Froyman Wouter, Wynants Laure, Landolfo Chiara, Bourne Tom, Valentin Lil, Testa Antonia, Sladkevicius Povilas, Franchi Dorella, Fischerova Daniela, Savelli Luca, Van Calster Ben, Timmerman Dirk
Department of Development and Regeneration, KU Leuven, Leuven post code3000, Belgium.
Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven 3000, Belgium.
Diagnostics (Basel). 2017 Jun 2;7(2):32. doi: 10.3390/diagnostics7020032.
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.
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.
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%).
This study shows that all three IOTA strategies have good ability to discriminate between stage I-II ovarian malignancy and benign disease.
本研究的目的是评估和比较不同的基于超声的国际卵巢肿瘤分析（IOTA）策略以及主观评估对早期卵巢恶性肿瘤的诊断性能。
这是一项对前瞻性多中心横断面诊断准确性研究的二次分析，该研究纳入了2009年至2012年在18个中心招募的1653例患者。所有患者均由经验丰富的超声检查人员进行标准化经阴道超声检查。我们评估了IOTA简单规则（SRs）、简单规则风险（SRR）、附件不同肿瘤评估（ADNEX）模型以及主观评估在鉴别I-II期卵巢癌和良性疾病方面的测试性能。参考标准为术后组织学检查。
230例（13.9%）患者被证实患有I-II期原发性侵袭性卵巢恶性肿瘤，1423例（86.1%）患有良性疾病。原始SRs（将所有不确定病例分类为恶性）对恶性肿瘤的敏感性和特异性（95%置信区间）分别为94.3%（90.6%至96.7%）和73.4%（71.0%至75.6%）。主观评估的敏感性和特异性分别为90.0%（85.4%至93.2%）和86.7%（84.9%至88.4%）。SRR和ADNEX的受试者工作特征曲线下面积分别为0.917（0.902至0.933）和0.905（0.920至0.934）。在1%的风险临界值时 SRR的敏感性和特异性分别为100%（98.4%至100%）和38.0%（35.5%至40.6%），ADNEX的敏感性和特异性分别为100%（98.4%至100%）和19.4%（17.4%至21.5%）。在30%的风险临界值时，SRR的敏感性和特异性分别为88.3%（83.5%至91.8%）和81.1%（79%至83%），ADNEX的敏感性和特异性分别为84.5%（80.5%至89.6%）和84.5%（82.6%至86.3%）。
本研究表明，所有三种IOTA策略在鉴别I-II期卵巢恶性肿瘤和良性疾病方面均具有良好的能力。
