2024
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study
Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.Peer-Reviewed Original ResearchNational Comprehensive Cancer NetworkNational Comprehensive Cancer Network guidelinesComprehensive Cancer NetworkFood and Drug AdministrationCancer NetworkUS Food and Drug AdministrationCategories of evidenceAccelerated approvalCross sectional studyDrug treatmentConfirmatory trialsClinical benefitTrial resultsOncological indicationsTraditional approvalGuideline recommendationsOutcome measuresSectional studyApproval statusFDA decisionRecommended alignmentOncologyUpdate recommendationsPostapproval trialsGuidelines
2023
A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials
Ciani O, Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartssson A, Amstutz A, Bertolaccini L, Bruno V, Devane D, Faria C, Gilbert P, Harris R, Lassere M, Marinelli L, Markham S, Powers J, Rezaei Y, Richert L, Schwendicke F, Tereshchenko L, Thoma A, Turan A, Worrall A, Christensen R, Collins G, Ross J, Taylor R. A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. EClinicalMedicine 2023, 65: 102283. PMID: 37877001, PMCID: PMC10590868, DOI: 10.1016/j.eclinm.2023.102283.Peer-Reviewed Original ResearchSurrogate endpointsInterventional trialsIntermediate outcomesHealth technology assessment expertsPrimary outcome measureMeasures of functionTreatment effectsE-Delphi studyOutcome measuresConsensus meetingBetter HealthTarget outcomesTrialsEndpointLack of consensusOutcomesPatientsFuture reportingCurrent definitionUrgent needSymptomsCliniciansSettingBiomarkersMultinational patterns of second line antihyperglycaemic drug initiation across cardiovascular risk groups: federated pharmacoepidemiological evaluation in LEGEND-T2DM
Khera R, Dhingra L, Aminorroaya A, Li K, Zhou J, Arshad F, Blacketer C, Bowring M, Bu F, Cook M, Dorr D, Duarte-Salles T, DuVall S, Falconer T, French T, Hanchrow E, Horban S, Lau W, Li J, Liu Y, Lu Y, Man K, Matheny M, Mathioudakis N, McLemore M, Minty E, Morales D, Nagy P, Nishimura A, Ostropolets A, Pistillo A, Posada J, Pratt N, Reyes C, Ross J, Seager S, Shah N, Simon K, Wan E, Yang J, Yin C, You S, Schuemie M, Ryan P, Hripcsak G, Krumholz H, Suchard M. Multinational patterns of second line antihyperglycaemic drug initiation across cardiovascular risk groups: federated pharmacoepidemiological evaluation in LEGEND-T2DM. BMJ Medicine 2023, 2: e000651. PMID: 37829182, PMCID: PMC10565313, DOI: 10.1136/bmjmed-2023-000651.Peer-Reviewed Original ResearchType 2 diabetes mellitusSecond-line treatmentCardiovascular risk groupsDiabetes mellitusCardiovascular diseaseAntihyperglycaemic drugsLine treatmentRisk groupsObservational Health Data SciencesGlucagon-like peptide-1 receptor agonistsElectronic health recordsSodium-glucose cotransporter 2 inhibitorsCalendar year trendsPeptide-1 receptor agonistsUS databaseOutcomes of patientsCotransporter 2 inhibitorsAdministrative claims databaseSecond-line drugsHealth recordsSodium-glucose cotransporter-2 inhibitorsMedication useMetformin monotherapyGuideline recommendationsOutcome measures
2021
Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices
Bartlett VL, Ross JS, Shah ND, Ciaccio L, Akar JG, Noseworthy PA, Dhruva SS. Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices. Cardiovascular Digital Health Journal 2021, 2: 212-221. PMID: 35265911, PMCID: PMC8890038, DOI: 10.1016/j.cvdhj.2021.06.002.Peer-Reviewed Original ResearchPatient-reported outcome measuresMedian daily stepsAtrial fibrillationDaily stepsPostprocedural recoveryBariatric surgeryClinical eventsAF ablation patientsPatient-reported symptomsElectronic health record dataUsual clinical settingSignificant mean decreaseHealth record dataAntiarrhythmic drug prescriptionAblation patientsAF ablationCatheter ablationDrug prescriptionsPatient recoveryOutcome measuresPROM dataPhysical activityMean decreasePatientsRhythm assessmentCardiovascular 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 measuresPatientsMisreporting of Results of Research in Psychiatry
Bowcut J, Levi L, Livnah O, Ross JS, Knable M, Davidson M, Davis JM, Weiser M. Misreporting of Results of Research in Psychiatry. Schizophrenia Bulletin 2021, 47: 1254-1260. PMID: 33860793, PMCID: PMC8379531, DOI: 10.1093/schbul/sbab040.Peer-Reviewed Original Research
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
Age of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrialsDefining Multiple Chronic Conditions for Quality Measurement
Drye EE, Altaf FK, Lipska KJ, Spatz ES, Montague JA, Bao H, Parzynski CS, Ross JS, Bernheim SM, Krumholz HM, Lin Z. Defining Multiple Chronic Conditions for Quality Measurement. Medical Care 2018, 56: 193-201. PMID: 29271820, DOI: 10.1097/mlr.0000000000000853.Peer-Reviewed Original ResearchConceptsMultiple chronic conditionsChronic conditionsMedicare feeService beneficiariesMedicare Chronic Conditions WarehouseMCC cohortBroad cohortChronic Conditions WarehouseRisk-standardized ratesNational quality measuresUnplanned admissionsFinal cohortTotal admissionsAdmission riskAccountable care organizationsAdmission ratesOutcome measuresAdmissionCohortCohort conditionCare organizationsPatientsStakeholder inputNarrow cohortBeneficiariesVariation 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
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 journalsCharacterisation 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
2015
Differences in Colonoscopy Quality Among Facilities: Development of a Post-Colonoscopy Risk-Standardized Rate of Unplanned Hospital Visits
Ranasinghe I, Parzynski CS, Searfoss R, Montague J, Lin Z, Allen J, Vender R, Bhat K, Ross JS, Bernheim S, Krumholz HM, Drye EE. Differences in Colonoscopy Quality Among Facilities: Development of a Post-Colonoscopy Risk-Standardized Rate of Unplanned Hospital Visits. Gastroenterology 2015, 150: 103-113. PMID: 26404952, DOI: 10.1053/j.gastro.2015.09.009.Peer-Reviewed Original ResearchConceptsUnplanned hospital visitsDay of colonoscopyHospital visitsOutpatient facilitiesColonoscopy qualityHealthcare costsRisk-standardized ratesHospital outpatient departmentsUtilization Project dataAmbulatory surgery centersLogistic regression modelsHierarchical logistic regressionQuality improvement effortsPrior arrhythmiaAbdominal painElectrolyte imbalanceOutpatient departmentSurgery centersCommon causeHospital careOutcome measuresPsychiatric disordersColonoscopyUtilization ProjectPatient choice
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
2010
State-Sponsored Public Reporting Of Hospital Quality: Results Are Hard To Find And Lack Uniformity
Ross JS, Sheth S, Krumholz HM. State-Sponsored Public Reporting Of Hospital Quality: Results Are Hard To Find And Lack Uniformity. Health Affairs 2010, 29: 2317-2322. PMID: 21134936, PMCID: PMC3020979, DOI: 10.1377/hlthaff.2010.0564.Peer-Reviewed Original Research
2008
Dual Use of Veterans Affairs Services and Use of Recommended Ambulatory Care
Ross JS, Keyhani S, Keenan PS, Bernheim SM, Penrod JD, Boockvar KS, Krumholz HM, Siu AL. Dual Use of Veterans Affairs Services and Use of Recommended Ambulatory Care. Medical Care 2008, 46: 309-316. PMID: 18388846, DOI: 10.1097/mlr.0b013e31815b9db3.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAmbulatory CareBehavioral Risk Factor Surveillance SystemCross-Sectional StudiesFemaleHealth Services AccessibilityHumansMaleMiddle AgedPrimary Health CareQuality Indicators, Health CareQuality of Health CareSocioeconomic FactorsUnited StatesUnited States Department of Veterans AffairsConceptsVA usersPatient characteristicsCancer screeningDual usersVeterans Affairs Medical SystemBehavior Risk Factor Surveillance SystemRisk Factor Surveillance SystemCardiovascular risk reductionMultivariable logistic regressionProstate cancer screeningAmbulatory care servicesVeterans Affairs servicesCommunity-dwelling adultsBreast cancer screeningLow useCross-sectional analysisInfectious disease preventionHealth care systemInfluenza vaccinationCare patientsSelf-reported useUnadjusted analysesCancer preventionOutcome measuresAmbulatory care