2023
Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity
Kumar A, Ross J, Patel N, Rathi V, Redberg R, Dhruva S. Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity. Health Affairs 2023, 42: 1559-1567. PMID: 37931187, DOI: 10.1377/hlthaff.2023.00384.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticDigital therapeuticsClinical studiesRetrospective cross-sectional analysisCross-sectional analysisStrong evidence baseHalf of studiesUpper age limitPremarket studiesDrug AdministrationClinician's prescriptionClinical useClinical researchEvidence baseTherapeuticsOne-thirdTherapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Vokinger K, Glaus C, Kesselheim A, Serra-Burriel M, Ross J, Hwang T. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study. The BMJ 2023, 382: e074166. PMID: 37407074, PMCID: PMC10320829, DOI: 10.1136/bmj-2022-074166.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysiciansTrends in the Use of Gabapentinoids and Opioids in the Postoperative Period Among Older Adults
Bongiovanni T, Gan S, Finlayson E, Ross J, Harrison J, Boscardin W, Steinman M. Trends in the Use of Gabapentinoids and Opioids in the Postoperative Period Among Older Adults. JAMA Network Open 2023, 6: e2318626. PMID: 37326989, PMCID: PMC10276300, DOI: 10.1001/jamanetworkopen.2023.18626.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalgesics, OpioidCross-Sectional StudiesDrug PrescriptionsFemaleHumansMaleMedicarePainPractice Patterns, Physicians'Retrospective StudiesUnited StatesConceptsPostoperative periodCross-sectional studyGabapentinoid prescribingSurgical proceduresConcomitant prescribingGabapentinoid prescriptionOlder adultsPostoperative prescribingProcedure typeSerial cross-sectional studyPatients 66 yearsUse of gabapentinoidsProportion of patientsTotal study cohortAdverse drug eventsCommon surgical procedureConcurrent prescribingMultimodal painPostoperative opioidsOpioid prescribingOpioid usePain SocietyStudy cohortMean ageDrug events
2022
Artificial Intelligence in Breast Cancer Screening
Potnis K, Ross J, Aneja S, Gross C, Richman I. Artificial Intelligence in Breast Cancer Screening. JAMA Internal Medicine 2022, 182: 1306-1312. PMID: 36342705, PMCID: PMC10623674, DOI: 10.1001/jamainternmed.2022.4969.Peer-Reviewed Original ResearchEmulating 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 criteriaProlonged use of newly prescribed gabapentin after surgery
Bongiovanni T, Gan S, Finlayson E, Ross J, Harrison JD, Boscardin J, Steinman MA. Prolonged use of newly prescribed gabapentin after surgery. Journal Of The American Geriatrics Society 2022, 70: 3560-3569. PMID: 36000860, PMCID: PMC9771946, DOI: 10.1111/jgs.18005.Peer-Reviewed Original ResearchConceptsUse of gabapentinProlonged useOpioid useNon-opioid pain medicationsHigher Charlson comorbidity scoreOlder adultsPostoperative opioid prescribingProlonged opioid useCharlson comorbidity scoreLength of stayAdverse drug eventsTotal hip replacementLogistic regression modelsGabapentinoid useMore comorbiditiesComorbidity scoreGabapentin useOpioid prescribingOpioid prescriptionsDischarge dispositionEmergency surgeryPain medicationPatient characteristicsPrimary outcomeMultivariable analysisSafety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
Dhruva SS, Zhang S, Chen J, Noseworthy PA, Doshi AA, Agboola KM, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin KR, Ross JS, Coplan PM, Drozda JP. Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice. JAMA Network Open 2022, 5: e2227134. PMID: 35976649, PMCID: PMC9386540, DOI: 10.1001/jamanetworkopen.2022.27134.Peer-Reviewed Original ResearchMeSH KeywordsAgedAtrial FibrillationCatheter AblationCathetersCohort StudiesFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeConceptsPersistent AF ablationRoutine clinical practiceMercy HealthAF ablationMayo ClinicSafety outcomesClinical practiceCatheter groupCohort studyCatheter ablationPersistent AFParoxysmal atrial fibrillation ablationThermocool SmartTouch catheterComposite of deathPrimary safety outcomeAtrial fibrillation ablationPersistent atrial fibrillationElectronic health record dataHealth system dataHealth record dataHealth care systemSmartTouch catheterThromboembolic eventsFibrillation ablationProcedural complicationsAssociation 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 ResearchMeSH KeywordsAdultAgedDrug SubstitutionDrugs, GenericFemaleHormone Replacement TherapyHumansMaleMiddle AgedPregnancyRetrospective StudiesThyrotropinThyroxineConceptsComparative 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 ResearchMeSH KeywordsAdultAgedDrugs, GenericFemaleHumansMaleMedicareMiddle AgedRetrospective StudiesThyroid HormonesThyroxineUnited StatesConceptsL-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 analysisAssessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019
Zhou T, Liu P, Dhruva SS, Shah ND, Ramachandran R, Berg KM, Ross JS. Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019. JAMA Internal Medicine 2022, 182: 185-195. PMID: 34982097, PMCID: PMC8728660, DOI: 10.1001/jamainternmed.2021.7457.Peer-Reviewed Original ResearchMeSH KeywordsAgedAtrial FibrillationChronic DiseaseCross-Sectional StudiesDiabetes Mellitus, Type 2Drug CostsHealth ExpendituresHeart FailureHumansHypercholesterolemiaHypertensionMedicare Part CMedicare Part DMultiple Chronic ConditionsOsteoarthritisOsteoporosisPrescription DrugsPulmonary Disease, Chronic ObstructiveRetrospective StudiesUnited StatesConceptsCommon chronic diseasesGuideline-recommended medicationsGuideline-recommended managementPrescription drug plansCross-sectional studyChronic conditionsChronic diseasesPocket costsOlder adultsOutpatient medicationsMedicare prescription drug plansInitial treatmentMedicare Advantage plansRetrospective cross-sectional studyMultiple chronic conditionsMedicare Part D plansPart D plansSubstantial financial burdenAtrial fibrillationMAIN OUTCOMEExclusion criteriaMedicare beneficiariesAnnual outHypothetical patientsMedicationsAssociation Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology
Duarte-García A, Crowson CS, McCoy RG, Herrin J, Lam V, Putman MS, Ross JS, Matteson EL, Shah ND. Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology. Mayo Clinic Proceedings 2022, 97: 250-260. PMID: 35120693, PMCID: PMC9013005, DOI: 10.1016/j.mayocp.2021.08.026.Peer-Reviewed Original ResearchAssociation of Psychiatric Diagnoses and Medicaid Coverage with Length of Stay Among Inpatients Discharged to Skilled Nursing Facilities
Bartlett VL, Ross JS, Balasuriya L, Rhee TG. Association of Psychiatric Diagnoses and Medicaid Coverage with Length of Stay Among Inpatients Discharged to Skilled Nursing Facilities. Journal Of General Internal Medicine 2022, 37: 3070-3079. PMID: 35048298, PMCID: PMC9485316, DOI: 10.1007/s11606-021-07320-4.Peer-Reviewed Original ResearchConceptsSkilled nursing facilitiesLength of staySubstance use diagnosesPsychiatric diagnosisHospital stayDischarge diagnosisPrimary payorUse diagnosesNursing facilitiesMedicaid coverageRetrospective cross-sectional study designPrimary discharge diagnosisCross-sectional study designNational Inpatient SampleDiagnosis-related groupsMultivariable adjustmentGeometric mean lengthMedian lengthInpatient hospitalizationInpatient SampleMedicaid patientsMedicare patientsInpatient dischargesMAIN OUTCOMEPatients
2021
Clinician Trends in Prescribing Direct Oral Anticoagulants for US Medicare Beneficiaries
Wheelock KM, Ross JS, Murugiah K, Lin Z, Krumholz HM, Khera R. Clinician Trends in Prescribing Direct Oral Anticoagulants for US Medicare Beneficiaries. JAMA Network Open 2021, 4: e2137288. PMID: 34870678, PMCID: PMC8649845, DOI: 10.1001/jamanetworkopen.2021.37288.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAtrial FibrillationFactor Xa InhibitorsHumansMedicarePractice Patterns, Physicians'Retrospective StudiesTime FactorsUnited StatesWarfarinConceptsDOAC useAnticoagulant prescriptionOral anticoagulantsUS cliniciansMedicare beneficiariesNational clinical practice guidelinesElevated bleeding riskOral anticoagulant prescriptionsRetrospective cohort studyDirect oral anticoagulantsClinical practice guidelinesUS Medicare beneficiariesInternal medicine physiciansNumber of cliniciansAnticoagulant prescribingDOAC prescriptionsUnique cliniciansBleeding riskCohort studyAnticoagulant strategiesPrescription claimsPractice guidelinesMAIN OUTCOMEMost indicationsMedicare populationCardiovascular 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 ResearchMeSH KeywordsAgedDrugs, GenericFemaleHumansLongitudinal StudiesRetrospective StudiesThyroid HormonesThyroxineConceptsCongestive 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 measuresPatientsUS Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. The BMJ 2020, 371: m3434. PMID: 33028575, PMCID: PMC7537471, DOI: 10.1136/bmj.m3434.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyTherapeutic valueHigh therapeutic valueNew drugsCohort studyLow therapeutic valueEMA approvalUS FoodDrug AdministrationMedicines AgencyFDA approvalDrugsFDARegulatory approvalApproval programsNew medicinesAssociationGreater proportionApprovalProportionAdministrationComparative 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 vsAssessment of Health Status and Barriers to Employment Among Medicaid Beneficiaries Not Meeting Work Requirements After Accounting for State Medical Frailty Exemptions
Silvestri DM, Gluck AR, Ross JS. Assessment of Health Status and Barriers to Employment Among Medicaid Beneficiaries Not Meeting Work Requirements After Accounting for State Medical Frailty Exemptions. JAMA Internal Medicine 2020, 180: 1008-1010. PMID: 32364563, PMCID: PMC7199172, DOI: 10.1001/jamainternmed.2020.1039.Peer-Reviewed Original ResearchProstaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017
Bartlett VL, Liu P, Dhruva SS, Shah ND, Bollinger KE, Ross JS. Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017. Journal Of Managed Care & Specialty Pharmacy 2020, 26: 10.18553/jmcp.2020.26.4.562. PMID: 32223594, PMCID: PMC10391193, DOI: 10.18553/jmcp.2020.26.4.562.Peer-Reviewed Original Research