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Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis.
- Source :
-
Value in Health . Apr2019, Vol. 22 Issue 4, p453-466. 14p. - Publication Year :
- 2019
-
Abstract
- <bold>Objectives: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *FATIGUE (Physiology)
*MULTIPLE sclerosis
*ELECTRONIC paper
*STATISTICAL reliability
*COGNITIVE interviewing
*MEASURING instruments
*MULTIPLE sclerosis diagnosis
*MENTAL health
*COGNITION
*COMPARATIVE studies
*ECONOMIC aspects of diseases
*HEALTH status indicators
*RESEARCH methodology
*MEDICAL cooperation
*PSYCHOMETRICS
*QUESTIONNAIRES
*READABILITY (Literary style)
*RESEARCH
*QUALITATIVE research
*ACTIVITIES of daily living
*EVALUATION research
*PREDICTIVE tests
*CROSS-sectional method
RESEARCH evaluation
Subjects
Details
- Language :
- English
- ISSN :
- 10983015
- Volume :
- 22
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Value in Health
- Publication Type :
- Academic Journal
- Accession number :
- 135822735
- Full Text :
- https://doi.org/10.1016/j.jval.2018.11.007