Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis.
Activities of Daily Living
Adolescent
Adult
Aged
Cognition
Comprehension
Cost of Illness
Cross-Sectional Studies
Fatigue
/ diagnosis
Female
Health Status
Health Status Indicators
Humans
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting
/ diagnosis
Patient Reported Outcome Measures
Predictive Value of Tests
Psychometrics
Qualitative Research
Reproducibility of Results
Young Adult
fatigue
patient-reported outcome
relapsing multiple sclerosis
symptoms
Journal
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
ISSN: 1524-4733
Titre abrégé: Value Health
Pays: United States
ID NLM: 100883818
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
received:
11
04
2018
revised:
05
10
2018
accepted:
11
11
2018
entrez:
13
4
2019
pubmed:
13
4
2019
medline:
29
5
2019
Statut:
ppublish
Résumé
A new patient-reported outcome (PRO) instrument to measure fatigue symptoms and impacts in relapsing multiple sclerosis (RMS) was developed in a qualitative stage, followed by psychometric validation and migration from paper to an electronic format. Adult patients with relapsing-remitting multiple sclerosis (RRMS) were interviewed to elicit fatigue-related symptoms and impacts. A draft questionnaire was debriefed in cognitive interviews with further RRMS patients, and revised. Content confirmation interviews were conducted with patients with progressive-relapsing multiple sclerosis (PRMS) and relapsing secondary-progressive multiple sclerosis (RSPMS). Psychometric analyses used data from adult patients with different RMS subtypes and matched non-RMS controls in a multicenter, observational study. After item reduction, the final instrument was migrated to a smartphone (eDiary) and usability was confirmed in interviews with additional adult RMS patients. The qualitative stage included 37 RRMS, 5 PRMS, and 5 RSPMS patients. Saturation of concepts was reached during concept elicitation. Cognitive interviews confirmed that participants understood the instructions, items, and response options of the instrument-named FSIQ-RMS-as intended. Psychometric validation included 164 RMS and 74 control patients. Internal consistency and test-retest reliability were demonstrated. The symptoms domain discriminated along the RMS symptom-severity continuum and between patients and controls. Patients were able to attribute fatigue-related symptoms to RMS. Usability and conceptual equivalence of the eDiary were confirmed (n = 10 participants). With 7 symptom items and 13 impact items (in 3 impacts subdomains: physical, cognitive and emotional, and coping) after item reduction, the FSIQ-RMS is a comprehensive, valid, and reliable measure of fatigue-related symptoms and impacts in RMS patients.
Identifiants
pubmed: 30975397
pii: S1098-3015(18)36304-6
doi: 10.1016/j.jval.2018.11.007
pii:
doi:
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
453-466Informations de copyright
Copyright © 2018 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.