2022
Emulating the GRADE trial using real world data: retrospective comparative effectiveness study
Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. The BMJ 2022, 379: e070717. PMID: 36191949, PMCID: PMC9527635, DOI: 10.1136/bmj-2022-070717.Peer-Reviewed Original ResearchConceptsSecondary outcomesMetformin monotherapyTreatment groupsRetrospective comparative effectiveness studyCox proportional hazards regressionPropensity scoreIncident microvascular complicationsNationwide claims databaseProportional hazards regressionType 2 diabetesComparative effectiveness studiesMacrovascular complicationsMicrovascular complicationsProspective trialAdverse eventsGlycemic controlHospital admissionInsulin glarginePrimary outcomeMedian timeHazards regressionClaims databaseObservational studyInverse propensity scoreEligibility criteriaAssociation Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Internal Medicine 2022, 182: 418-425. PMID: 35226058, PMCID: PMC8886450, DOI: 10.1001/jamainternmed.2022.0045.Peer-Reviewed Original ResearchConceptsComparative effectiveness research studyIndex dateProportion of patientsTSH levelsNormal TSH levelsMIU/LThyrotropin levelsLevothyroxine productsGeneric levothyroxineNational administrative claims databasePropensity-matched patient pairsBaseline TSH levelsMean TSH levelsThyroid replacement therapyAdministrative claims databaseCurrent guideline recommendationsSerum thyrotropin levelsOptumLabs Data WarehouseStandardized mean differenceLevothyroxine doseLevothyroxine prescriptionsPropensity matchingGuideline recommendationsClaims databaseReplacement therapyRates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Rates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults. Endocrine 2022, 76: 349-358. PMID: 35107758, PMCID: PMC9210352, DOI: 10.1007/s12020-022-02987-z.Peer-Reviewed Original ResearchConceptsL-thyroxineLarge administrative claims databaseMultivariate logistic regression analysisAdministrative claims databaseThyroid hormone valuesLogistic regression analysisNumber of pharmaciesSettingRetrospective studyPrescription fillsTreatment initiationGuideline recommendationsThyroid surgeryClaims databaseFill dateMean ageHormone valuesLevothyroxine preparationsMore pharmaciesPractice guidelinesAdditional studiesGeneric preparationsNational dataAmerican adultsPatientsRegression analysis
2021
Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation
Benning TJ, Shah ND, Inselman JW, Van Houten HK, Ross JS, Wyatt KD. Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation. Clinical Trials 2021, 18: 732-740. PMID: 34269090, PMCID: PMC10119689, DOI: 10.1177/17407745211030683.Peer-Reviewed Original ResearchConceptsPediatric Research Equity ActClinical trialsBest PharmaceuticalsOncology drugsDrug utilizationPediatric indicationsLabel changesPediatric-specific evidenceAdministrative claims databasePediatric Hematology/OncologyQuality of evidenceDrug labelling changesHematology/oncologyDrug utilization ratesNew pediatric indicationsLow methodological rigorClaims databaseComparator groupPediatric utilizationTrial characteristicsBACKGROUND/Pediatric useMonthly utilization ratesDrug safetyStudy designCardiovascular 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
2020
Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation
Yao X, Inselman JW, Ross JS, Izem R, Graham DJ, Martin DB, Thompson AM, Ross Southworth M, Siontis KC, Ngufor CG, Nath KA, Desai NR, Nallamothu BK, Saran R, Shah ND, Noseworthy PA. Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006515. PMID: 33012172, PMCID: PMC7580213, DOI: 10.1161/circoutcomes.120.006515.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAnticoagulantsAntithrombinsAtrial FibrillationComparative Effectiveness ResearchDabigatranDatabases, FactualFactor Xa InhibitorsFemaleGlomerular Filtration RateHemorrhageHumansKidneyMaleMiddle AgedPyrazolesPyridonesRenal Insufficiency, ChronicRetrospective StudiesRisk AssessmentRisk FactorsRivaroxabanTime FactorsTreatment OutcomeUnited StatesWarfarinConceptsGlomerular filtration rateKidney functionMajor bleedingAtrial fibrillationOral anticoagulantsLower riskFiltration rateComparative effectivenessGlomerular filtration rate categoriesUS administrative claims databaseFalsification end pointsKidney function declineReduced kidney functionProportion of patientsAdministrative claims databaseSubstantial residual confoundingBaseline characteristicsFunction declineClaims databaseComparative safetyResidual confoundingTreatment weightingSimilar riskTreatment groupsPatientsComparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels
Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Network Open 2020, 3: e2017645. PMID: 32997127, PMCID: PMC7527873, DOI: 10.1001/jamanetworkopen.2020.17645.Peer-Reviewed Original ResearchConceptsNormal thyrotropin levelsPropensity score-matched patientsThyrotropin levelsLevothyroxine prescriptionsThyrotropin valuesProportion of patientsAdministrative claims databaseMonths of initiationMIU/LMild thyroid dysfunctionLongitudinal cohort studyMedicare Advantage enrolleesNormal thyrotropin valuesEligible patientsInitial therapyLevothyroxine formulationsCohort studyThyroid dysfunctionClaims databaseGeneric levothyroxineLevothyroxineMAIN OUTCOMENormal rangePatientsNormal vs
2019
Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016
Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016. The Journal Of Clinical Endocrinology & Metabolism 2019, 104: 2305-2314. PMID: 30690529, DOI: 10.1210/jc.2018-02197.Peer-Reviewed Original ResearchConceptsBrand-name useDrug useMedicare AdvantageThyroid hormone replacement therapyLarge administrative claims databaseBeneficiary populationAdministrative claims databaseHormone replacement therapyCertain patient characteristicsMedicare Part DPrescriber specialtyPatient characteristicsPrescriber characteristicsClaims databaseReplacement therapyGeneric levothyroxineWhite raceHealth plansOlder adultsHormone drugsInsurance coverageProduct useLevothyroxineNational dataPart D
2015
HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study
McCoy RG, Van Houten HK, Ross JS, Montori VM, Shah ND. HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study. The BMJ 2015, 351: h6138. PMID: 26646052, PMCID: PMC4673101, DOI: 10.1136/bmj.h6138.Peer-Reviewed Original ResearchConceptsType 2 diabetesGlycemic controlControlled type 2 diabetesNational administrative claims databaseExcessive testingAdministrative claims databaseGood glycemic controlStable glycemic controlStudy patientsTreatment intensificationSevere hypoglycemiaTreatment regimenStudy cohortUS patientsClaims databasePotential overtreatmentUS cohortHypoglycemic drugsInsulin treatmentPatient burdenRetrospective analysisStudy populationUS adultsDiabetes managementObservational population
2014
Association of Physician Specialty and Medical Therapy for Benign Prostatic Hyperplasia
Han LC, Kim SP, Gross CP, Ross JS, Van Houten HK, Smaldone MC, Krambeck AE, Shah ND. Association of Physician Specialty and Medical Therapy for Benign Prostatic Hyperplasia. Medical Care 2014, 52: 128-136. PMID: 24423810, DOI: 10.1097/mlr.0000000000000078.Peer-Reviewed Original ResearchConceptsIncident benign prostatic hyperplasiaBenign prostatic hyperplasiaPrimary care providersMedical therapyProstatic hyperplasiaPhysician specialtyNew agentsRespective drug classesAdministrative claims databaseLittle available evidenceRetrospective cohortMedical managementClaims databaseMonths postdiagnosisInsured patientsDrug classesCare providersBlockersReductase inhibitorsPatientsExisting agentsAvailable evidenceUrologistsOverall useHyperplasia