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

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dc.contributor.authorCharlton, R. A.
dc.contributor.authorMcGrogan, A.
dc.contributor.authorSnowball, J.
dc.contributor.authorYates, L. M.
dc.contributor.authorWood, A.
dc.contributor.authorClayton-Smith, J.
dc.contributor.authorSmithson, W. Henry
dc.contributor.authorRichardson, J. L.
dc.contributor.authorMcHugh, N.
dc.contributor.authorThomas, S. H. L.
dc.contributor.authorBaker, G. A.
dc.contributor.authorBromley, Rebecca
dc.contributor.funderEpilepsy Research UK
dc.contributor.funderNational Institute for Health Research
dc.date.accessioned2018-06-15T11:47:05Z
dc.date.available2018-06-15T11:47:05Z
dc.date.issued2017
dc.description.abstractIntroduction 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.en
dc.description.sponsorshipEpilepsy Research UK (P1403); National Institute for Health Research (PDF-2013-06-041)en
dc.description.statusPeer reviewed
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationCharlton, 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, 40(5), pp. 387-397. doi: 10.1007/s40264-017-0506-5en
dc.identifier.doi10.1007/s40264-017-0506-5
dc.identifier.endpage397
dc.identifier.issn0114-5916
dc.identifier.issued5
dc.identifier.journaltitleDrug Safetyen
dc.identifier.startpage387
dc.identifier.urihttps://hdl.handle.net/10468/6311
dc.identifier.volume40
dc.language.isoenen
dc.publisherSpringer International Publishing AGen
dc.relation.urihttps://link.springer.com/article/10.1007%2Fs40264-017-0506-5
dc.rights© 2017, the Authors. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectPractice research databaseen
dc.subjectAutism-spectrumen
dc.subjectPregnancyen
dc.subjectPrevalenceen
dc.subjectDisordersen
dc.subjectEpilepsyen
dc.subjectChildrenen
dc.subjectRisken
dc.subjectMalformationsen
dc.titleSensitivity of the UK clinical practice research datalink to detect neurodevelopmental effects of medicine exposure in utero: comparative analysis of an antiepileptic drug-exposed cohorten
dc.typeArticle (peer-reviewed)en
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