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

Health and Quality of Life Outcomes

Tara Symonds¹  Tom Roth³  Malca Resnick⁵  Verne Pitman²  Kelly McQuarrie⁷  Kellee Howard⁷  Claire Burbridge¹  Lesley M Arnold⁶  Sally Mannix⁴  Leah Kleinman⁴ 

[1] Pfizer Ltd, Walton Oaks, Dorking Road, Walton on the Hill, Surrey KT20 7NS, Tadworth, UK;Pfizer Inc, New York, New York, USA;Henry Ford Health System, Detroit, Michigan, USA;Evidera, Bethesda, Maryland, USA;Pfizer Inc, Groton, Connecticut, USA;University of Cincinnati College of Medicine, Cincinnati, Ohio, USA;With United BioSource Corporation at the time of the study, Topeka, USA

关键词: Diary;    Patient;    Qualitative;    Sleep;    Fibromyalgia;   

Others  :  1164562
DOI  :  10.1186/s12955-014-0111-6

 received in 2014-01-15, accepted in 2014-06-30,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Kleinman et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [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.
• [2]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.
• [3]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.
• [4]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.
• [5]Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Fed Regist 2009, 74:65132-65133.
• [6]Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L: Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1–eliciting concepts for a new PRO instrument. Value Health 2011, 14:967-977.
• [7]Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L: Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2–assessing respondent understanding. Value Health 2011, 14:978-988.
• [8]Swick TJ, Alvarez-Horine S, Zheng Y, Guinta D, Inhaber N, Holman A, Smith TR, Russell I: Impaired sleep and daytime functioning at baseline in subjects with fibromyalgia from a 14-week randomized, double-blind, placebo-controlled trial of sodium oxybate. Sleep 2009, 32:A330.
• [9]Osorio CD, Gallinaro AL, Lorenzi-Filho G, Lage LV: Sleep quality in patients with fibromyalgia using the Pittsburgh sleep quality index. J Rheumatol 2006, 33:1863-1865.
• [10]Cappelleri JC, Bushmakin AG, McDermott AM, Sadosky A, Petrie CD, Martin S: Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia. Sleep 2009, 32:A328.
• [11]Chervin RD, Teodorescu M, Kushwaha R, Deline AM, Brucksch CB, Ribbens-Grimm C, Ruzicka DL, Stein PK, Clauw DJ, Crofford LJ: Objective measures of disordered sleep in fibromyalgia. J Rheumatol 2009, 36:2009-2016.
• [12]Campos RMS, Silva A, Monico Neto M, Queiroz S, Antunes HK, Tufik S, de Mello M: Profile level of physical activity and quality of sleep in patients with fibromyalgia. Sleep Med 2009, 10:S44.
• [13]Moldofsky H: The significance, assessment, and management of nonrestorative sleep in fibromyalgia syndrome. CNS Spectr 2008, 13:22-26.
• [14]Moldofsky H, Inhaber NH, Guinta DR, Alvarez-Horine SB: Effects of sodium oxybate on sleep physiology and sleep/wake-related symptoms in patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled study. J Rheumatol 2010, 37:2156-2166.
• [15]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. BioMed Central Full Text
• [16]Martin S, Chandran A, Zografos L, Zlateva G: Evaluation of the impact of fibromyalgia on patients’ sleep and the content validity of two sleep scales. Health Qual Life Outcomes 2009, 7:64. BioMed Central Full Text
• [17]Martinez JE, Cruz CG, Aranda C, Boulos FC, Lagoa LA: Disease perceptions of Brazilian fibromyalgia patients: do they resemble perceptions from other countries? Int J Rehabil Res 2003, 26:223-227.
• [18]Mease PJ, Clauw DJ, Arnold LM, Goldenberg DL, Witter J, Williams DA, Simon LS, Strand CV, Bramson C, Martin S, Wright TM, Littman B, Wernicke JF, Gendreau RM, Crofford LJ: Fibromyalgia syndrome. J Rheumatol 2005, 32:2270-2277.
• [19]Burckhardt CS, Clark SR, Bennett RM: The fibromyalgia impact questionnaire: development and validation. J Rheumatol 1991, 18:728-733.
• [20]Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 1989, 28:193-213.
• [21]Hays RD, Stewart AL: Sleep measures. In Measuring functioning and well-being: the medical outcomes study approach. Edited by Stewart AL, Ware JE. Duke University Press, Durham, NC; 1992:235-259.
• [22]Johns MW: A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991, 14:540-545.
• [23]Jenkins CD, Stanton BA, Niemcryk SJ, Rose RM: A scale for the estimation of sleep problems in clinical research. J Clin Epidemiol 1988, 41:313-321.
• [24]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, 39:315-325.
• [25]Leidy NK, Vernon M: Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics 2008, 26:363-370.