纤维肌痛女性随机对照试验中患者报告结果测量信息系统（PROMIS）睡眠简表的重测信度及反应度
Test-Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia.
作者信息
Chimenti Ruth L, Rakel Barbara A, Dailey Dana L, Vance Carol G T, Zimmerman Miriam B, Geasland Katharine M, Williams Jon M, Crofford Leslie J, Sluka Kathleen A
机构信息
Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.
College of Nursing, University of Iowa, Iowa City, IA, United States.
出版信息
Front Pain Res (Lausanne). 2021 Jun 8;2:682072. doi: 10.3389/fpain.2021.682072. eCollection 2021.
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. (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. 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. 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)]. The PROMIS sleep measures are reliable, valid, and responsive to improvement in restorative sleep in women with fibromyalgia. www.ClinicalTrials.gov, identifier: NCT01888640.
纤维肌痛患者普遍报告存在睡眠恢复不足的情况，但关于该人群自我报告睡眠测量方法的可靠性和反应性的信息有限。（1）检验患者报告结局测量信息系统（PROMIS）睡眠测量方法在纤维肌痛女性中的可靠性和有效性，以及（2）确定与其他恢复性睡眠测量方法相比，PROMIS睡眠测量方法对纤维肌痛女性进行为期4周的每日经皮电刺激神经疗法（TENS）干预的反应性。在一项双盲、双中心临床试验中，301名纤维肌痛女性被随机分配在家中使用主动TENS、安慰剂TENS或不使用TENS。在基线和治疗4周后收集测量数据。为了评估自我报告的睡眠情况，参与者完成了三项PROMIS简表：睡眠障碍、睡眠相关损害、疲劳，以及匹兹堡睡眠质量指数（PSQI）。为了评估设备测量的睡眠情况，使用活动记录仪来量化总睡眠时间、睡眠开始后的觉醒时间和睡眠效率。采用线性混合模型来检验治疗、时间以及治疗*时间交互作用的影响。PROMIS简表具有中等的重测信度（组内相关系数ICC为0.62至0.71）和较高的内部一致性（Cronbach's α为0.89至0.92）。PROMIS睡眠测量指标[4周内的平均变化，95%置信区间（CI）]，睡眠障碍：-1.9（-3.6至-0.3），睡眠相关损害：-3（-4.6至-1.4），以及疲劳：-2.4（-3.9至-0.9）对恢复性睡眠的改善有反应，且对主动TENS组具有特异性，但对安慰剂TENS组[睡眠障碍：-1.3（-3至0.3），睡眠相关损害：-1.2（-2.8至0.4），疲劳：-1.1（-2.7至0.9）]或不使用TENS组[睡眠障碍：-0.1（-1.6至1.5），睡眠相关损害：-0.2（-1.7至1.4），疲劳：-0.3（-1.8至1.2）]则无反应。PSQI有反应，但不具有特异性，在主动TENS组：-0.9（-1.7至-0.1）和安慰剂TENS组：-0.9（-1.7至0）均检测到改善，但在不使用TENS组：-0.3（-1.1至0.5）未检测到改善。活动记录仪对主动TENS治疗后恢复性睡眠的任何变化均不敏感[睡眠效率：-1（-2.8至0.9），总睡眠时间：3.3（-19.8至26.4）]。PROMIS睡眠测量指标在纤维肌痛女性中对于恢复性睡眠的改善是可靠、有效的且具有反应性。ClinicalTrials.gov网站，标识符：NCT01888640。
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