Principles for evaluating the clinical implementation of novel digital healthcare devices

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

Prediction of Local Tumor Progression after Radiofrequency Ablation (RFA) of Hepatocellular Carcinoma by Assessment of Ablative Margin Using Pre-RFA MRI and Post-RFA CT Registration

OBJECTIVE: To evaluate the clinical impact of using registration software for ablative margin assessment on pre-radiofrequency ablation (RFA) magnetic resonance imaging (MRI) and post-RFA computed tomography (CT) compared with the conventional side-by-side MR-CT visual comparison. MATERIALS AND METHODS: In this Institutional Review Board-approved prospective study, 68 patients with 88 hepatocellulcar carcinomas (HCCs) who had undergone pre-RFA MRI were enrolled. Informed consent was obtained from all patients. Pre-RFA MRI and post-RFA CT images were analyzed to evaluate the presence of a sufficient safety margin (≥ 3 mm) in two separate sessions using either side-by-side visual comparison or non-rigid registration software. Patients with an insufficient ablative margin on either one or both methods underwent additional treatment depending on the technical feasibility and patient's condition. Then, ablative margins were re-assessed using both methods. Local tumor progression (LTP) rates were compared between the sufficient and insufficient margin groups in each method. RESULTS: The two methods showed 14.8% (13/88) discordance in estimating sufficient ablative margins. On registration software-assisted inspection, patients with insufficient ablative margins showed a significantly higher 5-year LTP rate than those with sufficient ablative margins (66.7% vs. 27.0%, p = 0.004). However, classification by visual inspection alone did not reveal a significant difference in 5-year LTP between the two groups (28.6% vs. 30.5%, p = 0.79). CONCLUSION: Registration software provided better ablative margin assessment than did visual inspection in patients with HCCs who had undergone pre-RFA MRI and post-RFA CT for prediction of LTP after RFA and may provide more precise risk stratification of those who are treated with RFA.

Status of Interchange of Medical Imaging in Korea: A Questionnaire Survey of Physicians

The purpose of this study was to summarize the results of a survey for physicians with specialties other than radiology about imaging studies of patients referred from other institutions. The survey was promoted through individual contacts or social network service and physicians who voluntarily responded to the survey were the subjects of the study. The questionnaire consisted of 11 questions about basic information and referrals about medical imaging. A total of 160 physicians from 30 specialties participated in the survey and 95.6% of the respondents worked in tertiary care center or general hospital. Patients were frequently referred with outside medical images. The most frequently referred imaging modalities were computed tomography and magnetic resonance imaging. However, radiological reports from outside institutions were rarely referred. Most physicians thought that reinterpretation for outside imaging is necessary to acquire a secondary opinion. In conclusion, considering that outside radiological reports are frequently missing and there are high demands on reinterpretation for outside imaging, guidelines for referral of radiological reports with medical imaging, basic elements of radiological reports, and reinterpretation need to be developed.

Suggested Protocol for Efficient Medical Image Information Exchange in Korea: Breast MRI

PURPOSE@#Establishment of an appropriate protocol for breast magnetic resonance imaging (MRI) in the study of image quality standards to enhance the effectiveness of medical image information exchange, which is part of the construction and activation of clinical information exchange for healthcare informatization.@*MATERIALS AND METHODS@#The recommended protocols of breast and MRI scans were reviewed and the questionnaire was prepared by a responsible researcher. Then, a panel of 9 breast dedicated radiologists was set up in Korea. The expert panel conducted a total of three Delphi agreements to draw up a consensus on the breast MRI protocol.@*RESULTS@#The agreed breast MRI recommendation protocol is a 1.5 Tesla or higher device that acquires images with prone position using a breast dedicated coil and includes T2-weighted and pre-contrast T1-weighted images. Contrast enhancement images are acquired at least two times, and include 60–120 seconds between images and after 4 minutes. The contrast enhancement T1-weighted image should be less than 3 mm in thickness, less than 120 seconds in temporal resolution, and less than 1.5 mm² in-plane pixel resolution.@*CONCLUSION@#The Delphi agreement of the domestic breast imaging specialist group has established the recommendation protocol of the effective breast MRI.

Principles for evaluating the clinical implementation of novel digital healthcare devices

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

Ruptured Corpus Luteal Cyst: Prediction of Clinical Outcomes with CT

OBJECTIVE: To evaluate the determinant pretreatment CT findings that can predict surgical intervention for patients suffering from corpus luteal cyst rupture with hemoperitoneum. MATERIALS AND METHODS: From January 2009 to December 2014, a total of 106 female patients (mean age, 26.1 years; range, 17–44 years) who visited the emergency room of our institute for acute abdominal pain and were subsequently diagnosed with ruptured corpus luteal cyst with hemoperitoneum were included in the retrospective study. The analysis of CT findings included cyst size, cyst shape, sentinel clot sign, ring of fire sign, hemoperitoneum depth, active bleeding in portal phase and attenuation of hemoperitoneum. The comparison of CT findings between the surgery and conservative management groups was performed with the Mann-Whitney U test or chi-square test. Logistic regression analysis was used to determine significant CT findings in predicting surgical intervention for a ruptured cyst. RESULTS: Comparative analysis revealed that the presence of active bleeding and the hemoperitoneum depth were significantly different between the surgery and conservative management groups and were confirmed as significant CT findings for predicting surgery, with adjusted odds ratio (ORs) of 3.773 and 1.318, respectively (p 5.8 cm and concurrent active bleeding, the OR for surgery increased to 5.786. CONCLUSION: The presence of active bleeding and the hemoperitoneum depth on a pretreatment CT scan can be predictive warning signs of surgery for a patient with a ruptured corpus luteal cyst with hemoperitoneum.

Differentiating between Adenomyomatosis and Gallbladder Cancer: Revisiting a Comparative Study of High-Resolution Ultrasound, Multidetector CT, and MR Imaging

OBJECTIVE: To compare the diagnostic performance of high-resolution ultrasound (HRUS) with contrast-enhanced CT and contrast-enhanced magnetic resonance imaging (MRI) with MR cholangiopancreatography (MRCP) to differentiate between adenomyomatosis (ADM) and gallbladder cancer (GBCA). MATERIALS AND METHODS: Forty patients with surgically proven ADM (n = 13) or GBCA at stage T2 or lower (n = 27) who previously underwent preoperative HRUS, contrast-enhanced CT, and contrast-enhanced MRI with MRCP were retrospectively included in this study. According to the well-known diagnostic criteria, two reviewers independently analyzed the images from each modality separately with a five-point confidence scale. The interobserver agreement was calculated using weighted kappa statistics. A receiver operating characteristic curve analysis was performed and the sensitivity, specificity, and accuracy were calculated for each modality when scores of 1 or 2 indicated ADM. RESULTS: The interobserver agreement between the two reviewers was good to excellent. The mean Az values for HRUS, multidetector CT (MDCT), and MRI were 0.959, 0.898, and 0.935, respectively, without any statistically significant differences between any of the modalities (p > 0.05). The mean sensitivity of MRI with MRCP (80.8%) was significantly higher than that of MDCT (50.0%) (p = 0.0215). However, the mean sensitivity of MRI with MRCP (80.8%) was not significantly different from that of HRUS (73.1%) (p > 0.05). The mean specificities and accuracies among the three modalities were not significantly different (p > 0.05). CONCLUSION: High-resolution ultrasound and MRI with MRCP have comparable sensitivity and accuracy and MDCT has the lowest sensitivity and accuracy for the differentiation of ADM and GBCA.

Hospital Wireless Local Area Network-Based Tracking System / 대한의료정보학회지

OBJECTIVES: The purpose of this study was to develop a prototype wireless local area network (LAN)-based tracking system and evaluate its efficacy. METHODS: A wireless LAN-based tracking system was developed with a personal digital assistant (PDA) having a simple text messaging function and a prototype stand-alone tracking device. Evaluation of the effectiveness of the tracking system was performed in two ways. Twenty-five messages were sent to nurses by direct communication and 46 messages were sent by the wireless system. Thirty cases by nurses and 30 cases by the wireless system to locate hospital equipment were performed. The time required to transfer messages and to locate equipment was measured and analyzed with a Mann-Whitney test and a paired t-test, respectively. RESULTS: The mean time required to transfer messages by direct communication and by the wireless system were 37.92 +/- 19.19 seconds and 30.65 +/- 9.80 seconds, respectively which were not statistically different (p = 0.108). The mean time required to locate equipment by the nurses and by the wireless system was 234.00 +/- 59.99 and 23.97 +/- 6.17 seconds, respectively which was statistically different (p < 0.001). CONCLUSIONS: The wireless LAN-based tracking system can save time for nurses to communicate and to check for the location of equipment in wards which allows nurses to spend more time and attention to patient care and safety.