METHODS: Between January and December 2021, all women with an hCG measurement from the gynaecological emergency department of a teaching hospital were screened for inclusion in this study. Women with a pregnancy location determined before or at the second visit were excluded. The diagnostic test was based on logistic regression of the M6NP model, with classification into two groups: high risk of EP (≥5%) and low risk of EP (<5%). The reference test was the final outcome based on clinical, biological and sonographic results: failed PUL (FPUL), intrauterine pregnancy (IUP) or EP. Diagnostic performance for risk prediction of EP, and also IUP and FPUL, was calculated.
RESULTS: In total, 759 women with possible PUL were identified. After screening, 341 women with PUL were included in the main analysis. Of these, 186 (54.5%) were classified as low risk, including three (1.6%) with a final outcome of EP. The remaining 155 women with PUL were classified as high risk, of whom 60 (38.7%), 66 (42.8%) and 29 (18.7%) had a final outcome of FPUL, IUP and EP, respectively. Of the 32 women with PUL with a final outcome of EP, 29 (90.6%) were classified as high risk and three (9.4%) were classified as low risk. Therefore, the performance of the M6NP model to predict EP had a negative predictive value of 98.4%, a positive predictive value of 18.7%, sensitivity of 90.6% and specificity of 59.2%. If the prediction model had been used, it is estimated that 4.5 visits per patient could have been prevented.
CONCLUSIONS: The M6NP model could be used safely in the French population for risk stratification of PUL. Its use in clinical practice should result in a substantial reduction in the number of visits to a gynaecological emergency room.
方法:在2021年1月至12月之间,对来自教学医院妇科急诊科的所有进行hCG测量的女性进行了筛查,以纳入本研究。排除在第二次访视之前或在第二次访视时确定妊娠位置的妇女。诊断检验基于M6NP模型的逻辑回归,分为两组:EP高风险(≥5%)和EP低风险(<5%)。参考测试是基于临床的最终结果,生物学和超声检查结果:失败的PUL(FPUL),宫内妊娠(IUP)或EP。EP风险预测的诊断性能,还有IUP和FPUL,已计算。
结果:总计,确定了759名可能患有PUL的妇女。筛选后,341名患有PUL的女性被纳入主要分析。其中,186(54.5%)被归类为低风险,包括三个(1.6%),最终结果为EP。其余155名患有PUL的女性被归类为高风险,其中60人(38.7%),66(42.8%)和29(18.7%)的最终结果为FPUL,IUP和EP,分别。在32名患有PUL且最终结果为EP的女性中,29人(90.6%)被归类为高风险,3人(9.4%)被归类为低风险。因此,M6NP模型预测EP的表现为98.4%的负预测值,阳性预测值为18.7%,敏感性为90.6%,特异性为59.2%。如果使用了预测模型,据估计,每位患者可避免4.5次就诊.
结论:M6NP模型可安全地用于法国人群的PUL危险分层。它在临床实践中的使用应大大减少妇科急诊室的就诊次数。