2023
Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov
Rivero-de-Aguilar A, Pérez-Ríos M, Ruano-Raviña A, Candal-Pedreira C, Puente-Hernandez M, Ross J, Varela-Lema L. Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov. Journal Of Neurology Neurosurgery & Psychiatry 2023, 94: 597-604. PMID: 36977551, DOI: 10.1136/jnnp-2023-331132.Peer-Reviewed Original ResearchConceptsClinical trialsPeer-reviewed journalsTrial publicationsPublication biasMultivariate logistic regression analysisMultiple sclerosis clinical trialsFavorable primary outcomeMS clinical researchPhase IIILogistic regression analysisMultiple sclerosis drugsCase-control designTreatment tolerabilityMore patientsPrimary outcomeUnpublished trialsMS drugsTreatment decisionsLower oddsStudy design characteristicsMultivariate analysisClinical researchUnpublished studiesTrialsGoogle Scholar
2022
Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE
Manyara AM, Davies P, Stewart D, Weir CJ, Young A, Butcher NJ, Bujkiewicz S, Chan AW, Collins GS, Dawoud D, Offringa M, Ouwens M, Ross JS, Taylor RS, Ciani O. Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open 2022, 12: e064304. PMID: 36220321, PMCID: PMC9557267, DOI: 10.1136/bmjopen-2022-064304.Peer-Reviewed Original ResearchConceptsSurrogate endpointsPeer-reviewed publicationsSurrogate primary endpointOpen-access peer-reviewed publicationPATIENTS/PARTICIPANTSCompleteness of reportingTranslation of effectsPhase 1Primary endpointPrimary outcomeTrial findingsEthical approvalCONSORT extensionSuch trialsEthics CommitteeEndpointHealth benefitsTrialsPhase 3Final outcomePhase 2Transparent reportingOutcomesPhase 4Additional itemsEmulating 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 criteriaProlonged use of newly prescribed gabapentin after surgery
Bongiovanni T, Gan S, Finlayson E, Ross J, Harrison JD, Boscardin J, Steinman MA. Prolonged use of newly prescribed gabapentin after surgery. Journal Of The American Geriatrics Society 2022, 70: 3560-3569. PMID: 36000860, PMCID: PMC9771946, DOI: 10.1111/jgs.18005.Peer-Reviewed Original ResearchConceptsUse of gabapentinProlonged useOpioid useNon-opioid pain medicationsHigher Charlson comorbidity scoreOlder adultsPostoperative opioid prescribingProlonged opioid useCharlson comorbidity scoreLength of stayAdverse drug eventsTotal hip replacementLogistic regression modelsGabapentinoid useMore comorbiditiesComorbidity scoreGabapentin useOpioid prescribingOpioid prescriptionsDischarge dispositionEmergency surgeryPain medicationPatient characteristicsPrimary outcomeMultivariable analysisPreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial
Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open 2022, 12: e062041. PMID: 35940841, PMCID: PMC9364397, DOI: 10.1136/bmjopen-2022-062041.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticPatient-reported outcomesHealthcare utilisationClinical outcomesDigital therapeuticsIndividual patient-reported outcomesReal-world patient experienceInsomnia Severity Index scoreSeverity Index scoreHealth utility scoresInstitutional review boardCognitive behavioral therapyPeer-reviewed journalsSecondary outcomesPrimary outcomeTrial protocolDaytime sleepinessChronic insomniaMayo ClinicHealth centersDepressive symptomsPatient experienceSleep outcomesIndex scoreSleep diaryHospital-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 centerOutcomesPayers
2021
Heart Watch Study: protocol for a pragmatic randomised controlled trial
Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open 2021, 11: e054550. PMID: 35234659, PMCID: PMC8719216, DOI: 10.1136/bmjopen-2021-054550.Peer-Reviewed Original ResearchConceptsHealthcare utilisationSecondary outcomesAtrial fibrillationAtrial flutterDuke University Health SystemRoutine clinical care settingsAtrial Fibrillation EffectLife global scoresTime of cardioversionAdditional secondary outcomesPopulation of patientsPatient-reported outcomesClinical care settingsUniversity Health SystemQuality of lifeInstitutional review boardMulticentre pragmaticPeer-reviewed journalsPrimary outcomePatients' qualityTrial protocolClinical trialsMayo ClinicECG featuresCare settingsEvaluation 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 companiesApprovalMedian
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 paymentsAssociationClinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction
Jackevicius CA, Krumholz HM, Ross JS, Koh M, Chong A, Austin PC, Stukel TA, Azizi P, Ko DT. Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction. Canadian Journal Of Cardiology 2020, 36: 1633-1640. PMID: 32416066, DOI: 10.1016/j.cjca.2020.01.024.Peer-Reviewed Original ResearchConceptsPrior myocardial infarctionMyocardial infarctionStable patientsPopulation-based observational studyAngina 1 yearDeath/hospitalizationHistory of revascularisationBeta-blocker useMajor cardiovascular eventsHospital discharge diagnosisUse of BBsIndividual end pointsContemporary clinical trialsYears of ageCardiovascular eventsIndex dateCohort studyComposite outcomeBB useHeart failureMedian agePrimary outcomeClinical outcomesAtrial fibrillationDischarge diagnosis
2019
Home Health Care After Skilled Nursing Facility Discharge Following Heart Failure Hospitalization
Weerahandi H, Bao H, Herrin J, Dharmarajan K, Ross JS, Jones S, Horwitz LI. Home Health Care After Skilled Nursing Facility Discharge Following Heart Failure Hospitalization. Journal Of The American Geriatrics Society 2019, 68: 96-102. PMID: 31603248, PMCID: PMC6964248, DOI: 10.1111/jgs.16179.Peer-Reviewed Original ResearchConceptsSkilled nursing facilitiesHF hospitalizationReadmission ratesReadmission riskHeart failure readmission ratesDays of dischargeHeart failure hospitalizationRetrospective cohort studyHospital discharge practicesMore functional impairmentHome health careFailure hospitalizationHF patientsUnplanned readmissionCohort studyHospital dischargePrimary outcomeRestorative therapySNF stayFunctional impairmentHome healthcare servicesService Medicare dataAdjusted modelCox modelNursing facilitiesFeasibility 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 OUTCOME
2018
Emergency Department Volume and Outcomes for Patients After Chest Pain Assessment
Ko DT, Dattani ND, Austin PC, Schull MJ, Ross JS, Wijeysundera HC, Tu JV, Eberg M, Koh M, Krumholz HM. Emergency Department Volume and Outcomes for Patients After Chest Pain Assessment. Circulation Cardiovascular Quality And Outcomes 2018, 11: e004683. PMID: 30354285, DOI: 10.1161/circoutcomes.118.004683.Peer-Reviewed Original ResearchConceptsAcute coronary syndromeChest painHigh-volume EDsCoronary syndromeED volumeVolume thresholdCardiac medication useChest pain assessmentLower adverse outcomesEmergency department visitsAdjusted odds ratioPopulation-based dataProcess of carePotential confounding variablesHigher ED volumesHierarchical logistic regression modelsLogistic regression modelsEmergency department volumeCause deathCardiac testingComposite outcomeDepartment visitsDiabetes mellitusMedication usePrimary outcomeAdherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals
Gopal AD, Wallach JD, Aminawung JA, Gonsalves G, Dal-Ré R, Miller JE, Ross JS. Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals. Trials 2018, 19: 448. PMID: 30134950, PMCID: PMC6106722, DOI: 10.1186/s13063-018-2825-y.Peer-Reviewed Original ResearchConceptsPrimary outcome dataOutcome dataCross-sectional analysisUnregistered trialsTrial characteristicsClinical trialsFavorable findingsProfessional medical societiesMedical societiesIndustry-funded trialsFrequency of registrationPrimary outcomeRegistered trialsEnrollment siteProspective fashionChi-square analysisProportion of trialsOriginal research reportsInitial ascertainmentTrialsHigh-impact journalsMedical Journal EditorsRegistration timingRetrospective registrationLower rates
2017
Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study
Zeitoun J, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study. International Journal Of Cancer 2017, 142: 414-423. PMID: 28929484, DOI: 10.1002/ijc.31061.Peer-Reviewed Original ResearchConceptsPost-marketing trialsPrimary outcomeNovel anticancer agentsPost-market researchAnticancer agentsSupplemental indicationsCross-sectional studyPost-marketing researchEuropean Medicines AgencyCross-sectional analysisTypes of cancerPost-market trialClinical endpointsHematologic malignanciesKidney cancerSolid cancersSurrogate endpointsUS FoodDrug AdministrationMedicines AgencyOverall populationCancerTrialsPublication rateOutcomes
2016
Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome
Jackevicius CA, Tu JV, Krumholz HM, Austin PC, Ross JS, Stukel TA, Koh M, Chong A, Ko DT. Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome. Journal Of The American Heart Association 2016, 5: e003350. PMID: 27098970, PMCID: PMC4859299, DOI: 10.1161/jaha.116.003350.Peer-Reviewed Original ResearchConceptsGeneric atorvastatinACS hospitalizationSecondary outcomesClinical effectivenessAcute coronary syndrome hospitalizationPopulation-based cohort studyNew-onset diabetesAcute coronary syndromeDays of dischargePrespecified subgroup analysisPropensity-matched pairsInfrequent side effectsBrand-name medicationsSignificant differencesHealth care plansRecurrent ACSAdmission diagnosisAtorvastatin doseCardiovascular outcomesCoronary syndromeCohort studyRenal failureHeart failurePrimary outcomeMean age
2014
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2013
Hospital-based, acute care after ambulatory surgery center discharge
Fox JP, Vashi AA, Ross JS, Gross CP. Hospital-based, acute care after ambulatory surgery center discharge. Surgery 2013, 155: 743-753. PMID: 24787100, PMCID: PMC4114736, DOI: 10.1016/j.surg.2013.12.008.Peer-Reviewed Original ResearchMeSH KeywordsAdmitting Department, HospitalAdolescentAdultAgedAged, 80 and overAmbulatory Care FacilitiesAmbulatory Surgical ProceduresCaliforniaEmergency Service, HospitalFemaleFloridaHumansMaleMiddle AgedNebraskaOutcome Assessment, Health CarePatient DischargePatient ReadmissionPatient TransferTime FactorsYoung AdultConceptsAmbulatory surgery centersAcute care ratesHospital transfer ratesTime of dischargeHospital transferSurgery centersAcute careAdult patientsCare ratesAcute care needsRate of needAmbulatory care centersPrimary outcomeCare centerOperative procedureAmbulatory careHealthcare costsCare needsPatientsCenter dischargeUtilization ProjectFirst weekMeasures of qualityCareCenter level
2012
Financial Stress and Outcomes after Acute Myocardial Infarction
Shah SJ, Krumholz HM, Reid KJ, Rathore SS, Mandawat A, Spertus JA, Ross JS. Financial Stress and Outcomes after Acute Myocardial Infarction. PLOS ONE 2012, 7: e47420. PMID: 23112814, PMCID: PMC3480393, DOI: 10.1371/journal.pone.0047420.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionSeattle Angina QuestionnaireLong-term outcomesMyocardial infarctionAMI patientsWorse long-term outcomesMulticenter US studyPost-AMI outcomesYear post-AMIDisease-specific QoLImportant risk factorHealth status outcomesWorse physical healthHealth care outcomesAngina QuestionnaireProspective registryInitial hospitalizationSecondary outcomesPrimary outcomeReadmission ratesPost-AMIRisk factorsCare characteristicsCare outcomesStatus outcomesComparison 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