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-third
2022
In 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 preferencesPatients
2021
Implementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original Research
2020
Vibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk
Chu L, Ioannidis JPA, Egilman AC, Vasiliou V, Ross JS, Wallach JD. Vibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk. International Journal Of Epidemiology 2020, 49: 608-618. PMID: 31967637, PMCID: PMC7266551, DOI: 10.1093/ije/dyz271.Peer-Reviewed Original ResearchConceptsObservational studyRelative effect estimatesImpact of alcoholEffect estimatesExposure definitionAlcohol-breast cancer relationshipDifferent exposure definitionsBreast cancer riskVibration of effectsRelative risk estimatesMost observational studiesAdjustment covariatesCancer relationshipEligible studiesBreast cancerStudy populationEpidemiologic studiesCancer riskSmaller effect estimatesAlcohol consumptionRisk estimatesContrast levelsSame associationStability of findingsOne-third
2017
US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologicClinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014. Otolaryngology 2017, 156: 285-288. PMID: 28093943, DOI: 10.1177/0194599816684094.Peer-Reviewed Original ResearchConceptsPostapproval studiesPivotal studiesUS FoodPrimary effectiveness end pointAvailable FDA documentsEffectiveness end pointPivotal clinical studiesBenefit-risk assessmentCross-sectional analysisPremarket evidenceMedian durationClinical evidenceDrug Administration premarket approvalsOtolaryngologic diseaseMedian enrollmentClinical studiesHigh-risk medical devicesDrug AdministrationEnd pointHigh-risk devicesFDA documentsOne-thirdTwo-thirdsPremarket approvalFDA