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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Research article

Multidimensional daily diary of fatigue–fibromyalgia–17 items (MDF-fibro-17). part 1: development and content validity

Authors: S. Morris, Y. Li, J.A.M. Smith, S. Dube’, C. Burbridge, T. Symonds

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

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Abstract

Background

Fibromyalgia (FM), a disorder characterized by chronic widespread pain and tenderness, affects greater than five million individuals in the United States alone. Patients experience multiple symptoms in addition to pain, and among them, fatigue is one of the most bothersome and disabling. There is a growing body of literature suggesting that fatigue is a multidimensional concept. Currently, to our knowledge, no multidimensional Patient Reported Outcome (PRO) measure of FM-related fatigue meets Food and Drug Administration (FDA) requirements to support a product label claim. Therefore, the objective of this research was to evaluate qualitative and quantitative data previously gathered to inform the development of a comprehensive, multidimensional, PRO measure to assess FM-related fatigue in FM clinical trials.

Methods

Existing qualitative and quantitative data from three previously conducted studies in patients with FM were reviewed to inform the initial development of a multidimensional PRO measure of FM-related fatigue: 1) a concept elicitation study involving in-depth, open-ended interviews with patients with FM in the United States (US) (N = 20), Germany (N = 10), and France (N = 10); 2) a cognitive debriefing and pilot study of a preliminary pool of 23 items (N = 20 US patients with FM); and 3) a methodology study that explored initial psychometrics of the item pool (N = 145 US patients with FM).

Results

Five domains were identified that intend to capture the broad experience of FM-related fatigue reported in the qualitative research: the Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Seventeen of the original pool of 23 items were selected to best capture these five dimensions. These 17 items formed the basis of a newly developed multidimensional PRO measure to assess FM-related fatigue in clinical trials: the Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 (MDF-Fibro-17).

Conclusion

Qualitative analysis, and preliminary quantitative item level data, confirmed that FM-related fatigue is multidimensional and provided strong support for the content validity of the MDF-Fibro-17. The next stage was to quantitatively evaluate the measure to confirm the factor structure, psychometric properties, sensitivity to change, and meaningful change. This has been conducted and is being reported separately.
Literature
1.
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the united states. Part II Arthritis Rheum. 2008;58:26–35.CrossRefPubMed
2.
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American college of rheumatology 1990 criteria for the classification of fibromyalgia. Report of the multicenter criteria committee. Arthritis Rheum. 1990;33:160–72.CrossRefPubMed
3.
Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995;38:19–28.CrossRefPubMed
4.
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American college of rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010;62:600–10.CrossRef
5.
Arnold LM, Hirsch I, Sanders P, Ellis A, Hughes B. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2012;64:2387–97.CrossRefPubMed
6.
Burbridge C, Symonds T, Humphrey L, Arbuckle R, Hirsch I, Whelan L. Validation of the Daily Diary of Fatigue Symptoms – Fibromyalgia (DFS-Fibro). Open J Rheumatol Autoimmune Dis. 2013;3:92–103. 
7.
Perrot S, Winkelmann A, Dukes E, Xu X, Schaefer C, Ryan K, et al. Characteristics of patients with fibromyalgia in France and Germany. Int J Clin Pract. 2010;64:1100–8.CrossRefPubMed
8.
Robinson RL, Birnbaum HG, Morley MA, Sisitsky T, Greenberg PE, Claxton AJ. Economic cost and epidemiological characteristics of patients with fibromyalgia claims. J Rheumatol. 2003;30:1318–25.PubMed
9.
Schaefer C, Chandran A, Hufstader M, Baik R, McNett M, Goldenberg D, et al. The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States. Health Qual Life Outcomes. 2011;9:71.CrossRefPubMedPubMedCentral
10.
Mapi Values UK. Fatigue, physical and cognitive functioning in Fibromyalgia: Findings from the concept elicitation patient interviews (internal report, unpublished). Report PI5912A v18.0. 2009.
11.
White KP, Speechley M, Harth M, Ostbye T. Comparing self-reported function and work disability in 100 community cases of fibromyalgia syndrome versus controls in London, Ontario: the London fibromyalgia epidemiology study. Arthritis Rheum. 1999;42:76–83.CrossRefPubMed
12.
Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011;13:R86.CrossRefPubMedPubMedCentral
13.
Hudson JI, Arnold LM, Bradley LA, Choy EH, Mease PJ, Wang F, et al. What makes patients with fibromyalgia feel better? correlations between patient global impression of improvement and changes in clinical symptoms and function: a pooled analysis of 4 randomized placebo-controlled trials of duloxetine. J Rheumatol. 2009;36:2517–22.CrossRefPubMed
14.
Humphrey L, Arbuckle R, Mease P, Williams DA, Samsoe BD, Gilbert C. Fatigue in fibromyalgia: a conceptual model informed by patient interviews. BMC Musculoskelet Disord. 2010;11:216.CrossRefPubMedPubMedCentral
15.
Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum. 2008;59:952–60.CrossRefPubMed
16.
Hauser W, Klose P, Langhorst J, Moradi B, Steinbach M, Schiltenwolf M, et al. Efficacy of different types of aerobic exercise in fibromyalgia syndrome: a systematic review and meta-analysis of randomised controlled trials. Arthritis Res Ther. 2010;12:R79.CrossRefPubMedPubMedCentral
17.
Mease P, Arnold LM, Bennett R, Boonen A, Buskila D, Carville S, et al. Fibromyalgia syndrome. J Rheumatol. 2007;34:1415–25.PubMed
18.
Mease PJ, Clauw DJ, Gendreau RM, Rao SG, Kranzler J, Chen W, et al. The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009;36:398–409.CrossRefPubMed
19.
Cudney SA, Butler MR, Weinert C, Sullivan T. Ten rural women living with fibromyalgia tell it like it is. Holist Nurs Pract. 2002;16:35–45.CrossRefPubMed
20.
Cunningham MM, Jillings C. Individuals’ descriptions of living with fibromyalgia. Clin Nurs Res. 2006;15:258–73.CrossRefPubMed
21.
Hellstrom O, Bullington J, Karlsson G, Lindqvist P, Mattsson B. A phenomenological study of fibromyalgia. Patient perspectives. Scand J Prim Health Care. 1999;17:11–6.CrossRefPubMed
22.
Schaefer KM. The lived experience of fibromyalgia in African American women. Holist Nurs Pract. 2005;19:17–25.CrossRefPubMed
23.
Sturge-Jacobs M. The experience of living with fibromyalgia: confronting an invisible disability. Res Theory Nurs Pract. 2002;16:19–31.CrossRefPubMed
24.
Hauser W, Bernardy K, Uceyler N, Sommer C. Treatment of fibromyalgia syndrome with gabapentin and pregabalin--a meta-analysis of randomized controlled trials. Pain. 2009;145:69–81.CrossRefPubMed
25.
Hauser W, Bernardy K, Arnold B, Offenbacher M, Schiltenwolf M. Efficacy of multicomponent treatment in fibromyalgia syndrome: a meta-analysis of randomized controlled clinical trials. Arthritis Rheum. 2009;61:216–24.CrossRefPubMed
26.
Hauser W, Wolfe F, Tolle T, Uceyler N, Sommer C. The role of antidepressants in the management of fibromyalgia syndrome: a systematic review and meta-analysis. CNS Drugs. 2012;26:297–307.CrossRefPubMed
27.
Hauser W, Burgmer M, Kollner V, Schaefert R, Eich W, Hausteiner-Wiehle C, et al. Fibromyalgia syndrome as a psychosomatic disorder - diagnosis and therapy according to current evidence-based guidelines. Z Psychosom Med Psychother. 2013;59:132–52.PubMed
28.
Smets EM, Garssen B, Bonke B, de Haes JC. The multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39:315–25.CrossRefPubMed
29.
Metadata
Title
Multidimensional daily diary of fatigue–fibromyalgia–17 items (MDF-fibro-17). part 1: development and content validity
Authors
S. Morris
Y. Li
J.A.M. Smith
S. Dube’
C. Burbridge
T. Symonds
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-017-1544-y

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