4006821c9dc8d65c80f6242ee38ad70e 327726.pdf 791c422f4079da5c623a3bdc22f87d5f7a0643a0 327726.pdf a623c47f257106091e273a636ee949f2a5984e2be1c4640c8917f306d4c19e5b 327726.pdf Title: Development of a New Patient-Reported Outcome to Measure Fatigue in Patients with Multiple Sclerosis Subject: Background: Fatigue is a multidimensional and subjective experience, and it is one of the most common symptoms of multiple sclerosis (MS), affecting up to 80% of patients and acting as a major driver of work disability. Despite its clinical significance, existing assessment tools often lack conceptual clarity or remain too lengthy for routine clinical use. Objective: To develop and evaluate a new patient-reported outcome instrument designed to assess multidimensional fatigue domains in patients with multiple sclerosis (MS) for use in clinical practice. Methods: This study was carried out in three research stages. Stage 1 (Concept Elicitation) involved qualitative interviews (n = 19) to identify core fatigue domains based on patient experience. Stage 2 (Cognitive Interviews) consisted of interviews with 50 patients to ensure the relevance and clarity of the items. Stage 3 (Exploratory Factor Analysis) and internal consistency testing (Cronbach’s alpha) were performed on the same sample of 50 patients to examine the preliminary factor structure and reliability. Results: Concept elicitation identified lack of energy and persistent exhaustion as core symptoms. The resulting 14-item instrument covers three subdomains: Psychosocial, Physical, and Cognitive. Exploratory factor analysis supported a three-factor solution explaining 75% of the total variance (Factor 1: 28%; Factor 2: 27%; Factor 3: 20%). Internal consistency was high across all factors: Psychosocial ( = 0.923), Physical ( = 0.895), and Cognitive ( = 0.844). Conclusions: This new instrument is a conceptually robust tool that captures the interconnected nature of fatigue in multiple sclerosis (MS). These initial findings support its internal structure and conceptual foundation, providing a practical tool for symptom monitoring in neurological consultations. Keywords: multiple sclerosis; fatigue; patient-reported outcome measure; nursing; factor analysis; patient-centered care Author: Miguel Angel Jorquera-Ruzzi, Cristina Ramo Tello, Maria José Durà-Mata and Irma Casas Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25; modified using OpenPDF 1.4.2 CreationDate: Fri Mar 13 04:44:04 2026 CET ModDate: Fri Mar 13 04:48:20 2026 CET Custom Metadata: yes Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 19 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 683693 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- VGYPEQ+URWPalladioL-Bold Type 1 Custom yes yes yes 77 0 WNWTFR+VnURWPalladioL-Bold Type 1 Custom yes yes yes 78 0 CKBPVA+EURM10 Type 1 Builtin yes yes yes 79 0 AACGZA+URWPalladioL-Roma Type 1 Custom yes yes yes 80 0 SOFEYK+URWPalladioL-Ital Type 1 Custom yes yes yes 81 0 GQWIGS+CMSY10 Type 1 Builtin yes yes yes 231 0 OFJIPB+PalatinoLinotype TrueType WinAnsi yes yes no 254 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 300 0 CZOINJ+EURB10 Type 1 Builtin yes yes yes 315 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-04-16 03:59:33 CEST RepresentationInformation: 327726.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-04-15 15:15:20 CEST Size: 683693 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 480 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: true CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Item: Title: Materials and Methods Item: Title: Results Item: Title: Discussion Item: Title: Strengths and Limitations Item: Title: Conclusions Item: Title: References Info: Title: Development of a New Patient-Reported Outcome to Measure Fatigue in Patients with Multiple Sclerosis Author: Miguel Angel Jorquera-Ruzzi, Cristina Ramo Tello, Maria José Durà-Mata and Irma Casas Subject: Background: Fatigue is a multidimensional and subjective experience, and it is one of the most common symptoms of multiple sclerosis (MS), affecting up to 80% of patients and acting as a major driver of work disability. Despite its clinical significance, existing assessment tools often lack conceptual clarity or remain too lengthy for routine clinical use. Objective: To develop and evaluate a new patient-reported outcome instrument designed to assess multidimensional fatigue domains in patients with multiple sclerosis (MS) for use in clinical practice. Methods: This study was carried out in three research stages. Stage 1 (Concept Elicitation) involved qualitative interviews (n = 19) to identify core fatigue domains based on patient experience. Stage 2 (Cognitive Interviews) consisted of interviews with 50 patients to ensure the relevance and clarity of the items. Stage 3 (Exploratory Factor Analysis) and internal consistency testing (Cronbach’s alpha) were performed on the same sample of 50 patients to examine the preliminary factor structure and reliability. Results: Concept elicitation identified lack of energy and persistent exhaustion as core symptoms. The resulting 14-item instrument covers three subdomains: Psychosocial, Physical, and Cognitive. Exploratory factor analysis supported a three-factor solution explaining 75% of the total variance (Factor 1: 28%; Factor 2: 27%; Factor 3: 20%). Internal consistency was high across all factors: Psychosocial ( = 0.923), Physical ( = 0.895), and Cognitive ( = 0.844). Conclusions: This new instrument is a conceptually robust tool that captures the interconnected nature of fatigue in multiple sclerosis (MS). These initial findings support its internal structure and conceptual foundation, providing a practical tool for symptom monitoring in neurological consultations. 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