Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76).

ABSTRACT:

Background

Fatigue is a key symptom in patients with systemic lupus erythematosus (SLE), and regulatory bodies recommend its assessment in clinical trials of SLE therapies.

Methods

This post hoc pooled analysis of the three BeLimumab In Subjects with Systemic lupus erythematosus (BLISS) Phase 3 randomised, double-blind, parallel-group controlled trials evaluated the measurement properties of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Patients (N = 2520) completed the FACIT-Fatigue every 4 weeks from baseline until the end of each study period. Internal consistency, test-retest reliability, convergent validity, and ability to detect changes in SLE were evaluated for the FACIT-Fatigue.

Results

The FACIT-Fatigue showed good internal consistency

SUBMITTER: Rendas-Baum R 

PROVIDER: S-EPMC8032841 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature