Evidence map›Paper›PMID 31956997›Full record

Observational studyClinical pharmacology and therapeutics2020

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.

Gianmario Candore, Karin Hedenmalm, Jim Slattery, Alison Cave, Xavier Kurz, Peter Arlett

Abstract readObservational StudyValidation Study
In one paragraph

Observational study in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Evaluating Frailty Index Integrity: Insights from an International Network Study.medRxiv : the preprint server for health sciences · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Deep-learning-based automated terminology mapping in OMOP-CDM.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Gianmario CandoreBusiness Data Department, European Medicines Agency, Amsterdam, The Netherlands.
Karin HedenmalmBusiness Data Department, European Medicines Agency, Amsterdam, The Netherlands.
Jim SlatteryPharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.
Alison CavePharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.
Xavier KurzPharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.
Peter ArlettPharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Analgesics, OpioidBiomedical ResearchChildChild, PreschoolCodeineDatabases, FactualData ManagementDrug PrescriptionsElectronic Health RecordsFemaleHumansMaleRetrospective StudiesTreatment OutcomeUnited KingdomAnalgesics, OpioidCodeine

Identifiers

PMID31956997
PMCPMC7158210

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.