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EORTC QLQ-C30中文版评介

目的介绍欧洲癌症研究与治疗组织开发的生命质量测定量表EORTC QLQ—C30的中文版，重点评价计分方法和应用效果。方法通过量表的翻译、回译及文化调适制定中国版的EORTC QLQ—C30，并通过226例恶性肿瘤患者进行的生命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，配对t检验。结果15个领域的重测信度均在0．73以上；各领域内部一致性信度的a值均在0．5以上；各条目与其领域的相关系数r值均在0．5以上；30个条目中提取了15个因子，累计方差贡献率为84．7％；该量表在人院治疗四周后基本上能够反映出生存质量的变化。结论EORTC QLQ—C30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共性模块的研制(二):信度与效度分析

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),但其心理测量学特性有待考评.本研究拟考评QLICP-GM的信度与效度.方法:用QLICP-GM对600例肺癌、乳腺癌、大肠癌、胃癌和头颈癌患者的生命质量进行测定和评价,用相关分析、配对t检验、等效检验、结构方程模型等统计学方法分析QLICP-GM的信度和效度;同时与FACT-G量表测定和评价结果比较,分析QLICP-GM的效标效度.结果:QLICP-GM各领域及总量表的重测信度均在0.85以上,除社会功能外各领域内部一致性信度α值均在0.70以上,总量表的α值和分半信度分别为0.88和0.93;相关分析与结构方程模型分析显示量表有较好的结构效度:与FACT-G的相关分析显示有较好的效标关联效度.结论:QLICPGM具有较好的信度和效度,可用于癌症患者生命质量测定.     

大肠癌患者生命质量测定量表QLQ-CR68中文版的研制与应用评价

[目的]研制并通过实际测定评价欧洲癌症研究与治疗组织EORTC的大肠癌患者生命质量测定量表QLQ-CR68中文版的应用效果。[方法]通过翻译、回译、预调查和文化调试等步骤研制相应的中文版,通过110例大肠癌患者进的生命质量测定对量表的信度、效度和反应度进行评价。[结果]相关分析与因子分析显示较好的结构效度;内部一致性除认知功能(0.49)、化疗副作用(0.44)和社会功能(0.67)较低外,其它领域均在0.70以上;重测信度除化疗副作用为0.60外,其余均在0.7以上,而且大部分在0.80以上;发现核心模块的躯体功能、角色功能、社会功能、总健康状况领域及特异模块的所有领域治疗前后得分差异均有统计学意义。[结论]QLQ-CR68中文版具有较好的信度、效度和反应度,可用于中国大肠癌患者的生命质量测定。     

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体系之大肠癌量表QLICP-CR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 instrumentsfor 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。     

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.     

鼻咽癌患者中SF-36量表的信度和效度的研究

目的：评价简明健康调查量表（36-items short form health survey，SF-36）在鼻咽癌患者生存质量应用中的信度和效度。方法：2007年1月21日～2月7日，统一受训的调查员使用SF-36对526例确诊的鼻咽癌患者进行自评量表式调查，并采用相关分析、信度分析和因子分析等统计方法分析量表的信度和效度。结果：SF-36具有较好的分半信度和内部信度；除活力（VT）和社会功能（SF）外（信度系数≥O．6），各领域的内部信度系数均≥0．7。每务目跟相关领域的相关系数均〉0．53，而且高于该条目与其他领域的相关系数，说明SF36有良好的内容效度和区分效度。所有条目提取的7个主成分分布代表了各个领域，累计贡献达61．18％；8个领域得分提取2个公共因子，解释58．90％的变异。因子分析产生的结果与量表的理论结构假设基本一致。结论：SF-36有较好的信度和效度，可用于评价鼻咽癌患者的生存质量。     

食管癌化疗患者生存质量测定量表中文版的研制与考评

目的：应用欧洲癌症研究与治疗组织（EORTC）开发的问卷表QLQ—OES18为蓝本来研制其中文版，并对其进行考评。方法：通过量表的翻译、回译和文化调适制定出中文版的QLQ—OES18，并通过考查133例食管癌患者的生存质量对量表进行评价。对EORTCQLQ—OES18中文版量表主要进行信度、效度和反应度三方面的考评，采用克朗巴赫系数考察内部一致性；计算各个领域及方面间相关系数来分析量表的内容效度；使用配对t检验进行第1、2次测定及第1、3次测定得分均数的比较，考察量表的区分效度。结果：EORTCQLQ—OES18显示出较好的可靠性和良好的鉴别能力，能显示出化疗带来的生存质量改变。各领域内部一致性的信度都在0．61以上；各条目与其领域的相关系数值在0．6以上。结论：QLQ—OES18显示出较好的心理测定学和临床有效性，可推荐其与核心量表QLQ—C30联用，用来评估化疗后食管癌患者的生存质量。     

Psychometric properties of the simplified Chinese version of the EORTC QLQ-BR53 for measuring quality of life for breast cancer patients

A Simplified Chinese version of the EORTC QLQ-BR53 was evaluated using responses from 233 patients with breast cancer in China by assessing the construct and criterion-related validity, internal consistency and test–retest reliability, and responsiveness as measured by score changes of the scales. Internal consistency reliability measured by Cronbach’s coefficient α is greater than 0.75 for most multi-item scales except cognitive functioning (0.41) and breast symptoms (0.71). Test–retest reliability coefficients for all domains are greater than 0.80 with the exception of physical functioning (0.65), social functioning (0.75), appetite loss (0.75), diarrhea (0.72), and body image (0.72). Correlation and factor analysis among domains and items showed good construct validity for both QLQ-C30 and QLQ-BR23. Score changes over time were observed in most domains except emotional functioning, global health status/QOL, dyspnoea, constipation, diarrhea, financial difficulties, sexual functioning, sexual enjoyment, and breast symptoms. Therefore, the Simplified Chinese version of QLQ-BR53 shows reasonable validity, reliability, and responsiveness and can be used to measure QOL for Chinese patients with breast cancer.     

Validation of the Turkish Versions of EORTC QLQ-C30 and BR23 Modules in Breast Cancer Patients

Purpose: To test the validity and reliability of The European Organization for Research and Treatment ofCancer (EORTC) core (QLQ-C30) and breast cancer module (QLQ-BR23) for Turkish breast cancer patients.Patients and Methods: A total of 127 patients treated with radiotherapy (RT) enrolled to this prospective study.EORTC QLQ-C30 and QLQ-BR23 modules applied to patients before initiation of RT and at follow-up period.Statistical analyses were performed by SPSS 13.0. Results: Questionnaires’ were found reliable and valid forTurkish breast cancer patients. Six of the 8 multi-item scales of QLQ-C30 had a high reliability (Cronbach’s α>0.7); where physical functioning and pain scores were less reliable (Cronbach’s α of 0.66 and 0.68 respectively).In the QLQ-BR23, 3 of 5 multi-item scales were reliable; less reliable were breast and arm symptoms scale(Cronbach’s α of 0.65 and 0.61 respectively). In our analysis the most determinative subscales of QLQ-C30on global health was emotional functioning followed by fatigue, role functioning and appetite loss (respectivelyp=0.002, p=0.01; p=0.03 and p=0.08). Among QLQ-BR23 scales systemic therapy side effects, future perspectiveand upset by hair loss subscales had high impact on global health status (respectively p=0.006; p=0.01 and p=0.03).Conclusions: The Turkish version of EORTC QLQ-C30 and QLQ-BR23 modules are reliable and valid tools toassess quality of life of Turkish breast cancer patients.     

Quality of life of breast cancer patients in Taiwan: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and EORTC QLQ-BR23

The objective of this study was to test the reliability and validity of the Taiwan Chinese version of the EORTC QLQ-C30 (version 3) and EORTC QLQ-BR23. The authors followed the guidelines of translation and pilot testing of the questionnaires. The questionnaires were given to 35 breast cancer patients under active treatment and 54 under follow-up at the National Taiwan University Hospital from November 2000 to October 2001. A retest was conducted one to two weeks after the first interview/form completion for the follow-up group. The intraclass correlation coefficients of the two questionnaires were moderate to high in the follow-up group. The Cronbach's alpha coefficients of most scales of the two questionnaires were > or = 0.70 except that of physical functioning (0.68), cognitive functioning (0.53), and arm symptoms (0.59). Correlations of scales measuring similar dimensions of the EORTC QLQ-C30 and the SF-36 were moderate. Patients in the active treatment group had more serious QOL problems due to disease and treatment. Results of this study showed that the Taiwan Chinese version of the two questionnaires had good test/retest reliability, high internal consistency in most scales, and could show the expected differences between patients in active chemotherapy and follow-up group.     

Validation of the Mexican-Spanish version of the EORTC QLQ-C30 and BR23 questionnaires to assess health-related quality of life in Mexican women with breast cancer

The aim of this study was to validate the Mexican-Spanish version of The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. The translation procedure followed EORTC guidelines. QLQ-C30 and QLQ-BR23 instruments were completed by Mexican women with breast cancer, attending a teaching referral cancer centre from February 2009 to January 2010. Patients were divided in two groups: (1) Patients with early stage of breast cancer; and (2) Patients with locally advanced breast cancer (LABC). Reliability and validity tests were performed, and validity over time (responsiveness) was conducted in a subset of patients. Two hundred and thirty-four women (mean age, 52.3 years) completed both questionnaires. Convergent and divergent validity was adequate. Cronbach's alpha of all multi-item scales showed values ≥0.7 except for Cognitive and Breast symptoms scales (0.52 and 0.65 respectively). Patients with early stages (n= 77) showed better functional scores and lower symptoms scores than patients with LABC (n= 157). Score means variation after responsiveness analysis demonstrated high sensitivity to change after breast cancer surgery. The Mexican-Spanish version of the EORTC QLQ-BR23 questionnaire is a valid and suitable instrument to estimate HRQL in patients with breast cancer.     

Quality of Life among Breast Cancer Patients In Malaysia

Background: Among the factors reported to determine the quality of life of breast cancer patients are socio- demographic background, clinical stage, type of treatment received, and the duration since diagnosis. Objective: The objective of this study was to determine the quality of life (QOL) scores among breast cancer patients at a Malaysian public hospital. Materials and Methods: This cross-sectional study of breast cancer patients was conducted between March to June 2013. QOL scores were determined using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer supplementary measure (QLQ-BR23). Both the QLQ-C30 and QLQ-BR23 assess items from functional and symptom scales. The QLQ-C30 in addition also measures the Global Health Status (GHS). Systematic random sampling was used to recruit patients. Results: 223 breast cancer patients were recruited with a response rate of 92.1%. The mean age of the patients was 52.4 years (95% CI = 51.0, 53.7, SD=10.3). Majority of respondents are Malays (60.5%), followed by Chinese (19.3%), Indians (18.4%), and others (1.8%). More than 50% of respondents are at stage III and stage IV of malignancy. The mean Global Health Status was 65.7 (SD = 21.4). From the QLQ-C30, the mean score in the functioning scale was highest for 'cognitive functioning' (84.1, SD=18.0), while the mean score in the symptom scale was highest for 'financial difficulties' (40.1, SD=31.6). From the QLQ-BR23, the mean score for functioning scale was highest for 'body image' (80.0, SD=24.6) while the mean score in the symptom scale was highest for 'upset by hair loss' (36.2, SD=29.4). Two significant predictors for Global Health Status were age and employment. The predictors explained 10.6% of the variation of global health status (R2=0.106). Conclusions: Age and employment were found to be significant predictors for Global Health Status (GHS). The Quality of Life among breast cancer patients reflected by the GHS improves as age and employment increases.     

Comparison of Quality of Life of Turkish Breast Cancer Patients Receiving Breast Conserving Surgery or Modified Radical Mastectomy

Purpose: The aim of this study was to investigate the differences in quality of life in patients who received breast conserving surgery (BCS) or modified radical mastectomy (MRM) for breast cancer. Materials and Methods: A total of 100 women with breast cancer who underwent either BCS or MRM between September 2011 and April 2012 at a private health center and completed their chemotherapy and radiation therapy cycles were included in the study. To assess the quality of life, we used a demographic questionnaire, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Quality of Life assessment in Breast Cancer (EORTC QLQ-BR23). Results: Using QLQ-C30, we found that patientswho underwent BCS had better functional status and fewer symptoms than patients who underwent MRM. In QLQ-BR23, independent factors improving the functional scales were BCS, higher level of education and marital status (married); independent factors improving symptoms were BCS, higher level of education, younger age and low and normal body mass index (BMI). In QLQ-C30, independent factors affecting the functional and symptom scales were only BCS and higher level of education. Conclusions: We determined that patients whoreceived BCS had better functional status and less frequent symptoms than patients who underwent MRM.     

Psychometric Validation of the Malaysian Chinese Version of the EORTC QLQ-C30 in Colorectal Cancer Patients

Background and Aims: Colorectal cancer is the second most frequent cancer in Malaysia. We aimed to assess the validity and reliability of the Malaysian Chinese version of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire core (QLQ-C30) in patients with colorectal cancer. Materials and Methods: Translated versions of the QLQ-C30 were obtained from the EORTC. A cross sectional study design was used to obtain data from patients receiving treatment at two teaching hospitals in Kuala Lumpur, Malaysia. The Malaysian Chinese version of QLQ-C30 was self administered in 96 patients while the Karnofsky Performance Scales (KPS) was generated by attending surgeons. Statistical analysis included reliability, convergent, discriminate validity, and known-groups comparisons. Statistical significance was based on p value ≤0.05. Results: The internal consistencies of the Malaysian Chinese version were acceptable [Cronbach’s alpha (α≥ 0.70)] in the global health status/overall quality of life (GHS/QOL), functioning scales except cognitive scale (α≤0.32) in all levels of analysis, and social/family functioning scale ( =0.63) in patients without a stoma. All questionnaire items fulfilled the criteria for convergent and discriminant validity except question number 5, with correlation with role (r = 0.62) and social/family (r = 0.41) functioning higher than with physical functioning scales (r = 0.34). The test-retest coefficients in the GHS/QOL, functioning scales and in most of the symptoms scales were moderate to high (r = 0.58 to 1.00). Patients with a stoma reported statistically significant lower physical functioning (p=0.015), social/family functioning (p=0.013), and higher constipation (p=0.010) and financial difficulty (p=0.037) compared to patients without stoma. There was no significant difference between patients with high and low KPS scores. Conclusions:Malaysian Chinese version of the QLQ-C30 is a valid and reliable measure of HRQOL in patients with colorectal cancer.     

Quality of life in metastatic breast cancer patients under chemotherapy or supportive care: a single-institution comparative study

The aim of the present study was to evaluate quality of life (QoL) parameters in patients with metastatic breast cancer (MBC) and assess the potential differences between patients receiving chemotherapy and those undergoing supportive care interventions. In total, 210 women with MBC were enrolled in this prospective, randomized, single-institution study. The primary outcome of the trial was QoL assessment, using the self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3) and Quality of Life Questionnaire Breast 23 (QLQ-BR23) questionnaires. Quality of life was found to be statistically better (P = 0.008) in MBC patients receiving chemotherapy than those under only supportive care. Statistically significant differences in favour of chemotherapy were also found in functioning subscales, symptom single-item questions and sexual functioning. Our findings suggest that chemotherapy in MBC patients with good performance status is the more rational therapeutic approach in terms of QoL improvement.     

Comparison of two quality-of-life instruments for cancer patients: the functional assessment of cancer therapy-general and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30.

PURPOSE: To compare two quality-of-life (QOL) questionnaires for cancer patients, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (Fact-G), on the basis of empirical data. PATIENTS AND METHODS: Two hundred forty-four patients with a diagnosis of breast cancer or Hodgkin's disease completed both the EORTC QLQ-C30 and the FACT-G (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis, canonical correlation, and multiple linear regression. RESULTS: Correlations between corresponding subscales of the FACT-G and the EORTC QLQ-C30 ranged from r =.14 for the social domain (very poor agreement) to r =.66 for the physical domain (good agreement), with r values for the other domains lying between these extremes. Canonical correlation analysis for the two sets of subscales revealed that overall agreement between the two instruments was only moderate (first canonical correlation coefficient r =.85, but overall redundancy less than 40%). Of the five FACT-G subscales, only one, physical well-being, was well represented by the EORTC QLQ-C30 subscales (multiple linear regression, R(2) =.67). Only three of eight EORTC QLQ-C30 subscales (physical functioning, global QOL, general symptoms) were represented fairly well by FACT-G subscales (R(2) =.43 to.60). The lowest R(2) values (<.15; ie, virtually no representation by the other instrument) were found for the FACT-G social well-being and relation with doctors and EORTC QLQ-C30 cognitive functioning subscales. CONCLUSION: For the sample investigated, the EORTC QLQ-C30 and the FACT-G were found to measure markedly different aspects of QOL, despite considerable overlap. Replicability provided, this implies that neither of the two QOL instruments can be replaced by the other and that a direct comparison of results obtained with the two instruments is not possible.     

乳腺癌初次与再次化疗患者生活质量调查

目的评估乳腺癌患者初次化疗与再次化疗时的生活质量。方法采用欧洲癌症研究与治疗组织（EORTC）开发的QLQ-BR53来测定初次与再次乳腺癌化疗患者的生活质量,所得资料用统计学方法进行配对t检验。结果①在一般生存状况中（QLQ-C30）,两组患者相比,再次化疗患者在物理症状、认知功能、情绪功能、社会功能及总体健康状况上与化疗前相比差异有显著性（P〈0.05或P〈0.01）。②乳腺癌特定生活质量比较中,再次化疗患者在性功能、性乐趣、系统疗法副作用、手臂症状及脱发引起的烦恼方面与初次化疗相比差异有显著性（P〈0.05或P〈0.01）。结论乳腺癌患者再次化疗时生命质量低于初次化疗时,再次化疗患者生活质量降低并非不可避免,提高手术质量,选择合适的化疗药物,改善化疗支持治疗,适当的心理治疗可以避免上述情况的发生。