■对外部验证ADNEX(附件中不同肿瘤形成的评估)模型以诊断卵巢癌的研究进行系统评价,并对其性能进行荟萃分析。
■外部验证研究的系统评价和荟萃分析。
■Medline,Embase,WebofScience,Scopus,和欧洲PMC,2014年10月15日至2023年5月15日。
■ADNEX性能的所有外部验证研究,任何研究设计和任何附件肿块患者的研究人群。两个独立的审阅者提取了数据。分歧通过讨论解决。根据TRIPOD(个体预后或诊断的多变量预测模型的透明报告)报告指南对研究的报告质量进行评分,以及使用PROBAST(预测模型风险偏差评估工具)的方法学行为和偏差风险。受试者工作特征曲线下面积(AUC)的随机效应荟萃分析,10%恶性肿瘤风险阈值的敏感性和特异性,在10%的恶性肿瘤风险阈值下进行净获益和相对效用。
■包括47项研究(17007例肿瘤),研究样本量中位数为261(范围24-4905)。平均而言,报告了61%的TRIPOD项目。处理丢失的数据,样本量的合理性,和模型校准很少描述。91%的验证存在高偏倚风险,主要是因为无法解释的排除了不完整的案例,小样本量,或没有校准评估。在接受手术的患者中,ADNEX与血清生物标志物区分良性和恶性肿瘤的汇总AUC为0.93(95%置信区间0.92至0.94,95%预测区间0.85至0.98)。癌抗原125(CA125),作为预测因子(9202个肿瘤,43个中心,18个国家,和21项研究)和0.93(95%置信区间0.91至0.94,95%预测区间0.85至0.98)的ADNEX没有CA125(6309肿瘤,31个中心,13个国家,和12项研究)。该模型在新中心临床使用的估计概率为95%(使用CA125)和91%(不使用CA125)。当将分析限制在低偏倚风险的研究时,总结AUC值分别为0.93(有CA125)和0.91(无CA125),模型在临床上使用的估计概率为89%(有CA125)和87%(无CA125).
■荟萃分析的结果表明,ADNEX在区分来自不同国家和地区的人群中的良性和恶性肿瘤方面表现良好,无论血清生物标志物,CA125被用作预测因子。一个关键的限制是很少评估校准。
■PROSPEROCRD42022373182。
UNASSIGNED: To conduct a systematic
review of studies externally validating the ADNEX (Assessment of Different Neoplasias in the adnexa) model for diagnosis of ovarian cancer and to present a meta-analysis of its performance.
UNASSIGNED: Systematic
review and meta-analysis of external validation studies.
UNASSIGNED: Medline, Embase, Web of Science, Scopus, and Europe PMC, from 15 October 2014 to 15 May 2023.
UNASSIGNED: All external validation studies of the performance of ADNEX, with any study design and any study population of patients with an adnexal mass. Two independent reviewers extracted the data. Disagreements were resolved by discussion. Reporting quality of the studies was scored with the TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) reporting guideline, and methodological conduct and risk of bias with PROBAST (Prediction model Risk Of Bias Assessment Tool). Random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity and specificity at the 10% risk of malignancy threshold, and net benefit and relative utility at the 10% risk of malignancy threshold were performed.
UNASSIGNED: 47 studies (17 007 tumours) were included, with a median study sample size of 261 (range 24-4905). On average, 61% of TRIPOD items were reported. Handling of missing data, justification of sample size, and model calibration were rarely described. 91% of validations were at high risk of bias, mainly because of the unexplained exclusion of incomplete cases, small sample size, or no assessment of calibration. The summary AUC to distinguish benign from malignant tumours in patients who underwent surgery was 0.93 (95% confidence interval 0.92 to 0.94, 95% prediction interval 0.85 to 0.98) for ADNEX with the serum biomarker, cancer antigen 125 (CA125), as a predictor (9202 tumours, 43 centres, 18 countries, and 21 studies) and 0.93 (95% confidence interval 0.91 to 0.94, 95% prediction interval 0.85 to 0.98) for ADNEX without CA125 (6309 tumours, 31 centres, 13 countries, and 12 studies). The estimated probability that the model has use clinically in a new centre was 95% (with CA125) and 91% (without CA125). When restricting analysis to studies with a low risk of bias, summary AUC values were 0.93 (with CA125) and 0.91 (without CA125), and estimated probabilities that the model has use clinically were 89% (with CA125) and 87% (without CA125).
UNASSIGNED: The results of the meta-analysis indicated that ADNEX performed well in distinguishing between benign and malignant tumours in populations from different countries and settings, regardless of whether the serum biomarker, CA125, was used as a predictor. A key limitation was that calibration was rarely assessed.
UNASSIGNED: PROSPERO CRD42022373182.