2022
Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2014
Big Data And New Knowledge In Medicine: The Thinking, Training, And Tools Needed For A Learning Health System
Krumholz HM. Big Data And New Knowledge In Medicine: The Thinking, Training, And Tools Needed For A Learning Health System. Health Affairs 2014, 33: 1163-1170. PMID: 25006142, PMCID: PMC5459394, DOI: 10.1377/hlthaff.2014.0053.Peer-Reviewed Original ResearchConceptsBig dataNext-generation analyticsHealth care dataNew data sourcesAdvanced analyticsData meaningLearning health systemInformation needsUnmet information needsMassive quantitiesData sourcesHealth policy makersComplexity of patientsAnalyticsLearning health care systemComparative effectiveness researchHealth care systemPopulation health researchKnowledge generationCare dataHealth systemPatientsCare systemEffectiveness researchHealth research