Diagnostic accuracy of ultrasound classifications - O-RADS US v2022, O-RADS US v2020, and IOTA SR - in distinguishing benign and malignant adnexal masses: Enhanced by combining O-RADS US v2022 with tumor marker HE4

Purpose: To assess the diagnostic accuracy of O-RADS Ultrasound (O-RADS US) v2022, O-RADS US v2020, and IOTA SR, and to evaluate whether combining imaging findings with tumor markers enhances the diagnosis of adnexal masses.

Methods: This retrospective study, conducted between January 2018 and December 2023, included consecutive women with adnexal masses scheduled for surgery. Histopathologic results served as the reference standard. Risk factors for malignancy were identified using univariate and multivariate logistic regression analyses. ROC analysis was employed to assess diagnostic test performances, while Kappa statistics evaluated inter-reviewer agreement.

Results: A total of 613 women (mean age, 49.39 ± 12.81 years; range, 16-87 years) with pelvic masses were included. O-RADS US v2022 exhibited comparable performance to O-RADS US v2020, with areas under the curve (AUC) values of 0.940 and 0.937, respectively (p = 0.02, exceeding the adjusted significance level of 0.0167). Both O-RADS models outperformed the IOTA SR, which had an AUC of 0.862 (p < 0.0001 for both comparisons). Multivariate analysis revealed that O-RADS US v2022 [OR 9.148, 95 %CI (4.912-17.039), p < 0.001] and HE4 [OR 1.023, 95 %CI (1.010-1.036), p = 0.001] were significant factors associated with malignant lesions. Furthermore, the combination of O-RADS US v2022 and HE4 demonstrated an AUC of 0.98, significantly outperforming either O-RADS US v2022 alone (AUC = 0.94) or HE4 alone (AUC = 0.92). The Kappa values for O-RADS US v2022, O-RADS US v2020 and IOTA SR were 0.933, 0.891 and 0.923, respectively, indicating substantial inter-reader agreement.

Conclusions: The O-RADS US v2022 demonstrates comparable performance in predicting ovarian malignant lesions when compared to O-RADS US v2020, while surpassing the performance of IOTA SR. Additionally, the combination of O-RADS US v2022 and HE4 provides improved diagnostic effectiveness over using either O-RADS US v2022 or HE4 alone.