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

2026年8月12日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

600

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Istanbul
      • Istanbul、Istanbul、土耳其(türkiye)、34899
        • Marmara University Pendik Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Accuracy of GPT-4.1 for ICD-10 Chapter-Level Diagnosis
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Cohen's Kappa Between GPT-4.1 Primary Diagnosis and the Reference Standard
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Emir Ünal、Marmara University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (实际的)

2026年8月3日

研究完成 (实际的)

2026年8月7日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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