Dataset Information

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

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.

SUBMITTER: Kleinman L

PROVIDER: S-EPMC4110695 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Kleinman Leah L Mannix Sally S Arnold Lesley M LM Burbridge Claire C Howard Kellee K McQuarrie Kelly K Pitman Verne V Resnick Malca M Roth Tom T Symonds Tara T

Health and quality of life outcomes 20140714

<h4>Objectives</h4>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.<h4>Methods</h4>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 us ...[more]

PMID: 25017455

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Project description:Purpose:The sleep diary is the gold standard of self-reported sleep duration, but its comparability to sleep questionnaires is uncertain. The purpose of this study was to compare self-reported sleep duration between a sleep diary and a sleep questionnaire and to test whether sleep-related disorders were associated with diary-questionnaire differences in sleep duration. Participants and methods:We compared self-reported sleep duration from 5,432 questionnaire-sleep diary pairs in a longitudinal cohort of 1,516 adults. Participants reported sleep information in seven-day sleep diaries and in questionnaires. Research staff abstracted average sleep durations for three time periods (overall; weekday; weekend) from diaries and questionnaires. For each time period, we evaluated diary-questionnaire differences in sleep duration with Welch's two-sample t-tests. Using linear mixed effects regression, we regressed overall diary-questionnaire sleep duration difference on several participant characteristics: reporting any insomnia symptoms, having sleep apnea, sex, body mass index, smoking status, Short Form-12 Physical Health Composite Score, and Short Form-12 Mental Health Composite Score. Results:The average diary-reported overall sleep duration (7.76 hrs) was longer than that of the questionnaire (7.07 hrs) by approximately 41 mins (0.69 hrs, 95% confidence interval: 0.62, 0.76 hrs). Results were consistent across weekday- and weekend-specific differences. Demographic-adjusted linear mixed effects models tested whether insomnia symptoms or sleep apnea were associated with diary-questionnaire differences in sleep duration. Insomnia symptoms were associated with a 17 min longer duration on the diary relative to the questionnaire (?=0.28 hrs, 95% confidence interval: 0.22, 0.33 hrs), but sleep apnea was not significantly associated with diary-questionnaire difference. Female sex was associated with greater diary-questionnaire duration differences, whereas better self-reported health was associated with lesser differences. Conclusion:Diaries and questionnaires are somewhat disparate methods of assessing subjective sleep duration, although diaries report longer duration relative to questionnaires, and insomnia symptoms may contribute to greater perceived differences.

Project description:BackgroundDisturbed sleep is commonly reported in fibromyalgia (FM). Both the Sleep Quality Numeric Rating Scale (NRS) and the Medical Outcomes Study Sleep Scale (MOS-Sleep) have demonstrated positive psychometric properties in patients with FM. However, these assessments were developed prior to the current recommendation to include patient input during the concept elicitation or item generation phases. Therefore, the objective of this study was to evaluate the impact of FM on participants, including their sleep, and to test the content validity of these two sleep measures in FM patients.MethodsQualitative interviews were conducted in Raleigh, North Carolina and Detroit, Michigan with 20 adults who reported a physician diagnosis of FM. Sixteen participants were female, 13 were white, and the average age was 50 years. Two researchers conducted all interviews using a structured guide.ResultsParticipants consistently reported that FM had a debilitating impact on their lives and their sleep, particularly getting to sleep and staying asleep. Participants responded positively to the Sleep Quality NRS as an assessment of their sleep. The majority of participants stated that they would not change the response numbering or wording of the item's anchors. Participants also responded positively to the 24-hour recall period of the Sleep Quality NRS. Participants found the 12-item MOS-Sleep to be appropriate and relevant; 19 participants indicated the measure captured all of their sleep-related symptoms. However, areas for potential modification were identified, such as the need to separate the item regarding awakening short of breath and awakening with a headache into two separate questions. Participants also questioned the relevance of the snoring and awakening short of breath items to FM. Half of participants expressed a preference for a daily rather than a weekly recall period.ConclusionThis study demonstrates the significant impact that FM has on patients' lives, particularly sleep. While patients with FM were not part of the development of the generic sleep assessments that were evaluated, this study provides evidence of their content validity, supporting their use in FM studies. Modifications to the MOS-Sleep may improve the psychometric properties and relevance to patients with FM.

Project description:STUDY OBJECTIVES:Individuals with primary insomnia often have poorer self-reported sleep than objectively measured sleep, a phenomenon termed negative sleep discrepancy. Recent studies suggest that this phenomenon might differ depending on comorbidities. This study examined sleep discrepancy, its night-to-night variability, and its correlates in comorbid insomnia and fibromyalgia. METHODS:Sleep diaries and actigraphy data were obtained from 223 adults with fibromyalgia and insomnia (age = 51.53 [standard deviation = 11.90] years; 93% women) for 14 days. Sleep discrepancy was calculated by subtracting diary from actigraphy estimates of sleep onset latency (SOL-D), wake after sleep onset (WASO-D), and total sleep time (TST-D) for each night. Night-to-night variability in sleep discrepancy was calculated by taking the within-individual standard deviations over 14 days. Participants completed measures of mood, pain, fatigue, sleep/pain medications, nap duration, and caffeine consumption. RESULTS:Average sleep discrepancies across 14 days were small for all sleep parameters (< 10 minutes). There was no consistent positive or negative discrepancy. However, sleep discrepancy for any single night was large, with average absolute discrepancies greater than 30 minutes for all sleep parameters. Greater morning pain was associated with larger previous-night WASO-D, although diary and actigraphy estimates of WASO remained fairly concordant. Taking prescribed pain medications, primarily opioids, was associated with greater night-to-night variability in WASO-D and TST-D. CONCLUSIONS:Unlike patients with primary insomnia, patients with comorbid fibromyalgia do not exhibit consistent negative sleep discrepancy; however, there are both substantial positive and negative discrepancies in all sleep parameters at the daily level. Future research is needed to investigate the clinical significance and implications of high night-to-night variability of sleep discrepancy, and the role of prescribed opioid medications in sleep perception.

Dataset Information

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

Objectives

Methods

Results

Conclusions

Publications

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

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