Back to Search Start Over

The Utility of Domain-Specific End Points in Acute Stroke Trials

Authors :
Daofen Chen
Warren D. Lo
Jeffrey L. Saver
Lawrence R. Wechsler
Claudia S. Moy
Maarten G Lansberg
Aneesh B. Singhal
Steven C. Cramer
Maarten G. Lansberg
Wade S. Smith
Brett C. Meyer
Joseph P. Broderick
Edward C. Jauch
Kari Dunning
Steven L. Wolf
Scott Janis
David S Liebeskind
Catherine Amlie-Lefond
Cheryl Bushnell
Lorie Richards
Phillip A. Scott
Dorothy F. Edwards
Carolee J. Winstein
Max Wintermark
Pooja Khatri
Enrique C. Leira
Gregory W. Albers
Caitlyn Meinzer
Kiva M Schindler
Andrew W. Grande
Renee H Martin
Karen C. Johnston
J D Mocco
Jordan J. Elm
Toby Gropen
Sean I Savitz
Alexander W. Dromerick
Randolph S. Marshall
Aimee Reiss
Robert J. Dempsey
Jin-Moo Lee
Stephen J. Page
Source :
Stroke
Publication Year :
2021

Abstract

Domain-specific endpoints are assessments that correspond to the output of individual neural systems and are useful for capturing treatment effects on specific behaviors. By contrast, global endpoints combine several attributes into a single score and are useful for capturing broad treatment effects in a summary way. While global endpoints have become the de facto mechanism required to define benefit in stroke trials, they also have important limitations, some of which might be addressed by simultaneously measuring domain-specific endpoints. Substantial opportunity remains to identify quantifiable patient benefit that would otherwise not be captured by global endpoints. Potential advantages of incorporating domain-specific endpoints in acute stroke trials are discussed, such as increased granularity of measurement, improved understanding of how therapies affect the brain between acute treatment and day 90, and optimized therapeutic translation. Potential disadvantages are also considered, including time and cost of administering domain-specific endpoints, as well as statistical implications. Domain-specific endpoints and global endpoints are not mutually exclusive, and both capture clinical benefits to patients. Incorporating a broader set of outcome assessments in stroke trials, including both global and domain-specific endpoints, is warranted.

Details

ISSN :
15244628
Volume :
52
Issue :
3
Database :
OpenAIRE
Journal :
Stroke
Accession number :
edsair.doi.dedup.....5223fd7a1f13d1c44934a0199c749679