1. Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis.
- Author
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Hudgens, Stacie, Schüler, René, Stokes, Jonathan, Eremenco, Sonya, Hunsche, Elke, and Leist, Thomas P.
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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 - Abstract
Objectives: 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.Methods: 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.Results: 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).Conclusions: 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]- Published
- 2019
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