Pajkrt 1998.
Clinical features and settings | Routine screening | |
Participants | 1473 participants The Netherlands tertiary maternity unit June 1994 to March 1997 Pregnant women Mean age 31.4 years (SD 5.7), 24% ≥ 35 years Singleton pregnancies 10‐14 weeks' gestation |
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Study design | Prospective cohort | |
Target condition and reference standard(s) | Down's syndrome: 9 cases Reference standards: prenatal karyotyping offered to patients considered high risk or maternal anxiety (conducted in 24%) or follow‐up to birth |
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Index and comparator tests | Maternal age NT (FMF method, Hitachi machines, 6 sonographers instructed to take 'sufficient time') Risk cut‐point ≥ 3 mm |
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Follow‐up | Follow‐up to outcome assessment in the delivery room. 68 women (4.4%) were excluded from the study due to loss to follow‐up | |
Aim of study | To evaluate the effectiveness of NT measurement in the detection of trisomy 21 in a low‐risk population | |
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 | Unclear | 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 | Yes | Unsuccessful NT measurement in 4.3% |
Withdrawals explained? All tests | No | No details of withdrawals given |