Huang 2010.
| Clinical features and settings | Routine screening | |
| Participants | 7118 participants undergoing combined first trimester screening and a fetal abnormality scan Taiwan ‐ single hospital January 2004 ‐ December 2007 Pregnant women Median maternal age 30 years (range 15‐47 years) 8‐13 weeks' gestation |
|
| Study design | Cohort study | |
| Target condition and reference standard(s) | Down's syndrome: 25 cases Reference standards: karyotyping or follow‐up to birth |
|
| Index and comparator tests | Maternal age First trimester NT (11‐13 weeks' gestation) (FMF accredited obstetricians) First trimester free ßhCG and PAPP‐A (8‐12 weeks' gestation) (time resolved amplified cryptate emission, automated Kryptor Analyser, Brahms) Combined cut‐point 1:300 Second trimester fetal abnormality scan (18‐22 weeks' gestation) for intracardiac echogenic focus (ICEF) (In accordance with the American Institute of Ultrasound in Medicine Practice Guideline) |
|
| Follow‐up | All neonates examined postnatally and Hospital records reviewed | |
| Aim of study | To determine the relation between intracardiac echogenic focus and trisomy 21 in a population of fetuses previously evaluated by first trimester combined 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 | 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 |