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

Shubha Dathatri; Luis Gruberg; Jatin Anand; Jamie Romeiser; Shephali Sharma; Eileen Finnin; A Laurie W Shroyer; Todd K Rosengart

doi:10.1016/j.athoracsur.2013.12.065

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.

Authors

Shubha Dathatri¹, Luis Gruberg², Jatin Anand¹, Jamie Romeiser³, Shephali Sharma³, Eileen Finnin³, A Laurie W Shroyer³, Todd K Rosengart⁴

Affiliations

¹ Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
² Division of Cardiovascular Diseases, Department of Medicine, Stony Brook School of Medicine, Stony Brook, New York.
³ Department of Surgery, Stony Brook University Medicine, Stony Brook, New York.
⁴ Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas; The Texas Heart Institute, Houston, Texas. Electronic address: todd.rosengart@bcm.edu.

PMID: 24629303
DOI: 10.1016/j.athoracsur.2013.12.065

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.

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