Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Jul 14:12:111.
doi: 10.1186/s12955-014-0111-6.

Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary

Leah Kleinman, Sally Mannix, Lesley M Arnold, Claire Burbridge  1 , Kellee Howard, Kelly McQuarrie, Verne Pitman, Malca Resnick, Tom Roth, Tara Symonds
Affiliations

Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary

Leah Kleinman et al. Health Qual Life Outcomes. .

Abstract

Objectives: Sleep disturbance is a common experience in fibromyalgia (FM). The field lacks a sleep specific patient reported outcome (PRO) measure developed and validated in a FM population. The study objective is to gain an in-depth understanding of sleep in FM and to develop a PRO measure of it.

Methods: Research involved the following stages: 1) A literature review conducted to identify key concepts associated with FM patient experience of sleep and PRO measures that have been used to assess this; 2) Qualitative interviews with therapeutic area experts; 3) Focus groups with FM patients who experienced sleep disturbance; 4) Development of a conceptual framework and the Fibromyalgia Sleep Diary (FMSD); and 5) Cognitive interviews with patients to explore content validity of the FMSD.

Results: The literature review and expert interviews supported sleep disturbance being an important aspect of the FM patient experience, and underscored the need for a new FM specific sleep PRO measure. Results from the focus groups demonstrated that FM patients experience sleep disturbances that they attribute to their FM symptoms, such as pain and stiffness, confirming the importance of understanding more about sleep changes. Aspects of sleep raised by FM patients included poor sleep quality and insufficient quantity including difficulty with falling asleep, getting comfortable, and staying asleep; restlessness; light sleep; not feeling rested upon awakening; and difficulty starting the day. Cognitive interview results showed that the 8-item FMSD, developed to reflect the concepts identified above, was relevant to FM patients with content that was interpreted as intended.

Conclusions: The FMSD was developed in line with the recommendations of the FDA PRO guidance and ISPOR PRO Task Force. The qualitative evidence generated thus far strongly supports the content validity of the FMSD as a PRO measure of sleep disturbance in FM populations. Psychometric evaluation of the FMSD to demonstrate reliability, validity and sensitivity to change is recommended as a next step.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Conceptual framework for sleep disturbance in fibromyalgia.
See this image and copyright information in PMC

References

    1. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, Fam AG, Farber SJ, Fiechtner JJ, Franklin CM, Gatter RA, Hamaty D, Lessard J, Lichtbroun AS, Masi AT, McCain GA, Reynolds WJ, Romano TJ, Russell IK, Sheon RP. The American college of rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990;33:160–172. doi: 10.1002/art.1780330203. - DOI - PubMed
    1. Mease P, Arnold LM, Choy EH, Clauw DJ, Crofford LJ, Glass JM, Martin SA, Morea J, Simon L, Strand CV, Williams DA, Group OFW. Fibromyalgia syndrome module at OMERACT 9: domain construct. J Rheumatol. 2009;36:2318–2329. doi: 10.3899/jrheum.090367. - DOI - PMC - PubMed
    1. Mease P, Arnold LM, Bennett R, Boonen A, Buskila D, Carville S, Chappell A, Choy E, Clauw D, Dadabhoy D, Gendreau M, Goldenberg D, Littlejohn G, Martin S, Perera P, Russell IJ, Simon L, Spaeth M, Williams D, Crofford L. Fibromyalgia syndrome. J Rheumatol. 2007;34:1415–1425. - PubMed
    1. Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L, Martin SA. Patient perspectives on the impact of fibromyalgia. Patient Educ Couns. 2008;73:114–120. doi: 10.1016/j.pec.2008.06.005. - DOI - PMC - PubMed
    1. Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Fed Regist. 2009;74:65132–65133. - PMC - PubMed

Publication types

MeSH terms