Benefit evaluation in multiple sclerosis relapse treatment from the patients' perspective - Development and validation of a new questionnaire.
Health-related quality of life
Patient benefit
Patient-reported outcomes
Relapsing remitting multiple sclerosis
validation
Journal
Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247
Informations de publication
Date de publication:
Feb 2019
Feb 2019
Historique:
received:
02
07
2018
revised:
20
11
2018
accepted:
15
12
2018
pubmed:
15
1
2019
medline:
14
6
2019
entrez:
15
1
2019
Statut:
ppublish
Résumé
Little is known on how to measure patient-relevant benefit of relapse treatment in relapsing-remitting multiple sclerosis (MS). The objective of this study was to develop and validate a new method for monitoring recovery from MS relapses and patient-relevant treatment benefits. A 27-item questionnaire was developed using a multi-step approach comprising open item collection, multidisciplinary expert panel and cognitive debriefing. It was evaluated regarding psychometric properties and feasibility in a longitudinal validation study with 100 patients with MS undergoing relapse treatment. Construct validity was tested by correlations with patient and physician global impressions of change as well as disease-specific and generic health-related quality of life (HRQoL) measures. Results of the feasibility survey indicated high patient acceptance. Reliability was high (Cronbach's α = 0.90). While the Expanded Disability Status Scale (EDSS) was not sensitive to change, Patient Benefit Index for Multiple Sclerosis (PBI-MS) showed a high correlation cross-sectionally with patient global impression of change (PaGIC) (r = 0.60, p < 0.001). Significant moderate to high correlations were found with change in generic HRQoL (r = 0.55-0.61, p < 0.001) and lower correlations with change in disease-specific HRQoL (r = -0.36, p < 0.01). The PBI-MS is a reliable and valid instrument for ascertaining patient-relevant benefits of acute relapse treatment; it appears suited for use in routine care and in clinical or health care studies.
Sections du résumé
BACKGROUND
BACKGROUND
Little is known on how to measure patient-relevant benefit of relapse treatment in relapsing-remitting multiple sclerosis (MS). The objective of this study was to develop and validate a new method for monitoring recovery from MS relapses and patient-relevant treatment benefits.
METHODS
METHODS
A 27-item questionnaire was developed using a multi-step approach comprising open item collection, multidisciplinary expert panel and cognitive debriefing. It was evaluated regarding psychometric properties and feasibility in a longitudinal validation study with 100 patients with MS undergoing relapse treatment. Construct validity was tested by correlations with patient and physician global impressions of change as well as disease-specific and generic health-related quality of life (HRQoL) measures.
RESULTS
RESULTS
Results of the feasibility survey indicated high patient acceptance. Reliability was high (Cronbach's α = 0.90). While the Expanded Disability Status Scale (EDSS) was not sensitive to change, Patient Benefit Index for Multiple Sclerosis (PBI-MS) showed a high correlation cross-sectionally with patient global impression of change (PaGIC) (r = 0.60, p < 0.001). Significant moderate to high correlations were found with change in generic HRQoL (r = 0.55-0.61, p < 0.001) and lower correlations with change in disease-specific HRQoL (r = -0.36, p < 0.01).
CONCLUSION
CONCLUSIONS
The PBI-MS is a reliable and valid instrument for ascertaining patient-relevant benefits of acute relapse treatment; it appears suited for use in routine care and in clinical or health care studies.
Identifiants
pubmed: 30639826
pii: S2211-0348(18)30551-0
doi: 10.1016/j.msard.2018.12.021
pii:
doi:
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
256-261Informations de copyright
Copyright © 2018 Elsevier B.V. All rights reserved.