Abstract
AimThis study aimed to compare different ultrasound-based International Ovarian Tumor Analysis (IOTA) prediction models, namely, the Simple Rules (SRs) the Assessment of Different NEoplasias in the adneXa (ADNEX) models, and the Risk of Malignancy Index (RMI), for the pre-operative diagnosis of adnexal mass.MethodsThis single-centre diagnostic accuracy study involved 486 patients. All ultrasound examinations were analyzed and the prediction models were applied. Pathology was the clinical reference standard. The diagnostic performances of prediction models were measured by evaluating receiver-operating characteristic curves, sensitivities, specificities, positive and negative predictive values, positive and negative likelihood ratios, and diagnostic odds ratios.ResultsTo discriminate benign and malignant tumors, areas under the ROC curves (AUCs) for ADNEX models were 0.94 (95% CI: 0.92–0.96) with CA125 and 0.94 (95% CI: 0.91–0.96) without CA125, which were significantly higher than the AUCs for RMI I-III: 0.87 (95% CI: 0.83–0.90), 0.83 (95% CI: 0.80–0.86), and 0.82 (95% CI: 0.78–0.86), (all P < 0.0001). At a cut-off of 10%, the ADNEX model with CA125 had the highest sensitivity (0.93; 95% CI: 0.87–0.97) compared with the other models. The SRs model achieved a sensitivity of 0.93 (95% CI: 0.86–0.97) and a specificity of 0.86 (95% CI: 0.82–0.89) when inconclusive diagnoses (11.7%) were classified as malignant.ConclusionADNEX and SRs models were excellent at characterising adnexal masses which were superior to the RMI in Chinese patients.
Highlights
Ovarian cancer (OC) has the highest mortality rate and most unfavourable prognosis among the gynaecological malignancies; the average 5-year survival rate is < 50% [1, 2]
The Risk of Malignancy Index (RMI), which accounts for the serum cancer antigen (CA) 125 levels, menopausal status, and the ultrasound findings, is a prediction model that is recommended by many national guidelines [19,20,21]
The ADNEX model is available in versions that include and exclude the CA125 level, and we evaluated the predictive accuracy of the ADNEX model with and without CA125 in this study
Summary
Ovarian cancer (OC) has the highest mortality rate and most unfavourable prognosis among the gynaecological malignancies; the average 5-year survival rate is < 50% [1, 2]. Several ultrasound-based prediction models have been developed to accurately discriminate between benign and malignant tumors, because the numbers of experienced examiners are insufficient and they are unavailable in some regions [18]. The Risk of Malignancy Index (RMI), which accounts for the serum cancer antigen (CA) 125 levels, menopausal status, and the ultrasound findings, is a prediction model that is recommended by many national guidelines [19,20,21]. The findings from previous external validation studies have shown that the SRs model is easy to use and its diagnostic performance is good, but it is not suitable for all adnexal masses [25,26,27]. The ADNEX model is excellent at differentiating between malignant and benign tumors [6, 29,30,31] and indicating the stages of malignant tumors, there is still no diagnostic accuracy study to compare these models abovementioned in a Chinese setting
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