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目的使用ICF分类作为参考,系统地确定和量化脑卒中临床试验结局测量中的概念。方法根据预先制定的标准,从MEDLINE数据库中筛选1992~2001年间随机控制实验,提取结局测量,并将结局测量中的概念与ICF建立联系。结果在320个合格研究中,有160个(50%)随机样本。共确定148个健康状况测量指标。在11 283个提取的概念中,有91%的概念可与ICF分类建立联系。在各成分中最常使用的ICF类目是:属于活动与参与的d450步行(70%)、属于身体功能的d525排便功能(62%)和属于环境因素的e399支持和相互联系(30%)。结论ICF分类为确定及量化脑卒中临床治疗结局测量中的概念提供了有用的参考价值;脑卒中结局测量涉及大量概念,对于研究结果的可比性而言,测量内容的一致性是必要的。
Purpose To use the ICF classification as a reference to systematically determine and quantify the notion of outcome measures in stroke clinical trials. Methods According to the pre-established criteria, the randomized controlled trials from 1992 to 2001 were screened from the MEDLINE database, the outcome measures were extracted, and the concepts in outcome measures were linked with ICF. Results Of the 320 eligible studies, there were 160 (50%) randomized samples. A total of 148 health indicators were determined. Of the 11,283 extracted concepts, 91% of the concepts were associated with the ICF classification. The most commonly used ICF categories for each component are d450 walking (70%) for activities and participation, d525 defecation (62%) for body functions, and e399 for environmental factors (30%) . Conclusion The ICF classification provides a useful reference value for determining and quantifying the concepts used in clinical outcome measures of stroke. Measurement of stroke outcomes involves a number of concepts that are necessary for measuring the comparability of findings.