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 ResearchMeSH KeywordsBiomarkersChecklistClinical Trial Protocols as TopicHumansRandomized Controlled Trials as TopicResearch DesignConceptsTrial 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
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials
Wallach J, Deng Y, Polley E, Dhruva S, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Jeffery M, Lyon T, Ross J, McCoy R. Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials. Clinical Trials 2023, 20: 689-698. PMID: 37589143, PMCID: PMC10843567, DOI: 10.1177/17407745231193137.Peer-Reviewed Original ResearchMeSH KeywordsHumansLongitudinal StudiesMyocardial InfarctionPandemicsRandomized Controlled Trials as TopicResearch DesignConceptsBaseline participant characteristicsParticipant characteristicsPrimary endpointSecondary endpointsTrial publicationsMajor adverse cardiovascular eventsPropensity score-matched participantsFirst major adverse cardiovascular eventAdverse cardiovascular eventsBaseline patient characteristicsNonfatal myocardial infarctionOptumLabs Data WarehouseElectronic health record dataRepresentative patient populationHealth record dataCardiovascular eventsClinical characteristicsPatient characteristicsPatient populationMyocardial infarctionExclusion criteriaDrug effectivenessTrialsRecord dataEndpointPress Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study
Purohit U, Sacks C, Raissi A, Hughes E, Boctor M, Manzoor S, Hodzic-Santor B, Zhu K, Raudanskis A, Ross J, Fralick M. Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study. Journal Of General Internal Medicine 2023, 38: 3107-3114. PMID: 37532876, PMCID: PMC10651612, DOI: 10.1007/s11606-023-08313-1.Peer-Reviewed Original ResearchHumansJournal Impact FactorObservational Studies as TopicPeer ReviewPeriodicals as TopicRandomized Controlled Trials as TopicUnited States
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 ResearchMeSH KeywordsConsensusHumansPublicationsRandomized Controlled Trials as TopicResearch DesignResearch ReportTreatment OutcomeConceptsSurrogate 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 criteriaPreScription 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 ResearchMeSH KeywordsHumansMulticenter Studies as TopicPrescriptionsProspective StudiesRandomized Controlled Trials as TopicSleepSleep Initiation and Maintenance DisordersTreatment OutcomeConceptsPrescription 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 diaryAgreement 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 ResearchMeSH KeywordsCOVID-19 Drug TreatmentDexamethasoneHumansHydroxychloroquineLopinavirMeta-Analysis as TopicObservational Studies as TopicRandomized Controlled Trials as TopicRitonavirConceptsCOVID-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
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 ResearchMeSH KeywordsAtrial FibrillationAtrial FlutterElectric CountershockHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicConceptsHealthcare 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 settingsGuidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances
Orkin AM, Gill PJ, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg PG, Weijer C, Simes J, Rombey T, Williams HC, Wittes J, Moher D, Richards DP, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, Ayala AP, Schulz KF, Calleja S, Boutron I, Ross JS, Golub RM, Khan KM, Mulrow C, Siegfried N, Heber J, Lee N, Kearney PR, Wanyenze RK, Hróbjartsson A, Williams R, Bhandari N, Jüni P, Chan AW, Orkin A, Gill P, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg P, Weijer C, Simes J, Rombey T, Williams H, Wittes J, Moher D, Richards D, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, Ayala A, Schulz K, Calleja S, Boutron I, Ross J, Golub R, Khan K, Mulrow C, Siegfried N, Heber J, Lee N, Kearney P, Wanyenze R, Hróbjartsson A, Williams R, Bhandari N, Jüni P, Chan A, Kiermer V, Corrigan-Curay J, Concato J. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances. JAMA 2021, 326: 257-265. PMID: 34152382, DOI: 10.1001/jama.2021.9941.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsClinical ProtocolsCOVID-19Delphi TechniqueGuidelines as TopicHumansPublishingRandomized Controlled Trials as TopicResearch ReportSurveys and QuestionnairesEvaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors
Long AS, Zhang AD, Meyer CE, Egilman AC, Ross JS, Wallach JD. Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors. JAMA Network Open 2021, 4: e215731. PMID: 33956134, PMCID: PMC8103227, DOI: 10.1001/jamanetworkopen.2021.5731.Peer-Reviewed Original ResearchMeSH KeywordsDrug ApprovalDrug CompoundingDrug PrescriptionsDrugs, GenericHumansMedicareRandomized Controlled Trials as TopicStereoisomerismUnited StatesConceptsRandomized clinical trialsSafety end pointEnd pointClinical trialsDrug pairsPrimary end point resultsEnd point resultsImproved efficacyEfficacy end pointCochrane Central RegistrySeparate end pointsSingle-enantiomer drugsSingle enantiomer formulationPrimary efficacySecondary efficacyControlled TrialsOvid EmbaseOvid MEDLINESuperior efficacyDrug AdministrationCentral RegistrySystematic reviewMore efficacyTrialsRacemic drugsMisreporting of Results of Research in Psychiatry
Bowcut J, Levi L, Livnah O, Ross JS, Knable M, Davidson M, Davis JM, Weiser M. Misreporting of Results of Research in Psychiatry. Schizophrenia Bulletin 2021, 47: 1254-1260. PMID: 33860793, PMCID: PMC8379531, DOI: 10.1093/schbul/sbab040.Peer-Reviewed Original ResearchMeSH KeywordsBiomedical ResearchData Interpretation, StatisticalHumansOutcome Assessment, Health CarePsychiatryPublication BiasRandomized Controlled Trials as TopicResearch Design
2020
Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. The BMJ 2020, 368: l7078. PMID: 32024657, PMCID: PMC7190063, DOI: 10.1136/bmj.l7078.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesHumansHypoglycemic AgentsInformation DisseminationRandomized Controlled Trials as TopicRisk FactorsRosiglitazoneConceptsIndividual patient-level dataCardiovascular related deathsCardiovascular riskMyocardial infarctionRelated deathsSummary-level dataHeart failureOdds ratioSystematic reviewIncreased cardiovascular riskMore myocardial infarctionsHeart failure eventsCochrane Central RegistryAcute myocardial infarctionMyocardial infarction eventsPatient-level dataRandom-effects modelWeb of ScienceAnalysis of trialsEligible trialsComposite outcomeAdverse eventsContinuity correctionControlled TrialsRosiglitazone treatment
2019
The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration.
Kent DM, van Klaveren D, Paulus JK, D'Agostino R, Goodman S, Hayward R, Ioannidis JPA, Patrick-Lake B, Morton S, Pencina M, Raman G, Ross JS, Selker HP, Varadhan R, Vickers A, Wong JB, Steyerberg EW. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration. Annals Of Internal Medicine 2019, 172: w1-w25. PMID: 31711094, PMCID: PMC7750907, DOI: 10.7326/m18-3668.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsClinical Decision RulesClinical Decision-MakingEvidence-Based MedicineHumansIndividualityModels, StatisticalRandomized Controlled Trials as TopicRisk AssessmentTreatment OutcomeThe Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement.
Kent DM, Paulus JK, van Klaveren D, D'Agostino R, Goodman S, Hayward R, Ioannidis JPA, Patrick-Lake B, Morton S, Pencina M, Raman G, Ross JS, Selker HP, Varadhan R, Vickers A, Wong JB, Steyerberg EW. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement. Annals Of Internal Medicine 2019, 172: 35-45. PMID: 31711134, PMCID: PMC7531587, DOI: 10.7326/m18-3667.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsClinical Decision RulesClinical Decision-MakingEvidence-Based MedicineHumansIndividualityModels, StatisticalRandomized Controlled Trials as TopicRisk AssessmentTreatment OutcomePrevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews
Liu P, Ross JS, Ioannidis JP, Dhruva SS, Vasiliou V, Wallach JD. Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews. Clinical Trials 2019, 17: 231-234. PMID: 31709809, DOI: 10.1177/1740774519887148.Peer-Reviewed Original ResearchMeSH KeywordsData Interpretation, StatisticalEthnicityHumansMeta-Analysis as TopicPrevalenceRace FactorsRandomized Controlled Trials as TopicReview Literature as TopicAge-treatment subgroup analyses in Cochrane intervention reviews: a meta-epidemiological study
Liu P, Ioannidis JPA, Ross JS, Dhruva SS, Luxkaranayagam AT, Vasiliou V, Wallach JD. Age-treatment subgroup analyses in Cochrane intervention reviews: a meta-epidemiological study. BMC Medicine 2019, 17: 188. PMID: 31639007, PMCID: PMC6805640, DOI: 10.1186/s12916-019-1420-8.Peer-Reviewed Original ResearchMeSH KeywordsAge DistributionAge FactorsData Interpretation, StatisticalEpidemiologic Research DesignEpidemiologic StudiesFemaleHumansPrecision MedicineRandomized Controlled Trials as TopicResearch DesignReview Literature as TopicConceptsCochrane intervention reviewsFormal interaction testingSubgroup analysisIntervention reviewsClinical practice resourcesInsufficient trial dataPotential subgroup differencesMeta-epidemiological studyIndividual subgroup analysisCochrane reviewAppropriate statistical testsClinical significanceClinical careSubgroup findingsTrial dataClinical resourcesHealthcare interventionsBiological rationaleAnalysis of ageTrialsIndividual trialsDemographic characteristicsPractice resourcesSubgroup differencesClinical translationClaims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke DatabaseAdverse 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 settingSubmissions 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 ResearchMeSH KeywordsBlood PressureCross-Sectional StudiesData AnalysisData CollectionHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRisk AssessmentConceptsRisk 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 outcome