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Diagnostic Accuracy of Two Large Language Models in Turkish Emergency Department Anamnesis Notes (LLM-ED-DX-TR)

12 août 2026 mis à jour par: Emir Ünal, Marmara University Pendik Training and Research Hospital

Diagnostic Accuracy of Two Large Language Models Against a Blinded Specialist Consensus Standard in Turkish Emergency Department Notes: A Retrospective Study of 600 Cases

This retrospective diagnostic accuracy study evaluates two large language models - GPT-4.1 (gpt-4.1-2025-04-14; OpenAI) and Claude Sonnet 4.6 (claude-sonnet-4-6; Anthropic) - as retrospective coding-quality instruments applied to anonymized Turkish-language emergency department anamnesis notes.

The reference standard is the majority consensus of three board-certified emergency medicine specialists who independently coded each note in ICD-10, blinded to one another, to the code entered by the treating physician at case closure, and to the subsequent clinical course. Cases without chapter-level majority agreement are excluded without replacement.

Both models are queried once per note with a single locked prompt at temperature 0 in stateless application programming interface calls, with no retrieval augmentation, no external tools and no extended-reasoning mode. The primary outcome is the proportion of cases in which each model's rank-1 diagnosis matches the reference standard at ICD-10 chapter level, reported with a Wilson 95% confidence interval. Registered secondary outcome measures are chapter-level Cohen's kappa between each model's rank-1 diagnosis and the reference standard; top-3 chapter accuracy for each model; and chapter-level concordance between the closure ICD-10 code and the reference standard. Additional prespecified analyses set out in the statistical analysis plan (paired between-model difference, three-character accuracy, note-length association, confidence calibration and model-to-model agreement) are reported in the primary publication.

The ICD-10 code entered at case closure is characterised against the same reference standard as a description of current documentation practice; it is not a comparator, and no test of superiority or inferiority against model output is performed. The analysis plan was finalised and frozen before any accuracy computation. Reporting follows STARD-AI 2025.

Aperçu de l'étude

Description détaillée

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

AI INDEX TESTS: (1) GPT-4.1 (model version gpt-4.1-2025-04-14; OpenAI API). (2) Claude Sonnet 4.6 (model version claude-sonnet-4-6; Anthropic API). Both accessed via the providers' developer application programming interfaces from Python. Temperature = 0. Zero-shot direct prompting with a single locked prompt version; stateless single-turn sessions with no cross-case context, no retrieval augmentation, no external tools and no extended-reasoning mode. No task-specific fine-tuning or additional training was applied; the models were used as released.

MODEL INTERPRETABILITY: Interpretability analyses such as SHAP, Grad-CAM or layer-attribution visualisation are not applicable to this study. Because GPT-4.1 and Claude Sonnet 4.6 are accessed as black-box models through proprietary, closed-source commercial interfaces, internal weights, gradients and attention structures are inaccessible for post-hoc interpretability computation.

REFERENCE STANDARD: Three board-certified emergency medicine specialists independently assess each anonymized note, blinded to one another, to the code entered by the treating physician, and to the subsequent clinical course. The primary diagnosis assigned by at least two of three assessors, reduced to ICD-10 chapter level, constitutes the reference standard. Cases in which all three assessors assign different chapters are excluded without replacement. No joint calibration session was held and no adjudication round was performed; each assessor coded once, according to their own clinical judgement.

DATA PRIVACY: All anamnesis notes are de-identified before processing; direct patient identifiers are removed and no patient name is present in any note at any stage. Each case carries a study-specific sequential number that is not a hospital record number, and no file linking study numbers to patient identities was created or retained. Note text is transmitted to commercial application programming interfaces operated by providers established outside Turkiye; all queries are issued through the providers' developer interfaces in stateless single-turn calls, and no patient identifier is present in any submitted text. De-identified notes are stored in an encrypted, access-restricted database. Conducted in accordance with Turkish Personal Data Protection Law no. 6698.

REPRODUCIBILITY OF THE INDEX TEST: The statistical analysis plan specified a test-retest assessment of within-model reproducibility. A random subset of 20 cases was drawn from the analysis set with a fixed seed recorded before the re-run, and both models were re-queried on those notes on 7 August 2026, after an interval of 3 days and 18 hours from the primary run (protocol minimum 48 hours), using the same prompt content, the same model identifiers and the same sampling parameters; the single-query-per-note statement above refers to the primary run. The prespecified measure is the proportion of cases in which the rank-1 code is identical between runs, at three-character and at ICD-10 chapter level. Two conditions differed from the primary run and are recorded in the deviation log: the byte-exact prompt file used in the primary run could not be recovered, only its SHA-256 digest having been retained, so the re-run used a prompt of identical content but unverified byte identity; and the structured-output mechanism for GPT-4.1 was JSON schema mode at re-run rather than the JSON object mode used originally, which the API rejected. The analysis is therefore reported as consistency of re-execution rather than strict prompt-identical reproducibility. This re-run is the last date of data collection and determines the study completion date.

STUDY DATES: The Actual Study Start Date (1 May 2026) denotes the beginning of the retrospective encounter window from which archived notes were drawn, not the start of data collection. Ethics approval (Clinical Research Ethics Committee of Marmara University, protocol 09.2026.26-0514) was granted on 14 May 2026. Because the study is retrospective, every note analysed was already present in the hospital record system when it was retrieved; no data were generated prospectively and no patient was enrolled.

STUDY FLOW: 630 consecutive eligible notes were screened and coded by all three assessors. Ten notes (cases 621-630) fell beyond the ethics-approved ceiling of 600 analysable cases and were excluded before analysis, leaving an assessment window of 620 on which inter-assessor agreement is reported. Within that window 20 notes had no chapter-level majority among the three assessors and were excluded without replacement, giving a primary analysis set of 600. A further 4 notes had no majority three-character code, giving 596 for the secondary three-character analysis.

STATISTICAL ANALYSIS: Analyses are performed in Python 3.11 (pandas, statsmodels, scipy) following a statistical analysis plan finalised and frozen before any accuracy computation; selected estimates are independently recomputed in jamovi by a second investigator using a prespecified verification checklist.

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

DATA SHARING: De-identified data are available from the principal investigator on reasonable request, subject to institutional approval. Eight supplementary files are provided with the primary publication: the statistical analysis plan with its deviation log; the full prompt text with its recorded SHA-256 digest; the data-preparation and analysis code; the data dictionary; the completed STARD-AI 2025 reporting checklist; the jamovi verification checklist used for independent recomputation of selected estimates; the technical specification of the two index tests; and the full chapter-level confusion matrices for both models.

Type d'étude

Observationnel

Inscription (Réel)

600

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Istanbul
      • Istanbul, Istanbul, Turquie (Türkiye), 34899
        • Marmara University Pendik Training and Research Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population comprises consecutive adult patients (aged 18 years and older) evaluated in the ambulatory (green/yellow triage) area of the emergency department of a tertiary care training and research hospital, and whose encounters were documented in the hospital information system (HBYS). Patients triaged to the high-acuity resuscitation area (Emergency Severity Index level 1) were excluded a priori; no Emergency Severity Index level 1 or level 2 presentation occurred within the sampling window, so resuscitation-area presentations are absent from the study population altogether. The findings do not extend to high-acuity emergency care.

La description

INCLUSION CRITERIA:

Adult patients (aged 18 years and older) presenting to the emergency department, evaluated in the ambulatory (green/yellow triage) area.

A free-text electronic anamnesis note entered at presentation in the hospital information system (HBYS). No minimum note length and no "sufficient information for diagnosis" requirement was applied, because such a criterion preferentially retains more readily classifiable cases; note length was treated as a covariate rather than as an eligibility threshold. A note was excluded only if all three of the following were absent: any symptom statement, any duration or onset information, and a non-empty anamnesis field.

An ICD-10 code entered by the treating emergency physician at case closure. Cases in which this entry was absent or did not form a valid ICD-10 code were retained in the analysis set and counted in the denominator of the closure-code analyses.

EXCLUSION CRITERIA:

Notes lacking all three of the following: any symptom statement, any duration or onset information, and a non-empty anamnesis field.

Pediatric cases (age under 18 years).

Patients critically ill and triaged to high-acuity resuscitation areas (Emergency Severity Index [ESI] level 1).

Clinical notes containing residual identifying information that cannot be fully de-identified, preventing compliance with data privacy regulations.

Non-independent clinical notes consisting solely of a brief cross-reference to a prior hospital visit without a new history entry.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Emergency Department Patient Cohort
Consecutive adult patients (aged 18 years and older) evaluated in the ambulatory (green/yellow triage) area of the emergency department, who had a free-text electronic anamnesis note recorded at presentation and an ICD-10 code entered by the treating physician at case closure. No note-completeness or minimum-length requirement was applied. The closure code is characterised against the reference standard as a description of current documentation practice; it is not a comparator, and no test of superiority or inferiority against model output is performed.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diagnostic Accuracy of GPT-4.1 for ICD-10 Chapter-Level Diagnosis
Délai: At the single index-test run on 3 August 2026
Proportion of cases in which the GPT-4.1 primary (rank 1) diagnosis matches the 3-specialist majority-vote reference standard at the ICD-10 chapter level (22 categories). Range: 0 to 1.00.
At the single index-test run on 3 August 2026
Diagnostic Accuracy of Claude Sonnet 4.6 for ICD-10 Chapter-Level Diagnosis
Délai: At the single index-test run on 3 August 2026
Proportion of cases in which the Claude Sonnet 4.6 primary (rank 1) diagnosis matches the 3-specialist majority-vote reference standard at the ICD-10 chapter level (22 categories). Range: 0 to 1.00.
At the single index-test run on 3 August 2026

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cohen's Kappa Between GPT-4.1 Primary Diagnosis and the Reference Standard
Délai: At the single index-test run on 3 August 2026
Kappa coefficient measuring agreement between the GPT-4.1 rank-1 ICD-10 chapter and the 3-specialist reference 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.
At the single index-test run on 3 August 2026
Cohen's Kappa Between Claude Sonnet 4.6 Primary Diagnosis and the Reference Standard
Délai: At the single index-test run on 3 August 2026
Kappa coefficient measuring agreement between the Claude Sonnet 4.6 rank-1 ICD-10 chapter and the 3-specialist reference 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.
At the single index-test run on 3 August 2026
Top-3 Diagnostic Accuracy of GPT-4.1
Délai: At the single index-test run on 3 August 2026
Proportion of cases in which the ICD-10 chapter of the reference standard diagnosis appears anywhere within the ranked list of three differential diagnoses returned by GPT-4.1. Range: 0 to 1.00. Cases in which no valid closure code was entered (5 of 600) are retained in the denominator; the figure restricted to resolvable entries is reported alongside.
At the single index-test run on 3 August 2026
Top-3 Diagnostic Accuracy of Claude Sonnet 4.6
Délai: At the single index-test run on 3 August 2026
Proportion of cases in which the ICD-10 chapter of the reference standard diagnosis appears anywhere within the ranked list of three differential diagnoses returned by Claude Sonnet 4.6. Range: 0 to 1.00.
At the single index-test run on 3 August 2026
Chapter-Level Concordance Between the Closure ICD-10 Code and the Reference Standard
Délai: At the original clinical encounter (retrospective data spanning 1 May to 3 August 2026)
Proportion of cases in which the ICD-10 code entered by the treating emergency physician at case closure matches the 3-specialist reference standard at the chapter level. This is reported as a descriptive benchmark of routine coding practice and is not a comparator: the closure code was entered after investigation, whereas the reference standard was constructed from the presentation note alone, to which the assessors were restricted. Range: 0 to 1.00.
At the original clinical encounter (retrospective data spanning 1 May to 3 August 2026)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Emir Ünal, Marmara University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2026

Achèvement primaire (Réel)

3 août 2026

Achèvement de l'étude (Réel)

7 août 2026

Dates d'inscription aux études

Première soumission

3 juin 2026

Première soumission répondant aux critères de contrôle qualité

3 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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