Abstract
INTRODUCTION: Despite the importance of informed consent in healthcare, the readability and specificity of consent forms often impedes patients’ comprehension. Health literacy is linked to patient outcomes, making it essential to address these issues. METHODS: Consent forms from multiple institutions were assessed for readability and simplified using GPT-4, with pre- and post-simplification readability metrics compared using nonparametric tests. Independent reviews by medical authors and a malpractice defense attorney were conducted. Finally, GPT-4's potential for generating de novo procedure-specific consent forms was assessed, with forms evaluated using a validated 8-item rubric and expert subspecialty surgeon review. RESULTS: Analysis of 15 academic medical centers' consent forms revealed significant reductions in average reading time, word rarity, and passive sentence frequency (all P < 0.05) following GPT-4-faciliated simplification. Readability improved from an average college freshman to an 8th-grade level (P = 0.004), matching the average American's reading level. Medical and legal sufficiency consistency was confirmed. GPT-4 generated procedure-specific consent forms for five varied surgical procedures at an average 6th-grade reading level. These forms received perfect scores on a standardized consent form rubric and withstood scrutiny upon expert subspeciality surgeon review. CONCLUSIONS: This study demonstrates the first AI-human expert collaboration to enhance surgical consent forms, significantly improving readability without sacrificing clinical detail. Moreover, the framework we utilize here can be employed broadly to improve the accessibility of all patient-facing literature in medicine, emphasizing clear communication and mitigating disparities related to health literacy barriers. Ensuring AI technologies are safely incorporated into clinical practice is crucial to reach a wide range of patients, including the most vulnerable.
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