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

Brameld 2008.

Clinical features and settings Routine screening
Participants 22,280 participants with complete screening results and outcome data
August 2001 ‐ October 2003
Australia ‐ State‐wide screening programme evaluation
Pregnant women
Median maternal age 31 years (range 14‐47 years), 20% ≥ 35
Singleton pregnancies
10‐14 weeks' gestation
Study design Retrospective cohort
Target condition and reference standard(s) Down's syndrome: 60 cases
Reference standards: karyotyping or follow‐up to birth
Index and comparator tests Maternal age
First trimester PAPP‐A, free ßhCG and NT (details not reported)
Risk cut‐point 1:300
Follow‐up Data on outcome from the Western Australia Midwives data collection, Birth Defects Registry and hospital morbidity and mortality data
Aim of study To identify first trimester indicators of adverse pregnancy outcomes
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