Sensitivity of the UK clinical practice research datalink to detect neurodevelopmental effects of medicine exposure in utero: comparative analysis of an antiepileptic drug-exposed cohort

Charlton, R. A., McGrogan, A., Snowball, J., Yates, L. M., Wood, A., Clayton-Smith, J., Smithson, W. H., Richardson, J. L., McHugh, N., Thomas, S. H. L., Baker, G. A. and Bromley, R. 2017, Sensitivity of the UK clinical practice research datalink to detect neurodevelopmental effects of medicine exposure in utero: comparative analysis of an antiepileptic drug-exposed cohort, Drug safety, vol. 40, no. 5, pp. 387-397, doi: 10.1007/s40264-017-0506-5.

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Title Sensitivity of the UK clinical practice research datalink to detect neurodevelopmental effects of medicine exposure in utero: comparative analysis of an antiepileptic drug-exposed cohort
Author(s) Charlton, R. A.
McGrogan, A.
Snowball, J.
Yates, L. M.
Wood, A.ORCID iD for Wood, A. orcid.org/0000-0002-1537-6858
Clayton-Smith, J.
Smithson, W. H.
Richardson, J. L.
McHugh, N.
Thomas, S. H. L.
Baker, G. A.
Bromley, R.
Journal name Drug safety
Volume number 40
Issue number 5
Start page 387
End page 397
Total pages 11
Publisher Springer
Place of publication Cham, Switzerland
Publication date 2017-05
ISSN 0114-5916
1179-1942
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Public, Environmental & Occupational Health
Pharmacology & Pharmacy
Toxicology
PRACTICE RESEARCH DATABASE
AUTISM-SPECTRUM
PREGNANCY
PREVALENCE
DISORDERS
EPILEPSY
CHILDREN
RISK
MALFORMATIONS
Summary © 2017, The Author(s). Introduction: Electronic healthcare data have several advantages over prospective observational studies, but the sensitivity of data on neurodevelopmental outcomes and its comparability with data generated through other methodologies is unknown. Objectives: The objectives of this study were to determine whether data from the UK Clinical Practice Research Datalink (CPRD) produces similar risk estimates to a prospective cohort study in relation to the risk of neurodevelopmental disorders (NDDs) following prenatal antiepileptic drug (AED) exposure. Methods: A cohort of mother–child pairs of women with epilepsy (WWE) was identified in the CPRD and matched to a cohort without epilepsy. The study period ran from 1 January 2000 to 31 March 2007 and children were required to be in the CPRD at age 6 years. AED exposure during pregnancy was determined from prescription data and children with an NDD diagnosis by 6 years were identified from Read clinical codes. The prevalence and risk of NDDs was calculated for mother–child pairs in WWE stratified by AED regimen and for those without epilepsy. Comparisons were made with the results of the prospective Liverpool and Manchester Neurodevelopment Group study which completed assessment on 201 WWE and 214 without epilepsy at age 6 years. Results: In the CPRD, 1018 mother–child pairs to WWE and 6048 to women without epilepsy were identified. The CPRD identified a lower prevalence of NDDs than the prospective study. In both studies, NDDs were more frequently reported in children of WWE than women without epilepsy, although the CPRD risk estimate was lower (2.16 vs. 0.96%, p < 0.001 and 7.46 vs. 1.87%, p = 0.0128). NDD prevalence differed across AED regimens but the CPRD data did not replicate the significantly higher risk of NDDs following in utero monotherapy valproate exposure (adjusted odds ratio [ORadj] 2.02, 95% confidence interval [CI] 0.52–7.86) observed in the prospective study (ORadj 6.05, 95% CI 1.65–24.53). Conclusion: It was possible to identify NDDs in the CPRD; however, the CPRD appears to under-record these outcomes. Larger studies are required to investigate further.
Language eng
DOI 10.1007/s40264-017-0506-5
Indigenous content off
Field of Research 1115 Pharmacology and Pharmaceutical Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2017, The Authors
Persistent URL http://hdl.handle.net/10536/DRO/DU:30128634

Document type: Journal Article
Collections: Faculty of Health
School of Psychology
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