BJOG : an international journal of obstetrics and gynaecology · 2020
External validation of models to predict the outcome of pregnancies of unknown location: a multicentre cohort study.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Christodoulou E, Bobdiwala S, Kyriacou C, Farren J, Mitchell-Jones N, Ayim F, Chohan B, Abughazza O, Guruwadahyarhalli B, Al-Memar M, Guha S, Vathanan V, Gould D, Stalder C, Wynants L, Timmerman D, Bourne T, Van Calster B
Аннотация
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 ≤2 nmol/l; the remaining cases returned 2 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 (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.
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 2 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 (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.