慢性病患者生命质量测定量表体系之慢性肾衰竭量表QLICD-CRF的研制与应用
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摘要
目的采用程序化的方法开发适合中国人群的慢性肾衰竭患者生命质量量表(Q LICD-CRF),并对其进行各测量学特性的考评。结合SF-36量表,采用以锚为基础和以分布为基础的方法,制定Q LICD-CRF各领域最小显著差异(MID),分析慢性肾衰竭患者生命质量影响因素。
方法提出Q LICD-CRF特异模块理论框架、条目池,专家讨论后筛选条目形成预调查特异模块；预调查后采用变异度法、相关系数法、重要性评分法进行数据分析,并再次召开核心小组会议讨论,形成慢性肾衰竭患者生命质量测量量表的特异模块,其与共性模块一起形成量表测试版。应用测试版再次收集大量数据,首先根据此数据对条目进行再筛选,主要有变异度法、因子分析法和相关系数法等,形成正式量表。基于经典测量理论和概化理论,根据调整后的正式量表进行测量学特性的评估,并采用以锚为基础的方法和以分布为基础的方法制定正式量表的最小显著差异,评估生命质量影响因素等。
结果(1)预调查数据通过统计分析与专家讨论结合的方法,筛选出13个条目形成慢性肾衰竭患者生命质量测定量表的特异模块；
(2)根据测试版量表调查数据,再次筛选特异模块条目,最后形成10个条目三个侧面的特异模块：
(3)概化理论分析的结果显示,QI LCD-CRF量表生理、心理、社会以特异模块四个领域总的来说概化系数和可靠性系数都比较好,
(4)对量表的测量学特性进行考评
①信度：慢性肾衰竭患者生命质量测评量表共性模块和特异模块不同领域和侧面重测信度系数均在0.8以上,；除了排尿排便异常(ASU)、认知(COG)、社会支持(SSS)、社会角色(SOR)外,各领域和侧面内部一致信度大多数在0.6以上,总体内部一致信度为0.90,总体量表分半信度为0.76;
②效度：Q LICD-CRF量表具有较好的内容效度；对于结构效度,躯体、心理、社会等领域相关系数多数都较高,因子分析累积方差贡献率为57.36%,提取3个公因子,基本上与前面再筛选讨论后结果吻合。对于校标效度,研究采用SF-36量表为校标,除社会功能领域外,其他领域基本上都是相应的领域相关系数大于与其他领域的相关系数；
③反应度：除了心理、社会功能两个领域,其他均有统计学意义,且领域SRM分别为PDH0.64、SPD0.65、CGD0.23、TOT0.51。从侧面层面讲,心理领域中的COG、EMO、WIL以及社会领域的所有的侧面没有统计学意义,其他均有差异,并且SRM在0.21-0.63之间,反应度尚可。
(5)量表得分解释与临床最小差异(MID)：以锚为基础的方法结果在本研究中仅供参考,MID结果以以分布为基础的方法制定为准,最终结果是PHD是8.69、PSD是10.16、SOD是8.28、CGD是7.94、SPD是9.66、TOT是8.10。
(6)关于生命质量得分影响因素：采用两个量表分别筛选生命质量得分的影响因素,综合结果后得到,年龄、民族、职业、家庭经济状态、病程、血红蛋白的量、临床分期等是慢性肾衰竭患者生命质量的影响因素。
结论QILCD-CRF量表的制定过程科学、有序、合理,其具有较好的信度、效度和反应度。QILCD-CRF量表可以用于中国的慢性肾衰竭患者的评价,同时可以被临床工作者用于评价治疗方案。由于QLICD-CRF量表是在中国文化背景之下制定的,因此它为中国慢性肾衰竭患者生命质量评估提供了一个很好的基础和平台,以它作为国内慢性肾衰竭患者生命质量测定的工具,更能够收集到实际、具体、有效的数据和信息,从而能够提高相关研究和评价的质量。
Objective To develop and evaluate the Quality of Life (QOL)Instrument for Patients with Chronic Renal Failure(QLICD-CRF) fitting for Chinese by procedural methods; Combining with SF-36to formulate Clinical minimum significantly different(MID) through anchor-based and distribution-based methods; To analyze the influence factors of quality of life in patients with chronic renal failure.
Methods The specific modules'theoretical framework and item pool were proposed, after discussion of experts, the screened items were used to form a specific module for pilot test. Based on the pilot test data and methods of coefficient of variation, correlation analysis, importance rating procedure, and focus group discussion again to form specific module for the Quality of Life Instrument for Patients with Chronic Renal Failure beta version (QLICD-CRF beta version)(a general modules plus specific modules). The QLICD-CRF beta version was used to collect data and re-screen items by methods of coefficient of variation, factor analysis correlation analysis, and then, the Quality of Life Instrument for Patients with Chronic Renal Failure(QLICD-CRF) was developed. After development, psychological characteristics were evaluated based on Classical Test Theory (CTT) and Generalizability Theory(GT). Besides, the clinical minimum significantly difference (MID) through anchor-based and distribution-based methods for different domains of QLICD-CRF were computed. In addition, the influence factors of quality of life in patients with chronic renal failure factors were analyzed.
Results
(1) After pilot study, combining statistic analysis with expert s'discussion, there were13items of specific modules;
(2) The result of re-screening item was that the specific modules constituted by3aspects (10items);
(3) Based on the generalized theoretical results, generalized coefficient and reliability coefficient in Physical, psychological, social and the specific module domains were good;
(4) Assessment of QLICD-CRF
①reliability:test-retest reliability of every domain and facet was above0.8, almost all of the internal consistency reliability was larger than0.6except ASU, COG, SSS and SOR, the total internal consistency reliability was0.90, total split-half reliability was0.76;
②validity:QLICD-CRF had a good content validity; regarding construct validity, most of coefficients of correlation between item and its domain were larger, factor analysis extracted three principal components, the cumulated variance accounted for57.36%; Using SF-36as criterion, the correlation coefficient of corresponding domains were higher than others;
③responsiveness:except the psychological, social function domains, all others had statistical significance by paired t test, and standardized reaction mean (SRM) were PDH0.64,SPD0.65,CGD0.23,TOT0.51respectively. At facets level, there was no statistical significance in COG,EMO,WIL of PSD and all of the facets of SOD, but all others were statistical significant;
(5) Explanation of scale score and Clinical minimum significantly difference (MID):in this study, MID based on anchor-based method was just reference, it couldn't be see as criterion because of the sample size, and the MID assessed through distribution-based method was meaningful, so MID of PHD wa8.69、PSD was10.16、 SOD was8.28CGD was7.94、SPDw as9.66、TOT was8.10(standardized scores)
(6) The influence factors of quality of life in patients with chronic renal failure:the influence factors of QOL measured by two scales of SF-36and QLICD-CRF were analyzed, with the overall results showing that factors were age, nationality, occupation, family economic status, and the course, the amount of hemoglobin and clinical stage.
Conclusion The development of QLICD-CRF was scientific, orderly, reasonable, and it has good validity, reliability and responsiveness. QLICD-CRF can be used to measure QOL for Chinese patients with chronic renal failure. At the same time, clinicians can use it to evaluate treatments. Because QLICD-CRF was developed by regarding Chinese culture as background, so it provides a good foundation and platform for evaluation of QOL of Chinese patients with chronic renal failure. Investigators can get the authentic, specific and effective data and information of Chinese people by using QLICD-CRF, which can improve the quality of the research and evaluation.
方法提出Q LICD-CRF特异模块理论框架、条目池,专家讨论后筛选条目形成预调查特异模块；预调查后采用变异度法、相关系数法、重要性评分法进行数据分析,并再次召开核心小组会议讨论,形成慢性肾衰竭患者生命质量测量量表的特异模块,其与共性模块一起形成量表测试版。应用测试版再次收集大量数据,首先根据此数据对条目进行再筛选,主要有变异度法、因子分析法和相关系数法等,形成正式量表。基于经典测量理论和概化理论,根据调整后的正式量表进行测量学特性的评估,并采用以锚为基础的方法和以分布为基础的方法制定正式量表的最小显著差异,评估生命质量影响因素等。
结果(1)预调查数据通过统计分析与专家讨论结合的方法,筛选出13个条目形成慢性肾衰竭患者生命质量测定量表的特异模块；
(2)根据测试版量表调查数据,再次筛选特异模块条目,最后形成10个条目三个侧面的特异模块：
(3)概化理论分析的结果显示,QI LCD-CRF量表生理、心理、社会以特异模块四个领域总的来说概化系数和可靠性系数都比较好,
(4)对量表的测量学特性进行考评
①信度：慢性肾衰竭患者生命质量测评量表共性模块和特异模块不同领域和侧面重测信度系数均在0.8以上,；除了排尿排便异常(ASU)、认知(COG)、社会支持(SSS)、社会角色(SOR)外,各领域和侧面内部一致信度大多数在0.6以上,总体内部一致信度为0.90,总体量表分半信度为0.76;
②效度：Q LICD-CRF量表具有较好的内容效度；对于结构效度,躯体、心理、社会等领域相关系数多数都较高,因子分析累积方差贡献率为57.36%,提取3个公因子,基本上与前面再筛选讨论后结果吻合。对于校标效度,研究采用SF-36量表为校标,除社会功能领域外,其他领域基本上都是相应的领域相关系数大于与其他领域的相关系数；
③反应度：除了心理、社会功能两个领域,其他均有统计学意义,且领域SRM分别为PDH0.64、SPD0.65、CGD0.23、TOT0.51。从侧面层面讲,心理领域中的COG、EMO、WIL以及社会领域的所有的侧面没有统计学意义,其他均有差异,并且SRM在0.21-0.63之间,反应度尚可。
(5)量表得分解释与临床最小差异(MID)：以锚为基础的方法结果在本研究中仅供参考,MID结果以以分布为基础的方法制定为准,最终结果是PHD是8.69、PSD是10.16、SOD是8.28、CGD是7.94、SPD是9.66、TOT是8.10。
(6)关于生命质量得分影响因素：采用两个量表分别筛选生命质量得分的影响因素,综合结果后得到,年龄、民族、职业、家庭经济状态、病程、血红蛋白的量、临床分期等是慢性肾衰竭患者生命质量的影响因素。
结论QILCD-CRF量表的制定过程科学、有序、合理,其具有较好的信度、效度和反应度。QILCD-CRF量表可以用于中国的慢性肾衰竭患者的评价,同时可以被临床工作者用于评价治疗方案。由于QLICD-CRF量表是在中国文化背景之下制定的,因此它为中国慢性肾衰竭患者生命质量评估提供了一个很好的基础和平台,以它作为国内慢性肾衰竭患者生命质量测定的工具,更能够收集到实际、具体、有效的数据和信息,从而能够提高相关研究和评价的质量。
Objective To develop and evaluate the Quality of Life (QOL)Instrument for Patients with Chronic Renal Failure(QLICD-CRF) fitting for Chinese by procedural methods; Combining with SF-36to formulate Clinical minimum significantly different(MID) through anchor-based and distribution-based methods; To analyze the influence factors of quality of life in patients with chronic renal failure.
Methods The specific modules'theoretical framework and item pool were proposed, after discussion of experts, the screened items were used to form a specific module for pilot test. Based on the pilot test data and methods of coefficient of variation, correlation analysis, importance rating procedure, and focus group discussion again to form specific module for the Quality of Life Instrument for Patients with Chronic Renal Failure beta version (QLICD-CRF beta version)(a general modules plus specific modules). The QLICD-CRF beta version was used to collect data and re-screen items by methods of coefficient of variation, factor analysis correlation analysis, and then, the Quality of Life Instrument for Patients with Chronic Renal Failure(QLICD-CRF) was developed. After development, psychological characteristics were evaluated based on Classical Test Theory (CTT) and Generalizability Theory(GT). Besides, the clinical minimum significantly difference (MID) through anchor-based and distribution-based methods for different domains of QLICD-CRF were computed. In addition, the influence factors of quality of life in patients with chronic renal failure factors were analyzed.
Results
(1) After pilot study, combining statistic analysis with expert s'discussion, there were13items of specific modules;
(2) The result of re-screening item was that the specific modules constituted by3aspects (10items);
(3) Based on the generalized theoretical results, generalized coefficient and reliability coefficient in Physical, psychological, social and the specific module domains were good;
(4) Assessment of QLICD-CRF
①reliability:test-retest reliability of every domain and facet was above0.8, almost all of the internal consistency reliability was larger than0.6except ASU, COG, SSS and SOR, the total internal consistency reliability was0.90, total split-half reliability was0.76;
②validity:QLICD-CRF had a good content validity; regarding construct validity, most of coefficients of correlation between item and its domain were larger, factor analysis extracted three principal components, the cumulated variance accounted for57.36%; Using SF-36as criterion, the correlation coefficient of corresponding domains were higher than others;
③responsiveness:except the psychological, social function domains, all others had statistical significance by paired t test, and standardized reaction mean (SRM) were PDH0.64,SPD0.65,CGD0.23,TOT0.51respectively. At facets level, there was no statistical significance in COG,EMO,WIL of PSD and all of the facets of SOD, but all others were statistical significant;
(5) Explanation of scale score and Clinical minimum significantly difference (MID):in this study, MID based on anchor-based method was just reference, it couldn't be see as criterion because of the sample size, and the MID assessed through distribution-based method was meaningful, so MID of PHD wa8.69、PSD was10.16、 SOD was8.28CGD was7.94、SPDw as9.66、TOT was8.10(standardized scores)
(6) The influence factors of quality of life in patients with chronic renal failure:the influence factors of QOL measured by two scales of SF-36and QLICD-CRF were analyzed, with the overall results showing that factors were age, nationality, occupation, family economic status, and the course, the amount of hemoglobin and clinical stage.
Conclusion The development of QLICD-CRF was scientific, orderly, reasonable, and it has good validity, reliability and responsiveness. QLICD-CRF can be used to measure QOL for Chinese patients with chronic renal failure. At the same time, clinicians can use it to evaluate treatments. Because QLICD-CRF was developed by regarding Chinese culture as background, so it provides a good foundation and platform for evaluation of QOL of Chinese patients with chronic renal failure. Investigators can get the authentic, specific and effective data and information of Chinese people by using QLICD-CRF, which can improve the quality of the research and evaluation.
引文
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51. Cella D, Eton D, Fairclough D, et al. What is clinically meaningful change (CMC) on the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire? An analysis of data from ECOG 5592. J Clin Epidemiol 2002,55:286-295.
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5.钱家麒.关注血液透析中若干问题,进一步提高血液透析治疗水平.中华肾脏病杂志,2005,21(2)：63-64.
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23.孟凤芹,孟雷,马春梅.健康教育干预对慢性肾衰竭行维持性血液透析患者生活质量的影响.齐鲁护理杂志2007；13(17)：27-28
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1.靳艳军.生命质量测定量表在我国的应用.中国医学寄生虫杂志,2006,33(6)：333-336.
2.万崇华.癌症患者生命质量测定与应用.科学出版社,2007.10：3-9.
3.陈孝文,梁东,刘华锋.慢性肾衰竭[M].北京：中国医药科技出版社,2006：25232.
4.杜晓霞,彭佑铭.T2ESRD的发生率和治疗方式选择.国外医学：泌尿系统分册,2001,21(2)：60-61.
5.钱家麒.关注血液透析中若干问题,进一步提高血液透析治疗水平.中华肾脏病杂志,2005,21(2)：63-64.
6. Zuo L,WangM, Beijing Hemodialysis Quality Control and Improvement Center. Current status of hemodialysis treatment in Beijing, China. Ethn Dis,2006,16 (2 Supp 12):S2-31-34.
7.陈水云,朱琮.肾移植受者心理健康状态分析.浙江临床医学,2001,3(11)：852-853.
8. Hasegawa T, Suzukamo Y, Akizawa T, etal. Validation of the Japanese SF-36 v2 acute form in patients with chronic kidney disease.Nippon Jinzo Gakkai Shi.2008;50(l):42-50.
9. Saban KL, Stroupe KT, etal.Comparison of health-related quality of life measures for chronic renal failure:quality of well-being scale, short-form-6D, and the kidney disease quality of life instrument. Quality of Life Research:2008 Oct;17(8):l 103-1115.
10. Hays RD, Kallich JD, Mapes DL, Coons SJ & Carter WB (1994).Development of Kidney Disease Quality of Life (KDQOLTM) Instrument. Quality of Life Research,3:329-338.
11. Rao S, Carter WB, Mapes DL, Kallich JD, Kamberg CJ, Spritzer KL & Hays RD. Development of subscales from the symptoms/problems and effects of kidney disease scales of the Kidney DiseaseQuality of Life Instrument. Clinical Therapeutics.2000,22:1099-1111.
12. Carmichael P, Popoola J, John I, Stevens P & Cannichael A (2000). Assessment of quality of life in a single centre dialysis population using the KDQOL-SF questionnaire. Quality of Life Research,9:195-205. of the end-stage renal disease symptom checklist-transplantation module. Transplantation.2007 Dec 15;84(11):1428-35.
16. Spiegel DM, Evans RW, Gitlin M,etal. Psychometric evaluation of the National Kidney Dialysis and Kidney Transplantation Study symptom checklist:reliability and validity. Nephrol Dial Transplant.2009 Feb,24(2):19-25.
17. Gentile S, Delaroziere JCh, Fernandez, etal.Review of quality of life instruments used in end-stage renal disease. Nephrologie.2003;24(6):293-301.
18. FERRANS C E,POWERS MJ. Quality of Life Index:Development and psychometric properties [J]. Advance in Nursing Science,1985,8 (1):15-24.
19. Parfrey PS, Vavasour H, Bullock M, et al. Development of a health questionnaire specific for end-stage renal disease. Nephron 1989; 52:20-28.
20.刘红霞.健康教育对肾移植病人生活质量的影响[J].实用护理杂志,2002,18(4)：23-24.
21.范仲珍,袁浩斌,胡雁,等.行为医学量表手册[M].中华医学电子音像出版社,2005：152-154.
22.邓燕青,徐涛,祖丽安等.肾移植后患者生活质量评分专用量表的制订及相关因素分析[J].护理学杂志.2006,21(24)：7-10.
23.孟凤芹,孟雷,马春梅.健康教育干预对慢性肾衰竭行维持性血液透析患者生活质量的影响.齐鲁护理杂志2007；13(17)：27-28