Can patient self-evaluation of functional status be used for evaluation of impairment of motor function in Guillain-Barre syndrome? Mapping clinician- and patient-reported outcomes in a phase 3 study of eculizumab in Japan.

ABSTRACT:

Background and purpose

Guillain-Barré syndrome (GBS) is an autoimmune neurological disorder characterized by muscle weakness. In clinical trials, treatment benefit and disease severity are typically measured using clinician-reported outcome measures like the Hughes Functional Grading Scale (HFGS). However, patient-reported outcome measures, such as the Rasch-built Overall Disability Scale (R-ODS) may provide additional insight into the patient experience during treatment. In this study, exploratory analyses of clinical trial data were performed to investigate how existing clinician-reported outcomes and patient-reported outcomes can help to assess disease progression by providing an accurate measurement of functional status.

Methods

Data were collected as part of a phase 3 s

SUBMITTER: Regnault A 

PROVIDER: S-EPMC11908375 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature