One of PCORI’s goals is to improve the methods that researchers use for patient-centered outcomes research. PCORI funds methods projects like this one to better understand and advance the use of research methods that improve the strength and quality of comparative effectiveness research.
COVID-19-Related Project Enhancement
Patients with type 2 diabetes have a high risk of serious complications from COVID-19. In the hospital, diabetes patients with high blood sugar are more likely to have problems with multiple organs, need intense care, and even die.
With this enhancement, the research team will use the methods developed in the original award to look at whether early treatment intensification to lower blood sugar or improved medication adherence can prevent or reduce the severity of COVID-19 in type 2 diabetes patients.
Enhancement Award Amount: $353,289
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the project about?
Medicine nonadherence occurs when patients don’t take medicine as directed. If patients take the wrong dose or forget a dose, medicines may not work well or may cause health problems.
Many research studies assume that patients take their medicine as directed. Others make assumptions about how and when nonadherence happens. For example, studies might use data from electronic health records, or EHRs, that capture when and how much medicine a patient received. But EHRs don’t show whether a patient took his or her medicine, or if the patient took it as directed.
The research team is developing and testing new methods to help researchers who use EHR data avoid making incorrect assumptions about whether patients use medicines as directed after filling a prescription.
How can this project help improve research methods?
Results may help researchers improve studies that use EHR data to compare how well medicines work, and help them better understand the health effects of nonadherence.
What is the research team doing?
The research team is developing new methods that build on methods researchers currently use to estimate the effect of medicine refill patterns on patients’ health in studies using EHR data. The team is testing these new methods on a data set they create to see how well the methods work compared with existing methods. Then the team is testing the new methods using real EHR data from two studies comparing medicines for type 2 diabetes. Finally, the team is developing computer programs so that other researchers can use the new methods.
Research methods at a glance
Aim 1. Develop new methods for studying the health effects of prescription fill and refill regimens in studies using EHR data with time-dependent confounding.
Aim 2. Evaluate and compare the new methods with existing methods using simulation and analyses of data from two EHR-based studies of type 2 diabetes.Aim 3. Create and distribute free software that automates analyses of EHR data using the new methods.
|Approach||Theoretical derivations, simulation, secondary analyses, software development|
Improving Methods for Conducting Patient-Centered Outcomes Research