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The Impact of Large Language Models on Diagnostic Reasoning Among LLM-Trained Medical Doctors

Diagnostic Reasoning With and Without AI Support: A Randomized Controlled Trial of LLM-Trained Medical Doctors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06774612
Enrollment
60
Registered
2025-01-14
Start date
2025-01-10
Completion date
2025-05-17
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis

Keywords

clinical reasoning, large language models, computer-assisted diagnosis

Brief summary

This study aims to evaluate whether large language model-trained medical doctors demonstrate enhanced diagnostic reasoning performance when utilizing ChatGPT-4o alongside conventional resources compared to using conventional resources alone.

Detailed description

Diagnostic errors are a major source of preventable patient harm. Recent advances in Large Language Models (LLM), particularly ChatGPT-4o, have shown promise in enhancing medical decision-making. However, little is known about their impact on medical doctors' (e.g., physicians' and surgeons') diagnostic reasoning. Diagnostic accuracy relies on complex clinical reasoning and careful evaluation of patient data. While AI assistance could potentially reduce errors and improve efficiency, ChatGPT-4o lacks medical validation and could introduce new risks through incorrect information generation (also known as hallucinations). To mitigate these risks, doctors need adequate training in understanding ChatGPT-4o's capabilities, limitations, and proper usage. Given these uncertainties and the importance of proper AI training, systematic evaluation is essential before clinical implementation. This randomized study will assess whether ChatGPT-4o access improves LLM-trained medical doctors' diagnostic performance compared to conventional resources (e.g., textbooks, online medical databases) alone. All participating doctors will have completed at least a 10-hour training program covering ChatGPT-4o usage, prompt engineering techniques, and output evaluation strategies. Participants will provide differential diagnoses with supporting evidence and recommended next steps for clinical cases, with responses evaluated by blinded reviewers.

Interventions

OpenAI's ChatGPT-4o large language model with chat interface.

Sponsors

King Edward Medical University
CollaboratorOTHER
Lahore University of Management Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Single (Outcomes Assessor)

Intervention model description

The trial will be designed as a randomized, two-arm, single-blind parallel group study.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Full or Provisionally Registered Medical Practitioners with the Pakistan Medical and Dental Council (PMDC). * Completed Bachelor of Medicine, Bachelor of Surgery (MBBS) Exam. The equivalent degree of MBBS in US and Canada is called Doctor of Medicine (MD). * Participants must have completed a structured training program on the use of ChatGPT (or a comparable large language model), totaling at least 10 hours of instruction. The program must include hands-on practice related to LLM's aspects, specifically prompt engineering and content evaluation.

Exclusion criteria

* Any other Registered Medical Practitioners (Full or Provisional) with PMDC (e.g., Professionals with Bachelor of Dental Surgery or BDS).

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic reasoningAssessed at a single time point for each case, during the scheduled diagnostic reasoning evaluation session, which takes place between 0-4 days after participant enrollment.The primary outcome will be the percent correct for each case (range: 0 to 100). For each case, participants will be asked for three top diagnoses, findings from the case that support that diagnosis, and findings from the case that oppose that diagnosis. For each plausible diagnosis, participants will receive 1 point. Findings supporting the diagnosis and findings opposing the diagnosis will also be graded based on correctness, with 1 point for partially correct and 2 points for completely correct responses. Participants will then be asked to name their top diagnosis, earning one point for a reasonable response and two points for the most correct response. Finally participants will be asked to name up to 3 next steps to further evaluate the patient with one point awarded for a partially correct response and two points for a completely correct response. The primary outcome will be compared on the case-level by the randomized groups.

Secondary

MeasureTime frameDescription
Time Spent on DiagnosisAssessed at a single time point for each case, during the scheduled diagnostic reasoning evaluation session, which takes place between 0-4 days after participant enrollment.We will compare how much time (in seconds) participants spend per case between the two study arms.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026