BACKGROUND Polycystic ovary morphology (PCOM) on ultrasonography is considered as a cardinal feature of polycystic ovarian syndrome (PCOS). Its relevance as a diagnostic criterion for PCOS was reaffirmed in the most recent International Evidence-Based Guideline for the Assessment and Management of PCOS. However, there remains a lack of clarity regarding the best practices and specific ultrasonographic markers to define PCOM. OBJECTIVE AND RATIONALE The aim of this systematic review and diagnostic meta-analysis was to assess the diagnostic accuracy of various ultrasonographic features of ovarian morphology in the diagnosis of PCOS. SEARCH METHODS Relevant studies published from 1 January 1990 to 12 June 2023 were identified by a systematic search in PubMed, Web of Science, Scopus, CINAHL, and CENTRAL. Studies that generated diagnostic accuracy measures (e.g. proposed thresholds, sensitivity, specificity) for PCOS using the following ultrasonographic markers met criteria for inclusion: follicle number per ovary (FNPO) or per single cross-section (FNPS), ovarian volume (OV), and stromal features. Studies on pregnant or post-menopausal women were excluded. Risk of bias and applicability assessment for diagnostic test accuracy studies were determined using the QUADAS-2 and QUADAS-C tool for a single index test or between multiple index tests, respectively. Diagnostic meta-analysis was conducted using a bivariate model of pooled sensitivity and specificity, and visualized using forest plots and summary receiver-operating characteristic (SROC) curves. OUTCOMES From a total of 2197 records initially identified, 31 studies were included. Data from five and two studies were excluded from the meta-analysis due to duplicate study populations or limited data for the index test, leaving 24 studies. Pooled results of 20 adult studies consisted of 3883 control participants and 3859 individuals with PCOS. FNPO was the most accurate diagnostic marker (sensitivity: 84%, CI: 81-87%; specificity: 91%, CI: 86-94%; AUC: 0.905) in adult women. OV and FNPS had similar pooled sensitivities (OV: 81%, CI: 76-86%; FNPS: 81%, CI: 70-89%) but inferior pooled specificities (OV: 81%, CI: 75-86%; FNPS: 83%, CI: 75-88%) and AUCs (OV: 0.856; FNPS: 0.870) compared to FNPO. Pooled results from four adolescent studies consisting of 210 control participants and 268 girls with PCOS suggested that OV may be a robust ultrasonographic marker for PCOS diagnosis albeit the current evidence remains limited. The majority of the studies had high risk of bias for the patient selection (e.g. lack of randomized/consecutive patient selection) and index test (e.g. lack of pre-proposed thresholds for comparison) domains across all ultrasonographic markers. As such, diagnostic meta-analysis was unable to determine the most accurate cutoff for ultrasonographic markers to diagnose PCOS. Subgroup analysis suggested that stratification based on previously proposed diagnostic thresholds, age, BMI, or technology did not account for the heterogeneity in diagnostic accuracy observed across the studies. Studies that diagnosed PCOS using the Rotterdam criteria had improved sensitivity for FNPO. Studies from North America had lower diagnostic accuracy when compared to Asian studies (FNPO: sensitivity) and European studies (OV: specificity, diagnostic odds ratio and positive likelihood ratio). Geographic differences in diagnostic accuracy may potentially be due to differences in age, BMI, and diagnostic criteria of the PCOS group across regions. WIDER IMPLICATIONS This diagnostic meta-analysis supports the use of FNPO as the gold standard in the ultrasonographic diagnosis of PCOS in adult women. OV and FNPS provide alternatives if total antral follicle counts cannot be accurately obtained. Our findings support the potential for ultrasonographic evidence of PCOM in adolescents as more data becomes available. Subgroup analysis suggests the need to investigate any relative contributions of geographical differences on PCOS phenotypes. These findings may provide the basis for the development of strategies and best practices toward a standardized definition of PCOM and a more accurate ultrasonographic evaluation of PCOS.

中文翻译：

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诊断多囊卵巢综合征的超声标准：系统评价和诊断荟萃分析。


背景 超声检查上的多囊卵巢形态学 （PCOM） 被认为是多囊卵巢综合征 （PCOS） 的主要特征。它作为 PCOS 诊断标准的相关性在最新的 PCOS 评估和管理国际循证指南中得到重申。然而，关于定义 PCOM 的最佳实践和特定超声标志物仍然缺乏明确性。客观和基本原理 本系统评价和诊断荟萃分析的目的是评估卵巢形态的各种超声特征在 PCOS 诊断中的诊断准确性。检索方法 通过在 PubMed、Web of Science、Scopus、CINAHL 和 CENTRAL 中系统检索确定 1990 年 1 月 1 日至 2023 年 6 月 12 日发表的相关研究。使用以下超声标志物生成 PCOS 诊断准确性指标（例如建议的阈值、敏感性、特异性）的研究符合纳入标准：每个卵巢的卵泡数 （FNPO） 或每个单横截面 （FNPS）、卵巢体积 （OV） 和基质特征。排除了对孕妇或绝经后妇女的研究。使用 QUADAS-2 和 QUADAS-C 工具分别针对单个指标测试或多个指标测试确定诊断测试准确性研究的偏倚风险和适用性评估。使用合并敏感性和特异性的双变量模型进行诊断荟萃分析，并使用森林图和汇总受试者工作特征 （SROC） 曲线进行可视化。结果 从最初确定的总共 2197 条记录中，共纳入 31 项研究。 由于研究人群重复或指标测试数据有限，来自 5 项研究和 2 项研究的数据被排除在 meta 分析之外，剩下 24 项研究。20 项成人研究的汇总结果包括 3883 名对照参与者和 3859 名 PCOS 患者。FNPO 是最准确的诊断标志物 （敏感性： 84%， CI： 81-87%;特异性： 91%， CI： 86-94%;AUC：0.905）。OV 和 FNPS 具有相似的汇总敏感性 （OV： 81%，CI： 76-86%;FNPS：81%，CI：70-89%），但总体特异性较差（OV：81%，CI：75-86%;FNPS：83%，CI：75-88%）和 AUC （OV： 0.856;FNPS： 0.870）与 FNPO 相比。由 210 名对照参与者和 268 名 PCOS 女孩组成的四项青少年研究的汇总结果表明，OV 可能是 PCOS 诊断的强有力超声标志物，尽管目前的证据仍然有限。大多数研究在所有超声标志物的患者选择（例如缺乏随机/连续患者选择）和指标测试（例如缺乏预先建议的比较阈值）领域存在高偏倚风险。因此，诊断性荟萃分析无法确定超声标志物诊断 PCOS 的最准确临界值。亚组分析表明，基于先前提出的诊断阈值、年龄、BMI 或技术的分层并未解释在研究中观察到的诊断准确性的异质性。使用 Rotterdam 标准诊断 PCOS 的研究提高了对 FNPO 的敏感性。与亚洲研究 （FNPO： 敏感性） 和欧洲研究 （OV： 特异性、诊断比值比和阳性似然比） 相比，北美研究的诊断准确性较低。 诊断准确性的地理差异可能是由于不同地区 PCOS 组的年龄、BMI 和诊断标准存在差异。更广泛的意义 本诊断性荟萃分析支持使用 FNPO 作为成年女性 PCOS 超声诊断的金标准。如果无法准确获得总窦卵泡计数，OV 和 FNPS 提供了替代方案。随着更多数据的获得，我们的研究结果支持青少年 PCOM 超声证据的可能性。亚组分析表明需要调查地理差异对 PCOS 表型的任何相对贡献。这些发现可能为制定策略和最佳实践提供基础，以实现 PCOM 的标准化定义和更准确的 PCOS 超声评估。