| Chronic Heart Failure (CHF) is the ultimate phase of various of cardiovascular diseases. At present to reduce morbidity and mortality in CHF patients has become an urgent need to address major public health problem. Many researches have shown that the Traditional Chinese Medicine (TCM) has the unique advantages in improving the quality of life (QOL) of CHF patients. The preliminary CHF-QOL scale of Chinese and Western Integrated Medicine which contains 51 items has been developed by us. IT is the disease-specific scale which reflects the characteristics of Chinese Medicine.Objective:To formulate a quality of life scale in heart failure that reflects the characteristics of TCM, following the international principles and procedures. Measure each item to form the formal scale through the test of statistical methods. To evaluate the capability of the formal scale.Methods:We conducted a cross-section survey of 359 participants who diagnosised definitely with CHF in 12 hospitals in China from Oct,2007 to Dec,2010. It was performed using a test-retest design with to fill in the preliminary CHF-QOL scale of Chinese and Western Integrated Medicine. Scale's capability was measured by its reliability, validity, feasibility and responsibility. Seven methods were selected to measure each item. Only the item passed through at least five methods can enter the formal scale.Then we conducted a cross-section survey of 120 participants who diagnosised definitely with CHF in Beijing Dongfang Hospitals from Apr,2010 to Mar,2011. It was performed using a test-retest design with to fill in the CHF-QOL scale of Chinese and Western Integrated Medicine and the 36-item short-form health status survey (SF-36) and MLHFQ. To evaluate the capability of the formal scale.Results:(1) All of the items of the preliminary scale's accomplished rates were above 85%. Average time of accomplished the preliminary scale was 14.65±9.28 minites. Its cronbach's alpha reliability was 0.968, and its split-half reliability was 0.974. The factor analysis acquired six factors whose structures coincided with the preceding designed 6 domains. It was good on responsibility (p<0.01)(2) Thirty eight items were screened to form the formal scale through the test of seven statistical methods.(3) Formal scale's feasibility:Average time of accomplished the CHF-QOL of Chinese and Western Integrated Medicine was 7.94±2.51 minites. Average time of accomplished SF-36 was 8.74±2.94minites. All of the scales' accomplished rates were 97.50%.(4) Scale's reliability:Cronbach's alpha coefficient of the CHF-QOL scale of Chinese and Western Integrated Medicine was 0.942, Split-half reliability coefficient of it was 0.934. Cronbach's alpha coefficient of SF-36 was 0.905. Split-half reliability coefficient of it was 0.928. Cronbach's alpha coefficient of MLHFQ was 0.909, Split-half reliability coefficient of it was 0.879.(5) Scale's validity. All of the three scales were good on content validity, construct validity.(6) Correlative coefficient of the CHF-QOL scale of Chinese and Western Integrated Medicine with SF-36 was 0.793, p<0.01, the correlative coefficient with MLHFQ was 0.927, p<0.01.(7) Scale's responsibility:All scales were good on responsibility (p<0.01)Conclusions:The Chronic Heart Failure Quality of Life scale of Chinese and Western Integrated Medicine is good on reliability, validity and feasibility. The scale can be used for measuring the quality of life for chronic heart failure.
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