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, 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, 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, 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, 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 transparencyHarmReportsGuidelinesOutcomesEndpointAltmetric Attention Scores and Citations of Published Research With or Without Preprints
Zissette S, Gautam A, Krumholz H, Ross J, Wallach J. Altmetric Attention Scores and Citations of Published Research With or Without Preprints. JAMA Network Open 2024, 7: e2424732. PMID: 39058492, PMCID: PMC11282438, DOI: 10.1001/jamanetworkopen.2024.24732.Peer-Reviewed Original ResearchPrescription Digital Therapeutics: The Authors Reply
Kumar A, Redberg R, Dhruva S, Ross J. Prescription Digital Therapeutics: The Authors Reply. Health Affairs 2024, 43: 898-898. PMID: 38830149, DOI: 10.1377/hlthaff.2024.00278.Peer-Reviewed Original ResearchElectronic PrescribingHumansTackling the excesses of pharmaceutical marketing and promotion
Gupta R, Ramachandran R, Ross J. Tackling the excesses of pharmaceutical marketing and promotion. The BMJ 2024, 385: e076797. PMID: 38772671, DOI: 10.1136/bmj-2023-076797.Peer-Reviewed Original ResearchAssociations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug AdministrationIntravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices
Dhruva S, Ross J, Steinman M, Gan S, Muluk S, Anderson T. Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices. JAMA 2024, 331: 1499-1501. PMID: 38598231, PMCID: PMC11007652, DOI: 10.1001/jama.2024.4682.Peer-Reviewed Original ResearchPremarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original ResearchIntegrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study
Thanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Noble B, Paludo J, Powers B, Ross J, Ritchie J, Ruddy K, Schellhorn S, Tarver M, Dueck A, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open 2024, 14: e074030. PMID: 38199641, PMCID: PMC10806877, DOI: 10.1136/bmjopen-2023-074030.Peer-Reviewed Original ResearchConceptsPhysical function assessmentPhysical functionFunctional assessmentEvaluation of physical functionElectronic health record dataEvaluate physical functionHealth record dataSpanish-speaking patientsDigital health technologiesBreast cancerProspective cohort studyClinician-reported outcomesCancer clinical trialsClinical decision-makingStudy questionnairePatient-centred evaluationHealth technologiesMeasure symptomsOncology practiceCohort studyRecord dataPatient's impressionMayo ClinicEnglish-speakingWearable sensors
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original ResearchAssociation of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies
Wallach J, Gautam A, Ramachandran R, Ross J. Association of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies. The BMJ 2023, 383: e077166. PMID: 38123175, DOI: 10.1136/bmj-2023-077166.Peer-Reviewed Original ResearchFeasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.Peer-Reviewed Original ResearchStudies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity
Kumar A, Ross J, Patel N, Rathi V, Redberg R, Dhruva S. Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity. Health Affairs 2023, 42: 1559-1567. PMID: 37931187, DOI: 10.1377/hlthaff.2023.00384.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticDigital therapeuticsClinical studiesRetrospective cross-sectional analysisCross-sectional analysisStrong evidence baseHalf of studiesUpper age limitPremarket studiesDrug AdministrationClinician's prescriptionClinical useClinical researchEvidence baseTherapeuticsOne-thirdMedical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership
Bhat S, Ross J, Ramachandran R. Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. JAMA Internal Medicine 2023, 183: 1164-1166. PMID: 37603342, PMCID: PMC10442781, DOI: 10.1001/jamainternmed.2023.2842.Peer-Reviewed Original ResearchUnique Device Identifiers for Medical Devices at 10 Years
Dhruva S, Ross J, Wilson N. Unique Device Identifiers for Medical Devices at 10 Years. JAMA Internal Medicine 2023, 183: 1045-1046. PMID: 37603351, DOI: 10.1001/jamainternmed.2023.3572.Commentaries, Editorials and LettersFinancial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices
Lu A, Ji R, Ge A, Ross J, Ramachandran R, Redberg R, Dhruva S. Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices. JAMA 2023, 330: 1094-1096. PMID: 37589985, PMCID: PMC10436180, DOI: 10.1001/jama.2023.14414.Peer-Reviewed Original ResearchResearch misconduct as a challenge for academic institutions and scientific journals
Candal-Pedreira C, Ross J, Marušić A, Ruano-Ravina A. Research misconduct as a challenge for academic institutions and scientific journals. Journal Of Epidemiology & Community Health 2023, 78: 61-64. PMID: 37666652, DOI: 10.1136/jech-2023-220554.Peer-Reviewed Original ResearchConceptsResearch misconductScientific journalsGatekeepers of sciencePrevent research misconductUnethical practicesMisconductPublic skepticismScientific researchAcademic institutionsIncreasing distrustScientific communityScienceAcademic literatureSkepticismInstitutionsJournalsNegative consequencesDistrustRetraction of articlesResearch fundersDefenceJoint effortArticleResearchContextAssessing 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 ResearchConceptsBaseline 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 ResearchApproval of Drugs With Unmet Trial End Points—In Reply
Johnston J, Ross J, Ramachandran R. Approval of Drugs With Unmet Trial End Points—In Reply. JAMA Internal Medicine 2023, 183: 889-890. PMID: 37307009, DOI: 10.1001/jamainternmed.2023.2240.Peer-Reviewed Original Research