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MRI in the diagnosis of fetal developmental brain abnormalities: the MERIDIAN diagnostic accuracy study

Published on Sep 1, 2019in Health Technology Assessment3.819
· DOI :10.3310/hta23490
Paul D. Griffiths79
Estimated H-index: 79
(University of Sheffield),
Mike Bradburn35
Estimated H-index: 35
(University of Sheffield)
+ 13 AuthorsAllan Wailoo30
Estimated H-index: 30
(University of Sheffield)
Abstract
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 accurately. 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.
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  • Citations (1)
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References77
Newest
#1Ruth BattyH-Index: 9
#2Mary L. Gawne-Cain (University Hospital Southampton NHS Foundation Trust)H-Index: 4
Last. Paul D. Griffiths (University of Sheffield)H-Index: 79
view all 7 authors...
Objectives In utero magnetic resonance (iuMR) imaging to diagnose foetal brain abnormalities has been established and is supported by meta-analyses of retrospective and prospective studies. In this paper we describe and classify the iuMR errors made in the largest diagnostic accuracy study to date (MERIDIAN). We also correlate the error rates and types with the prior experience of the reporting radiologists in order to inform how to provide a national programme with the best diagnostic accuracy ...
3 CitationsSource
#1Paul D. Griffiths (University of Sheffield)H-Index: 79
#2Karen Brackley (University Hospital Southampton NHS Foundation Trust)H-Index: 6
Last. G. Mason (Leeds Teaching Hospitals NHS Trust)H-Index: 9
view all 11 authors...
OBJECTIVE: To assess the diagnostic and clinical contribution of in utero magnetic resonance (iuMR) imaging in fetuses diagnosed with abnormalities of the posterior fossa as the only intracranial abnormality recognised on antenatal ultrasonography (USS). METHODS: We report a sub-group analysis of fetuses with abnormalities of the posterior fossa diagnosed on antenatal USS (with or without ventriculomegaly) from the MERIDIAN cohort who had iuMR imaging within 2 weeks of USS and outcome reference ...
8 CitationsSource
#1Paul D. Griffiths (University of Sheffield)H-Index: 79
#2Karen Brackley (University Hospital Southampton NHS Foundation Trust)H-Index: 6
Last. G. Mason (Leeds Teaching Hospitals NHS Trust)H-Index: 9
view all 12 authors...
ObjectiveTo assess the contribution of in utero magnetic resonance (iuMR) imaging in fetuses diagnosed with either agenesis of the corpus callosum or hypogenesis of the corpus callosum (grouped as failed commissuration) on antenatal ultrasonography (USS) from the MERIDIAN cohort.MethodsWe report a sub-group analysis of fetuses with failed commissuration diagnosed on USS (with or without ventriculomegaly) from the MERIDIAN study who had iuMR imaging within 2 weeks of USS and outcome reference dat...
6 CitationsSource
#1Paul D. Griffiths (University of Sheffield)H-Index: 79
#2Karen Brackley (University Hospital Southampton NHS Foundation Trust)H-Index: 6
Last. G. Mason (Leeds Teaching Hospitals NHS Trust)H-Index: 9
view all 12 authors...
Objective To assess the contribution of fetal magnetic resonance imaging (MRI) in fetuses of the MERIDIAN cohort diagnosed with ventriculomegaly (VM) as the only abnormal intracranial finding on antenatal ultrasound. Methods This was a subgroup analysis of the MERIDIAN study of fetuses with only VM diagnosed on ultrasound in women who had a subsequent MRI examination within 2 weeks and for whom outcome reference data were available. The diagnostic accuracy of ultrasound and MRI was reported in r...
12 CitationsSource
#1Deborah Jarvis (University of Sheffield)H-Index: 6
#2Cara Mooney (University of Sheffield)H-Index: 6
Last. Paul D. Griffiths (University of Sheffield)H-Index: 79
view all 7 authors...
Objectives This systematic review was undertaken to define the diagnostic performance of in utero MR (iuMR) imaging when attempting to confirm, exclude or provide additional information compared with the information provided by prenatal ultrasound scans (USS) when there is a suspicion of foetal brain abnormality.
11 CitationsSource
#1Paul D. Griffiths (University of Sheffield)H-Index: 79
#2Mike Bradburn (University of Sheffield)H-Index: 35
Last. Allan Wailoo (University of Sheffield)H-Index: 30
view all 11 authors...
Summary Background In-utero MRI (iuMRI) has shown promise as an adjunct to ultrasound but the comparative diagnostic performance has been poorly defined. We aimed to assess whether the diagnostic accuracy and confidence of the prenatal diagnosis of fetal brain abnormalities is improved with iuMRI and assess the clinical impact and patient acceptability of iuMRI. Methods We did a multicentre, prospective, cohort study in the UK, at 16 fetal medicine centres, of pregnant women aged 16 years or old...
54 CitationsSource
#1Kate Reed (University of Sheffield)H-Index: 7
#2Inna Kochetkova (University of Leeds)H-Index: 2
Last. Elspeth H. Whitby (University of Sheffield)H-Index: 21
view all 3 authors...
Prenatal screening occupies a prominent role within sociological debates on medical uncertainty. A particular issue concerns the limitations of routine screening which tends to be based on risk prediction. Computer assisted visual technologies such as Magnetic Resonance Imaging (MRI) are now starting to be applied to the prenatal realm to assist in the diagnosis of a range of fetal and maternal disorders (from problems with the fetal brain to the placenta). MRI is often perceived in popular and ...
5 CitationsSource
#1Kate Reed (University of Sheffield)H-Index: 7
#2Inna Kochetkova (University of Leeds)H-Index: 2
Last. Susan Molyneux-Hodgson (University of Sheffield)H-Index: 7
view all 3 authors...
Magnetic resonance imaging (MRI) was first introduced into clinical practice during the 1980s. Originally used as a diagnostic tool to take pictures of the brain, spine, and joints, it is now used to visualise a range of organs and soft tissue around the body. Developments in clinical applications of the technology are rapid and it is often viewed as the 'gold standard' in many areas of medicine. However, most existing sociological work on MRI tends to focus on the profession of radiology, littl...
6 CitationsSource
AbstractPurpose: To evaluate the additional diagnostic value of fetal Magnetic Resonance Imaging (MRI) in fetuses with suspected brain abnormalities identified with advanced neurosonography (NS).Methods: A systematic literature search was performed for studies reporting on a comparison between diagnosis with NS and MRI, in fetuses suspected for brain abnormalities. Abnormalities detected on NS were compared with those detected on MRI as well as with postnatal imaging findings to assess the added...
20 CitationsSource
#1P. M. M. Bossuyt (UvA: University of Amsterdam)H-Index: 110
#2Johannes B. Reitsma (UU: Utrecht University)H-Index: 53
Last. Jérémie F. Cohen (Paris V: Paris Descartes University)H-Index: 15
view all 17 authors...
Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every ...
621 CitationsSource
Cited By1
Newest
#1Elizabeth Snyder (Monroe Carell Jr. Children's Hospital at Vanderbilt)
Source
#1Anthony R Hart (Boston Children's Hospital)H-Index: 11
#2Nicholas D. Embleton (RVI: Royal Victoria Infirmary)H-Index: 32
Last. Paul D. Griffiths (Royal Hallamshire Hospital)H-Index: 79
view all 7 authors...
Summary Background In utero MRI (iuMRI) detects fetal brain abnormalities more accurately than ultrasonography and provides additional clinical information in around half of pregnancies. We aimed to study whether postnatal neuroimaging after age 6 months changes the diagnostic accuracy of iuMRI and its ability to predict developmental outcome. Methods Families enrolled in the MERIDIAN study whose child survived to age 3 years were invited to have a case note review and assessment of developmenta...
1 CitationsSource