目的:在爱尔兰早产监测诊所(PSC)的高危无症状妇女的独立队列中,对QUiPPAppv.2算法进行外部验证。
方法:回顾性,单中心,在六个预先确定的临床时间点(怀孕30、34、37周前出生,评估QUiPPAppv.2的辨别和校准的观察性研究,和出生在一个,两周和四周的测试)。通过估计受试者工作特征(ROC)曲线(AUC)下的面积和固定假阳性率为5%的敏感性来评估歧视,10%和20%。评估模型校准以评估预期和观察结果之间的一致性。P值<0.05被认为具有统计学意义。没有对治疗效果进行调整。
结果:分析了2019年至2022年间使用QUiPP的762名妇女和1660名早产监测诊所(PSC)就诊。研究人群包括142名后来经历PTB的患者(18.6%)。QUiPP预测短期结局的表现,如一周内出生(AUC0.866,95%CI0.755-0.955),两周(AUC0.721,95%CI0.569-0.854)和四周(AUC0.775,95%CI0.699-0.842),30周前分娩(AUC0.747,95%CI0.613-0.865)优于其预测长期结局的能力(出生<37周;AUC0.631,95%CI0.596-0.668)。校准通常对低风险结果有利,因为这些患者的预测风险倾向于与观察到的发生率相匹配。然而,在被认为有更大分娩风险的妇女中,预测的概率取代了观察到的PTB发生率。
结论:QUiPP能够准确区分短期有PTB风险的女性。治疗悖论可能会影响高危女性的校准。需要进一步的研究来确定QUiPP治疗阈值是否可以安全地调整接受预防性治疗以预防PTB的女性,以及这是否会改善结果。本文受版权保护。保留所有权利。
OBJECTIVE: To validate externally the QUiPP App v.2 algorithms in an independent cohort of high-risk asymptomatic women attending a preterm birth (PTB) surveillance clinic in Ireland.
METHODS: This was a retrospective, single-center, observational study assessing discrimination and calibration of the QUiPP App v.2 at six predetermined clinical timepoints (PTB at < 30, < 34 and < 37 weeks of pregnancy and PTB within 1, 2 and 4 weeks of testing). Discrimination was assessed by estimating the area under the receiver-operating-characteristics curve (AUC) and sensitivity at fixed false-positive rates of 5%, 10% and 20%. Model calibration was assessed to evaluate the concordance between expected and observed outcomes. P-values < 0.05 were considered statistically significant. No adjustments for treatment effects were made.
RESULTS: Overall, 762 women with 1660 PTB surveillance clinic visits using the QUiPP App v.2 between 2019 and 2022 were analyzed. The study population included 142 (18.6%) patients who later experienced PTB. The QuiPP App\'s performance in the prediction of short-term outcomes, such as birth within 1 week (AUC, 0.866 (95% CI, 0.755-0.955)), 2 weeks (AUC, 0.721 (95% CI, 0.569-0.854)) and 4 weeks (AUC, 0.775 (95% CI, 0.699-0.842)), and delivery at < 30 weeks (AUC, 0.747 (95% CI, 0.613-0.865)), was superior to its ability to predict longer-term outcomes (PTB at < 37 weeks: AUC, 0.631 (95% CI, 0.596-0.668)). Calibration was generally good for low-risk results, as the predicted risk in these patients tended to match the observed incidence. However, in women deemed to be at greater risk of PTB, the predicted probability superseded the observed incidence of PTB.
CONCLUSIONS: The QUiPP App v.2 accurately discriminates women who are at short-term risk of PTB. A \'treatment paradox\' may influence calibration in high-risk women. Further research is needed to ascertain if QuiPP treatment thresholds can be safely adjusted in women receiving prophylactic treatment to prevent PTB, and whether this improves the outcome. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.