title: Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods.
abstract: BACKGROUND
  Patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) often have a poor understanding of their disease and of related therapeutic risks, benefits, and alternatives. This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients' knowledge of standard consent elements.
  
  
  METHODS
  Patients undergoing first-time elective, outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process (group I) or a web-based, audiovisual presentation (group II). Preconsent and postconsent questionnaires were administered to evaluate changes in patients' self-reported understanding of standard consent elements.
  
  
  RESULTS
  One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys (group I=48; group II=54). Changes in patient comprehension rates were similar between groups for risk and benefit consent elements, but group II had significantly greater improvement in the identification of treatment alternatives than group I (p=0.028). Independent of intervention, correct identification of all risks and alternatives increased significantly after consent (p<0.05); 4 of 5 queried risks were correctly identified by greater than 90% of respondents. However, misperceptions of benefits persisted after consent; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83% and 46% of respondents, respectively.
  
  
  CONCLUSIONS
  Although both scripted verbal and audiovisual informed consent improved patient comprehension, important patient misperceptions regarding PCI-related outcomes and alternatives persist, independent of informed consent approach, and considerable challenges still exist in educating patients about contemplated medical procedures. Future research appears warranted to improve patient comprehension.
authors.affiliation: Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: Shubha
authors.initials: S
authors.lastname: Dathatri
authors.affiliation: Division of Cardiovascular Diseases, Department of Medicine, Stony Brook School of Medicine, Stony Brook, New York.
authors.forename: Luis
authors.initials: L
authors.lastname: Gruberg
authors.affiliation: Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: Jatin
authors.initials: J
authors.lastname: Anand
authors.affiliation: Department of Surgery, Stony Brook University Medicine, Stony Brook, New York.
authors.forename: Jamie
authors.initials: J
authors.lastname: Romeiser
authors.affiliation: Department of Surgery, Stony Brook University Medicine, Stony Brook, New York.
authors.forename: Shephali
authors.initials: S
authors.lastname: Sharma
authors.affiliation: Department of Surgery, Stony Brook University Medicine, Stony Brook, New York.
authors.forename: Eileen
authors.initials: E
authors.lastname: Finnin
authors.affiliation: Department of Surgery, Stony Brook University Medicine, Stony Brook, New York.
authors.forename: A Laurie W
authors.initials: AL
authors.lastname: Shroyer
authors.affiliation: Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas; The Texas Heart Institute, Houston, Texas. Electronic address: todd.rosengart@bcm.edu.
authors.forename: Todd K
authors.initials: TK
authors.lastname: Rosengart
mesh_terms: D000556:Ambulatory Surgical Procedures / Q000379:methods; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D003142:Communication; D032882:Comprehension; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000601:surgery; D017558:Elective Surgical Procedures / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D008297:Male; D011939:Mental Recall; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D011300:Preoperative Care / Q000379:methods; D011859:Radiography; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D016896:Treatment Outcome