The Development and Content Validation of the Sjogren's Related Quality of Life Instrument (SRQoL).

ABSTRACT:

Introduction

Several clinical outcome assessment (COA) instruments assess Sjögren's disease (Sjögren's) symptoms, but do not provide comprehensive assessment of the health-related quality of life (HRQoL) impact of Sjögren's. This study aimed to develop a patient-reported outcome (PRO) instrument for the assessment of HRQoL, intended for use in clinical trials and clinical practice in the assessment of treatment benefit.

Methods

Review of study sponsor proprietary data and qualitative interviews informed the development of a conceptual model, the Sjögren's Related Quality of Life (SRQoL) and patient global impression of severity (PGI-S) and change (PGI-C) items. Combined concept elicitation and cognitive debriefing interviews with patients with Sjögren's explored their HRQoL

SUBMITTER: Marvel J 

PROVIDER: S-EPMC11557853 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature