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Coop/Wonca 图表在评估大样本复发性缓解型多发性硬化症患者 HRQoL 中的临床价值:一项多中心研究的结果。

The clinical value of Coop/Wonca charts in assessment of HRQoL in a large cohort of relapsing-remitting multiple sclerosis patients: Results of a multicenter study.

机构信息

Department of Rehabilitation, S.Marta & S.Venera Hospital, Acireale, Catania, Italy.

Department "GF Ingrassia", Section of Neurosciences, Multiple Sclerosis Center, University of Catania, Catania, Italy.

出版信息

Mult Scler Relat Disord. 2017 Oct;17:154-171. doi: 10.1016/j.msard.2017.07.022. Epub 2017 Jul 28.

Abstract

BACKGROUND

Multiple sclerosis (MS) is a chronic neurological disease impacting patients' health-related quality of life (HRQoL). Since MS specific HRQoL questionnaire are often time consuming; thus, simple, feasible and ease administering instruments are needed to assess MS HRQoL in clinical practice and clinical trials. Hence, aim of our study was to investigated the HRQoL in a large cohort of MS patients using the Coop/Wonca charts.

METHODS

This was multicenter, independent, non-sponsored, observational study, including patients from 40 Italian MS centers. Inclusion criteria were Expanded Disability Status Scale score between 1.0 and 5.5; stable disease at enrolment. HRQoL was assessed, using six Coop/Wonca charts for physical fitness, feelings, daily activities, social activities, changes in health, health condition, and the Composites Scores of Multiple Sclerosis Quality of Life-54 (MSQoL-54), physical health composite summary (PHCS) and the mental health composite summary (MHCS).

RESULTS

Out of 648, 593 relapsing-remitting MS patients, 415 (70%) women, mean age years, 417 (70%) were finally enrolled. We found a inter-rater agreement of 0.8, ranging from 0.64 to 0.91, as expressed by the alpha coefficient. Intra-rater agreement was 0.82, ranging from 0.78 to 0.96. Coop/Wonca charts were scored with a Likert method from one to five (corresponding to best and worst HRQoL respectively). According to this scoring, study population was stratified into three categories (score 1-2 corresponding to better HRQoL; score 3 corresponding to neutral profile; score 4-5 corresponding to worse HRQoL). Coop/Wonca charts resulted significantly correlated with PHCS and with MHCS.

摘要

背景

多发性硬化症(MS)是一种影响患者健康相关生活质量(HRQoL)的慢性神经系统疾病。由于 MS 特定的 HRQoL 问卷通常耗时较长;因此,需要简单、可行且易于管理的工具来评估临床实践和临床试验中的 MS HRQoL。因此,我们的研究旨在使用 Coop/Wonca 图表调查大量 MS 患者的 HRQoL。

方法

这是一项多中心、独立、非赞助的观察性研究,包括来自 40 个意大利 MS 中心的患者。纳入标准为扩展残疾状况量表评分在 1.0 到 5.5 之间;入组时疾病稳定。使用 Coop/Wonca 图表评估 HRQoL,包括身体适应力、感觉、日常活动、社会活动、健康变化、健康状况、多发性硬化症生活质量-54 综合评分(MSQoL-54)、身体健康综合评分(PHCS)和心理健康综合评分(MHCS)。

结果

在 648 名 RRMS 患者中,有 593 名(70%)为女性,平均年龄为岁,最终有 417 名(70%)患者入组。我们发现组内一致性为 0.8,范围为 0.64 到 0.91,用 alpha 系数表示。组内一致性为 0.82,范围为 0.78 到 0.96。Coop/Wonca 图表采用从 1 到 5 的李克特评分法(分别对应最佳和最差的 HRQoL)进行评分。根据这种评分,研究人群被分为三个类别(评分 1-2 对应更好的 HRQoL;评分 3 对应中性分布;评分 4-5 对应更差的 HRQoL)。Coop/Wonca 图表与 PHCS 和 MHCS 显著相关。

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