2024
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug Administration
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 Research
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-19TrialsEmulating 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 criteriaAgreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study
Moneer O, Daly G, Skydel JJ, Nyhan K, Lurie P, Ross JS, Wallach JD. Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study. The BMJ 2022, 377: e069400. PMID: 35537738, PMCID: PMC9086409, DOI: 10.1136/bmj-2021-069400.Peer-Reviewed Original ResearchConceptsCOVID-19 treatmentObservational studyMeta-epidemiological studyEfficacy outcomesLopinavir-ritonavirLiving reviewTreatment effectsCOVID-19 treatment guidelinesSame interventionCOVID-19Continuous outcomesMeta-analyze evidenceTrial sequential analysisSummary treatment effectsDistribution of sexTreatment guidelinesIndividual RCTsSelection of studiesEvidence DatabasePlacebo comparatorClinical dataStudy demographicsRCTsDichotomous outcomesTherapeutic interventions
2020
Patterns of Opioid Prescribing among Medicare Advantage Beneficiaries with Pain and Cardiopulmonary Conditions
Feder SL, Canavan ME, Wang S, Kent EE, Kapo J, Presley CJ, Ross J, Davidoff AJ. Patterns of Opioid Prescribing among Medicare Advantage Beneficiaries with Pain and Cardiopulmonary Conditions. Journal Of Palliative Medicine 2020, 24: 195-204. PMID: 32673139, PMCID: PMC7840305, DOI: 10.1089/jpm.2020.0193.Peer-Reviewed Original ResearchConceptsCardiopulmonary conditionsOpioid useMedicare Part D prescription claimsPatterns of opioidSevere pain interferenceUse of opioidsInitiation of opioidsMedicare Advantage beneficiariesNon-Hispanic blacksSelf-reported historyNon-Hispanic whitesOpioid prescribingSevere painNoncancer conditionsPain assessmentPain interferencePrescription claimsAdjusted proportionObservational studyPainPatientsOpioidsLogistic regressionOne-yearCancerEvaluation 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 investigatorsVibration 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
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 OUTCOMEAdverse Effects of Pharmacologic Treatments of Major Depression in Older Adults
Sobieraj DM, Martinez BK, Hernandez AV, Coleman CI, Ross JS, Berg KM, Steffens DC, Baker WL. Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults. Journal Of The American Geriatrics Society 2019, 67: 1571-1581. PMID: 31140587, DOI: 10.1111/jgs.15966.Peer-Reviewed Original ResearchConceptsSerotonin-norepinephrine reuptake inhibitorsSelective serotonin reuptake inhibitorsMajor depressive disorderOverall adverse eventsAdverse eventsYears of ageStudy withdrawalAcute phaseReuptake inhibitorsObservational studyAdverse effectsChoice of antidepressantSerious adverse eventsAcute treatment phaseNorepinephrine reuptake inhibitorsSerotonin reuptake inhibitorsSpecific adverse eventsComparative long-term studiesNonpharmacologic therapiesContinuation treatmentPatients 65Pharmacologic treatmentQTc prolongationMore fallsOutpatient setting
2018
Disparities in the Use of Programmed Death 1 Immune Checkpoint Inhibitors
O'Connor JM, Seidl‐Rathkopf K, Torres AZ, You P, Carson KR, Ross JS, Gross CP. Disparities in the Use of Programmed Death 1 Immune Checkpoint Inhibitors. The Oncologist 2018, 23: 1388-1390. PMID: 30012876, PMCID: PMC6291337, DOI: 10.1634/theoncologist.2017-0673.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAnti-PD1 agentsAnti-PD1 treatmentImmune checkpoint inhibitorsCheckpoint inhibitorsDeath-1 immune checkpoint inhibitorPrior anticancer therapyDeath protein 1Cell lung cancerCommunity-based cohortAdvanced-stage cancerRenal cell carcinomaSex-based disparitiesSystemic treatmentCell carcinomaLung cancerMultivariable modelObservational studyHigher oddsStage cancerRace-based disparitiesPatient careAnticancer therapyProtein 1PatientsAffordability 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
2012
Comparison of hospital risk-standardized mortality rates calculated by using in-hospital and 30-day models: an observational study with implications for hospital profiling.
Drye EE, Normand SL, Wang Y, Ross JS, Schreiner GC, Han L, Rapp M, Krumholz HM. Comparison of hospital risk-standardized mortality rates calculated by using in-hospital and 30-day models: an observational study with implications for hospital profiling. Annals Of Internal Medicine 2012, 156: 19-26. PMID: 22213491, PMCID: PMC3319769, DOI: 10.7326/0003-4819-156-1-201201030-00004.Peer-Reviewed Original ResearchConceptsRisk-standardized mortality ratesAcute myocardial infarctionHospital risk-standardized mortality ratesHospital mortality measuresHeart failureMortality rateObservational studyNonfederal acute care hospitalsMortality measuresAcute care hospitalsMean LOSPrimary outcomeStandardized followCare hospitalBlood InstituteService patientsMyocardial infarctionNational HeartPatient LOSMedicare feePneumoniaHospitalAdmissionHospital qualityHospital profiling
2010
Trends in Length of Stay and Short-term Outcomes Among Medicare Patients Hospitalized for Heart Failure, 1993-2006
Bueno H, Ross JS, Wang Y, Chen J, Vidán MT, Normand SL, Curtis JP, Drye EE, Lichtman JH, Keenan PS, Kosiborod M, Krumholz HM. Trends in Length of Stay and Short-term Outcomes Among Medicare Patients Hospitalized for Heart Failure, 1993-2006. JAMA 2010, 303: 2141-2147. PMID: 20516414, PMCID: PMC3020983, DOI: 10.1001/jama.2010.748.Peer-Reviewed Original ResearchConceptsLength of stayShort-term outcomesHeart failureReadmission ratesHospital mortalityDischarge dispositionRisk ratioThirty-day readmission ratesMortality risk ratioSkilled nursing facilitiesHome care servicesHospital stayOlder patientsUnadjusted analysesMedicare patientsObservational studyMedicare feeNursing facilitiesPatientsStayCare servicesMortalityMarked reductionMean lengthOutcomes
2009
Reduction in Acute Myocardial Infarction Mortality in the United States: Risk-Standardized Mortality Rates From 1995-2006
Krumholz HM, Wang Y, Chen J, Drye EE, Spertus JA, Ross JS, Curtis JP, Nallamothu BK, Lichtman JH, Havranek EP, Masoudi FA, Radford MJ, Han LF, Rapp MT, Straube BM, Normand SL. Reduction in Acute Myocardial Infarction Mortality in the United States: Risk-Standardized Mortality Rates From 1995-2006. JAMA 2009, 302: 767-773. PMID: 19690309, PMCID: PMC3349070, DOI: 10.1001/jama.2009.1178.Peer-Reviewed Original ResearchConceptsRisk-standardized mortality ratesAcute myocardial infarctionShort-term mortality rateMortality rateHospital variationNonfederal acute care hospitalsAcute myocardial infarction mortalityHospital mortality rateDay of admissionRisk standardized mortality ratesAcute care hospitalsMyocardial infarction mortalityHealth care professionalsIndex hospitalizationCare hospitalMyocardial infarctionNational averagePatient levelMedicare patientsObservational studyMedical adviceHospital varianceMAIN OUTCOMECare professionalsPatients