Content Validity of Sjogren's Syndrome Symptom Diary and Functional Assessment of Chronic Illness Therapy-Fatigue in Patients with Sjogren's.

ABSTRACT:

Introduction

Sjögren's Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are patient-reported outcome (PRO) instruments assessing Sjögren's symptoms. Original SSSD items have demonstrated content validity, however qualitative evidence supporting the updated 'tiredness' item and two new supplementary items is lacking. Although well established and validated in other rheumatic diseases, there is no qualitative evidence supporting content validity of FACIT-F in Sjögren's. This study addressed these evidence gaps to support use of SSSD and FACIT-F as clinical trial endpoints, in clinical practice and in other research settings.

Methods

Qualitative, semi-structured telephone interviews were conducted with patients with Sjögren's

SUBMITTER: Griffiths N 

PROVIDER: S-EPMC9561476 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature