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CompletedNCT06457269EPLLMMRDCUpdated Nov 27, 2024

Evaluating the Potential of Large Language Models for Respiratory Disease Consultations

An interventional study of Diagnosis by three human doctors and Diagnosis by ChatGPT-3.5 (with search capabilities) in Hay Fever, Asthma and Acute Upper Respiratory Infection, sponsored by North Sichuan Medical College. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by North Sichuan Medical College · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Oct 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
703
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Hay Fever
  • Asthma
  • Acute Upper Respiratory Infection
  • Pulmonary Embolism
  • Pneumonia
  • Tuberculosis
  • Acute Bronchitis
  • Pulmonary Fibrosis
  • Lung Cancer
  • Bronchiectasis
03

In context

Rhinitis, Allergic, Seasonal

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

This study's enrollment of 703 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

North Sichuan Medical College is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Self-reported symptoms of common respiratory diseases, such as cough, chest tightness, fever, and wheezing
  2. Ability to engage in LLM dialog operations independently or with minimal peer training
  3. A health status deemed suitable for study participation by the pulmonology experts

Exclusion criteria

Exclusion Criteria:

  1. Excessively poor health status
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
703 participants (actual)

Study arms

  • Other
    Cross-comparison group(the disease diagnosis section)

    Cross-comparison group (including human doctor controls and all LLMs)

    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)

  • Other
    Cross-comparison group(the medical explanation section)

    Cross-comparison group (including human doctor controls and all LLMs)

    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)

Interventions

  • Diagnostic testDiagnosis by three human doctors

    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.

  • Diagnostic testDiagnosis by ChatGPT-3.5 (with search capabilities)

    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.

  • Diagnostic testDiagnosis by ChatGPT-3.5 (without search capabilities)

    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.

  • Diagnostic testDiagnosis by ChatGPT-4.0 (with search capabilities)

    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.

  • Diagnostic testDiagnosis by ChatGPT-4.0 (without search capabilities)

    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.

  • Diagnostic testDiagnosis by Claude instant (with search capabilities)

    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.

  • Diagnostic testDiagnosis by Claude instant (without search capabilities)

    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.

  • Diagnostic testDiagnosis by Claude 2 (with search capabilities)

    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.

  • Diagnostic testDiagnosis by Claude 2 (without search capabilities)

    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.

  • Diagnostic testDiagnosis by Gemini Pro (with search capabilities)

    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.

  • Diagnostic testDiagnosis by Gemini Pro (without search capabilities)

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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.

  5. 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.

    Time frame: 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

  1. 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.

    Time frame: 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. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. Regular indicators-Total conversation cost ($)

    The total cost in dollars for completing the entire conversation.

    Time frame: 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.

  5. 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.

    Time frame: 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.

  6. Regular indicators-Number of output statements

    The total number of words output by the LLMs or real doctors.

    Time frame: 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.

  7. Regular indicators-Number of input statements

    The sum of the number of characters entered by the user.

    Time frame: 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.

07

Study locations

1 site
  • The Affiliated Hospital of North Sichuan Medical College
    Nanchong, Sichuan 637000, China
08

References and documents

Publications

  • 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. PubMed 15528286 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06457269
Lead sponsor
North Sichuan Medical College
Collaborators
University of Glasgow, Nanchong Central Hospital, Affiliated Hospital of North Sichuan Medical College
Responsible party
Zining Luo (Principal Investigator, North Sichuan Medical College) — Principal investigator
First posted
Jun 13, 2024
Start date
Oct 1, 2023
Primary completion
Dec 12, 2023
Completion
Oct 12, 2024
Last update
Nov 27, 2024

Study contacts

Jiebin Xie, Doctor
principal investigator · North Sichuan Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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