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dc.contributor.authorKucia, A.-
dc.contributor.authorHorowitz, J.-
dc.identifier.citationAmerican Heart Journal, 2000; 140(1):94-97-
dc.description.abstract<h4>Methods</h4>Patient understanding of clinical trial details was assessed on 2 occasions (10 +/- 4 and 24 +/- 3 hours after randomization) in 20 patients enrolled for randomized investigation of pharmacotherapy for unstable angina pectoris or non-Q-wave myocardial infarction in the Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organized Network (PARAGON B) and Organization to Assess Strategies in Ischemic Syndromes (OASIS-2) trials.<h4>Results</h4>Initial total score for understanding of 52.0% (+/-15.7%) of maximal values improved to 67.7% (+/-18.3%) at repeat interview (P <.001). The mean initial score for knowledge of potential benefit was 85.0% (+/-33.3%) with no significant improvement at repeat interview. Scores for knowledge of risk improved from 35.0% (+/-36.6%) to 68.2% (+/-41.2%) at repeat interview (P <.005). Significant determinants of poor initial score were female sex, limited education, and presence of pain during the consent process; young age was the only determinant of improvement on repeat assessment.<h4>Conclusion</h4>Thus initial understanding of the research protocols for patients with unstable angina pectoris or non-Q-wave acute myocardial infarction was imperfect, with far greater impairment of knowledge of risk than of benefit.-
dc.publisherMosby Inc-
dc.subjectCoronary Disease-
dc.subjectAngina, Unstable-
dc.subjectMyocardial Infarction-
dc.subjectPlatelet Aggregation Inhibitors-
dc.subjectMultivariate Analysis-
dc.subjectRisk Factors-
dc.subjectDouble-Blind Method-
dc.subjectHealth Knowledge, Attitudes, Practice-
dc.subjectAge Factors-
dc.subjectInformed Consent-
dc.subjectMiddle Aged-
dc.subjectClinical Trials as Topic-
dc.subjectSurveys and Questionnaires-
dc.titleIs informed consent to clinical trials an "upside selective" process in acute coronoary syndromes?-
dc.typeJournal article-
dc.identifier.orcidKucia, A. [0000-0002-7606-7717]-
dc.identifier.orcidHorowitz, J. [0000-0001-6883-0703]-
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