2021
Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use
Brito JP, Ross JS, Deng Y, Sangaralingham L, Graham DJ, Qiang Y, Wang Z, Yao X, Zhao L, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use. Endocrine 2021, 74: 592-602. PMID: 34089480, PMCID: PMC9210353, DOI: 10.1007/s12020-021-02779-x.Peer-Reviewed Original ResearchConceptsCongestive heart failureRate of fracturesCardiovascular outcomesL-thyroxineRate of fallHeart failureHip fractureAtrial fibrillationMyocardial infarctionNational administrative claims databasePropensity-matched patientsAdministrative claims databaseRate of hospitalizationMIU/L.Main outcome measuresSignificant differencesDose subgroupsHospitalization ratesClaims databaseThyroid cancerInpatient settingBaseline thyroidHormone levelsOutcome measuresPatients
2019
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary management
2018
Patterns and predictors of off-label prescription of psychiatric drugs
Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLOS ONE 2018, 13: e0198363. PMID: 30024873, PMCID: PMC6053129, DOI: 10.1371/journal.pone.0198363.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntipsychotic AgentsBipolar DisorderCitalopramCross-Sectional StudiesDrug PrescriptionsFemaleHumansInappropriate PrescribingInsurance, Major MedicalMaleMiddle AgedOffice VisitsOff-Label UseOutpatientsPractice Patterns, Physicians'Retrospective StudiesSleep Initiation and Maintenance DisordersTrazodoneUnited StatesConceptsNational Ambulatory Medical Care SurveyLabel prescribingChronic care managementPsychiatric drugsOutpatient visitsLabel prescriptionsCare managementAmbulatory Medical Care SurveyCommon off-label usesAdult outpatient visitsMore chronic conditionsMain outcome measuresOff-label useCross-sectional studyOff-label usesTypes of cliniciansManic-depressive psychosisStrong scientific evidenceVisit diagnosesAdverse eventsOffice visitsCare SurveyLabel usePsychiatric medicationsChronic conditions
2017
Comparison 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
2016
Frequency and Importance of Incomplete Screening Fetal Anatomic Sonography in Pregnancy
Silvestri MT, Pettker CM, Raney JH, Xu X, Ross JS. Frequency and Importance of Incomplete Screening Fetal Anatomic Sonography in Pregnancy. Journal Of Ultrasound In Medicine 2016, 35: 2665-2673. PMID: 27821652, DOI: 10.7863/ultra.16.01084.Peer-Reviewed Original ResearchConceptsRepeat sonographyUltrasound examinationAbnormal fetal anatomyRepeat screeningFetal anatomyIncomplete visualizationLarge single-center studyMean gestational ageRetrospective cohort studySingle-center studyMean maternal ageMain outcome measuresProportion of womenCohort studySingleton pregnanciesWeeks' gestationGestational ageMaternal ageRepeat imagingUltrasound centersOutcome measuresSonographyAnatomic componentsWomenPregnancyCompliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting
Dal-Ré R, Ross JS, Marušić A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. Journal Of Clinical Epidemiology 2016, 75: 100-107. PMID: 26820559, DOI: 10.1016/j.jclinepi.2016.01.017.Commentaries, Editorials and LettersConceptsPrimary end pointInterim analysisTRIAL REGISTRATIONEnd pointHigh-impact general medicine journalsICMJE policyMain outcome measuresPublic trials registryPredictors of complianceProspective trial registrationTrials of FDACross-sectional analysisPercent of trialsTrials RegistryGeneral medicine journalsProspective registrationOutcome measuresClinical researchStudy designTrial resultsHigh-impact journalsRetrospective registrationTrialsAscertainmentMedicine journals
2014
Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey
Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Dzara K, Ross JS. Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey. Trials 2014, 15: 384. PMID: 25277128, PMCID: PMC4192345, DOI: 10.1186/1745-6215-15-384.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationAgedAttitude of Health PersonnelChi-Square DistributionClinical Trials as TopicCooperative BehaviorCross-Sectional StudiesDatabases, FactualFemaleHealth Knowledge, Attitudes, PracticeHumansInformation DisseminationInternetMaleMiddle AgedPerceptionRegistriesResearch PersonnelSurveys and QuestionnairesConceptsTrial funding sourceExact testMain outcome measuresFisher's exact testCross-sectional surveyChi-square testClinical trialsTrial characteristicsOutcome measuresGeneral medical journalsClinical trialistsWeb-based surveyTrialistsExploratory analysisBackgroundA numberStatistical significanceSignificant differencesExternal investigatorsClinical trial data sharingTrialsMedical journalsPharmaceutical companiesFunding sourcesIndustry fundingPotential respondentsImpact of the ENHANCE Trial on the use of ezetimibe in the United States and Canada
Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA. Impact of the ENHANCE Trial on the use of ezetimibe in the United States and Canada. American Heart Journal 2014, 167: 683-689. PMID: 24766978, PMCID: PMC4215424, DOI: 10.1016/j.ahj.2014.01.014.Peer-Reviewed Original ResearchConceptsUse of ezetimibeENHANCE trialEzetimibe useProgression of atherosclerosisMain outcome measuresAtherosclerosis regression trialsMonthly numberOutcome measuresRegression trialsEzetimibeIMS HealthCommon evidence baseEvidence baseTrialsUnited StatesUtilization patternsFurther investigationDifferent utilization patternsPopulationDifferent patternsUse trendsAtherosclerosisSimvastatinProgressionUsual Source of Care and Outcomes Following Acute Myocardial Infarction
Spatz ES, Sheth SD, Gosch KL, Desai MM, Spertus JA, Krumholz HM, Ross JS. Usual Source of Care and Outcomes Following Acute Myocardial Infarction. Journal Of General Internal Medicine 2014, 29: 862-869. PMID: 24553957, PMCID: PMC4026492, DOI: 10.1007/s11606-014-2794-0.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionUsual sourceMyocardial infarctionMortality rateBaseline risk factorsAcute clinical eventsMain outcome measuresAMI severityAMI patientsMultivariable analysisKey ResultsAmongClinical eventsSocio-demographic characteristicsRisk factorsOutcome measuresReadmissionHigh mortalityPatientsMortalityCareMonthsInfarctionAdultsOutcomesAssociation