Belics 2011.
| Clinical features and settings | High‐risk referral for invasive testing | |
| Participants | 2032 participants with adequate imaging on ultrasound screening Budapest ‐ single centre January 2003 ‐ February 2010 Pregnant women Mean age 36.4 years (15‐46 years) (Down's syndrome) and 29.8 years (15‐49 years) (no Down's syndrome) 11‐20 weeks' gestation |
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| Study design | Cohort study | |
| Target condition and reference standard(s) | Down's syndrome: 52 cases Reference standards: amniocentesis or CVS (85% of women), or follow‐up to birth |
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| Index and comparator tests | First and second trimester fetal iliac angle (GE Medical System Kretztechnik GmbH & Co OHG, AC2‐5 transabdominal and IC5‐9 transvaginal curved array transducer and Medison Co., LTD EC4‐9ES transvaginal and C3‐7IM transabdominal curved array transducer) Measurement taken from a transverse section of the fetal pelvis Cut‐off angles of 75‐100o |
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| Follow‐up | Followed up to delivery (no cases were detected at birth) | |
| Aim of study | To present results of the sonographic measurement of the fetal iliac angle during the first and second trimesters of pregnancy | |
| Notes | ||
| 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 | Yes | All women received a reference standard |
| Differential verification avoided? All tests | No | Different reference standards used |
| 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 | 95.2% had adequate imaging |
| Withdrawals explained? All tests | No | No details of withdrawals given |