癌症患者生命质量测定量表体系之胃癌量表QLICP-ST的研制

背景与目的:有关癌症患者生命质量测定量表体系共性模块(qualityof life instruments for cancer patients-general module, QLICP-GM)的研制已有报道.本研究在此基础上研制癌症患者生命质量测定量表体系之胃癌量表(quality0f life instruments for cancer patients-stomach cancer,QLICP-ST),并对其进行评价.方法:采用量表开发的程序化方法研制量表,并应用该呈表对86例胃癌患者进行生命质量测评.用内部一致性系数、相关分析、配对t检验和探索性因子分析等对呈表的信度、效度和反应度进行考评.结果:总量表重测相关系数为0.98,各领域的重测相关系数均大于0.90.各个领域的内部一致性系数a在0.65以上,总量表的内部一致性系数a为0.91.相关分析与探索性因子分析结果显示量表的结构效度较好.躯体功能领域、心理功能领域、共性症状与剐作用领域、特异模块以及总量表治疗前后的生命质量得分差异均有统计学意义(P<0.05).而且,这些领域的标准化反应均数(standardized response mean,SRM)均在0.30以上.结论:QLICP-ST有较好的信度、效度和反应度,可用于临床胃癌患者生命质量的测评.     

癌症患者生命质量测定量表体系中各量表的测量学特性分析

目的:分析癌症患者生命质量测定量表体系(Quality of Life Instruments for Cancer Patients, QLICP)中,已研制的用于测定肺癌、乳腺癌、头颈癌、胃癌、结直肠癌和宫颈癌等6种癌症患者的量表构成及信度、效度和反应度。方法:采用量表开发的程序化方法研制各量表,然后对692例恶性肿瘤(包括85例肺癌、186例乳腺癌、133例头颈癌、86例胃癌、110例结直肠癌和92例宫颈癌)患者进行生命质量测定,通过计算总量表及各领域的克朗巴赫系数α和重测相关系数,应用探索性因子以及采用配对t检验等分析方法,考评研制量表的信度和效度。结果:6种癌症患者的生命质量测定量表均有较好的结构和符合要求的测量学特性,即有较好的信度、效度和一定的反应度。结论:肺癌、乳腺癌、头颈癌、胃癌、结直肠癌和宫颈癌等6种癌症的特异模块与QLICP体系中的共性模块结合后,可用于临床上相应癌症患者生命质量的测定。     

癌症患者生命质量测定量表体系共性模块的研制(三):反应度分析

背景与目的:我们已经开发了癌症患者生命质量测定量表体系共性模块(quality of life instruments for cancer patients-general module,QLICP-GM),并对其信度、效度进行了评价.本文拟对其反应度进行分析.方法:用QLICP-GM量表测定5种癌症600例患者治疗前后的生命质量,采用传统假设检验并结合效应大小、标准化反应均数等指标以及等效检验方法进行分析.结果:躯体功能、心理功能、共性症状及副作用3个领域和总量表均发现统计学意义的变化,其标准化反应均数在0.16～0.67之间;等效检验也发现这些领域和总量表治疗前后不具等效性.结论:QLICP-GM具有一定的反应度,可用于临床生命质量测评.     

癌症患者生命质量测定量表体系之乳腺癌量表QLICP-BR的研制

背景与目的:我们已经研制了癌症患者生命质量测定量表体系的共性模块(quality of life instruments for cancer patients-general module,QLICP-GM).本研究在此基础上再研制乳腺癌患者生命质量测定量表(QLICP-BR),并对其进行评价.方法:采用量表开发的程序化决策方式研制适合中国文化的QLICP-BR,并通过对186例乳腺癌患者进行的生存质量测定对量表进行评价.结果:总量表及各个领域的重测相关系数均在0.75以上;各领域内部一致性信度的α值除社会功能领域为0.58外,其余均在0.65以上;各条目与其领域的相关性均大于与其它领域的相关性,相关系数r值大多都在0.6以上;总量表、共性模块、躯体功能、心理功能及社会功能领域得分均显示治疗前后差异有统计学意义.结论:QLICP-BR具有较好的信度、效度和一定的反应度,可作为我国乳腺癌患者生命质量的测评工具.     

癌症患者生命质量测定量表体系之肺癌量表QLICP-LU的研制与测量学特性评价

[目的]研制肺癌患者生命质量测定量表QLICP-LU并对其测量学特性进行评价。[方法]采用程序化决策方式(议题小组和核心小组)和量表开发理论分别研制共性模块与特异模块,二者结合形成量表,并通过85例肺癌患者进行的生命质量测定对量表的测量学特性(信度、效度、反应度)进行评价。所用到的统计学方法有相关分析、因子分析及配对t检验等。[结果]该量表的重测信度为0.78,各领域内部一致性α值及重测信度值大多在0.7以上;相关分析与因子分析显示较好的结构效度;与FACT-L为效标的效标关联效度为0.82;治疗后各领域及总量表得分均有统计学意义,且标准化反应均数SRM除社会功能外均大于0.8。[结论]QLICP-LU具有较好的信度、效度及反应度,可用于中国肺癌患者的生命质量测定。     

癌症患者生命质量测定量表FACT-G中文版评介

目的介绍美国转归研究与教育中心的癌症治疗功能评价系统中的共性模块FACT-G中文版，重点是其计分方法和应用效果评价。方法通过552例恶性肿瘤患者进行的生存质量测定对量表进行评价。采用的统计学方法有相关分析、因子分析和配对t检验。结果4个领域的重测信度均在0．85以上；各领域内部一致性信度的α值均在0．8以上；各条目与其领域的相关系数r值均在0．5以上；27个条目中提取了4个因子，累计方差贡献率为65．8％；该量表在入院治疗4周后基本上能够反映出生命质量的变化。结论FACT-G中文版具有较好的信度、效度及反应度，可用于中国癌症患者的生命质量测定。     

癌症患者生命质量测定量表体系之宫颈癌量表QLICP-CE的研制及考评

[目的]研制癌症患者生命质量测定量表体系之宫颈癌量表QLICP-CE,并对其进行考评.[方法]通过程序化决策方式并多轮的访谈和预调查等研制量表QLICP-CE.并通过对92例宫颈癌患者的测定进行评价.统计学方法包括相关分析、因子分析和配对t检验等.[结果]该量表的重测信度y为0.95,克朗巴赫系数为0.68;相关分析与因子分析显示较好的结构效度;治疗后除社会功能领域外各领域及总量表得分均有统计学意义.治疗前后基本上能够反映出生命质量的变化.[结论]QLICP-CE具有较好的信度、效度及反应度,可以用于中国宫颈癌患者的生命质量测定.     

肿瘤患者生命质量量表维文版测试效果评价

[目的]分析维文版EORTC QLQ-C30（V3）生命质量量表、维文版QLICP-GM（V1.0）量表的信度和效度。[方法]将EORTC QLQ-C30（V3）生命质量量表、我国自主研制的中文版QLICPGM（V1.0）量表进行翻译、回译及部分文化调适后分别产生维文量表,分别对497例在新疆维吾尔族自治区肿瘤医院住院确诊的恶性肿瘤患者进行问卷调查,分析量表的内部一致性、重测信度、内容效度、区分效度和结构效度等指标。[结果]QLICP-GM量表的内部一致性优于EORTC QLQ-C30量表,但重测信度不如EORTC QLQ-C30量表。QLICP-GM量表的内容效度、区分效度均优于EORTC QLQ-C30量表。[结论]维文版QLICP-GM量表具有良好的信度和效度,更适合应用于新疆公共卫生和其它医学领域。     

乳腺癌患者生命质量测定量表的考评

[目的]考评乳腺癌患者生命质量测定量表。[方法]通过随机抽取临床165例女性乳腺癌患者进行的生命质量测定资料对癌症病人生命质量测定量表体系-乳腺癌量表,简称为QLICP-BR（V1.0)进行考评。所用的统计学方法包括相关分析、因子分析,逐步回归分析的t检验。[结果]（1）躯体、心理、症状及副作用、社会功能四个领域和量表总分的重测相关系数分别为因子分析、逐步回归分析和t检验。[结果]（1）躯体、心理、症状及副作用、社会功能四个领域和量表总分的重测相关系数分别为0.86、0.84、0.87、0.85和0.89;分半信度为0.88;躯体、心理、症状及副作用、社会功能四个领域的克朗巴赫系数α分别为0.74、0.80、0.75和0.62。（2）量表的结构与设计时的概念构想吻合,以美国的FAFCT-B量表为效标进行评价,其效标效度为0.85。（3）量表能够反应治疗前后生命质量的变化。[结论]本文研究的量表具有较好的效度,信度和反应度,可作为我国乳腺癌患者生命质量的测评工具。     

癌症患者生命质量测定量表体系共性模块的研制(一):条目筛选及共性模块的形成

背景与目的:癌症患者的生命质量研究受到全球关注,美国、欧洲已经开发出相应的测定量表体系FACT(癌症治疗功能评价系统)和QLQ(生命质量量表系列)并得到了广泛的应用,但中国缺乏相应的测定量表体系.本文拟研制中国人使用的癌症患者生命质量测定量表体系共性模块(quality of life instruments for cancer patients-general module,QLICP-GM).方法:采用议题小组和核心小组的程序化决策方式,通过定性和定量相结合的量表开发理论和方法对条目进行初步筛选、评价和修改,形成初步量表.随机抽取恶性肿瘤患者448人,采用变异度法、因子分析、聚类分析和相关分析等统计学方法对结果进行分析.结果:研制出QLICP-GM,该测定量表体系含有躯体功能、心理功能、社会功能、共性症状及副作用4个领域32个条目.结论:QLICP-GM反映了WHO关于生命质量的内涵及癌症患者的共同问题,具有较好的内容效度.     

Development and validation of the general module of the system of quality of life instruments for cancer patients

Based on World Health Organization (WHO)'s definition of Quality of Life (QOL) and programmed decision procedures, we developed a general module of the System of Quality of Life Instruments for Cancer Patients (QLICP-GM) utilizing focus group discussions, pilot tests of 448 cases and field tests of 600 cases of 5 different cancer patients. The number of items in the final version was reduced to 32 from a 78-item pool. The psychometric properties of the scale were evaluated by indicators such as validity and reliability coefficients, SRM, and statistical methods of correlational analysis, t tests, and structural equation modeling. Correlational and structural equation model analyses indicate good construct validity with RMSEA 0.086, NNFI 0.947 and CFI 0.961. Good criterion-related validity was found when FACT-G was used as the criterion. The test-retest reliability for all domains and the overall scale is above 0.85; the internal consistency alpha for each domain is higher than 0.70 except of the social function; alpha and the split-half reliability of the overall scale is 0.88 and 0.93, respectively. The pre-post changes of QOL scores are of statistical significances in 3 domains of physical function, psychological function, common symptoms and side effects, and the overall instrument, with standardized response mean ranging from 0.16 to 0.67. Equivalence tests showed nonequivalence on quality of life score changes of these domains and the overall instrument. Our study shows that the QLICP-GM has good validity, reliability, responsiveness, and can be used as the general module for cancer patients in China.     

Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer

The simplified Chinese version of the FACT-B was evaluated by QOL data measured from 376 patients with breast cancer. The results showed that test–retest reliability for five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, additional concerns, and the overall scales and trial outcome index were 0.82, 0.85, 0.91, 0.86, 0.90, 0.84 and 0.91, 0.89 respectively. The internal consistency α for the five domains mentioned above were 0.85, 0.82, 0.84, 0.84 and 0.59 respectively. Correlation analysis, factor analysis and structural equation model showed good construct validity. Criterion-related validity was also confirmed using QLICP-BR as a criterion. The instrument can find the change of QOL for cancer patients after treatment. It’s concluded that the simplified Chinese version of FACT-B can be used to measure QOL for Chinese patients with breast cancer with good validity, reliability and responsiveness. This research is sponsored by the Natural Sciences Funds of Yunnan Province (99C0016G).     

癌症患者生命质量测定量表体系之大肠癌量表QLICP-GR的研制

背景与目的:癌症患者生命质量测定量表体系(quality of life instruments for cancer patients,QLICP)共性模块的研制已有报道,本研究在此基础上将研制大肠癌患者生命质量测定量表(QLICP-colorectal cancer,QLICP-CR).方法:采用量表开发的程序化决策方式研制适合中国文化背景下使用的QLICP-CR,并通过110例大肠癌患者的生存质量测定对量表进行评价.采用统计描述、相关分析、配对t检验和聚类分析等进行统计学处理.结果:总量表及各个领域的重测相关系数均在0.78以上;各领域内部一致性信度的α值除社会功能及共性症状和副作用领域分别为0.66、0.63外,其余均在0.85以上;各条目与其领域的相关均大于与其它领域的相关,相关系数r值大多都在0.6以上;总量表、共性模块、特异模块、心理功能及共性症状和副作用领域得分均显示治疗前后差异有统计学意义.结论:QLICP-CR具有较好的信度、效度及反应度,可作为我国大肠癌患者生命质量的测评工具.     

Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer

Background: European Organization for Research and Treatment quality of life (QOL) questionnaire (QLQ-C30) has been used frequently and many language versions have been developed, including the simplified Chinese version. It is important to study psychometric properties of the simplified Chinese version from the clinical standpoint.Patients and methods: The simplified Chinese version of the QLQ-C30 was used in a longitudinal study of 600 patients with five types of cancer: lung, breast, head and neck, colorectal, and stomach. The psychometric properties of the scale were evaluated by indicators of validity and reliability coefficients such as Cronbach's α and Pearson's correlation coefficient r, standardized response mean (SRM), correlational analysis, t-tests, and structural equation models.Results: Correlation and structural equation model analyses confirmed good construct validity with root mean square error of approximation 0.054, standardized root mean square residual 0.037, non-normed fit index 0.972, and comparative fit index 0.980. The α coefficients for all domains are >0.7 except for cognitive functioning (0.49). The test–retest reliability coefficients for most domains are >0.80 except for appetite loss (0.77) and diarrhea (0.75). The QOL score changes after treatments were of statistical significance with higher or moderate SRM in most domains.Conclusion: The simplified Chinese version of QLQ-C30 has good validity, reliability, and responsiveness and can be used to measure QOL for Chinese cancer patients.     

Psychometric properties of the Chinese version of the FACT-L for measuring quality of life in patients with lung cancer

A Simplified Chinese version of the FACT-L was evaluated using responses from 181 patients with lung cancer in China by assessing the construct, discriminative and criterion-related validity, internal consistency, test-retest reliability, and responsiveness as measured by score changes of the scales. Correlation and factor analysis among domains and items showed good construct validity, correlation analysis of domain scores between FACT-L and Quality of Life Instruments for Cancer Patients-Lung cancer (QLICP-LU) displayed good criterion-related validity, and comparison of two age groups demonstrated discriminative validity. Test-retest reliability and Internal consistency coefficients for all domains were greater than 0.75 with the exception of the domain of additional concerns (alpha=0.56). Score changes over time were statistically significant in the overall scale and all domains: standardized response mean (SRM) for physical well-being is 1.56, social/ family well-being 0.70, emotional well-being 0.93, and functioning well-being 1.51. Therefore, the Simplified Chinese version of FACT-L can be used to measure quality of life (QOL) for Chinese patients with lung cancer with good validity, reliability, and responsiveness.     

Development and validation of the system of quality of life instruments for cancer patients: head and neck cancer (QLICP-HN)

Quality of life for patients with head and neck is now concerned worldwide, but the available QOL instruments are seldom and lack of Chinese culture. Therefore, this paper aimed to develop and validate a QOL instrument for patients with head and neck cancer, QLICP-HN. Using the programmed decision methods and the theory in instrument development, the QLICP-HN was developed and evaluated based on the data measuring QOL three times before and after treatment from a sample of 133 in-patients of head and neck cancer. The psychometric properties of the scale were evaluated by indicators such as validity and reliability coefficients: Cronbach α, Pearson r, standardized response mean. The statistical methods included Pearson correlation, multi-trait scaling analysis, factor analysis, cluster analysis and paired t test. The internal consistency α for the overall scale and domains is above 0.70 with the exception of the social function (0.65) and common symptom and side effect (0.66); the test-retest reliability for each domain and the overall scale is higher than 0.80; most correlation coefficients between each item and its domain are above 0.40; the scores differences between pre-treatment and post-treatment have statistical significance for three domains of physical, psychological, the specific, and the overall instrument, with higher SRM of 0.33, 0.59, 0.44 and 0.53. The QLICP-HN is of good validity, reliability and responsiveness, and can be used to assess quality of life for patients with head and neck cancer in China.     

Development and validation of the system of quality of life instruments for cancer patients: lung cancer (QLICP-LU)

Using the structured group methods (nominal and focus group) and the theory in instrument development, the quality of life instrument for lung cancer (QLICP-LU) with Chinese cultural background was developed, and evaluated based on the data from a sample of 85 in-patients of lung cancer. Statistical methods used were correlation analysis, factor analysis and paired t-test, etc. The results showed that test-retest reliability of the overall scale was 0.78, and test-retest reliability and internal consistency alpha for most domains were higher than 0.70; correlation and factor analysis demonstrated good construct validity; criterion-related validity were confirmed given FACT-L and QLQ-LC43 (QLQ-C30 plus QLQ-LC13) as the criterions; statistically significant changes were found for each domain and the overall scale with standardized response mean SRM being greater than 0.80 except for the social function domain. We conclude that the QLICP-LU can be used to measure QOL for patients with lung cancer with better validity, reliability and responsiveness in China.