Publications by authors named "Megan Klopchin"
Article Synopsis
- - The FDA is developing guidelines for using real-world evidence (RWE) to help make decisions about how effective products are, moving beyond traditional randomized clinical trials (RCTs).
- - There’s a focus on replicating RCT results with RWE to find valid evidence of drug effects, but challenges such as different healthcare settings and patient populations can complicate this process.
- - Using RWE can sometimes provide a clearer picture of treatment effectiveness in everyday care compared to RCTs, and finding ways to integrate both types of evidence could improve regulatory science.
Aims: We sought to create a new research and clinical instrument -the Influence and Motivation for Patient ACTivation in Diabetes care (IMPACT-D™) - to measure the degree to which patients with type 2 diabetes (T2DM) value health and believe they can influence it.
Methods: Candidate items were generated via a literature review, expert opinion, and qualitative interviews and focus groups with T2DM patients in Chicago, IL and Chapel Hill, NC. Psychometric testing guided by item response theory was conducted among an online panel of 500 English-speaking adults with T2DM.