUnited StatesWarfarinConceptsGlomerular filtration rateKidney functionMajor bleedingAtrial fibrillationOral anticoagulantsLower riskFiltration rateComparative effectivenessGlomerular filtration rate categoriesUS administrative claims databaseFalsification end pointsKidney function declineReduced kidney functionProportion of patientsAdministrative claims databaseSubstantial residual confoundingBaseline characteristicsFunction declineClaims databaseComparative safetyResidual confoundingTreatment weightingSimilar riskTreatment groupsPatientsAttribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data
Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac‐Dabic D, Sedrakyan A, Normand S, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. Journal Of The American Heart Association 2020, 9: e013606. PMID: 32063087, PMCID: PMC7070203, DOI: 10.1161/jaha.119.013606.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overCoronary RestenosisCoronary ThrombosisDatabases, FactualDrug-Eluting StentsFemaleHumansMaleMedicareMyocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetreatmentRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsIndex percutaneous coronary interventionPercutaneous coronary interventionSame coronary arteryDrug-eluting stentsNCDR CathPCI RegistrySubsequent percutaneous coronary interventionAcute myocardial infarctionCoronary arteryClaims dataCathPCI RegistryAdverse eventsIndex procedureMyocardial infarctionRepeat percutaneous coronary interventionReal-world registry dataTarget vessel revascularizationCoronary stent placementAdministrative claims dataLong-term safetyLongitudinal claims dataPotential safety eventsVessel revascularizationCoronary interventionDES placementStent thrombosis
2019
The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration.
Kent DM, van Klaveren D, Paulus JK, D'Agostino R, Goodman S, Hayward R, Ioannidis JPA, Patrick-Lake B, Morton S, Pencina M, Raman G, Ross JS, Selker HP, Varadhan R, Vickers A, Wong JB, Steyerberg EW. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration. Annals Of Internal Medicine 2019, 172: w1-w25. PMID: 31711094, PMCID: PMC7750907, DOI: 10.7326/m18-3668.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsThe Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement.
Kent DM, Paulus JK, van Klaveren D, D'Agostino R, Goodman S, Hayward R, Ioannidis JPA, Patrick-Lake B, Morton S, Pencina M, Raman G, Ross JS, Selker HP, Varadhan R, Vickers A, Wong JB, Steyerberg EW. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement. Annals Of Internal Medicine 2019, 172: 35-45. PMID: 31711134, PMCID: PMC7531587, DOI: 10.7326/m18-3667.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsRisk of Readmission After Discharge From Skilled Nursing Facilities Following Heart Failure Hospitalization: A Retrospective Cohort Study
Weerahandi H, Li L, Bao H, Herrin J, Dharmarajan K, Ross JS, Kim KL, Jones S, Horwitz LI. Risk of Readmission After Discharge From Skilled Nursing Facilities Following Heart Failure Hospitalization: A Retrospective Cohort Study. Journal Of The American Medical Directors Association 2019, 20: 432-437. PMID: 30954133, PMCID: PMC6486375, DOI: 10.1016/j.jamda.2019.01.135.Peer-Reviewed Original ResearchConceptsSkilled nursing facilitiesSNF dischargeRetrospective cohort studySNF lengthHeart failureHF hospitalizationComposite outcomeCohort studyNursing facilitiesService beneficiaries 65Heart failure hospitalizationRisk of readmissionHazard rate ratiosFailure hospitalizationUnplanned readmissionHF diagnosisHospital dischargePostdischarge outcomesSNF stayMedicare patientsMedicare feeHome transitionPatientsReadmissionDay 3Submissions 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 outcomeAssociation of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary Embolism
Bikdeli B, Wang Y, Jimenez D, Ross JS, Monreal M, Goldhaber SZ, Krumholz HM. Association of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary Embolism. JAMA Internal Medicine 2019, 179: 263-265. PMID: 30535318, PMCID: PMC6439651, DOI: 10.1001/jamainternmed.2018.5287.Peer-Reviewed Original Research
2018
Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals
Charalel RA, Durack JC, Mao J, Ross JS, Meltzer AJ, Sedrakyan A. Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals. Medical Care 2018, 56: 260-265. PMID: 29356721, DOI: 10.1097/mlr.0000000000000867.Peer-Reviewed Original ResearchConceptsIVC filter placementFilter placementIVC filtersFilter retrievalIVC filter-related complicationsProphylactic IVC filter placementInferior vena cava filter placementVena cava filter placementFilter-related complicationsPulmonary embolism riskAverage patient ageDrug Administration (FDA) safety communicationRetrospective cohort studyCava filter placementKaplan-Meier analysisAge-adjusted ratesIVC filter retrievalCohort studyPatient agePE occurrencePE ratePE eventsCumulative riskPopulation-level trendsClinical practiceVariation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes
Lindenauer PK, Strait KM, Grady JN, Ngo CK, Parisi ML, Metersky M, Ross JS, Bernheim SM, Dorsey K. Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes. Annals Of The American Thoracic Society 2018, 15: 562-569. PMID: 29298090, DOI: 10.1513/annalsats.201709-728oc.Peer-Reviewed Original ResearchConceptsAspiration pneumoniaHospital mortalityHospital patientsMortality rateLower risk-standardized mortality ratesRisk-standardized mortality ratesRisk-standardized ratesPatients 65 yearsHospital readmission ratesNational mortality ratesPneumonia cohortPneumonia outcomesHospital outcomesReadmission ratesHospital differencesPrincipal diagnosisOutcome measuresReadmission measuresHospital codingMedicare feePneumoniaService claimsPatientsMedian proportionMortality
2017
Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014. Otolaryngology 2017, 156: 285-288. PMID: 28093943, DOI: 10.1177/0194599816684094.Peer-Reviewed Original ResearchConceptsPostapproval studiesPivotal studiesUS FoodPrimary effectiveness end pointAvailable FDA documentsEffectiveness end pointPivotal clinical studiesBenefit-risk assessmentCross-sectional analysisPremarket evidenceMedian durationClinical evidenceDrug Administration premarket approvalsOtolaryngologic diseaseMedian enrollmentClinical studiesHigh-risk medical devicesDrug AdministrationEnd pointHigh-risk devicesFDA documentsOne-thirdTwo-thirdsPremarket approvalFDA
2016
Declining Admission Rates And Thirty-Day Readmission Rates Positively Associated Even Though Patients Grew Sicker Over Time
Dharmarajan K, Qin L, Lin Z, Horwitz LI, Ross JS, Drye EE, Keshawarz A, Altaf F, Normand SL, Krumholz HM, Bernheim SM. Declining Admission Rates And Thirty-Day Readmission Rates Positively Associated Even Though Patients Grew Sicker Over Time. Health Affairs 2016, 35: 1294-1302. PMID: 27385247, DOI: 10.1377/hlthaff.2015.1614.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCenters for Medicare and Medicaid Services, U.S.Chronic DiseaseDatabases, FactualDisease ProgressionFemaleGeriatric AssessmentHospital MortalityHumansIncidenceLength of StayMaleOutcome Assessment, Health CarePatient AdmissionPatient ReadmissionRetrospective StudiesRisk AssessmentSeverity of Illness IndexTime FactorsUnited StatesImpact of Hospitalization for Acute Myocardial Infarction on Adherence to Statins Among Older Adults
Kronish IM, Ross JS, Zhao H, Muntner P. Impact of Hospitalization for Acute Myocardial Infarction on Adherence to Statins Among Older Adults. Circulation Cardiovascular Quality And Outcomes 2016, 9: 364-371. PMID: 27220368, PMCID: PMC4956547, DOI: 10.1161/circoutcomes.115.002418.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overDatabases, FactualDyslipidemiasFemaleHealth Knowledge, Attitudes, PracticeHospitalizationHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMedicareMedication AdherenceMyocardial InfarctionRisk AssessmentRisk FactorsTherapeuticsTime FactorsUnited StatesConceptsAcute myocardial infarctionImpact of hospitalizationAMI hospitalizationMyocardial infarctionProportion of patientsPatients adherentStatin adherentNonadherent patientsAdherent patientsMedicare patientsHospitalizationAdministrative claimsStatinsMedicare beneficiariesPatientsPneumoniaSubsequent adherenceOlder adultsInfarctionRandom sampleAdherenceAdherentYearsProportionCohort
2015
National assessment of early β-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)–Retrospective AMI Study
Zhang H, Masoudi FA, Li J, Wang Q, Li X, Spertus JA, Ross JS, Desai NR, Krumholz HM, Jiang L, Group C. National assessment of early β-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)–Retrospective AMI Study. American Heart Journal 2015, 170: 506-515.e1. PMID: 26385034, PMCID: PMC5459420, DOI: 10.1016/j.ahj.2015.05.012.Peer-Reviewed Original ResearchConceptsΒ-blocker therapyAcute myocardial infarctionΒ-blocker useCardiogenic shockRisk factorsAbsolute contraindicationMyocardial infarctionEarly β-blocker useLower systolic blood pressureHours of admissionMedical record reviewSystolic blood pressureClinical practice guidelinesLower heart rateQuality of careChest discomfortCardiac eventsBlood pressureRecord reviewChina PatientIdeal patientPractice guidelinesHeart rateHigh riskPatterns of useTrajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study
Dharmarajan K, Hsieh AF, Kulkarni VT, Lin Z, Ross JS, Horwitz LI, Kim N, Suter LG, Lin H, Normand SL, Krumholz HM. Trajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study. The BMJ 2015, 350: h411. PMID: 25656852, PMCID: PMC4353309, DOI: 10.1136/bmj.h411.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionRetrospective cohort studyHeart failureRisk of deathMyocardial infarctionFirst readmissionAbsolute riskOlder patientsCohort studyRelative riskMedicare feeService beneficiariesRisk of readmissionGeneral elderly populationGeneral older populationRisk trajectoriesHigh-risk periodHospital dischargeHospital admissionDischarge diagnosisAdverse outcomesReadmissionHospitalizationTrajectories of riskElderly population
2014
Decision-making and cancer screening: A qualitative study of older adults with multiple chronic conditions
Gross CP, Fried TR, Tinetti ME, Ross JS, Genao I, Hossain S, Wolf E, Lewis CL. Decision-making and cancer screening: A qualitative study of older adults with multiple chronic conditions. Journal Of Geriatric Oncology 2014, 6: 93-100. PMID: 25544380, DOI: 10.1016/j.jgo.2014.12.001.Peer-Reviewed Original ResearchConceptsCancer screening decisionsCancer screeningChronic conditionsCancer statusEducational promptsOlder personsMultiple chronic conditionsScreening decisionsDirect health benefitsMedical conditionsOverall healthOlder adultsThematic saturationHealth benefitsLife expectancyIndependent readersHealth scenarioMost respondentsScreeningAdultsAgeQualitative studySample sizeStatusMedicationsHospital variation in risk-standardized hospital admission rates from US EDs among adults
Capp R, Ross JS, Fox JP, Wang Y, Desai MM, Venkatesh AK, Krumholz HM. Hospital variation in risk-standardized hospital admission rates from US EDs among adults. The American Journal Of Emergency Medicine 2014, 32: 837-843. PMID: 24881514, DOI: 10.1016/j.ajem.2014.03.033.Peer-Reviewed Original ResearchConceptsHospital admission ratesEmergency departmentAdmission ratesClinical characteristicsED visitsHospital factorsClinical factorsAdult ED visitsUS emergency departmentsHospital teaching statusCross-sectional analysisPatient characteristicsHospital admissionHospital variationPatientsTeaching statusHospitalED dataVisitsRepresentative sampleAdultsRural locationsAdmissionFactorsNational variations
2013
Regional Density of Cardiologists and Rates of Mortality for Acute Myocardial Infarction and Heart Failure
Kulkarni VT, Ross JS, Wang Y, Nallamothu BK, Spertus JA, Normand SL, Masoudi FA, Krumholz HM. Regional Density of Cardiologists and Rates of Mortality for Acute Myocardial Infarction and Heart Failure. Circulation Cardiovascular Quality And Outcomes 2013, 6: 352-359. PMID: 23680965, PMCID: PMC5323047, DOI: 10.1161/circoutcomes.113.000214.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCardiologyCohort StudiesFemaleHealth Services AccessibilityHealth Services Needs and DemandHealthcare DisparitiesHeart FailureHospitalizationHumansLinear ModelsLogistic ModelsMaleMedicareMyocardial InfarctionOdds RatioPhysiciansPneumoniaPrognosisResidence CharacteristicsRisk AssessmentRisk FactorsTime FactorsUnited StatesWorkforceConceptsAcute myocardial infarctionHeart failureHospital referral regionsMortality riskLowest quintileMyocardial infarctionReferral regionsMedicare administrative claims dataCharacteristics of patientsRisk of deathAdministrative claims dataHierarchical logistic regression modelsLogistic regression modelsRate of mortalityRegional densityHighest quintileNumber of cardiologistsWorse outcomesClaims dataPatientsPneumoniaCardiologistsHospitalizationAdmissionQuintile
2009
Determinants of Cardiac Catheterization Use in Older Medicare Patients With Acute Myocardial Infarction
Ko DT, Ross JS, Wang Y, Krumholz HM. Determinants of Cardiac Catheterization Use in Older Medicare Patients With Acute Myocardial Infarction. Circulation Cardiovascular Quality And Outcomes 2009, 3: 54-62. PMID: 20123672, PMCID: PMC3024143, DOI: 10.1161/circoutcomes.109.858456.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overCardiac CatheterizationChi-Square DistributionComorbidityFemaleHemorrhageHospitalizationHumansLikelihood FunctionsLogistic ModelsMaleMedicareMyocardial InfarctionPatient SelectionPractice Patterns, Physicians'Risk AssessmentRisk FactorsSeverity of Illness IndexSex FactorsTime FactorsTreatment OutcomeUnited StatesConceptsAcute myocardial infarctionCardiac catheterization useCardiac catheterizationInappropriate indicationsAMI patientsAppropriate indicationsMyocardial infarctionRisk scoreCardiology/American Heart Association class IBaseline cardiovascular riskOlder Medicare patientsHigh-risk patientsDemographic factorsMore comorbiditiesCardiovascular riskOlder patientsMale sexProcedure indicationFemale sexMedicare patientsAmerican CollegeAMI admissionsMedicare feePatientsCatheterization