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 |
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Index and comparator tests | Maternal age First trimester PAPP‐A, free ßhCG and NT (details not reported) Risk cut‐point 1:300 |
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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 |