2023
Association of Receipt of Paycheck Protection Program Loans With Staffing Patterns Among US Nursing Homes
Travers J, McGarry B, Friedman S, Holaday L, Ross J, Lopez L, Chen K. Association of Receipt of Paycheck Protection Program Loans With Staffing Patterns Among US Nursing Homes. JAMA Network Open 2023, 6: e2326122. PMID: 37498597, PMCID: PMC10375300, DOI: 10.1001/jamanetworkopen.2023.26122.Peer-Reviewed Original ResearchConceptsUS nursing homesNursing homesPaycheck Protection ProgramPPP loansMean differenceEconomic evaluationLoan programsLoan recipientsAssociation of receiptArea Deprivation IndexHealthcare Cost Report Information SystemAgriculture Rural-Urban Continuum CodesRural-Urban Continuum CodesTotal weekly hoursEvent study approachNursing Home CompareMinimum Data SetSmall Business AdministrationPaycheck Protection Program (PPP) loansMAIN OUTCOMELPN hoursPractical nursesResident careLoan amountStudy period
2022
Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles
Janda G, Khetpal V, Shi X, Ross J, Wallach J. Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles. JAMA Network Open 2022, 5: e2245847. PMID: 36484989, PMCID: PMC9856222, DOI: 10.1001/jamanetworkopen.2022.45847.Peer-Reviewed Original ResearchConceptsPrimary end pointPrimary end point resultsPeer-reviewed journalsClinical studiesEnd pointClinical trialsObservational studyStudy characteristicsEnd point resultsClinical study resultsMost clinical studiesCross-sectional studyHealth-related outcomesSample sizeMAIN OUTCOMEPeer-reviewed publicationsMedRxivEffect estimatesStudy interpretationDiscordant pairsCOVID-19TrialsHospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance
Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. JAMA Internal Medicine 2022, 182: 603-611. PMID: 35435948, PMCID: PMC9016607, DOI: 10.1001/jamainternmed.2022.1022.Peer-Reviewed Original ResearchConceptsCancer CenterCancer therapyCross-sectional studyHospital acquisition costNational Cancer InstituteCross-sectional analysisPrimary outcomeSecondary outcomesPrivate health insuranceMAIN OUTCOMEClinical careCancer InstituteMedicare Part B spendingTherapyAcquisition costsPart B spendingHospitalCancer treatmentHealth insuranceFinancial burdenB spendingPatientsSame centerOutcomesPayersSpending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial resultsApprovals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
Gupta R, Morten CJ, Zhu AY, Ramachandran R, Shah ND, Ross JS. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021. JAMA Health Forum 2022, 3: e221096. PMID: 35977259, PMCID: PMC9123500, DOI: 10.1001/jamahealthforum.2022.1096.Peer-Reviewed Original ResearchConceptsCross-sectional studyNovel drugsTherapeutic valueUS FoodDrug AdministrationWorld Health Organization Model ListGeneric approvalCapsule formMultivariable analysisAccelerated approvalClinical usefulnessMAIN OUTCOMEPrescription drugsBrand-name drugsModel ListEssential medicinesDrugsApproval statusMedicine inclusionFDANovel tabletBlockbuster statusApprovalAdministrationDrug salesAssessment 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 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
Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration
Sankar A, Swanson KM, Zhou J, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration. JAMA Network Open 2021, 4: e2136662. PMID: 34851398, PMCID: PMC8637256, DOI: 10.1001/jamanetworkopen.2021.36662.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAmbulatory CareAnti-Bacterial AgentsBronchitisCross-Sectional StudiesDrug LabelingDrug PrescriptionsFemaleFluoroquinolonesHealth Plan ImplementationHumansInterrupted Time Series AnalysisMaleMedicareMiddle AgedPractice Patterns, Physicians'SinusitisUnited StatesUnited States Food and Drug AdministrationUrinary Tract InfectionsConceptsPrescribing of fluoroquinolonesCross-sectional studyBlack box warningFDA warningCare physiciansPrescribing levelsBox warningMAIN OUTCOMEUS FoodDrug AdministrationMedicare administrative claims dataUncomplicated urinary tract infectionsNon-primary care physiciansAcute care visitsUrinary tract infectionFDA black box warningPrimary care physiciansAdministrative claims dataCase mix indexFluoroquinolone prescriptionsPrescribing trendsCare visitsPrescribing ratesTract infectionsOutpatient visitsClinician 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 ResearchConceptsDOAC 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 populationIdentification of Hospitals That Care for a High Proportion of Patients With Social Risk Factors
Matty R, Heckmann R, George E, Barthel AB, Suter LG, Ross JS, Bernheim SM. Identification of Hospitals That Care for a High Proportion of Patients With Social Risk Factors. JAMA Health Forum 2021, 2: e211323. PMID: 35977204, PMCID: PMC8796989, DOI: 10.1001/jamahealthforum.2021.1323.Peer-Reviewed Original ResearchConceptsSocial risk factorsIdentification of hospitalsProportion of patientsRisk factorsCross-sectional studyHospital performance measuresPatient populationHospital Readmissions Reduction ProgramAfrican American raceProportion of hospitalsDisadvantaged patient populationsReadmissions Reduction ProgramHigher proportionSocioeconomic status scoresSame hospitalStatus scoreCrowded householdsMAIN OUTCOMEMedicaid coverageAmerican racePatientsHospitalHealthcare ResearchDisadvantaged populationsSuch hospitalsCharacteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Zhang AD, Puthumana J, Downing NS, Shah ND, Ross JS. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2021, 4: e2113224. PMID: 34110392, PMCID: PMC8193429, DOI: 10.1001/jamanetworkopen.2021.13224.Peer-Reviewed Original ResearchConceptsPrimary efficacy end pointEfficacy end pointPivotal trialsIndication approvalsActive comparatorClinical outcomesSupplemental indicationsUS FoodEnd pointOriginal approvalTherapeutic areasPivotal efficacy trialsCross-sectional studyAdditional clinical dataDrug Administration approvalNew indication approvalsStrength of evidenceAdministration approvalMonths durationClinical dataClinical studiesEfficacy trialsMedian numberCancer indicationsMAIN OUTCOMEEvaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs
Miller JE, Mello MM, Wallach JD, Gudbranson EM, Bohlig B, Ross JS, Gross CP, Bach PB. Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA Network Open 2021, 4: e217075. PMID: 33950209, PMCID: PMC8100865, DOI: 10.1001/jamanetworkopen.2021.7075.Peer-Reviewed Original ResearchConceptsFDA approvalHigh-income countriesDrug approvalIncome countriesNovel drugsDrug Administration (FDA) drug approvalsRegulatory agency websitesCross-sectional analysisProportion of drugPrimary outcomeFDA drug approvalsProportion of countriesDrug trialsMAIN OUTCOMEUS FoodClinical researchCountry income levelLow-income countriesMarketing approvalTrialsGoogle ScholarDrugsDrug companiesApprovalMedianReporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatients
2020
Association Between Industry Payments to Physicians and Device Selection in ICD Implantation
Annapureddy AR, Henien S, Wang Y, Minges KE, Ross JS, Spatz ES, Desai NR, Peterson PN, Masoudi FA, Curtis JP. Association Between Industry Payments to Physicians and Device Selection in ICD Implantation. JAMA 2020, 324: 1755-1764. PMID: 33141208, PMCID: PMC7610190, DOI: 10.1001/jama.2020.17436.Peer-Reviewed Original ResearchConceptsCRT-D implantationCRT-D devicesCross-sectional studyNational Cardiovascular Data Registry ICD RegistryFirst-time ICDFirst-time implantationProportion of patientsEntire study cohortDevice selectionProportion of devicesICD implantationICD RegistryPrimary outcomeCardiac resynchronizationStudy cohortPatient groupMAIN OUTCOMEPatientsPhysiciansICDAbsolute differenceImplantationManufacturer CHigher total paymentsAssociationComparative 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 Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approval
2019
Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence
Bartlett VL, Dhruva SS, Shah ND, Ryan P, Ross JS. Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence. JAMA Network Open 2019, 2: e1912869. PMID: 31596493, PMCID: PMC6802419, DOI: 10.1001/jamanetworkopen.2019.12869.Peer-Reviewed Original ResearchConceptsPrimary end pointClinical trialsReal-world evidenceEnd pointElectronic health recordsEHR dataExclusion criteriaClinical trial evidenceRandomized clinical trialsHigh-impact general medical journalsReal-world populationInsurance claimsTraditional clinical trialsCross-sectional analysisSame clinical questionPercentage of trialsPrimary outcomeClinical outcomesClinical evidenceTrial evidenceTrial populationTrial inclusionObservational studyAdministrative claimsMAIN OUTCOMERates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016
Jeffery MM, Hooten WM, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Rates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016. JAMA Network Open 2019, 2: e198325. PMID: 31373650, PMCID: PMC6681551, DOI: 10.1001/jamanetworkopen.2019.8325.Peer-Reviewed Original ResearchConceptsLong-term opioid useOpioid usePrevention guidelinesMA groupDisease controlCoprescription of opioidsRetrospective cohort studyUS national databaseInsurance groupsMedicare AdvantageSickle cell diseaseGuideline releasePrescription daysPrescribed opioidsBenzodiazepine prescriptionsCohort studyMedian agePharmacy claimsChronic painCell diseaseCoprescriptionMAIN OUTCOMESame clinicianClaims dataHospice careAnalysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
Skydel JJ, Luxkaranayagam AT, Dhruva SS, Ross JS, Wallach JD. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments. JAMA Network Open 2019, 2: e193410. PMID: 31074812, PMCID: PMC6512282, DOI: 10.1001/jamanetworkopen.2019.3410.Peer-Reviewed Original ResearchConceptsPostapproval clinical trialsClinical trialsPrimary completion datePostmarketing requirementsNovel therapeuticsDrug AdministrationUS FoodNew indicationsPharmaceutical companiesNew clinical studiesCross-sectional analysisClinical outcomesStudy design elementsPatient populationUnapproved indicationsEfficacy dataClinical studiesStudy completionMAIN OUTCOMEFirst approvalMost trialsTrialsFDATherapeutic approvalsTherapeuticsAssociation of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing
Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS. Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing. JAMA Network Open 2019, 2: e191340. PMID: 30924899, PMCID: PMC6450314, DOI: 10.1001/jamanetworkopen.2019.1340.Peer-Reviewed Original ResearchConceptsMedicare Part D beneficiariesPart D beneficiariesOpioid toleranceClock opioid analgesicsMitigation strategy programAccess programOpioid prescribing trendsPercentage of prescriptionsInterrupted time series analysisREMS implementationBreakthrough painCohort studyPrescribing trendsOpioid analgesicsCancer definitionsMAIN OUTCOMECancer statusPatientsUS FoodDrug AdministrationPrescribingCancerFentanyl drugsPrescriptionMonthly decrease