Crossley 2002.
Clinical features and settings | Routine screening | |
Participants | 17,229 participants UK ‐ 15 centres Dates not specified Pregnant women Median age 29.9 years, 15.4% ≥ 35 years 10‐14 weeks' gestation |
|
Study design | Prospective cohort | |
Target condition and reference standard(s) | Down’s syndrome: 45 cases Reference standards: CVS (offered where women had high NT measurements), amniocentesis or follow‐up to birth |
|
Index and comparator tests | Maternal age NT (FMF method) in 73% of patients Clotted blood samples tested for: Free ßhCG and PAPP‐A (Kryptor analyser) in 98.4% of patients |
|
Follow‐up | Reported that the outcome of all pregnancies was followed up | |
Aim of study | To evaluate the use of NT measurement in combination with biochemical markers as a first trimester test for Down's syndrome in routine antenatal setting | |
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 | Yes | Report average success rate of NT (72.9%) |
Withdrawals explained? All tests | Yes | Numbers of patients not undergoing NT and biochemical testing given |