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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

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...

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Autores principales: Candore, Gianmario, Hedenmalm, Karin, Slattery, Jim, Cave, Alison, Kurz, Xavier, Arlett, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158210/
https://www.ncbi.nlm.nih.gov/pubmed/31956997
http://dx.doi.org/10.1002/cpt.1785
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author Candore, Gianmario
Hedenmalm, Karin
Slattery, Jim
Cave, Alison
Kurz, Xavier
Arlett, Peter
author_facet Candore, Gianmario
Hedenmalm, Karin
Slattery, Jim
Cave, Alison
Kurz, Xavier
Arlett, Peter
author_sort Candore, Gianmario
collection PubMed
description 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.
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spelling pubmed-71582102020-04-20 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 Candore, Gianmario Hedenmalm, Karin Slattery, Jim Cave, Alison Kurz, Xavier Arlett, Peter Clin Pharmacol Ther Research 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. John Wiley and Sons Inc. 2020-03-02 2020-04 /pmc/articles/PMC7158210/ /pubmed/31956997 http://dx.doi.org/10.1002/cpt.1785 Text en © 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Candore, Gianmario
Hedenmalm, Karin
Slattery, Jim
Cave, Alison
Kurz, Xavier
Arlett, Peter
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158210/
https://www.ncbi.nlm.nih.gov/pubmed/31956997
http://dx.doi.org/10.1002/cpt.1785
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