| Background and Purpose: There is certain gap on outcome indexes in stroke trials between China and overseas, especially on the report of fatality rate, measurements of activities of daily living and quality of life on disability and handicap level. Psychometric evaluations such as reliability and validity of common indexes in clinical trial have been studied in abroad but not yet began in domestic. The clinic trials relating to stroke in Traditional Chinese Medicine (TCM) fields in domestic mainly stressed on laboratory indexes and improvement of symptoms, while indexes of function and quality of life seldom used, and lacking of appropriate effectiveness assessment criteria of TCM syndrome, which went against the proper assessments of TCM inventions based on the theory of reating on Differentiation of TCM Syndrome? This study is directed under the above ideas and expected to construct a scientific system of outcome assessment indexes of stroke with strictly approved validity and reliability including indexes of conventional clinical outcomes, assessments of TCM syndrome related indicators and quality of life, which was carried out through systematic evaluations of commonly used indexes under the constructions of principles of Clinical Epidemiology/DME. It is hoped that it will benefit the evaluations of real efficacy of TCM therapies more scientifically and accurately than before, and find a proper way to construct a clinical outcome indicator system with TCM characteristics. Objects and Methods: Cross-section survey combined with prospective follow-up. 245 patients with stroke were assessed of neurologic impairment scale, classify of living ability, activities of daily living (ADL), diagnostic and evaluation criteria for strokes of TCM, scales of TCM syndrome related indexes, Health Survey Questionnaire (Short form 36, SF-36), Quality of Life Index, and along with the recording of the social demographic characteristics. Some patients were re-evaluated 2 months after first evaluation. SPSS 10 For Windows was used to evaluated the validity, reliability and responsiveness of the indexes, by the method of multivariate relations, liner regression, factor analysis and principle component analysis, Cronbach?s a coefficients, and the estimation of responsiveness. Results: (1)The modified scale of neurological functions contains 7 items, which has good reliability and validity(Cronbach's a =0.868), superior to those of the present criteria: neurologic impairment scale with the Cronbach's a =0.801, and diagnostic and evaluating criteria for strokes of TCM with that of 0.783, it has higher responsiveness too. (2)Physical functioning scale contains 16 items after modifications of ADL and Physical Functioning Sub-scale in SF-36 (Cronbach's a = 0.914), and can make up for the eiling effect?that ADL showed in this study. (3)New-built family relationship scale in suitable for use in China(Cronbach's a = 0.779), which contains three items: family relationships, family support and family scrapes. (4)The elementary TCM Syndrome scale for strokes contains 18 items with Cronbach's a = 0.645. (5) System of outcome indicators for stroke was initially formed which contained 57 items ,with clarified construction and classification and proved validity and reliability (Cronbach's a = 0.791). Conclusions: (l)The initially formed system of outcome indicators for stroke has g...
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