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NCT Number: NCT07632859

Diagnostic Accuracy of GPT-4o and Claude 4.6 Sonnet in Turkish ED Anamnesis Notes

This retrospective diagnostic accuracy study evaluates the ability of two large language models (LLMs) - GPT-4o (gpt-4o-2024-11-20; OpenAI) and Claude 4.6 Sonnet (claude-sonnet-4-6; Anthropic) - to generate correct diagnoses from anonymized Turkish-language emergency department (ED) anamnesis notes, and compares their performance with the diagnosis entered by the treating emergency physician. A consensus gold standard is established by three independent board-certified emergency medicine specialists who blindly review each note and vote on the primary diagnosis using ICD-10 three-character codes; the majority vote (at least 2 of 3 specialists agreeing) constitutes the reference standard. Both LLMs are evaluated using a standardized zero-shot direct prompting strategy (temperature=0, stateless API sessions). The primary outcome is diagnostic accuracy (proportion of ICD-10 chapter-level matches) and Cohen's kappa for each LLM against the gold standard. Secondary outcomes include top-3 accuracy, treating physician accuracy, inter-model agreement, and subgroup analyses by ESI triage level and ICD-10 chapter. Inter-rater reliability among the three specialists is quantified using Fleiss' kappa. Analyses are performed in Jamovi. This study represents the first evaluation of LLM diagnostic accuracy using Turkish-language clinical notes and the first to benchmark LLM performance against an independent three-specialist majority-vote gold standard rather than against the treating physician's own diagnosis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location status: Recruiting

Location contact

Emir ünal

CONTACT

[email protected]

About this study

STUDY DESIGN: Retrospective diagnostic accuracy study, STARD-AI 2025 reporting, single center, cohort design.

AI INDEX TESTS: (1) GPT-4o (model version gpt-4o-2024-11-20; OpenAI API). (2) Claude 4.6 Sonnet (model version claude-sonnet-4-6; Anthropic API). Both accessed via Python (Google Colab). Temperature=0 for reproducibility. Zero-shot, stateless sessions - no cross-case context. No task-specific fine-tuning or additional training applied; models used as-is via API.

MODEL INTERPRETABILITY: Model interpretability analyses (such as SHAP, Grad-CAM, or layer-attribute visualizations) are not applicable to this study. Because GPT-4o and Claude 4.6 Sonnet are accessed as black-box models through proprietary, closed-source commercial APIs, internal model weights, gradients, and attention architectures are structurally inaccessible for post-hoc interpretability computations.

REFERENCE STANDARD: Three board-certified emergency medicine specialists independently evaluate each anonymized note, blinded to the original physician diagnosis and to each other. Primary diagnosis assigned by at least 2/3 specialists (majority vote) constitutes the gold standard. A 5-case calibration session precedes the main evaluation.

DATA PRIVACY: All anamnesis notes are fully de-identified (name, ID number, date of birth, physician name removed) prior to processing. De-identified notes are stored in a password-protected encrypted database. Only de-identified text is transmitted to LLM APIs - no personal health data. Compliant with Turkish Personal Data Protection Law (KVKK No. 6698).

PATIENT AND PUBLIC INVOLVEMENT: Not applicable. This retrospective study uses fully anonymized existing records; no patient or public involvement in design or conduct.

DATA SHARING: Anonymized dataset will be shared via Zenodo upon article acceptance. Statistical analysis code (Jamovi project files and Python prompt scripts) will be available on GitHub.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged 18 years and older) presenting to the emergency department.
  • Complete electronic health record available in the hospital information system (HBYS) containing a detailed anamnesis note with chief complaint, symptom duration, associated symptoms, and relevant medical history.
  • A definitive primary diagnosis recorded by the treating emergency physician using ICD-10 codes at the time of patient file closure.

Exclusion criteria

  • Emergency department anamnesis notes containing fewer than 50 words or completely lacking substantive clinical content[cite: 1].
  • Pediatric cases (age under 18 years)[cite: 1].
  • Patients critically ill and triaged to high-acuity resuscitation areas (Emergency Severity Index [ESI] level 1)[cite: 1].
  • Clinical notes containing residual identifying information that cannot be fully de-identified, preventing compliance with data privacy regulations[cite: 1].
  • Non-independent clinical notes consisting solely of a brief cross-reference to a prior hospital visit without a new history entry[cite: 1].

Treatment and study plan

Primary outcomes

  1. Diagnostic Accuracy of GPT-4o for ICD-10 Chapter-Level Diagnosis

    Time frame: At the time of single-session algorithmic evaluation (each case evaluated once following data extraction in June 2026).

    Proportion of cases in which GPT-4o primary (rank 1) diagnosis matches the 3-specialist majority-vote gold standard at the ICD-10 chapter level (22 categories). Range: 0 to 1.00.

  2. Diagnostic Accuracy of Claude 4.6 Sonnet for ICD-10 Chapter-Level Diagnosis

    Time frame: At the time of single-session algorithmic evaluation (each case evaluated once following data extraction in June 2026).

    Proportion of cases in which Claude 4.6 Sonnet primary (rank 1) diagnosis matches the 3-specialist majority-vote gold standard at the ICD-10 chapter level (22 categories). Range: 0 to 1.00.

Secondary outcomes

  1. Cohen's Kappa Between GPT-4o Primary Diagnosis and Gold Standard

    Time frame: At the time of algorithmic evaluation (June-July 2026)

    Kappa coefficient measuring agreement between GPT-4o rank-1 ICD-10 chapter and the 3-specialist gold standard . Interpreted per Landis & Koch (1977): <=0.20 slight; 0.21-0.40 fair; 0.41-0.60 moderate; 0.61-0.80 substantial; >0.80 almost perfect . Range: -1.00 to 1.00 .

  2. Cohen's Kappa Between Claude 4.6 Sonnet Primary Diagnosis and Gold Standard

    Time frame: At the time of algorithmic evaluation (June-July 2026)

    appa coefficient measuring agreement between Claude 4.6 Sonnet rank-1 ICD-10 chapter and the 3-specialist gold standard . Interpreted per Landis & Koch (1977): <=0.20 slight; 0.21-0.40 fair; 0.41-0.60 moderate; 0.61-0.80 substantial; >0.80 almost perfect . Range: -1.00 to 1.00

  3. Top-3 Diagnostic Accuracy of GPT-4o

    Time frame: At the time of algorithmic evaluation (June-July 2026)

    Proportion of cases in which the 3-specialist gold standard diagnosis appears within GPT-4o's ranked list of three differential diagnoses . Range: 0 to 1.00

  4. Top-3 Diagnostic Accuracy of Claude 4.6 Sonnet

    Time frame: At the time of algorithmic evaluation (June-July 2026)

    Proportion of cases in which the 3-specialist gold standard diagnosis appears within Claude 4.6 Sonnet's ranked list of three differential diagnoses[cite: 1]. Range: 0 to 1.00

  5. Treating Physician Diagnostic Accuracy Against Gold Standard

    Time frame: At the time of the original clinical encounter (retrospective data spanning August-December 2025)

    Proportion of cases in which the ICD-10 code entered by the treating emergency physician at file closure matches the 3-specialist majority-vote gold standard at the chapter level[cite: 1]. Range: 0 to 1.00

Study contacts

Contact information is provided by the study sponsor or research team.

Emir Unal, Assistant Professor

CONTACT

[email protected]

Emir Ünal, Assistant Professor

CONTACT

[email protected]

+905327766010

Sponsors and collaborators

Lead sponsor

Marmara University Pendik Training and Research Hospital

Other

Registry information

Official study title

Diagnostic Accuracy of Large Language Models From Emergency Department Anamnesis Notes: A Comparison of GPT-4o and Claude 4.6 Sonnet With Emergency Medicine Specialists

Acronym: LLM-ED-DX-TR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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