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Refining clinical trial inclusion criteria to optimize the standardized response mean of the CMTPedS
Journal article   Open access   Peer reviewed

Refining clinical trial inclusion criteria to optimize the standardized response mean of the CMTPedS

Kayla M D Cornett, Manoj P Menezes, Paula Bray, Rosemary R Shy, Isabella Moroni, Emanuela Pagliano, Davide Pareyson, Tim Estilow, Sabrina W Yum, Trupti Bhandari, …
Annals of clinical and translational neurology, Vol.7(9), pp.1713-1715
09/2020
DOI: 10.1002/acn3.51145
PMID: 32762141
url
https://doi.org/10.1002/acn3.51145View
Published (Version of record) Open Access

Abstract

The CMT Pediatric Scale (CMTPedS) is a reliable, valid, and responsive clinical outcome measure of disability in children with CMT. The aim of this study was to identify the most responsive patient subset(s), based on the standardized response mean (SRM), to optimize the CMTPedS as a primary outcome measure for upcoming clinical trials. Analysis was based on a 2-year natural history data from 187 children aged 3-20 years with a range of CMT genetic subtypes. Subsets based on age (3-8 years), disability level (CMTPedS score 0-14), and CMT type (CMT1A) increased the SRM of the CMTPedS considerably. Refining the inclusion criteria in clinical trials to younger, mildly affected cases of CMT1A optimizes the responsiveness of the CMTPedS.

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