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

O'Callaghan 2000.

Clinical features and settings Routine screening
Participants 1000 participants
Australia ‐ public and private sector venues
September 1997 to September 1999
Pregnant women
Singleton or multifetal pregnancies (2000 fetuses including 25 sets of dichorionic twins, 7 sets of monochorionic twins and 4 sets of triplets but the numbers amongst the 1000 fetuses reported in the paper were not stated)
Median age 32 years
11‐14 weeks' gestation
Study design Prospective cohort
Target condition and reference standard(s) Down’s syndrome: 8 cases
Reference standards: CVS, amniocentesis, neonatal karyotyping or follow‐up to birth
Index and comparator tests Maternal age
NT (FMF methods)
Follow‐up Follow‐up from cytogenetics laboratory records but the completeness of follow‐up is not reported
Aim of study To evaluate a risk assessment tool based on first trimester NT
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 Unclear Unclear if all women had a reference standard
Differential verification avoided? 
 All tests Unclear Unclear if the 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