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

Abstract

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 progressiverelapsing multiple sclerosis (PRMS) and relapsing secondaryprogressive 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 instrumentdnamed FSIQ-RMSdas intended. Psychometric validation included 164 RMS and 74 control patients. Internal consistency and testeretest reliability were demonstrated. The symptoms domain discriminated along the RMS symptom-severity continuum and between patients and controls. Patients were able to attribute fatiguerelated symptoms to RMS. Usability and conceptual equivalence of the eDiary were confirmed (n ¼ 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.

Standardizing fatigue measurement in multiple sclerosis: the validity, responsiveness and score interpretation of the PROMIS SF v1.0 – Fatigue (MS) 8a

“…33 From a practical standpoint, the PROMIS Fatigue (MS) 8a is publicly available, has minimal respondent burden, and is scored on the same mathematical metric as PROMIS Fatigue scores derived by other short forms, the full item bank, and computer adaptive administration. 39 These practical aspects differentiate the PROMIS Fatigue (MS) 8a from other rigorously developed modern fatigue MS instruments, such as the FSIQ-RMS, and the NFI-MS. 40,41 The strength of the current research is multifold. The mixed-methods design allowed evaluation of content validity as well as psychometric properties of the PROMIS Fatigue (MS) 8a.…”

A novel disease specific scale to characterize the symptoms and impacts of fatigue in US adults with relapsing multiple sclerosis: A real-world study

“…The FSIQ-RMS is a 20-item questionnaire specifically developed to measure RMS patient's fatigue-related symptoms and their impacts on everyday life (Hudgens et al, 2019(Hudgens et al, , 2018. The first seven items measure dimensions of fatigue experienced in the previous 24 h and were completed daily for 7 days.…”

“…The FSIQ-RMS score was calculated for the symptom domain score, based on the first seven items, and the three impact subdomain scores, based on the remaining 13 items. The FSIQ-RMS scores range from 0 to 100, with a higher score indicating greater severity (Hudgens et al, 2019).…”

“…Only those participants who indicated RRMS or secondary progressive MS (SPMS) with superimposed relapses in the last 12 months were included in the data analysis. The inclusion criteria of ambulatory patients (PDDS < 6) with RRMS and those with SPMS with relapses in the last 12 months mirror the population selected for the phase 3 OPTIMUM study patient population (Hudgens et al, 2019). Participants also indicated the use of disease-modifying therapies (DMT) for MS, current treatment(s), number of past DMTs, and concomitant symptomatic treatments for their MS, including fatigue, comorbidities, and burden of MS-related symptoms on QoL.…”

“…Recognizing this need for the development of high-quality, MS-specific PROs, the Fatigue Symptoms and Impacts Questionnaire -Relapsing Multiple Sclerosis (FSIQ-RMS), a novel self-administered instrument, was developed following Food and Drug Administration (FDA) PRO guidance (http://www.fda.gov/downloads/Drugs/Guidances/UCM1 93282.pdf), (Hudgens et al, 2019), and validated for use in the RMS population. The FSIQ-RMS was designed to assess fatigue symptoms, relevant to patients with RMS, and their impact on physical activity, cognitive and emotional function, and coping mechanisms.…”