韩国某单家医院临床实践中卵巢恶性肿瘤风险算法的诊断准确性。
Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea.
机构信息
Department of Laboratory Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Obstetrics and Gynecology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
出版信息
Ann Lab Med. 2019 May;39(3):252-262. doi: 10.3343/alm.2019.39.3.252.
BACKGROUND
The risk of ovarian malignancy algorithm (ROMA) is used for assessing ovarian cancer risk in women with a pelvic mass. Its diagnostic accuracy is variable. We investigated whether the clinically acceptable minimal sensitivity of >80.0% could be obtained with the suggested cutoff of 7.4%/25.3% for pre/postmenopausal women and with adjusted cutoffs set to a specificity of ≥75.0% or a sensitivity of 95.0%, in a hospital with a lower ovarian cancer (OC) prevalence than previously reported.
METHODS
ROMA scores were calculated from measurements of human epididymis protein 4 and cancer antigen 125 in blood specimens from 443 patients with a pelvic mass. The ROMA-based risk group was compared against biopsy (N=309) or clinical follow-up with imaging (N=134) results. The ROMA sensitivity and specificity for predicting epithelial OC (EOC) and borderline ovarian tumor (BOT) were calculated for the suggested and adjusted cutoff values.
RESULTS
When targeting BOT and EOC, the prevalence was 7.4% and sensitivity and specificity at the suggested cutoff were 63.6% and 90.7%, respectively. Sensitivity was 81.8% at the 4.65%/13.71% cutoff set to a specificity of 75.0%. When targeting only EOC, the prevalence was 4.1% and sensitivity and specificity at the suggested cutoff were 77.8% and 89.4%, respectively. Sensitivity was 88.9% at the 4.78%/14.35% cutoff set to a specificity of 75.0%.
CONCLUSIONS
The sensitivity of ROMA was lower than expected when using the suggested cutoff. When using the adjusted cutoff, its sensitivity reached 80.0%.
背景
卵巢恶性肿瘤风险算法（ROMA）用于评估盆腔肿块女性的卵巢癌风险。其诊断准确性存在差异。我们研究了在卵巢癌患病率低于以往报道的医院中，是否可以通过设定绝经前/后妇女的建议截断值 7.4%/25.3%和调整截断值以特异性≥75.0%或敏感性 95.0%，获得 >80.0%的临床可接受最小敏感性。
方法
从 443 例盆腔肿块患者的血液标本中测量人附睾蛋白 4 和癌抗原 125 后计算 ROMA 评分。比较 ROMA 风险组与活检（N=309）或影像学临床随访（N=134）结果。计算建议和调整截断值下预测上皮性卵巢癌（EOC）和交界性卵巢肿瘤（BOT）的 ROMA 敏感性和特异性。
结果
当针对 BOT 和 EOC 时，患病率为 7.4%，建议截断值的敏感性和特异性分别为 63.6%和 90.7%。特异性为 75.0%时，4.65%/13.71%截断值的敏感性为 81.8%。当仅针对 EOC 时，患病率为 4.1%，建议截断值的敏感性和特异性分别为 77.8%和 89.4%。特异性为 75.0%时，4.78%/14.35%截断值的敏感性为 88.9%。
结论
使用建议的截断值时，ROMA 的敏感性低于预期。使用调整后的截断值时，其敏感性达到 80.0%。
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