A study using Observational Health Data Sciences and Informatics tools to characterize treatment pathways for stroke prevention in Atrial Fibrillation across diverse population settings (TxPath-AF)

Study type
Protocol
Date of Approval
Study reference ID
18_295
Lay Summary

Atrial fibrillation (AF) is a serious condition in which the heart beats in an irregular, rapid manner. AF increases one’s risk of experiencing a stroke by about five-fold; therefore, these patients are prescribed antithrombotic treatments for stroke prevention of atrial fibrillation (SPAF). The drugs administered for antithrombotic therapy have changed in recent years with the introduction of a new type of drug known as non-vitamin K oral anticoagulants (NOACs). Prior to this, oral anticoagulants and vitamin K antagonists (VKAs) were considered the main therapies of choice for SPAF treatment. This project aims to describe the clinical landscape of SPAF treatment and to assess any changes over time in SPAF treatment since the introduction of NOACs. The study will be conducted using the Observational Health Data Sciences and Informatics (OHDSI) analytic tools. OHDSI is a network of researchers and observational health databases whose overarching goal is to bring out the value of health data through large scale analytics. Encompassed with the OHDSI network is a variety of tools, including ATLAS and the treatment pathway tool (TxPath) which will both be used in this current study. Using several healthcare databases, the TxPath tool will be used to produce sunburst graphs which show the pathways through which patients receive their different treatments over time. This study will impact the knowledge of the current landscape of the treatments received by AF patients and any switching patterns that may occur.

Technical Summary

The AF treatment pathways study is a retrospective network study using Observational Medical Outcomes Partnership (OMOP) data sources available either internally (CCAE and MDCR from US, and CPRD from UK) or from a research collaborator in the OHDSI network. The intention of this study is to characterize treatment for stroke prevention of AF (SPAF) while accounting for database heterogeneity, population diversity and variance in care. The study population is patients taking antithrombotic agents for SPAF. The initial event is first time exposure to antithrombotic medication. The patients must at least a year of observation prior to the initial event. SPAF treatment prevalence is calculated following the tabulation generated by the database query (SQL code). A count of each unique treatment sequence is tabled from which the sunburst graphs will be created. Each data source will produce its own sunburst graph for SPAF treatment to see how treatment pathways vary by population, geography and data source type. Additionally, we will provide information on the temporal trends in SPAF treatment by stratifying results by year. This will enable us to assess any changes over time in SPAF treatment since the introduction of NOACs.

Health Outcomes to be Measured

Treatment pathways for stroke prevention in atrial fibrillation patients. This includes treatment type and switching patterns.

Collaborators

Alex Asiimwe - Chief Investigator - Bayer AG
Pareen Vora - Corresponding Applicant - Bayer AG
Beth Russell - Collaborator - Bayer AG
Gunnar Brobert - Collaborator - Bayer AG