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[临床试验中与健康相关的生活质量:结果的信息性测量。实际示例:哮喘/慢性阻塞性肺疾病]

[Health-related quality of life informative measure of outcome in clinical trials. Practical examples: asthma/chronic obstructive lung disease].

作者信息

Sullivan M, Tunsäter A

机构信息

Göteborgs universitet, Göteborg.

出版信息

Lakartidningen. 2001 Oct 10;98(41):4428-33.

PMID:11699248
Abstract

Methods for measuring health-related quality of life have been developed and proven valid during the past two decades. It was accomplished through international collaborations between clinicians and method experts. Standardized questionnaires, self-administered by patients, include key domains such as symptoms, functional limitations and well-being from a physical, mental and social perspective. The commonly used instruments are adapted and validated for Swedish conditions. Clinical trials can be powered also according to these outcome measures, as they show documented responsiveness to important changes in patients' everyday functioning and well-being. Patient-reported outcome of treatment efficacy is nowadays adequately standardized for scientific reviews according to the conventional criteria of evidence based medicine. Most importantly, health-related quality of life measures will provide new information of clinical value as demonstrated here in the example of asthma/chronic obstructive pulmonary disease. Thus, outcome can be better assessed by changes in the total burden of disease and its consequences than in terms of pulmonary function tests or biochemical markers.

摘要

在过去二十年中,已经开发出了测量健康相关生活质量的方法,并证明其有效。这是通过临床医生和方法专家之间的国际合作实现的。由患者自行填写的标准化问卷,包括从身体、心理和社会角度的关键领域,如症状、功能限制和幸福感。常用工具已针对瑞典情况进行了调整和验证。临床试验也可以根据这些结果指标进行设计,因为它们显示出对患者日常功能和幸福感的重要变化具有记录在案的反应性。根据循证医学的传统标准,如今患者报告的治疗疗效结果已得到充分标准化,可用于科学审查。最重要的是,如哮喘/慢性阻塞性肺疾病的例子所示,健康相关生活质量测量将提供具有临床价值的新信息。因此,通过疾病总负担及其后果的变化来评估结果,比通过肺功能测试或生化标志物更好。

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Lakartidningen. 2001 Oct 10;98(41):4428-33.
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