Patient Perceptions of Surgical Informed Consent: Is Repeat Back Helpful or Harmful?

BACKGROUNDInformed consent (IC)comprehension is suboptimal. Repeat back (RB)—asking the patient to repeat in their own words key elements of the consent—is believed to improve the consent process. OBJECTIVEThis study aims to assess the impact of RB on patient perceptions of surgical informed consent. DESIGNSecondary analysis of a randomized trial. SUBJECTSElective surgical patients were consented using iMedConsent, the VA’s computer-based IC platform. Patients were randomized to RB (IC could not be signed until the patient satisfactorily expressed key elements) or standard iMedConsent (no RB). MEASURESA questionnaire was given immediately after IC assessing time for decision, satisfaction with and ease of understanding consent, and the amount of information provided about the proposed surgery (e.g., indications, benefits, risks, and alternatives). Groups were compared with Χ tests. RESULTSWe enrolled 575 subjects (276 RB and 299 no RB); 92% were men with a mean age of 61.6 years and high school level reading ability. The groups were comparable in their perceptions regarding time to make a decision (RB 88% Strongly Agree (SA), no RB 88% SA; P = 0.61), satisfaction with consent (RB 90% SA, no RB 87% SA; P = 0.27), ease of understanding (RB 69% SA, no RB 67% SA; P = 0.73) receipt of the right amount of information regarding the indications (RB 85% SA, no RB 87%; P = 0.61), the benefits (RB 87% SA, no RB 86% SA; P = 0.29), and the risks (RB 87% SA, no RB 84% SA; P = 0.19) of surgery. More of the RB group felt they received the right amount of information about alternatives to surgery (RB 80% SA) than did the no RB group (69% SA); P = 0.01. CONCLUSIONSPatients were highly satisfied with RB during surgical IC RB is not detrimental to the consent process and may improve informed consent for surgery. TRIAL REGISTRATIONClinical Trials Identifier NCT00288899 http://www.clinicaltrials.gov