Predictors of Comprehension during Surgical Informed Consent

Presented at the American College of Surgeons 95th Annual Clinical Congress, Chicago, IL, October 2009.

Received 17 December 2009; received in revised form 27 January 2010; accepted 24 February 2010. published online 29 April 2010.

Background

Patient comprehension during surgical informed consent remains problematic. Using data from our randomized trial of methods to improve informed consent comprehension, we performed an additional analysis to define independent factors associated with improved patient understanding.

Study Design

Patients scheduled for 1 of 4 elective operations (total hip arthroplasty [n = 137], carotid endarterectomy [n = 178], laparoscopic cholecystectomy [n = 179], or radical prostatectomy [n = 81]) at 7 Department of Veterans Affairs (VA) medical centers were enrolled. All informed consent discussions were performed using iMedConsent (Dialog Medical), the VA's computerized informed consent platform. Using a unique module within iMedConsent, we randomized patients to repeat back (RB), requiring correct reiteration of procedure-specific facts, or standard (STD) iMedConsent. Patient comprehension was tested after the informed consent discussion using procedure-specific questionnaires. Time spent completing the informed consent process was measured using time stamps within iMedConsent. Multiple linear regression identified factors independently associated with improved comprehension.

Results

We enrolled 575 patients (276 RB, 299 standard); 93% were male, 74% were Caucasian, and 89% had at least a high school education. Independent factors associated with improved comprehension included race (p < 0.01), ethnicity (p < 0.05), age (p < 0.02), operation type (p < 0.01), group assignment (± RB; p < 0.05), and total consent time (p < 0.0001). Patient comprehension was maximized when informed consent took between 15 and 30 minutes. RB's positive impact on patient comprehension was weaker in the analysis including consent time.

Conclusions

Comprehension during informed consent discussions may be limited in individuals with potential language difficulty due to ethnicity or education. Total consent time was the strongest predictor of patient comprehension. Affording adequate time for informed consent discussions and using informed consent adjuncts such as RB may enhance comprehension in such individuals.

Abbreviations and Acronyms: RB, repeat back, REALM, Rapid Estimate of Adult Literacy in Medicine, SF-12, Short Form Health Survey-12, STAI, State-Trait Anxiety Inventory, VHA, Veterans Health Administration

a Atlanta VAMC, Decatur, GA

b Department of Surgery, Emory University School of Medicine, Atlanta, GA

c Denver VAMC, Denver, CO

d University of Colorado Health Outcomes Program, Denver, CO

e Michael DeBakey VAMC and Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX

f Boston VAMC and Departments of Surgery, Boston University and Harvard Medical School, Boston, MA

g Denver VAMC and Department of Surgery, University of Colorado, Denver, CO

h Portland VAMC and Department of Surgery, Oregon Health & Science University, Portland, OR

i Pittsburgh VAMC and Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA

j Tampa VAMC and Department of Surgery, University of South Florida, Tampa, FL

k Department of Psychology, University of Alabama, Tuscaloosa, AL

Correspondence address: Aaron S Fink, MD, VAMC Atlanta (112), 1670 Clairmont Rd, Decatur, GA 30033

The work was supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (Project no. IAF 05-308-01). The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

Disclosure Information: Nothing to disclose.

PII: S1072-7515(10)00177-8

doi:10.1016/j.jamcollsurg.2010.02.049

Published by Elsevier Inc.

6 of 31