TY - JOUR
T1 - External validation of models to predict the outcome of pregnancies of unknown location
T2 - a multicentre cohort study
AU - Christodoulou, E.
AU - Bobdiwala, S.
AU - Kyriacou, C.
AU - Farren, J.
AU - Mitchell-Jones, N.
AU - Ayim, F.
AU - Chohan, B.
AU - Abughazza, O.
AU - Guruwadahyarhalli, B.
AU - Al-Memar, M.
AU - Guha, S.
AU - Vathanan, V.
AU - Gould, D.
AU - Stalder, C.
AU - Wynants, L.
AU - Timmerman, D.
AU - Bourne, T.
AU - Van Calster, B.
N1 - Funding Information:
EC, BVC and DT are supported by Research Foundation – Flanders (FWO) grant G0B4716N and Internal Funds KU Leuven grant C24/15/037. SB is supported by NIHR CLAHRC NWL (Collaboration for Leadership in Applied Health Research & Care, NorthWest London, grant RDIP033). TB is supported by the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. DT is Fundamental Clinical Researcher of FWO. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funders had no role in study design, data collection, analysis and interpretation or reporting.
Funding Information:
BVC reports grants from Research Foundation – Flanders (FWO) and Internal Funds KU Leuven for the submitted work. TB reports grants, personal fees and non‐financial support from Samsung Medison, non‐financial support from Roche Diagnostics, non‐financial support from Abbott Diagnostics, all outside the submitted work. The remaining authors have no disclosures. Completed disclosure of interest forms are available to view online as Supporting Information.
Publisher Copyright:
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd
PY - 2021/2
Y1 - 2021/2
N2 - Objective To validate externally 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 = 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 (10%) women who were lost to follow up. The area under the ROC curve for EP was 0.89 (95% CI 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 for prediction and triage in PUL. Tweetable abstract The M6 model, as part of a two-step triage strategy, is the best approach to characterise and triage PULs.
AB - Objective To validate externally 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 = 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 (10%) women who were lost to follow up. The area under the ROC curve for EP was 0.89 (95% CI 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 for prediction and triage in PUL. Tweetable abstract The M6 model, as part of a two-step triage strategy, is the best approach to characterise and triage PULs.
KW - Beta human chorionic gonadotrophin ratio
KW - ectopic pregnancy
KW - prediction model
KW - prediction model validation
KW - pregnancy of unknown location
KW - progesterone
KW - SERUM PROGESTERONE
KW - ECTOPIC PREGNANCY
KW - MANAGEMENT
KW - HCG
KW - WOMEN
U2 - 10.1111/1471-0528.16497
DO - 10.1111/1471-0528.16497
M3 - Article
C2 - 32931087
SN - 1470-0328
VL - 128
SP - 552
EP - 562
JO - Bjog-an International Journal of Obstetrics and Gynaecology
JF - Bjog-an International Journal of Obstetrics and Gynaecology
IS - 3
ER -