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

Abstract

ImportanceUltrasonography-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.ObjectiveTo 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).Design, Setting, and ParticipantsThis 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.ExposureEvaluation of adnexal lesions using the Simple Rules, ADNEX, and O-RADS.Main Outcomes and MeasuresThe 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.ResultsThe 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.Conclusions and RelevanceIn 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.

Comparison of O-RADS with the ADNEX model and IOTA SR for risk stratification of adnexal lesions: a systematic review and meta-analysis

“…We reviewed the remaining 134 full-text articles, and 122 were excluded for reasons as follows: insufficient data to determine diagnostic performance ( n = 23) and not in the field of interest ( n = 99). Finally, a total of 12 studies were included in this meta-analysis ( 20 – 31 ). The flowchart of the literature selection process is demonstrated in Figure 1 .…”

“…For this meta-analysis, all the studies included had a retrospective study design, with eight studies reporting a head-to-head comparison between O-RADS and the ADNEX model ( 21 , 23 – 28 , 31 ) and seven studies reporting a direct comparison between O-RADS and IOTA SR (including three studies performing a comparison between all three guidelines) ( 20 , 22 , 23 , 25 , 29 – 31 ). The study sample ranged from 122 to 1,179 patients, with an average age of 35–52.3.…”

“…The average size of the adnexal mass lesion in seven studies was 60–190 mm. In most studies, surgical pathology results were used as the reference; however, in two studies, a follow-up of 12–24 months was also used when histopathological results were not available ( 20 , 31 ). Borderline lesions were reported in 11 studies, and all of these studies classified those masses as malignant.…”

“…Moreover, the interpretation of ultrasound findings can be subjective and may vary among examiners, leading to potential discrepancies in risk assessment and diagnostic accuracy. Considering the low incidence but high mortality rate, risk stratification of adnexal masses is a trade-off between sensitivity and specificity, which should take into consideration a number of factors such as risk tolerance for missing cancer and surgery risk ( 31 ). Therefore, the physician and the patient have to contemplate the risks and benefits of any procedure and determine the individual cutoff in specific circumstances in which the adnexal mass is evaluated.…”

Ultrasound-based ADNEX model for differentiating between benign, borderline, and malignant epithelial ovarian tumors

“…It is the rst multiclassi cation model that consists of three clinical indexes and six ultrasonic indexes [13]. A previous study demonstrated that the ADNEX model showed diagnostic performance for identifying adnexal lesions [14,15]. However, no studies have reported the validation of the ADNEX model in epithelial ovarian tumors.…”