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The primary aim of the IOTA5 study is to describe the cumulative incidence of complications during follow\u2010up of adnexal masses classified as benign on ultrasound examination. Consecutive patients with an adnexal mass detected between June 2012 and September 2016 in a private center offering screening for gynecological cancer were included and followed up until February 2020. Tumors were classified as benign or malignant based on histology (if patients underwent surgery) or the outcome of clinical and ultrasound  follow\u2010up at 12 (range, 10\u201314)\u2009months. Multiple imputation was used when outcomes were uncertain. The ability of the ADNEX model without CA125 and of the IOTA two\u2010step strategy to distinguish benign from malignant masses was evaluated retrospectively using the prospectively collected data. We assessed performance with regard to discrimination (area under the receiver\u2010operating\u2010characteristics curve (AUC)), calibration, classification (sensitivity and specificity) and clinical utility (Net Benefit). In the group of patients with a mass judged to be benign who were selected for conservative management, we evaluated the occurrence of spontaneous resolution or any mass complication during the first 5\u2009years of follow\u2010up by assessing the cumulative incidence of malignancy, torsion, cyst rupture and minor mass complications (inflammation, infection or adhesions) and the time to occurrence of an event.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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. Of those, 1684 (83%) masses were benign, 49 (2%) masses were malignant and, for 306 (15%) masses, the outcome was uncertain and therefore imputed. The AUC was 0.95 (95%\u2009CI, 0.89\u20130.98) for ADNEX without CA125 and 0.94 (95%\u2009CI, 0.88\u20130.97) for the two\u2010step strategy. Calibration performance could not be meaningfully interpreted because the small number of malignancies resulted in very wide confidence intervals. The two\u2010step strategy had better clinical utility than did the ADNEX model at malignancy risk thresholds &lt;\u20093%. There were 1472 (72%) patients whose mass was judged to be benign based on pattern recognition by an experienced ultrasound examiner and were managed with clinical and ultrasound  follow\u2010up. In this group, the 5\u2010year cumulative incidence was 66% (95%\u2009CI, 63\u201369%) for spontaneous resolution of the mass, 0% (95%\u2009CI, 0\u20130.2%) for torsion, 0.1% (95%\u2009CI, &lt;\u20090.1\u20130.4%) for cyst rupture, 0.2% (95%\u2009CI, 0.1\u20130.6%) for a borderline tumor and 0.2% (95%\u2009CI, 0.1\u20130.6%) for invasive malignancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The ADNEX model and IOTA two\u2010step strategy performed well to distinguish benign from malignant adnexal masses detected in a low\u2010risk population. Conservative management is safe for masses with a benign ultrasound  appearance in this population. \u00a9 2024 International Society of Ultrasound in Obstetrics and Gynecology.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/uog.27642","type":"journal-article","created":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T05:19:11Z","timestamp":1710307151000},"page":"395-404","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Validation of\n                    <scp>ADNEX<\/scp>\n                    and\n                    <scp>IOTA<\/scp>\n                    two\u2010step strategy and estimation of risk of complications during follow\u2010up of adnexal masses in low\u2010risk population"],"prefix":"10.1002","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5095-6981","authenticated-orcid":false,"given":"M. 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