2023
Press 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 Research
2022
Characteristics of Retracted Research Articles About COVID-19 vs Other Topics
Shi X, Abritis A, Patel RP, Grewal M, Oransky I, Ross JS, Wallach JD. Characteristics of Retracted Research Articles About COVID-19 vs Other Topics. JAMA Network Open 2022, 5: e2234585. PMID: 36194415, PMCID: PMC9533180, DOI: 10.1001/jamanetworkopen.2022.34585.Peer-Reviewed Original Research
2021
Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals
Shi X, Ross JS, Amancharla N, Niforatos JD, Krumholz HM, Wallach JD. Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals. JAMA Network Open 2021, 4: e212110. PMID: 33734411, PMCID: PMC7974637, DOI: 10.1001/jamanetworkopen.2021.2110.Peer-Reviewed Original Research
2020
Non-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 ResearchMeSH KeywordsBiomarkersCardiovascular DiseasesEndpoint DeterminationEquivalence Trials as TopicHumansJournal Impact FactorPhenotypeResearch DesignResearch ReportConceptsNon-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 interpretationOutcomesMarkersInterventionAssessment of Preprint Policies of Top-Ranked Clinical Journals
Massey DS, Opare MA, Wallach JD, Ross JS, Krumholz HM. Assessment of Preprint Policies of Top-Ranked Clinical Journals. JAMA Network Open 2020, 3: e2011127. PMID: 32697320, PMCID: PMC7376388, DOI: 10.1001/jamanetworkopen.2020.11127.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesEditorial PoliciesHumansJournal Impact FactorJournalism, MedicalPeriodicals as TopicPreprints as Topic
2019
Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals
Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone G, Ross JS, Krumholz HM. Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals. Circulation 2019, 140: 379-389. PMID: 31177811, PMCID: PMC8416048, DOI: 10.1161/circulationaha.119.040214.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesEquivalence Trials as TopicHumansJournal Impact FactorPeriodicals as TopicConceptsNoninferiority marginNoninferiority trialCardiovascular trialsAllocation concealmentLower riskOpen labelHazard ratioRelative riskMethodological qualityProportion of trialsIndependent reviewersRisk differenceNew England JournalNoninferiorityHigh-impact journalsNew interventionsTrialsCohortDiscrepant resultsProtocol analysisTime trendsRiskTreatInterventionFactors
2018
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
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 ratesAge of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesJournal Impact FactorPublishingRandomized Controlled Trials as TopicResearch DesignTime FactorsConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrials
2016
Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting
Dal-Ré R, Ross JS, Marušić A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. Journal Of Clinical Epidemiology 2016, 75: 100-107. PMID: 26820559, DOI: 10.1016/j.jclinepi.2016.01.017.Commentaries, Editorials and LettersConceptsPrimary end pointInterim analysisTRIAL REGISTRATIONEnd pointHigh-impact general medicine journalsICMJE policyMain outcome measuresPublic trials registryPredictors of complianceProspective trial registrationTrials of FDACross-sectional analysisPercent of trialsTrials RegistryGeneral medicine journalsProspective registrationOutcome measuresClinical researchStudy designTrial resultsHigh-impact journalsRetrospective registrationTrialsAscertainmentMedicine journals
2015
Poorly Cited Articles in Peer-Reviewed Cardiovascular Journals from 1997 to 2007
Ranasinghe I, Shojaee A, Bikdeli B, Gupta A, Chen R, Ross JS, Masoudi FA, Spertus JA, Nallamothu BK, Krumholz HM. Poorly Cited Articles in Peer-Reviewed Cardiovascular Journals from 1997 to 2007. Circulation 2015, 131: 1755-1762. PMID: 25812573, PMCID: PMC4560203, DOI: 10.1161/circulationaha.114.015080.Peer-Reviewed Original Research
2014
Reporting of Results in ClinicalTrials.gov and High-Impact Journals
Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of Results in ClinicalTrials.gov and High-Impact Journals. JAMA 2014, 311: 1063-1065. PMID: 24618969, PMCID: PMC3979514, DOI: 10.1001/jama.2013.285634.Peer-Reviewed Original Research
2012
Sharing of clinical trial data among trialists: a cross sectional survey
Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Strait KM, Ross JS. Sharing of clinical trial data among trialists: a cross sectional survey. The BMJ 2012, 345: e7570. PMID: 23169870, PMCID: PMC3502744, DOI: 10.1136/bmj.e7570.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCross-Sectional StudiesInformation DisseminationJournal Impact FactorSurveys and QuestionnairesConceptsClinical trial dataTrial dataGeneral medical journalsHigh-impact general medical journalsCross-sectional surveyDe-identified dataMedical journalsClinical trialsTrial fundersClinical trialistsSectional surveyTrialistsTrialsInvestigatorsExperiences of sharingPrevalence of dataPotential respondentsHigh impact factorAppropriate data usePrevalenceRespondents