- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06921447
Evaluating Decision-making Using ChatGPT-4 Among Trainees in Surgery (EDuCATe)
Evaluating ChatGPT-4 as a Decision-Making Support Tool for Surgical Trainees
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Artificial Intelligence (AI) is rapidly transforming the medical landscape, offering new possibilities in education, diagnostics, and decision support. In surgery, clinical decision-making is a core competency developed progressively through training. ChatGPT-4, a state-of-the-art large language model developed by OpenAI, has demonstrated competence in handling medical queries and clinical reasoning tasks. However, its performance in complex surgical decision-making compared to human trainees remains largely unexplored.
Objective:
The EDuCATe study aims to evaluate the accuracy and reliability of ChatGPT-4's responses to clinical scenarios involving general surgery cases. Specifically, the study compares the model's performance to that of junior residents, senior residents, and attending surgeons to understand if ChatGPT-4 can serve as a safe and effective educational tool for surgical trainees.
Methods:
Seven clinical scenarios will be constructed using real anonymized patient data representing common general surgery conditions. Each case will be presented step-by-step, mimicking the clinical decision-making process. Participants will answer a question related to treatment choice.
Participants will include junior residents (PGY1-2), senior residents (PGY3+), and attending surgeons from a single surgical department. ChatGPT-4 will be prompted with the same scenarios. All participants will be instructed to complete the cases without using external resources such as AI tools or internet searches, relying solely on their clinical knowledge.
Statistical analysis will compare performance across groups using non-parametric tests (e.g., Wilcoxon rank sum).
Expected Outcomes:
The study hypothesizes that ChatGPT-4 will perform at a level comparable to senior residents or attending surgeons and outperform junior residents in decision-making. If confirmed, these results could support the safe use of ChatGPT-4 as a training aid for junior surgical residents, potentially improving educational outcomes and clinical reasoning skills.
Significance:
This study will provide novel insight into the role of AI in surgical education. By rigorously comparing ChatGPT-4's decision-making capabilities to that of human surgeons at various levels, the study hopes to define its utility, limitations, and appropriate use in residency training programs.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Manuela Mastronardi
- Phone Number: 0403994152
- Email: manuela.mastronardi@gmail.com
Study Locations
-
-
-
Trieste, Italy
- University of Trieste
-
Contact:
- Manuela Mastronardi
- Phone Number: 0403994152
- Email: manuela.mastronardi@gmail.com
-
Principal Investigator:
- Silvia Palmisano
-
Principal Investigator:
- Manuela Mastronardi
-
Sub-Investigator:
- Paola Germani
-
Sub-Investigator:
- Margherita Sandano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Actively enrolled or employed in the general surgery residency or department at the participating institution
- Willingness to participate and complete all clinical case scenarios
- Consent to participate in the study
Exclusion Criteria:
- Incomplete responses
- Use of external assistance (e.g., internet search, AI tools) when answering scenarios, as self-reported in instructions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Residents
Junior and Senior Residents in General Surgery
|
Seven clinical cases that have to be analysed
|
|
Consultants
Senior General Surgeons
|
Seven clinical cases that have to be analysed
|
|
ChatGPT 4
Artificial Intelligence System
|
Seven clinical cases that have to be analysed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of correct responses
Time Frame: Baseline
|
Binary outcome (correct vs. incorrect decision)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of accuracy across experience levels
Time Frame: Baseline
|
Proportion of correct responses by group: Junior residents, Senior residents, Attending surgeons, ChatGPT-4
|
Baseline
|
|
Confidence level
Time Frame: Baseline
|
Participants and ChatGPT are asked to rate how confident they feel in their answer (1-5 Likert scale, where 1 means no confident and 5 very confident)
|
Baseline
|
|
Percentage of use of AI for clinical cases evaluation
Time Frame: Baseline
|
Participants are asked if they use or not ChatGPT in their clinical activity
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AI-Surgical training
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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