MRI in the diagnosis of fetal developmental brain abnormalities: the MERIDIAN diagnostic accuracy study
Research output: Contribution to journal › Article
Colleges, School and Institutes
- Academic Unit of Radiology; University of Sheffield; Glossop Road Sheffield S10 2JF England
- Clinical Trials Research Unit, School of Health and Related Research; University of Sheffield; S1 4DA
- Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne, UK
- School of Geography, Politics and Sociology, Newcastle University, Newcastle upon Tyne, UK
- Department of Perinatal and Paediatric Neurology, Sheffield Children’s Hospital NHS Foundation Trust, Sheffield, UK
- Centre for Women’s and Newborn Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
- Fetal Medicine Centre, Birmingham Women’s and Children’s NHS Foundation Trust (Birmingham Health Partners), Birmingham, UK
- Newcastle upon Tyne Hospitals NHS Foundation Trust and Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne
- Leeds Teaching Hospitals NHS Trust
- Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Regent Court, Sheffield, S1 4DA
Background: Ultrasonography has been the mainstay of
antenatal screening programmes in the UK for many years. Technical factors and
physical limitations may result in suboptimal images that can lead to incorrect
diagnoses and inaccurate counselling and prognostic information being given to
parents. Previous studies suggest that the addition of in utero magnetic
resonance imaging (iuMRI) may improve diagnostic accuracy for fetal brain
abnormalities. These studies have limitations, including a lack of an outcome
reference diagnosis (ORD), which means that improvements could not be assessed
Objectives: To assess the diagnostic impact, acceptability and cost consequence of iuMRI among fetuses with a suspected fetal brain abnormality.
Design: A pragmatic, prospective, multicentre, cohort study with a health economics analysis and a sociological substudy.
Setting: Sixteen UK fetal medicine centres.
Participants: Pregnant women aged ≥ 16 years carrying a fetus (at least 18 weeks’ gestation) with a suspected brain abnormality detected on ultrasonography.
Interventions: Participants underwent iuMRI and the findings were reported to their referring fetal medicine clinician.
Main outcome measures: Pregnancy outcome was followed up and an ORD from postnatal imaging or postmortem autopsy/imaging collected when available. Developmental data from the Bayley Scales of Infant Development and questionnaires were collected from the surviving infants aged 2–3 years. Data on the management of the pregnancy before and after the iuMRI were collected to inform the economic evaluation. Two surveys collected data on patient acceptability of iuMRI and qualitative interviews with participants and health professionals were undertaken.
Results: The primary analysis consisted of 570 fetuses. The absolute diagnostic accuracies of ultrasonography and iuMRI were 68% and 93%, respectively [a difference of 25%, 95% confidence interval (CI) 21% to 29%]. The difference between ultrasonography and iuMRI increased with gestational age. In the 18–23 weeks group, the figures were 70% for ultrasonography and 92% for iuMRI (difference of 23%, 95% CI 18% to 27%); in the ≥ 24 weeks group, the figures were 65% for ultrasonography and 94% for iuMRI (difference of 29%, 95% CI 23% to 36%). Patient acceptability was high, with at least 95% of respondents stating that they would have iuMRI again in a similar situation. Health professional interviews suggested that iuMRI was acceptable to clinicians and that iuMRI was useful as an adjunct to ultrasonography, but not as a replacement. Across a range of scenarios, iuMRI resulted in additional costs compared with ultrasonography alone. The additional cost was consistently < £600 per patient and the cost per management decision appropriately changed was always < £3000. There is potential for reporting bias from the referring clinicians on the diagnostic and prognostic outcomes. Lower than anticipated follow-up rates at 3 years of age were observed.
Conclusions: iuMRI as an adjunct to ultrasonography significantly improves the diagnostic accuracy and confidence for the detection of fetal brain abnormalities. An evaluation of the use of iuMRI for cases of isolated microcephaly and the diagnosis of fetal spine abnormalities is recommended. Longer-term follow-up studies of children diagnosed with fetal brain abnormalities are required to fully assess the functional significance of the diagnoses.
Trial registration: Current Controlled Trials ISRCTN27626961.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 49. See the NIHR Journals Library website for further project information.
|Pages (from-to)||i-xxviii, 1-144|
|Number of pages||176|
|Journal||Health Technology Assessment|
|Publication status||Published - 1 Sep 2019|