Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis
2019
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
psychometricvalidation 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
debriefedin
cognitive interviewswith 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).
Psychometricanalyses 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 interviewsconfirmed that participants understood the instructions, items, and response options of the instrument—named FSIQ-RMS—as intended.
Psychometricvalidation 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.
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