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Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov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L. Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov.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
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-19TrialsConsistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy designPreScription 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 diary
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 settings
2019
Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
Wallach JD, Luxkaranayagam AT, Dhruva SS, Miller JE, Ross JS. Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis. BMC Medicine 2019, 17: 117. PMID: 31203816, PMCID: PMC6572730, DOI: 10.1186/s12916-019-1344-3.Peer-Reviewed Original ResearchConceptsNew clinical trialsClinical trialsPostmarketing commitmentFDA approvalPeer-reviewed journalsNovel drugsPharmaceutical companiesCross-sectional analysisRate of completionRates of registrationClinical studiesPublic reporting requirementsFirst approvalTherapeutic evaluationUS FoodDrug AdministrationTrialsNew drugsFDA documentsBiologicsFDADrugsFDA recordsApprovalStatus
2018
Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences
Wallach JD, Egilman AC, Gopal AD, Swami N, Krumholz HM, Ross JS. Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences. Research Integrity And Peer Review 2018, 3: 1. PMID: 29451557, PMCID: PMC5803634, DOI: 10.1186/s41073-017-0045-8.Peer-Reviewed Original Research