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
2020
Confidentiality 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 LettersConceptsLegal practicePublic interestMedical device litigationImportant public health informationLegal standardsMedical device manufacturersLitigationSpecial communicationCourtObscure patternsCompany marketingMedical expertsRulesPublic health informationDevice manufacturersPublic healthSuccessful effortsLitigantsPracticePlaintiffsLawsuitsCertain typesInterestAccessDrug Administration
2011
Promoting transparency in pharmaceutical industry-sponsored research.
Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry-sponsored research. American Journal Of Public Health 2011, 102: 72-80. PMID: 22095335, PMCID: PMC3319748, DOI: 10.2105/ajph.2011.300187.Commentaries, Editorials and LettersConceptsClinical trial researchTrial researchIndividual clinical decisionsGuideline recommendationsEvidence-based practiceTRIAL REGISTRATIONSystematic reviewClinical decisionInvestigator contributionsTrial outcomesMedical literaturePublic healthSelective publicationClinical trial data analysisHealthTrial data analysisIndustry-sponsored researchPatientsPhysicians
2001
Cardiopatía isquémica en el anciano
Krumholz H. Cardiopatía isquémica en el anciano. Revista Española De Cardiología 2001, 54: 819-826. PMID: 11446955, DOI: 10.1016/s0300-8932(01)76405-6.Peer-Reviewed Original ResearchConceptsOlder patientsClinical trialsClinical practiceObservational studyPrognosis of illnessOlder patient groupGroup of patientsAcute myocardial infarctionDaily clinical practiceComorbidities increasesYounger patientsHeart failureMortal complicationsPatient groupMyocardial infarctionHigh incidencePatientsMedical focusFunctional changesField of cardiologyTrialsPublic healthDevelopment of strategiesHeterogeneous populationAge