2023
Association of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies
Wallach J, Gautam A, Ramachandran R, Ross J. Association of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies. The BMJ 2023, 383: e077166. PMID: 38123175, DOI: 10.1136/bmj-2023-077166.Peer-Reviewed Original ResearchGeographic 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 ResearchPain Management in Older Adults Before and During the First Year of COVID-19 Pandemic: Prevalence, Trends, and Correlates
Manhapra A, Fortinsky R, Berg K, Ross J, Rhee T. Pain Management in Older Adults Before and During the First Year of COVID-19 Pandemic: Prevalence, Trends, and Correlates. The Journals Of Gerontology Series A 2023, 78: 1627-1640. PMID: 37096328, PMCID: PMC10460550, DOI: 10.1093/gerona/glad115.Peer-Reviewed Original ResearchConceptsHigh-impact chronic painChronic painPain managementOlder adultsCoronavirus diseasePain treatmentNational Health Interview SurveyNonpharmacological pain treatmentsUtilization of opioidsHealth Interview SurveyUS older adultsFirst yearOpioid useNonpharmacological treatmentsNonpharmacological interventionsTreatment utilizationLong-term effectsPainU.S. adultsPrevalenceInterview SurveyDiseaseAdultsCOVID-19 pandemicTreatment
2021
Outcomes-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 Research
2020
Evaluation of confounding in epidemiologic studies assessing alcohol consumption on the risk of ischemic heart disease
Wallach JD, Serghiou S, Chu L, Egilman AC, Vasiliou V, Ross JS, Ioannidis JPA. Evaluation of confounding in epidemiologic studies assessing alcohol consumption on the risk of ischemic heart disease. BMC Medical Research Methodology 2020, 20: 64. PMID: 32171256, PMCID: PMC7071725, DOI: 10.1186/s12874-020-0914-6.Peer-Reviewed Original ResearchConceptsIschemic heart disease riskHeart disease riskObservational studyImpact of alcoholPotential confoundersHeart diseaseDisease riskMultivariate modelIschemic heart diseaseResidual confoundingDisease relationshipsEpidemiologic studiesAlcohol consumptionConfoundersMultivariate analysisLack of consensusIndividual studiesStratification variablesDiseaseRiskSame exposureConfoundingDifferent studiesStudy findingsDifferent investigators
2018
The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data
Wilcox MA, Savitz AJ, Addington AM, Gray GS, Guinan EC, Jackson JW, Lehner T, Normand SL, Ranu H, Senthil G, Spertus J, Valeri L, Ross JS. The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data. Schizophrenia 2018, 4: 14. PMID: 29950580, PMCID: PMC6021398, DOI: 10.1038/s41537-018-0055-7.Commentaries, Editorials and LettersClinical trialsOverall public health burdenSchizophrenia ProjectPublic health burdenClinical trial dataReal-world studyTranslational scienceHarvard CatalystHealth burdenTherapeutic safetyTrial dataBrain diseasesBiology of diseaseGold standardBest treatmentPharmaceutical safetyDisease etiologyTrialsDiseaseEfficacyProject investigatorsSafetyEtiologySchizophreniaAvailability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonthsComparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDiseaseAffordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. The BMJ 2018, 360: k831. PMID: 29555641, PMCID: PMC5858606, DOI: 10.1136/bmj.k831.Peer-Reviewed Original ResearchConceptsOff-patent drugsObservational studyRare diseasePrescription drugsPatent drugsStudy drugTotal Medicaid spendingCardiovascular diseaseOrphan drug designationPsychiatric diseasesDrug AdministrationPatient accessInfectious diseasesDiseaseDrug characteristicsEssential medicinesDrugsGeneric versionsGeneric drugsMedicaid spendingNovel tabletRegulatory agenciesFDAUnited StatesTreatment area
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewersPostapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkersAssessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open 2017, 7: e014582. PMID: 28179418, PMCID: PMC5306516, DOI: 10.1136/bmjopen-2016-014582.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyCohort studyClinical impactRare diseaseHealth CanadaNew therapeuticsLikely clinical impactPotential clinical impactUS patientsAvailable therapiesNovel mechanismDrug AdministrationMedicines AgencyNovel therapeuticsUS approvalNew drugsDrugsFDA submissionsReview outcomesTherapeuticsSafety concernsDiseaseFDAMechanistic noveltyAffected population
2015
Older Women With Localized Breast Cancer: Costs And Survival Rates Increased Across Two Time Periods
Feinstein AJ, Long J, Soulos PR, Ma X, Herrin J, Frick KD, Chagpar AB, Krumholz HM, Yu JB, Ross JS, Gross CP. Older Women With Localized Breast Cancer: Costs And Survival Rates Increased Across Two Time Periods. Health Affairs 2015, 34: 592-600. PMID: 25847641, DOI: 10.1377/hlthaff.2014.1119.Peer-Reviewed Original ResearchConceptsStage II diseaseStage III diseaseCancer-related costsCancer careBreast cancerMedian costSurvival rateEnd Results Program-MedicareFive-year survivalCancer care costsBreast surgerySurvival outcomesImproved outcomesOlder womenRadiation therapyCare costsStage IIDiseaseStudy periodWomenCancerCareSignificant national attentionOutcomesPercent
2012
Association of Chronic Diseases and Impairments With Disability in Older Adults
Hung WW, Ross JS, Boockvar KS, Siu AL. Association of Chronic Diseases and Impairments With Disability in Older Adults. Medical Care 2012, 50: 501-507. PMID: 22584885, PMCID: PMC3353149, DOI: 10.1097/mlr.0b013e318245a0e0.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingAgedAgingCardiovascular DiseasesChronic DiseaseCognition DisordersCross-Sectional StudiesDiabetes MellitusDisabled PersonsFemaleHealth SurveysHearing LossHumansHypertensionMaleMobility LimitationResidence CharacteristicsRespiratory Tract DiseasesSelf CareSocioeconomic FactorsUnited StatesVision DisordersConceptsSelf-care disabilityChronic diseasesLung diseaseOlder adultsSelf-care ADLChronic lung diseaseCommunity-dwelling adultsCross-sectional analysisADL disabilityHeart failureHeart diseaseDaily livingHypertensionDiseaseDiabetesImpairmentDisabilityAdultsRetirement StudySpecific disabilitiesAssociationArthritisStrokeCancerADL
2011
US Cardiologist Workforce From 1995 To 2007: Modest Growth, Lasting Geographic Maldistribution Especially In Rural Areas
Aneja S, Ross JS, Wang Y, Matsumoto M, Rodgers GP, Bernheim SM, Rathore SS, Krumholz HM. US Cardiologist Workforce From 1995 To 2007: Modest Growth, Lasting Geographic Maldistribution Especially In Rural Areas. Health Affairs 2011, 30: 2301-2309. PMID: 22147857, PMCID: PMC3332098, DOI: 10.1377/hlthaff.2011.0255.Peer-Reviewed Original ResearchConceptsPrimary care physiciansCare physiciansGeographic maldistributionChronic cardiovascular diseaseHospital referral regionsUse of telemedicineCardiology workforceNumber of cardiologistsTotal physician workforceCardiovascular diseaseCardiovascular careReferral regionsElderly populationUS populationTotal physiciansCardiologistsPhysiciansAge sixtyPhysician workforceDisadvantaged areasPercentRural areasPopulationDiseaseVariety of strategiesRecent trends in chronic disease, impairment and disability among older adults in the United States
Hung WW, Ross JS, Boockvar KS, Siu AL. Recent trends in chronic disease, impairment and disability among older adults in the United States. BMC Geriatrics 2011, 11: 47. PMID: 21851629, PMCID: PMC3170191, DOI: 10.1186/1471-2318-11-47.Peer-Reviewed Original ResearchConceptsPrevalence of impairmentChronic diseasesOlder adultsDaily livingChronic lung diseaseMore chronic diseasesImpairment of cognitionPrevalence of disabilityOlder U.S. adultsProportion of respondentsIADL disabilityUrinary incontinenceLung diseaseHeart diseasePrevalence trendsInstrumental activitiesU.S. adultsDiseasePrevalenceImpairmentAdultsDisabilityMore diseasesRetirement StudyUnited States