2024
Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson 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, Ciani O. Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078525. PMID: 38981624, PMCID: PMC11231880, DOI: 10.1136/bmj-2023-078525.Peer-Reviewed Original ResearchConceptsTrial protocolRandomised controlled trial protocolTarget outcomesReduce research wasteStandard Protocol ItemsRandomised controlled trialsIntervention effectsProtocol ItemsInterpretation of findingsResearch wasteImprove reportingPrimary outcome(sIntervention trialsControlled trialsChecklistSurrogate endpointsInterventionItemsIncreasing callsTrialsGuidelinesOutcomesLimited informationOutcome(sHarmReporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson 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, Ciani O. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078524. PMID: 38981645, PMCID: PMC11231881, DOI: 10.1136/bmj-2023-078524.Peer-Reviewed Original ResearchConceptsRandomised controlled trial reportsTrial reportsRandomised controlled trialsControlled trial reportsIntervention treatment effectsResearch wasteTrial findingsTreatment effectsControlled trialsTarget outcomesChecklistAdequate informationSurrogate endpointsInterventionCONSORTItemsTrialsImprove transparencyHarmReportsGuidelinesOutcomesEndpoint
2023
A 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 needSymptomsCliniciansSettingBiomarkers
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 itemsHospital-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
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
Swanson MJ, Johnston JL, Ross JS. Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA. Trials 2021, 22: 817. PMID: 34789308, PMCID: PMC8597303, DOI: 10.1186/s13063-021-05790-9.Peer-Reviewed Original ResearchConceptsHigh-risk cardiovascular devicesPrimary efficacy outcomeFDA Amendments ActPivotal clinical trialsClinical trialsEfficacy outcomesFDA approvalTrial interpretationPivotal clinical studiesPrimary clinical evidenceFDA summariesPivotal trialsClinical evidenceResultsBetween 2005Clinical studiesHigh-risk medical devicesOutcome reportingUS FoodDrug AdministrationTrialsReporting of findingsInterpretation of findingsPeer-reviewed literatureOutcomesCardiovascular devicesThe Association Between History of Depression and Access to Care Among Medicare Beneficiaries During the COVID-19 Pandemic
Balasuriya L, Quinton JK, Canavan ME, Holland ML, Edelman EJ, Druss BG, Ross JS. The Association Between History of Depression and Access to Care Among Medicare Beneficiaries During the COVID-19 Pandemic. Journal Of General Internal Medicine 2021, 36: 3778-3785. PMID: 34405350, PMCID: PMC8370448, DOI: 10.1007/s11606-021-06990-4.Peer-Reviewed Original ResearchConceptsSelf-reported historyHistory of depressionMental health outcomesMedicare beneficiariesHealth outcomesCOVID-19Adverse health outcomesPARTICIPANTSCross-sectional studyMental health effectsUnmet social needsClinical characteristicsHigh riskKey ResultsParticipantsPublic Use FileMedical careGreater riskMental healthHealth effectsCareDepressionUse FileCOVID-19 pandemicOutcomesGreater inabilityMedicare
2020
Reporting of substance use treatment quality in United States adult drug courts
Joudrey PJ, Howell BA, Nyhan K, Moravej A, Doernberg M, Ross JS, Wang EA. Reporting of substance use treatment quality in United States adult drug courts. International Journal Of Drug Policy 2020, 90: 103050. PMID: 33310636, PMCID: PMC8046712, DOI: 10.1016/j.drugpo.2020.103050.Peer-Reviewed Original ResearchConceptsService utilizationTreatment qualityTreatment quality measuresProcess evaluationRelated health outcomesSubstance use treatmentGrey literature searchSystematic grey literature searchMeasures of substanceTreatment outcomesHealth outcomesLiterature searchUse treatmentDrug courtsProcess measuresLow uptakePractice informationOutcomesDrug court programProgram graduationAdult drug courtsNon-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersIntervention
2019
Submissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation
Jackevicius CA, An J, Ko DT, Ross JS, Angraal S, Wallach JD, Koh M, Song J, Krumholz HM. Submissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation. BMJ Open 2019, 9: e025936. PMID: 30904868, PMCID: PMC6475140, DOI: 10.1136/bmjopen-2018-025936.Peer-Reviewed Original ResearchConceptsRisk prediction toolsCross-sectional evaluationClinical risk predictionClinical performanceCardiovascular disease historyClinical risk scoreHigh-risk patientsLow-risk patientsClinical prediction toolRisk predictionEfficacy outcomesC-statisticDisease historyInclusion criteriaIndependent reviewersRisk scoreExternal validationPatientsPrediction toolsEfficacyOutcomesSame outcomeAssociation of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes
Chui PW, Parzynski CS, Ross JS, Desai NR, Gurm HS, Spertus JA, Seto AH, Ho V, Curtis JP. Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes. Journal Of The American Heart Association 2019, 8: e010373. PMID: 30642222, PMCID: PMC6497347, DOI: 10.1161/jaha.118.010373.Peer-Reviewed Original ResearchConceptsAcute coronary syndromePercutaneous coronary interventionPCI proceduresCON statesAppropriate use criteriaNon-CON statesCoronary syndromePCI registryCoronary interventionCON regulationsIntervention appropriatenessChi-square analysisAmerican CollegeHealthcare costsNeed regulationsPCI appropriatenessUse criteriaAbsolute differenceHealthcare servicesNew healthcare servicesAssociationPCILower proportionOutcomesACS
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
2015
Predictors and outcomes of unplanned readmission to a different hospital
Kim H, Hung WW, Paik MC, Ross JS, Zhao Z, Kim GS, Boockvar K. Predictors and outcomes of unplanned readmission to a different hospital. International Journal For Quality In Health Care 2015, 27: 513-519. PMID: 26472739, PMCID: PMC4665363, DOI: 10.1093/intqhc/mzv082.Peer-Reviewed Original ResearchConceptsDifferent-hospital readmissionsReadmission groupAcute care hospitalsDifferent hospitalsUnplanned readmissionCare hospitalSame hospitalThirty-day unplanned readmissionsPercent of patientsSame-hospital readmissionsBetter care coordinationHospital deathIndex dischargeIndex hospitalCare coordinationHospital costsReadmissionHigher oddsMAIN OUTCOMEPatientsHealth outcomesCost outcomesHospitalSecondary analysisOutcomesOlder 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
2014
High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities
Wang EA, Aminawung JA, Wildeman C, Ross JS, Krumholz HM. High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities. Health Affairs 2014, 33: 848-855. PMID: 24799583, PMCID: PMC4065793, DOI: 10.1377/hlthaff.2013.1325.Peer-Reviewed Original ResearchConceptsClinical studiesHealth outcomesBlack menProspective clinical studyObservational clinical researchBlood InstituteNational HeartClinical researchWhite womenRacial disparitiesWhite menMinimal riskMenBlack womenHigh rateJail inmatesMinority populationsWomenOutcomesEffects of incarcerationImpact of incarcerationHigh incarceration ratesIncarcerationLungFollowUsual Source of Care and Outcomes Following Acute Myocardial Infarction
Spatz ES, Sheth SD, Gosch KL, Desai MM, Spertus JA, Krumholz HM, Ross JS. Usual Source of Care and Outcomes Following Acute Myocardial Infarction. Journal Of General Internal Medicine 2014, 29: 862-869. PMID: 24553957, PMCID: PMC4026492, DOI: 10.1007/s11606-014-2794-0.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionUsual sourceMyocardial infarctionMortality rateBaseline risk factorsAcute clinical eventsMain outcome measuresAMI severityAMI patientsMultivariable analysisKey ResultsAmongClinical eventsSocio-demographic characteristicsRisk factorsOutcome measuresReadmissionHigh mortalityPatientsMortalityCareMonthsInfarctionAdultsOutcomesAssociation
2012
Based On Key Measures, Care Quality For Medicare Enrollees At Safety-Net And Non-Safety-Net Hospitals Was Almost Equal
Ross JS, Bernheim SM, Lin Z, Drye EE, Chen J, Normand SL, Krumholz HM. Based On Key Measures, Care Quality For Medicare Enrollees At Safety-Net And Non-Safety-Net Hospitals Was Almost Equal. Health Affairs 2012, 31: 1739-1748. PMID: 22869652, PMCID: PMC3527010, DOI: 10.1377/hlthaff.2011.1028.Peer-Reviewed Original ResearchConceptsSafety-net hospitalNet hospitalReadmission ratesUrban hospitalHeart failure mortalityRisk-standardized ratesAcute myocardial infarctionIndicators of careService Medicare beneficiariesHeart failureClinical outcomesMyocardial infarctionWorse outcomesMedicare beneficiariesHospitalMedicare enrolleesHospital qualityCare qualityVulnerable populationsGreater financial strainOutcomesMortalityFinancial strainCareMore affluent populationsImpact of State Laws That Extend Eligibility for Parents’ Health Insurance Coverage to Young Adults
Blum AB, Kleinman LC, Starfield B, Ross JS. Impact of State Laws That Extend Eligibility for Parents’ Health Insurance Coverage to Young Adults. Pediatrics 2012, 129: 426-432. PMID: 22331339, PMCID: PMC3356137, DOI: 10.1542/peds.2011-1505.Peer-Reviewed Original ResearchConceptsHealth insurance coverageParents' insurancePhysical examYoung adultsBehavior Risk Factor Surveillance SystemRisk Factor Surveillance SystemRecent physical examInsurance coveragePhysicians/cliniciansForgone careAffordable Care ActClinician identificationHealth insurance companiesSelf-reported health insurance coverageAge 26Parents' policiesHealth insuranceCare ActCareDifferential improvementEligibilityAdultsSurveillance systemOutcomesPast year
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
2008
Influence of Patients’ Socioeconomic Status on Clinical Management Decisions: A Qualitative Study
Bernheim SM, Ross JS, Krumholz HM, Bradley EH. Influence of Patients’ Socioeconomic Status on Clinical Management Decisions: A Qualitative Study. The Annals Of Family Medicine 2008, 6: 53-59. PMID: 18195315, PMCID: PMC2203396, DOI: 10.1370/afm.749.Peer-Reviewed Original ResearchConceptsClinical management decisionsPatients' socioeconomic statusClinical managementSocioeconomic statusPatient sPatient outcomesPrimary care physiciansStandard of careInfluence of patientLow socioeconomic statusVaried practice settingsHealth care qualitySES influencesCare physiciansHispanic ethnicityPhysician perspectivesPractice settingsCare qualityPatientsPhysiciansPatient interestMinority racial backgroundsInterview guideFinancial strainOutcomes