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

Giulia Spagnol; Matteo Marchetti; Orazio De Tommasi; Amerigo Vitagliano; Francesco Cavallin; Roberto Tozzi; Carlo Saccardi; Marco Noventa

doi:10.1016/j.ygyno.2023.08.012

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

Gynecol Oncol. 2023 Oct:177:109-116. doi: 10.1016/j.ygyno.2023.08.012. Epub 2023 Sep 1.

Authors

Giulia Spagnol¹, Matteo Marchetti¹, Orazio De Tommasi¹, Amerigo Vitagliano², Francesco Cavallin³, Roberto Tozzi¹, Carlo Saccardi¹, Marco Noventa⁴

Affiliations

¹ Department of Women and Children's Health, Unit of Gynecology and Obstetrics, University of Padua, Padua, Italy.
² Department of Biomedical and Human Oncological Science (DIMO), 1st Unit of Obstetrics and Gynecology, University of Bari, Policlinico, Bari, Italy.
³ Independent Statistician (collaboration with University of Padua), Solagna, Italy.
⁴ Department of Women and Children's Health, Unit of Gynecology and Obstetrics, University of Padua, Padua, Italy. Electronic address: marco.noventa.2@unipd.it.

PMID: 37660412
DOI: 10.1016/j.ygyno.2023.08.012

Abstract

Objective: To 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).

Methods: We 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.

Results: A 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.

Conclusions: O-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.

Keywords: ADNEX; O-RADS; Ovarian cancer; SRR; Simple rules; Ultrasound.