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研究方案:探究高度专业化康复对多发性硬化症患者的影响。一项个性化多学科干预的随机对照试验。

Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention.

机构信息

Centre for Applied Health Services Research and Technology Assessment, University of Southern Denmark, J, B, Winsløws Vej 9B, 1, 5000, Odense, Denmark.

出版信息

BMC Health Serv Res. 2012 Sep 6;12:306. doi: 10.1186/1472-6963-12-306.

DOI:10.1186/1472-6963-12-306
PMID:22954027
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3479000/
Abstract

BACKGROUND

Multiple sclerosis (MS) is a complex, chronic and progressive disease and rehabilitation services can provide important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The objective of this study is to assess the effects in terms of changes measured by a variety of standardized quality of life, mastery, coping, compliance and individual goal-related endpoints. This combination provides the basis for analyzing the complexity of MS and outcomes of a personalized rehabilitation.

METHODS/DESIGN: Patients with MS referred to hospital rehabilitation services will be randomized to either early admission (within two months) or usual admission (after an average waiting time of eight months). They will complete a battery of standardized health outcome instruments prior to randomization, and again six and twelve months after randomization, and a battery of goal-related outcome measures at admission and discharge, and again one, six and twelve months after randomization.

DISCUSSION

The results of the study are expected to contribute to further development of MS rehabilitation services and to discussions about the design and content of such services. The results will also provide additional information to health authorities responsible for providing and financing rehabilitation services.

TRIAL REGISTRATION

Current Controlled Trials (ISRCTN05245917).

摘要

背景

多发性硬化症(MS)是一种复杂、慢性且进行性的疾病,康复服务可以为患者提供重要支持。很少有 MS 康复计划被证明能够以具有成本效益的方式为患者提供健康改善。本研究的目的是评估通过各种标准化生活质量、掌握、应对、依从性和个体目标相关终点来衡量的变化的效果。这种组合为分析 MS 的复杂性和个性化康复的结果提供了基础。

方法/设计:被转介到医院康复服务的 MS 患者将被随机分为早期入院(在两个月内)或常规入院(在平均等待时间八个月后)。他们将在随机分组前完成一系列标准化健康结果测量工具的测试,然后在随机分组后六个月和十二个月再次进行测试,并在入院和出院时以及随机分组后一个月、六个月和十二个月再次进行一系列与目标相关的结果测量。

讨论

该研究的结果有望促进 MS 康复服务的进一步发展,并讨论此类服务的设计和内容。结果还将为负责提供和资助康复服务的卫生当局提供额外信息。

试验注册

当前对照试验(ISRCTN05245917)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5e9/3479000/168f28afd441/1472-6963-12-306-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5e9/3479000/168f28afd441/1472-6963-12-306-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5e9/3479000/168f28afd441/1472-6963-12-306-1.jpg

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