An inventory of European data sources to support pharmacoepidemiologic research on neurodevelopmental outcomes in children following medication exposure in pregnancy: A contribution from the ConcePTION project.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2022
2022
Historique:
received:
25
10
2021
accepted:
27
09
2022
entrez:
14
10
2022
pubmed:
15
10
2022
medline:
19
10
2022
Statut:
epublish
Résumé
Studies on medication safety in pregnancy are increasingly focusing on child neurodevelopmental outcomes. Establishing neurodevelopmental safety is complex due to the range of neurodevelopmental outcomes and the length of follow-up needed for accurate assessment. The aim of this study was to provide an inventory of European data sources for use in pharmacoepidemiologic studies investigating neurodevelopment following maternal medication exposure. The EUROmediSAFE inventory of data sources in Europe for evaluating perinatal and long-term childhood risks associated with in-utero exposure to medication was updated by contacting colleagues across 31 European countries, literature review and internet searches. Included data sources must record at least one neurodevelopmental outcome and maternal medication use in pregnancy must be available, either in the data source itself or through linkage with another data source. Information on the domain of neurodevelopment, measure/scale used and the approach to measurement were recorded for each data source. Ninety data sources were identified across 14 countries. The majority (63.3%) were created for health surveillance and research with the remaining serving administrative purposes (21.1% healthcare databases,15.6% other administrative databases). Five domains of neurodevelopment were identified-infant development (36 data sources,13 countries), child behaviour (27 data sources, 10 countries), cognition (29 data sources, 12 countries), educational achievement (20 data sources, 7 countries), and diagnostic codes for neurodevelopmental disorders (42 data sources, 11 countries). Thirty-nine data sources, in 12 countries, had information on more than one domain of neurodevelopment. This inventory is invaluable to future studies planning to investigate the neurodevelopmental impact of medication exposures during pregnancy. Caution must be used when combining varied approaches to neurodevelopment outcome measurement, the age of children in the data source, and the sensitivity and specificity of the outcome measure selected should be borne in mind.
Sections du résumé
BACKGROUND
Studies on medication safety in pregnancy are increasingly focusing on child neurodevelopmental outcomes. Establishing neurodevelopmental safety is complex due to the range of neurodevelopmental outcomes and the length of follow-up needed for accurate assessment. The aim of this study was to provide an inventory of European data sources for use in pharmacoepidemiologic studies investigating neurodevelopment following maternal medication exposure.
METHOD
The EUROmediSAFE inventory of data sources in Europe for evaluating perinatal and long-term childhood risks associated with in-utero exposure to medication was updated by contacting colleagues across 31 European countries, literature review and internet searches. Included data sources must record at least one neurodevelopmental outcome and maternal medication use in pregnancy must be available, either in the data source itself or through linkage with another data source. Information on the domain of neurodevelopment, measure/scale used and the approach to measurement were recorded for each data source.
RESULTS
Ninety data sources were identified across 14 countries. The majority (63.3%) were created for health surveillance and research with the remaining serving administrative purposes (21.1% healthcare databases,15.6% other administrative databases). Five domains of neurodevelopment were identified-infant development (36 data sources,13 countries), child behaviour (27 data sources, 10 countries), cognition (29 data sources, 12 countries), educational achievement (20 data sources, 7 countries), and diagnostic codes for neurodevelopmental disorders (42 data sources, 11 countries). Thirty-nine data sources, in 12 countries, had information on more than one domain of neurodevelopment.
CONCLUSION
This inventory is invaluable to future studies planning to investigate the neurodevelopmental impact of medication exposures during pregnancy. Caution must be used when combining varied approaches to neurodevelopment outcome measurement, the age of children in the data source, and the sensitivity and specificity of the outcome measure selected should be borne in mind.
Identifiants
pubmed: 36240253
doi: 10.1371/journal.pone.0275979
pii: PONE-D-21-33083
pmc: PMC9565459
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0275979Déclaration de conflit d'intérêts
I have read the journal’s policy and the authors of this manuscript have the following competing interests: Florence Coste is a Sanofi employee. Sandra Lopez is a Novartis employee. This work was conducted following the ENCePP Code of Conduct http://www.encepp.eu/code_of_conduct/documents/ENCePPCodeofConduct.pdf
Références
CNS Spectr. 2014 Aug;19(4):305-15
pubmed: 24571806
PLoS One. 2021 Aug 27;16(8):e0256535
pubmed: 34449798
JAMA Pediatr. 2017 Jun 1;171(6):555-563
pubmed: 28418571
J Clin Psychiatry. 2017 Jan;78(1):e48-e58
pubmed: 28129495
Res Dev Disabil. 2011 Mar-Apr;32(2):419-36
pubmed: 21236634
Eur Child Adolesc Psychiatry. 2013 Oct;22(10):605-18
pubmed: 23508655
PLoS One. 2019 Jul 11;14(7):e0219778
pubmed: 31295318
Dev Neuropsychol. 2001;20(1):385-406
pubmed: 11827095
Neurosci Biobehav Rev. 2015 Feb;49:82-9
pubmed: 25498856
JAMA Netw Open. 2019 Jan 4;2(1):e186606
pubmed: 30646190
Soc Psychiatry Psychiatr Epidemiol. 2012 Mar;47(3):395-8
pubmed: 21293843
Am J Psychiatry. 2003 May;160(5):993-6
pubmed: 12727706
Reprod Toxicol. 2016 Oct;65:170-178
pubmed: 27474253
BJOG. 2006 May;113(5):559-68
pubmed: 16637899
Neuroreport. 1999 Sep 9;10(13):2817-21
pubmed: 10511446
Ann Agric Environ Med. 2010;17(1):153-7
pubmed: 20684493
Am J Med Genet C Semin Med Genet. 2011 Aug 15;157C(3):175-82
pubmed: 21766440
J Am Acad Child Adolesc Psychiatry. 2014 Feb;53(2):209-220.e4
pubmed: 24472255
Epilepsy Behav. 2011 Sep;22(1):9-16
pubmed: 21684214
Sci Rep. 2020 Oct 22;10(1):17362
pubmed: 33093466
BMJ Open. 2014 Feb 17;4(2):e004365
pubmed: 24534260
BMJ. 2017 Oct 16;359:j4587
pubmed: 29038130
Autism. 2019 Jan;23(1):131-140
pubmed: 29113453
Ther Drug Monit. 2017 Apr;39(2):197-201
pubmed: 28045861
Reprod Toxicol. 2016 Dec;66:31-43
pubmed: 27667009
Pharmacopsychiatry. 2009 May;42(3):95-100
pubmed: 19452377
J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):915-22
pubmed: 12874493
Am J Obstet Gynecol. 2014 Dec;211(6):690.e1-11
pubmed: 24912093
Dev Psychopathol. 2020 Feb;32(1):21-30
pubmed: 30728091
JAMA. 2013 Apr 24;309(16):1696-703
pubmed: 23613074
Reprod Toxicol. 1993;7(2):175-7
pubmed: 8499668