ORCID
- Hobart, Jeremy: 0000-0002-2114-7920
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 aspects they perceive important. Results Definitions, clarifications and conceptualisations of the measurement variables were often lacking. PlwMS were variably involved in PRO development. Ethnic diversity was rarely documented. PlwMS identified individualisation, ease of understanding, time burden, and mode of administration as factors affecting PRO usability. Conclusions To date, the PRO development process has consistently lacked clear definitions of concepts of interest, use of conceptual frameworks and patient involvement, thereby compromising the validity of data they generate. PRO instrument development must be conducted more robustly to maximise the value of pivotal clinical trials.
DOI
10.1177/20552173221105642
Publication Date
2022-05-21
Publication Title
Multiple Sclerosis Journal - Experimental, Translational and Clinical
Volume
8
Issue
2
First Page
205521732211056
Last Page
205521732211056
Embargo Period
2022-07-23
Organisational Unit
Peninsula Medical School
Recommended Citation
Bharadia, T., Vandercappellen, J., Chitnis, T., Eelen, P., Bauer, B., Brichetto, G., Lloyd, A., Schmidt, H., King, M., Fitzgerald, J., Hach, T., & Hobart, J. (2022) 'Patient-reported outcome measures in MS: Do development processes and patient involvement support valid quantification of clinically important variables?', Multiple Sclerosis Journal - Experimental, Translational and Clinical, 8(2), pp. 205521732211056-205521732211056. Available at: https://doi.org/10.1177/20552173221105642
