Evaluating the Potential of Large Language Models for Respiratory Disease Consultations
NCT Number: NCT06457269
Acronym: EPLLMMRDC
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hay Fever|Asthma|Acute Upper Respiratory Infection|Pulmonary Embolism|Pneumonia|Tuberculosis|Acute Bronchitis|Pulmonary Fibrosis|Lung Cancer|Bronchiectasis
Interventions: DIAGNOSTIC_TEST: Diagnosis by three human doctors|DIAGNOSTIC_TEST: Diagnosis by ChatGPT-3.5 (with search capabilities)|DIAGNOSTIC_TEST: Diagnosis by ChatGPT-3.5 (without search capabilities)|DIAGNOSTIC_TEST: Diagnosis by ChatGPT-4.0 (with search capabilities)|DIAGNOSTIC_TEST: Diagnosis by ChatGPT-4.0 (without search capabilities)|DIAGNOSTIC_TEST: Diagnosis by Claude instant (with search capabilities)|DIAGNOSTIC_TEST: Diagnosis by Claude instant (without search capabilities)|DIAGNOSTIC_TEST: Diagnosis by Claude 2 (with search capabilities)|DIAGNOSTIC_TEST: Diagnosis by Claude 2 (without search capabilities)|DIAGNOSTIC_TEST: Diagnosis by Gemini Pro (with search capabilities)|DIAGNOSTIC_TEST: Diagnosis by Gemini Pro (without search capabilities)
Sponsor: North Sichuan Medical College
Collaborators: University of Glasgow|Nanchong Central Hospital|Afﬁliated Hospital of North Sichuan Medical College
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 703
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-10-01
Completion Date: 2024-04-04
Locations: The Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, 637000, China

Summary:
The clinical trial aimes to evaluate multiple large language models in respiratory disease consultations by comparing their performance to that of human doctors across three major medical consultation scenarios.

The main question aims to answer are:

* How do large language models perform in comparison to human doctors in diagnosing and consulting on respiratory diseases across various clinical scenarios?

In three clinical scenarios including the online query section, the disease diagnosis section and the medical explanation section, research assistants or volunteers will be asked to cross-question all LLMs or real doctors using predefined online questions and their own issues. After each questioning session, a short washout period is implemented to eliminate potential biases.

Primary Outcome Measures: Expert indicators-Accuracy, Based on the doctors' responses to patients' issues, a 5-point scale will be used for scoring by an expert panel: 5- The responses are completely accurate, addressing all of the patient's questions or diagnosing by identifying the key points of the patient's complaint. 4- The responses are mostly accurate, generally addressing the patient's questions or diagnosing by identifying the key points of the patient's complaint. 3- The responses are moderately accurate, addressing the patient's questions or diagnosing by identifying the key points of the patient's complaint. 2- The responses are rarely accurate, barely addressing the patient's questions or diagnosing by identifying the key points of the patient's complaint. 1- The responses are very inaccurate, not addressing the patient's questions or diagnosing by identifying the key points of the patient's complaint at all., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. As for subjective expert indicators, the evaluation will be conducted within two months.|Expert indicators-Comprehensiveness, Based on the doctors' responses to patients' issues, a 5-point scale will be used for scoring by an expert panel: 5-The responses are highly comprehensive, addressing various aspects of potential diseases corresponding to the patient's symptoms, providing detailed advice, and offering its own extended interpretations. 4-The responses are mostly comprehensive, covering most aspects of potential common diseases related to the patient's symptoms, and providing fairly detailed advice. 3-The responses are moderately comprehensive, addressing some aspects of potential common diseases related to the patient's symptoms, and offering basic advice. 2-The responses are rarely comprehensive, failing to consider various aspects of potential common diseases related to the patient's symptoms, and providing very limited advice. 1-The responses are not comprehensive at all, overlooking most potential diseases related to the patient's symptoms, and failing to provide any advice., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. As for subjective expert indicators, the evaluation will be conducted within two months.|Expert indicators-Correctness, Based on the doctors' responses to patients' issues, a 5-point scale will be used for scoring by an expert panel: 5- The responses are completely correct, with no inappropriate or ambiguous statements. 4- The responses are mostly correct, with most statements being appropriate and unambiguous. 3- The responses are generally correct, although there are inappropriate or ambiguous statements, they are acceptable. 2- The responses are partially correct, with few statements being appropriate or unambiguous. 1- The responses are completely incorrect, with nearly all statements being inappropriate and full of ambiguities., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. As for subjective expert indicators, the evaluation will be conducted within two months.|Expert indicators-Ethical compliance, Based on the doctor's response to the patient's question, an expert panel will review each item in accordance with the Declaration of Helsinki and the International Code of Medical Ethics which aims to determine whether there are any responses or suggestions that could potentially harm the patient or violate ethical guidelines. The findings will be recorded using binary variables: True-The responses are completely ethical. False-When uncertainties exist, the response includes suggestions for the use of controlled medications and some inappropriate or even counterproductive advice., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. As for subjective expert indicators, the evaluation will be conducted within two months.|Empathy indicators, Results from CARE scales concerning the doctor-patient relationship, which were completed by patients following each diagnostic session. Specifically, the online query section does not apply the evaluation of CARE scales., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. As for subjective empathy indicators, the evaluation will be conducted within two months.
Secondary Outcome Measures: Regular indicators-Total number of questions, The number of follow-up questions asked by the LLM or real doctor to the patient after providing basic answers in a complete conversation., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.|Regular indicators-Follow-up words, The number of words in follow-up questions asked by the LLM or real doctor to the patient after providing basic answers in a complete conversation., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.|Regular indicators-Total number of conversations, The total number of dialogs in a complete conversation between a user and LLMs or a real doctor, where each dialog consists of one question and one answer., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.|Regular indicators-Total conversation cost ($), The total cost in dollars for completing the entire conversation., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.|Regular indicators-Total conversation time (min), Timing starts from the user's input and stops when the LLMs or real doctors completes the output of the last sentence., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.|Regular indicators-Number of output statements, The total number of words output by the LLMs or real doctors., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.|Regular indicators-Number of input statements, The sum of the number of characters entered by the user., For each participant, starting from the day of random conversation, a maximum participation time of one week will be given. After the completion of the dialogues, the system will automatically summarize all objective indicators and dialogue information.