Marsis 2004.
| Clinical features and settings | Screening of patients ≥ 35 years of age | |
| Participants | 262 participants Indonesia ‐ 4 hospitals January 2001 to January 2003 Pregnant women Mean age 37.7 years (35‐43 years) Singleton pregnancies 11‐13 weeks' gestation |
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| Study design | Prospective cohort | |
| Target condition and reference standard(s) | Down's syndrome: 8 cases Reference standards: amniocentesis (unclear in which patients this was conducted) or follow‐up to birth |
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| Index and comparator tests | First trimester NT (all patients) with > 3.0 mm cut‐off (FMF methods, Apoge 800‐ATL, SSD 680‐Aloka, Logic alpha 200 GE, Veluson 730 Pro GE) First trimester nasal bone assessment (97 (55%) patients who also had NT) |
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| Follow‐up | Follow‐up to birth in patients with no nasal bone and NT > 3 mm. Unclear if screen‐negative patients had follow‐up to birth | |
| Aim of study | Evaluation of a non‐invasive method to screen for Down's syndrome at a maternal age of 35 years or more | |
| Notes | No cases of Down’s detected that were not picked up in screening tests | |
| Table of Methodological Quality | ||
| Item | Authors' judgement | Description |
| Representative spectrum? All tests | Yes | Selective testing of high‐risk women as done in practice |
| 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 |