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- Title
Applicability of first-trimester combined screening for fetal trisomy 21 in a resource-limited setting in mainland China.
- Authors
Li, B; Sahota, DS; Lao, TT; Xu, J; Hu, SQ; Zhang, L; Liu, QY; Sun, Q; Tang, D; Ma, RM
- Abstract
<bold>Objective: </bold>To assess the feasibility and performance of the first-trimester combined screening test for trisomy 21 in a resource-limited setting in mainland China.<bold>Design: </bold>Prospective observational cohort study.<bold>Setting: </bold>First Affiliated Hospital of Kunming Medical University, China.<bold>Population: </bold>Ten thousand four hundred and forty-two pregnant women requesting first-trimester screening.<bold>Methods: </bold>The combined screening test was performed from May 2012 to December 2014. Women with a high-risk result (≥1:600) were offered further confirmatory tests after counselling. The threshold for high risk was determined by Monte Carlo simulation to achieve a 5% false-positive rate according to the local age distribution. Pregnancy outcome and screening results were recorded for all women and monthly audits were conducted.<bold>Main Outcome Measures: </bold>Sensitivity, screen positive rate, cost per case of Down syndrome detected.<bold>Results: </bold>Six hundred and ten women (5.8% of the total screened) had a high-risk screening test, of whom 274 (44.9%) underwent a diagnostic test and 169 (27.7%) opted for a noninvasive prenatal screening test (NIPT); 160 (26.2%) declined further testing after counselling. The pregnancy outcome was available for 10 174 (97.4%) of the women. The observed incidence of Down syndrome was 0.13% (1/750). All 14 women with a trisomy 21 pregnancy had a high-risk screening test result. The cost per Down syndrome detected was RMB596 686 compared with RMB1.79 million if all had been screened by NIPT.<bold>Conclusions: </bold>The combined screening test appears to be a more cost-effective strategy in mainland China. Screening performance in China would be improved by adopting Chinese-specific models, external quality control and assurance, and establishing risk thresholds appropriate for the age distribution of the population.<bold>Tweetable Abstract: </bold>Combined first-trimester Downs screening in China was improved by adopting Chinese-specific models and external QC.
- Subjects
CHINA; TRISOMY; COST effectiveness; DOWN syndrome; PRENATAL diagnosis; DIAGNOSIS of Down syndrome; ULTRASONIC imaging; MEDICAL care use; CHORIONIC gonadotropins; FETAL ultrasonic imaging; LONGITUDINAL method; MATERNAL age; EVALUATION of medical care; PREGNANCY; FIRST trimester of pregnancy; PREGNANCY proteins; PILOT projects; ECONOMICS
- Publication
BJOG: An International Journal of Obstetrics & Gynaecology, 2016, Vol 123, p23
- ISSN
1470-0328
- Publication type
journal article
- DOI
10.1111/1471-0528.14004