DOI: 10.1177/20552076261477303 ISSN: 2055-2076

Impact of AI-Augmented informed consent on preoperative anxiety and patient understanding: A prospective Observational Study

Yavuz Mert Aydın, Tevfik Erdem Özarslan, Reha Girgin, Engin Denizhan Demirkıran, Bülent Akduman, Necmettin Aydın Mungan

Objective

This study evaluated the clinical integration of a large language model (LLM) as a supportive communication tool within the preoperative informed consent pathway.

Methods

Participants completed the State-Trait Anxiety Inventory (STAI)-1, STAI-2, and Amsterdam Preoperative Anxiety and Information Scale (APAIS) scales after undergoing both the standard informed consent process and the subsequent ChatGPT consultation. Additionally, they completed a five-item questionnaire to assess their experience with the digital consultation. Anxiety scores were statistically compared before and after the AI consultation. Patient satisfaction regarding the digital consultation process was analyzed. Additionally, ChatGPT’s responses to the eleven most frequently asked questions were evaluated by three independent urologists in terms of accuracy, comprehensibility, and appropriateness.

Results

Anxiety scores decreased significantly. STAI-1 decreased by 3.2 points and STAI-2 by 1.3 points (both p<0.001). ROC analysis identified minimal clinically significant difference (MCID) thresholds of 1.5 for STAI-1 and 0.5 for STAI-2, indicating that these reductions were clinically significant. In contrast, APAIS scores decreased by 0.89 points (p < 0.001), but the ROC analysis was not significant (AUC = 0.559, p = 0.327), suggesting limited clinical relevance. Subgroup analyses showed that reductions in STAI scores generally exceeded the MCID thresholds, whereas APAIS changes did not consistently achieve clinical meaningfulness. Most participants reported that the ChatGPT consultation contributed to their understanding of the surgery (68%).

Conclusion

LLM-assisted consultation may serve as a scalable adjunct to clinician-led consent by enhancing perioperative communication and reducing situational anxiety, while requiring continued clinical oversight for safe implementation.

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