Drug utilisation studies allow regulators, health care professionals and the pharmaceutical industry to monitor the drug - in terms of frequency of use and treatment characteristics - once the drug is launched.
A prerequisite of this research it to have access to treatment data such as prescription and/or dispensing data. These data are now available through electronic health care data such as primary care databases and offer the potential to study drug use on a large scale, including millions of people from different regions all over the world.
To facilitate international research, these databases ideally use a common data structure and the same coding dictionary. EHDEN (European Health Data and Evidence Network) is an international project aiming to develop and implement tools to facilitate research on large electronic health care databases mapped to a common data structure also called Common Data Model (CDM). We want to conduct a drug-utilisation study using CPRD data mapped to CDM.
As proof of concept study we want to investigate characteristics of respiratory drug use in patients with asthma and chronic obstructive pulmonary disease, both prevalent conditions and primarily treated by GPs. By means of a drug utilisation study we aim to investigate the frequency of use (incidence and prevalence), characteristics of patients initiating treatment with respiratory drugs, treatment patterns and changes over time and treatment adherence. In addition we will investigate whether the results of this study are consistent with the results when using the standard CPRD data (thus not mapped to the CDM).
Background: The use of electronic healthcare data is increasingly being proposed as a source of evidence to support drug development and regulatory decision making but also to understand the pathogenesis of diseases.
The use of multiple electronic health care databases is recommended, not only to increase sample size but also to investigate country specific differences, differences by type of databases (e.g. primary vs. secondary care) and to replicate findings. One of the challenges is the heterogeneity between the databases with regard to the underlying structures and semantic mapping. The interoperability of the data can be strongly improved by standardising the data to the OMOP common data model (CDM) and Standardized Vocabularies. This enables the use of standardised analytical pipelines, e.g. for drug utilization studies across Europe.
Aims: EHDEN (European Health Data and Evidence Network) a European network project supported by the Innovative Medicines Initiative (IMI) aims to standardize health care data to a CDM and to develop and implement tools to facilitate research using databases mapped to the CDM.
As proof-of-concept study, we want to investigate respiratory drug use in patients with asthma or COPD
The specific aims of this study are the following:
To test existing drug utilisation techniques and methodologies.
To identify gaps in current drug utilisation techniques/methodologies hampering the fast conduct of drug utilisation studies.
To develop key graphical assets facilitating the interpretation of drug utilisation data.
To compare drug utilisation data gathered from CPRD mapped to the CDM to non-mapped CPRD data.
Methods
CPRD GOLD will be mapped to OMOP CDM using validated extraction-transformation-loading (ETL) codes. Study participants are patients diagnosed with asthma or COPD based on the presence of a READ code for asthma and/or COPD (see appendix). Gemscript codes for respiratory drugs are also provided in the appendix.
The following drug utilisation components will be investigated:
Incidence and prevalence of drug use expressed as number of users, number of defined daily doses and number of prescriptions
Patient characteristics of users with regard to demographics (age and gender), use of concomitant drugs and disease severity.
Changes over time such as changes in prescribing patterns over calendar time, effect of guidelines or safety warnings (= time series analysis) but also changes over time with regard to disease severity (treatment step-up and treatment step-down)
Patient adherence expressed as medication possession ratio, proportion of days covered, treatment persistence
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Katia Verhamme - Collaborator - Erasmus University Medical Center ( EMC )
Sara Khalid - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of Oxford