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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.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.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 (p0.01), ethnicity (p0.05), age (p0.02), operation type (p0.01), group assignment (+/- RB; p0.05), and total consent time (p0.0001). 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.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.

In this randomized, controlled, unblinded trial, we sought to test Repeat Back's (RB) effect on comprehension following informed consent discussions.RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. Despite preliminary data, this practice has not been evaluated in any large scale study.This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA's computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and chi tests.A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4%) versus the no RB group (68.2%, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4% vs. no RB = 67.7%, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB.RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).