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 transparencyHarmReportsGuidelinesOutcomesEndpointPrescription 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 ResearchIntravascular 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 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 ResearchTherapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Vokinger K, Glaus C, Kesselheim A, Serra-Burriel M, Ross J, Hwang T. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study. The BMJ 2023, 382: e074166. PMID: 37407074, PMCID: PMC10320829, DOI: 10.1136/bmj-2022-074166.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysiciansAssociation of Receipt of Paycheck Protection Program Loans With Staffing Patterns Among US Nursing Homes
Travers J, McGarry B, Friedman S, Holaday L, Ross J, Lopez L, Chen K. Association of Receipt of Paycheck Protection Program Loans With Staffing Patterns Among US Nursing Homes. JAMA Network Open 2023, 6: e2326122. PMID: 37498597, PMCID: PMC10375300, DOI: 10.1001/jamanetworkopen.2023.26122.Peer-Reviewed Original ResearchConceptsUS nursing homesNursing homesPaycheck Protection ProgramPPP loansMean differenceEconomic evaluationLoan programsLoan recipientsAssociation of receiptArea Deprivation IndexHealthcare Cost Report Information SystemAgriculture Rural-Urban Continuum CodesRural-Urban Continuum CodesTotal weekly hoursEvent study approachNursing Home CompareMinimum Data SetSmall Business AdministrationPaycheck Protection Program (PPP) loansMAIN OUTCOMELPN hoursPractical nursesResident careLoan amountStudy periodAvailability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original Research