Johan Fistouris, Helen Garbergs, Katja Bergman, Christina Bergh, Annika Strandell
{"title":"使用M4预测模型或NICE算法管理未知位置的妊娠：一项具有横断面诊断准确性数据的随机对照试验","authors":"Johan Fistouris, Helen Garbergs, Katja Bergman, Christina Bergh, Annika Strandell","doi":"10.1111/1471-0528.18079","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>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).</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Setting</h3>\n \n <p>Emergency gynaecology units in Sweden.</p>\n </section>\n \n <section>\n \n <h3> Population</h3>\n \n <p>595 women with PUL.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Main Outcome Measures</h3>\n \n <p>The proportion of EP categorised as high risk (sensitivity) and non-ectopic pregnancies categorised as low risk (specificity). Clinical outcomes were assessed.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The sensitivity for EP was 79% (115 of 146) for M4 versus 85% (124 of 146) for the NICE algorithm, <i>p</i> = 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, <i>p</i> = 0.0003. Clinical outcomes were similar between groups.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>NCT 03461835, https://www.clinicaltrials.gov\n </p>\n </section>\n </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 6","pages":"742-751"},"PeriodicalIF":4.7000,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18079","citationCount":"0","resultStr":"{\"title\":\"Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data\",\"authors\":\"Johan Fistouris, Helen Garbergs, Katja Bergman, Christina Bergh, Annika Strandell\",\"doi\":\"10.1111/1471-0528.18079\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>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).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Design</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Setting</h3>\\n \\n <p>Emergency gynaecology units in Sweden.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Population</h3>\\n \\n <p>595 women with PUL.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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. 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Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data
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.
期刊介绍：
BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.
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