BACKGROUND: The aim of this study was to assess and compare the performance of different ultrasound-based International Ovarian Tumor Analysis (IOTA) strategies and subjective assessment for the diagnosis of early stage ovarian malignancy. METHODS: This is a secondary analysis of a prospective multicenter cross-sectional diagnostic accuracy study that included 1653 patients recruited at 18 centers from 2009 to 2012. All patients underwent standardized transvaginal ultrasonography by experienced ultrasound investigators. We assessed test performance of the IOTA Simple Rules (SRs), Simple Rules Risk (SRR), the Assessment of Different NEoplasias in the adneXa (ADNEX) model and subjective assessment to discriminate between stage I-II ovarian cancer and benign disease. Reference standard was histology after surgery. RESULTS: 230 (13.9%) patients proved to have stage I-II primary invasive ovarian malignancy, and 1423 (86.1%) had benign disease. Sensitivity and specificity with respect to malignancy (95% confidence intervals) of the original SRs (classifying all inconclusive cases as malignant) were 94.3% (90.6% to 96.7%) and 73.4% (71.0% to 75.6%). Subjective assessment had a sensitivity and specificity of 90.0% (85.4% to 93.2%) and 86.7% (84.9% to 88.4%), respectively. The areas under the receiver operator characteristic curves of SRR and ADNEX were 0.917 (0.902 to 0.933) and 0.905 (0.920 to 0.934), respectively. At a 1% risk cut-off, sensitivity and specificity for SRR were 100% (98.4% to 100%) and 38.0% (35.5% to 40.6%), and for ADNEX were 100% (98.4% to 100%) and 19.4% (17.4% to 21.5%). At a 30% risk cut-off, sensitivity and specificity for SRR were 88.3% (83.5% to 91.8%) and 81.1% (79% to 83%), and for ADNEX were 84.5% (80.5% to 89.6%) and 84.5% (82.6% to 86.3%). CONCLUSION: This study shows that all three IOTA strategies have good ability to discriminate between stage I-II ovarian malignancy and benign disease.

Department of Development and Regeneration KU Leuven Leuven post code3000 Belgium

Department of Obstetrics and Gynecology S Orsola Malpighi Hospital University of Bologna Bologna 40138 Italy

Department of Obstetrics and Gynecology Skåne University Hospital Malmö Lund University Malmö 20502 Sweden

Department of Obstetrics and Gynecology University Hospitals Leuven Leuven 3000 Belgium

Department of Oncology Catholic University of the Sacred Heart Rome 00168 Italy

Gynecological Oncology Center Department of Obstetrics and Gynecology Charles University Prague 12108 Czech Republic

Preventive Gynecology Unit Division of Gynecology European Institute of Oncology Milan 20141 Italy

Queen Charlotte's and Chelsea Hospital Imperial College London W12 0HS UK

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