慢性病患者生命质量测定量表体系之肺结核患者生命质量测定量表QLICD-PT研制与应用
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摘要
目的研制慢性病患者生命质量测定量表体系之肺结核量表QLICD-PT,并对其进行考评；同时,应用QLICD-PT量表对肺结核患者的生命质量及其影响因素进行初步分析并制定最小临床显著差异(MCID)。
方法慢性病患者生命质量测定量表体系共性模块QLICD-GM (Quality of Life Instruments for Chronic Disease-General module)已研制完成。依据共性模块与特异模块相结合的研究思想,在对文献回顾的基础上,结合我国文化特色,采用量表开发的程序化决策方式来研制量表QLICD-PT,并通过实测数据对量表进行效度、信度、反应度的考评。应用QLICD-PT量表分析肺结核患者生命质量影响因素、分析肺结核患者家庭关怀指数及社会支持评分与生命质量的关系、比较肺结核患者治疗前、治疗2个月末和完成疗程时的生命质量得分及制定QLICD-PT各领域最小临床显著差异(MCID)。整个研究过程中用到的统计学方法有统计描述、相关分析、配对t检验、因子分析、多重线性回归方法分析等。
结果
1.研制出了由慢性病共性模块QLICD-GM(29个条目)和肺结核特异模块(12个条目)构成的肺结核患者生命质量量表QLICD-PT。
2.对肺结核患者生命质量量表QLICD-PT进行考评①信度考评：QLICD-PT量表各领域克朗巴哈α系数均大于0.7；各领域分半信度均大于0.6,总量表的分半信度为0.82,可以认为QLICD-PT量表信度较好。②效度考评：肺结核特异模块得分经因子分析与临床专家预先提出的理论结构基本上吻合。各个条目与所属领域相关系数较大,与不同领域的相关系数较小。QLICD-PT的共性模块与SF-36的8个领域的相关系数除情绪角色与共性模块的相关系数较低外,其余的相关系数在0.44-0.57。说明具有良好的效度。③反应度考评：治疗前与治疗2个月末各领域得分进行配对t检验均有统计学意义,可以认为QLICD-PT量表反应度较好。
3. QLICD-PT量表的初步应用：①影响肺结核患者生命质量的因素主要是文化程度和职业。②家庭关怀指数、社会支持评分与肺结核患者生命质量得分呈正相关,与QLICD-PT量表社会功能领域的相关系数高于其他领域的相关系数。③分别对不同性别、民族、婚姻状况不同治疗时间的肺结核患者生命质量得分进行重复测量资料方差分析后,结果显示随着治疗时间的推移,肺结核患者生命质量得分逐渐上升。④以锚为基础的方法制定的领域DHD、PSD、SOD、CGD、SPD、TOT的MCID分别为12.82、16.14、15.61、15.88、13.64、16.79。以分布为基础的方法制定的领域PHD、PSD、SOD、CGD、SPD、TOT的MCID分别为8.50、7.38、10.40、10.34、10.52、10.73。
结论肺结核患者生命质量量表(QLICD-PT)有较好的信度、效度和反应度,可以用于肺结核患者生命质量的测评；影响肺结核患者生命质量的因素主要是文化程度和职业；家庭关怀和社会支持较多的肺结核患者的生命质量较高；通过治疗肺结核患者的生命质量得到了提高；以锚为基础的方法结果在本研究中仅供参考,MCID结果以分布为基础的方法制定为准,最终结果是PHD、PSD、SOD、CGD、 SPD、TOT的MCID分别为8.50、7.38、10.40、10.34、10.52、10.73。
Objective To develop and validate the Quality of Life Instruments for Chronic Diseases-Pulmonary Tuberculosis (QLICD-PT). In addition, the preliminary analysis about quality of life in patients with pulmonary tuberculosis and its influence factors was carried out, with minimal clinically important difference (MCID) being established.
Methods The General Module of the system of Quality of Life Instruments for Chronic Diseases (QLICD-GM) has been developed. In accordance with the research idea of combination of the General Module and Specific ones, on the basis of the literature review and cultural characteristics of China, the Quality of Life Instruments for Chronic Diseases-Pulmonary Tuberculosis (QLICD-PT) was developed using the instruments developing program decision-making procedures. The psychometrics of the scale was also carried out including instruments' validity, reliability, and responsibility to change. Regard to preliminary applications of QLICD-PT, the influence factors to pulmonary tuberculosis patients' quality of life was analyzed. The relation between pulmonary tuberculosis patients' family care index and social support scores and quality of life, and comparisons of pulmonary tuberculosis patients' quality of life score changes before treatment, two months after treatment and six months after treatment were studied. Also the minimal clinically important differences (MCID) for each domain of QLICD-PT were estimated. The statistical methods used throughout the course of the study include statistical description, correlation analysis, paired T-test, factor analysis, multiple linear regression analysis etc.
Results
1. The QLICD-PT for patients with pulmonary tuberculosis was developed with the general module (29entries) combining with the pulmonary tuberculosis specific module (12entries).
2.Evaluation about quality of life instrument for patients with pulmonary Tuberculosis QLICD-PT:①reliability: QLICD-PT Chronbach'a coefficients in various domains are greater than0.7; split-half reliabilities of all domains are greater than0.6, total instruments' split-half reliability is0.824. It can be considered that the reliability of QLICD-PT is good.②validity: pulmonary tuberculosis specific domain score is basically consistent with the theoretical structure proposed in advance by clinical experts after factor analysis. And the correlation coefficients of each item and its relevant domain are relatively large; the correlation coefficients of each item and its irrelevant domain are small. Correlation coefficients of QLICD-GM and eight relevant domains of SF-36are0.44～0.57, exception of lower correlation coefficients of emotional role and general module. So it has good validity.③responsibility to change:the scores of each domain before treatment and two month later from the treatment are statistically significant by paired T-tests, it can be said that the responsibility to change of QLICD-PT is relatively good.
3. Preliminary application of QLICD-PT:①the factors that affecting pulmonary tuberculosis patients' quality of life are mainly education and career.②Family care index and social support score were positively correlated with pulmonary tuberculosis patients' quality of life scores, the correlation coefficient with QLICD-PT of the Social domain is higher than the correlation coefficients in other domain.③The possible influence factors on quality of life of gender, nationality, marital status, and different treatment time of pulmonary tuberculosis patients were analyzed by repeated measurement ANOVA respectively. The results showed that pulmonary tuberculosis patients' quality of life scores rise gradually as treatment time.④MCID of domain PHD, PSD, SOD, CGD, SPD, and TOT developed with anchor-based method are12.82,16.14,15.61,15.88,13.64and16.79respectively. MCID of domain PHD, PSD, SOD, CGD, SPD, and TOT developed with distribution-based approach are8.50,7.38, 10.40,10.34,10.52and10.73respectively.
Conclusion Quality of life instrument for patients with pulmonary Tuberculosis (QLICD-PT) has good reliability, validity and responsibility to change, which can be used for evaluating pulmonary tuberculosis patients' quality of life. The factors affecting pulmonary tuberculosis patients' quality of life are mainly education and career. Pulmonary tuberculosis patients with more family care and social support have higher quality of life; pulmonary tuberculosis patients' quality of life could be improved after the treatment. The result derived from anchor-based approach in this study are for reference only, the MCID results are subject to approach to distribution-based approach, the final results for MCID of PHD, PSD, SOD, CGD, SPD and TOT are respectively8.50,7.38,10.40,10.34,10.52and10.73.
方法慢性病患者生命质量测定量表体系共性模块QLICD-GM (Quality of Life Instruments for Chronic Disease-General module)已研制完成。依据共性模块与特异模块相结合的研究思想,在对文献回顾的基础上,结合我国文化特色,采用量表开发的程序化决策方式来研制量表QLICD-PT,并通过实测数据对量表进行效度、信度、反应度的考评。应用QLICD-PT量表分析肺结核患者生命质量影响因素、分析肺结核患者家庭关怀指数及社会支持评分与生命质量的关系、比较肺结核患者治疗前、治疗2个月末和完成疗程时的生命质量得分及制定QLICD-PT各领域最小临床显著差异(MCID)。整个研究过程中用到的统计学方法有统计描述、相关分析、配对t检验、因子分析、多重线性回归方法分析等。
结果
1.研制出了由慢性病共性模块QLICD-GM(29个条目)和肺结核特异模块(12个条目)构成的肺结核患者生命质量量表QLICD-PT。
2.对肺结核患者生命质量量表QLICD-PT进行考评①信度考评：QLICD-PT量表各领域克朗巴哈α系数均大于0.7；各领域分半信度均大于0.6,总量表的分半信度为0.82,可以认为QLICD-PT量表信度较好。②效度考评：肺结核特异模块得分经因子分析与临床专家预先提出的理论结构基本上吻合。各个条目与所属领域相关系数较大,与不同领域的相关系数较小。QLICD-PT的共性模块与SF-36的8个领域的相关系数除情绪角色与共性模块的相关系数较低外,其余的相关系数在0.44-0.57。说明具有良好的效度。③反应度考评：治疗前与治疗2个月末各领域得分进行配对t检验均有统计学意义,可以认为QLICD-PT量表反应度较好。
3. QLICD-PT量表的初步应用：①影响肺结核患者生命质量的因素主要是文化程度和职业。②家庭关怀指数、社会支持评分与肺结核患者生命质量得分呈正相关,与QLICD-PT量表社会功能领域的相关系数高于其他领域的相关系数。③分别对不同性别、民族、婚姻状况不同治疗时间的肺结核患者生命质量得分进行重复测量资料方差分析后,结果显示随着治疗时间的推移,肺结核患者生命质量得分逐渐上升。④以锚为基础的方法制定的领域DHD、PSD、SOD、CGD、SPD、TOT的MCID分别为12.82、16.14、15.61、15.88、13.64、16.79。以分布为基础的方法制定的领域PHD、PSD、SOD、CGD、SPD、TOT的MCID分别为8.50、7.38、10.40、10.34、10.52、10.73。
结论肺结核患者生命质量量表(QLICD-PT)有较好的信度、效度和反应度,可以用于肺结核患者生命质量的测评；影响肺结核患者生命质量的因素主要是文化程度和职业；家庭关怀和社会支持较多的肺结核患者的生命质量较高；通过治疗肺结核患者的生命质量得到了提高；以锚为基础的方法结果在本研究中仅供参考,MCID结果以分布为基础的方法制定为准,最终结果是PHD、PSD、SOD、CGD、 SPD、TOT的MCID分别为8.50、7.38、10.40、10.34、10.52、10.73。
Objective To develop and validate the Quality of Life Instruments for Chronic Diseases-Pulmonary Tuberculosis (QLICD-PT). In addition, the preliminary analysis about quality of life in patients with pulmonary tuberculosis and its influence factors was carried out, with minimal clinically important difference (MCID) being established.
Methods The General Module of the system of Quality of Life Instruments for Chronic Diseases (QLICD-GM) has been developed. In accordance with the research idea of combination of the General Module and Specific ones, on the basis of the literature review and cultural characteristics of China, the Quality of Life Instruments for Chronic Diseases-Pulmonary Tuberculosis (QLICD-PT) was developed using the instruments developing program decision-making procedures. The psychometrics of the scale was also carried out including instruments' validity, reliability, and responsibility to change. Regard to preliminary applications of QLICD-PT, the influence factors to pulmonary tuberculosis patients' quality of life was analyzed. The relation between pulmonary tuberculosis patients' family care index and social support scores and quality of life, and comparisons of pulmonary tuberculosis patients' quality of life score changes before treatment, two months after treatment and six months after treatment were studied. Also the minimal clinically important differences (MCID) for each domain of QLICD-PT were estimated. The statistical methods used throughout the course of the study include statistical description, correlation analysis, paired T-test, factor analysis, multiple linear regression analysis etc.
Results
1. The QLICD-PT for patients with pulmonary tuberculosis was developed with the general module (29entries) combining with the pulmonary tuberculosis specific module (12entries).
2.Evaluation about quality of life instrument for patients with pulmonary Tuberculosis QLICD-PT:①reliability: QLICD-PT Chronbach'a coefficients in various domains are greater than0.7; split-half reliabilities of all domains are greater than0.6, total instruments' split-half reliability is0.824. It can be considered that the reliability of QLICD-PT is good.②validity: pulmonary tuberculosis specific domain score is basically consistent with the theoretical structure proposed in advance by clinical experts after factor analysis. And the correlation coefficients of each item and its relevant domain are relatively large; the correlation coefficients of each item and its irrelevant domain are small. Correlation coefficients of QLICD-GM and eight relevant domains of SF-36are0.44～0.57, exception of lower correlation coefficients of emotional role and general module. So it has good validity.③responsibility to change:the scores of each domain before treatment and two month later from the treatment are statistically significant by paired T-tests, it can be said that the responsibility to change of QLICD-PT is relatively good.
3. Preliminary application of QLICD-PT:①the factors that affecting pulmonary tuberculosis patients' quality of life are mainly education and career.②Family care index and social support score were positively correlated with pulmonary tuberculosis patients' quality of life scores, the correlation coefficient with QLICD-PT of the Social domain is higher than the correlation coefficients in other domain.③The possible influence factors on quality of life of gender, nationality, marital status, and different treatment time of pulmonary tuberculosis patients were analyzed by repeated measurement ANOVA respectively. The results showed that pulmonary tuberculosis patients' quality of life scores rise gradually as treatment time.④MCID of domain PHD, PSD, SOD, CGD, SPD, and TOT developed with anchor-based method are12.82,16.14,15.61,15.88,13.64and16.79respectively. MCID of domain PHD, PSD, SOD, CGD, SPD, and TOT developed with distribution-based approach are8.50,7.38, 10.40,10.34,10.52and10.73respectively.
Conclusion Quality of life instrument for patients with pulmonary Tuberculosis (QLICD-PT) has good reliability, validity and responsibility to change, which can be used for evaluating pulmonary tuberculosis patients' quality of life. The factors affecting pulmonary tuberculosis patients' quality of life are mainly education and career. Pulmonary tuberculosis patients with more family care and social support have higher quality of life; pulmonary tuberculosis patients' quality of life could be improved after the treatment. The result derived from anchor-based approach in this study are for reference only, the MCID results are subject to approach to distribution-based approach, the final results for MCID of PHD, PSD, SOD, CGD, SPD and TOT are respectively8.50,7.38,10.40,10.34,10.52and10.73.
引文
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