Large Language Model-Based Chatbot vs Surgeon-Generated Informed Consent Documentation for Common Procedures.

IMPORTANCE

Informed consent is a critical component of patient care before invasive procedures, yet it is frequently inadequate. Electronic consent forms have the potential to facilitate patient comprehension if they provide information that is readable, accurate, and complete; it is not known if large language model (LLM)-based chatbots may improve informed consent documentation by generating accurate and complete information that is easily understood by patients.

OBJECTIVE

To compare the readability, accuracy, and completeness of LLM-based chatbot- vs surgeon-generated information on the risks, benefits, and alternatives (RBAs) of common surgical procedures.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study compared randomly selected surgeon-generated RBAs used in signed electronic consent forms at an academic referral center in San Francisco with LLM-based chatbot-generated (ChatGPT-3.5, OpenAI) RBAs for 6 surgical procedures (colectomy, coronary artery bypass graft, laparoscopic cholecystectomy, inguinal hernia repair, knee arthroplasty, and spinal fusion).

MAIN OUTCOMES AND MEASURES

Readability was measured using previously validated scales (Flesh-Kincaid grade level, Gunning Fog index, the Simple Measure of Gobbledygook, and the Coleman-Liau index). Scores range from 0 to greater than 20 to indicate the years of education required to understand a text. Accuracy and completeness were assessed using a rubric developed with recommendations from LeapFrog, the Joint Commission, and the American College of Surgeons. Both composite and RBA subgroup scores were compared.

RESULTS

The total sample consisted of 36 RBAs, with 1 RBA generated by the LLM-based chatbot and 5 RBAs generated by a surgeon for each of the 6 surgical procedures. The mean (SD) readability score for the LLM-based chatbot RBAs was 12.9 (2.0) vs 15.7 (4.0) for surgeon-generated RBAs (P = .10). The mean (SD) composite completeness and accuracy score was lower for surgeons' RBAs at 1.6 (0.5) than for LLM-based chatbot RBAs at 2.2 (0.4) (P < .001). The LLM-based chatbot scores were higher than the surgeon-generated scores for descriptions of the benefits of surgery (2.3 [0.7] vs 1.4 [0.7]; P < .001) and alternatives to surgery (2.7 [0.5] vs 1.4 [0.7]; P < .001). There was no significant difference in chatbot vs surgeon RBA scores for risks of surgery (1.7 [0.5] vs 1.7 [0.4]; P = .38).

CONCLUSIONS AND RELEVANCE

The findings of this cross-sectional study suggest that despite not being perfect, LLM-based chatbots have the potential to enhance informed consent documentation. If an LLM were embedded in electronic health records in a manner compliant with the Health Insurance Portability and Accountability Act, it could be used to provide personalized risk information while easing documentation burden for physicians.