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. 2017 Mar 15;2017(3):CD012599. doi: 10.1002/14651858.CD012599

Herman 2002.

Clinical features and settings Routine screening
Participants 531 participants: 23 cases and 508 consecutive controls
Israel ‐ Medical centre
Pregnant women
10‐14 and 16‐19 weeks' gestation
Study design Case‐control
Target condition and reference standard(s) Down's syndrome: 23 cases
Reference standard: karyotyping or follow‐up to birth
Index and comparator tests Maternal age
First trimester NT ()
Second trimester AFP, hCG and uE3 ()
Follow‐up Some cases obtained through follow‐up to birth. No details of follow‐up in controls reported
Aim of study To compare the results of the disclosure and non‐disclosure approaches, using the clinical data of first trimester ultrasound and second trimester serum screening tests among the same groups of normal and trisomy 21‐affected pregnancies
Test characteristics  
Reference standard used  
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