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

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