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

Pajkrt 1998.

Clinical features and settings Routine screening
Participants 1473 participants
The Netherlands tertiary maternity unit
June 1994 to March 1997
Pregnant women
Mean age 31.4 years (SD 5.7), 24% ≥ 35 years
Singleton pregnancies
10‐14 weeks' gestation
Study design Prospective cohort
Target condition and reference standard(s) Down's syndrome: 9 cases
Reference standards: prenatal karyotyping offered to patients considered high risk or maternal anxiety (conducted in 24%) or follow‐up to birth
Index and comparator tests Maternal age
NT (FMF method, Hitachi machines, 6 sonographers instructed to take 'sufficient time')
Risk cut‐point ≥ 3 mm
Follow‐up Follow‐up to outcome assessment in the delivery room. 68 women (4.4%) were excluded from the study due to loss to follow‐up
Aim of study To evaluate the effectiveness of NT measurement in the detection of trisomy 21 in a low‐risk population
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 Unclear 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 Unsuccessful NT measurement in 4.3%
Withdrawals explained? 
 All tests No No details of withdrawals given