2024
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug Administration
2021
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors
Long AS, Zhang AD, Meyer CE, Egilman AC, Ross JS, Wallach JD. Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors. JAMA Network Open 2021, 4: e215731. PMID: 33956134, PMCID: PMC8103227, DOI: 10.1001/jamanetworkopen.2021.5731.Peer-Reviewed Original ResearchConceptsRandomized clinical trialsSafety end pointEnd pointClinical trialsDrug pairsPrimary end point resultsEnd point resultsImproved efficacyEfficacy end pointCochrane Central RegistrySeparate end pointsSingle-enantiomer drugsSingle enantiomer formulationPrimary efficacySecondary efficacyControlled TrialsOvid EmbaseOvid MEDLINESuperior efficacyDrug AdministrationCentral RegistrySystematic reviewMore efficacyTrialsRacemic drugs
2020
Updating 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 ResearchConceptsIndividual 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
2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkersComparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project
Low J, Ross JS, Ritchie JD, Gross CP, Lehman R, Lin H, Fu R, Stewart LA, Krumholz HM. Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project. Systematic Reviews 2017, 6: 28. PMID: 28196521, PMCID: PMC5310069, DOI: 10.1186/s13643-017-0422-x.Peer-Reviewed Original ResearchConceptsParticipant-level dataSystematic reviewSummary estimatesRecombinant human bone morphogenetic protein-2Inclusion criteriaCenter BIndividual participant-level dataMeta-analysis inclusion criteriaHuman bone morphogenetic protein-2Trial inclusion criteriaMulti-site clinical trialMain outcome measuresMost clinical outcomesStatistical methodsConcurrent systematic reviewIndependent systematic reviewsProtein 2Bone morphogenetic protein-2Summary efficacyMorphogenetic protein-2Adverse eventsClinical outcomesSurgical approachTrial inclusionClinical trials
2011
Promoting transparency in pharmaceutical industry-sponsored research.
Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry-sponsored research. American Journal Of Public Health 2011, 102: 72-80. PMID: 22095335, PMCID: PMC3319748, DOI: 10.2105/ajph.2011.300187.Commentaries, Editorials and LettersConceptsClinical trial researchTrial researchIndividual clinical decisionsGuideline recommendationsEvidence-based practiceTRIAL REGISTRATIONSystematic reviewClinical decisionInvestigator contributionsTrial outcomesMedical literaturePublic healthSelective publicationClinical trial data analysisHealthTrial data analysisIndustry-sponsored researchPatientsPhysicians
2008
Statistical Models and Patient Predictors of Readmission for Heart Failure: A Systematic Review
Ross JS, Mulvey GK, Stauffer B, Patlolla V, Bernheim SM, Keenan PS, Krumholz HM. Statistical Models and Patient Predictors of Readmission for Heart Failure: A Systematic Review. JAMA Internal Medicine 2008, 168: 1371-1386. PMID: 18625917, DOI: 10.1001/archinte.168.13.1371.Peer-Reviewed Original ResearchMeSH KeywordsDisease ProgressionEvidence-Based MedicineFemaleHeart FailureHospitalizationHumansIncidenceMaleModels, StatisticalPatient ReadmissionPredictive Value of TestsProportional Hazards ModelsQuality-Adjusted Life YearsRisk FactorsSensitivity and SpecificitySeverity of Illness IndexSurvival AnalysisUnited StatesConceptsPatient characteristicsPatient readmission riskReadmission riskPatient riskSystematic reviewReadmission ratesHospital ratesOvid Evidence-Based Medicine ReviewsEligible English-language publicationsEvidence-Based Medicine ReviewsHeart failure hospitalizationPatient risk stratificationEnglish-language literatureEnglish-language publicationsFailure hospitalizationHF hospitalizationAdult patientsHeart failureHospital readmissionMedicine ReviewsRisk stratificationPatient predictorsInclusion criteriaReadmissionCombined outcome