Evaluating the Potential of Large Language Models for Respiratory Disease Consultations
EPLLMMRDC
5 other identifiers
interventional
703
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2023
CompletedFirst Submitted
Initial submission to the registry
June 4, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2024
CompletedNovember 27, 2024
November 1, 2024
2 months
June 4, 2024
November 24, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (7)
Regular indicators-Total number of questions
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
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
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 ($)
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)
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.
- +2 more secondary outcomes
Study Arms (2)
Cross-comparison group(the disease diagnosis section)
OTHERCross-comparison group (including human doctor controls and all LLMs)
Cross-comparison group(the medical explanation section)
OTHERCross-comparison group (including human doctor controls and all LLMs)
Interventions
This intervention involves answering patient inquiries by different human doctors. Each patient is randomly assigned by the system to three doctors from different provinces in China selected from the database of doctors. The doctors all come from multiple online consultation platforms in China, and their diagnostic qualifications and medical licenses have undergone strict verification.
This intervention involves answering patient inquiries by ChatGPT-3.5 with search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by ChatGPT-3.5 without search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by ChatGPT-4.0 with search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by ChatGPT-4.0 without search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by Claude instant with search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by Claude instant without search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by Claude 2 with search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by Claude 2 without search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by Gemini Pro with search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
This intervention involves answering patient inquiries by Gemini Pro without search capabilities, before answering any questions, clear the chat history from the previous patient and input the predetermined initialization statement.
Eligibility Criteria
You may qualify if:
- Self-reported symptoms of common respiratory diseases, such as cough, chest tightness, fever, and wheezing
- Ability to engage in LLM dialog operations independently or with minimal peer training
- A health status deemed suitable for study participation by the pulmonology experts
You may not qualify if:
- \) Excessively poor health status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- North Sichuan Medical Collegelead
- University of Glasgowcollaborator
- Nanchong Central Hospitalcollaborator
- Affiliated Hospital of North Sichuan Medical Collegecollaborator
Study Sites (1)
The Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Related Publications (1)
Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
PMID: 15528286BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiebin Xie, Doctor
North Sichuan Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2024
First Posted
June 13, 2024
Study Start
October 1, 2023
Primary Completion
December 12, 2023
Study Completion
October 12, 2024
Last Updated
November 27, 2024
Record last verified: 2024-11