FAQ

Choosing and Specifying Endpoints and Outcomes


Section 7


FAQ

Contributors

Lesley Curtis, PhD

Adrian F. Hernandez, MD, MHS

Kevin P. Weinfurt, PhD

 

Contributing Editor

Karen Staman, MS

Frequently Asked Questions

Question

Answer

How do you deal with disenrollment, or the lack of it? Even if an event is not recorded in the EHR, it doesn’t necessarily mean it didn’t happen. There are a lot of practices around what you do when you don’t have complete data capture for data elements that might be critical. You can link to other providers, claims data, or registries. You can also indicate that this is a limitation of the data.
I need a measure of physical activity as an outcome. Will my trial be considered not pragmatic because measuring this outcome is challenging? Some dimensions of a trial can be more pragmatic than others, and it can still be embedded, pragmatic research.

 

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Version History

Published December 15, 2018

Citation:

Choosing and Specifying Endpoints and Outcomes: FAQ. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/chapters/design/choosing-specifying-end-points-outcomes/faq/. Updated January 4, 2019. DOI: 10.28929/101.