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

R. A. Charlton (), A. McGrogan, J. Snowball, L. M. Yates, A. Wood, J. Clayton-Smith, W. H. Smithson, J. L. Richardson, N. McHugh, S. H. L. Thomas, G. A. Baker and R. Bromley
Additional contact information
R. A. Charlton: University of Bath
A. McGrogan: University of Bath
J. Snowball: University of Bath
L. M. Yates: Newcastle upon Tyne Hospitals NHS Foundation Trust
A. Wood: Aston University
J. Clayton-Smith: Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre
W. H. Smithson: University College Cork
J. L. Richardson: Newcastle upon Tyne Hospitals NHS Foundation Trust
N. McHugh: University of Bath
S. H. L. Thomas: Newcastle upon Tyne Hospitals NHS Foundation Trust
G. A. Baker: University of Liverpool
R. Bromley: University of Manchester

Drug Safety, 2017, vol. 40, issue 5, No 4, 387-397

Abstract: Abstract 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

Keywords: Autistic Spectrum Disorder; Valproate; Neurodevelopmental Outcome; Read Code; Clinical Practice Research Datalink (search for similar items in EconPapers)
Date: 2017
References: View complete reference list from CitEc
Citations: View citations in EconPapers (3)

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DOI: 10.1007/s40264-017-0506-5

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