Artificial Intelligence Diagnostic System Research Articles

99 - Application of perfusion-weighted imaging technology combined with artificial intelligence diagnostic system in acute ischemic stroke

99 - Application of perfusion-weighted imaging technology combined with artificial intelligence diagnostic system in acute ischemic stroke

101 - Application of SMS-RESOLVE DWI technology combined with artificial intelligence diagnostic system in acute cerebral infarction

101 - Application of SMS-RESOLVE DWI technology combined with artificial intelligence diagnostic system in acute cerebral infarction

Evaluating the effectiveness of artificial intelligence imaging in the qualitative diagnosis of pulmonary nodules

Our study aimed to evaluate the effectiveness of artificial intelligence (AI) image diagnostic systems in the qualitative diagnosis of pulmonary nodules. We analyzed 291 cases from June 2023 to January 2024 at Chongqing University Three Gorges Hospital. All patients in the study underwent low-dose chest computed tomography scans, which identified lung nodules, followed by thoracic surgery for pathological confirmation. We compared the predictive accuracy of AI-based diagnosis with that of physician-based diagnosis in distinguishing between benign and malignant lung nodules. Among the 291 lung nodules examined, 226 were cancerous, and 65 were benign. Receiver operating characteristic (ROC) curves, plotted based on the malignancy probabilities predicted by both methods, revealed that the AI group achieved an area under the ROC curve (AUC) of 0.727, with a sensitivity of 90.27% and a specificity of 58.46%. In comparison, the physician-reading group had an AUC of 0.737, with a sensitivity of 83.19% and a specificity of 66.15%. Our findings demonstrate that the AI diagnostic system effectively calculates malignancy probabilities for lung nodules, highlighting its significant predictive potential. This system can serve as a valuable adjunct tool for clinicians and imaging physicians in the diagnostic process.

Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies Using AI (QUADAS-AI): Protocol for a Qualitative Study.

Quality assessment of diagnostic accuracy studies (QUADAS), and more recently QUADAS-2, were developed to aid the evaluation of methodological quality within primary diagnostic accuracy studies. However, its current form, QUADAS-2 does not address the unique considerations raised by artificial intelligence (AI)-centered diagnostic systems. The rapid progression of the AI diagnostics field mandates suitable quality assessment tools to determine the risk of bias and applicability, and subsequently evaluate translational potential for clinical practice. We aim to develop an AI-specific QUADAS (QUADAS-AI) tool that addresses the specific challenges associated with the appraisal of AI diagnostic accuracy studies. This paper describes the processes and methods that will be used to develop QUADAS-AI. The development of QUADAS-AI can be distilled into 3 broad stages. Stage 1-a project organization phase had been undertaken, during which a project team and a steering committee were established. The steering committee consists of a panel of international experts representing diverse stakeholder groups. Following this, the scope of the project was finalized. Stage 2-an item generation process will be completed following (1) a mapping review, (2) a meta-research study, (3) a scoping survey of international experts, and (4) a patient and public involvement and engagement exercise. Candidate items will then be put forward to the international Delphi panel to achieve consensus for inclusion in the revised tool. A modified Delphi consensus methodology involving multiple online rounds and a final consensus meeting will be carried out to refine the tool, following which the initial QUADAS-AI tool will be drafted. A piloting phase will be carried out to identify components that are considered to be either ambiguous or missing. Stage 3-once the steering committee has finalized the QUADAS-AI tool, specific dissemination strategies will be aimed toward academic, policy, regulatory, industry, and public stakeholders, respectively. As of July 2024, the project organization phase, as well as the mapping review and meta-research study, have been completed. We aim to complete the item generation, including the Delphi consensus, and finalize the tool by the end of 2024. Therefore, QUADAS-AI will be able to provide a consensus-derived platform upon which stakeholders may systematically appraise the methodological quality associated with AI diagnostic accuracy studies by the beginning of 2025. AI-driven systems comprise an increasingly significant proportion of research in clinical diagnostics. Through this process, QUADAS-AI will aid the evaluation of studies in this domain in order to identify bias and applicability concerns. As such, QUADAS-AI may form a key part of clinical, governmental, and regulatory evaluation frameworks for AI diagnostic systems globally. DERR1-10.2196/58202.

Stacking Ensemble Artificial Intelligence Model for Heart Disease Diagnosis

Personalized treatment plans, predictive analytics, and artificial intelligence (AI)-driven diagnostics are becoming more and more popular as a way to improve decision-making, expedite operations, and improve patient care. But there are still a number of substantial barriers to overcome, which includes but not limited to issues with user adoption, trust, prejudice, and fairness brought on by resistance from healthcare providers and a lack of confidence in the system's recommendations. To overcome these challenges and realize the full potential of AI-driven solutions, the system's accuracy and safety through meticulous testing and validation of AI algorithms becomes indispensable. This research provides a hybrid AI model that blends three base models with a Meta model in order to diagnose heart disease effectively. The essence is to revalidate the existing AI diagnostic models for cardiac diseases diagnostics and to tackle the concerns impeding the full utilization of the available AI diagnostic system. The study makes use of each model's advantages by merging these various and complimentary algorithms into a stacking ensemble model to create a diagnostic system that is more potent. Using publicly available heart disease data, the model performs remarkably well; it achieves 89% accuracy, 85% recall (sensitivity), 92% specificity, and 89% precision. This hybrid model's performance and proven efficacy are expected to boost trust in the system's recommendations and encourage broader implementation in clinical practice.

DeepMonitoring: a deep learning-based monitoring system for assessing the quality of cornea images captured by smartphones.

Smartphone-based artificial intelligence (AI) diagnostic systems could assist high-risk patients to self-screen for corneal diseases (e.g., keratitis) instead of detecting them in traditional face-to-face medical practices, enabling the patients to proactively identify their own corneal diseases at an early stage. However, AI diagnostic systems have significantly diminished performance in low-quality images which are unavoidable in real-world environments (especially common in patient-recorded images) due to various factors, hindering the implementation of these systems in clinical practice. Here, we construct a deep learning-based image quality monitoring system (DeepMonitoring) not only to discern low-quality cornea images created by smartphones but also to identify the underlying factors contributing to the generation of such low-quality images, which can guide operators to acquire high-quality images in a timely manner. This system performs well across validation, internal, and external testing sets, with AUCs ranging from 0.984 to 0.999. DeepMonitoring holds the potential to filter out low-quality cornea images produced by smartphones, facilitating the application of smartphone-based AI diagnostic systems in real-world clinical settings, especially in the context of self-screening for corneal diseases.

Development of an Artificial Intelligence Diagnostic System Using Linked Color Imaging for Barrett's Esophagus.

Background: Barrett's esophagus and esophageal adenocarcinoma cases are increasing as gastroesophageal reflux disease increases. Using artificial intelligence (AI) and linked color imaging (LCI), our aim was to establish a method of diagnosis for short-segment Barrett's esophagus (SSBE). Methods: We retrospectively selected 624 consecutive patients in total at our hospital, treated between May 2017 and March 2020, who experienced an esophagogastroduodenoscopy with white light imaging (WLI) and LCI. Images were randomly chosen as data for learning from WLI: 542 (SSBE+/- 348/194) of 696 (SSBE+/- 444/252); and LCI: 643 (SSBE+/- 446/197) of 805 (SSBE+/- 543/262). Using a Vision Transformer (Vit-B/16-384) to diagnose SSBE, we established two AI systems for WLI and LCI. Finally, 126 WLI (SSBE+/- 77/49) and 137 LCI (SSBE+/- 81/56) images were used for verification purposes. The accuracy of six endoscopists in making diagnoses was compared to that of AI. Results: Study participants were 68.2 ± 12.3 years, M/F 330/294, SSBE+/- 409/215. The accuracy/sensitivity/specificity (%) of AI were 84.1/89.6/75.5 for WLI and 90.5/90.1/91.1/for LCI, and those of experts and trainees were 88.6/88.7/88.4, 85.7/87.0/83.7 for WLI and 93.4/92.6/94.6, 84.7/88.1/79.8 for LCI, respectively. Conclusions: Using AI to diagnose SSBE was similar in accuracy to using a specialist. Our finding may aid the diagnosis of SSBE in the clinic.

Diagnostic decisions of specialist optometrists exposed to ambiguous deep-learning outputs

Artificial intelligence (AI) has great potential in ophthalmology. We investigated how ambiguous outputs from an AI diagnostic support system (AI-DSS) affected diagnostic responses from optometrists when assessing cases of suspected retinal disease. Thirty optometrists (15 more experienced, 15 less) assessed 30 clinical cases. For ten, participants saw an optical coherence tomography (OCT) scan, basic clinical information and retinal photography (‘no AI’). For another ten, they were also given AI-generated OCT-based probabilistic diagnoses (‘AI diagnosis’); and for ten, both AI-diagnosis and AI-generated OCT segmentations (‘AI diagnosis + segmentation’) were provided. Cases were matched across the three types of presentation and were selected to include 40% ambiguous and 20% incorrect AI outputs. Optometrist diagnostic agreement with the predefined reference standard was lowest for ‘AI diagnosis + segmentation’ (204/300, 68%) compared to ‘AI diagnosis’ (224/300, 75% p = 0.010), and ‘no Al’ (242/300, 81%, p = < 0.001). Agreement with AI diagnosis consistent with the reference standard decreased (174/210 vs 199/210, p = 0.003), but participants trusted the AI more (p = 0.029) with segmentations. Practitioner experience did not affect diagnostic responses (p = 0.24). More experienced participants were more confident (p = 0.012) and trusted the AI less (p = 0.038). Our findings also highlight issues around reference standard definition.

Role of the artificial intelligence in the management of T1 colorectal cancer

Approximately 10% of submucosal invasive (T1) colorectal cancers demonstrate extraintestinal lymph node metastasis, necessitating surgical intervention with lymph node dissection. The ability to identify T1b (submucosal invasion depth ≥ 1000 µm) as a risk factor for lymph node metastasis via pre-treatment endoscopy is crucial in guiding treatment strategies. Accurately distinguishing T1b from T1a (submucosal invasion depth < 1000 µm) or dysplasia remains a significant challenge for artificial intelligence (AI) systems, which require high and consistent diagnostic capabilities. Moreover, as endoscopic therapies like endoscopic full-thickness resection and endoscopic intermuscular dissection evolve, and the focus on reducing unnecessary surgeries intensifies, the initial management of T1 colorectal cancers via endoscopic treatment is anticipated to increase. Consequently, the development of highly accurate and reliable AI systems is essential, not only for pre-treatment depth assessment but also for post-treatment risk stratification of lymph node metastasis. While such AI diagnostic systems are still under development, significant advancements are expected in the near future to improve decision-making in T1 colorectal cancer management.

Value of CT examination combined with serum tumor markers assisted with artificial intelligence diagnostic system in the diagnosis of benign and malignant pulmonary nodules

Value of CT examination combined with serum tumor markers assisted with artificial intelligence diagnostic system in the diagnosis of benign and malignant pulmonary nodules

Real-time detection of laryngopharyngeal cancer using an artificial intelligence-assisted system with multimodal data

BackgroundLaryngopharyngeal cancer (LPC) includes laryngeal and hypopharyngeal cancer, whose early diagnosis can significantly improve the prognosis and quality of life of patients. Pathological biopsy of suspicious cancerous tissue under the guidance of laryngoscopy is the gold standard for diagnosing LPC. However, this subjective examination largely depends on the skills and experience of laryngologists, which increases the possibility of missed diagnoses and repeated unnecessary biopsies. We aimed to develop and validate a deep convolutional neural network-based Laryngopharyngeal Artificial Intelligence Diagnostic System (LPAIDS) for real-time automatically identifying LPC in both laryngoscopy white-light imaging (WLI) and narrow-band imaging (NBI) images to improve the diagnostic accuracy of LPC by reducing diagnostic variation among on-expert laryngologists.MethodsAll 31,543 laryngoscopic images from 2382 patients were categorised into training, verification, and test sets to develop, validate, and internal test LPAIDS. Another 25,063 images from five other hospitals were used as external tests. Overall, 551 videos were used to evaluate the real-time performance of the system, and 200 randomly selected videos were used to compare the diagnostic performance of the LPAIDS with that of laryngologists. Two deep-learning models using either WLI (model W) or NBI (model N) images were constructed to compare with LPAIDS.ResultsLPAIDS had a higher diagnostic performance than models W and N, with accuracies of 0·956 and 0·949 in the internal image and video tests, respectively. The robustness and stability of LPAIDS were validated in external sets with the area under the receiver operating characteristic curve values of 0·965–0·987. In the laryngologist-machine competition, LPAIDS achieved an accuracy of 0·940, which was comparable to expert laryngologists and outperformed other laryngologists with varying qualifications.ConclusionsLPAIDS provided high accuracy and stability in detecting LPC in real-time, which showed great potential for using LPAIDS to improve the diagnostic accuracy of LPC by reducing diagnostic variation among on-expert laryngologists.

Artificial intelligence system-based histogram analysis of computed tomography features to predict tumor invasiveness of ground-glass nodules.

The use of an artificial intelligence (AI)-based diagnostic system can significantly aid in analyzing the histogram of pulmonary nodules. The aim of our study was to evaluate the value of computed tomography (CT) histogram indicators analyzed by AI in predicting the tumor invasiveness of ground-glass nodules (GGNs) and to determine the added value of contrast-enhanced CT (CECT) compared with nonenhanced CT (NECT) in this prediction. This study enrolled patients with persistent GGNs who underwent preoperative NECT and CECT scanning. AI-based histogram analysis was performed for pathologically confirmed GGNs, which was followed by screening invasiveness-related factors via univariable analysis. Multivariable logistic models were developed based on candidate CT histogram indicators measured on either NECT or CECT. Receiver operating characteristic (ROC) curve and precision-recall (PR) curve were used to evaluate the models' performance. A total of 116 patients comprising 121 GGNs were included and divided into the precancerous lesion and adenocarcinoma groups based on invasiveness. In the AI-based histogram analysis, the mean CT value [NECT: odds ratio (OR) =1.009; 95% confidence interval (CI): 1.004-1.013; P<0.001] and solid component volume (NECT: OR =1.005; 95% CI: 1.000-1.010; P=0.032) were associated with the adenocarcinoma and used for multivariable logistic modeling. The area under ROC curve (AUC) and PR curve (AUPR) were not significantly different between the NECT model (AUC =0.765, 95% CI: 0.679-0.837; AUPR =0.907, 95% CI: 0.825-0.953) and the optimal CECT model (delayed phase: AUC =0.772, 95% CI: 0.687-0.843; AUPR =0.895, 95% CI: 0.812-0.944). No significantly different metrics were observed between the NECT and CECT models (precision: 0.707 vs. 0.742; P=0.616). The AI diagnostic system can help in the diagnosis of GGNs. The system displayed decent performance in GGN detection and alert to malignancy. Mean CT value and solid component volume were independent predictors of tumor invasiveness. CECT provided no additional improvement in diagnostic performance as compared with NECT.

Preoperative prediction of sinonasal papilloma by artificial intelligence using nasal video endoscopy: a retrospective study

Sinonasal inverted papilloma (IP) is at risk of recurrence and malignancy, and early diagnosis using nasal endoscopy is essential. We thus developed a diagnostic system using artificial intelligence (AI) to identify nasal sinus papilloma. Endoscopic surgery videos of 53 patients undergoing endoscopic sinus surgery were edited to train and evaluate deep neural network models and then a diagnostic system was developed. The correct diagnosis rate based on visual examination by otolaryngologists was also evaluated using the same videos and compared with that of the AI diagnostic system patients. Main outcomes evaluated included the percentage of correct diagnoses compared to AI diagnosis and the correct diagnosis rate for otolaryngologists based on years of practice experience. The diagnostic system had an area under the curve of 0.874, accuracy of 0.843, false positive rate of 0.124, and false negative rate of 0.191. The average correct diagnosis rate among otolaryngologists was 69.4%, indicating that the AI was highly accurate. Evidently, although the number of cases was small, a highly accurate diagnostic system was created. Future studies with larger samples to improve the accuracy of the system and expand the range of diseases that can be detected for more clinical applications are warranted.

Artificial intelligence for the diagnosis of clinically significant prostate cancer based on multimodal data: a multicenter study

BackgroundThe introduction of multiparameter MRI and novel biomarkers has greatly improved the prediction of clinically significant prostate cancer (csPCa). However, decision-making regarding prostate biopsy and prebiopsy examinations is still difficult. We aimed to establish a quick and economic tool to improve the detection of csPCa based on routinely performed clinical examinations through an automated machine learning platform (AutoML).MethodsThis study included a multicenter retrospective cohort and two prospective cohorts with 4747 cases from 9 hospitals across China. The multimodal data, including demographics, clinical characteristics, laboratory tests, and ultrasound reports, of consecutive participants were retrieved using extract-transform-load tools. AutoML was applied to explore potential data processing patterns and the most suitable algorithm to build the Prostate Cancer Artificial Intelligence Diagnostic System (PCAIDS). The diagnostic performance was determined by the receiver operating characteristic curve (ROC) for discriminating csPCa from insignificant prostate cancer (PCa) and benign disease. The clinical utility was evaluated by decision curve analysis (DCA) and waterfall plots.ResultsThe random forest algorithm was applied in the feature selection, and the AutoML algorithm was applied for model establishment. The area under the curve (AUC) value in identifying csPCa was 0.853 in the training cohort, 0.820 in the validation cohort, 0.807 in the Changhai prospective cohort, and 0.850 in the Zhongda prospective cohort. DCA showed that the PCAIDS was superior to PSA or fPSA/tPSA for diagnosing csPCa with a higher net benefit for all threshold probabilities in all cohorts. Setting a fixed sensitivity of 95%, a total of 32.2%, 17.6%, and 26.3% of unnecessary biopsies could be avoided with less than 5% of csPCa missed in the validation cohort, Changhai and Zhongda prospective cohorts, respectively.ConclusionsThe PCAIDS was an effective tool to inform decision-making regarding the need for prostate biopsy and prebiopsy examinations such as mpMRI. Further prospective and international studies are warranted to validate the findings of this study.Trial registrationChinese Clinical Trial Registry ChiCTR2100048428. Registered on 06 July 2021.

Characteristics of uroflowmetry patterns in men with detrusor underactivity revealed by artificial intelligence.

To elucidate the characteristics of uroflowmetry (UFM) observed in men with detrusor underactivity (DU) using our developed artificial intelligence (AI) diagnostic algorithm to distinguish between DU and bladder outlet obstruction (BOO). Subjective and objective parameters, including four UFM parameters (first peak flow rate, time to first peak, gradient to first peak, and the ratio of first peak flow rate to maximum flow rate [Qmax ]) selected by analyzing the judgment basis of the AI diagnostic system, were compared in 266 treatment-naive men with lower urinary tract symptoms (LUTS). Patients were divided into the DU (70; 26.32%) and non-DU (196; 73.68%) groups, and the UFM parameters for predicting the presence of DU were determined by multivariate analysis and receiver operating characteristic (ROC) curve analysis. Detrusor underactivity was defined as a bladder contractility index <100 and a BOO index <40. Most parameters on the first peak flow of UFM were significantly lower in the DU group. On multivariate analysis, lower first peak flow rate and lower ratio of first peak flow rate to Qmax were significant parameters to predict DU. In the ROC analysis, the ratio of the first peak flow rate to Qmax showed the highest area under the curve (0.848) and yielded sensitivities of 76% and specificities of 83% for DU diagnosis, with cutoff values of 0.8. Parameters on the first peak flow of UFM, especially the ratio of the first peak flow rate to Qmax , can diagnose DU with high accuracy in men with LUTS.

Abstract P1-05-06: Establishment of the breast ultrasound support system using deep-learning system

Abstract Although the categorization of ultrasound using the Breast Imaging Reporting and Data System (BI-RADS) has become widespread worldwide, the problem of inter-observer variability remains. To maintain uniformity in diagnostic accuracy, we have developed a novel artificial intelligence (AI) system in which AI can distinguish whether a static image obtained using a breast ultrasound represents BI-RADS3 or lower, or BI-RADS4a or higher, to determine the medical management that should be performed on a patient whose breast ultrasound shows abnormalities. To establish and validate the AI system, a training dataset consisting of 4,028 images containing 5,014 lesions and a test dataset consisting of 3,166 images containing 3,656 lesions were collected and annotated. We selected a setting that maximized the area under the curve (AUC) and minimized the difference in sensitivity and specificity by adjusting the internal parameters of the AI system, achieving an AUC, sensitivity, and specificity of 0.95, 90.0%, and 88.5%, respectively. Furthermore, based on 30 images extracted from the test data, the diagnostic accuracy of 20 clinicians and the AI system was compared, and the AI system was found to be significantly superior to the clinicians (McNemar test, p &amp;lt; 0.001). Then, we conducted a trial to introduce the system for use in clinical practice. Physicians reviewed the images and determined whether they were BI-RADS3 or lower, or BI-RADS4a or higher. Next, the classification was performed again for the same images concerning the AI diagnosis. At this time, the initial judgment was allowed to be overturned. We checked whether there was any difference in the diagnostic accuracy, sensitivity, and specificity before and after reviewing to the AI diagnosis. Reviews by 24 physicians were evaluated: 4 Japanese Breast Cancer Society breast specialists, 5 non-specialists and physicians with experience treating more than 40 cases of breast cancer, and 15 non-specialists and physicians with no experience treating more than 40 cases of breast cancer. The average rate of accuracy before confirming the AI diagnosis increased to 73.1% after confirming the AI diagnosis (p=0.00548), compared to 69.3% on average before the AI diagnosis. Compared to practice experience, the accuracy increased from an average of 77.1% to 79.6% for the 9 physicians who were breast specialists or who had treated 40 or more cases of breast cancer. For the 15 physicians with less than 40 breast cancer cases, the average rate of accuracy increased from 64.7% to 69.2%. Furthermore, sensitivity increased significantly to an average of 99.7% after reviewing of the AI diagnosis from an average of 88.8% prior to reviewing the AI-diagnosis.(p&amp;lt; 0.01). Specificity increased from an average of 62.4% to 63.8% (p=0.433) after reviewing AI diagnosis. We showed that our AI system, when applied to clinical practice and used by physicians, contributes to the improvement of diagnostic accuracy. Our results indicated that our AI diagnostic system was sufficiently accurate to be used in the clinical practice. Citation Format: Erina Odani, Tetsu Hayashida, masayuki kikuchi, Aiko Nagayama, tomoko seki, maiko takahashi, Akiko Matsumoto, Takeshi Murata, Rurina Watanuki, Takamichi Yokoe, Ayako Nakashoji, Hinako Maeda, Tatsuya Onishi, Sota Asaga, Takashi Hojo, Hiromitsu Jinno, Keiichi Sotome, Akira Matsui, Akihiko Suto, Shigeru Imoto, Yuko Kitagawa. Establishment of the breast ultrasound support system using deep-learning system [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-05-06.

The combination of CD138/MUM1 dual-staining and artificial intelligence for plasma cell counting in the diagnosis of chronic endometritis.

To investigate the utility of combination of CD138/MUM1 dual-staining (DS) and artificial intelligence (AI) for plasma cell (PC) counting in the diagnosis of chronic endometritis (CE). Two hundred ninety-eight infertile women underwent endometrial biopsy were included. In 100 women, three successivesections were cut from each paraffin-embedded tissue block for CD138 immunohistochemical (IHC) single-staining (SS), MUM1 SS and CD138/MUM1 DS. The prevalence of CE and the sensitivity/specificity in the diagnosis of CE with different methods was studied. These sections diagnosed as CE with DS were collected to train artificial intelligence (AI) diagnostic system. In other 198 women, their tissue sections stained with CD138/MUM1 DS were used to test the AI system in the diagnosis of CE. CD138/MUM1 DS revealed that the cell membranes and nuclei of PCs were simultaneously labelled by CD138 and MUM1, respectively. The positive rate of ECs identified by CD138/MUM1 DS (38%, 38/100) was lower than CD138 SS (52%, 52/100) and MUM1 SS (62%, 62/100) (p<.05). The sensitivity, specificity and accuracy of CD138/MUM1 DS in the diagnosis of ECs reached 100%. The sensitivity, specificity and accuracy rates of AI diagnostic system of ECs were 100%, 83.3% and 91.4%, respectively. The 17 cases over-diagnosed as EC with the AI were corrected quickly by pathologists reviewing these false PC pictures listed by the AI. The combination of CD138/MUM1 DS and AI is a promising method to improve the accuracy and efficiency of CE diagnosis.

Improving the efficiency of identifying malignant pulmonary nodules before surgery via a combination of artificial intelligence CT image recognition and serum autoantibodies.

To construct a new pulmonary nodule diagnostic model with high diagnostic efficiency, non-invasive and simple to measure. This study included 424 patients with radioactive pulmonary nodules who underwent preoperative 7-autoantibody (7-AAB) panel testing, CT-based AI diagnosis, and pathological diagnosis by surgical resection. The patients were randomly divided into a training set(n = 212) and avalidation set(n = 212). The nomogram was developed through forward stepwise logistic regression based on the predictive factors identified by univariate and multivariate analyses in the training set and was verified internally in the verification set. A diagnostic nomogram was constructed based on the statistically significant variables of age as well as CT-based AI diagnostic, 7-AAB panel, and CEA test results. In the validation set, the sensitivity, specificity, positive predictive value, and AUC were 82.29%, 90.48%, 97.24%, and 0.899 (95%[CI], 0.851-0.936), respectively. The nomogram showed significantly higher sensitivity than the 7-AAB panel test result (82.29% vs. 35.88%, p < 0.001) and CEA (82.29% vs. 18.82%, p < 0.001); it also had a significantly higher specificity than AI diagnosis (90.48% vs. 69.04%, p = 0.022). For lesions with a diameter of ≤ 2 cm, the specificity of the Nomogram was higher than that of the AI diagnostic system (90.00% vs. 67.50%, p = 0.022). Based on the combination of a 7-AAB panel, an AI diagnostic system, and other clinical features, our Nomogram demonstrated good diagnostic performance in distinguishing lung nodules, especially those with ≤ 2 cm diameters. • A novel diagnostic model of lung nodules was constructed by combining high-specific tumor markers with a high-sensitivity artificial intelligence diagnostic system. • The diagnostic model has good diagnostic performance in distinguishing malignant and benign pulmonary nodules, especially for nodules smaller than 2 cm. • The diagnostic model can assist the clinical decision-making of pulmonary nodules, with the advantages of high diagnostic efficiency, noninvasive, and simple measurement.

Establishment of a deep-learning system to diagnose BI-RADS4a or higher using breast ultrasound for clinical application.

Although the categorization of ultrasound using the Breast Imaging Reporting and Data System (BI‐RADS) has become widespread worldwide, the problem of inter‐observer variability remains. To maintain uniformity in diagnostic accuracy, we have developed a system in which artificial intelligence (AI) can distinguish whether a static image obtained using a breast ultrasound represents BI‐RADS3 or lower or BI‐RADS4a or higher to determine the medical management that should be performed on a patient whose breast ultrasound shows abnormalities. To establish and validate the AI system, a training dataset consisting of 4028 images containing 5014 lesions and a test dataset consisting of 3166 images containing 3656 lesions were collected and annotated. We selected a setting that maximized the area under the curve (AUC) and minimized the difference in sensitivity and specificity by adjusting the internal parameters of the AI system, achieving an AUC, sensitivity, and specificity of 0.95, 91.2%, and 90.7%, respectively. Furthermore, based on 30 images extracted from the test data, the diagnostic accuracy of 20 clinicians and the AI system was compared, and the AI system was found to be significantly superior to the clinicians (McNemar test, p < 0.001). Although deep‐learning methods to categorize benign and malignant tumors using breast ultrasound have been extensively reported, our work represents the first attempt to establish an AI system to classify BI‐RADS3 or lower and BI‐RADS4a or higher successfully, providing important implications for clinical actions. These results suggest that the AI diagnostic system is sufficient to proceed to the next stage of clinical application.

What Are the Users’ Needs? Design of a User-Centered Explainable Artificial Intelligence Diagnostic System

The application of artificial intelligence (AI) systems has surged in the high-risk area of medicine, and these systems must explain their decisions to different users. However, existing explainable AI (XAI) design practices in the medical domain are mostly focused on domain experts, such as physicians, and there is a lack of XAI design practices for consumer users. Therefore, we developed a library of XAI user needs in the medical domain, which can be used as an auxiliary tool for the development of user-centered XAI design solutions in this domain. Moreover, through empirical research, based on our XAI user Needs Library, we designed an XAI-based electrocardiogram diagnostic system prototype for consumer users and conducted a user evaluation. The results provide the empirical experience of the design space of XAI and promote consumer user-centered XAI practices.