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Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F

Completed
Conditions
Myasthenia Gravis
Registration Number
NCT02470364
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Brief Summary

The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.

Detailed Description

It is a translation and validation of a quality of life scale.

Step 1: Translation and cultural adaptation (Forward and back translation, committee review, pre-testing with 10 patients for content and face validity).

Step 2 : Psychometric testing : Test-retest with a 2 day interval, correlation with clinical scores - the Myasthenic Muscle Score and the (MG-ADL) score and with a global quality of life score (WHOQOL-BREF).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Auto-immune myasthenia gravis
  • Age ≥ 18 years old
  • Clinical Classification (MGFA) I-IV
  • French speaking
Exclusion Criteria
  • cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire3 days
Secondary Outcome Measures
NameTimeMethod
Global quality of life evaluated via the WHOQOL-BREF scale1 day
Clinical evaluation : Myasthenic Muscle Score1 day
Disease severity assessed via the Myasthenic Muscle Score1 day
Impact of symptoms on daily activities and daily life using the MG-ADL score1day

Trial Locations

Locations (1)

Institute of Myology, La Pitié-Salpêtrière Hospital

🇫🇷

Paris, France

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