在澳大利亚人群中对风险预测模型 M4 的外部验证：合理管理位置不明的妊娠。

External validation of risk prediction model M4 in an Australian population: Rationalising the management of pregnancies of unknown location.

机构信息

Acute Gynaecology, Early Pregnancy and Advanced Endoscopic Surgery Unit, Nepean Hospital, Nepean Clinical School University of Sydney, Sydney, New South Wales, Australia.

Department of Obstetrics and Gynaecology, Liverpool Hospital, Sydney, New South Wales, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2020 Dec;60(6):928-934. doi: 10.1111/ajo.13201. Epub 2020 Jun 15.

DOI:10.1111/ajo.13201

PMID:32538482

Abstract

BACKGROUND

The prediction model M4 can successfully classify pregnancy of unknown location (PUL) into a low- or high-risk group in developing ectopic pregnancy. M4 was validated in UK centres but in very few other countries outside UK.

AIM

To validate the M4 model's ability to correctly classify PULs in a cohort of Australian women.

MATERIALS AND METHODS

A retrospective analysis of women classified with PUL, attending a Sydney-based teaching hospital between 2006 and 2018. The reference standard was the final characterisation of PUL: failed PUL (FPUL) or intrauterine pregnancy (IUP; low risk) vs ectopic pregnancy (EP) or persistent PUL (PPUL; high risk). Each patient was entered into the M4 model calculator and an estimated risk of FPUL/IUP or EP/PPUL was recorded. Diagnostic accuracy of the M4 model was evaluated.

RESULTS

Of 9077 consecutive women who underwent transvaginal sonography, 713 (7.9%) classified with a PUL. Six hundred and seventy-seven (95.0%) had complete study data and were included. Final outcomes were: 422 (62.3%) FPULs, 150 (22.2%) IUPs, 105 (15.5%) EPs and PPULs. The M4 model classified 455 (67.2%) as low-risk PULs of which 434 (95.4%) were FPULs/IUPs and 21 (4.6%) were EPs or PPULs. EPs/PPULs were correctly classified with sensitivity of 80.0% (95% CI 71.1-86.5%), specificity of 75.9% (95% CI 72.2-79.3%), positive predictive value of 37.8% (95% CI 33.8-42.1%) and negative predictive value of 95.3% (95% CI 93.1-96.9%).

CONCLUSIONS

We have externally validated the prediction model M4. It classified 67.2% of PULs as low risk, of which 95.4% were later characterised as FPULs or IUPs while still classifying 80.0% of EPs as high risk.

摘要

背景

M4 预测模型能够成功地将不明位置妊娠（PUL）分为低风险或高风险组，以预测是否会发生宫外孕。该模型在英国中心得到验证，但在英国以外的其他国家很少得到验证。

目的

验证 M4 模型在澳大利亚女性人群中正确分类 PUL 的能力。

材料与方法

对 2006 年至 2018 年间在悉尼一家教学医院就诊的 PUL 患者进行回顾性分析。参考标准为 PUL 的最终特征：未破裂 PUL（FPUL）或宫内妊娠（IUP；低风险）与宫外孕（EP）或持续性 PUL（PPUL；高风险）。每位患者均输入 M4 模型计算器，记录 FPUL/IUP 或 EP/PPUL 的风险估计值。评估 M4 模型的诊断准确性。

结果

在 9077 例连续接受经阴道超声检查的患者中，713 例（7.9%）被诊断为 PUL。其中 677 例（95.0%）具有完整的研究数据，纳入本研究。最终结局为：422 例（62.3%）FPUL，150 例（22.2%）IUP，105 例（15.5%）EP 和 PPUL。M4 模型将 455 例（67.2%）患者分类为低风险 PUL，其中 434 例（95.4%）为 FPUL/IUP，21 例（4.6%）为 EP 或 PPUL。M4 模型对 EP/PPUL 的分类具有 80.0%（95%CI 71.1-86.5%）的敏感性、75.9%（95%CI 72.2-79.3%）的特异性、37.8%（95%CI 33.8-42.1%）的阳性预测值和 95.3%（95%CI 93.1-96.9%）的阴性预测值。