The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States

Caroline Schaefer, Arthi Chandran, Meghan Hufstader, Rebecca Baik, Michael McNett, Don Goldenberg, Robert Gerwin, Gergana Zlateva, Caroline Schaefer, Arthi Chandran, Meghan Hufstader, Rebecca Baik, Michael McNett, Don Goldenberg, Robert Gerwin, Gergana Zlateva

Abstract

Background: Fibromyalgia (FM) is characterized by chronic, widespread pain, fatigue, and other symptoms; yet few studies have comprehensively assessed its humanistic burden. This observational study evaluates the impact of FM severity on patients' symptoms, health-related quality of life (HRQoL), and productivity in the United States.

Methods: 203 FM subjects were recruited from 20 physician offices. Subjects completed a questionnaire including the EuroQol 5D (EQ-5D), Fibromyalgia Impact Questionnaire (FIQ), Multidimensional Assessment of Fatigue (MAF), Medical Outcomes Study Sleep Scale (MOS-SS), and Hospital Anxiety and Depression Scale (HADS) and questions about demographics, pain and other symptoms, HRQoL and productivity. FIQ total scores were used to define FM severity, with 0- < 39, 39- < 59, and 59-100, representing mild, moderate, and severe FM, respectively. Sites recorded subjects' clinical characteristics and FM treatment on case report forms using medical records. Summary statistics were calculated for continuous variables and frequency distributions for categorical variables. Differences across FM severity groups were evaluated using the Kruskal-Wallis or Chi-square tests. Statistical significance was evaluated at the 0.05 level.

Results: Mean (SD) age was 47.9 (10.9); 95% were female. Most (92%) were prescribed medication for FM; 24% and 66% reported moderate and severe FM, respectively. Mean (SD) scores were: 6.3 (2.1) for pain intensity; 0.35 (0.35) for EQ-5D; 30.7 (14.2) for MAF; 57.5 (18.4) for MOS-SS Sleep Problems Index; 10.2 (4.8) for HADS anxiety and 9.4 (4.4) for HADS depression. Subjects with worse FM severity reported significantly increased pain severity, HRQoL, fatigue, sleep disturbance, anxiety and depression (p < 0.001). Overall, 50% of subjects reported some disruption in their employment due to FM; this differed across severity levels (p < 0.001). Employed subjects missed a mean (SD) of 1.8 (3.9) workdays during the past 4 weeks; this also differed across severity levels (p = 0.03).

Conclusions: FM imposes a substantial humanistic burden on patients in the United States, and leads to substantial productivity loss, despite treatment. This burden is higher among subjects with worse FM severity.

Figures

Figure 1
Figure 1
Impact of Fibromyalgia on HRQoL: Mean Study Sample EQ-5D Scores Compared to US General Population. Source: Subject Questionnaire and Fryback et al, 2007 (US Norm for age range 45-54) [28]. Note: Higher scores indicate better HRQoL.
Figure 2
Figure 2
Impact of Fibromyalgia on Sleep: Mean Study Sample MOS-SS Scores Compared to US General Population. Source: Subject Questionnaire and Hays et al, 2005 (US Norms for age range 18-94) [26]. Note: Higher scores indicate more of the concept being measured. Higher scores represent worse outcomes on all scales except for sleep adequacy, where higher scores represent better outcomes.
Figure 3
Figure 3
Impact of Fibromyalgia on Employment: Overall and by Severity Level. Source: Subject Questionnaire. * P-value < 0.001 (Chi-square test; mild vs. moderate vs. severe by impact of FM on employment status).

References

    1. 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. doi: 10.1002/art.1780380104.
    1. Weir PT, Harlan GA, Nkoy FL, Jones SS, Hegmann KT, Gren LH, Lyon JL. Incidence of Fibromyalgia and Its Associated Comorbidities. Journal of Clinical Rheumatology. 2006;12(3):124–128. doi: 10.1097/01.rhu.0000221817.46231.18.
    1. Jones J, Rutledge DN, Jones KD, Matallana L, Rooks DS. Self-Assessed Physical Function Levels of Women with Fibromyalgia: A National Study. Women's Health Issues. 2008;18:406–412. doi: 10.1016/j.whi.2008.04.005.
    1. Arnold LM, Hudson JI, Keck PE Jr, Auchenback MB, Javaras KN, Hess EV. Comorbidity of fibromyalgia and psychiatric disorders. J Clin Psychiatry. 2006;67:1219–1225. doi: 10.4088/JCP.v67n0807.
    1. White KP, Speechley M, Harth M, Ostbye T. The London Fibromyalgia Epidemiology Study: Comparing self-reported function and work disability in 100 community cases of fibromyalgia syndrome versus controls in London, Ontario. Arthritis and Rheumatism. 1999;42(1):76–83. doi: 10.1002/1529-0131(199901)42:1<76::AID-ANR10>;2-G.
    1. Park DC, Glass JM, Minear M, Crofford LJ. Cognitive Function in Fibromyalgia Patients. Arthritis and Rheumatism. 2001;44(9):2125–2133. doi: 10.1002/1529-0131(200109)44:9<2125::AID-ART365>;2-1.
    1. Annemans L, Le Lay K, Taïeb C. Societal and patient burden of fibromyalgia syndrome. Pharmacoeconomics. 2009;27(7):547–559. doi: 10.2165/11313650-000000000-00000.
    1. Gormsen L, Rosenberg R, Bach FW, Jensen TS. Depression, anxiety, health-related quality of life and pain in patients with chronic fibromyalgia and neuropathic pain. Eur J Pain. 2010;14(2):127. e1-8.
    1. Moore RA, Straube S, Paine J, Phillips CJ, Derry S, McQuay HJ. Fibromyalgia: Moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain. Pain. 2010;149(2):360–364. doi: 10.1016/j.pain.2010.02.039.
    1. 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(6):1318–1325.
    1. White LA, Birnbaum HG, Kaltenboeck A, Tang J, Mallett D, Robinson RL. Employees with fibromyalgia: medical comorbidity, healthcare costs, and work loss. J Occup Environ Med. 2008;50:13–24. doi: 10.1097/JOM.0b013e31815cff4b.
    1. Mease PJ, Clauw DJ, Arnold LM. et al.Fibromyalgia syndrome. J Rheumatol. 2005;32:2270–2277.
    1. Perrot S, Winkelmann A, Dukes E, Xu X, Schaefer C, Ryan K, Chandran A, Sadosky A, Zlateva G. Characteristics of patients with fibromyalgia in France and Germany. Int J Clin Pract. 2010;64(8):1100–1108. doi: 10.1111/j.1742-1241.2010.02418.x.
    1. Wolfe F, Michaud K, Li T, Katz RS. EQ-5D and SF-36 quality of life measures in systemic lupus erythematosus: comparisons with rheumatoid arthritis, noninflammatory rheumatic disorders, and fibromyalgia. J Rheumatol. 2010;37(2):296–304. doi: 10.3899/jrheum.090778.
    1. Bigatti SM, Hernandez AM, Cronan TA, Rand KL. Sleep disturbances in fibromyalgia syndrome: relationship to pain and depression. Arthritis Rheum. 2008;59(7):961–967. doi: 10.1002/art.23828.
    1. Cappelleri JC, Bushmakin AG, McDermott AM, Dukes E, Sadosky A, Petrie CD, Martin S. Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia. Sleep Med. 2009;10(7):766–770. doi: 10.1016/j.sleep.2008.09.004.
    1. Sinclair JD, Starz TW, Turk DC. The Manual Tender Point Survey. Pittsburgh, PA: University of Pittsburgh Medical Center. Copyright 1997 by the University of Pittsburgh Medical Center, Center for Continuing Education in the Health Sciences. Instructions adapted from The Manual Tender Point Survey, by JD Sinclair TW Starz and DC Turk; 1997. Instructions adapted from The Manual Tender Point Survey, by JD Sinclair TW Starz and DC Turk, accessed on September 2, 2011.
    1. EuroQol Group. EuroQol: a new facility for the measurement of health related quality of life. Health Policy. 1990;16(3):199–208.
    1. Burckhardt CS, Clark SR, Bennett RM. The Fibromyalgia Impact Questionnaire: Development and validation. J Rheumatol. 1991;18(5):728–734.
    1. Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky A. Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire. J Rheumatol. 2009;36(6):1304–1311. doi: 10.3899/jrheum.081090.
    1. Belza B, Henke C, Yelin E, Epstein W, Gilliss C. Correlates of fatigue in older adults with rheumatoid arthritis. Nursing Research. 1993;42(2):93–99.
    1. Hays RD, Stewart AL. In: Measuring Functioning and Well-being: the Medical Outcomes Study Approach. Stewart AL, Ware JE, Durham, NC, editor. Duke University Press; 1992. Sleep measures; pp. 235–259.
    1. Zigmond A, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatrica Scandinavica. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Zelman D, Dukes E, Brandenburg N, Bostrom A, Gore M. Identification of cut-points for mild, moderate and severe pain due to diabetic peripheral neuropathy. Pain. 2005;115(1-2):29–36. doi: 10.1016/j.pain.2005.01.028.
    1. SAS Institute, Cary, North Carolina
    1. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical outcomes Study Sleep measure. Sleep Med. 2005;6(1):41–44. doi: 10.1016/j.sleep.2004.07.006.
    1. Moldofsky H. The significance, assessment, and management of nonrestorative sleep in fibromyalgia syndrome. CNS Spectr. 2008;13(3):22–26.
    1. Fryback DG, Dunham NC, Palta M, Hanmer J, Buechner J, Cherepanov D, Herrington SA, Hays RD, Kaplan RM, Ganiats TG, Feeny D, Kind P. U.S. Norms from six generic health-related quality-of-life indexes from the National Health Measurement Study. Med Care. 2007;45(12):1162–70. doi: 10.1097/MLR.0b013e31814848f1.
    1. Wolfe F, Anderson J, Harkness D, Bennett RM, Caro XJ, Goldenberg DL, Russell IJ, Yunus MB. Health status and disease severity in fibromyalgia. Arth Rheum. 1997;40(9):1571–1579. doi: 10.1002/art.1780400905.
    1. Salaffi F, Sarzi-Puttini P, Girolimetti R, Atzeni F, Gasparini S, Grassi W. Health-related quality of life in fibromyalgia patients: a comparison with rheumatoid arthritis patients and the general population using the SF-36 health survey. Clin Exp Rheumatol. 2009;27(5 Suppl 56):S67–74.
    1. Hoffman DL, Dukes EM. The health status burden of people with fibromyalgia: a review of studies that assessed health status with the SF-36 or the SF-12. International Journal of Clinical Practice. 2008;62(1):115–126.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere