Patient-reported outcome measures in MS: Do development processes and patient involvement support valid quantification of clinically important variables?

ABSTRACT:

Background

Patient-reported outcomes (PROs) are widely measured in multiple sclerosis (MS) studies. However, the quality of instrument development processes varies, raising concerns about the meaningfulness of associated data.

Objectives

To review the development of selected PROs commonly used in MS studies, including definitions of the concepts measured, use of conceptual frameworks, and degree of input from people living with MS (PlwMS). To gain insights and recommendations from PlwMS on their experience with these PROs.

Methods

We assessed 6 PROs (FSIQ-RMS, modified-FIS, MSQoL-54, Leeds 8-item MSQoL, MSIS-29 and EQ-5D) for alignment with regulatory and scientific requirements on PRO structure/development. PlwMS evaluated the degree to which the PROs reflect disease

SUBMITTER: Bharadia T 

PROVIDER: S-EPMC9228659 | biostudies-literature | 2022 Apr-Jun

REPOSITORIES: biostudies-literature