A Simulated Case Study of a Peritoneal Dialysis-Specialized Large Language Model Assisting Doctors in Improving Decision-Making in Peritoneal Dialysis Management

Официальное название

Generative AI-Assisted Understanding and Decision Enhancement in Peritoneal Dialysis: A Randomized Controlled Trial (The GUIDE-PD Trial)

Обзор

This study is a randomized controlled trial based on simulated clinical cases, aiming to establish a standardized evaluation system for PD physicians, to assess the differences in PD management quality between a workflow assisted by a PD-specialized large language model and physician-only decision-making, and to identify potential risks (such as generating obviously erroneous or even harmful recommendations). This simulated clinical case framework not only supports standardized and blinded evaluation, but also provides preliminary evidence for the model's effectiveness and safety before its deployment in real clinical settings, while avoiding direct impact on real patients.

Вмешательства

• Другое Peritoneal dialysis-specialized large language model.
  The peritoneal dialysis-specialized large language model (PD-LLM) used in this study was jointly developed by the Department of Nephrology at the First Affiliated Hospital of Sun Yat-sen University and Digital Health China (DHC).

Первичные конечные точки

• Management Reasoning [Срок оценки: Within the 120-minute test period of the first test.]

Вторичные конечные точки (5)

• Domain-Specific Scores [Срок оценки: Within the 120-minute test period of the first test.]
• Severity of Potential Harm [Срок оценки: Within the 120-minute test period of the first test.]
• Time per Scenario Case [Срок оценки: Within the 120-minute test period of the first test.]
• Self-Reported Confidence per Case [Срок оценки: Within the 120-minute test period of the first test.]
• Difference between the Phys group's scores when tested with PD-LLM assistance and when assisted only by traditional search methods [Срок оценки: After 1-2 months of washout of first test]

Критерии участия

Критерии включения

• Internal medicine or nephrology standardized training residents, licensed residents, or attending physicians.
• Independent experience in PD management ≤ 3 years.
• Provided signed informed consent and agreed to comply with the trial procedures.

Критерии исключения

• Direct involvement in the development or training of the specialized PD large language model, or in the construction of the clinical scenarios/ scoring criteria used in this trial.
• Participation in the pilot testing of all clinical scenarios used in this trial.
• Inability or unwillingness to access the study platform or use online resources during the study period.
• Experienced PD experts.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07724327 · IIT-2026-511

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗