2021
Optimiser les données accessibles dans le portail de renseignements cliniques de Santé Canada
Egilman AC, Ross JS, Herder M. Optimiser les données accessibles dans le portail de renseignements cliniques de Santé Canada. Canadian Medical Association Journal 2021, 193: e1616-1618. PMID: 34663613, PMCID: PMC8547254, DOI: 10.1503/cmaj.210877-f.Commentaries, Editorials and Letters
2020
Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products
Dhruva SS, Shah ND, Ross JS. Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products. Mayo Clinic Proceedings 2020, 95: 2609-2611. PMID: 33289654, DOI: 10.1016/j.mayocp.2020.04.013.Commentaries, Editorials and LettersThe Promise of Big Data and Digital Solutions in Building a Cardiovascular Learning System: Opportunities and Barriers.
Mori M, Khera R, Lin Z, Ross JS, Schulz W, Krumholz HM. The Promise of Big Data and Digital Solutions in Building a Cardiovascular Learning System: Opportunities and Barriers. Methodist DeBakey Cardiovascular Journal 2020, 16: 212-219. PMID: 33133357, PMCID: PMC7587314, DOI: 10.14797/mdcj-16-3-212.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsLearning health systemLearning systemCommon data modelDynamic learning systemAdvanced analyticsBig dataData assetsData modelDigital solutionsCustomer interactionContinuous learningKnowledge generationEffective useConceptual modelAnalyticsSystemGoogleHealth systemLearningComparable scaleModelDataCompaniesConfidentiality Orders and Public Interest in Drug and Medical Device Litigation
Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A. Confidentiality Orders and Public Interest in Drug and Medical Device Litigation. JAMA Internal Medicine 2020, 180: 292-299. PMID: 31657836, DOI: 10.1001/jamainternmed.2019.5161.Commentaries, Editorials and LettersMeSH KeywordsAccess to InformationConfidentialityDisclosureDrug IndustryHumansJurisprudenceLiability, LegalConceptsLegal practicePublic interestMedical device litigationImportant public health informationLegal standardsMedical device manufacturersLitigationSpecial communicationCourtObscure patternsCompany marketingMedical expertsRulesPublic health informationDevice manufacturersPublic healthSuccessful effortsLitigantsPracticePlaintiffsLawsuitsCertain typesInterestAccessDrug Administration
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewers
2016
Open Access Platforms for Sharing Clinical Trial Data
Ross JS, Krumholz HM. Open Access Platforms for Sharing Clinical Trial Data. JAMA 2016, 316: 666-666. PMID: 27532929, DOI: 10.1001/jama.2016.8794.Commentaries, Editorials and LettersAvailability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials
Murugiah K, Ritchie JD, Desai NR, Ross JS, Krumholz HM. Availability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials. Journal Of The American Heart Association 2016, 5: e003307. PMID: 27098969, PMCID: PMC4859296, DOI: 10.1161/jaha.116.003307.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationCardiotonic AgentsCardiovascular DiseasesDrug IndustryHumansInformation DisseminationRandomized Controlled Trials as TopicConceptsIndividual participant-level dataLarge cardiovascular trialsCardiovascular trialsParticipant-level dataClinical trial dataPharmaceutical companiesMajor pharmaceutical companiesIndustry-sponsored clinical trialsInterventional trialsAvailable trialsClinical trialsTrial dataTrialsPatientsSpecific reasons
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
Attitudes of Hospital Leaders Toward Publicly Reported Measures of Health Care Quality
Lindenauer PK, Lagu T, Ross JS, Pekow PS, Shatz A, Hannon N, Rothberg MB, Benjamin EM. Attitudes of Hospital Leaders Toward Publicly Reported Measures of Health Care Quality. JAMA Internal Medicine 2014, 174: 1904-1911. PMID: 25286316, PMCID: PMC4250277, DOI: 10.1001/jamainternmed.2014.5161.Peer-Reviewed Original ResearchConceptsPatient experience measuresPredictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey
Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Dzara K, Ross JS. Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey. Trials 2014, 15: 384. PMID: 25277128, PMCID: PMC4192345, DOI: 10.1186/1745-6215-15-384.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationAgedAttitude of Health PersonnelChi-Square DistributionClinical Trials as TopicCooperative BehaviorCross-Sectional StudiesDatabases, FactualFemaleHealth Knowledge, Attitudes, PracticeHumansInformation DisseminationInternetMaleMiddle AgedPerceptionRegistriesResearch PersonnelSurveys and QuestionnairesConceptsTrial funding sourceExact testMain outcome measuresFisher's exact testCross-sectional surveyChi-square testClinical trialsTrial characteristicsOutcome measuresGeneral medical journalsClinical trialistsWeb-based surveyTrialistsExploratory analysisBackgroundA numberStatistical significanceSignificant differencesExternal investigatorsClinical trial data sharingTrialsMedical journalsPharmaceutical companiesFunding sourcesIndustry fundingPotential respondents
2011
A Model for Dissemination and Independent Analysis of Industry Data
Krumholz HM, Ross JS. A Model for Dissemination and Independent Analysis of Industry Data. JAMA 2011, 306: 1593-1594. PMID: 21990302, PMCID: PMC3688082, DOI: 10.1001/jama.2011.1459.Commentaries, Editorials and Letters