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.
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 research about?
To know how well medical treatments and health improvement programs work, doctors and patients depend on results from clinical trials. Clinical trials that study individual patients are the most common. Trials that study groups, such as clinics, are less common. As a result, research methods for designing studies of groups are underdeveloped. For example, standard statistical models assume that treatment or program effects will be the same across groups, which may not always be the case.
In this study, the research team is developing new methods and resources for conducting studies that follow groups over time. The team is focusing on a study design called the stepped wedge design. In this design, groups, such as clinics, start offering the treatment or program at different times during the study period. In this way, all clinics offer the treatment but serve as a control group at some point during the study. Researchers can see how well treatments work both in one clinic and across several clinics.
Who can this research help?
Researchers may be able to use the methods and resources from this study to improve the design and conduct of studies using the stepped wedge design. Such studies can help researchers draw better conclusions about the effectiveness of medical treatments and health programs.
What is the research team doing?
This study has three parts. In the first part, the research team is developing a way to select, interpret, and apply results from studies that use a stepped wedge design.
In the second part, the team is developing software to help researchers plan clinical trials using the stepped wedge design. The team is creating an online calculator for figuring out how many people should be in a study. The calculator is part of an existing free statistical software package.
In the third part, the team is coming up with ways for researchers to spot early signs of harm or benefit of the treatment or program they are testing. Doing so can allow researchers to change the study design if needed while the study is in progress.
Research methods at a glance
|Goal||To develop statistical methods and resources for designing, analyzing, and monitoring stepped wedge cluster randomized trials|
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Other Stakeholder Partners
- Jerry Jarvik, MD, MPH