2024
Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022
Swanson M, Uyeki C, Yoder S, Dhruva S, Miller J, Ross J. Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022. Medical Devices Evidence And Research 2024, 17: 165-172. PMID: 38707869, PMCID: PMC11067925, DOI: 10.2147/mder.s457152.Peer-Reviewed Original ResearchFood and Drug AdministrationHigh-risk cardiovascular devicesSubgroup analysisPremarketing studiesUS Food and Drug AdministrationResults of subgroup analysisParticipation of older adultsStudy participantsClinical trialsSocioeconomic positionTrial populationDrug AdministrationStudy populationConduction of subgroup analysisDemographic dataOlder adultsReporting of demographicsSubgroupsPatients' socioeconomic position.PatientsTrials
2023
Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies
Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.Peer-Reviewed Original ResearchA 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 needSymptomsCliniciansSettingBiomarkersTherapeutic 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 subsetProportionPhysiciansMetrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study
Varma T, Mello M, Ross J, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Medicine 2023, 2: e000395. PMID: 36936269, PMCID: PMC9951369, DOI: 10.1136/bmjmed-2022-000395.Peer-Reviewed Original ResearchRetrospective cross-sectional studyCross-sectional studyPivotal trialsOlder adultsSectional studyNovel oncology therapeuticsUS cancer populationUS Cancer StatisticsUS patient populationAmerican Cancer SocietyPatient populationCancer populationOncology therapeuticsCancer SocietyCancer statisticsNovel cancer therapeuticsOncology trialsBaseline scoresPatientsUS FoodDrug AdministrationTrial dataStudy participantsTrialsEthics Committee
2022
PreScription DigitaL ThErapEutic For Patients with Insomnia (SLEEP-I): A Protocol for a Pragmatic Randomized Controlled Trial
Dreyer R, Berkowitz A, Yaggi H, Schneeberg L, Shah N, Emanuel L, Prakash K, Jeffery M, Thorndike F, Deeg M, Ervin K, Ross J. PreScription DigitaL ThErapEutic For Patients with Insomnia (SLEEP-I): A Protocol for a Pragmatic Randomized Controlled Trial. Sleep Medicine 2022, 100: s133-s134. DOI: 10.1016/j.sleep.2022.05.365.Peer-Reviewed Original ResearchAnalysis of Patient-Focused Information About Left Atrial Appendage Occlusion on US Hospital Web Pages
Dhruva SS, Ji RZ, Ross JS, Spatz ES, Redberg RF. Analysis of Patient-Focused Information About Left Atrial Appendage Occlusion on US Hospital Web Pages. JAMA Internal Medicine 2022, 182: 1226-1229. PMID: 36190724, PMCID: PMC9531069, DOI: 10.1001/jamainternmed.2022.4287.Peer-Reviewed Original ResearchHospital-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 centerOutcomesPayersIn Medicaid Managed Care Networks, Care Is Highly Concentrated Among A Small Percentage Of Physicians
Ludomirsky AB, Schpero WL, Wallace J, Lollo A, Bernheim S, Ross JS, Ndumele CD. In Medicaid Managed Care Networks, Care Is Highly Concentrated Among A Small Percentage Of Physicians. Health Affairs 2022, 41: 760-768. PMID: 35500192, DOI: 10.1377/hlthaff.2021.01747.Peer-Reviewed Original ResearchConceptsCare plansPercent of specialistsOutpatient primary carePrimary care physiciansManaged Care NetworkCare physiciansPrimary careMedicaid patientsMedicaid beneficiariesPhysicians' willingnessSpecialist physiciansPhysiciansCare networkMedicaid ServicesCareMedicaid participationOne-thirdNetwork adequacy standardsSmall percentagePercentBeneficiary preferencesPatientsAccess to High-Volume Hospitals for High-Risk Cancer Surgery for Racial and Ethnic Minoritized Groups
Salazar MC, Canavan ME, Holaday LW, Billingsley KG, Ross J, Boffa DJ, Gross CP. Access to High-Volume Hospitals for High-Risk Cancer Surgery for Racial and Ethnic Minoritized Groups. JNCI Cancer Spectrum 2022, 6: pkac024. PMID: 35603855, PMCID: PMC8997114, DOI: 10.1093/jncics/pkac024.Peer-Reviewed Original ResearchConceptsHigh-risk cancer surgeryHigh-volume hospitalsCancer surgeryHispanic patientsNational Cancer DatabaseNon-Hispanic patientsNon-black patientsLung resectionBlack patientsCancer DatabaseBetter outcomesPatientsSurgeryHospitalPancreatectomyLow probabilityInequitable accessEsophagectomyProctectomyResectionRates 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 analysisAssociation 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
Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center
Dhruva SS, Jiang G, Doshi AA, Friedman DJ, Brandt E, Chen J, Akar JG, Ross JS, Ervin KR, Farr K, Shah ND, Coplan P, Noseworthy PA, Zhang S, Forsyth T, Schulz WL, Yu Y, Drozda JP. Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center. BMJ Surgery Interventions & Health Technologies 2021, 3: e000089. PMID: 35047806, PMCID: PMC8749235, DOI: 10.1136/bmjsit-2021-000089.Peer-Reviewed Original ResearchPositive predictive valuePersistent atrial fibrillationIschemic ventricular tachycardiaAblation catheterHealth systemAtrial fibrillationVentricular tachycardiaCardiac ablation catheterAcute heart failureDuration of patientsHealth system dataCardiac tamponadeIschemic strokeRetrospective cohortHeart failureClinical outcomesEndpoint ascertainmentPredictive valueCatheterChart validationCoordinating CenterTachycardiaPatientsFibrillationParticipant populationOutcomes-Driven Clinical Phenotyping in Cardiogenic Shock using a Mixture of Experts
Hurley N, Berkowitz A, Masoudi F, Ross J, Desai N, Shah N, Dhruva S, Mortazavi B. Outcomes-Driven Clinical Phenotyping in Cardiogenic Shock using a Mixture of Experts. 2021, 00: 1-4. DOI: 10.1109/bhi50953.2021.9508568.Peer-Reviewed Original ResearchImpact of SGLT2 inhibitors in comparison with DPP4 inhibitors on ascites and death in veterans with cirrhosis on metformin
Saffo S, Kaplan DE, Mahmud N, Serper M, John BV, Ross JS, Taddei T. Impact of SGLT2 inhibitors in comparison with DPP4 inhibitors on ascites and death in veterans with cirrhosis on metformin. Diabetes Obesity And Metabolism 2021, 23: 2402-2408. PMID: 34227216, PMCID: PMC8429193, DOI: 10.1111/dom.14488.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsDipeptidyl peptidase-4 inhibitorsPeptidase-4 inhibitorsDiabetes mellitusLiver diseaseNon-alcoholic fatty liver diseaseCotransporter 2 inhibitorsChronic liver diseaseFatty liver diseaseVeterans Affairs hospitalIncidence of ascitesAdditional pharmacotherapyTreat analysisElectronic health dataSGLT2 inhibitorsSGLT2i usersSurrogate biomarkerDPP4 inhibitorsMetabolic effectsPatientsCirrhosisPropensity scoreAscitesConfirmatory studiesMetforminPhysical 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 assessmentIdentification 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 hospitalsCardiovascular 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 measuresPatientsReporting 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 samplePatientsTo Expand the Evidence Base About Harms from Tests and Treatments
Korenstein D, Harris R, Elshaug AG, Ross JS, Morgan DJ, Cooper RJ, Cho HJ, Segal JB. To Expand the Evidence Base About Harms from Tests and Treatments. Journal Of General Internal Medicine 2021, 36: 2105-2110. PMID: 33479928, PMCID: PMC8298733, DOI: 10.1007/s11606-021-06597-9.Commentaries, Editorials and LettersReporting of harmsAssessment of harmsCare cascadeComorbid illnessesRange of severityTreatment burdenSocial determinantsHealthcare interventionsPatientsEvidence basePsychological distressPhysical impairmentPotential harmTreatmentRigorous evidenceHarmDomains of harmFinancial impactPsychological stateIllnessCliniciansImpairmentSeverityDisruptionDemographics