IOTA ADNEX模型、两步策略与RMI在丹麦常规妇科诊疗中的评估及实施启示：前瞻性多中心队列研究
该前瞻性多中心队列研究纳入966例附件包块患者，比较IOTA ADNEX模型、两步策略与RMI在常规妇科诊疗中的分诊与转诊表现。结果显示IOTA模型阴性预测值在非三级中心≥96%，优于RMI的95%，但提高转诊率；15%风险阈值在灵敏度约63%与转诊率约14%间取得最佳平衡。
要点
- IOTA模型在非三级中心阴性预测值≥96%，高于RMI的95%。
- 15%阈值下灵敏度约63%、转诊率约14%，为最佳平衡点。
- 25%以上阈值转诊率与RMI相似（约8%），灵敏度提升有限。
核心结论
- 基于IOTA的模型可改善恶性肿瘤早期检出，但增加转诊率。
- 15%风险阈值在早期检出与转诊负担之间提供临床上合理的平衡。
研究设计与样本
- 完整病例队列共966例附件包块患者，参考标准为组织病理学或≥12个月临床随访。
- 使用前瞻性收集的临床数据、超声所见和CA125水平估算恶性风险。
主要发现
- 非三级中心IOTA模型阴性预测值≥96%，RMI为95%；三级中心分别为82%-100%和78%。
- 阳性预测值随阈值升高而增加，在20%阈值时接近RMI。
- 非三级中心15%阈值下灵敏度约63%、转诊率约14%，为最佳平衡。
- 25%及以上阈值转诊率与RMI相似（约8%），灵敏度仅约50%对39%。
- 额外检出的肿瘤多为I期卵巢癌或交界性肿瘤。
关键数值与推荐
- ADNEX/两步策略评估阈值范围1%-30%，RMI阈值≥200。
- 改良良性描述符判为良性的包块，ADNEX阴性预测值高但阳性预测值低、净获益可忽略。
临床怎么用
- 在非三级中心可考虑采用IOTA ADNEX模型或两步策略进行附件包块分诊。
- 15%风险阈值可作为兼顾早期检出与转诊负担的参考阈值。
局限性
- 原文未报告具体局限性内容。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
OBJECTIVE: To evaluate whether the IOTA ADNEX model and the Two-Step Strategy improve triage and referral of adnexal masses in routine gynaecologic care compared with the RMI and to identify an appropriate malignancy-risk threshold. DESIGN: Prospective multicenter cohort study. SETTING: Thirteen non-tertiary hospitals and clinics and one tertiary referral hospital in Denmark. SAMPLE: A complete-case cohort of 966 patients with adnexal masses. METHODS: Malignancy risk was estimated using prospectively collected clinical data, ultrasound findings, and CA125 levels. Reference standard was histopathology or ≥ 12 months of clinical follow-up. Performance was evaluated across predefined thresholds (1%-30% for ADNEX/Two-Step Strategy (modified benign descriptors + ADNEX); ≥ 200 for RMI), stratified by centre type. OUTCOME MEASURES: Negative and positive predictive values (NPV, PPV), sensitivity, referral rates to assess correct and incorrect referrals. RESULTS: In non-tertiary centres, NPVs were ≥ 96% for IOTA models versus 95% for RMI; corresponding values in the tertiary centre were 82%-100% versus 78%. PPVs increased with higher thresholds and approached RMI at 20% threshold. In non-tertiary centres, where referral decisions are made, a 15% threshold provided the most favourable balance between sensitivity (~63%) and referral rate (~14%). At thresholds ≥ 25%, referral rates were similar to RMI (~8%), with only marginal gains in sensitivity (~50% vs. 39%). Most additionally detected tumours were stage I ovarian cancers or borderline tumours. For masses classified as benign by modified benign descriptors, ADNEX showed high NPVs but low PPVs and negligible net benefit, providing limited additional diagnostic value over the Two-Step Strategy. CONCLUSIONS: IOTA-based models improve early detection but increase referral rates. A 15% risk threshold appears to offer a clinically reasonable balance between early detection of malignancy and referral burden, based on observed trade-offs between detection and referral rates. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04188652.
引用
- Karlsen NS, Dreisler E, Høgdall CK, et al. Evaluation of the IOTA ADNEX Model, Two-Step Strategy and RMI in Routine Gynaecologic Care in Denmark and Implications for Implementation: A Prospective Multicenter Cohort Study. BJOG. 2026. PMID: 42036775. doi:10.1111/1471-0528.70253
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。