欧洲癌症研究与治疗组织研制的生活质量核心调查问卷第3版中文版生活质量调查问卷测评

Assessment on the standard Chinese version of the quality of life core questionnaire version 3.0 designed by European Organization for Research and Treatment of Cancer

目的:在应用生活质量核心调查问卷第3版中文版调查贵州省少数民族地区癌症患者生活质量及相关状况之前,首先对该问卷量表进行信度、效度和反应度的测评,并与卡氏功能状态量表进行比较。方法:选择2003-11/2004-11贵州省人民医院肿瘤科癌症患者215例进行生活质量调查。原则上问卷由患者本人完成报告及填写,如患者不能书写可由家属及或医务人员代为填写,但必须是患者自我的真实表现。纳入标准:经病理或细胞学确诊的恶性肿瘤患者(病种及病期不限),需住院进行放射治疗、化学治疗以及姑息支持治疗者,预计生存期超过3个月者,年龄≥18岁,文化程度及民族不限,卡氏功能状态量表评分不限,既往和目前均无精神疾病及意识障碍,能真实理解问卷内容,自愿接受调查。为了测试该问卷的重测信度,随机选取癌症患者56例在完成第1次调查后第4天再重新调查1次。调查同期随机对贵州省人民医院住院的非恶性肿瘤患者100例进行生活质量核心调查问卷健康调查,以作为对照组进行问卷区分效度的分析。①生活质量核心调查问卷第3版共15项领域30个条目,包括5个功能量表:躯体功能、角色功能、认知功能、情绪功能、社会功能;3个症状量表:疲乏、疼痛、恶心呕吐;6个单项测量项目和1个整体生活质量量表。②卡氏功能状态量表:分为10个等级,根据患者的机体功能状态给予0～100分的评定。该量表作为生活质量核心调查问卷的对照量表。结果:所有接受调查者大部分能独立完成问卷,极少数文盲在调查者及或家属帮助下完成,问卷回收100%,无一例脱落。①该问卷内部一致性信度检验除认知功能量表和角色功能量表克朗巴赫系数较低(0.51,0.57)外,其余均大于0.70。问卷分半信度检验相关系数r=0.85,重测信度检验各对应量表和单项目之间均有较高的相关性(r>0.81)。②在结构效度主成分分析中,提取9个主成因,累计贡献率达75.12%。所有条目与量表之间相关分析除了第6条目与其相对应的角色功能量表相关较低(r=0.357)外,其余r>0.4。量表与量表间相关分析均有统计学意义(P<0.01),除认知功能量表与疲乏症状量表相关较高(r=-0.592)外,其他均为中、下相关。③问卷反应度测评显示不同治疗时期及非癌症患者生活质量大部分领域得分差异均有显著性。④卡氏功能状态量表与生活质量核心调查问卷第3版的功能量表间相关最高(r=0.63,P<0.01),并且能够反映不同机体功能状况(卡氏功能状态量表评分)癌症患者生活质量的差异(P<0.01)。结论:生活质量核心调查问卷第3版中文版具有较硬的心理测量学参数,可以作为国内癌症生活质量研究的测评工具。

AIM： To test the reliability, validity and clinic response of the standard Chinese version of cancer quality of life core questionnaire version 3.0 （E-ORTC QLQ-C30） before applying it to investigate the quality of life （QOL） and correlation about the cancer patients in minority areas of Guizhou province. Meanwhile, compare the correlation between the Kamofsky performance status （KPS）. METHODS： 215 cancer inpatients of Department of Oncology in People＇s Hospital of Guizhou Province were selected to investigate the QOL from November 2003 to November 2004. Generally, the questionnaire was filled in by the patients themselves, and if they cannot fill in for some reasons, it was filled in by their family members or their doctors. But what they filing in should be real ideas of the patients. Inclusive criteria： the malignant tumor patients who definite by pathology and/or cytology （regardless their clinic entity and stage）. These sampled patients who should be treated with radiotherapy, chemotherapy, or palliation therapy in hospital. The patients whose expected survive time was more then 3 months, and whose age should be at least 18 years old. There was no limit on their educational background and nationalities; they were no limit on the KPS, either. And these patients should have no mental disorder and normal thinking obstacle at present and before, furthermore, they should be able to fully understand the content of the questionnaire and should be willing to be investigated. In order to test the retest reliability of the questionnaire, a retest was conducted four days after the first interview in 56 cancer patients randomly selected. At the same time, a health related QOL examination was conducted in 100 patients without malignant cancer in the People＇s Hospital of Guizhou Province. The aim was to use the result of the examination to conduct an analysis of the validity of questionnaire as the control group. ①The QLQ-C30 （V3.0） was composed of 15 territories and 30-items measures. These included five functional scales： Physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning; three symptom scales： fatigue, pain, nausea and vomiting; six single items and a global QOL scale. ②The KPS composed of ten ranks, giving evaluation on the scale of 0-100 points according to the physical functional performance statue of the patients, which was used for the control scale of key investigation questionnaire of QOL. RESULTS： Most of the quizzers could conduct the questionnaire independently; only a few illiteracy people performed the questionnaire with. the help of the investigator or their family member. The recovery rate of the questionnaire was 100%, without drop out. ①All the scales met the minimal standards of reliability （Cronbach＇s alpha ≥ 0.70） except cognitive and role functioning （0.51, 0.57）. In the test of constructive reliability, the correlation coefficient in split-half analysis was 0.85. The interelass correlation between test and retest was high （r 〉 0.81 ）.②Applied principal constituent to analysis construction validity to retrieval nine main factors that adds up to 75.12% in the total factors. All items with its own scale correlations were statistically significant （r 〉 0.4） except the sixth item and the role functioning （r=0.357）. Most interscales correlation of the questionnaire was statistically significant （P 〈 0.01） except cognitive scale and fatigue functioning （r=-0.592）; other correlations between scales were moderate and low. ③The clinical response test showed that there was significant difference between different periods of treatment, and the difference was also found in most fields of the QOL of patients without cancer. ④The correlation between the-KP5 and functioning scale of the EORTC QLQ-C30 （V3.0） was the strongest （r=0.63 ,P 〈 0.01 ）; Furthermore, it could reflect the different KSP performance status （KPS） and the difference of the QOL of cancer patients （P 〈 0.01 ）. CONCLUSION： The standard Chinese version EORTC QLQ-C30 （V3） has a valid parameter of psychometrics, which can be used as the measured tool for QOL of domestic cancer.