Multi-center Validation Study of a Large Language Model-based Intelligent Agent for Blood Cell Analysis

Обзор

I. Study Background: Currently, in most medical institutions, the review of blood cell analysis still heavily relies on manual verification by laboratory staff. This process requires a comprehensive analysis of instrument parameters, alarm flags, historical comparison results, and, when necessary, microscopic examination. However, with the increasing volume of test samples and the high concentration of review tasks during peak hours, the traditional manual review model increasingly shows problems such as prolonged turnaround time (TAT), uneven workload distribution, and decreased consistency in reviews. In recent years, intelligent review systems based on Large Language Models (LLM) have shown potential in analyzing abnormal results and stratifying sample risks by integrating preset rules, clinical diagnostic information, and multi-dimensional laboratory data, which is expected to optimize the review workflow. II. Study Objective: To evaluate the difference in overall sample review turnaround time between the experimental process and the control process during the formal study phase, and to test its superiority. III. Subjects: The investigators need to recruit approximately 20,000 subjects, regardless of age or gender. IV. Study Procedures: If participants agree to participate in the study, participants only need to allow us to use participants test results after participants have completed your routine blood test (CBC). V. Risks and Benefits: 1. Risks: This study poses no risk to the subjects. The investigators only use the result data of patients after participants have had their routine blood test; there is no need for patients to undergo additional blood draws. 2. Benefits: It will shorten the turnaround time for routine blood test results and share the workload of doctors in reviewing these results. VI. Privacy: All of participants information will be kept strictly confidential and will only be used for this scientific research.

Вмешательства

• Другое LLM-Assisted Review Group
  This study introduces an intelligent auxiliary review system based on a medical Large Language Model (LLM), aimed at optimizing the traditional CBC report review process. The core functions and intervention mechanisms are as follows: Multi-source Data Integration: The system integrates seamlessly with the Laboratory Information System (LIS) to automatically retrieve patient demographics (age, sex), current CBC indices, historical results, and clinical diagnoses. Deep Analysis and Anomaly Detec

Первичные конечные точки

• Overall Report Turnaround Time [Срок оценки: one year]

Критерии участия

Критерии включения

• Subjects who underwent routine blood tests in the outpatient, emergency, or inpatient departments of the participating centers during the study period.

Corresponding samples must have complete instrument results, review trails, and report timestamp records.

Approved for inclusion by the Ethics Committee.

Критерии исключения

• Samples collected during periods of instrument malfunction or interface transmission anomalies.

Missing key research data, particularly samples where the final review conclusion or key timestamps cannot be confirmed.

Subjects or their legal representatives explicitly refuse to participate in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607184 · KY2026-084

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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