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. 2017 Mar 15;2017(3):CD012600. doi: 10.1002/14651858.CD012600

Wright 2008.

Clinical features and settings Routine screening
Participants 37,488 participants with complete outcome data
UK ‐ single centre
July 1999 ‐ July 2005
Pregnant women
Singleton pregnancies
Median maternal age 35.2 years (16‐52 years)
11‐13 weeks' gestation
Study design Cohort
Target condition and reference standard(s) Down's syndrome: 264 cases
Reference standards: karyotyping or follow‐up to birth
Index and comparator tests Maternal age
First trimester NT
First trimester PAPP‐A and free ßhCG (Kryptor system, Brahms AG)
Follow‐up Maternal characteristics and test results were recorded in a computer database and karyotype results and details on pregnancy outcomes added as they became available. Women without complete outcome data (n = 1231, 3.2%) were excluded from the study
Aim of study To examine the validity of methods used to derive patient‐specific risks form NT measurements
Notes  
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Routine screening of typical pregnant population
Acceptable reference standard? 
 All tests Yes Karyotyping or follow‐up to birth
Partial verification avoided? 
 All tests Yes All women received a reference standard
Differential verification avoided? 
 All tests No Choice of reference standard depended on index test results
Incorporation avoided? 
 All tests Yes Reference standard was independent of the index test
Reference standard results blinded? 
 All tests No Reference standard interpreted with knowledge of index test results
Index test results blinded? 
 All tests Yes Index test interpreted without knowledge of reference standard results
Relevant clinical information? 
 All tests Yes Information available as would be in standard clinical practice
Uninterpretable results reported? 
 All tests No No details given for test failures/uninterpretable measurements
Withdrawals explained? 
 All tests No No details of withdrawals given