Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Compare results from the original database versus the transformed database into OMOP CDM
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive analyses

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R05DA04) codeine

  codeine

Population studied

• Short description of the study population:
  Children below the age of 18 years.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  The main objective was to compare the prescribing of codeine for treatment of pain in children in the OMOP CDM converted database against results in the original IMRD-UK source database. The specific objective was to explore any potential loss of information and inaccuracy resulting from the conversion, and, if so, whether these changes would have impacted on the interpretation of study results
• Data analysis plan:
  Results will be analysed descriptively. Differences between OMOP CDM and IMRD-UK source data will be identified and, if found to have appreciable impact on the study results, further investigated.Joinpoint regression analysis with log-linear model will be used to evaluate statistically significant changes in prescribing trend

Documents

Study publications

Candore, G., Hedenmalm, K., Slattery, J., Cave, A., Kurz, X. and Arlett, P. (20…