| Research objectives:Based on the etiopathogenisis and pathogenesis of chronic obstructive pulmonary disease (COPD) with pulmonary heart disease in traditional Chinese medicine theory, built with traditional features of the disease in patients with primary of self reported outcome (PRO) scale for evaluation, to assess their for the evaluation of the Chinese medicine for the treatment of the disease, clinical efficacy and to help build the disease clinical characteristics of traditional Chinese medicine for evaluationResearch methods:This PRO scales concerning COPD with pulmonary heart disease, which is used in this researchment, is based on the theory of the traditional Chinese medicine, through the ancient and modern literature database retrieval, extracting the primary clinical symptoms of the disease. Then investigate the experts' preliminary advice on this PRO scales and the patients'self report about the main clinical symptoms of this disease. And then collect the data and combine the two ancient and modern literature database for statistical analysis and ultimately determine the scale of the master of entries. This research primarily investigates 91 patients, who are COPD with pulmonary heart disease in three tertiary hospital of Guangzhou, in order to evaluate their quality of life and assess the PRO scales'reliability, validity and sensitivity. This measurement measures twice, before and after. As to verify the rmeasurement reliability of this PRO scales, we investigate these 91 patients before and after the treatment of the disease, and then repeat the test on the second day again. In order to assess validity and responsibility of the PRO scales, we investigate these patients with this PRO scales, at the same time, we used the effective and world-recognized "St George's respiratory questionnaire" and " The adult chronic obstructive pulmonary disease life quality score", which is more appropriate to our national conditions, by Prof. Choi Ying in Shanghai as the control. This topic uses the SPSS11.5 package for data entry, and using the related analysis, reliability analysis, t-test, factor analysis the results of the data for statistical analysis, and related data to assess the reliability, validity, responsibility.Results:The Alpha coefficient of the PRO scales'first measurement was 0.70;after the treatment of the disease, the Alpha coefficient was 0.66. The split-half reliability of the first measurement was 0.68;after the treatment of the disease, the split-half reliability was 0.63. The test-retest correlation coefficient of the first measurement was 0.99(P<0.01);the test-retest correlation coefficient of the measurement, which was after the treatment of the disease, was 1.00(P<0.01). The comparison of the test and retest means of the domains which indicated that there were no statistically significant differences (P>0.05). It was inferred from the correlation analysis that there were strong correlation between the items and their own domains, conversely there were weak correlation between the items and other domains. At the part of the criterion validity, this PRO scales with the "St George's respiratory questionnaire", the validity coefficient was 0.59(P<0.01);with "The adult chronic obstructive pulmonary disease life quality score", the validity coefficient was 0.55 (P<0.01). Though the t-test, the correlation coefficient of the measurement of the before and after treatment of the disease was 0.56(P<0.05).The scale can differentinate the quality of life of the patients,who are COPD with pulmonary heart disease.Conclusion:This PRO scales have better reliability, validity and sensitivity.It can reflect the quality of life of patients, who are COPD with pulmonary heart disease, which comprehensive, specific and accurate. Specially, this PRO scales have the characteristic of traditional Chinese medicine, which is used to assess the clinical effectiveness in traditional Chinese medical treatment. It can be used as an instrument to measure the quality of life for these patients.
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