Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?: A Validation Study Based on Prescribing Codeine in Children.


Journal

Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741

Informations de publication

Date de publication:
04 2020
Historique:
received: 17 10 2019
accepted: 17 12 2019
pubmed: 21 1 2020
medline: 28 10 2020
entrez: 21 1 2020
Statut: ppublish

Résumé

Exploring and combining results from more than one real-world data (RWD) source might be necessary in order to explore variability and demonstrate generalizability of the results or for regulatory requirements. However, the heterogeneous nature of RWD poses challenges when working with more than one source, some of which can be solved by analyzing databases converted into a common data model (CDM). The main objective of the study was to evaluate the implementation of the Observational Medical Outcome Partnership (OMOP) CDM on IQVIA Medical Research Data (IMRD)-UK data. A drug utilization study describing the prescribing of codeine for pain in children was used as a case study to be replicated in IMRD-UK and its corresponding OMOP CDM transformation. Differences between IMRD-UK source and OMOP CDM were identified and investigated. In IMRD-UK updated to May 2017, results were similar between source and transformed data with few discrepancies. These were the result of different conventions applied during the transformation regarding the date of birth for children younger than 15 years and the start of the observation period, and of a misclassification of two drug treatments. After the initial analysis and feedback provided, a rerun of the analysis in IMRD-UK updated to September 2018 showed almost identical results for all the measures analyzed. For this study, the conversion to OMOP CDM was adequate. Although some decisions and mapping could be improved, these impacted on the absolute results but not on the study inferences. This validation study supports six recommendations for good practice in transforming to CDMs.

Identifiants

pubmed: 31956997
doi: 10.1002/cpt.1785
pmc: PMC7158210
doi:

Substances chimiques

Analgesics, Opioid 0
Codeine UX6OWY2V7J

Types de publication

Journal Article Observational Study Validation Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

915-925

Informations de copyright

© 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Références

Inform Prim Care. 2011;19(4):251-5
pubmed: 22828580
Drug Saf. 2014 Nov;37(11):893-6
pubmed: 25187018
J Am Med Inform Assoc. 2015 May;22(3):553-64
pubmed: 25670757
EGEMS (Wash DC). 2014 Nov 11;2(1):1110
pubmed: 25848597
Stat Med. 2000 Feb 15;19(3):335-51
pubmed: 10649300
Int J Epidemiol. 2015 Jun;44(3):827-36
pubmed: 26050254
Clin Pharmacol Ther. 2020 Apr;107(4):827-833
pubmed: 31330042
J Am Med Inform Assoc. 2012 Jan-Feb;19(1):54-60
pubmed: 22037893
Clin Drug Investig. 2019 Feb;39(2):205-213
pubmed: 30465300
Biometrics. 2006 Sep;62(3):847-54
pubmed: 16984328
Clin Pharmacol Ther. 2019 Jul;106(1):36-39
pubmed: 30970161
Appl Clin Inform. 2018 Jan;9(1):54-61
pubmed: 29365340
Clin Pharmacol Ther. 2016 Mar;99(3):265-8
pubmed: 26667601
J Med Syst. 2019 Sep 7;43(10):314
pubmed: 31494719
Stud Health Technol Inform. 2019 Aug 21;264:233-237
pubmed: 31437920
Drug Saf. 2015 Aug;38(8):749-65
pubmed: 26055920
Pharmacoepidemiol Drug Saf. 2015 Sep;24(9):999-1003
pubmed: 26213344
Healthc Inform Res. 2016 Jan;22(1):54-8
pubmed: 26893951
Stud Health Technol Inform. 2019;258:151-152
pubmed: 30942734
Drug Saf. 2014 Nov;37(11):945-59
pubmed: 25187016
Aten Primaria. 2002 Dec;30(10):655-61
pubmed: 12525343
Int J Clin Pharmacol Ther. 2009 Oct;47(10):617-26
pubmed: 19825325
Stud Health Technol Inform. 2015;216:574-8
pubmed: 26262116
Drug Saf. 2013 Feb;36(2):119-34
pubmed: 23329543
Stud Health Technol Inform. 2017;245:467-470
pubmed: 29295138
Am J Law Med. 2018 May;44(2-3):197-217
pubmed: 30106649
Pharmacoepidemiol Drug Saf. 2019 Jan 15;:
pubmed: 30648307
Pharmacoepidemiol Drug Saf. 2019 Aug;28(8):1086-1096
pubmed: 31219227

Auteurs

Gianmario Candore (G)

Business Data Department, European Medicines Agency, Amsterdam, The Netherlands.

Karin Hedenmalm (K)

Business Data Department, European Medicines Agency, Amsterdam, The Netherlands.

Jim Slattery (J)

Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.

Alison Cave (A)

Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.

Xavier Kurz (X)

Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.

Peter Arlett (P)

Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.

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