Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis

Apr 1, 2019, 00:00
10.1016/j.jval.2018.11.007
https://www.valueinhealthjournal.com/article/S1098-3015(18)36304-6/fulltext
Title : Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis
Citation : https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(18)36304-6&doi=10.1016/j.jval.2018.11.007
First page : 453
Section Title : PATIENT-REPORTED OUTCOMES
Open access? : Yes
Section Order : 453

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.

Categories :
  • Instrument Development, Validation, & Translation
  • Musculoskeletal Disorders
  • Patient-reported Outcomes & Quality of Life Outcomes
  • PRO & Related Methods
  • Prospective Observational Studies
Tags :
  • fatigue
  • patient-reported outcome
  • relapsing multiple sclerosis
  • symptoms
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