Project Summary

What is this research about? 

When planning a course of treatment for a patient, doctors rely on results from randomized trials. Randomized trials are a strong method of understanding the average effect of a treatment. However, results may not apply equally to all patients — there may be subgroups of patients within a trial that respond better or worse to treatment. 

Current methods for finding subgroups have not yielded results that have been replicated in later studies. These methods are only able to look at one variable at a time and also do not balance important variables in the subgroups found. This study proposes a method that can look at multiple variables at once and also can balance important variables in the subgroups it finds. A key component of the study is producing a picture of the findings that can be easily used and understood by patients and doctors when planning a course of treatment. 

Who can this research help? 

Doctors and patients planning a course of treatment can use findings from this study for shared decision making. Public health systems leaders can use the method to help allocate resources to target groups that may benefit most. Researchers can use the method to study where a treatment may work best. 

What is the research team doing? 

The research team will apply the method to a range of studies to understand more about how it works. The first study is a large study of the effect of intensive versus standard blood pressure lowering on time to cardiovascular event. The second study examines the impact of diabetes pump on glycemic control among patients with type 1 diabetes. The third study also looks at the impact of diabetes pump on glycemic control, but this time uses data from the electronic health record. 

The research team has put together a diverse Stakeholder Advisory Committee (SAC) panel of patients, parents/guardians, patient advocates, doctors and researchers to guide strategic decisions throughout the project. The SAC will advise on how to create pictures that easily display the results of the method, making it clear who will benefit most (and least) from treatment. These visualizations must be easily understood by doctors and patients to enable shared decision making. The research team is also creating software to make the method available to researchers everywhere, to apply to their own research questions.

Project Information

Joseph Rigdon, B.S., M.S., Ph.D.
Wake Forest University
$1,069,896 *

Key Dates

36 months *
April 2024

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.


Project Status
Award Type
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Last updated: April 23, 2024