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.     

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.     

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.     

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(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.     

A systematic review of the use and validation of health-related quality of life instruments in older cancer patients

AimThe aim of this paper is to systematically review the use and validation of HRQOL instruments in older cancer patients.MethodA systematic review of 5 databases and 3 research registers identified studies reporting the use and validation of HRQOL instruments in cancer patients aged over 65 years from 1995 to mid 2007.ResultsThirty-one studies reported the use of HRQOL measures in older people, using a range of generic and disease-specific instruments. Little work was reported in patients aged over 80 years. All studies exhibited methodological limitations. Fourteen studies were identified with variable evidence on the psychometric properties and clinical usefulness of identified instruments.ConclusionOur review identified that the development, validation and use of HRQOL instruments often ignore the specific needs of older people. This review highlights the need for a HRQOL instrument specifically designed to capture the issues and concerns most relevant to older cancer patients.     

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.     

肝癌患者生活质量测评工具及应用

介绍肝癌患者生活质量测评专用量表,主要有美国的肝胆肿瘤治疗功能评定量表(Functional Assessmentof Cancer Therapy-Hepatobiliary,FACT-HEP)、欧洲癌症研究和治疗组织(European Organization for Research and Treatment of Cancer,EORTC)的肝癌患者生命质量量表(Quality of Life Questionnaire-Hepatocellular Carcinoma,QLQ-HCC18)以及国内万崇华等人研制的肝癌患者生命质量测定量表(Quality of Life-Liver Cancer,QOL-LC)。这3种量表给从事与肝癌相关的临床医护人员、社区医护人员提供了有效的测评工具,从而可以对肝癌患者生活质量进行全面、有效的评估。     

肺癌患者癌因性疲乏的影响因素及其与生活质量关系的研究

目的调查肺癌患者癌因性疲乏的发生率及程度,研究癌因性疲乏的相关症状及影响因素,初步探讨癌因性疲乏的治疗,研究肺癌患者癌因性疲乏与生存质量的相互关系,为肺癌患者的姑息性治疗提供一定的依据。方法采用收集病史与问卷调查相结合的办法,测试者本人填写附表。将调查表发给72例肺癌患者由患者自愿填写,填写后收回。其中接受放疗的肺癌患者于放疗第15天再次接受疲乏数字等级量评估疲乏程度并记录。所得数据采用SPSS13.0统计软件分析。结果乏力发生率为80.6%,以中重度疲乏为主占81.3%,乏力评分为4.65±2.87;疼痛和睡眠障碍是乏力最常见的相关症状,抑郁是癌症患者常见的情绪障碍且与癌因性疲乏相关,食欲与患者情感疲乏呈负相关;血红蛋白、血清白蛋白、白细胞及中性粒细胞计数与乏力程度有显著相关性;放疗影响患者的疲乏程度;肺癌患者对自身生存质量评价不满意者占51.4%,癌因性疲乏与生存质量呈负相关。结论肺癌患者中疲乏的发生率高,程度较重,在很大程度上影响患者的生活质量。改善患者的合并症如疼痛、睡眠障碍、抑郁、贫血、白细胞低下、低蛋白血症等,能在一定程度上降低疲乏的程度,提高患者的生活质量。     

Quick-FLIC: validation of a short questionnaire for assessing quality of life of cancer patients

A practically useful measure of quality of life should be simple and quick to complete. A shortened Chinese version of the Functional Living Index - Cancer (FLIC) was recently proposed and was called Quick-FLIC. This study aims to assess the measurement properties of the Quick-FLIC. A total of 190 patients who received care from the National Cancer Centre of Singapore completed a questionnaire package at baseline. Patients filled in a retest questionnaire on average 2 weeks after baseline to assess test-retest reliability and responsiveness to change. The Quick-FLIC scores correlated well with the Functional Assessment of Chronic Therapy - General scores (r=0.78). Patients with different treatment status, performance status and self-rated health had significantly different Quick-FLIC scores in the expected directions (ANOVA; each P<0.001). Internal consistency (Cronbach's alpha=0.87) and 2-week test-retest reliability (intraclass correlation=0.81) were also satisfactory. The measure was responsive to changes in health status (P<0.001). The Quick-FLIC is a valid and reliable measure of health-related quality of life of cancer patients. The shortening of established health-related quality of life instruments should be considered in order to reduce the burden of having patients to answer lengthy questionnaires.     

Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation

The classical criteria for the evaluation of clinical trials in cancer reflect alterations in physical well-being, but are insensitive to other important factors, such as psychosocial state, sociability, and somatic sensation that may play a critical role in determining the patients' functional response to their illness and its treatment. The Functional Living Index-Cancer is designed for easy, repeated patient self-administration. It is a 22-item questionnaire that has been validated on 837 patients in two cities over a three-year period. Criteria for validity include stability of factor analysis, concurrent validation studies against the Karnofsky, Beck Depression, Spielberger State and Trait Anxiety, and Katz Activities of Daily Living scales, as well as the scaled version of The General Health Questionnaire and The McGill/ Melzack Pain Index. The index is uncontaminated by social desirability issues. The validation studies demonstrate the lack of correlation between traditional measures of patient response and other significant functional factors such as depression and anxiety (r = 0.33), sociability and family interaction, and nausea. These findings elucidate the frequently observed discrepancies between traditional assessments of clinical response and overall functional patient outcome. The index is proposed as an adjunct to clinical trials assessment and may provide additional patient functional information on which to analyse the outcome of clinical trials or offer specific advice to individual patients.     

中国人肺癌生命质量可行性的初步探讨

目的　建立适合中国人的肺癌患者生命质量评价表 ,并对之进行可行性评价。方法　参照国外肺癌患者生命质量评价表 ,结合中国国情设计肺癌患者生命质量评价表 ,内容包含生物学、社会学、心理学三方面 ,分为 5个因子 6 5个条目。调查 35 5例经组织学或细胞学证实的肺癌患者 ,并将获得的评分与KPS评分比较。采用均数±标准差表示评分 ,t检验进行统计学分析。结果　所有患者、医师都能理解调查表的内容 ,仅有 2例患者 (均为初中以下文化程度 )在回答情感状况方面问题与经管医师有所不同。不同期别患者在总平均分、疾病症状、情感状况三方面有统计学差异 ;Ⅳ期患者的功能状况与Ⅰ～Ⅲ期患者亦有统计学差异 ;不同性别患者的情感状况相比也有统计学差异。结论　本表有良好的有效性、重复性和可行性。     

肺癌患者生活质量的影响因素

临床研究显示,多种因素都可影响肺癌患者的生活质量(QOL),生理因素有呼吸困难、癌因性疲乏等,抑郁、焦虑等心理因素起主要作用,社会和家庭支持对提高肺癌患者的QOL也很关键.     

Feasibility study of quality of life (QOL) instrument in patients with advanced lung cancer

We have studied the feasibility of the QOL measurement for the group of patients with advanced lung cancer using the QOL questionnaires modified from FLIC (Functional Living Index Cancer). The 16-items instrument showed that the Cronbach's alpha of all categories were over 0.6. as the quality of reliability. Using the principal component method of multivariate analysis, four major factors were identified as a part of the construct validity. We concluded that the QOL of patients with advanced lung cancer under the clinical research setting can be evaluated using this questionnaires even in Japan which has different cultural background from the Western Countries.     

宫颈癌患者生命质量评价量表的编制及测评

目的:编制一套适合测评中国宫颈癌患者的生命质量评价量表(quality of life scale for cervical cancer patients,QLS-CCP),并评价其信度和效度.方法:通过文献查阅法、访谈法和专家咨询等方法确定条目池,形成初始量表.采用变异度法、t检验法、相关系数法和逐步回归法对初始量表进行条目筛选,形成最终的测试量表;采用新编制的Q LS-CCP对136例子宫颈癌患者进行调查,并对其信度和效度进行评价.结果:最终QLS-CCP包含躯体功能、心理、社会及与疾病症状4个维度,共32个条目.量表的重测相关系数、Cronbach'α系数和分半信度系数分别为0.96、0.93和0.85.效标效度较好(rs=0.591,P=0.000).因子分析找到4个公因子,可以解释总变异的57.22％,显示量表的结构效度良好,量表结构与理论构想相符,具有较好的区分效度.结论:新编制的QLS-CCP具有良好的信度和效度,可用于中国宫颈癌患者生存质量的测评.     

癌症患者生活质量调查表的编制及试测

随着癌症患者生存期的延长，癌症患者生活研究越来越引起人们的关注。因此，在引进，修订国外有关ＱＯＬ问卷的同时，编制，评估我国自己的ＱＯＬ问卷将有助于我国在这一年轻领域的研究工本。本文简介了中国癌症化疗患者生活质量调查顺卷的编制，试测及应用情况，初步研究结果表明ＱＬＱ－ＣＣＣ在评价中国癌症化疗患者ＱＯＬ时具有可靠，有效，灵敏及实用等特点。     

The EORTC quality of life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients

Introduction  

The EORTC Quality of Life (QL) Group has developed a questionnaire -the EORTC QLQ-CR29- for evaluating QL in colorectal cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQ-CR29 when applied to a sample of Spanish patients.