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使用M4预测模型或英国国家卫生与临床优化研究所（NICE）算法管理异位妊娠：一项包含横断面诊断准确性数据的随机对照试验

Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data.

作者信息

Fistouris Johan, Garbergs Helen, Bergman Katja, Bergh Christina, Strandell Annika

机构信息

Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Region Västra Götaland, Department of Gynecology and Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.

出版信息

BJOG. 2025 May;132(6):742-751. doi: 10.1111/1471-0528.18079. Epub 2025 Jan 22.

DOI:10.1111/1471-0528.18079
PMID:39840550
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11969908/
Abstract

OBJECTIVE

To determine the diagnostic performance and clinical utility of the M4 prediction model and the NICE algorithm managing women with pregnancy of unknown location (PUL).

DESIGN

The study has a superiority design regarding specificity for non-ectopic pregnancy for M4, given that the primary outcome of sensitivity for ectopic pregnancy (EP) is non-inferior in comparison with the NICE algorithm.

SETTING

Emergency gynaecology units in Sweden.

POPULATION

595 women with PUL.

METHODS

Participants were randomised (1:1) to M4 or the NICE algorithm after two serum human chorionic (hCG) levels and were categorised as high or low risk of having an EP. The diagnostic performance was evaluated on cross-sectional data and utility by parallel groups.

MAIN OUTCOME MEASURES

The proportion of EP categorised as high risk (sensitivity) and non-ectopic pregnancies categorised as low risk (specificity). Clinical outcomes were assessed.

RESULTS

The sensitivity for EP was 79% (115 of 146) for M4 versus 85% (124 of 146) for the NICE algorithm, p = 0.1496 and the specificity for non-ectopic pregnancies was 67% (300 of 449) for M4 and 74% (334 of 449) for the NICE algorithm, p = 0.0003. Clinical outcomes were similar between groups.

CONCLUSIONS

The sensitivity for EP by M4 was non-inferior to NICE, but specificity was better for the NICE algorithm. No between group differences were observed for clinical outcomes.

TRIAL REGISTRATION

NCT03461835, https://www.

CLINICALTRIALS

gov.

摘要

目的

确定M4预测模型和英国国家卫生与临床优化研究所（NICE）算法对不明部位妊娠（PUL）女性的诊断性能及临床效用。

设计

鉴于M4对非异位妊娠的特异性的主要结果与NICE算法相比在异位妊娠敏感性方面非劣效，该研究采用优效性设计。

地点

瑞典的急诊妇科病房。

研究对象

595例PUL女性。

方法

在检测两次血清人绒毛膜促性腺激素（hCG）水平后，将参与者随机（1:1）分为M4组或NICE算法组，并分为异位妊娠高风险或低风险。通过横断面数据评估诊断性能，并通过平行组评估效用。

主要观察指标

分类为高风险的异位妊娠比例（敏感性）和分类为低风险的非异位妊娠比例（特异性）。评估临床结局。

结果

M4对异位妊娠的敏感性为79%（146例中的115例），而NICE算法为85%（146例中的124例），p = 0.1496；M4对非异位妊娠的特异性为67%（449例中的300例），NICE算法为74%（449例中的334例），p = 0.0003。两组间临床结局相似。

结论

M4对异位妊娠的敏感性不劣于NICE，但NICE算法的特异性更好。两组间未观察到临床结局差异。

试验注册

NCT03461835，https://www.clinicaltrials.gov 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a07/11969908/07c7e24ea357/BJO-132-742-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a07/11969908/07c7e24ea357/BJO-132-742-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a07/11969908/07c7e24ea357/BJO-132-742-g001.jpg

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Development of a single-visit protocol for the management of pregnancy of unknown location following in vitro fertilization: a retrospective study.单次就诊方案在体外受精后不明位置妊娠管理中的应用：一项回顾性研究。
Hum Reprod. 2024 Mar 1;39(3):509-515. doi: 10.1093/humrep/deae002.
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Evaluation of clinical prediction models (part 1): from development to external validation.
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Impact of Variation between Assays and Reference Intervals in the Diagnosis of Endocrine Disorders.检测方法与参考区间的差异对内分泌疾病诊断的影响
Diagnostics (Basel). 2023 Nov 16;13(22):3453. doi: 10.3390/diagnostics13223453.
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A core outcome set for future research in ectopic pregnancy: an international consensus development study.未来异位妊娠研究的核心结局集：一项国际共识发展研究。
Fertil Steril. 2023 May;119(5):804-812. doi: 10.1016/j.fertnstert.2023.01.042. Epub 2023 Feb 1.
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