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 |
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Study design | Cohort | |
Target condition and reference standard(s) | Down's syndrome: 264 cases Reference standards: karyotyping or follow‐up to birth |
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Index and comparator tests | Maternal age First trimester NT First trimester PAPP‐A and free ßhCG (Kryptor system, Brahms AG) |
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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 |