摘要
慢性心力衰竭,简称慢性心衰,是各种心血管疾病的终末阶段,它的发生和发展是一个复杂、连锁、动态的过程。降低慢性心衰患者的发病率与死亡率,改善其生存质量已经成为迫切需要解决的重大公共卫生问题。研究表明,中医在改善慢性心衰患者生存质量方面具有独特的优势,将生存质量评价引入中医药治疗慢性心衰领域,将更好地评价中医药的疗效。前期研究中我们已经研制成功了含有51个条目具有中医特色的心衰疾病特异性量表——慢性心衰中西医结合生存质量量表初表。
研究目的：
参照世界卫生组织生存质量工作组的要求,完成慢性心衰中西医结合生存质量量表初表的预调查,并对初表进行考评及条目筛选,制定具有中医特色的慢性心衰中西医结合生存质量量表,并对其性能进行评价。
研究方法：
(1)采用横断面调查法,于2007年10月至2009年12月,应用慢性心衰中西医结合生存质量量表初表对全国12家医院内符合纳入标准的359名慢性心衰住院患者,实施患者知情同意基础上的生存质量调查,评价初表的性能,并运用主观评价法、离散趋势法、相关系数法、克朗巴赫系数法、重测信度法、选项反应度分析法等7种统计方法完成条目筛选,形成慢性心衰中西医结合生存质量量表。
(2)采用横断面调查法,于2010年4月至2011年3月,对北京中医药大学东方医院心血管内科就诊的符合纳入标准的120名慢性心衰患者,实施慢性心衰中西医结合生存质量量表、SF-36简明健康状况量表(SF-36量表)、明尼苏达心力衰竭生存质量量表(MLHFQ量表)调查,对其性能进行对比评价及考评。
研究结果：
(1)慢性心衰中西医结合生存质量量表初表考评结果：慢性心衰中西医结合生存质量量表初表各条目应答率均高于85%,平均答题时间为14.65±9.28分钟,初表的克朗巴赫α系数为0.968,分半信度为0.974。经主成分因子分析法分析,表明初表的结构效度较好。将治疗前后的生存质量测评总分进行配对T检验,P值小于0.01,具有统计学差异,表明量表具有较好的反应度。
(2)条目筛选结果：采用7种统计学方法对条目进行筛选,共筛选出38条条目构成慢性心衰中西医结合生存质量量表；条目内容包括MLHFQ中19条条目的内容,及26条与心衰相关的中医条目,其中中医特色条目中17条为新增中医条目。
(3)慢性心衰中西医结合生存质量量表的考评：
①量表的可行性：慢性心衰中西医结合生存质量量表平均应答时间7.94士2.51分钟,SF-36量表平均应答时间8.74±2.94分钟,因MLHFQ量表包含于慢性心衰中西医结合生存质量量表中,故未单独计算其填表时间,三种量表完成率均为97.50%。
②量表的信度：慢性心衰中西医结合生存质量量表的克朗巴赫α系数为0.942,分半信度系数为0.934；SF-36量表的克朗巴赫α系数为0.905,分半信度系数为0.928；MLHFQ量表的克朗巴赫a系数为0.909,分半信度系数为0.879。
③量表的效度：内容效度：应用相关系数法证实三种量表均具有较好的内容效度。结构效度：经因子分析,三种量表的测量结果与研究者对量表构想的结构是相符的。标准效度：将SF-36量表、MLHFQ量表作为标准参照,计算慢性心衰中西医结合生存质量量表与SF-36量表的相关系数为0.745,p＜0.01,与MLHFQ量表的相关系数为0.927,p<0.01,均大于0.7,可以认为慢性心衰中西医结合生存质量量表具有较好的标准效度。
④量表的反应度：三种量表均具备区分不同时间(治疗前后)患者生存质量变化的能力(p<0.01)。
研究结论：
慢性心衰中西医结合生存质量量表具有较好的信度、效度和反应度,临床操作可行,能被患者接受,可以作为心衰中西医结合生存质量的评价工具。
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.
引文
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