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一项基于网络的随机对照试验的远程监测,该试验评估了一项为期24周的多组分干预对纤维肌痛患者关键健康结局的时间累积效应。

Web/Internet-based telemonitoring of a randomized controlled trial evaluating the time-integrated effects of a 24-week multicomponent intervention on key health outcomes in patients with fibromyalgia.

作者信息

Salaffi Fausto, Ciapetti Alessandro, Gasparini Stefania, Atzeni Fabiola, Sarzi-Puttini Piercarlo, Baroni Marinella

机构信息

Rheumatology Department, Polytechnic University of Marche, C. Urbani Hospital, Jesi, Ancona, Italy.

IRCCS Galeazzi Orthopaedic Institute, Milan, Italy.

出版信息

Clin Exp Rheumatol. 2015 Jan-Feb;33(1 Suppl 88):S93-101. Epub 2015 Mar 18.

Abstract

OBJECTIVES

The aims of the study were to assess the efficacy of a multicomponent intervention and evaluate the feasibility and user acceptance of an internet-based home telemedical surveillance system for the evaluation of pain and other key health outcomes in patients with fibromyalgia (FM).

METHODS

The study involved 76 FM patients who were randomised to usual care or the multicomponent exercise programme, which consisted of 24 twice-weekly sessions of combined aerobic, muscle strength training exercises and education. All the patients completed the revised version of the Fibromyalgia Impact Questionnaire (FIQR) and the self-administered Fibromyalgia Activity Score (FAS). A predefined website allowed authorised users to enter data via a personal computer (PC) and Internet browser. The differences between the groups were assessed using the Mann-Whitney U-test and Fisher's exact test, and the correlations were analysed using Spearman's rank correlation test.

RESULTS

The multicomponent intervention led to a clinically relevant difference in improvement in comparison with the standard approach. It markedly improved the FIQR symptom subscale score, significantly increased the time-integrated area under the curve (AUC) of the FAS scores, and led to a greater benefit in terms of fatigue and the quality of sleep. The mean change in the AUC of the total FIQR score closely correlated with the changes in the AUC of the total FAS score.

CONCLUSIONS

The multicomponent approach to FM was effective in treating the key symptoms and maintaining the improvements in the short term, and telemonitoring proved to be an easyto-use solution for patient-centred data acquisition.

摘要

目的

本研究旨在评估多组分干预的疗效,并评价基于互联网的家庭远程医疗监测系统在评估纤维肌痛(FM)患者疼痛及其他关键健康结局方面的可行性和用户接受度。

方法

该研究纳入了76例FM患者,他们被随机分为接受常规护理或多组分运动计划组,多组分运动计划包括每周两次、共24节的有氧运动、肌肉力量训练及教育课程。所有患者均完成了修订版纤维肌痛影响问卷(FIQR)和自我管理的纤维肌痛活动评分(FAS)。一个预定义的网站允许授权用户通过个人电脑(PC)和互联网浏览器输入数据。使用曼-惠特尼U检验和费舍尔精确检验评估组间差异,并使用斯皮尔曼等级相关检验分析相关性。

结果

与标准方法相比,多组分干预在改善方面产生了临床相关差异。它显著改善了FIQR症状子量表评分,显著增加了FAS评分曲线下的时间积分面积(AUC),并在疲劳和睡眠质量方面带来了更大益处。总FIQR评分的AUC平均变化与总FAS评分的AUC变化密切相关。

结论

FM的多组分方法在短期内有效治疗关键症状并维持改善效果,远程监测被证明是一种便于以患者为中心获取数据的解决方案。

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