Assessment Of Different NEoplasias Research Articles

Validation of the IOTA ADNEX Model Among Japanese Women Performed by Gynecology Trainees and Ultrasound Specialists: A Retrospective Diagnostic Accuracy Study.

This study aimed to validate the diagnostic accuracy of the International Ovarian Tumor Analysis (IOTA) Assessment of Different NEoplasias in the adneXa (ADNEX) model in Japanese women, population with a distinct adnexal mass distribution compared with European women, and to evaluate the model's utility by gynecology trainees and ultrasound specialists. This single-center, retrospective study analyzed ultrasound data from January 2017 to March 2020 of 206 women with adnexal masses. Patients who underwent ultrasonography and serum CA-125 measurement and received postsurgery histological diagnosis were included. The ADNEX model's diagnostic performance was evaluated by two trainees and two specialists using the area under the receiver operating characteristic curve (AUC) and measures of accuracy, sensitivity, specificity, and predictive values for overall performance and each examiner. Of the 206 included Japanese women, the prevalence of malignancy was 30.1%, including borderline cases. The overall AUC for distinguishing malignancy was 0.848 (95% confidence interval [CI]: 0.817-0.880). The AUC for each examiner ranged from 0.791 to 0.898, with Specialist 2 showing the highest accuracy and sensitivity varying between 0.677 and 0.839. A moderate degree of agreement was noted among the four examiners (Fleiss' kappa was 0.586). The performance of trainees and specialists differed significantly in evaluating the solid tissue and the papillary projections in both malignant and benign groups (P < .001). The IOTA ADNEX model effectively differentiates benign and malignant adnexal masses in Japanese women. Although the accuracy matched up moderately among the four examiners, better accuracy is expected with training in evaluating solid tissue and papillary projections.

Performance of Pre-Operative IOTA Three-Step Algorithm in Detecting Ovarian Carcinoma in a Referral Center in Indonesia

Background: To assess the diagnostic performance of a three-step algorithm using the International Ovarian Tumor Analysis (IOTA) Group ‘simple rules’, ‘simple descriptors’, and Assessment of Different NEoplasias in the adneXa (ADNEX) model for discriminating benign and malignant adnexal masses. Methods: This was a retrospective observational study, performed at a tertiary-care university hospital, on women diagnosed with adnexal mass on ultrasonography from January 2021 and February 2022. The examiner first classified the mass using ‘simple descriptors’ (first step) and, if not possible, using ‘simple rules’ (second step). For inconclusive masses, an assessment using the ADNEX model was done as the third step. All masses were managed surgically. Histopathology results were used as the reference standard.Results: One hundred and forty-one women were included (median age of 48 years). Histopathology results showed 104 (73.76%) mass to be malignant, and 37 (26.24%) mass to be benign. Twelve (8.51%) of 141 masses could be classified using simple descriptors, 89 (63.12%) masses were classified using simple rules, and 40 (28.37%) masses were classified using the ADNEX model. Overall accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of the three-step algorithm were 89.36%, 94.23%, 75.68%, 91.59%, 82.35%, 3.87, and 0.08 respectively.Conclusions: The IOTA three-step algorithm, based on the sequential use of simple descriptors, simple rules, and ADNEX model, performs well for classifying adnexal masses as benign or malignant

Validation of ADNEX and IOTA two-step strategy and estimation of risk of complications during follow-up of adnexal masses in low-risk population.

The aim is to evaluate the ability of the Assessment of Different NEoplasias in the adneXa model (ADNEX) and the International Ovarian Tumour Analysis (IOTA) two-step strategy to predict malignancy in adnexal masses detected in an outpatient low-risk setting, and to estimate the risk of complications in masses with benign ultrasound morphology managed with clinical and ultrasound follow-up. This single center (Hospital Universitari Dexeus Barcelona) study was performed using interim data of the ongoing prospective observational IOTA phase 5 study. The primary aim of the IOTA 5 study is to describe the cumulative incidence of complications during follow-up of adnexal masses classified as benign on ultrasound. Consecutive patients with adnexal masses detected between June 2012 and September 2016 in a private center offering screening for gynecological cancers were included and followed-up until February 2020. Tumors were classified as benign or malignant based on histology (if patients underwent surgery) or outcome of clinical and ultrasound follow-up at 12 (±2) months. Multiple imputation was used when follow-up information was uncertain. The ability of the ADNEX model without CA125 and of the IOTA two-step strategy to distinguish benign from malignant masses was evaluated retrospectively using the prospectively collected data. We describe performance as discrimination (area under the receiver operating characteristic curve, AUC), calibration, classification (sensitivity and specificity) and clinical utility (Net Benefit). In the group of patients with a benign looking mass selected for conservative management we evaluated the occurrence of spontaneous resolution or any mass complication during the first 5 years of follow-up by assessing the cumulative incidence for malignancy, torsion, cyst rupture, or minor mass complications (inflammation, infection, or adhesions) and the time to occurrence of an event. A total of 2654 patients were recruited to the study. After application of exclusion criteria, 2039 patients with a newly detected mass were included for the model validation. 1684 (82.6%) masses were benign, 49 (2.4%) masses were malignant and for 306 (15.0%) masses the outcome was uncertain and imputed. The AUC was 0.95 (95% CI 0.89-0.98) for ADNEX and 0.94 (95% CI 0.88-0.97) for the two-step strategy. Calibration performance could not be meaningfully interpreted due to few malignancies resulting in very wide confidence intervals. The two-step strategy had better clinical utility than ADNEX at malignancy risk thresholds < 3%. 1472 (72%) patients had a mass judged to be benign based on pattern recognition by an experienced ultrasound examiner and were managed with clinical and ultrasound follow-up. In this group, the 5-year cumulative incidence was 66% for spontaneous resolution of the mass (95% CI 63-69), 0% for torsion (95%CI 0-0.002), 0.1% for cyst rupture (<0.1-0.6), 0.2% for a borderline tumor (<0.1-0.6), and 0.2% (0.1-0.6) for invasive malignancy. The ADNEX model and IOTA two-step strategy performed well to distinguish benign from malignant adnexal masses detected in a low-risk population. Conservative management is safe for masses with benign ultrasound appearance in such a population. This article is protected by copyright. All rights reserved.

Prospective external validation of IOTA methods for classifying adnexal masses and retrospective assessment of two-step strategy using benign descriptors and ADNEX: a Portuguese multicenter study.

This study aimed to externally and prospectively validate the International Ovarian Tumor Analysis (IOTA) Simple Rules (SRs), Logistic Regression model 2 (LR2) and Assessment of Different NEoplasias in the adneXa (ADNEX) in a Portuguese population, comparing them with operator subjective assessment (SA), Risk-of-Malignancy Index (RMI), as well as with each other. This study also aimed to retrospectively validate IOTA two-step strategy, using modified benign descriptors (MBDs) followed by the application of ADNEX in cases where MBDs were not applicable (MBDs + ADNEX). In this multicenter diagnostic accuracy study, conducted between January 2016 and December 2021, three tertiary referral centers prospectively included consecutive patients with ultrasound diagnosis of at least one adnexal tumor who underwent surgery. All ultrasound assessments were performed by level II or III sonologists with IOTA certification. Patient clinical data and serum cancer antigen (CA125) levels were collected from the hospital databases. Each adnexal mass was classified as benign or malignant using SA, RMI, IOTA SRs, LR2 and ADNEX (with and without CA125). The reference standard was histopathological diagnosis. In the second phase, all adnexal tumors were retrospectively classified using the two-step strategy (MBDs + ADNEX). The sensitivity, specificity, positive (PPV) and negative predictive value (NPV), positive (LR+) and negative likelihood ratio (LR-) as well as overall accuracy were determined for SA, RMI, IOTA SRs, LR2, ADNEX and two-step strategy (MBDs + ADNEX). Receiver-operator characteristic curves were constructed and corresponding areas under the curve (AUC) determined for RMI, LR2 and ADNEX and two-step strategy (MBDs + ADNEX). The ADNEX calibration plots were constructed and estimated by LOESS smoother. Of the 571 included patients, 428 had benign disease, 42 borderline ovarian tumors, 93 primary invasive adnexal cancers and 8 metastatic tumors in adnexa (malignancy prevalence: 25.0%). The operator SA had an overall sensitivity of 97.9% and a specificity of 83.6% for distinguishing between benign and malignant lesions. RMI showed high specificity (95.6%) but very low sensitivity (58.7%), with an AUC of 0.913. The IOTA SRs were applicable in 80.0% of patients, with a sensitivity of 94.8% and a specificity of 98.6%. LR2 revealed a sensitivity of 84.6%, a specificity of 86.9% and an AUC of 0.939, at the malignancy risk cut-off of 10%. At the same cut-off, ADNEX with and without CA125 had a sensitivity of 95.8% and 98.6%, respectively, and a specificity of 82.5% and 79.7%, respectively. The AUC of ADNEX with vs. without CA125 was 0.962 vs. 0.960. The ADNEX model provided heterogeneous results in distinguishing between benign and different subtypes of malignancy, with the highest AUC (0.991) for discriminating benign masses from primary adnexal cancer stage II-IV, and the lowest AUC (0.696) for distinguishing primary adnexal cancer stage I and metastatic lesion in adnexa. The ADNEX calibration plots suggested an underestimation of the predicted risk in relation with the observed proportion of malignancies. The MBDs were applicable in 26.3% of cases (150/571 tumors, none of which were malignant). Similar to the ADNEX model applied in all patients, the two-step strategy using ADNEX in the second step only, with and without CA125, had an AUC of 0.964 and 0.961, respectively. Our results showed a good to excellent performance of the IOTA methods in the studied Portuguese population, outperforming RMI. ADNEX was superior in accuracy, but interpretation of its ability to distinguish malignant subtypes was fundamentally limited not only by sample size but also by large differences in the prevalence of tumor subtypes. The IOTA MBDs have been shown to be reliable in identifying benign disease. The two-step strategy based on the application of MBDs, followed by the ADNEX model if MBDs are not applicable, has proven to be suitable for daily practice circumventing the need to use electronic support in all patients. This article is protected by copyright. All rights reserved.

A modified CEUS risk stratification model for adnexal masses with solid components: prospective multicenter study and risk adjustment.

To evaluate the additional advantages of integrating contrast-enhanced ultrasound (CEUS) into the Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound (US) for the characterization of adnexal lesions with solid components. This prospective multicenter study recruited women suspected of having adnexal lesions with solid components between September 2021 and December 2022. All patients scheduled for surgery underwent preoperative CEUS and US examinations. The lesions were categorized according to the O-RADS US system, and quantitative CEUS indexes were recorded. Pathological results served as the reference standard. Univariable and multivariable analyses were performed to identify risk factors for malignancy in adnexal lesions with solid components. Receiver operating characteristic (ROC) curve analysis was employed to assess diagnostic performance. A total of 180 lesions in 175 women were included in the study. Among these masses, 80 were malignant and 100 were benign. Multivariable analysis revealed that serum CA-125, the presence of acoustic shadowing, and peak intensity (PI) ratio (PImass/PIuterus) of solid components on CEUS were independently associated with adnexal malignancy. The modified CEUS risk stratification model demonstrated superior diagnostic value in assessing adnexal lesions with solid components compared to O-RADS US (AUC: 0.91 vs 0.78, p < 0.001) and exhibited comparable performance to the Assessment of Different NEoplasias in the adnexa (ADNEX) model (AUC 0.91 vs 0.86, p = 0.07). Our findings underscore the potential value of CEUS as an adjunctive tool for enhancing the precision of diagnostic evaluations of O-RADS US. The promising performance of the modified CEUS risk stratification model suggests its potential to mitigate unnecessary surgeries in the characterization of adnexal lesions with solid components. • The additional value of CEUS to O-RADS US in distinguishing between benign and malignant adnexal lesions with solid components requires further evaluation. • The modified CEUS risk stratification model displayed superior diagnostic value and specificity in characterizing adnexal lesions with solid components when compared to O-RADS US. • The inclusion of CEUS demonstrated potential in reducing the need for unnecessary surgeries in the characterization of adnexal lesions with solid components.

ADNEX risk prediction model for diagnosis of ovarian cancer: systematic review and meta-analysis of external validation studies

ObjectivesTo conduct a systematic review of studies externally validating the ADNEX (Assessment of Different Neoplasias in the adnexa) model for diagnosis of ovarian cancer and to present a meta-analysis of...

Evaluating the risk of malignancy in adnexal masses: validation of O-RADS and comparison with ADNEX model, SA, and RMI.

To evaluate the diagnostic value of Ovarian-adnexal Reporting and Data System (O-RADS), and to compare it with Assessment of Different NEoplasias in the adnexa (ADNEX) model, Subjective Assessment (SA), and Risk of Malignancy Index (RMI) in differentiating benign and malignant adnexal masses (AMs). Ultrasound characteristics of 445 patients included in the study were retrospectively analyzed and evaluated using diagnostic models. The diagnostic performances of ultrasound diagnostic models were measured by assessing, receiver-operating characteristic curves, sensitivities, positive predictive values, positive likelihood ratios, specificities, negative predictive values, and negative likelihood ratios. Kappa values were used to evaluate inter-reviewer agreement (IRA). Of the 445 AMs, 265 were benign and 180 were malignant. The area under the curve (AUC) of O-RADS (0.941), ADNEX model (0.925), and SA (0.931) were higher than RMI (0.815) (all p < 0.05). The sensitivity of O-RADS (93.3%), ADNEX model (94.4%), and SA (96.1%) were higher than RMI (70.6%) (p > 0.05), and there was no statistical significance among them (p > 0.05). The specificity of O-RADS, ADNEX model, SA, and RMI was 90.2%, 90.6%, 90.2%, and 92.5%, respectively, with no statistical significance (p > 0.05). All four ultrasound diagnostic methods showed better IRA. O-RADS, ADNEX model and SA have better diagnostic value in differentiating benign and malignant AMs than RMI.

Comparison of International Ovarian Tumor Analysis ADNEX model and Ovarian-Adnexal Reporting and Data System with final histological diagnosis in adnexal masses: a retrospective study.

The International ovarian tumor analysis (IOTA)-Assessment of Different NEoplasias in the adneXa (ADNEX) model and the ovarian-adnexal reporting and data system (O-RADS) were developed to improve the diagnostic accuracy of adnexal masses in the preoperative period. This study aimed to evaluate the predictive values of both models in patients who underwent surgery for an adnexal mass at our hospital, based on the final pathological results. This study included patients who underwent surgery for adnexal masses at our hospital between 2019 and 2021 and met the inclusion criteria. The IOTA ADNEX model and O-RADS scores were calculated preoperatively. Of the 413 patients, 295 were diagnosed with benign tumors and 118 were diagnosed with malignant tumors. The mean cancer antigen 125 (CA-125) levels for patients diagnosed with benign and malignant were 15.2 unit/mL and 72.5 unit/mL, respectively. According to the receiver operator characteristic analysis for serum CA-125 in postmenopausal and premenopausal patients, the cutoff value of 34.8 unit/mL had a sensitivity of 70.8% and specificity of 83.8% and 180.5 unit/mL had a sensitivity of 32.1% and a specificity of 92.7%, respectively (P<0.001). The sensitivity and specificity values of the IOTA ADNEX model and O-RADS were found as 78.8-48.3% and 97.9-93.5% respectively (P<0.001). There was moderate agreement between the IOTA ADNEX model and O-RADS (Kappa=0.53). The IOTA ADNEX model has a similar specificity to the O-RADS in malignancy risk assessment, but the sensitivity of the IOTA ADNEX model is higher than that of the O-RADS. The IOTA-ADNEX model can help avoid unnecessary surgeries.

Subjective assessment and IOTA ADNEX model in evaluation of adnexal masses in patients with history of breast cancer.

To evaluate the performance of subjective assessment and the Assessment of Different NEoplasias in the adneXa (ADNEX) model in discriminating between benign and malignant adnexal tumors and between metastatic and primary adnexal tumors in patients with a personal history of breast cancer. This was a retrospective single-center study including patients with a history of breast cancer who underwent surgery for an adnexal mass between 2013 and 2020. All patients had been examined with transvaginal or transrectal ultrasound using a standardized examination technique and all ultrasound reports had been stored and were retrieved for the purposes of this study. The specific diagnosis suggested by the original ultrasound examiner in the retrieved report was analyzed. For each mass, the ADNEX model risks were calculated prospectively and the highest relative risk was used to categorize each into one of five categories (benign, borderline, primary Stage I, primary Stages II-IV or metastatic ovarian cancer) for analysis of the ADNEX model in predicting the specific tumor type. The performance of subjective assessment and the ADNEX model in discriminating between benign and malignant adnexal tumors and between primary and metastatic adnexal tumors was evaluated, using final histology as the reference standard. Included in the study were 202 women with a history of breast cancer who underwent surgery for an adnexal mass. At histology, 93/202 (46.0%) masses were benign, 76/202 (37.6%) were primary malignancies (four borderline and 72 invasive tumors) and 33/202 (16.3%) were metastases. The original ultrasound examiner classified correctly 79/93 (84.9%) benign adnexal masses, 72/76 (94.7%) primary adnexal malignancies and 30/33 (90.9%) metastatic tumors. Subjective ultrasound evaluation had a sensitivity of 93.6%, specificity of 84.9% and accuracy of 89.6%, while the ADNEX model had higher sensitivity (98.2%) but lower specificity (78.5%), with similar accuracy (89.1%), in discriminating between benign and malignant ovarian masses. Subjective evaluation had a sensitivity of 51.5%, specificity of 88.8% and accuracy of 82.7% in distinguishing metastatic and primary tumors (including benign, borderline and invasive tumors), and the ADNEX model had a sensitivity of 63.6%, specificity of 84.6% and similar accuracy (81.2%). The performance of subjective assessment and the ADNEX model in discriminating between benign and malignant adnexal masses in this series of patients with history of breast cancer was relatively similar. Both subjective assessment and the ADNEX model demonstrated good accuracy and specificity in discriminating between metastatic and primary tumors, but the sensitivity was low. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

Current uptake and barriers to wider use of the International Ovarian Tumor Analysis (IOTA) models in Dutch gynaecological practice

ObjectiveCorrect referral of women with an ovarian tumor to an oncology department remains challenging. The International Ovarian Tumor Analysis (IOTA) consortium has developed models with higher diagnostic accuracy than the alternative Risk of Malignancy Index (RMI). This study explores the uptake of the IOTA models in Dutch hospitals and factors that impede or promote implementation. Optimal implementation is crucial to improve pre-operative classification of ovarian tumors, which may lead to better patient referral to the appropriate level of care. Study DesignIn February 2021, an electronic questionnaire consisting of 37 questions was sent to all 72 hospitals in the Netherlands. One pre-selected gynaecologist per hospital was asked to respond on behalf of the department. ResultsThe study had a response rate of 93% (67/72 hospitals). All respondents (100%) were familiar with the IOTA models with 94% using them in practice. The logistic regression 2 (LR2)-model, Simple ultrasound-based rules (SR) and Assessment of Different NEoplasias in the adneXa (ADNEX) model were used in respectively 40%, 67% and 73% of these hospitals. Respondents rated the models overall with an 8.2 (SD 1.8), 8.3 (SD 1.6) and 8.9 (SD 1.3) respectively for LR2, SR and ADNEX on a scale from 1 to 10. Moreover, 89% indicated to have confidence in the results of the IOTA models. The most important factors to improve further implementation are more training (43%), research on sensitivity, specificity and cost-effectiveness in the Dutch health care system (27%), easier usability (24%) and more consultation time (19%). ConclusionThe IOTA ultrasound models are adopted in the majority of Dutch hospitals with the ADNEX model being used the most. While Dutch gynecologists have a strong familiarity and confidence in the models, the uptake varies in reality. Areas that warrant improvement in the Dutch context are more uniformity, education and more research. These findings can be helpful for other countries considering adopting the IOTA models.

Simple rules, O-RADS, ADNEX and SRR model: Single oncologic center validation of diagnostic predictive models alone and combined (two-step strategy) to estimate the risk of malignancy in adnexal masses and ovarian tumors

ObjectiveTo compare performance of Assessment of Different NEoplasias in the adneXa (ADNEX model), Ovarian-Adnexal Reporting and Data System (O-RADS), Simple Rules Risk (SRR) assessment and the two-step strategy based on the application of Simple Rules (SR) followed by SRR and SR followed by ADNEX in the pre-operative discrimination between benign and malignant adnexal masses (AMs). MethodsWe conducted a retrospective study from January-2018 to December-2021 in which consecutive patients with at AMs were recruited. Accuracy metrics included sensitivity (SE) and specificity (SP) with their 95% confidence intervals (CI) were calculated for ADNEX, O-RADS and SRR. When SR was inconclusive a “two-step strategy” was adopted applying SR + ADNEX model and SR + SRR assessment. ResultsA total of 514 women were included, 400 (77.8%) had a benign ovarian tumor and 114 (22.2%) had a malignant tumor. At a threshold malignancy risk of >10%, the SE and SP of ADNEX model, O-RADS and SRR were: 0.92 (95% CI, 0.86–0.96) and 0.88 (95% CI, 0.85–0.91); 0.93 (95% CI, 0.87–0.97) and 0.89 (95% CI, 0.96–0.92); 0.88 (95% CI, 0.80–0.93) and 0.84 (95% CI, 0.80–0.87), respectively. When we applied SR, 109 (21.2%) cases resulted inconclusive. The SE and SP of two-step strategy SR + SRR assessment and SR + ADNEX model were 0.88 (95% CI, 0.80–0.93) and 0.92 (95% CI, 0.89–0.94), SR + ADNEX model 0.90 (95% CI, 0.83–0.95) and 0.93 (95% CI, 0.90–0.96), respectively. ConclusionsO-RADS presented the highest SE, similar to ADNEX model and SR + ADNEX model. However, the SR + ADNEX model presented the higher performance accuracy with the higher SP and PPV. This two-step strategy, SR and ADNEX model applicated to inconclusive SR, is convenient for clinical evaluation.

Diagnostic Performance of Ultrasonography-Based Risk Models in Differentiating Between Benign and Malignant Ovarian Tumors in a US Cohort

Ultrasonography-based risk models can help nonexpert clinicians evaluate adnexal lesions and reduce surgical interventions for benign tumors. Yet, these models have limited uptake in the US, and studies comparing their diagnostic accuracy are lacking. To evaluate, in a US cohort, the diagnostic performance of 3 ultrasonography-based risk models for differentiating between benign and malignant adnexal lesions: International Ovarian Tumor Analysis (IOTA) Simple Rules with inconclusive cases reclassified as malignant or reevaluated by an expert, IOTA Assessment of Different Neoplasias in the Adnexa (ADNEX), and Ovarian-Adnexal Reporting and Data System (O-RADS). This retrospective diagnostic study was conducted at a single US academic medical center and included consecutive patients aged 18 to 89 years with adnexal masses that were managed surgically or conservatively between January 2017 and October 2022. Evaluation of adnexal lesions using the Simple Rules, ADNEX, and O-RADS. The main outcome was diagnostic performance, including area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios. Surgery or follow-up were reference standards. Secondary analyses evaluated the models' performances stratified by menopause status and race. The cohort included 511 female patients with a 15.9% malignant tumor prevalence (81 patients). Mean (SD) ages of patients with benign and malignant adnexal lesions were 44.1 (14.4) and 52.5 (15.2) years, respectively, and 200 (39.1%) were postmenopausal. In the ROC analysis, the AUCs for discriminative performance of the ADNEX and O-RADS models were 0.96 (95% CI, 0.93-0.98) and 0.92 (95% CI, 0.90-0.95), respectively. After converting the ADNEX continuous individualized risk into the discrete ordinal categories of O-RADS, the ADNEX performance was reduced to an AUC of 0.93 (95% CI, 0.90-0.96), which was similar to that for O-RADS. The Simple Rules combined with expert reevaluation had 93.8% sensitivity (95% CI, 86.2%-98.0%) and 91.9% specificity (95% CI, 88.9%-94.3%), and the Simple Rules combined with malignant classification had 93.8% sensitivity (95% CI, 86.2%-98.0%) and 88.1% specificity (95% CI, 84.7%-91.0%). At a 10% risk threshold, ADNEX had 91.4% sensitivity (95% CI, 83.0%-96.5%) and 86.3% specificity (95% CI, 82.7%-89.4%) and O-RADS had 98.8% sensitivity (95% CI, 93.3%-100%) and 74.4% specificity (95% CI, 70.0%-78.5%). The specificities of all models were significantly lower in the postmenopausal group. Subgroup analysis revealed high performances independent of race. In this diagnostic study of a US cohort, the Simple Rules, ADNEX, and O-RADS models performed well in differentiating between benign and malignant adnexal lesions; this outcome has been previously reported primarily in European populations. Risk stratification models can lead to more accurate and consistent evaluations of adnexal masses, especially when used by nonexpert clinicians, and may reduce unnecessary surgeries.

P-757 The classification and management of adnexal masses identified during pregnancy

Abstract Study question How do we classify adnexal masses (ovarian cysts) identified during pregnancy and how should we manage them? Summary answer Adnexal masses (ovarian cysts) should be managed expectantly in pregnancy, given the low rate of complications and low prevalence of malignancy. What is known already Conservative management of adnexal masses (ovarian cysts) is preferable during pregnancy, due to the maternal and fetal risks associated with surgery. Accurate diagnosis is key to safe expectant management. Various ultrasound-based models exist to classify adnexal masses; however, none have been validated for use in pregnancy. Adnexal mass morphology can change during pregnancy due to decidualisation, which is often difficult to distinguish from underlying neoplastic processes. We aim to evaluate:(1) the performance of current methods of adnexal mass classification in pregnancy, (2) understand the natural course of adnexal masses in pregnancy, particularly the presence of decidualisation and incidence of complications. Study design, size, duration Retrospective analysis of prospectively collected data between January 2017- November 2022. To classify adnexal masses (ovarian cysts), we evaluated: Expert subjective assessment (SA), IOTA Simple Rules (SR) and the IOTA Assessment of Different Neoplasias of the Adnexa (ADNEX) model. The end point was either the histological examination of tissue removed at surgery or the subjective classification of adnexal masses at the postnatal scan in women managed conservatively. Participants/materials, setting, methods Women with an adnexal mass identified on gynaecological ultrasound in pregnancy at a tertiary London University Hospital were included. Relevant clinical data was extracted, including age, gestation and cyst-related complications. Adnexal masses were classified at the first antenatal and postnatal ultrasound examination according to SA, SR and the ADNEX model (10% risk of malignancy cut off) and correlated to histology for adnexal masses managed surgically. IOTA simple descriptors were used to classify benign adnexal masses. Main results and the role of chance 254 women (median age 33-years old, range:18-49) with an adnexal mass/cyst were included at a median gestation of 12 weeks, (range:4-36). 13 (5.1%) conceived through assisted reproductive techniques. Spontaneous resolution occurred in 24.5% of cases, and 21 were lost to follow up (8.3%). According to Simple Descriptors, 38.6% were simple, 22.0% were endometriomas and 19.7% were dermoid cysts. Antenatally, SA outperformed ADNEX, based on specificity (94.6 vs.92.2%) and sensitivity (60 vs.55.6%) respectively. SA and ADNEX had a negative predictive value(NPV) of 96.1% and 98.3% respectively. Postnatally, SA had a higher sensitivity than ADNEX (75 vs.50%), but a lower specificity (94.1 vs.96.9%). SA and ADNEX had a NPV of 94.1% and 97.5% respectively. Three (1.3%) underwent acute surgery during pregnancy: one ovarian torsion (9/40), and two cyst ruptures (11/40, 30/40). Presumed decidualisation occurred in 29.5% of endometriomas. Three (1.3%) underwent cyst removal during caesarean section, two for suspicion of BOTs (one had suspected decidualisation) and one for patient preference. On histology, the suspected decidualised mass was a serous BOT, and the suspected BOT was a struma ovarii. In the postnatal period (12 weeks), four underwent surgery for suspicion of BOTs, two were confirmed BOTs and two were benign cystadenomas on histology. Limitations, reasons for caution The dataset as expected contains a relatively small number of malignancies (prevalence 3.9%) and so any analysis of test performance to discriminate between benign and malignant disease must be interpreted with caution. A larger prospective multicentre study is needed to do this. Wider implications of the findings Our data suggest that a number of cysts in pregnancy will resolve, a few will be associated with acute complications and the risk of malignancy is very low. Accordingly, the study supports an expectant management approach for adnexal masses (ovarian cysts) detected in pregnancy. Trial registration number Not applicable

Systematic Review and Meta-Analysis of O-RADS Ultrasound and O-RADS MRI for Risk Assessment of Ovarian and Adnexal Lesions.

BACKGROUND. O-RADS ultrasound (US) and O-RADS MRI have been developed to standardize risk stratification of ovarian and adnexal lesions. OBJECTIVE. The purpose of this study was to perform a meta-analysis evaluating the diagnostic performance of O-RADS US and O-RADS MRI for risk stratification of ovarian and adnexal lesions. EVIDENCE ACQUISITION. We searched the Web of Science, PubMed, Cochrane Library, Embase, and Google Scholar databases from January 1, 2020, until October 31, 2022, for studies reporting on the performance of O-RADS US or O-RADS MRI in the diagnosis of malignancy of ovarian or adnexal lesions. Study quality was assessed with QUADAS-2. A hierarchic summary ROC model was used to estimate pooled sensitivity and specificity. Heterogeneity was assessed with the Q statistic. Metaregression analysis was performed to explore potential sources of heterogeneity. O-RADS US was compared with the International Ovarian Tumor Analysis (IOTA) simple rules and Assessment of Different Neoplasias in the Adnexa (ADNEX) model in studies providing head-to-head comparisons. EVIDENCE SYNTHESIS. Twenty-six studies comprising 9520 patients were included. O-RADS US was evaluated in 15 and O-RADS MRI in 12 studies; both systems were evaluated in one of the studies. Quality assessment revealed that risk of bias or concern about applicability most commonly related to patient selection. Pooled sensitivity and specificity of O-RADS US were 95% (95% CI, 91-97%) and 82% (95% CI, 76-87%) and of O-RADS MRI were 95% (95% CI, 92-97%) and 90% (95% CI, 84-94%). Analysis with the Q statistic revealed significant heterogeneity among studies of O-RADS US in both sensitivity and specificity (both p < .001) and among studies of O-RADS MRI in specificity (p < .001) but not sensitivity (p = .07). In metaregression, no factor was significantly associated with sensitivity or specificity of either system (all p > .05). O-RADS US showed no significant difference in sensitivity or specificity versus IOTA simple rules in four studies (sensitivity, 96% vs 93%; specificity, 76% vs 82%) or versus the ADNEX model in three studies (sensitivity, 96% vs 96%; specificity, 79% vs 78%). CONCLUSION. O-RADS US and O-RADS MRI both have high sensitivity for ovarian or adnexal malignancy. O-RADS MRI, but not O-RADS US, also has high specificity. CLINICAL IMPACT. Awareness of the diagnostic performance results regarding O-RADS US and O-RADS MRI will be helpful as these systems are increasingly implemented into clinical practice.

Comparison of performance between O-RADS, IOTA simple rules risk assessment and ADNEX model in the discrimination of ovarian Brenner tumors.

To describe the clinical and sonographic features of ovarian benign Brenner tumor (BBT) and malignant Brenner tumor (MBT), and to compare performance of four diagnostic models in differentiating them. Fifteen patients with BBTs and nine patients with MBTs were retrospectively identified in our institution from January 2003 and December 2021. One ultrasound examiner categorized each mass according to ovarian-adnexal reporting and data system (O-RADS), international ovarian tumor analysis (IOTA) Simple Rules Risk (SR-Risk) assessment and assessment of different neoplasias in the adnexa (ADNEX) models with/without CA125. Receiver operating characteristic curves were generated to compare diagnostic performance. Patients with MBT had higher CA125 serum level (62.5% vs. 6.7%, P = 0.009) and larger maximum diameter of lesion (89mm vs. 43mm, P = 0.009) than did those with BBT. BBT tended to have higher prevalence of calcifications (100% vs. 55.6%, P = 0.012) and acoustic shadowing (93.3% vs. 33.3%, P = 0.004), and lower color scores manifesting none or minimal flow (100.0% vs. 22.2%, P < 0.001). Areas under curves of O-RADS, IOTA SR-Risk and ADNEX models with/without CA125 were 0.896, 0.913, 0.892 and 0.896, respectively. There were no significant differences between them. BBTs are often small solid tumors with sparse color Doppler signals, which contain calcifications with posterior acoustic shadowing. The most common pattern of MBT is a large multilocular-solid or solid mass with irregular tumor borders, and most were moderately or richly vascularized at color Doppler. These four models have excellent performance in distinguishing them.

Comparison of ultrasound-based ADNEX model with magnetic resonance imaging for discriminating adnexal masses: a multi-center study.

The ADNEX model offered a good diagnostic performance for discriminating adnexal tumors, but research comparing the abilities of the ADNEX model and MRI for characterizing adnexal tumors has not been reported to our knowledge. The aim of this study was to evaluate the diagnostic accuracy of the ultrasound-based ADNEX (Assessment of Different NEoplasias in the adneXa) model in comparison with that of magnetic resonance imaging (MRI) for differentiating benign, borderline and malignant adnexal masses. This prospective study included 529 women with adnexal masses who underwent assessment via the ADNEX model and subjective MRI analysis before surgical treatment between October 2019 and April 2022 at two hospitals. Postoperative histological diagnosis was considered the gold standard. Among the 529 women, 92 (17.4%) masses were diagnosed histologically as malignant tumors, 67 (12.7%) as borderline tumors, and 370 (69.9%) as benign tumors. For the diagnosis of malignancy, including borderline tumors, overall agreement between the ADNEX model and MRI pre-operation was 84.9%. The sensitivity of the ADNEX model of 0.91 (95% confidence interval [CI]: 0.85-0.95) was similar to that of MRI (0.89, 95% CI: 0.84-0.94; P=0.717). However, the ADNEX model had a higher specificity (0.90, 95% CI: 0.87-0.93) than MRI (0.81, 95% CI: 0.77-0.85; P=0.001). The greatest sensitivity (0.96, 95% CI: 0.92-0.99) and specificity (0.94, 95% CI: 0.91-0.96) were achieved by combining the ADNEX model and subjective MRI assessment. While the total diagnostic accuracy did not differ significantly between the two methods (P=0.059), the ADNEX model showed greater diagnostic accuracy for borderline tumors (P<0.001). The ultrasound-based ADNEX model demonstrated excellent diagnostic performance for adnexal tumors, especially borderline tumors, compared with MRI. Accordingly, we recommend that the ADNEX model, alone or with subjective MRI assessment, should be used for pre-operative assessment of adnexal masses.

Diagnostic Performance of Ultrasound-Based International Ovarian Tumor Analysis Simple Rules and Assessment of Different NEoplasias in the adneXa Model for Predicting Malignancy in Women with Ovarian Tumors: A Prospective Cohort Study.

Comparative performance of various ultrasound models in diagnosing ovarian lesions has not been adequately studied. This study aimed to evaluate the diagnostic performance of the International Ovarian Tumor Analysis (IOTA) simple rules and Assessment of Different NEoplasias in the adneXa (ADNEX) models in women with ovarian lesions. Women 18-80 years, with an ovarian lesion planned for surgery were recruited in this prospective observational cohort study. Preoperative risk stratification was done by both IOTA simple rules and the ADNEX model. The diagnostic performance of both models was estimated using histopathology as the gold standard. A total of 90 women were recruited into the study. The IOTA simple rules were applicable to 77 (85.5%) participants and the ADNEX model on 100% women. Both the simple rules and the ADNEX model had good diagnostic performance. The sensitivity and specificity of the IOTA simple rules for predicting malignancy was 66.6% and 91%, while that of the ADNEXA model was 80% and 94%, respectively. The maximum diagnostic accuracy for prediction of both benign and malignant tumors was obtained when cancer antigen-125 (CA-125) was combined with the IOTA ADNEX model (91.0%), but for Stage I malignancy, the maximum diagnostic accuracy was for ADNEX without CA-125 (91.0%). Both the IOTA models have a good diagnostic accuracy and are of paramount importance in differentiating benign from malignant tumors and predicting the stage of the malignant disease.

Evaluation of IOTA-ADNEX Model and Simple Rules for Identifying Adnexal Masses by Operators with Varying Levels of Expertise: A Single-Center Diagnostic Accuracy Study.

Objectives The discrimination of ovarian lesions presents a significant problem in everyday clinical practice with ultrasonography appearing to be the most effective diagnostic technique. The aim of our study was to externally evaluate the performance of different diagnostic models when applied by examiners with various levels of experience. Methods This was a diagnostic accuracy study including women who were admitted for adnexal masses, between July 2018 and April 2021, to a Greek tertiary oncology center. Preoperatively sonographic data were evaluated by an expert gynecologist, a 6 th and a 1 st year gynecology resident, who applied the International Ovarian Tumor Analysis (IOTA) Simple Rules (SR) and Assessment of Different NEoplasias in the adneXa (ADNEX) model to discriminate between benign and malignant ovarian tumors. The explant pathology report was used as the reference diagnosis. Kappa statistics were used for the investigation of the level of agreement between the examined systems and the raters. Results We included 66 women, 39 with benign and 27 with malignant ovarian tumors. ADNEX (with and without "CA-125") had high sensitivity (96-100%) when applied by all raters but a rather low specificity (36%) when applied by the 1st year resident. SR could not be applied in 6% to 17% of the cases. It had slightly lower sensitivity, higher specificity, and higher overall accuracy, especially when applied by the 1st year resident (61% vs. 92%), compared to ADNEX. Conclusion Both ADNEX and SR can be utilized for screening in non-oncology centers since they offer high sensitivity even when used by less experienced examiners. In the hands of inexperienced examiners, SR appears to be the best model for assessing ovarian lesions.

Performance of the IOTA ADNEX model combined with HE4 for identifying early-stage ovarian cancer

ObjectiveThis work was designed to investigate the performance of the International Ovarian Tumor Analysis (IOTA) ADNEX (Assessment of Different NEoplasias in the adneXa) model combined with human epithelial protein 4 (HE4) for early ovarian cancer (OC) detection.MethodsA total of 376 women who were hospitalized and operated on in Women and Children’s Hospital of Chongqing Medical University were selected. Ultrasonographic images, cancer antigen-125 (CA 125) levels, and HE4 levels were obtained. All cases were analyzed and the histopathological diagnosis serves as the reference standard. Based on the IOTA ADNEX model post-processing software, the risk prediction value was calculated. We analyzed receiver operating characteristic curves to determine whether the IOTA ADNEX model alone or combined with HE4 provided better diagnostic accuracy.ResultsThe area under the curve (AUC) of the ADNEX model alone or combined with HE4 in predicting benign and malignant ovarian tumors was 0.914 (95% CI, 0.881–0.941) and 0.916 (95% CI, 0.883–0.942), respectively. With the cutoff risk of 10%, the ADNEX model had a sensitivity of 0.93 (95% CI, 0.87–0.97) and a specificity of 0.73 (95% CI, 0.67–0.78), while combined with HE4, it had a sensitivity of 0.90 (95% CI, 0.84–0.95) and a specificity of 0.81 (95% CI, 0.76–0.86). The IOTA ADNEX model combined with HE4 was better at improving the accuracy of the differential diagnosis between different OCs than the IOTA ADNEX model alone. A significant difference was found in separating borderline masses from Stage II–IV OC (p = 0.0257).ConclusionsA combination of the IOTA ADNEX model and HE4 can improve the specificity of diagnosis of ovarian benign and malignant tumors and increase the sensitivity and effectiveness of the differential diagnosis of Stage II–IV OC and borderline tumors.

Menopausal status, ultrasound and biomarker tests in combination for the diagnosis of ovarian cancer in symptomatic women.

Menopausal status, ultrasound and biomarker tests in combination for the diagnosis of ovarian cancer in symptomatic women.