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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

Listed:
  • 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
    Newcastle University)

  • A. Wood

    (Aston University)

  • J. Clayton-Smith

    (Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre
    University of Manchester)

  • 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
    Newcastle University)

  • G. A. Baker

    (University of Liverpool)

  • R. Bromley

    (University of Manchester
    Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre)

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

Suggested Citation

  • 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 & R. Bromley, 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, Springer, vol. 40(5), pages 387-397, May.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:5:d:10.1007_s40264-017-0506-5
    DOI: 10.1007/s40264-017-0506-5
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    Cited by:

    1. Alana Cavadino & Lovisa Sandberg & Inger Öhman & Tomas Bergvall & Kristina Star & Helen Dolk & Maria Loane & Marie-Claude Addor & Ingeborg Barisic & Clara Cavero-Carbonell & Ester Garne & Miriam Gatt , 2021. "Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference," Drug Safety, Springer, vol. 44(7), pages 765-785, July.
    2. Jonathan L. Richardson & Alan Moore & Rebecca L. Bromley & Michael Stellfeld & Yvonne Geissbühler & Matthew Bluett-Duncan & Ursula Winterfeld & Guillaume Favre & Amalia Alexe & Alison M. Oliver & Yrea, 2023. "Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project," Drug Safety, Springer, vol. 46(5), pages 479-491, May.

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