类风湿关节炎患者睡眠与应对数字评定量表的心理测量学特性：一项依那西普试验的亚分析

Psychometric properties of sleep and coping numeric rating scales in rheumatoid arthritis: a subanalysis of an etanercept trial.

作者信息

Avila-Ribeiro Pedro, Brault Yves, Dougados Maxime, Gossec Laure

机构信息

Sorbonne Universités, UPMC Univ.Paris 06, Inst. Pierre Louis d'Epidémiologie et de Santé Publique, and Dept.of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France; and Dept.of Rheumatology, Santa Maria Hosp., Centro Hospitalar Lisboa, Portugal.

Pfizer, Paris, France.

出版信息

Clin Exp Rheumatol. 2017 Sep-Oct;35(5):786-790. Epub 2017 Mar 23.

PMID:28339355

Abstract

OBJECTIVES

In rheumatoid arthritis, quality of sleep and ability to cope are important for patients; however their usefulness as outcome measures is not well established.

METHODS

Post-hoc analysis of an open-label 12-week trial of etanercept in biologic-naïve rheumatoid arthritis patients with visits at screening, baseline and over 12 weeks. Outcomes measured included Disease Activity Score 28 erythrocyte sedimentation rate (DAS28), numeric rating scales for sleep, coping, patient and physician-global assessment, pain and fatigue, and modified-HAQ. Reliability between screening and baseline visits by intra-class correlation, and responsiveness between baseline and 12 weeks by standardised response means were assessed for each outcome.

RESULTS

In 108 patients, mean age 54 (standard deviation (SD) 13) years, mean disease duration 8 (SD 7) years, 75% women; disease activity was high at baseline: mean DAS28 5.5 (SD 0.8). Reliability intra-class correlation was 0.83[95% confidence interval: 0.77;0.88] for sleep, 0.81[0.74;0.87] for modified-HAQ, 0.80[0.71;0.86] for fatigue, 0.72[0.62;0.80] for physician-global assessment, 0.66[0.54;076] for coping, 0.65[0.53;0.75] for pain and 0.63[0.50;0.73] for patient-global assessment. Responsiveness standardised response means was 1.65[1.32;2.10] for physician-global assessment, 1.37[1.09;1.73] for pain, 1.36[1.08;1.73] for patient-global assessment, 1.15[0.95;1.41] for fatigue, 0.96[0.70;1.28] for coping, 0.92[0.73;1.15] for sleep and 0.86[0.69;1.07] for modified-HAQ.

CONCLUSIONS

Numeric rating scales assessing sleep and coping were found to be generally as reliable as 'usual' outcomes in rheumatoid arthritis. Responsiveness was less high, indicating these domains of health may be less accessible to biologic treatment. When assessing the patient's perspective on treatment, it is feasible and valid to measure sleep and coping by numeric rating scales.

摘要

目的

在类风湿关节炎中，睡眠质量和应对能力对患者很重要；然而，它们作为结局指标的有效性尚未得到充分证实。

方法

对一项开放标签的12周试验进行事后分析，该试验在初治的类风湿关节炎患者中使用依那西普，在筛查、基线及12周期间进行访视。测量的结局包括28个关节疾病活动评分（DAS28）、红细胞沉降率、睡眠、应对、患者及医生整体评估、疼痛和疲劳的数字评分量表，以及改良健康评估问卷（HAQ）。通过组内相关系数评估筛查和基线访视之间的可靠性，通过标准化反应均值评估基线和12周之间的反应性，对每个结局指标进行评估。

结果

108例患者，平均年龄54（标准差[SD]13）岁，平均病程8（SD 7）年，75%为女性；基线时疾病活动度较高：平均DAS28为5.5（SD 0.8）。睡眠的组内相关系数可靠性为0.83[95%置信区间：0.77；0.88]，改良HAQ为0.81[0.74；0.87]，疲劳为0.80[0.71；0.86]，医生整体评估为0.72[0.62；0.80]，应对为0.66[0.54；0.76]，疼痛为0.65[0.53；0.75]，患者整体评估为0.63[0.50；0.73]。医生整体评估的反应性标准化反应均值为1.65[1.32；2.10]，疼痛为1.37[1.09；1.73]，患者整体评估为1.36[1.08；1.73]，疲劳为1.15[0.95；1.41]，应对为0.96[0.70；1.28]，睡眠为0.92[0.73；1.15]，改良HAQ为0.86[0.69；1.07]。