External validation of models to predict the outcome of pregnancies of unknown location: a multicentre cohort study.
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Author(s)
Christodoulou, Evangelia
Bobdiwala, Shabnam
Kyriacou, Christopher
Farren, Jessica
Mitchell-Jones, Nicola
Type
Journal Article
Abstract
OBJECTIVE: To externally validate five approaches to predict ectopic pregnancy (EP) in pregnancies of unknown location (PUL): the M6P and M6NP risk models, the two-step triage strategy (2ST, which incorporates M6P), the M4 risk model, and beta human chorionic gonadotropin ratio cut-offs (BhCG-RC). DESIGN: Secondary analysis of a prospective cohort study. SETTING: Eight UK early pregnancy assessment units. POPULATION: Women presenting with a PUL and BhCG >25 IU/L. METHODS: Women were managed using the 2ST protocol: PUL were classified as low risk of EP if presenting progesterone ≤2 nmol/L; the remaining cases returned two days later for triage based on M6P. EP risk ≥5% was used to classify PUL as high risk. Missing values were imputed, and predictions for the five approaches were calculated post hoc. We meta-analysed centre-specific results. MAIN OUTCOME MEASURES: Discrimination, calibration and clinical utility (decision curve analysis) for predicting EP. RESULTS: Of 2899 eligible women, the primary analysis excluded 297 (1 0%) women who were lost to follow-up. The area under the ROC curve for EP was 0.89 (95% confidence interval 0.86-0.91) for M6P, 0.88 (0.86-0.90) for 2ST, 0.86 (0.83-0.88) for M6NP, and 0.82 (0.78-0.85) for M4. Sensitivities for EP were 96% (M6P), 94% (2ST), 92% (N6NP), 80% (M4), and 58% (BhCG-RC); false positive rates were 35%, 33%, 39%, 24%, and 13%. M6P and 2ST had the best clinical utility and good overall calibration, with modest variability between centres. CONCLUSIONS: 2ST and M6P performed best to predict and triage PUL.
Date Issued
2021-02
Date Acceptance
2020-08-28
Citation
BJOG: an International Journal of Obstetrics and Gynaecology, 2021, 128 (3), pp.552-562
ISSN
1470-0328
Publisher
Wiley
Start Page
552
End Page
562
Journal / Book Title
BJOG: an International Journal of Obstetrics and Gynaecology
Volume
128
Issue
3
Copyright Statement
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Sponsor
Imperial Health Charity
Genesis Research Trust
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/32931087
Grant Number
Grant Reference: 151649
0118 / GEN 101
Subjects
Pregnancy of unknown location
beta human chorionic gonadotrophin (BhCG) ratio
ectopic pregnancy
prediction model
prediction model validation
progesterone
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2020-09-15