AI improves nodule detection on chest radiographs in a health screening population: a randomized controlled trial
Abstract
Background The impact of artificial intelligence (AI)–based computer-aided detection (CAD) software has not been prospectively explored in real-world populations. Purpose To investigate whether commercial AI-based CAD software could improve the detection rate of actionable lung nodules on chest radiographs in participants undergoing health checkups. Materials and Methods In this single-center, pragmatic, open-label randomized controlled trial, participants who underwent chest radiography between July 2020 and December 2021 in a health screening center were enrolled and randomized into intervention (AI group) and control (non-AI group) arms. One of three designated radiologists with 13–36 years of experience interpreted each radiograph, referring to the AI-based CAD results for the AI group. The primary outcome was the detection rate, that is, the number of true-positive radiographs divided by the total number of radiographs, of actionable lung nodules confirmed on CT scans obtained within 3 months. Actionable nodules were defined as solid nodules larger than 8 mm or subsolid nodules with a solid portion larger than 6 mm (Lung Imaging Reporting and Data System, or Lung-RADS, category 4). Secondary outcomes included the positive-report rate, sensitivity, false-referral rate, and malignant lung nodule detection rate. Clinical outcomes were compared between the two groups using univariable logistic regression analyses. Results A total of 10 476 participants (median age, 59 years [IQR, 50–66 years]; 5121 men) were randomized to an AI group (n = 5238) or non-AI group (n = 5238). The trial met the predefined primary outcome, demonstrating an improved detection rate of actionable nodules in the AI group compared with the non-AI group (0.59% [31 of 5238 participants] vs 0.25% [13 of 5238 participants], respectively; odds ratio, 2.4; 95% CI: 1.3, 4.7; P = .008). The detection rate for malignant lung nodules was higher in the AI group compared with the non-AI group (0.15% [eight of 5238 participants] vs 0.0% [0 of 5238 participants], respectively; P = .008). The AI and non-AI groups showed similar false-referral rates (45.9% [56 of 122 participants] vs 56.0% [56 of 100 participants], respectively; P = .14) and positive-report rates (2.3% [122 of 5238 participants] vs 1.9% [100 of 5238 participants]; P = .14). Conclusion In health checkup participants, artificial intelligence–based software improved the detection of actionable lung nodules on chest radiographs. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Auffermann in this isssue.
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Nam and colleagues reported from a single-center, open-label randomized controlled trial that an AI-based chest X-ray system improved detection of actionable lung nodules compared with non-AI.
“Nam and colleagues (31) have published promising results from a singlecenter, open-label randomized control trial that utilized an AI-based system for chest X-rays from the company Lunit, and reported that the AI arm had an improved detection rate of actionable nodules compared with the non-AI arm.”
From Artificial Intelligence in Oncology: Current Landscape, Challenges, and Future Directions (2024) · cites this paper as [31]
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- Authors
- Nam, J. G., Hwang, E. J., Kim, J., Park, N., Lee, E. H., Kim, H. J., Nam, M., Lee, J. H., Park, C. M., & Goo, J. M.
- Affiliations
- Ewha Womans University (KR)
- ORCID
- Venue
- Radiology
- Published
- 2023-04-01
- Volume
- 307
- Issue
- 2
- Pages
- e221894-e221894
- ISSN
- 0033-8419 (ISSN-L)
- 1527-1315
- OpenAlex
- W4319333852
- Cited by
- 141
- References
- 26
- Citations by year
- 2026: 34 · 2025: 52 · 2024: 35 · 2023: 20
- FWCI
- 25.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Radiology (publishedVersion)
- PubMed (publishedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- Ministry of Health and Welfare (HI19C1129)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Physical Sciences › Computer Science › Artificial Intelligence › AI in cancer detection
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiomics and Machine Learning in Medical Imaging
- Keywords
- artificial intelligence, computer-aided detection, lung nodule detection, chest radiography, health screening, lung cancer screening, radiologist interpretation, early detection of lung cancer, positive predictive value, cost-effectiveness, health care utilization
- MeSH terms
- Artificial Intelligence, Humans, Lung, Lung Neoplasms, Male, Middle Aged, Precancerous Conditions, Radiographic Image Interpretation, Computer-Assisted, Radiography, Sensitivity and Specificity, Radiography, Thoracic, Tomography, X-Ray Computed
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