2021
Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis
Axson S, Mello MM, Lincow D, Yang C, Gross C, Ross JS, Miller J. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open 2021, 11: e053248. PMID: 34281933, PMCID: PMC8291313, DOI: 10.1136/bmjopen-2021-053248.Peer-Reviewed Original ResearchCardiovascular 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
2018
Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016
Roginiel AC, Dhruva SS, Ross JS. Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016. Medicine 2018, 97: e12715. PMID: 30290675, PMCID: PMC6200488, DOI: 10.1097/md.0000000000012715.Peer-Reviewed Original ResearchConceptsOriginal clinical trialsCMS national coverage determinationsNational Coverage DeterminationClinical trialsFDA approvalControl armFDA approval documentsQuality of trialsCross-sectional studySignificant differencesCoverage determinationMedian ageMedian timePivotal trialsQuantity of evidenceInclusion criteriaTrial participantsMedicare populationCMS coverageDrug AdministrationStudy sizeNovel therapeuticsMedicaid ServicesMarketing approvalTrials
2017
Hospital-Readmission Risk — Isolating Hospital Effects from Patient Effects
Krumholz HM, Wang K, Lin Z, Dharmarajan K, Horwitz LI, Ross JS, Drye EE, Bernheim SM, Normand ST. Hospital-Readmission Risk — Isolating Hospital Effects from Patient Effects. New England Journal Of Medicine 2017, 377: 1055-1064. PMID: 28902587, PMCID: PMC5671772, DOI: 10.1056/nejmsa1702321.Peer-Reviewed Original ResearchConceptsRisk-standardized readmission ratesReadmission ratesObserved readmission ratesSimilar diagnosesHospital effectsDifferent hospitalsHospital readmission performanceRate of readmissionHospital readmission ratesLower readmission ratesStudy sampleYears of ageSignificant differencesMultiple admissionsReadmission outcomesOnly significant differencePatient effectsSame patientMedicare recipientsPatientsReadmission performanceRisk-standardized hospital readmission ratesHospitalHospital qualityQuartile
2016
Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome
Jackevicius CA, Tu JV, Krumholz HM, Austin PC, Ross JS, Stukel TA, Koh M, Chong A, Ko DT. Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome. Journal Of The American Heart Association 2016, 5: e003350. PMID: 27098970, PMCID: PMC4859299, DOI: 10.1161/jaha.116.003350.Peer-Reviewed Original ResearchConceptsGeneric atorvastatinACS hospitalizationSecondary outcomesClinical effectivenessAcute coronary syndrome hospitalizationPopulation-based cohort studyNew-onset diabetesAcute coronary syndromeDays of dischargePrespecified subgroup analysisPropensity-matched pairsInfrequent side effectsBrand-name medicationsSignificant differencesHealth care plansRecurrent ACSAdmission diagnosisAtorvastatin doseCardiovascular outcomesCoronary syndromeCohort studyRenal failureHeart failurePrimary outcomeMean ageCharacterisation of trials where marketing purposes have been influential in study design: a descriptive study
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Trials 2016, 17: 31. PMID: 26792624, PMCID: PMC4720997, DOI: 10.1186/s13063-015-1107-1.Peer-Reviewed Original ResearchConceptsMedian numberDrug trialsGeneral medical journalsComposite primary outcome measureStudy designTerms of blindingPrimary outcome measureTrials of drugsHigh-impact general medical journalsKey trial characteristicsIndustry-funded trialsMedical journalsAdverse eventsCategories of trialsTrial characteristicsOutcome measuresStudy populationSafety outcomesBlinded researcherStudy characteristicsDescriptive studyTrial documentationTrialsSignificant differencesMarketing trials
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 respondents
2009
Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. PLOS Medicine 2009, 6: e1000144. PMID: 19901971, PMCID: PMC2728480, DOI: 10.1371/journal.pmed.1000144.Peer-Reviewed Original ResearchConceptsOptional data elementsClinical trialsTrial publicationsInternet-based registryCompleteness of registrationCross-sectional analysisSelective publicationPrimary outcomeUS National LibraryReporting TrialsPublication statusTrial resultsPhase ITrialsData elementsSignificant differencesEditors' SummaryEnd dateSystematic protocolClinicalTrials