Radiologist's Guide to Evaluating Publications of Clinical Research on AI: How We Do It.

Literacy in research studies of artificial intelligence (AI) has become an important skill for radiologists. It is required to make a proper assessment of the validity, reproducibility, and clinical applicability of AI studies. However, AI studies are generally perceived to be more difficult for clinician readers to evaluate than traditional clinical research studies. This special report-as an effective, concise guide for readers-aims to assist clinical radiologists in critically evaluating different types of clinical research articles involving AI. It does not intend to be a comprehensive checklist or methodological summary for complete clinical evaluation of AI or a reporting guideline. Ten key items for readers to check are described, regarding study purpose, function and clinical context of AI, training data, data preprocessing, AI modeling techniques, test data, AI performance, helpfulness and value of AI, interpretability of AI, and code sharing. The important aspects of each item are explained for readers to consider when reading publications on AI clinical research. Evaluating each item can help radiologists assess the validity, reproducibility, and clinical applicability of clinical research articles involving AI.

Association between visceral obesity and tumor recurrence in hepatocellular carcinoma recipients undergoing liver transplantation.

BACKGROUND: Excessive visceral obesity in recipients of living donor liver transplantation (LDLT) is associated with mortality, and a recent study reported the correlation between visceral adiposity of male LDLT recipients and hepatocellular carcinoma (HCC) recurrence. However, there is no study on the relationship between the donor's visceral adiposity and surgical outcomes in LDLT recipients. We investigated the association of the visceral-to-subcutaneous fat area ratio (VSR) in donors and recipients with HCC recurrence and mortality in LDLT. METHODS: We analyzed 1386 sets of donors and recipients who underwent LDLT between January 2008 and January 2018. The maximal chi-square method was used to determine the optimal cutoff values for VSR for predicting overall HCC recurrence and mortality. Cox regression analyses were performed to evaluate the association of donor VSR and recipient VSR with overall HCC recurrence and mortality in recipients. RESULTS: The cutoff values of VSR was determined as 0.73 in males and 0.31 in females. High donor VSR was significantly associated with overall HCC recurrence (adjusted hazard ratio [HR]: 1.43, 95% confidence interval [CI]: 1.06-1.93, p = 0.019) and mortality (HR: 1.35, 95% CI: 1.03-1.76, p = 0.030). High recipient VSR was significantly associated with overall HCC recurrence (HR: 1.40, 95% CI: 1.04-1.88, p = 0.027) and mortality (HR: 1.50, 95% CI: 1.14-1.96, p = 0.003). CONCLUSIONS: Both recipient VSR and donor VSR were significant risk factors for HCC recurrence and mortality in LDLT recipients. Preoperative donor VSR and recipient VSR may be strong predictors of the surgical outcomes of LDLT recipients with HCC.

Association of sex-specific donor skeletal muscle index with surgical outcomes in living donor liver transplantation recipients.

BACKGROUND: A recent study reported a correlation between the muscle mass of male donors and graft failure in living donor liver transplantation (LDLT) recipients. We investigated the association of sex-specific donor skeletal muscle index (SMI) with mortality and graft failure in LDLT recipients. METHODS: We retrospectively analysed 2750 sets of donors and recipients between January 2008 and January 2018. The recipient outcomes were analysed by dividing the data according to donor sex. Cox regression analyses were performed to evaluate the association between donor SMI by sex and 1-year mortality and graft failure in recipients. RESULTS: In the male donor group, robust donor (increased SMI) was significantly associated with higher risks for mortality (hazard ratio [HR]: 1.03, 95% confidence interval [CI]: 1.00-1.06, p = .023) and graft failure (HR: 1.04, 95% CI: 1.01-1.06, p = .007) at 1 year. In the female donor group, the robust donor was significantly associated with lower risks for mortality (HR: 0.92, 95% CI: 0.87-0.97, p = .003) and graft failure (HR: 0.95, 95% CI: 0.90-1.00, p = .032) at 1 year. CONCLUSIONS: Donor SMI was associated with surgical outcomes in recipients. Robust male and female donors were a significant negative and protective factor for grafts respectively.

Impact of Sarcopenia on Clinical Course of Inflammatory Bowel Disease in Korea.

BACKGROUND AND AIMS: Reduced body muscle mass is a poor prognostic factor for inflammatory bowel disease (IBD). In this study, we investigated the prevalence of sarcopenia at diagnosis and its clinical significance in Korean patients with IBD. METHODS: The prevalence of sarcopenia in IBD patients between June 1989 and December 2016 was investigated using a well-characterized referral center-based cohort. Abdominopelvic computed tomography within six months from IBD diagnosis was used for the evaluation. Sarcopenia was defined as an L3 skeletal muscle index of < 49 cm2/m2 for male and < 31 cm2/m2 for female. The clinical characteristics and outcomes were evaluated with respect to sarcopenia. RESULTS: A total of 1,027 patients (854 Crohn's disease [CD]; 173 ulcerative colitis [UC]) were evaluated. Sarcopenia was found in 56.8% of the population (CD, 57.5%; UC, 53.2%), and male were more likely to be sarcopenic (CD, 94.3%; UC, 91.6%). There were no significant differences in the cumulative risk of using steroids, immunomodulators, biologics, and bowel resections (or colectomy) with or without sarcopenia during follow-up (median: CD, 5.8 years; UC, 3.7 years). In sarcopenic patients with CD, there was a significantly higher cumulative risk of perianal surgeries than in non-sarcopenic patients with CD (Log-rank test; P = 0.001). However, the risk of perianal surgeries was not significant in multivariate analysis (Odds ratio 1.368; 95% confidence interval 0.782-2.391; P = 0.272). CONCLUSION: Sarcopenia at diagnosis may have no significant prognostic value for medical treatment and bowel resection, but it may be associated with perianal CD.

Associations of sarcopenia with graft failure and mortality in patients undergoing living donor liver transplantation.

Recent studies have reported that sarcopenia influences morbidity and mortality in surgical patients. However, few studies have investigated the associations of sarcopenia with short-term and long-term graft failure in recipients after living donor liver transplantation (LDLT). In this study, we investigated the associations between sarcopenia and graft failure/mortality in patients undergoing LDLT. We retrospectively examined 2816 recipients who underwent LDLT between January 2008 and January 2018. Cox regression analysis was performed to evaluate the associations between sarcopenia and graft failure/mortality in recipients at 60 days, 180 days, and 1 year and overall. Sarcopenia in the recipient was significantly associated with 60-day graft failure (adjusted hazard ratio [HR], 1.98; 95% confidence interval [CI], 1.09-3.61; p = 0.03), 180-day graft failure (HR, 1.85; 95% CI, 1.19-2.88; p = 0.01), 1-year graft failure (HR, 1.45; 95% CI, 1.01-2.17; p = 0.05), and overall graft failure (HR, 1.42; 95% CI, 1.08-1.87; p = 0.01). In addition, recipient sarcopenia was associated with 180-day mortality (HR, 1.88; 95% CI, 1.17-3.01; p = 0.01), 1-year mortality (HR, 1.53; 95% CI, 1.01-2.29; p = 0.04), and overall mortality (HR, 1.43; 95% CI, 1.08-1.90; p = 0.01). Preoperative sarcopenia was associated with high rates of graft failure and mortality in LDLT recipients. Therefore, preoperative sarcopenia may be a strong predictor of the surgical prognosis in LDLT recipients.

Transient severe motion artifacts on gadoxetic acid-enhanced MRI: risk factor analysis in 2230 patients.

OBJECTIVES: To determine risk factors for transient severe motion (TSM) artifact on arterial phase of gadoxetic acid-enhanced MRI using a large cohort. METHODS: A total of 2230 patients who underwent gadoxetic acid-enhanced MRI was consecutively included. Two readers evaluated respiratory motion artifact on arterial phase images using a 5-point grading scale. Clinical factors including demographic data, underlying disease, laboratory data, presence of ascites and pleural effusion, and previous experience of gadoxetic acid-enhanced MRI were investigated. Univariable and multivariable logistic regression analyses were performed to determine significant risk factors for TSM. Predictive value of TSM was calculated according to the number of significant risk factors. RESULTS: Overall incidence of TSM was 5.0% (111/2230). In the multivariable analysis, old age (≥ 65 years; odds ratio [OR] = 2.01 [95% CI, 1.31-3.07]), high body mass index (≥ 25 kg/m2; OR = 1.76 [1.18-2.63]), chronic obstructive pulmonary disease (OR = 6.11 [2.32-16.04]), and moderate to severe pleural effusion (OR = 3.55 [1.65-7.65]) were independent significant risk factors for TSM. Presence of hepatitis B (OR = 0.66 [0.43-0.99]) and previous experience of gadoxetic acid-enhanced MRI (OR = 0.52 [0.33-0.83]) were negative risk factors for TSM. When at least one of the significant factors was present, the predictive risk was 5.7% (109/1916), whereas it was 16.3% (17/104) when at least four factors were present. CONCLUSION: Knowing risk factors for transient severe motion artifact on gadoxetic acid-enhanced MRI can be clinically useful for providing diagnostic strategies more tailored to individual patients. KEY POINTS: • Old age, high body mass index, chronic obstructive pulmonary disease, and moderate to severe pleural effusion were independent risk factors for transient severe motion artifact on gadoxetic acid-enhanced MRI. • Patients with hepatitis B or previous experience of gadoxetic acid-enhanced MRI were less likely to show transient severe motion artifact. • As the number of risk factors for transient severe motion artifact increased, the predicted risk for it also showed a tendency to increase.

Development and validation of an ensemble artificial intelligence model for comprehensive imaging quality check to classify body parts and contrast enhancement.

BACKGROUND: Despite the dramatic increase in the use of medical imaging in various therapeutic fields of clinical trials, the first step of image quality check (image QC), which aims to check whether images are uploaded appropriately according to the predefined rules, is still performed manually by image analysts, which requires a lot of manpower and time. METHODS: In this retrospective study, 1669 computed tomography (CT) images with five specific anatomical locations were collected from Asan Medical Center and Kangdong Sacred Heart Hospital. To generate the ground truth, two radiologists reviewed the anatomical locations and presence of contrast enhancement using the collected data. The individual deep learning model is developed through InceptionResNetv2 and transfer learning, and we propose Image Quality Check-Net (Image QC-Net), an ensemble AI model that utilizes it. To evaluate their clinical effectiveness, the overall accuracy and time spent on image quality check of a conventional model and ImageQC-net were compared. RESULTS: ImageQC-net body part classification showed excellent performance in both internal (precision, 100%; recall, 100% accuracy, 100%) and external verification sets (precision, 99.8%; recovery rate, 99.8%, accuracy, 99.8%). In addition, contrast enhancement classification performance achieved 100% precision, recall, and accuracy in the internal verification set and achieved (precision, 100%; recall, 100%; accuracy 100%) in the external dataset. In the case of clinical effects, the reduction of time by checking the quality of artificial intelligence (AI) support by analysts 1 and 2 (49.7% and 48.3%, respectively) was statistically significant (p < 0.001). CONCLUSIONS: Comprehensive AI techniques to identify body parts and contrast enhancement on CT images are highly accurate and can significantly reduce the time spent on image quality checks.

A reliable and robust method for the upper thigh muscle quantification on computed tomography: toward a quantitative biomarker for sarcopenia.

BACKGROUND: We aimed to evaluate the feasibility of the upper thigh level as a landmark to measure muscle area for sarcopenia assessment on computed tomography (CT). METHODS: In the 116 healthy subjects who performed CT scans covering from mid-abdomen to feet, the skeletal muscle area in the upper thigh level at the inferior tip of ischial tuberosity (SMAUT), the mid-thigh level (SMAMT), and L3 inferior endplate level (SMAL3) were measured by two independent readers. Pearson correlation coefficients between SMAUT, SMAMT, and SMAL3 were calculated. Inter-reader agreement between the two readers were evaluated using intraclass correlation coefficient (ICC) and Bland-Altman plots with 95% limit of agreement (LOA). RESULTS: In readers 1 and 2, very high positive correlations were observed between SMAUT and SMAMT (r = 0.91 and 0.92, respectively) and between SMAUT and SMAL3 (r = 0.90 and 0.91, respectively), while high positive correlation were observed between SMAMT and SMAL3 (r = 0.87 and 0.87, respectively). Based on ICC values, the inter-reader agreement was the best in the SMAUT (0.999), followed by the SMAL3 (0.990) and SMAMT (0.956). The 95% LOAs in the Bland-Altman plots indicated that the inter-reader agreement of the SMAUT (- 0.462 to 1.513) was the best, followed by the SMAL3 (- 9.949 to 7.636) and SMAMT (- 12.105 to 14.605). CONCLUSION: Muscle area measurement at the upper thigh level correlates well with those with the mid-thigh and L3 inferior endpoint level and shows the highest inter-reader agreement. Thus, the upper thigh level might be an excellent landmark enabling SMAUT as a reliable and robust biomarker for muscle area measurement for sarcopenia assessment.

A Deep Residual U-Net Algorithm for Automatic Detection and Quantification of Ascites on Abdominopelvic Computed Tomography Images Acquired in the Emergency Department: Model Development and Validation.

BACKGROUND: Detection and quantification of intra-abdominal free fluid (ie, ascites) on computed tomography (CT) images are essential processes for finding emergent or urgent conditions in patients. In an emergency department, automatic detection and quantification of ascites will be beneficial. OBJECTIVE: We aimed to develop an artificial intelligence (AI) algorithm for the automatic detection and quantification of ascites simultaneously using a single deep learning model (DLM). METHODS: We developed 2D DLMs based on deep residual U-Net, U-Net, bidirectional U-Net, and recurrent residual U-Net (R2U-Net) algorithms to segment areas of ascites on abdominopelvic CT images. Based on segmentation results, the DLMs detected ascites by classifying CT images into ascites images and nonascites images. The AI algorithms were trained using 6337 CT images from 160 subjects (80 with ascites and 80 without ascites) and tested using 1635 CT images from 40 subjects (20 with ascites and 20 without ascites). The performance of the AI algorithms was evaluated for diagnostic accuracy of ascites detection and for segmentation accuracy of ascites areas. Of these DLMs, we proposed an AI algorithm with the best performance. RESULTS: The segmentation accuracy was the highest for the deep residual U-Net model with a mean intersection over union (mIoU) value of 0.87, followed by U-Net, bidirectional U-Net, and R2U-Net models (mIoU values of 0.80, 0.77, and 0.67, respectively). The detection accuracy was the highest for the deep residual U-Net model (0.96), followed by U-Net, bidirectional U-Net, and R2U-Net models (0.90, 0.88, and 0.82, respectively). The deep residual U-Net model also achieved high sensitivity (0.96) and high specificity (0.96). CONCLUSIONS: We propose a deep residual U-Net-based AI algorithm for automatic detection and quantification of ascites on abdominopelvic CT scans, which provides excellent performance.

Intermuscular fat density as a novel prognostic factor in breast cancer patients treated with adjuvant chemotherapy.

BACKGROUND: Body composition, including sarcopenia and fat parameters, has received much attention as a prognostic factor in breast cancer. METHODS: A total of 479 breast cancer patients who underwent surgery and received adjuvant chemotherapy were enrolled in this study. Body composition, including the index and density of skeletal muscle, visceral fat, subcutaneous fat, and intermuscular fat calculated by CT scan, was used as a prognostic factor. The endpoints were breast cancer-specific survival (BCSS) and overall survival (OS). RESULTS: The number of patients with stages I, II, and III was 146 (30.5%), 237 (49.5%), and 96 (20%), respectively. Sarcopenia and muscle density were not significant prognostic factors for BCSS and OS. A high visceral fat index (VFI) was an independent prognostic factor for BCSS (HR, 2.55; 95% CI 1.10-5.95, p = 0.03) and OS (HR 2.55, 95% CI 1.26-5.16, p = 0.01). In addition, high intermuscular fat density (IMFD) was also a significant prognostic factor for BCSS (HR, 2.95; 95% CI 1.34-6.46, p = 0.007) and OS (HR 2.28, 95% CI 1.22-4.26, p = 0.01) in multivariate analysis. CONCLUSION: VFI and IMFD were significant prognostic factors for BCSS and OS in breast cancer patients treated with adjuvant chemotherapy.

The role of muscle depletion and visceral adiposity in HCC patients aged 65 and over undergoing TACE.

BACKGROUND: The incidence of hepatocellular carcinoma (HCC) has been increasing among the elderly populations. Trans-arterial chemoembolization (TACE), a widely used first-line non-curative therapy for HCCs is an issue in geriatrics. We investigated the prognosis of elderly HCC patients treated with TACE and determined the factors that affect the overall survival. METHODS: We included 266 patients who were older than 65 years and had received TACE as initial treatment for HCC. We analyzed the skeletal muscle index (SMI) and visceral-to-subcutaneous fat ratio (VSR) around the third lumbar vertebrae using computed tomography scans. Muscle depletion with visceral adiposity (MDVA) was defined by falling below the median SMI and above the median VSR value sex-specifically. We evaluated the overall survival in association with MDVA and other clinical factors. RESULTS: The mean age was 69.9 ± 4.5 years, and 70.3% of the patients were men. According to the Barcelona Clinic Liver Cancer (BCLC) staging system, 29, 136, and 101 patients were classified as BCLC 0, A, and B stages, respectively, and 79 (29.7%) had MDVA. During the median follow-up of 4.1 years, patients with MDVA had a shorter life expectancy than those without MDVA (P = 0.007) even though MDVA group had a higher objective response rate after the first TACE (82.3% vs. 75.9%, P = 0.035). Multivariate analysis revealed that MDVA (Hazard ratio [HR] 1.515) age (HR 1.057), liver function (HR 1.078), tumor size (HR 1.083), serum albumin level (HR 0.523), platelet count (HR 0.996), tumor stage (stage A, HR 1.711; stage B, HR 2.003), and treatment response after the first TACE treatment (HR 0.680) were associated with overall survival. CONCLUSIONS: MDVA is a critical prognostic factor for predicting survival in the elderly patients with HCC who have undergone TACE.

Final diagnosis and patient disposition following equivocal results on 2-mSv CT vs. conventional-dose CT in adolescents and young adults with suspected appendicitis: a post hoc analysis of large pragmatic randomized trial data.

OBJECTIVE: To compare 2-mSv CT and conventional-dose CT (CDCT, typically 7-8 mSv) regarding final diagnosis and patient disposition following equivocal CT results in adolescents and young adults with suspected appendicitis. METHODS: In total, 3074 patients of 15-44 years (28 ± 9 years, 1672 women) from 20 hospitals were randomized to undergo contrast-enhanced 2-mSv CT (n = 1535) or CDCT (n = 1539) from December 2013 through August 2016. One hundred sixty-one radiologists prospectively rated the likelihood of appendicitis in a Likert scale (i.e., grades 1-5). The final diagnosis was based on CT image, surgical, pathologic, and clinical findings. Post hoc analysis was performed for final diagnosis, surgical procedure, and delay in patient management following equivocal results (i.e., grade 3). RESULTS: The 2-mSv CT and CDCT groups were comparable for final diagnosis following equivocal results, including confirmed appendicitis (1.2% [18 patients] vs. 1.2% [19], p > 0.99), negative appendectomy (0.1% [2] vs. 0.3% [4], p = 0.53), and perforated appendicitis (0.1% [1] vs. 0.2% [3], p = 0.53). More patients were confirmed as not having appendicitis following equivocal results in the CDCT group than in the 2-mSv CT group (2.2% [34] vs. 1.0% [16], p = 0.016). The two groups were comparable for the need of appendectomy (1.4% [22] vs. 1.5% [23], p > 0.99), need of additional imaging tests (0.7% [11] vs. 1.1% [17], p = 0.35), and delay in patient management following equivocal results. CONCLUSION: 2-mSv CT is comparable to CDCT regarding final diagnosis and patient disposition following equivocal CT results. KEY POINTS: • Our results strengthen evidence justifying the use of low-dose CT instead of conventional-dose CT (CDCT) in adolescents and young adults with suspected appendicitis. • The 2-mSv CT and CDCT groups were comparable for final diagnosis following equivocal CT results, including confirmed appendicitis (1.2% vs. 1.2%, p > 0.99), negative appendectomy (0.1% vs. 0.3%, p = 0.53), and perforated appendicitis (0.1% vs. 0.2%, p = 0.53). • The two groups were comparable for the need for appendectomy (1.4% vs. 1.5%, p > 0.99), need for additional imaging tests (0.7% vs. 1.1%, p = 0.35), and delay in patient management, following equivocal CT results.

Conventional-Dose CT Versus 2-mSv CT for Right Colonic Diverticulitis as an Alternate Diagnosis of Appendicitis: Secondary Analysis of Large Pragmatic Randomized Trial Data.

BACKGROUND. Adoption of low-dose CT for the diagnosis of appendicitis has been slow in children and in adults, partly because of concern about missing alternative diagnoses including right colonic diverticulitis. OBJECTIVE. The purpose of our study was to retrospectively compare the diagnostic performance of IV contrast-enhanced 2-mSv and conventional-dose CT (CDCT) for the diagnosis of right colonic diverticulitis in adolescents and young adults with suspected appendicitis. METHODS. This post hoc analysis of a prospective randomized controlled trial included 3074 patients (1672 female patients and 1402 male patients) ranging in age from 15 to 44 years old (mean ± SD, 28 ± 9 years) from 20 hospitals. From December 2013 to August 2016, patients were randomized to either the 2-mSv CT group (n = 1535 patients) or the CDCT (median, 7 mSv) group (n = 1539 patients). A total of 161 radiologists prospectively issued CT reports in which they suggested alternative diagnoses for 976 (2-mSv CT) and 924 (CDCT) patients. Seven independent assessors adjudicated final diagnoses on the basis of clinical and CT findings. Endpoints of test-positives, test-negatives, sensitivity, and specificity for right colonic diverticulitis were compared using chi-square and Mann-Whitney U tests. Characteristics and disposition of patients with test-positive results were assessed. Four readers retrospectively reviewed CT images of 400 patients selected from the trial (113 and 108 patients with diverticulitis from 2-mSv CT and CDCT groups, respectively) to evaluate interobserver agreement for right colonic diverticulitis in terms of Gwet coefficients. RESULTS. Between-group differences were minute for most endpoints related to right colonic diverticulitis: test-positives (difference, 0.2% [95% CI, -1.8% to 2.1%]; 7.8% [119/1535 patients] vs 7.6% [117/1539 patients]; p = .93), test-negatives (0.5% [95% CI, -1.5% to 2.5%]; 91.7% [1407/1535] vs 91.2% [1403/1539]; p = .67), sensitivity (0% [95% CI, -6% to 6%]; 95% [110/116] vs 95% [105/111]; p > .99), and specificity (0.3% [95% CI, -0.5% to 0.9%]; 99.4% [1401/1410] vs 99.1% [1397/1409]; p = .66). The characteristics and disposition of test-positive patients were similar between the two groups. Gwet coefficients were high and comparable between the two groups (2-mSv CT vs CDCT, 0.849 vs 0.889; p = .20). CONCLUSION. Two-millisievert CT is comparable to conventional-dose CT for the diagnosis of right colonic diverticulitis. CLINICAL IMPACT. By mitigating concern about a missed diagnosis of right colonic diverticulitis, the results further support the use of low-dose CT in patients with suspected appendicitis. TRIAL REGISTRATION. ClinicalTrials.gov NCT01925014.

CDISC-compliant clinical trial imaging management system with automatic verification and data Transformation: Focusing on tumor response assessment data in clinical trials.

OBJECTIVE: Major issues in imaging data management of tumor response assessment in clinical trials include high human errors in data input and unstandardized data structures, warranting a new breakthrough IT solution. Thus, we aim to develop a Clinical Data Interchange Standards Consortium (CDISC)-compliant clinical trial imaging management system (CTIMS) with automatic verification and transformation modules for implementing the CDISC Study Data Tabulation Model (SDTM) in the tumor response assessment dataset of clinical trials. MATERIALS AND METHODS: In accordance with various CDISC standards guides and Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, the overall system architecture of CDISC-compliant CTIMS was designed. Modules for standard-compliant electronic case report form (eCRF) to verify data conformance and transform into SDTM data format were developed by experts in diverse fields such as medical informatics, medical, and clinical trial. External validation of the CDISC-compliant CTIMS was performed by comparing it with our previous CTIMS based on real-world data and CDISC validation rules by Pinnacle 21 Community Software. RESULTS: The architecture of CDISC-compliant CTIMS included the standard-compliant eCRF module of RECIST, the automatic verification module of the input data, and the SDTM transformation module from the eCRF input data to the SDTM datasets based on CDISC Define-XML. This new system was incorporated into our previous CTIMS. External validation demonstrated that all 176 human input errors occurred in the previous CTIMS filtered by a new system yielding zero error and CDISC-compliant dataset. The verified eCRF input data were automatically transformed into the SDTM dataset, which satisfied the CDISC validation rules by Pinnacle 21 Community Software. CONCLUSIONS: To assure data consistency and high quality of the tumor response assessment data, our new CTIMS can minimize human input error by using standard-compliant eCRF with an automatic verification module and automatically transform the datasets into CDISC SDTM format.

Diagnostic sensitivity and specificity of 2-mSv CT vs. conventional-dose CT in adolescents and young adults with suspected appendicitis: post hoc subgroup analysis of the LOCAT data.

OBJECTIVES: To test whether the difference in sensitivity or specificity between 2-mSv CT and conventional-dose CT (CDCT) for the diagnosis of appendicitis differs across subgroups of adolescents and young adults with suspected appendicitis. MATERIALS AND METHODS: We used the per-protocol analysis data of a trial conducted between Dec 2013 and Aug 2016, including 2773 patients (median age [interquartile range], 28 [21-35] years) and 160 radiologists from 20 hospitals. We defined subgroups by sex, body size, clinical risk scores for appendicitis, time of CT examination (i.e., working vs. after hours), CT machines, radiologists' experience, previous site experience in 2-mSv CT, and site practice volume. We drew forest plots and tested for additive or multiplicative interaction between radiation dose and subgroup attributes. If any subgroup had fewer than 200 patients, we considered the results from that subgroup not meaningful. RESULTS: For most subgroups, the 95% CIs for the differences in sensitivity and specificity were 4.0 percentage points or narrower and contained the minute overall between-group differences. There was no significant interaction on sensitivity or specificity. A few subgroups, including those of extreme body sizes, high appendicitis inflammatory response scores, and hospitals with small appendectomy volume, were regarded to have insufficient numbers of patients. CONCLUSIONS: There was no notable subgroup heterogeneity, which implies that 2-mSv CT can replace CDCT in diverse populations. Further studies are needed for the subgroups for which we had only small data. KEY POINTS: • The minute difference in sensitivity or specificity between the 2-mSv CT and conventional-dose CT (typically 7 mSv) groups were consistent across various patient or hospital characteristics. • These results indicate that 2-mSv CT can replace conventional-dose CT in diverse populations. • Further studies are needed to confirm whether 2-mSv CT can replace conventional-dose CT in patients of extreme body sizes, high appendicitis inflammatory response scores, or hospitals with small appendectomy volume, as those subgroups in our data included limited numbers of patients.

Small area estimation of receiver operating characteristic curves for ordinal data under stochastic ordering.

There has been a recent increase in the diagnosis of diseases through radiographic images such as x-rays, magnetic resonance imaging, and computed tomography. The outcome of a radiological diagnostic test is often in the form of discrete ordinal data, and we usually summarize the performance of the diagnostic test using the receiver operating characteristic (ROC) curve and the area under the curve (AUC). The ROC curve will be concave and called proper when the outcomes of the diagnostic test in the actually positive subjects are higher than in the actually negative subjects. The diagnostic test for disease detection is clinically useful when a ROC curve is proper. In this study, we develop a hierarchical Bayesian model to estimate the proper ROC curve and AUC using stochastic ordering in several domains when the outcome of the diagnostic test is discrete ordinal data and compare it with the model without stochastic ordering. The model without stochastic ordering can estimate the improper ROC curve with a nonconcave shape or a hook when the true ROC curve of the population is a proper ROC curve. Therefore, the model with stochastic ordering is preferable over the model without stochastic ordering to estimate the proper ROC curve with clinical usefulness for ordinal data.

Detection and False-Referral Rates of 2-mSv CT Relative to Standard-Dose CT for Appendiceal Perforation: Pragmatic Multicenter Randomized Controlled Trial.

OBJECTIVE. The objective of our study was to compare diagnostic performance of 2-mSv CT and standard-dose CT (SDCT) for the diagnosis of perforated appendicitis in adolescents and young adults. MATERIALS AND METHODS. We used the intention-to-treat analysis set of a pragmatic randomized controlled trial involving 3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals. The patients were randomized to undergo either 2-mSv CT or SDCT. Predefined endpoints were sensitivity and specificity. Considering potential verification bias caused by the difference in diagnostic interventions (2-mSv CT vs SDCT), we added endpoints of detection rate (DR) and false-referral rate. The reference standards were surgical or pathologic findings. We used Fisher exact tests. Sensitivity analyses included the following: first, a per-protocol analysis; second, an analysis of a surgical reference standard but not a pathologic reference standard; and, third, an analysis to adjust for site clustering. We tested for heterogeneity in DR and false-referral rate across various patient and hospital characteristics. RESULTS. The 2-mSv CT and SDCT groups were comparable regarding DR (5.1% [78/1535] vs 4.9% [76/1539]; 95% CI for the difference, -1.4 to 1.7 percentage points; p = 0.87), false-referral rate (3.1% [48/1535] vs 3.1% [47/1539]; 95% CI for the difference, -1.2 to 1.3 percentage points; p = 0.92), sensitivity (42.9% [78/182] vs 43.2% [76/176]; 95% CI for the difference, -10.6 to 9.9 percentage points; p > 0.99), and specificity (89.2% [305/342] vs 91.2% [354/388]; 95% CI for the difference, -6.4 to 2.3 percentage points; p = 0.38). Sensitivity analyses showed similar results. We found no significant subgroup heterogeneity. CONCLUSION. The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.

CT in Differentiating Complicated From Uncomplicated Appendicitis: Presence of Any of 10 CT Features Versus Radiologists' Gestalt Assessment.

OBJECTIVE. The purpose of this study is to propose a sensitive CT criterion (the presence of any of 10 CT features) for complicated appendicitis that could be used in the nonoperative management of appendicitis and to compare the diagnostic performance of this sensitive CT criterion with that of gestalt assessment. MATERIALS AND METHODS. This retrospective study, which was conducted in a tertiary teaching hospital, included 100 patients with suspected appendicitis on CT. Complicated appendicitis, defined as gangrenous or perforated appendicitis, was pathologically or surgically confirmed in 32 patients. Six radiologists independently determined the presence of 10 previously reported CT features of complicated appendicitis (contrast enhancement defect of the appendiceal wall, abscess, extraluminal air, intraluminal air, extraluminal appendicolith, intraluminal appendicolith, moderate-to-severe periappendiceal fat stranding, periappendiceal fluid, ileus, and ascites) and rated the likelihood score for complicated appendicitis using gestalt assessment. The sensitivity and specificity of CT for complicated appendicitis were measured by the presence of any of 10 CT features (the any-of-10-features criterion) and by the radiologists' gestalt assessment. Pooled sensitivity and specificity were compared using a generalized linear mixed model. RESULTS. The pooled sensitivity of the presence of any of 10 CT features was higher than that of gestalt assessment (92% vs 64%; difference, 28% [95% CI, 10-46%]; p < 0.001), although the pooled specificity was lower (43% vs 76%; difference, -33% [95% CI, -48% to -17%]; p < 0.001). CONCLUSION. The pooled sensitivity of the presence of any of 10 CT features was higher than that of gestalt assessment, at the cost of lower specificity. For prudent selection of patients who should receive nonoperative treatment of appendicitis, the any-of-10-features criterion may be used to decrease treatment failure associated with a false-negative diagnosis of complication.

Development of an algorithm to automatically compress a CT image to visually lossless threshold.

BACKGROUND: To develop an algorithm to predict the visually lossless thresholds (VLTs) of CT images solely using the original images by exploiting the image features and DICOM header information for JPEG2000 compression and to evaluate the algorithm in comparison with pre-existing image fidelity metrics. METHODS: Five radiologists independently determined the VLT for 206 body CT images for JPEG2000 compression using QUEST procedure. The images were divided into training (n = 103) and testing (n = 103) sets. Using the training set, a multiple linear regression (MLR) model was constructed regarding the image features and DICOM header information as independent variables and regarding the VLTs determined with median value of the radiologists' responses (VLTrad) as dependent variable, after determining an optimal subset of independent variables by backward stepwise selection in a cross-validation scheme. The performance was evaluated on the testing set by measuring absolute differences and intra-class correlation (ICC) coefficient between the VLTrad and the VLTs predicted by the model (VLTmodel). The performance of the model was also compared two metrics, peak signal-to-noise ratio (PSNR) and high-dynamic range visual difference predictor (HDRVDP). The time for computing VLTs between MLR model, PSNR, and HDRVDP were compared using the repeated ANOVA with a post-hoc analysis. P < 0.05 was considered to indicate a statistically significant difference. RESULTS: The means of absolute differences with the VLTrad were 0.58 (95% CI, 0.48, 0.67), 0.73 (0.61, 0.85), and 0.68 (0.58, 0.79), for the MLR model, PSNR, and HDRVDP, respectively, showing significant difference between them (p < 0.01). The ICC coefficients of MLR model, PSNR, and HDRVDP were 0.88 (95% CI, 0.81, 0.95), 0.85 (0.79, 0.91), and 0.84 (0.77, 0.91). The computing times for calculating VLT per image were 1.5 ± 0.1 s, 3.9 ± 0.3 s, and 68.2 ± 1.4 s, for MLR metric, PSNR, and HDRVDP, respectively. CONCLUSIONS: The proposed MLR model directly predicting the VLT of a given CT image showed competitive performance to those of image fidelity metrics with less computational expenses. The model would be promising to be used for adaptive compression of CT images.

Reliability of self-reported questionnaire on occupational radiation practices among diagnostic radiologic technologists.

BACKGROUND: We aimed to assess the reliability of a self-reported questionnaire on occupational radiation practices among radiologic technologists. METHODS: We enrolled 941 participants who had repeatedly completed the questionnaire from the 2012-2013 radiologic technologists' health study in South Korea. We used percentage agreement, kappa statistics, and intraclass correlation coefficient (ICC) to assess the reliability of responses on work practices. RESULTS: Overall agreement for ever-never diagnostic radiation procedures was high (87.5-97.5%), and κ values indicated substantial agreement (0.66-0.86) in all procedures except cephalometric and intraoral radiography. For the information of year of work start and working duration, high agreement was obtained (ICC: 0.99 and 0.98, respectively). However, use of a worn dosimeter and of personal protective equipment showed only moderate to substantial agreement. CONCLUSIONS: Self-reported information on working practices regarding radiation exposure in radiologic technologists was reliable enough for epidemiologic studies. Am. J. Ind. Med. 60:377-385, 2017. © 2017 Wiley Periodicals, Inc.