癌症患者生命质量测定量表体系之白血病量表（QLICP-LE）的条目筛选

[目的]开发适合中国特色的白血病患者生命质量量表的特异模块.[方法]采用议题小组和核心小组的程序化决策方式,通过定性访谈和定量调查分析相结合的方法对条目进行初步筛选、评价和修改形成初步量表.对2011年8月至10月经确诊后收住入院的24例白血病患者进行预调查,并抽取23名血液科相关医务工作者进行问卷调查和访谈,采用变异度法、因子分析法、相关系数分析法、病人重要性评分及医生重要性评分法进行分析.[结果]最终得出包含21个条目的特异模块,这些条目涵盖了白血病患者的出血症状、感染症状、特殊心理问题及其他特异症状等4个方面.[结论]白血病生命质量测定量表特异模块严格按程序执行,具有较好的代表性和内容效度.     

癌症患者生命质量测定量表体系之淋巴瘤量表QLICP-LY的条目筛选

[目的]研制适合国内恶性淋巴瘤患者的生命质量测定量表的特异模块。[方法]采用议题小组和核心小组的程序化决策方式,通过定性访谈和定量调查分析相结合的方法对条目进行初步筛选、评价和修改形成初步量表,对2010年4月～5月确诊的21名恶性淋巴瘤患者进行预调查,并抽取25名血液科相关医务工作者进行问卷调查和访谈,采用变异系数法、因子分析、相关分析、患者重要性评分及医生重要性评分法对结果进行分析。[结果]采用上述5种方法分别选出了13、13、21、21和13个条目,最终得出包含12个条目的特异模块,包含恶性淋巴瘤全身症状、首发症状及侵犯其他器官引起的特异症状等3个小方面。[结论]恶性淋巴瘤生命质量测定量表特异模块严格按程序执行,具有较好的代表性和内容效度。     

癌症患者生命质量测定量表体系之肝癌量表QLICP-LI的条目筛选

[目的]研制肝癌患者生命质量测定量表的特异模块。[方法]采用议题小组和核心小组的程序化决策方式,通过定性访谈和定量调查分析相结合的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30名肝癌患者和27名医护人员进行问卷调查,采用变异系数法、相关分析法、因子分析法、医生重要性评分及患者重要性评分法对结果进行分析。[结果]采用上述5种方法分别选出10、17、18、10和15个条目,最终得出包含18个条目的特异模块。[结论]该特异模块的条目均按严格的程序筛选得出,具有较好的内容效度和代表性。     

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。     

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.     

鼻咽癌患者生存质量量表QOL-NPC研制中的条目筛选

背景与目的:目前,全世界广泛使用癌症患者生存质量量表、头颈癌生存质量量表、SF-36等非特异性的量表去测定鼻咽癌患者的生存质量量表;鼻咽癌患者特异性量表(scale of quality of life for nasopharyngeal carcinoma,SQOL-NPC)至今未进行更新.本研究的目的在于研制符合中国国情的鼻咽癌患者生存质量(quality of life for nasopharyngeal carcinoma,QOL-NPC)评价量表.方法:参照WHO关于生存质量的定义,在文献复习的基础上,听取肿瘤医护人员及专家、生存质量专家、鼻咽癌患者的意见,制定初步的量表.2007年1～2月,在中山大学肿瘤防治中心随机抽取鼻咽癌患者433例,采用离散趋势、相关系数、因子分析和克朗巴赫系数统计学方法筛选条目.结果:研制出QOL-NPC量表,该量表包含身体机能(physical domain,PH)、心理精神状况(psychological domain,PS)、社会关系(social domain,SO)、副作用(side effect domain,SE)4个领域共30个条目.结论:QOL-NPC量表反映了WHO关于生存质量的内涵和鼻咽癌患者的特殊问题,并按程序化方式进行条目筛选,可以认为该量表适合评价鼻咽癌患者的生存质量.     

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。     

食管癌生命质量测定量表QLICP-ES的条目筛选

目的研制食管癌患者生命质量测定特异量表.方法采用议题小组和核心小组的程序化决策方式及借鉴国内外建立量表的方法和经验来对量表进行研制,首先通过对住院确诊患者定性访谈和定量调查分析相结合的方法对条目进行初步分析、评价和修改形成初步特异量表,然后随机抽取28例食管癌患者和25名医务人员进行问卷预调查和访谈,采用变异度法、相关系数法、患者重要性评分及医生重要性评分法对初步特异量表条目进行统计分析.结果根据以上4种方法和临床专家的建议,最终得到含有19个条目的食管癌特异模块.结论食管癌特异模块的各个条目均严格按照条目筛选程序得出,具有较好的代表性和内容效度.     

大肠癌中文版生命质量总分客观指标影响因素逐步回归分析

[目的]探讨大肠癌中文版生命质量量表总分客观指标影响因素。[方法]采用大肠癌中文版生命质量量表(QLICP)对97例大肠癌患者生命质量进行测评。[结果]经逐步回归分析,大肠癌中文版生命质量量表总分客观指标影响因素主要是总蛋白、血氯、文化程度、年龄、白细胞计数和红细胞计数。[结论]大肠癌中文版生命质量量表总分客观指标影响因素是多因素的。建议医务人员治疗病人时应随时注意总蛋白、白细胞和红细胞等客观指标的变化情况。     

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.     

The development of a method for assessing the quality of life of cancer patients.

Although the need for a method of measuring the quality of life of patients undergoing therapy for cancer has been widely recognised, no adequately evaluated or feasible method has been established. We describe a method in which 31 items were assessed by patient self report using linear analogue scales. Eighteen items inquiring about general health problems were derived from the Sickness Impact Profile, an established method of assessing the effect of health upon behaviour and function. Thirteen items inquiring about major problems associated with breast cancer were derived from clinical experience and the opinions of patients with this disease. Each item of the measurement method (instrument) has been evaluated for content, feasibility, reliability and validity by methods that are widely used in psychometry but less familiar in medicine. It appeared easy to use, acceptable and reliable in these assessment. Validity was evaluated indirectly since no standard measurements of quality of life exist for comparison. Most items appeared valid when compared to alternative measurement methods including the Sickness Impact Profile and evaluation by a physician in a structured interview. The correlations between items in the instrument were analysed by factor analysis and seemed to fit with the clinical features of breast cancer. The method distinguished between clinically distinct groups of patients and detected changes with time. The study illustrates the possible approaches to the scientific evaluation of methods for measuring subjective features of patients lives. This method appears suitable for some purposes to measure quality of life in breast cancer and is intended to be flexible enough to be modified for other diseases. However, further evaluation, development and refinement will be needed before routine clinical application can be recommended.     

QLQ-C30用于测评鼻咽癌患者生存质量的计量心理学考核

目的对EORTC QLQ-C30(QLQ-C30)进行计量心理学考核,以考核该量表是否适合于鼻咽癌患者生存质量的评价。方法收集中山大学肿瘤医院的391名鼻咽癌患者的QLQ-C30和人口学资料,采用信度效度理论考核量表的信度、效度、区分度及项目反应理论考核条目的项目功能差异（DIF）。结果除躯体功能和认知功能外,各个领域的Cronbach′s α系数均大于0.7。除认知功能和疲倦外,各个领域的分半系数均大于0.7。所有领域的重测系数都大于0.7。因子分析的结果显示实际的数据跟理论模型一致。不同放疗阶段的患者在大部分领域得分的差别具有统计学意义。项目反应理论结果显示条目在性别、年龄分组上没有一致性DIF和非一致性DIF。结论QLQ-C30是一个具有良好的信度、效度、区分度和计量心理学特征的癌症量表,操作性强,可用于鼻咽癌患者的生存质量评价。     

Quality of Life Determinants in Breast Cancer Patients in Central Rural India

Introduction: Breast cancer is the most frequently diagnosed cancer among women throughout world, with incidence rates increasing in India. Improved survival in breast cancer patients has resulted in their quality of life (QOL) becoming an important issue. Identifying determinants for QOL may provide insights into how to improve their living conditions. This study aimed to assess socio-demographic and clinical factors, as well as the role of self-efficacy, in relation to QOL among women with breast cancer in rural India. Methods: A total of 208 female patients with infiltrating carcinoma of the breast participated in the study. A questionnaire was administered that included sections for socio-demographic characteristics, clinical stage of the cancer and patient delay in seeking health care. A standardized instrument to measure self-efficacy was applied. To assess QOL, the WHOQOL – BREF instrument was used. Results: The overall mean score for QOL was 59.3. For domain 1 (physical health) the mean score across all groups was 55.5, for psychological health 58.2, for social relationships 63.2 and for environmental factors, 60.4. The environmental domain in QOL was negatively associated with lower education. Being divorced/widowed/unmarried had a negative association with the psychological health and social relationship dimensions, whereas higher income was positively associated with QOL parameters such as psychology, social relationships and environmental factors. Self-efficacy was positively associated with all four domains of QOL. Conclusions: The present study demonstrated a moderate QOL in women with breast cancer in rural India. Young age, lack of education and being without a partner were negatively related to QOL, and employment as casual and industrial workers, high monthly family income and higher self-efficacy were positively associated with QOL. A comprehensive public health initiative is required, including social, financial and environmental support, that can provide better QOL for breast cancer survivors.     

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.     

Assessing the impact of cancer: development of a new instrument for long-term survivors

OBJECTIVE: To develop and evaluate a new instrument that measures aspects of long-term survivorship not measured by existing tools. METHODS: In qualitative interviews, 47 long-term cancer survivors (LTS) detailed ways that cancer has impacted their lives. Content analysis resulted in the creation of 325 candidate items for inclusion in a new Impact of Cancer (IOC) instrument. Following expert review, item reduction and pilot testing, 81 items were administered with other established health status and quality of life (QOL) instruments to 193 LTS of breast, prostate, colorectal cancers and lymphoma. Internal consistency reliability and validity of newly-derived scales was assessed. RESULTS: Factor analysis of items using a priori QOL domains resulted in the derivation of ten new and specific subscales: Health Awareness, Body Changes, Health Worries, Positive and Negative Self-Evaluation, Positive and Negative Life Outlook, Social Life Interferences, Relationships, and Meaning of Cancer. Internal consistency measurements for these subscales ranged from 0.67 to 0.89. Expected associations within and among the IOC subscales and standardized measures of health status and QOL were observed, as were some unexpected findings. CONCLUSIONS: Psychometric analysis indicated that this initial version of the Impact of Cancer instrument measures distinct and relevant constructs for LTS. Future work is necessary to confirm the factor structure, responsiveness and further validation of the instrument.     

乳腺癌与抑郁相关性的初步研究

目的:探讨抗抑郁治疗对乳腺癌化疗患者生活质量及其免疫功能的影响。方法:对363例乳腺癌术后化疗的患者行汉密顿抑郁量表(Hamilton Depression Scale,HAMD)(24项)法检测;将积分在20分以上的156例抑郁患者随机分成2组:化疗加抗抑郁治疗组78例(研究组)和单纯化疗组78例(对照组);6周后采用生活质量(quality of life,QOL)量表法观察患者治疗前后生活质量的改变,同时行血清免疫指标的检测和评定。结果:化疗加抗抑郁治疗组患者的情绪、睡眠障碍和依从性较单纯化疗组明显改善,差异有统计学意义(P<0.05)。化疗加抗抑郁治疗组患者血清中CD3+、CD4+、CD8+、CD4+/CD8+及自然杀伤细胞数治疗后较治疗前均有提高,而对照组患者中CD3+治疗后较治疗前明显降低(P<0.05),研究组患者血清中CD3+和CD4+T细胞的含量在抗抑郁治疗后明显高于对照组(P<0.05)。结论:抗抑郁治疗可明显提高乳腺癌化疗患者的生活质量及改善免疫损害。     

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.     

Comparison of early quality of life in patients treated with radiotherapy following mastectomy or breast conservation therapy: A prospective study

Introduction

To compare quality of life (QOL) in breast cancer patients from a developing country after breast conservation surgery (BCS) or mastectomy and adjuvant radiotherapy (RT).

Materials and methods

In a 6-month period, all consecutive early and locally advanced breast cancer patients treated with either BCS or mastectomy and treated with RT were analyzed. All patients who underwent mastectomy were treated with 45 Gray/20#/4 weeks. Patients with BCS were treated with a dose of 45-50 Gray/25#/5 weeks to whole breast followed by tumor bed boost (15 Gray/6#/6 days with suitable energy electrons). Prospective evaluation of QOL using EORTC QLQ C30 and breast cancer specific QLQ BR23 was done before starting RT (baseline), at mid-RT and at RT conclusion for all patients.

Results

One hundred and thirteen patients had mastectomy and 142 patients underwent BCS. Reliability test (Cronbach alpha) for questionnaire filling was 0.669-0.886. At pre-RT assessment, global QOL scores in mastectomy and BCS groups were 71.1 and 71.3, respectively. There was no significant difference in pre-RT EORTC QLQ C30 functional and symptom domains between mastectomy and BCS patients. However, social function domain score was higher in patients who underwent mastectomy (83 versus 73.9; p = 0.018). In QLQ BR23 domains, body image and sexual functioning domains were similar between the two groups. However, sexual enjoyment (10.9 versus 47.6; p = 0.006) and future perspective (7.4 versus 37.1; p = 0.036) domains were significantly better in BCS arm. There was no difference between systemic side effect (BRSSE), breast symptom (BRBS) and arm symptom (BRAS) domain scores between the groups. There was no significant difference in change of QOL scores between mastectomy and BCS patients at RT completion as compared to baseline.

Conclusions

There was no significant difference in quality of life in patients with BCS versus those with mastectomy. However, patients who underwent BCS had better sexual enjoyment and future perspective scores compared with mastectomy patients. There was no significant change of QOL domain scores after RT in mastectomy and BCS patients.