- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07846553
Artificial Intelligence Versus Anesthesiology Residents in Chest X-Ray Interpretation
Comparison of the Diagnostic Performance of an Artificial Intelligence System and Anesthesiology Residents in Interpreting Posteroanterior Chest Radiographs
This observational study will compare how accurately anesthesiology residents and an artificial intelligence system (hChestXR) identify abnormalities on chest X-rays. Approximately 35 volunteer anesthesiology residents at Kayseri City Hospital will review the same set of 150 anonymized posteroanterior chest radiographs selected from the hospital imaging archive. The set will include normal images and images showing findings such as infiltration, atelectasis, and pleural effusion. Two radiologists will independently assess the images and resolve disagreements by consensus to establish the reference standard. Residents will not see the radiologists' assessments or the artificial intelligence results while interpreting the images. The study will measure diagnostic accuracy and other measures of diagnostic performance. No additional imaging, treatment, or change in patient care is planned.
Přehled studie
Postavení
Podmínky
Detailní popis
This single-center, cross-sectional, observational diagnostic accuracy study will be coordinated by the Department of Anesthesiology and Reanimation at Kayseri City Hospital. Volunteer resident assessments will be collected prospectively using retrospectively selected chest radiographs. The observational model is classified as Other because this is a comparative multi-reader, multi-case assessment of a fixed image set, without longitudinal follow-up.
A dataset of 150 posteroanterior chest radiographs will be selected from the hospital PACS to represent normal findings, common thoracic abnormalities, and a limited number of atypical or diagnostically challenging cases. The distribution of findings will be balanced to avoid marked overrepresentation or underrepresentation of particular abnormalities. All patient-identifying information will be removed before assessment.
Two radiologists will independently evaluate each radiograph. Disagreements will be resolved through joint review and consensus. Their final assessments will serve as the reference standard. The same radiographs will be analyzed by the hChestXR artificial intelligence system and independently interpreted by approximately 35 anesthesiology residents who provide informed consent. Residents will record suspected findings using a predefined multiple-choice assessment form and will be blinded to the radiologist and artificial intelligence assessments. Resident training year will also be recorded.
Diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be calculated overall and by finding. Comparisons between resident and hChestXR performance will account for the paired image assessments and the multi-reader, multi-case structure of the data. McNemar testing will be used for appropriate paired comparisons, and analyses will account for variability across readers and radiographs. Agreement with the radiologist reference standard will be evaluated using Cohen's kappa. A multi-reader, multi-case approach will consider individual resident performance and variability across readers interpreting the same image set. Analyses will use SPSS version 31.0, with p < 0.05 considered statistically significant.
An a priori sample size calculation was performed to determine the number of resident readers. Assuming an absolute difference of 15 percentage points in diagnostic accuracy between anesthesiology residents and hChestXR, a standard deviation of 25 percentage points in reader-level accuracy, a two-sided significance level of 0.05, and 90% power, the required minimum sample size was 32 residents (standardized effect size, Cohen's d = 0.60). To allow for incomplete assessments or participant withdrawal, at least 35 anesthesiology residents are planned for enrollment. The 150 radiographs constitute the image dataset and are distinct from the enrolled resident participants.
The study involves no patient intervention. Resident assessment data will be coded and de-identified for analysis, and identifying information will remain confidential. The planned study period is October 15, 2026, through November 15, 2026. Ethics approval was granted by the Kayseri City Hospital Non-Interventional Clinical Research Ethics Committee on August 26, 2026 (decision number 1081).
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Çiğdem Ünal Kantekin, MD
- Telefonní číslo: +90 505 443 30 56
- E-mail: drcgdm@hotmail.com
Studijní záloha kontaktů
- Jméno: Yusuf Yılmaz, MD
- Telefonní číslo: +90 555 538 30 94
- E-mail: doktoryusufyilmaz@gmail.com
Studijní místa
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Kayseri, Turecko (Türkiye), 38080
- Kayseri City Hospital
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Kontakt:
- Çiğdem Ünal Kantekin, MD
- Telefonní číslo: +90 505 443 30 56
- E-mail: drcgdm@hotmail.com
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Approximately 35 adult anesthesiology and reanimation residents working at Kayseri City Hospital who volunteer and provide written informed consent. Enrollment refers to resident readers, not to the 150 retrospectively selected, anonymized chest radiographs used as the assessment dataset.
Popis
Inclusion Criteria:
- An anesthesiology and reanimation resident working at Kayseri City Hospital.
- Voluntarily agrees to participate in the study.
- Provides written informed consent.
- Agrees to evaluate the posteroanterior chest radiographs presented in the study.
Exclusion Criteria:
- Failure to complete the 150-radiograph assessment.
- Withdrawal of consent before completion of the assessment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: OTHER
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
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Anesthesiology Residents
Approximately 35 volunteer anesthesiology and reanimation residents at Kayseri City Hospital will independently interpret 150 anonymized posteroanterior chest radiographs using a predefined multiple-choice form. Residents will be blinded to radiologist assessments and hChestXR outputs. Their diagnostic performance will be compared with hChestXR analysis of the same images, using the consensus of two radiologists as the reference standard. The artificial intelligence system is an image-level comparator, not a separate participant cohort. No treatment is assigned and no patient care is changed. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diagnostic Accuracy for Detection of Thoracic Abnormalities
Časové okno: During completion of the 150-radiograph assessment, within the 1-month study period
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Percentage of correctly classified image-finding pairs, calculated as (true positives + true negatives) / all evaluated image-finding classifications × 100, using the consensus of two radiologists as the reference standard. Accuracy will be calculated for each resident and for hChestXR overall and separately for each predefined thoracic finding. |
During completion of the 150-radiograph assessment, within the 1-month study period
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sensitivity for Detection of Thoracic Abnormalities
Časové okno: During completion of the 150-radiograph assessment, within the 1-month study period
|
Percentage of reference-positive classifications correctly identified: true positives / (true positives + false negatives) × 100. Sensitivity will be calculated for residents and hChestXR overall and by finding, using the consensus of two radiologists as the reference standard. |
During completion of the 150-radiograph assessment, within the 1-month study period
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Specificity for Detection of Thoracic Abnormalities
Časové okno: During completion of the 150-radiograph assessment, within the 1-month study period
|
Percentage of reference-negative classifications correctly identified: true negatives / (true negatives + false positives) × 100. Specificity will be calculated for residents and hChestXR overall and by finding, using the consensus of two radiologists as the reference standard. |
During completion of the 150-radiograph assessment, within the 1-month study period
|
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Positive Predictive Value
Časové okno: During completion of the 150-radiograph assessment, within the 1-month study period
|
Percentage of positive classifications confirmed by the radiologist reference standard: true positives / (true positives + false positives) × 100. Calculated for residents and hChestXR overall and by finding within the constructed study dataset. |
During completion of the 150-radiograph assessment, within the 1-month study period
|
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Negative Predictive Value
Časové okno: During completion of the 150-radiograph assessment, within the 1-month study period
|
Percentage of negative classifications confirmed by the radiologist reference standard: true negatives / (true negatives + false negatives) × 100. Calculated for residents and hChestXR overall and by finding within the constructed study dataset. |
During completion of the 150-radiograph assessment, within the 1-month study period
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Agreement With the Radiologist Reference Standard
Časové okno: During completion of the 150-radiograph assessment, within the 1-month study period
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Agreement of resident interpretations and hChestXR classifications with the consensus radiologist reference standard will be assessed using Cohen's kappa. Cohen's kappa will be calculated separately for each resident and for hChestXR, with resident results summarized across readers. Kappa ranges from -1 to 1; 1 indicates perfect agreement, 0 agreement expected by chance, and negative values less agreement than expected by chance. Individual reader results will be evaluated within the multi-reader, multi-case framework. |
During completion of the 150-radiograph assessment, within the 1-month study period
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Çiğdem Ünal Kantekin, MD, Kayseri City Hospital
Publikace a užitečné odkazy
Obecné publikace
- Nam JG, Park S, Hwang EJ, Lee JH, Jin KN, Lim KY, Vu TH, Sohn JH, Hwang S, Goo JM, Park CM. Development and Validation of Deep Learning-based Automatic Detection Algorithm for Malignant Pulmonary Nodules on Chest Radiographs. Radiology. 2019 Jan;290(1):218-228. doi: 10.1148/radiol.2018180237. Epub 2018 Sep 25.
- Colquitt J, Jordan M, Court R, Loveman E, Parr J, Ghosh I, Auguste P, Patel M, Stinton C. Artificial intelligence software for analysing chest X-ray images to identify suspected lung cancer: an evidence synthesis early value assessment. Health Technol Assess. 2024 Aug;28(50):1-75. doi: 10.3310/LKRT4721.
- Rajpurkar P, Irvin J, Ball RL, Zhu K, Yang B, Mehta H, Duan T, Ding D, Bagul A, Langlotz CP, Patel BN, Yeom KW, Shpanskaya K, Blankenberg FG, Seekins J, Amrhein TJ, Mong DA, Halabi SS, Zucker EJ, Ng AY, Lungren MP. Deep learning for chest radiograph diagnosis: A retrospective comparison of the CheXNeXt algorithm to practicing radiologists. PLoS Med. 2018 Nov 20;15(11):e1002686. doi: 10.1371/journal.pmed.1002686. eCollection 2018 Nov.
- Eisen LA, Berger JS, Hegde A, Schneider RF. Competency in chest radiography. A comparison of medical students, residents, and fellows. J Gen Intern Med. 2006 May;21(5):460-5. doi: 10.1111/j.1525-1497.2006.00427.x.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KCH-PAAG-AI-2026-1081
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data will not be shared with third parties, in accordance with the confidentiality provisions of the study protocol. Data will be used for scientific analyses, and findings will be disseminated in aggregate through presentations and publications.
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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