Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods

Ann Thorac Surg. 2014 May;97(5):1505-11; discussion 1511-2. doi: 10.1016/j.athoracsur.2013.12.065. Epub 2014 Mar 12.


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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Ambulatory Surgical Procedures / methods
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / methods*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Communication
  • Comprehension*
  • Coronary Disease / diagnostic imaging
  • Coronary Disease / surgery
  • Elective Surgical Procedures / methods
  • Female
  • Follow-Up Studies
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Informed Consent*
  • Male
  • Mental Recall
  • Middle Aged
  • Patient Education as Topic / methods*
  • Pilot Projects
  • Preoperative Care / methods
  • Radiography
  • Risk Assessment
  • Surveys and Questionnaires
  • Treatment Outcome