2020
The 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 documentsDrugsDiabetesFDAAAReviewersData Escrow and Clinical Trial Transparency.
Krumholz HM, Kim J. Data Escrow and Clinical Trial Transparency. Annals Of Internal Medicine 2017, 166: 893-894. PMID: 28384786, DOI: 10.7326/m17-0743.Peer-Reviewed Original Research
2016
Healthcare Disparities Affecting Americans in the US Territories: A Century-Old Dilemma
Rodríguez-Vilá O, Nuti SV, Krumholz HM. Healthcare Disparities Affecting Americans in the US Territories: A Century-Old Dilemma. The American Journal Of Medicine 2016, 130: e39-e42. PMID: 27593609, DOI: 10.1016/j.amjmed.2016.07.036.Peer-Reviewed Original ResearchOpen 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
The End of Journals
Krumholz HM. The End of Journals. Circulation Cardiovascular Quality And Outcomes 2015, 8: 533-534. PMID: 26555127, PMCID: PMC5322965, DOI: 10.1161/circoutcomes.115.002415.Peer-Reviewed Original ResearchPoorly 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
Predictors 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 respondentsIncreasing value and reducing waste: addressing inaccessible research
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HB. Increasing value and reducing waste: addressing inaccessible research. The Lancet 2014, 383: 257-266. PMID: 24411650, PMCID: PMC4533904, DOI: 10.1016/s0140-6736(13)62296-5.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationBiomedical ResearchClinical Trials as TopicHumansInformation DisseminationPeriodicals as TopicPublication BiasPublishingResearch DesignConceptsFull study reports
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 LettersPublic reporting of hospital outcomes: a challenging road ahead
Gallagher MP, Krumholz HM. Public reporting of hospital outcomes: a challenging road ahead. The Medical Journal Of Australia 2011, 194: 658-660. PMID: 21692729, DOI: 10.5694/j.1326-5377.2011.tb03156.x.Peer-Reviewed Original Research