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
2003
Overestimation of genetic risks owing to small sample sizes in cardiovascular studies
Morgan T, Coffey C, Krumholz H. Overestimation of genetic risks owing to small sample sizes in cardiovascular studies. Clinical Genetics 2003, 64: 7-17. PMID: 12791034, DOI: 10.1034/j.1399-0004.2003.00088.x.Peer-Reviewed Original ResearchConceptsACE DMyocardial infarctionRisk factorsPublication biasEnzyme deletion polymorphismStudies of angiotensinThrombotic risk factorsGenetic risk factorsPotential publication biasCardiovascular outcomesPlA2 polymorphismOdds ratioEgger's testFunnel plotSystematic reviewCardiovascular studiesRelevant outcomesOverall riskSmall sample sizeGenetic riskSample sizeDeletion polymorphismUnderpowered studiesInfarctionPLA2