Nunes N, Ambler G, Foo X, Naftalin J, Widschwendter M, Jurkovic D
Gynaecological Diagnostic Outpatient Treatment Unit, University College Hospital, London, UK.
Ultrasound Obstet Gynecol. 2014 Nov;44(5):503-14. doi: 10.1002/uog.13437. Epub 2014 Oct 13.
To present data on prospective evaluation of the International Ovarian Tumor Analysis (IOTA) 'simple-rules' tool for the diagnosis of ovarian cancer and to perform a meta-analysis of studies that utilized the same diagnostic method.
In the present study a level-II ultrasound operator systematically assessed the tumors of women with an ultrasound diagnosis of adnexal tumor(s) according to the IOTA simple-rules protocol to determine the risk of the tumor being malignant. The results of simple rules were compared with the 'pattern recognition' method and with histological findings. This validation study was included in the subsequent meta-analysis, for which we searched MEDLINE, EMBASE and Cochrane from the publication of the first study in 2008. The terms used were 'simple rules', 'simple rules ovarian', 'ovar tumor' and 'ultrasound'. Quality assessment was performed using the modified Quality Assessment of the Diagnostic Accuracy of Studies (QUADAS-2) checklist. Random effects meta-analysis was used to calculate pooled estimates of sensitivity and specificity for the simple-rules tool, and meta-regression was used to investigate heterogeneity across the studies.
Three hundred and three women were included in the validation study with 168 (55.4%) benign, 19 (6.3%) borderline and 116 (38.3%) malignant tumors on histological examination. The rules were applicable in 237 (78.2%) of the tumors and for these tumors, sensitivity was 96.2% (95% CI, 90.5-99.0%) and specificity was 88.6% (95% CI, 82.0-93.5%). Six of the 88 discovered studies were included in the meta-analysis along with the current validation study, which resulted in inclusion of a total of 3568 patients. When the meta-analysis was performed the pooled sensitivity (when the rules were applicable) was 93% (95% CI, 90-96%) (I(2) = 32.1%) and the pooled specificity was 95% (95% CI, 93-97%) (I(2) = 78.1%). Heterogeneity was observed across the studies. Sensitivity was higher and specificity lower in the study populations in which the prevalence of malignant tumors was greatest.
The simple rules protocol could be used in 76-89% of tumors and is an accurate test for the diagnosis of ovarian cancer. Assessment by an ultrasound expert is required when the protocol cannot be applied.
呈现关于国际卵巢肿瘤分析（IOTA）“简易规则”工具用于卵巢癌诊断的前瞻性评估数据，并对使用相同诊断方法的研究进行荟萃分析。
在本研究中，一名II级超声操作员根据IOTA简易规则方案系统地评估超声诊断为附件肿瘤的女性的肿瘤，以确定肿瘤为恶性的风险。将简易规则的结果与“模式识别”方法及组织学结果进行比较。这项验证研究被纳入后续的荟萃分析，为此我们检索了MEDLINE、EMBASE和Cochrane数据库，检索时间从2008年第一项研究发表起。使用的检索词为“简易规则”“卵巢简易规则”“卵巢肿瘤”和“超声”。使用改良的诊断准确性研究质量评估（QUADAS - 2）清单进行质量评估。采用随机效应荟萃分析计算简易规则工具的敏感性和特异性的合并估计值，并使用荟萃回归研究各研究间的异质性。
验证研究纳入了303名女性，组织学检查发现168例（55.4%）为良性肿瘤，19例（6.3%）为交界性肿瘤，116例（38.3%）为恶性肿瘤。这些规则适用于237例（78.2%）肿瘤，对于这些肿瘤，敏感性为96.2%（95%可信区间，90.5 - 99.0%），特异性为88.6%（95%可信区间，82.0 - 93.5%）。在检索到的88项研究中，6项与当前的验证研究一起纳入荟萃分析，共纳入3568例患者。进行荟萃分析时，合并敏感性（规则适用时）为93%（95%可信区间，90 - 96%）（I² = 32.1%），合并特异性为95%（95%可信区间，93 - 97%）（I² = 78.1%）。各研究间存在异质性。在恶性肿瘤患病率最高的研究人群中，敏感性较高而特异性较低。
简易规则方案可应用于76 - 89%的肿瘤，是诊断卵巢癌的一种准确检测方法。当该方案无法应用时，需要由超声专家进行评估。
