2024
Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM
Khera R, Aminorroaya A, Dhingra L, Thangaraj P, Pedroso Camargos A, Bu F, Ding X, Nishimura A, Anand T, Arshad F, Blacketer C, Chai Y, Chattopadhyay S, Cook M, Dorr D, Duarte-Salles T, DuVall S, Falconer T, French T, Hanchrow E, Kaur G, Lau W, Li J, Li K, Liu Y, Lu Y, Man K, Matheny M, Mathioudakis N, McLeggon J, McLemore M, Minty E, Morales D, Nagy P, Ostropolets A, Pistillo A, Phan T, Pratt N, Reyes C, Richter L, Ross J, Ruan E, Seager S, Simon K, Viernes B, Yang J, Yin C, You S, Zhou J, Ryan P, Schuemie M, Krumholz H, Hripcsak G, Suchard M. Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM. Journal Of The American College Of Cardiology 2024, 84: 904-917. PMID: 39197980, DOI: 10.1016/j.jacc.2024.05.069.Peer-Reviewed Original ResearchConceptsGLP-1 RAsSecond-line agentsGLP-1Antihyperglycemic agentsCardiovascular diseaseMACE riskGlucagon-like peptide-1 receptor agonistsSodium-glucose cotransporter 2 inhibitorsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsEffects of SGLT2isType 2 diabetes mellitusPeptidase-4 inhibitorsAdverse cardiovascular eventsCox proportional hazards modelsRandom-effects meta-analysisCardiovascular risk reductionTarget trial emulationProportional hazards model
2021
Covid-19, open science, and the CVD-COVID-UK initiative
Ross JS. Covid-19, open science, and the CVD-COVID-UK initiative. The BMJ 2021, 373: n898. PMID: 33827892, DOI: 10.1136/bmj.n898.Commentaries, Editorials and LettersAge‐Related Trajectories of Cardiovascular Risk and Use of Aspirin and Statin Among U.S. Adults Aged 50 or Older, 2011–2018
Rhee TG, Kumar M, Ross JS, Coll PP. Age‐Related Trajectories of Cardiovascular Risk and Use of Aspirin and Statin Among U.S. Adults Aged 50 or Older, 2011–2018. Journal Of The American Geriatrics Society 2021, 69: 1272-1282. PMID: 33598936, PMCID: PMC9869399, DOI: 10.1111/jgs.17038.Peer-Reviewed Original ResearchConceptsUse of aspirinStatin useAspirin useCardiovascular riskSecondary preventionMedication usePrimary preventionAge-related trajectoriesAge 50Prevention treatmentAngina/angina pectorisLow-dose aspirin dailyLong-term statin useOlder adultsDaily aspirin usePrimary prevention treatmentSecondary prevention treatmentSubsequent CVD eventsFirst cardiovascular eventCoronary heart diseaseAdults Aged 50Nutrition Examination SurveyCross-sectional studyHealth Interview SurveyNon-institutionalized adults
2020
Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersCardiovascular DiseasesEndpoint DeterminationEquivalence Trials as TopicHumansJournal Impact FactorPhenotypeResearch DesignResearch ReportConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersInterventionUpdating 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
Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment
DuBose‐Briski V, Yao X, Dunlay SM, Dhruva SS, Ross JS, Shah ND, Noseworthy PA. Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment. Journal Of The American Heart Association 2019, 8: e012065. PMID: 31566106, PMCID: PMC6806052, DOI: 10.1161/jaha.119.012065.Peer-Reviewed Original ResearchConceptsValvular heart diseaseClinical practice guidelinesAmerican Heart AssociationLevel of evidenceAmerican CollegeLOE BHeart failureHeart AssociationHeart diseasePractice guidelinesCardiology/American Heart Association (ACC/AHA) guideline recommendationsCardiology/American Heart Association guidelinesCardiology/American Heart AssociationMedian proportionCardiology clinical practice guidelinesAmerican Heart Association guidelinesHeart Association guidelinesClass of recommendationLOE AGuideline recommendationsResults ThirtyAssociation guidelinesMedian numberStable ischemiaLevel IClaims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke DatabaseNoninferiority Designed Cardiovascular Trials in Highest-Impact Journals
Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone G, Ross JS, Krumholz HM. Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals. Circulation 2019, 140: 379-389. PMID: 31177811, PMCID: PMC8416048, DOI: 10.1161/circulationaha.119.040214.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesEquivalence Trials as TopicHumansJournal Impact FactorPeriodicals as TopicConceptsNoninferiority marginNoninferiority trialCardiovascular trialsAllocation concealmentLower riskOpen labelHazard ratioRelative riskMethodological qualityProportion of trialsIndependent reviewersRisk differenceNew England JournalNoninferiorityHigh-impact journalsNew interventionsTrialsCohortDiscrepant resultsProtocol analysisTime trendsRiskTreatInterventionFactors
2018
Weighing the Harms and Benefits of Using Statins for Primary Prevention: Raising the Risk Threshold.
Richman IB, Ross JS. Weighing the Harms and Benefits of Using Statins for Primary Prevention: Raising the Risk Threshold. Annals Of Internal Medicine 2018, 170: 62-63. PMID: 30508426, DOI: 10.7326/m18-3066.Commentaries, Editorials and LettersAccurate 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
Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011
Bikdeli B, Punnanithinont N, Akram Y, Lee I, Desai NR, Ross JS, Krumholz HM. Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011. Journal Of The American Heart Association 2017, 6: e005285. PMID: 28325713, PMCID: PMC5524035, DOI: 10.1161/jaha.116.005285.Peer-Reviewed Original ResearchConceptsClinical outcome trialsOutcome trialsEndpoint trialsPrimary endpointCardiovascular trialsClinical outcome studiesClinical outcomesSurrogate markerPatient's perspectiveSurrogate endpointsOutcome studiesNew England JournalSample cohortTrial resultsTrialsSurrogate trialsEndpointPositive resultsAmerican MedicalInterventionHigh-impact journalsCohortMedicare Formulary Changes After the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline
Dhruva SS, Desai NR, Karaca-Mandic P, Shah ND, Ross JS. Medicare Formulary Changes After the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline. Journal Of The American College Of Cardiology 2017, 69: 244-246. PMID: 28081832, DOI: 10.1016/j.jacc.2016.10.053.Peer-Reviewed Original Research
2016
Availability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials
Murugiah K, Ritchie JD, Desai NR, Ross JS, Krumholz HM. Availability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials. Journal Of The American Heart Association 2016, 5: e003307. PMID: 27098969, PMCID: PMC4859296, DOI: 10.1161/jaha.116.003307.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationCardiotonic AgentsCardiovascular DiseasesDrug IndustryHumansInformation DisseminationRandomized Controlled Trials as TopicConceptsIndividual participant-level dataLarge cardiovascular trialsCardiovascular trialsParticipant-level dataClinical trial dataPharmaceutical companiesMajor pharmaceutical companiesIndustry-sponsored clinical trialsInterventional trialsAvailable trialsClinical trialsTrial dataTrialsPatientsSpecific reasonsPublication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study
Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA Internal Medicine 2016, 176: 551. PMID: 26902933, DOI: 10.1001/jamainternmed.2015.8590.Peer-Reviewed Original Research
2015
FDA Policy and Cardiovascular Medicine
Ross JS, Kesselheim AS. FDA Policy and Cardiovascular Medicine. Circulation 2015, 132: 1136-1145. PMID: 26391294, PMCID: PMC4586041, DOI: 10.1161/circulationaha.114.010295.Commentaries, Editorials and Letters
2014
Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis
Downing NS, Cheng T, Krumholz HM, Shah ND, Ross JS. Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis. JAMA Internal Medicine 2014, 174: 1176-1182. PMID: 24796406, PMCID: PMC4124903, DOI: 10.1001/jamainternmed.2014.1371.Peer-Reviewed Original ResearchConceptsACCORD lipid trialACCORD-LipidFibrate useTrial interpretationImproved cardiovascular outcomesCross-sectional studyCross-sectional analysisStatin therapyCardiovascular outcomesCardiovascular riskDiabetes (ACCORD) trialDiabetes mellitusConflicts of interestTrialsPatientsFenofibrateAuthor conflictsLipid componentsMellitusTherapyPhysiciansMonths
2013
The Case for Generic Statins: Not If They Don’t Work So Well—Reply
Green JB, Ross JS, Krumholz HM. The Case for Generic Statins: Not If They Don’t Work So Well—Reply. JAMA Internal Medicine 2013, 173: 1474-1474. PMID: 23939523, DOI: 10.1001/jamainternmed.2013.7781.Commentaries, Editorials and LettersWhen Choosing Statin Therapy: The Case for Generics
Green JB, Ross JS, Jackevicius CA, Shah ND, Krumholz HM. When Choosing Statin Therapy: The Case for Generics. JAMA Internal Medicine 2013, 173: 229-232. PMID: 23303273, DOI: 10.1001/jamainternmed.2013.1529.Commentaries, Editorials and LettersMeSH KeywordsCardiovascular DiseasesChoice BehaviorDrugs, GenericDyslipidemiasEvidence-Based MedicineHumansHydroxymethylglutaryl-CoA Reductase InhibitorsTherapeutic Equivalency
2012
Association of Chronic Diseases and Impairments With Disability in Older Adults
Hung WW, Ross JS, Boockvar KS, Siu AL. Association of Chronic Diseases and Impairments With Disability in Older Adults. Medical Care 2012, 50: 501-507. PMID: 22584885, PMCID: PMC3353149, DOI: 10.1097/mlr.0b013e318245a0e0.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingAgedAgingCardiovascular DiseasesChronic DiseaseCognition DisordersCross-Sectional StudiesDiabetes MellitusDisabled PersonsFemaleHealth SurveysHearing LossHumansHypertensionMaleMobility LimitationResidence CharacteristicsRespiratory Tract DiseasesSelf CareSocioeconomic FactorsUnited StatesVision DisordersConceptsSelf-care disabilityChronic diseasesLung diseaseOlder adultsSelf-care ADLChronic lung diseaseCommunity-dwelling adultsCross-sectional analysisADL disabilityHeart failureHeart diseaseDaily livingHypertensionDiseaseDiabetesImpairmentDisabilityAdultsRetirement StudySpecific disabilitiesAssociationArthritisStrokeCancerADL
2011
Use of Fibrates in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of Fibrates in the United States and Canada. JAMA 2011, 305: 1217-1224. PMID: 21427374, PMCID: PMC3332101, DOI: 10.1001/jama.2011.353.Peer-Reviewed Original ResearchMeSH KeywordsCanadaCardiovascular DiseasesCohort StudiesCosts and Cost AnalysisDiabetes Mellitus, Type 2Drug CostsDrugs, GenericFenofibrateFibric AcidsHealth ExpendituresHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsMedical AuditPractice Patterns, Physicians'PrescriptionsUnited StatesConceptsUse of fibratesRole of fibratesObservational cohort studyIMS Health dataFenofibrate useCardiovascular riskCohort studyDiabetes (ACCORD) trialClinical benefitFibratesMonthsPrescriptionUnited StatesPatientsNegative resultsFenofibrateHealth dataCurrent useGeneric formulationPopulationStatinsTherapyTrials