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

Rodrigues 2009.

Clinical features and settings Routine screening
Participants 3299 participants: 2290 undergoing integrated and 1009 undergoing serum integrated screening
Portugal ‐ screening programme
March 2003 ‐ August 2007
Pregnant women
Median maternal age: integrated screening 30.6 years, serum integrated screening 30.9 years
First and second trimester
Study design Retrospective cohort
Target condition and reference standard(s) Down's syndrome: 14 cases (integrated screening 8, serum integrated screening 6)
Reference standards: karyotyping or follow‐up to birth
Index and comparator tests Maternal age
First trimester NT (details not reported)
First trimester PAPP‐A and second trimester free ßhCG and AFP (TRACE technology, Brahms Kryptor Systems)
Risk cut‐point 1:300 for integrated and serum integrated screening
Follow‐up Detail of follow‐up not reported
Aim of study To report an audit of an integrated and serum integrated screening programme
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 Unclear Unclear if 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