Test–Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia

Abstract

Background: Nonrestorative sleep is commonly reported by individuals with fibromyalgia, but there is limited information on the reliability and responsiveness of self-reported sleep measures in this population.Objectives: (1) Examine the reliability and validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep measures in women with fibromyalgia, and (2) Determine the responsiveness of the PROMIS sleep measures to a daily transcutaneous electrical nerve stimulation (TENS) intervention in women with fibromyalgia over 4 weeks compared with other measures of restorative sleep.Methods: In a double-blinded, dual-site clinical trial, 301 women with fibromyalgia were randomly assigned to utilize either Active-TENS, Placebo-TENS, or No-TENS at home. Measures were collected at baseline and after 4 weeks of treatment. To assess self-reported sleep, the participants completed three PROMIS short forms: Sleep Disturbance, Sleep-Related Impairment, Fatigue, and the Pittsburgh Sleep Quality Index (PSQI). To assess device-measured sleep, actigraphy was used to quantify total sleep time, wake after sleep onset, and sleep efficiency. Linear mixed models were used to examine the effects of treatment, time, and treatment*time interactions.Results: The PROMIS short forms had moderate test–retest reliability (ICC 0.62 to 0.71) and high internal consistency (Cronbach's alpha 0.89 to 0.92). The PROMIS sleep measures [mean change over 4 weeks, 95% confidence interval (CI)], Sleep Disturbance: −1.9 (−3.6 to −0.3), Sleep-Related Impairment: −3 (−4.6 to −1.4), and Fatigue: −2.4 (−3.9 to −0.9) were responsive to improvement in restorative sleep and specific to the Active-TENS group but not in the Placebo-TENS [Sleep Disturbance: −1.3 (−3 to 0.3), Sleep-Related Impairment: −1.2 (−2.8 to 0.4), Fatigue: −1.1 (−2.7 to 0.9)] or No-TENS [Sleep Disturbance: −0.1 (−1.6 to 1.5), Sleep-Related Impairment: −0.2 (−1.7 to 1.4), Fatigue: –.3 (−1.8 to 1.2)] groups. The PSQI was responsive but not specific with improvement detected in both the Active-TENS: −0.9 (−1.7 to −0.1) and Placebo-TENS: −0.9 (−1.7 to 0) groups but not in the No-TENS group: −0.3 (−1.1 to 0.5). Actigraphy was not sensitive to any changes in restorative sleep with Active-TENS [Sleep Efficiency: −1 (−2.8 to 0.9), Total Sleep Time: 3.3 (−19.8 to 26.4)].Conclusion: The PROMIS sleep measures are reliable, valid, and responsive to improvement in restorative sleep in women with fibromyalgia.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT01888640.

Assessing sleep and pain among adults with myalgic encephalomyelitis/chronic fatigue syndrome: psychometric evaluation of the PROMIS® sleep and pain short forms

“…Although a reliability coefficient > 0.70 (or a T-score standard error of measurement [T-SEM] < 5.5) is considered acceptable for group-level analyses, a reliability coefficient > 0.90 (or a T-SEM < 3.2) is needed for precisely assessing individual patients [ 71 , 72 ]. We hypothesized that, consistent with previous findings with other health conditions [ 73 – 77 ], the PROMIS sleep and pain scores among participants with ME / CFS would have reliability estimates exceeding those recommended for individual-level comparisons ( i.e., omega > 0.90 and T-SEM < 3.2 ).…”

“…The PROMIS sleep and pain short forms are generic (i.e., not condition-specific) measures that have been tested in various patient populations (e.g., fibromyalgia, hypertension, sleep disorder, rheumatoid arthritis, sickle cell disease) [ 53 , 77 , 94 , 95 ]. The current study demonstrated that the four PROMIS short forms had strong reliability and validity to assess sleep and pain outcomes for individuals with ME/CFS, thus they are useful tools for researchers and clinicians to examine individuals with varying levels of functional impairment due to ME/CFS as well as comparing them to those with other illnesses.…”

Mind wandering and sleep in daily life: A combined actigraphy and experience sampling study

“…Despite few items, this scale correlates strongly with the long form and shows greater measurement precision than other standard questionnaires of sleep quality (Yu et al, 2011). It has shown moderate test-retest reliability over four weeks and correlates negatively with sleep efficiency measured with actigraphy (Chimenti et al, 2021).…”

A cross-sectional observational study comparing individuals with a symptomatic full-thickness rotator cuff tear with age-matched controls

“… 9 , 23 , 36 They include the 4-item Perceived Stress Scale (PSS), an instrument with adequate reliability ( r = 0.76) 80 which aims to measure how different situations affect one’s feelings and perceived stress, 44 the Pain Catastrophizing Scale, 21 , 75 which reliably (ICC = 0.83-0.93) 85 measures the extent to which individuals have overly negative and pervasive thoughts about pain, the Patient Health Questionnaire (PHQ), a reliable (ICC = 0.84-0.94) 91 tool developed to diagnose the presence and severity of depression, 74 the State-Trait Anxiety Inventory, a measure of state and trait anxiety, 2 and the PROMIS short-form 4a, a measure of sleep disturbance with moderate reliability (ICC = 0.62-0.71). 7 4) Pain sensitivity: Pressure pain threshold (PPT), which evaluates modulation of pain-related processes in the central nervous system, 47 was assessed. PPT is defined as the minimal amount of pressure at which pain is perceived.…”