Jaques 2010 FTS.
| Clinical features and settings | Routine screening | |
| Participants | 38,584 participants Australia ‐ State screening programme 2003 ‐ 2004 Pregnant women Maternal age ≥ 37 years in 16.3% of women First and second trimester |
|
| Study design | Retrospective cohort | |
| Target condition and reference standard(s) | Down's syndrome: 110 cases Reference standards: karyotyping (CVS = 774, amniocentesis =1644) or follow‐up to birth |
|
| Index and comparator tests | Maternal age First trimester NT, PAPP‐A and free ßhCG (n = 38,584) (details not reported) |
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| Follow‐up | Probabilistic record linkage was used to link health records from the Prenatal Screening Database, prenatal diagnostic data from cytogenetic laboratories, the Victoria Birth Register (Perinatal Data collection Unit) and the Victoria Birth Defects Register | |
| Aim of study | To map prenatal screening and diagnostic testing pathways in Victorian pregnant women during 2003‐2004; measure the impact of prenatal diagnostic testing uptake on the effectiveness of prenatal screening for Down's syndrome; and assess factors influencing uptake of diagnostic testing following screening | |
| 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 | Yes | Invalid results obtained for 7.4% of first and 0.1% of second trimester screenings |
| Withdrawals explained? All tests | Yes | 48% of pregnant women in the state did not undergo prenatal testing |