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Purpose: To assess the inter-reader and intra-reader agreement of the Prostate imaging quality version 2 (PI-QUAL v.2) for multiparametric magnetic resonance imaging (mpMRI) among radiologists with varying levels of expertise., Methods: Fifty men underwent 3 T mpMRI scans in a tertiary referral center. Images were anonymized and assessed by six readers of different expertise (2 expert, 2 basic and 2 beginners) in two sessions: first using PI-QUAL v.2, and then using both PI-QUAL v.2 and v.1 after a 2-week interval. PI-QUAL v.2 scores were considered overall and, for comparison with PI-QUAL v.1, dichotomized according to the threshold of acceptable image quality. Gwet AC 1 index was used to calculate the inter-reader and intra-reader agreement of the scores., Results: The inter-reader agreement for PI-QUAL v.2 scores was overall moderate (Gwet's AC 1  = 0.55), being higher for expert readers compared to the beginner and basic ones (Gwet's AC 1  = 0.66 versus 0.45-0-58). Intra-reader agreement varied from moderate to perfect (Gwet's AC 1  = 0.43-1.00) and improved with increasing levels of expertise. The ratings were more reproducible for DWI and DCE sequences (Gwet's AC 1  = 0.62-1.00) compared to T2w (Gwet's AC 1  = 0.24-0.70). The intra-reader agreement between PI-QUAL v.2 and v.1 scores across readings ranged from almost perfect to perfect (Gwet's AC 1  = 0.96-1.00)., Conclusions: In a tertiary referral center context, PI-QUAL v.2 is a moderately reliable tool for standardizing prostate mpMRI quality evaluations among readers with varying expertise., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Purpose: To test the inter-reader agreement in classifying pulmonary hypertension (PH) on chest contrast-enhanced computed tomography (CECT) between a consensus of two cardio-pulmonary-devoted radiologists (CRc) and inexperienced readers (radiology residents, RRs) when using a CECT-based quick hands-on tool built upon PH imaging literature, i.e., the "Rapid Access and Practical Information Digest on Computed Tomography for PH-RAPID-CT-PH"., Material and Methods: The observational study retrospectively included 60 PH patients who underwent CECT between 2015 and 2022. Four RRs independently reviewed all CECTs and classified each case into one of the five PH groups per the 2022 ESC/ERS guidelines. While RR3 and RR4 (RAPID-CT-PH group) used RAPID-CT-PH, RR1 and RR2 (control group) did not. RAPID-CT-PH and control groups' reports were compared with CRc using unweighted Cohen's Kappa (k) statistics. RRs' report completeness and reporting time were also compared using the Wilcoxon-Mann-Whitney test., Results: The inter-reader agreement in classifying PH between the RAPID-CT-PH group and CRc was substantial (k = 0.75 for RR3 and k = 0.65 for RR4); while, it was only moderate for the control group (k = 0.57 for RR1 and k = 0.49 for RR2). Using RAPID-CT-PH resulted in significantly higher report completeness (all p < 0.0001) and significantly lower reporting time (p < 0.0001) compared to the control group., Conclusion: RRs using RAPID-CT-PH showed a substantial agreement with CRc on CECT-based PH classification. RAPID-CT-PH improved report completeness and reduced reporting time. A quick hands-on tool for classifying PH on chest CECT may help inexperienced radiologists effectively contribute to the PH multidisciplinary team., (© 2024. The Author(s).)

Objectives: To retrospectively investigate whether a case-by-case combination of the Prostate Imaging Reporting and Data System version 2.1 (PI-RADS) with the Likert score improves the diagnostic performance of mpMRI for clinically significant prostate cancer (csPCa), especially by reducing false-positives., Methods: One hundred men received mpMRI between January 2020 and April 2021, followed by prostate biopsy. Reader 1 (R1) and reader 2 (R2) (experience of > 3000 and < 200 mpMRI readings) independently reviewed mpMRIs with the PI-RADS version 2.1. After unveiling clinical information, they were free to add (or not) a Likert score to upgrade or downgrade or reinforce the level of suspicion of the PI-RADS category attributed to the index lesion or, rather, identify a new index lesion. We calculated sensitivity, specificity, and predictive values of R1/R2 in detecting csPCa when biopsying PI-RADS ≥ 3 index-lesions (strategy 1) versus PI-RADS ≥ 3 or Likert ≥ 3 index-lesions (strategy 2), with decision curve analysis to assess the net benefit. In strategy 2, the Likert score was considered dominant in determining biopsy decisions., Results: csPCa prevalence was 38%. R1/R2 used combined PI-RADS and Likert categorization in 28%/18% of examinations relying mainly on clinical features such as prostate specific antigen level and digital rectal examination than imaging findings. The specificity/positive predictive values were 66.1/63.1% for R1 (95%CI 52.9-77.6/54.5-70.9) and 50.0/51.6% (95%CI 37.0-63.0/35.5-72.4%) for R2 in the case of PI-RADS-based readings, and 74.2/69.2% for R1 (95%CI 61.5-84.5/59.4-77.5%) and 56.6/54.2% (95%CI 43.3-69.0/37.1-76.6%) for R2 in the case of combined PI-RADS/Likert readings. Sensitivity/negative predictive values were unaffected. Strategy 2 achieved greater net benefit as a trigger of biopsy for R1 only., Conclusion: Case-by-case combination of the PI-RADS version 2.1 with Likert score translated into a mild but measurable impact in reducing the false-positives of PI-RADS categorization, though greater net benefit in reducing unnecessary biopsies was found in the experienced reader only., (© 2024. The Author(s).)

Prenatal and perinatal complications represent well-known risk factors for the future development of psychiatric disorders. Such influence might become manifested during childhood and adolescence, as key periods for brain and behavioral changes. Internalizing and externalizing behaviors in adolescence have been associated with the risk of psychiatric onset later in life. Both brain morphology and behavior seem to be affected by obstetric complications, but a clear link among these three aspects is missing. Here, we aimed at analyzing the association between prenatal and perinatal complications, behavioral issues, and brain volumes in a group of children and adolescents. Eighty-two children and adolescents with emotional-behavioral problems underwent clinical and 3 T brain magnetic resonance imaging (MRI) assessments. The former included information on behavior, through the Child Behavior Checklist/6-18 (CBCL/6-18), and on the occurrence of obstetric complications. The relationships between clinical and gray matter volume (GMV) measures were investigated through multiple generalized linear models and mediation models. We found a mutual link between prenatal complications, GMV alterations in the frontal gyrus, and withdrawn problems. Specifically, complications during pregnancy were associated with higher CBCL/6-18 withdrawn scores and GMV reductions in the right superior frontal gyrus and anterior cingulate cortex. Finally, a mediation effect of these GMV measures on the association between prenatal complications and the withdrawn dimension was identified. Our findings suggest a key role of obstetric complications in affecting brain structure and behavior. For the first time, a mediator role of frontal GMV in the relationship between prenatal complications and internalizing symptoms was suggested. Once replicated on independent cohorts, this evidence will have relevant implications for planning preventive interventions., (© 2024. The Author(s).)

Objectives: To investigate the influence of preoperative breast MRI on mastectomy and reoperation rates in patients with pure ductal carcinoma in situ (DCIS)., Methods: The MIPA observational study database (7245 patients) was searched for patients aged 18-80 years with pure unilateral DCIS diagnosed at core needle or vacuum-assisted biopsy (CNB/VAB) and planned for primary surgery. Patients who underwent preoperative MRI (MRI group) were matched (1:1) to those who did not receive MRI (noMRI group) according to 8 confounding covariates that drive referral to MRI (age; hormonal status; familial risk; posterior-to-nipple diameter; BI-RADS category; lesion diameter; lesion presentation; surgical planning at conventional imaging). Surgical outcomes were compared between the matched groups with nonparametric statistics after calculating odds ratios (ORs)., Results: Of 1005 women with pure unilateral DCIS at CNB/VAB (507 MRI group, 498 noMRI group), 309 remained in each group after matching. First-line mastectomy rate in the MRI group was 20.1% (62/309 patients, OR 2.03) compared to 11.0% in the noMRI group (34/309 patients, p = 0.003). The reoperation rate was 10.0% in the MRI group (31/309, OR for reoperation 0.40) and 22.0% in the noMRI group (68/309, p < 0.001), with a 2.53 OR of avoiding reoperation in the MRI group. The overall mastectomy rate was 23.3% in the MRI group (72/309, OR 1.40) and 17.8% in the noMRI group (55/309, p = 0.111)., Conclusions: Compared to those going directly to surgery, patients with pure DCIS at CNB/VAB who underwent preoperative MRI had a higher OR for first-line mastectomy but a substantially lower OR for reoperation., Clinical Relevance Statement: When confounding factors behind MRI referral are accounted for in the comparison of patients with CNB/VAB-diagnosed pure unilateral DCIS, preoperative MRI yields a reduction of reoperations that is more than twice as high as the increase in overall mastectomies., Key Points: • Confounding factors cause imbalance when investigating the influence of preoperative MRI on surgical outcomes of pure DCIS. • When patient matching is applied to women with pure unilateral DCIS, reoperation rates are significantly reduced in women who underwent preoperative MRI. • The reduction of reoperations brought about by preoperative MRI is more than double the increase in overall mastectomies., (© 2023. The Author(s).)

Objectives: To investigate whether using the diffusion levels (DLs) proposed by the European Society of Breast Imaging (EUSOBI) improves the diagnostic accuracy of breast MRI., Materials and Methods: This retrospective study included 145 women who, between September 2019 and June 2020, underwent breast 1.5-T MRI with DWI. Reader 1 and reader 2 (R1-R2) independently assessed breast lesions using the BI-RADS on dynamic contrast-enhanced imaging and T2-weighted imaging. DWI was subsequently disclosed, allowing readers able to measure lesions ADC and subjectively express the overall risk of malignancy on a 1-5 Likert scale. ADCs were interpreted as a range of values corresponding to the EUSOBI DLs. The analysis evaluated the inter-reader agreement in measuring ADC and DLs, the per-DL malignancy rate, and accuracy for malignancy using ROC analysis against histological examination or a 3-year follow-up., Results: Lesions were malignant and showed non-mass enhancement in 67.7% and 76.1% of cases, respectively. ADC was measurable in 63.2%/66.7% of lesions (R1/R2), with a minimal discrepancy on Bland-Altman analysis and 0.948 (95%CI 0.925-0.965)/0.989 (95%CI 0.988-0.991) intraclass correlation coefficient in measuring ADC/DLs. The malignancy rate (R1/R2) increased from 0.5/0.5% ("very high" DL) to 96.0/96.8% ("very low" DL), as expected. Likert categorization showed larger areas under the curve than the BI-RADS for both R1 (0.91 versus 0.87; p = 0.0208) and R2 (0.91 versus 0.89; p = 0.1171), with improved specificity (81.5% versus 78.5% for R1 and 84.4% versus 81.2% for R2)., Conclusion: Though ADC was not measurable in about one-third of lesions, DLs were categorized with excellent inter-reader agreement, improving the specificity for malignancy., Clinical Relevance Statement: DLs proposed by the EUSOBI are a reproducible tool to interpret the ADC of breast lesions and, in turn, to improve the specificity of breast MRI and reduce unnecessary breast biopsies., Key Points: • The European Society of Breast Imaging proposed diffusion levels for the interpretation of the apparent diffusion coefficient in diffusion-weighted imaging of the breast. • Adding diffusion levels to the interpretation of magnetic resonance imaging improved the diagnostic accuracy for breast cancer, especially in terms of specificity. • Diffusion levels can favor a more widespread and standardized use of diffusion-weighted imaging of the breast., (© 2023. The Author(s).)

Diagnostic work-up and risk stratification in patients with bladder cancer before and after treatment must be refined to optimize management and improve outcomes. MRI has been suggested as a non-invasive technique for bladder cancer staging and assessment of response to systemic therapy. The Vesical Imaging-Reporting And Data System (VI-RADS) was developed to standardize bladder MRI image acquisition, interpretation and reporting and enables accurate prediction of muscle-wall invasion of bladder cancer. MRI is available in many centres but is not yet recommended as a first-line test for bladder cancer owing to a lack of high-quality evidence. Consensus-based evidence on the use of MRI-VI-RADS for bladder cancer care is needed to serve as a benchmark for formulating guidelines and research agendas until further evidence from randomized trials becomes available., (© 2023. Springer Nature Limited.)

The Torricelli-Bernoulli sign is a rare radiologic sign seen on computed tomography (CT) or magnetic resonance imaging (MRI), which helps direct the diagnosis of a gastrointestinal tumor. It indicates the presence of non-dependent air trapped within a necrotic ulcer located in a gastrointestinal tumor; sometimes, a vertical stream of bubbles emanating from the opening of the ulcer is present. The term Torricelli-Bernoulli sign first appeared in the literature in 1999, referring to the homonymous physical theorems., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the clinical utility of chest computed tomography (CT) reports for non-small-cell lung cancer (NSCLC) staging generated by inexperienced readers using structured reporting (SR) templates from the Royal College of Radiologists (RCR-SR) and the Italian Society of Medical and Interventional Radiology (SIRM-SR), compared to traditional non-systematic reports (NSR)., Methods: In a cohort of 30 NSCLC patients, six third-year radiology residents reported CT examinations in two 2-month-apart separate sessions using NSR in the first and NSR, RCR-SR, or SIRM-SR in the second. Couples of expert radiologists and thoracic oncologists in consensus evaluated completeness, accuracy, and clarity. All the quality indicators were expressed on a 100-point scale. The Wilcoxon signed ranks, and Wilcoxon-Mann Whitney tests were used for statistical analyses., Results: Results showed significantly higher completeness for RCR-SR (90 %) and SIRM-SR (100 %) compared to NSR (70 %) in the second session (all p < 0.001). SIRM-SR demonstrated superior accuracy (70 % vs. 55 %, p < 0.001) over NSR, while RCR-SR and NSR accuracy did not significantly differ (60 % vs. 62.5 %, p = 0.06). In the second session, RCR-SR and SIRM-SR surpassed NSR in completeness, accuracy, and clarity (all p < 0.001, except p = 0.04 for accuracy between RCR-SR and NSR). SIRM-SR outperformed RCR-SR in completeness (100 % vs. 90 %, p < 0.001) and accuracy (70 % vs. 62.5 %, p = 0.002), with equivalent clarity (90 % for both, p = 0.27)., Conclusions: Inexperienced readers using RCR-SR and SIRM-SR demonstrated high-quality reporting, indicating their potential in radiology residency programs to enhance reporting skills for NSCLC staging and effective interaction with all the physicians involved in managing NSCLC patients., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Purpose: To propose a new quality scoring tool, METhodological RadiomICs Score (METRICS), to assess and improve research quality of radiomics studies., Methods: We conducted an online modified Delphi study with a group of international experts. It was performed in three consecutive stages: Stage#1, item preparation; Stage#2, panel discussion among EuSoMII Auditing Group members to identify the items to be voted; and Stage#3, four rounds of the modified Delphi exercise by panelists to determine the items eligible for the METRICS and their weights. The consensus threshold was 75%. Based on the median ranks derived from expert panel opinion and their rank-sum based conversion to importance scores, the category and item weights were calculated., Result: In total, 59 panelists from 19 countries participated in selection and ranking of the items and categories. Final METRICS tool included 30 items within 9 categories. According to their weights, the categories were in descending order of importance: study design, imaging data, image processing and feature extraction, metrics and comparison, testing, feature processing, preparation for modeling, segmentation, and open science. A web application and a repository were developed to streamline the calculation of the METRICS score and to collect feedback from the radiomics community., Conclusion: In this work, we developed a scoring tool for assessing the methodological quality of the radiomics research, with a large international panel and a modified Delphi protocol. With its conditional format to cover methodological variations, it provides a well-constructed framework for the key methodological concepts to assess the quality of radiomic research papers., Critical Relevance Statement: A quality assessment tool, METhodological RadiomICs Score (METRICS), is made available by a large group of international domain experts, with transparent methodology, aiming at evaluating and improving research quality in radiomics and machine learning., Key Points: • A methodological scoring tool, METRICS, was developed for assessing the quality of radiomics research, with a large international expert panel and a modified Delphi protocol. • The proposed scoring tool presents expert opinion-based importance weights of categories and items with a transparent methodology for the first time. • METRICS accounts for varying use cases, from handcrafted radiomics to entirely deep learning-based pipelines. • A web application has been developed to help with the calculation of the METRICS score ( https://metricsscore.github.io/metrics/METRICS.html ) and a repository created to collect feedback from the radiomics community ( https://github.com/metricsscore/metrics )., (© 2024. The Author(s).)

Venn diagrams graphically represent a cognitive approach that can assist in highlighting information shared by different data sets while eliminating nonoverlapping conditions. When applied to clinical reasoning, such an approach helps physicians visually focus on data pertaining to differential diagnoses. We present and discuss a 3-step reasoning pathway derived from a real-life case in which we used Venn diagrams to diagnose drug-related pneumonitis in a 67-year-old man with advanced bladder cancer and nodular lung findings at chest CT. This education paper supports using Venn diagrams in Radiology., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: To report mastectomy and reoperation rates in women who had breast MRI for screening (S-MRI subgroup) or diagnostic (D-MRI subgroup) purposes, using multivariable analysis for investigating the role of MRI referral/nonreferral and other covariates in driving surgical outcomes., Methods: The MIPA observational study enrolled women aged 18-80 years with newly diagnosed breast cancer destined to have surgery as the primary treatment, in 27 centres worldwide. Mastectomy and reoperation rates were compared using non-parametric tests and multivariable analysis., Results: A total of 5828 patients entered analysis, 2763 (47.4%) did not undergo MRI (noMRI subgroup) and 3065 underwent MRI (52.6%); of the latter, 2441/3065 (79.7%) underwent MRI with preoperative intent (P-MRI subgroup), 510/3065 (16.6%) D-MRI, and 114/3065 S-MRI (3.7%). The reoperation rate was 10.5% for S-MRI, 8.2% for D-MRI, and 8.5% for P-MRI, while it was 11.7% for noMRI (p ≤ 0.023 for comparisons with D-MRI and P-MRI). The overall mastectomy rate (first-line mastectomy plus conversions from conserving surgery to mastectomy) was 39.5% for S-MRI, 36.2% for P-MRI, 24.1% for D-MRI, and 18.0% for noMRI. At multivariable analysis, using noMRI as reference, the odds ratios for overall mastectomy were 2.4 (p < 0.001) for S-MRI, 1.0 (p = 0.957) for D-MRI, and 1.9 (p < 0.001) for P-MRI., Conclusions: Patients from the D-MRI subgroup had the lowest overall mastectomy rate (24.1%) among MRI subgroups and the lowest reoperation rate (8.2%) together with P-MRI (8.5%). This analysis offers an insight into how the initial indication for MRI affects the subsequent surgical treatment of breast cancer., Key Points: • Of 3065 breast MRI examinations, 79.7% were performed with preoperative intent (P-MRI), 16.6% were diagnostic (D-MRI), and 3.7% were screening (S-MRI) examinations. • The D-MRI subgroup had the lowest mastectomy rate (24.1%) among MRI subgroups and the lowest reoperation rate (8.2%) together with P-MRI (8.5%). • The S-MRI subgroup had the highest mastectomy rate (39.5%) which aligns with higher-than-average risk in this subgroup, with a reoperation rate (10.5%) not significantly different to that of all other subgroups., (© 2023. The Author(s).)

Over the last years, prostate magnetic resonance imaging (MRI) has gained a key role in the primary diagnosis of clinically significant prostate cancer (csPCa). While a negative MRI can avoid unnecessary prostate biopsies and the overdiagnosis of indolent cancers, a positive examination triggers biopsy samples targeted to suspicious imaging findings, thus increasing the diagnosis of csPCa with a sensitivity and negative predictive value of around 90%. The limitations of MRI, including suboptimal positive predictive values, are fueling debate on how to stratify biopsy decisions and management based on patient risk and how to correctly estimate it with clinical and/or imaging findings. In this setting, "next-generation imaging" imaging based on radiolabeled Prostate-Specific Membrane Antigen (PSMA)-Positron Emission Tomography (PET) is expanding its indications both in the setting of primary staging (intermediate-to-high risk patients) and primary diagnosis (e.g., increasing the sensitivity of MRI or acting as a problem-solving tool for indeterminate MRI cases). This review summarizes the current main evidence on the role of prostate MRI and PSMA-PET as tools for the primary diagnosis of csPCa, and the different possible interaction pathways in this setting.

Purpose: To identify clinical and multiparametric magnetic resonance imaging (mpMRI) factors predicting false positive target biopsy (FP-TB) of prostate imaging reporting and data system version 2.1 (PI-RADSv2.1) ≥ 3 findings., Method: We retrospectively included 221 men with and without previous negative prostate biopsy who underwent 3.0 T/1.5 T mpMRI for suspicious clinically significant prostate cancer (csPCa) between April 2019-July 2021. A study coordinator revised mpMRI reports provided by one of two radiologists (experience of > 1500/>500 mpMRI examinations, respectively) and matched them with the results of transperineal systematic biopsy plus fusion target biopsy (TB) of PI-RADSv2.1 ≥ 3 lesions or PI-RADSv2.1 ≤ 2 men with higher clinical risk. A multivariable model was built to identify features predicting FP-TB of index lesions, defined as the absence of csPCa (International Society of Urogenital Pathology [ISUP] ≥ 2). The model was internally validated with the bootstrap technique, receiving operating characteristics (ROC) analysis, and decision analysis., Results: Features significantly associated with FP-TB were age < 65 years (odds ratio [OR] 2.77), prostate-specific antigen density (PSAD) < 0.15 ng/mL/mL (OR 2.45), PI-RADS 4/5 category vs. category 3 (OR 0.15/0.07), and multifocality (OR 0.46), with a 0.815 area under the curve (AUC) in assessing FP-TB. When adjusting PI-RADSv2.1 categorization for the model, mpMRI showed 87.5% sensitivity and 79.9% specificity for csPCa, with a greater net benefit in triggering biopsy compared to unadjusted categorization or adjustment for PSAD only at decision analysis, from threshold probability ≥ 15%., Conclusion: Adjusting PI-RADSv2.1 categories for a multivariable risk of FP-TB is potentially more effective in triggering TB of index lesions than unadjusted PI-RADS categorization or adjustment for PSAD alone., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objectives: To evaluate MRI diagnostic performance in detecting clinically significant prostate cancer (csPCa) in peripheral-zone PI-RADS 4 lesions, comparing those with clearly restricted diffusion (DWI-score 4), and those with equivocal diffusion pattern (DWI-score 3) and positive dynamic contrast-enhanced (DCE) MRI., Methods: This observational prospective study enrolled 389 men referred to MRI and, if positive (PI-RADS 3 with PSA-density [PSAD] ≥ 0.15 ng/mL/mL, 4 and 5), to MRI-directed biopsy. Lesions with DWI-score 3 and positive DCE were classified as "PI-RADS 3up," instead of PI-RADS 4. Univariable and multivariable analyses were implemented to determine features correlated to csPCa detection., Results: Prevalence of csPCa was 14.5% and 53.3% in PI-RADS categories 3up and 4, respectively (p < 0.001). MRI showed a sensitivity of 100.0%, specificity 40.9%, PPV 46.5%, NPV 100.0%, and accuracy 60.9% for csPCa detection. Modifying the threshold to consider MRI positive and to indicate biopsy (same as previously described, but PI-RADS 3up only when associated with elevated PSAD), the sensitivity changed to 93.9%, specificity 57.2%, PPV 53.0%, NPV 94.8%, and accuracy 69.7%. Age (p < 0.001), PSAD (p < 0.001), positive DWI (p < 0.001), and PI-RADS score (p = 0.04) resulted in independent predictors of csPCa., Conclusions: Most cases of PI-RADS 3up were false-positives, suggesting that upgrading peripheral lesions with DWI-score 3 to PI-RADS 4 because of positive DCE has a detrimental effect on MRI accuracy, decreasing the true prevalence of csPCa in the PI-RADS 4 category. PI-RADS 3up should not be upgraded and directed to biopsy only if associated with increased PSAD., Key Points: • As per PI-RADS v2.1 recommendations, in case of a peripheral zone lesion with equivocal diffusion-weighted imaging (DWI score 3), but positive dynamic contrast-enhanced (DCE) MRI, the overall PI-RADS score should be upgraded to 4. • The current PI-RADS recommendation of upgrading PI-RADS 3 lesions of the peripheral zone to PI-RADS 4 because of positive DCE decreased clinically significant prostate cancer detection rate in our series. • According to our results, the most accurate threshold for setting indication to prostate biopsy is PI-RADS 3 or PI-RADS 3 with positive DCE both associated with increased PSA density., (© 2023. The Author(s).)

Quality is currently recognized as the pre-requisite for delivering the clinical benefits expected by magnetic resonance imaging (MRI)-informed prostate biopsy (MRI-i-PB) in patients with a suspicion for clinically significant prostate cancer (csPCa). The "quality chain" underlying MRI-i-PB is multidisciplinary in nature, and depends on several factors related to the patient, imaging technique, image interpretation and biopsy procedure. This review aims at making the radiologist aware of biopsy-related factors impacting on MRI-i-PB quality, both in terms of biopsy planning (threshold for biopsy decisions, association with systematic biopsy and number of targeted cores) and biopsy acquisition (biopsy route, targeting technique, and operator's experience). While there is still space for improvement and better standardization of several biopsy-related procedures, current evidence suggests that high-quality MRI-i-PB can be delivered by acquiring and increased the number of biopsy cores targeted to suspicious imaging findings and perilesional area ("focal saturation biopsy"). On the other hand, uncertainty still exists as to whether software-assisted fusion of MRI and transrectal ultrasound images can outperform cognitive fusion strategy. The role for operator's experience and quality assurance/quality control procedures are also discussed., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

The goal of any radiological diagnostic process is to gain information about the patient's status. However, the mathematical notion of information is usually not adopted to measure the performance of a diagnostic test or the agreement among readers in providing a certain diagnosis. Indeed, commonly used metrics for assessing diagnostic accuracy (e.g., sensitivity and specificity) or inter-reader agreement (Cohen [Formula: see text] statistics) use confusion matrices containing the number of true- and false positives/negatives results of a test, or the number of concordant/discordant categorizations, respectively, thus lacking proper information content. We present a methodological paradigm, based on Shannon's information theory, aiming to measure both accuracy and agreement in diagnostic radiology. This approach models the information flow as a "diagnostic channel" connecting the state of the patient's disease and the radiologist or, in the case of agreement analysis, as an "agreement channel" linking two or more radiologists evaluating the same set of images. For both cases, we proposed some measures, derived from Shannon's mutual information, which can represent an alternative way to express diagnostic accuracy and agreement in radiology.Key points• Diagnostic processes can be modeled with information theory (IT).• IT metrics of diagnostic accuracy are independent from disease prevalence.• IT metrics of inter-reader agreements can overcome Cohen κ pitfalls., (© 2023. The Author(s).)

(1) Purpose: To compare the diagnostic accuracy between full multiparametric contrast-enhanced prostate MRI (mpMRI) and abbreviated dual-sequence prostate MRI (dsMRI) in men with clinically significant prostate cancer (csPCa) who were candidates for active surveillance. (2) Materials and Methods: Fifty-four patients with a diagnosis of low-risk PCa in the previous 6 months had a mpMRI scan prior to a saturation biopsy and a subsequent MRI cognitive transperineal targeted biopsy (for PI-RADS ≥ 3 lesions). The dsMRI images were obtained from the mpMRI protocol. The images were selected by a study coordinator and assigned to two readers blinded to the biopsy results (R1 and R2). Inter-reader agreement for clinically significant cancer was evaluated with Cohen's kappa. The dsMRI and mpMRI accuracy was calculated for each reader (R1 and R2). The clinical utility of the dsMRI and mpMRI was investigated with a decision-analysis model. (3) Results: The dsMRI sensitivity and specificity were 83.3%, 31.0%, 75.0%, and 23.8%, respectively, for R1 and R2. The mpMRI sensitivity and specificity were 91.7%, 31.0%, 83.3%, and 23.8%, respectively, for R1 and R2. The inter-reader agreement for the detection of csPCa was moderate (k = 0.53) and good (k = 0.63) for dsMRI and mpMRI, respectively. The AUC values for the dsMRI were 0.77 and 0.62 for the R1 and R2, respectively. The AUC values for the mpMRI were 0.79 and 0.66 for R1 and R2, respectively. No AUC differences were found between the two MRI protocols. At any risk threshold, the mpMRI showed a higher net benefit than the dsMRI for both R1 and R2. (4) Conclusions: The dsMRI and mpMRI showed similar diagnostic accuracy for csPCa in male candidates for active surveillance.

Objective: To test the inter-reader agreement in assessing lung disease extent, HRCT signs, and Radiological Society of North America (RSNA) categorization between a chest-devoted radiologist (CR) and two HRCT-naïve radiology residents (RR1 and RR2) after the latter attended a COVID-19-based chest high-resolution computed tomography (HRCT) "crash course"., Methods: The course was built by retrospective inclusion of 150 patients who underwent HRCT for COVID-19 pneumonia between November 2020 and January 2021. During a first 10-days-long "training phase", RR1 and RR2 read a pool of 100/150 HRCTs, receiving day-by-day access to CR reports as feedback. In the subsequent 2-days-long "test phase", they were asked to report 50/150 HRCTs with no feedback. Test phase reports of RR1/RR2 were then compared with CR using unweighted or linearly-weighted Cohen's kappa (k) statistic and intraclass correlation coefficient (ICC)., Results: We observed almost perfect agreement in assessing disease extent between RR1-CR (k = 0.83, p < 0.001) and RR2-CR (k = 0.88, p < 0.001). The agreement between RR1-CR and RR2-CR on consolidation, crazy paving pattern, organizing pneumonia (OP) pattern, and pulmonary artery (PA) diameter was substantial (k = 0.65 and k = 0.68), moderate (k = 0.42 and k = 0.51), slight (k = 0.10 and k = 0.20), and good-to-excellent (ICC = 0.87 and ICC = 0.91), respectively. The agreement in providing RSNA categorization was moderate for R1 versus CR (k = 0.56) and substantial for R2 versus CR (k = 0.67)., Conclusion: HRCT-naïve readers showed an acceptable overall agreement with CR, supporting the hypothesis that a crash course can be a tool to readily make non-subspecialty radiologists available to cooperate in reading high burden of HRCT examinations during a pandemic/epidemic., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Pulmonary manifestations, including airway involvement and interstitial lung disease, are the most frequent extra-glandular complications of primary Sjögren's syndrome (pSS). Chest high-resolution computed tomography (HRCT) is a cornerstone of pulmonary diagnostic imaging, aiming to detect, characterise, and quantify such conditions. In patients with pSS-related lung abnormalities, HRCT proved helpful in various clinical scenarios, including baseline and follow-up evaluation, assessment of superimposed infections, suspected progressive interstitial lung diseases, and acute exacerbation. This review aims to provide a primer for rheumatologists on chest HRCT, illustrating the up-to-date technique, imaging findings, and clinical indications in pSS and highlighting the importance of rheumatologist-radiologist constructive collaboration in the clinical management of such patients.

PURPOSE To evaluate the performance of radiology residents (RRs) when using a dedicated structured report (SR) template for chest HRCT in patients with suspected connective tissue disease-interstitial lung disease (CTD-ILD), compared to the traditional narrative report (NR). METHODS We retrospectively evaluated 50 HRCT exams in patients with suspected CTD-ILD. A chest-devoted radiologist reported all the HRCT exams as the reference standard, pointing out pulmonary fibrosis findings (i.e., honeycombing, traction bronchiectasis, reticulation, and volume loss), presence and pattern of ILD, and possible other diagnoses. We divided four RRs into two groups according to their expertise level. In each group, RRs reported all HRCT examinations alternatively with NR or SR, noting each report's reporting time. The Cohen's Kappa, Wilcoxon, and McNemar tests were used for statistical analysis. RESULTS Regarding the pulmonary fibrosis findings, we found higher agreement between RRs and the reference standard reader when using SR than NR, regardless of their expertise level, except for volume loss.RRs' accuracy for "other diagnosis" was higher when using SR than NR, moving from 0.48 to 0.66 in the novel group (p = 0.035) and from 0.44 to 0.80 in the expertise group (p < 0.001). No differences in accuracy were found between ILD presence and ILD pattern. The reporting time was significantly lower (p = 0.001) when using SR than NR. CONCLUSION SR is of value in increasing the reporting of critical chest HRCT findings in the complex CTD-ILD scenario and should be used early and systematically during the residency.

Contrast-enhanced liver MR imaging is an important diagnostic tool for many different liver diseases with the sensitivity and specificity in diagnosing liver diseases typically far exceeding other imaging modalities. The safety profile of GBCA is excellent with minimal adverse events. Both extracellular and hepatobiliary contrast agents offer unique advantages and potential limitations. ECA is excellent for obtaining high-quality arterial phase imaging and can be particularly useful for the evaluation of hepatocellular carcinoma (HCC) in cirrhotic patients. In contrast, hepatobiliary agent (HBA) can help distinguish FNH from adenomas, detect liver metastases, and provide biliary imaging due to their uptake within normal hepatocytes and biliary excretion., (Copyright © 2022 Elsevier Inc. All rights reserved.)

The term "connective tissue diseases" (CTDs) refers to a heterogeneous group of autoimmune disorders, including systemic sclerosis, rheumatoid arthritis, Sjögren's syndrome, systemic lupus erythematosus, polymyositis, dermatomyositis, antisynthetase syndrome, and mixed connective tissue disease. Chest high-resolution computed tomography (HRCT) is the imaging method of choice for evaluating patients with known or suspected CTD-related interstitial lung disease (CTD-ILD), a complication accounting for substantial morbidity and mortality. While specific HRCT patterns and signs of CTD-ILD have been extensively described (hence the designation "the usual suspects"), the knowledge of various, less frequent conditions involving the lungs in patients with CTD would help the radiologist produce a clinically valuable report, thus potentially influencing patient management. This paper aims to provide an up-to-date review of various unusual pulmonary CTD-related conditions the radiologist should be aware of; namely, acute exacerbation of CTD-ILD, CTD-related interstitial lung abnormalities, lung amyloidosis, MALT lymphoma, antisynthetase syndrome, pleuroparenchymal fibroelastosis-like lesion, drug-induced ILD, combined pulmonary fibrosis and emphysema, and pulmonary hypertension. For each condition, the chest HRCT appearance and the key histopathological and clinical features are resumed, helping the radiologist participate actively in the multidisciplinary discussion of complex clinical cases., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Patients with Crohn's disease (CD) usually undergo magnetic resonance enterography (MRE) for evaluating small bowel involvement. Musculoskeletal symptoms are the most frequent extraintestinal manifestation in inflammatory bowel diseases, especially in CD, with sacroiliitis at imaging occurring in about 6-46% of patients and possibly correlating with axial spondyloarthritis. The primary study aim was to assess the prevalence of sacroiliitis in adult and pediatric patients with CD performing an MRE. We also evaluated the inter-rater agreement for MRE sacroiliitis and the association between sacroiliitis and patients' clinical data., Method: We retrospectively identified 100 adult and 30 pediatric patients diagnosed with CD who performed an MRE between December 2012 and May 2020 in three inflammatory bowel disease centers. Two radiologists assessed the prevalence of sacroiliitis at MRE. We evaluated the inter-rater agreement for sacroiliitis with Cohen's kappa and intraclass correlation coefficient statistics and assessed the correlation between sacroiliitis and demographic, clinical, and endoscopic data (Chi-square and Fisher's tests)., Results: The prevalence of sacroiliitis at MRE was 20% in adults and 6.7% in pediatric patients. The inter-rater agreement for sacroiliitis was substantial (k = 0.62, p < 0.001) in the adults and moderate (k = 0.46, p = 0.011) in the pediatric cohort. Age ≥ 50 years and the time between CD diagnosis and MRE (≥ 86.5 months) were significantly associated with sacroiliitis in adult patients (p = 0.049 and p = 0.038, respectively)., Conclusions: Sacroiliitis is a frequent and reliable abnormality at MRE in adult patients with CD, associated with the age of the patients ≥ 50 years and CD duration., (© 2022. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).)

Background Prostate cancer local recurrence location and extent must be determined in an accurate and timely manner. Because of the lack of a standardized MRI approach after whole-gland treatment, a panel of international experts recently proposed the Prostate Imaging for Recurrence Reporting (PI-RR) assessment score. Purpose To determine the diagnostic accuracy of PI-RR for detecting local recurrence in patients with biochemical recurrence (BCR) after radiation therapy (RT) or radical prostatectomy (RP) and to evaluate the interreader variability of PI-RR scoring. Materials and Methods This retrospective observational study included patients who underwent multiparametric MRI between September 2016 and May 2021 for BCR after RT or RP. MRI scans were analyzed, and a PI-RR score was assigned independently by four radiologists. The reference standard was defined using histopathologic findings, follow-up imaging, or clinical response to treatment. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were calculated to assess PI-RR performance for each reader. The intraclass correlation coefficient was used to determine interreader agreement. Results A total of 100 men were included: 48 patients after RT (median age, 76 years [IQR, 70-82 years]) and 52 patients after RP (median age, 70 years [IQR, 66-74 years]). After RT, with PI-RR of 3 or greater as a cutoff (assigned when recurrence is uncertain), diagnostic performance ranges were 71%-81% sensitivity, 74%-93% specificity, 71%-89% PPV, 79%-86% NPV, and 77%-88% accuracy across the four readers. After RP, with PI-RR of 3 or greater as a cutoff, performance ranges were 59%-83% sensitivity, 87%-100% specificity, 88%-100% PPV, 66%-80% NPV, and 75%-85% accuracy. The intraclass correlation coefficient was 0.87 across the four readers for both the RT and RP groups. Conclusion MRI scoring with the Prostate Imaging for Recurrence Reporting assessment provides structured, reproducible, and accurate evaluation of local recurrence after definitive therapy for prostate cancer. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Haider in this issue. An earlier incorrect version appeared online. This article was corrected on May 11, 2022.

Purpose: To determine the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, independently correlating with muscle-invasive bladder cancer (BCa), in a multicentric national setting., Method and Materials: Patients with BCa suspicion were offered magnetic resonance imaging (MRI) before trans-urethral resection of bladder tumor (TURBT). According to VI-RADS, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (MIBC). Trans-urethral resection of the tumor (TURBT) and/or cystectomy reports were compared with preoperative VI-RADS scores to assess accuracy of MRI for discriminating between non-muscle-invasive versus MIBC. Performance was assessed by ROC curve analysis. Two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and VI-RADS categories to determine the variables with an independent effect on MIBC., Results: A final cohort of 139 patients was enrolled (median age 70 [IQR: 64, 76.5]). MRI showed sensitivity, specificity, PPV, NPV, and accuracy for MIBC diagnosis ranging from 83-93%, 80-92%, 67-81%, 93-96%, and 84-89% for the more experienced readers. The area under the curve (AUC) was 0.95 (0.91-0.99). In the multivariable logistic regression model, the VI-RADS score, using both a cutoff of 3 and 4 (P < .0001), hematuria (P = .007), tumor size (P = .013), and concomitant hydronephrosis (P = .027) were the variables correlating with a bladder cancer staged as ≥ T2. The inter-reader agreement was substantial (k = 0.814)., Conclusions: VI-RADS assessment scoring proved to be an independent predictor of muscle-invasiveness, which might implicate a shift toward a more aggressive selection approach of patients' at high risk of MIBC, according to a novel proposed predictive pathway., (© 2022. The Author(s).)

Purpose: To investigate the inter-reader agreement of the Prostate imaging quality (PI-QUAL) for multiparametric magnetic resonance imaging (mpMRI)., Methods: We included 66 men who underwent 1.5 T mpMRI in June 2020-July 2020 in center 1, with no exclusion criteria. mpMRI included multiplanar T2-weighted imaging (T2WI), Diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE). Two readers from center 2 (experience <1000 to >1500 examinations), blinded to clinical history but not to acquisition parameters, independently assessed PI-QUAL qualitative/anatomical items of each mpMRI sequence, final PI-QUAL score (1-5), and the Prostate imaging reporting and data system version 2.1 (PI-RADSv2.1) category of the index lesion. Cohen's kappa statistics (k) or prevalence-adjusted-bias-adjusted kappa (PABAK) were used to calculate the inter-reader agreement in assessing the PI-QUAL (1-to-5 scale and 1-2 versus 3 versus 4-5), the diagnostic quality of each mpMRI sequence, qualitative/anatomical items, and PI-RADSv2.1 category., Results: The inter-reader agreement for PI-QUAL category was moderate upon 1-5 scale (k = 0.55; 95%CI 0.39-0.71) or 1-3 scale (k = 0.51; 95%CI 0.29-0.72), with 90.9% examinations categorized PI-QUAL ≥ 3 by readers. The agreement in assessing a sequence as diagnostic was higher for T2WI (k = 0.76) than DCE (PABAK = 0.61) and DWI (k = 0.46), ranging moderate-to-substantial for most of the items. Readers provided comparable PI-RADSv2.1 categorization (k = 0.88 [excellent agreement]; 95%CI 0.81-0.96), with most PI-RADSv2.1 ≥ 3 assignments found in PI-QUAL ≥ 3 examinations (43/46 by reader 1, and 47/47 by reader 2)., Conclusions: The reproducibility of PI-QUAL was moderate. Higher PI-QUAL scores were associated with excellent inter-reader agreement for PI-RADSv2.1 categorization., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Since 1948, Shannon theoretic methods for modeling information have found a wide range of applications in several areas where information plays a key role, which goes well beyond the original scopes for which they have been conceived, namely data compression and error correction over a noisy channel. Among other uses, these methods have been applied in the broad field of medical diagnostics since the 1970s, to quantify diagnostic information, to evaluate diagnostic test performance, but also to be used as technical tools in image processing and registration. This review illustrates the main contributions in assessing the accuracy of diagnostic tests and the agreement between raters, focusing on diagnostic test performance measurements and paired agreement evaluation. This work also presents a recent unified, coherent, and hopefully, final information-theoretical approach to deal with the flows of information involved among the patient, the diagnostic test performed to appraise the state of disease, and the raters who are checking the test results. The approach is assessed by considering two case studies: the first one is related to evaluating extra-prostatic cancers; the second concerns the quality of rapid tests for COVID-19 detection., (© 2022. The Author(s).)

Objectives: To compare the effect of different PSA density (PSAD) thresholds on the accuracy for clinically significant prostate cancer (csPCa) of the Prostate Imaging Reporting And Data System v.2.1 (PI-RADSv2.1)., Methods: We retrospectively included 123 biopsy-naïve men who underwent multiparametric magnetic resonance imaging (mpMRI) and transperineal mpMRI-targeted and systematic prostate biopsy between April 2019 and October 2020. mpMRI, obtained on a 3.0T magnet with a PI-RADSv2.1-compliant protocol, was read by two radiologists (>1500/>500 mpMRI examinations). csPCa was defined as International Society of Urogenital Pathology grading group ≥2. Receiver operating characteristic analysis was used to calculate per-index lesion sensitivity, specificity, and area under the curve (AUC) of PI-RADSv.2.1 categories after adjusting for PSAD ≥0.10,≥0.15, and ≥0.20 ng/mL ml -1 . Per-adjusted category cancer detection rate (CDR) was calculated, and decision analysis performed to compare PSAD-adjusted PI-RADSv.2.1 categories as a biopsy trigger., Results: csPCa prevalence was 43.9%. PSAD-adjustment increased the CDR of PI-RADSv2.1 category 4. Sensitivity/specificity/AUC were 92.6%/53.6%/0.82 for unadjusted PI-RADS, and 85.2%/72.4%/0.84, 62.9%/85.5%/0.83, and 92.4%/53.6%/0.82 when adjusting PI-RADS categories for a 0.10, 0.15, and 0.20 ng/ml ml -1 PSAD threshold, respectively. Triggering biopsy for PI-RADS four lesions and PSAD ≥0.10 ng/mL ml -1 was the strategy with greatest net benefit at 30 and 40% risk probability (0.307 and 0.271, respectively)., Conclusions: PI-RADSv2.1 category four with PSAD ≥0.10 ng/mL ml -1 was the biopsy-triggering cut-off with the highest net benefit in the range of expected prevalence for csPCa., Advances in Knowledge: 0.10 ng/mL ml -1 is the PSAD threshold with higher clinical utility in stratifying the risk for prostate cancer of PI-RADSv.2.1 categories.

Objectives: Preoperative breast magnetic resonance imaging (MRI) can inform surgical planning but might cause overtreatment by increasing the mastectomy rate. The Multicenter International Prospective Analysis (MIPA) study investigated this controversial issue., Methods: This observational study enrolled women aged 18-80 years with biopsy-proven breast cancer, who underwent MRI in addition to conventional imaging (mammography and/or breast ultrasonography) or conventional imaging alone before surgery as routine practice at 27 centers. Exclusion criteria included planned neoadjuvant therapy, pregnancy, personal history of any cancer, and distant metastases., Results: Of 5896 analyzed patients, 2763 (46.9%) had conventional imaging only (noMRI group), and 3133 (53.1%) underwent MRI that was performed for diagnosis, screening, or unknown purposes in 692/3133 women (22.1%), with preoperative intent in 2441/3133 women (77.9%, MRI group). Patients in the MRI group were younger, had denser breasts, more cancers ≥ 20 mm, and a higher rate of invasive lobular histology than patients who underwent conventional imaging alone (p < 0.001 for all comparisons). Mastectomy was planned based on conventional imaging in 22.4% (MRI group) versus 14.4% (noMRI group) (p < 0.001). The additional planned mastectomy rate in the MRI group was 11.3%. The overall performed first- plus second-line mastectomy rate was 36.3% (MRI group) versus 18.0% (noMRI group) (p < 0.001). In women receiving conserving surgery, MRI group had a significantly lower reoperation rate (8.5% versus 11.7%, p < 0.001)., Conclusions: Clinicians requested breast MRI for women with a higher a priori probability of receiving mastectomy. MRI was associated with 11.3% more mastectomies, and with 3.2% fewer reoperations in the breast conservation subgroup., Key Points: • In 19% of patients of the MIPA study, breast MRI was performed for screening or diagnostic purposes. • The current patient selection to preoperative breast MRI implies an 11% increase in mastectomies, counterbalanced by a 3% reduction of the reoperation rate. • Data from the MIPA study can support discussion in tumor boards when preoperative MRI is under consideration and should be shared with patients to achieve informed decision-making., (© 2021. The Author(s).)

Background: Enlargement of the major salivary glands (SGs) is a major risk factor for B-cell lymphoma among patients with primary Sjögren's syndrome (pSS). Ultrasound-guided core needle biopsy (US-guided CNB) could be a novel technique to manage SG enlargement among patients with pSS., Objective: Accordingly, this study's main aim was to evaluate the safety, patient tolerance and diagnostic accuracy of US-guided CNB procedure for patients with pSS with major SG enlargement., Methods: Patients with clinical diagnosis of pSS and a clinical indication for SG biopsy consecutively underwent US-guided CNB between September 2019 and June 2021. These patients were evaluated clinically 1, 2 and 12 weeks after US-guided CNB. Patients were asked to complete a questionnaire about postprocedural complications as well as periprocedural pain, using the Visual Analogue Scale. Complications were categorised as transient (<12 weeks) or persistent (≥12 weeks)., Results: US-guided CNB was performed on 30 major salivary glands (22 parotid glands and 8 submandibular glands). The procedure was well tolerated. Transient complications-such as haematoma, swelling-were observed among 43% of patients, and mean periprocedural pain was low. However, no persistent complications were reported during the study's follow-up period., Conclusion: US-guided CNB represents a novel approach for the management of patients with pSS with SG enlargement. The procedure showed remarkable patient safety and tolerance, allowing adequate glandular sampling and a definite diagnosis for almost all participating patients without long-term complications., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)