基于中医理论的恶性肿瘤生活质量评价体系之肺癌量表的研制

[目的]研制基于中医理论的恶性肿瘤生活质量评价体系之肺癌量表QLASTCM-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240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]该量表及各领域的重测信度在0.93～0.96间,各领域内部一致性α值在0.85～0.93间;相关分析与因子分析显示较好的结构效度;与QLQ-LC43为效标的效标关联效度较好;已知组比较显示较好的临床效度;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较QLQ-LC43为大。[结论]QLASTCM-Lu具有较好的信度、效度及一定的反应度,可用于肺癌患者的生命质量测定。     

2种量表测定慢性病患者生命质量效果评价

目的比较健康状况调查（SF-36）与慢性病患者生命质量测定量表体系共性模块（OLICD-GM）量表用于慢性病患者生命质量测定的效果。方法用SF-36和QLICD-GM 2个量表同时测定607例慢性病患者生命质量并对比分析其信度、效度和反应度。结果2个量表的信度、效度和反应度均比较好,但QLICD-GM更敏感。结论2个量表均能用于慢性病患者生命质量测定,但QLICD-GM更有针对性和敏感性。     

消化性溃疡患者生命质量测定量表研制及评价

目的 研制和评价慢性病患者生命质量测定量表体系之消化性溃疡量表(QLICD-PU).方法 用QLICD-PU对120名消化性溃疡患者住院治疗前后的生命质量进行测评,对量表信度、效度和反应度进行评价.结果 量表各条目与所属亚领域或领域的相关均大于该条目与其他亚领域或领域的相关,相关系数(r)>0.6;量表可以测出患者治疗前后各领域的生命质量变化,其中特异模块领域的标准化反应均数(SRM)=1.21,总量表SRM=1.10.结论 消化性溃疡患者生命质量测定量表(QLICD-PU)具有较好的信度、效度、反应度和临床可行性.     

基于中医理论胃癌生活质量评价量表研制

目的 研制基于中医理论的恶性肿瘤生活质量评价体系之胃癌量表QLASTCM-Ga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240例胃癌患者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,采用相关分析、因子分析及配对t检验等进行统计分析.结果 该量表及各领域的重测信度在为0.90～0.94,各领域内部一致性α值为0.86 ～0.93;相关分析与因子分析显示较好的结构效度;与QLQ-STO 52为效标的效标关联效度较好;已知组比较显示较好的临床效度;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与QLQ-STO 52接近.结论 QLASTCM-Ga具有较好的信度、效度及一定的反应度,可用于胃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白血病量表的测量学特性评价

[目的]对研制的癌症患者生命质量测定量表体系之白血病量表QLICP-LE (V1. 0)的心理测量学特性(信度、效度、反应度)进行分析评价。[方法]采用统计描述、相关分析、配对t检验等统计学方法对QLICP-LE (V1. 0)的信度、效度和反应度进行考评,同时与FACT-Leu量表为校标,分析QLICP-LE(V1. 0)的校标效度。[结果] QLICP-LE (V1. 0)总量表及各个领域的重测相关系数均大于0. 85;除了社会功能(0. 69)和共性症状与副作用(0. 65)外,各领域的内部一致信度α均大于0. 70;总量表的克朗巴赫系数α和分半信度分别为0. 92和0. 95;相关分析显示有较好的结构效度,与FACT-Leu相关分析显示有较好的效标关联效度;特异模块反应度较好,共性模块反应度尚不理想,但符合本研究中白血病患者的治疗进程。[结论] QLICP-LE (V1. 0)具有较好的信度、效度和一定的反应度,可用于白血病患者的生命质量测定。     

肺源性心脏病患者生命质量量表研制及评价

目的 评价慢性病患者生命质量测定量表体系的肺源性心脏病量表(QLICD-CPHD).方法 采用程序化决策方式进行量表的开发和研制,通过120例肺心病患者的测定结果 ,采用因子分析、直线相关分析、结构方程模型、配对t检验等方法 对量表的效度、信度、反应度进行考评.结果 QLICD-CPHD包括慢性病共性模块30个条目和慢性肺源性心脏病特异模块21个条目.量表大多数条目与其领域的r>0.5,大于与其他领域的相关系数;探索性因子分析和结构方程模型分析显示量表具有较好的结构效度;以SF-36为校标,其与量表相关领域的r在0.56～0.67之间,量表的效标效度一般;各领域及总量表内部一致性系数≥0.75,重侧信度系数≥0.927,分半信度系数≥0.712,显示量表具有较好的信度;治疗前后各领域及绝大多数小方面得分的配对t检验差异均有统计学意义(P<0.05),标准化反应均数在0.10～0.54之间,显示量表有较好的反应度;绝大多数患者能在15 min内完成测定.结论 QUCD-CPHD具有较好的信度、效度、反应度和临床可行性,可以作为慢性肺源性心脏病患者生命质量的测评工具.     

高血压患者生命质量量表研制及评价

目的 研制慢性病患者生命质量测定量表体系中的高血压量表(QLICD-HY),并对其进行测评.方法 采用程序化决策方式,结合我国语言和文化背景进行量表开发和研制,并通过157例高血压患者的测定对量表进行效度、信度、反应度等考核评价.采用统计描述、相关分析、因子分析、配对t检验等方法进行分析.结果 高血压患者生命质量测定量表(QLICD-HY),包括慢性病共性模块30个条目和高血压特异模块17个条目.量表各领域及亚领域(facet)的内部一致性信度α值基本在0.6以上、重测相关系数(r值)大多在0.8以上;各条目与所属亚领域及其领域的相关均大于与其他亚领域及领域的相关,相关系数(r值)在0.7以上者占56.52%;量表能够反映出高血压患者治疗前后生命质量的变化.结论 高血压患者生命质量测定量表(QLICD-HY)具有较好的信度、效度、反应度和临床可行性,可以作为我国高血压患者生命质量的测评工具.     

肿瘤患者生命质量测定量表EORTC QLQ-C30维文版评价北大核心CSCD

目的 评价恶性肿瘤患者维文版的生命质量测定量表EORTC QLQ-C30信度和效度。方法 通过量表的翻译、回译及文化调适制定维文版的EORTC QLQ-C30,通过对497例恶性肿瘤患者进行的生命质量测定对量表进行评价,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 问卷各维度的Cronbach’sα系数为0.663-0.824,第一次测量和第二次测量的配对t检验的P值均大于0.05,重测信度较好;各维度的内部信度系数均≥0.7。各维度间相关系数较小,均小于各个维度内的系数,说明问卷有良好的内容效度和区分效度。结构效度中,经因子分析,各主因子中各条目与其主成分大致相符;反应度评价比较第一次和第三次测定间的得分均数,大部分维度的P值都小于0.05,尚需进一步研究。结论 维文版生命质量量表具有良好的信度和效度,可以应用于新疆公共卫生和其他医学领域。     

肿瘤患者生命质量测定量表EORTC QLQ-C30维文版评价

目的评价恶性肿瘤患者维文版的生命质量测定量表EORTC QLQ-C30信度和效度。方法通过量表的翻译、回译及文化调适制定维文版的EORTC QLQ-C30,通过对497例恶性肿瘤患者进行的生命质量测定对量表进行评价,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。结果问卷各维度的Cronbach’sα系数为0.663~0.824,第一次测量和第二次测量的配对t检验的P值均大于0.05,重测信度较好;各维度的内部信度系数均≥0.7。各维度间相关系数较小,均小于各个维度内的系数,说明问卷有良好的内容效度和区分效度。结构效度中,经因子分析,各主因子中各条目与其主成分大致相符;反应度评价比较第一次和第三次测定间的得分均数,大部分维度的P值都小于0.05,尚需进一步研究。结论维文版生命质量量表具有良好的信度和效度,可以应用于新疆公共卫生和其他医学领域。     

肠易激综合征患者生命质量测定量表研制及评价

目的 研制与评价慢性病患者生命质量测定量表体系之肠易激综合征量表(QLICD-IBS).方法 采用程序化决策方式,结合中国人群背景,进行量表开发和研制;对99例肠易激综合征患者住院治疗前后的生命质量进行测评,评价量表效度、信度、反应度.结果 肠易激综合征患者生命质量测定量表(QLICD-IBS)包括慢性病共性模块30个条目和肠易激综合征特异模块15个条目,量表各领域及维度的内部一致性信度(α)基本>0.6以上、重测信度(r)>0.9;各条目与所属维度及其领域的相关均大于与其他维度及领域的相关,相关系数(r)值大多>0.6;量表能够反映出患者治疗前后生命质量的变化.结论 量表(QLICD-IBS)具有较好的信度、效度、反应度和临床可行性,可作为适合中国人群的生命质量测评工具.     

Korean Translation and Validation of the Functional Assessment of Cancer Therapy-Lung (FACT-L) Version 4

In this study, we have translated and cross-culturally adapted the Functional Assessment of Cancer Therapy-Lung (FACT-L) version 4 into Korean, and we have evaluated its reliability and validity. The FACT-L version 4 was translated into Korean following the standard Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology. The psychometric properties of the FACT-L were evaluated in 122 lung cancer patients (mean age, 60.88 years). Pre-testing was performed in 22 patients, and these results indicated good content coverage and overall comprehensibility. In validating the FACT-L version 4, our results indicated high internal consistency of the FACT-L scales, with Cronbach’s α coefficients ranging from 0.52 to 0.84. The FACT-L also demonstrated good convergent and divergent validity when correlated with the Functional Living Index-Cancer (FLIC) and the shortened forms of the Profile of Mood States (POMS). This reliable and valid instrument can now be used to properly evaluate the quality of life of Korean lung cancer patients.     

因子分析法评价肺癌患者生存质量

目的分析影响肺癌患者生存质量(qualityoflife,QOL)的关键因子,为肺癌的防治工作提供参考。方法应用肺癌生存质量FACT-L(4.0)中文版调查表,对164例肺癌患者进行生存质量测评,采用因子分析法研究肺癌患者生存质量的相关因素。结果在肺癌生存质量的13个因素中存在5种主要支配因子。结论肺癌患者早期发现,多学科治疗,可延长生存时间,同时提高生存质量。     

肺癌生存者生活质量及影响因素分析

[目的]探讨肺癌生存者生活质量(quality of life,QOL)的影响因素,为肺癌的防治提供科学依据。[方法]应用FACT-L(4.0)中文版QOL调查表,对164例肺癌存活患者的QOL进行测评。采用t检验及单因素方差分析(one way ANOVA),对其QOL影响因素进行分析;用Logistic回归模型分析方法,筛选QOL主要影响因素。[结果]临床分期、是否手术治疗和生存时间是肺癌生存者生活质量的主要影响因素(P﹤0.05)。临床分期越晚,生活质量越低;手术治疗QOL优于非手术治疗;随生存时间延长,QOL越好。[结论]早期诊断,及时手术治疗,可改善患者的QOL。     

化疗期卵巢癌患者焦虑与生活质量的关系

目的：调查卵巢癌患者化疗期的情绪和生活质量的特点及两者之间的关系。方法：采用汉密尔顿焦虑量表（HAMA）和卵巢癌生命质量测定量表（FACT-B4．0）对60例卵巢癌患者进行问卷调查。结果：患者化疗初期焦虑水平高于化疗中、末期，比较差异有统计学意义（P〈0．001）；卵巢癌患者生活质量的功能状况均数逐渐增加，其他因子和总分均数在化疗中期最低，化疗末期最高。焦虑与附加关注负相关（r=-0．221，P=0．028）。结论：患者的焦虑情绪随着化疗而改善，在化疗不同阶段，卵巢癌患者的生活质量有差异，化疗中期最差，化疗末最高。焦虑情绪对患者总体生活质量无明显影响，但会影响生活质量的某些方面。     

Translation and validation of the Standard Chinese version of the EORTC QLQ-C30

The majority of quality of life (QOL) questionnaires have been developed and used in English-speaking or Western European countries. The aims of this study were to provide the Standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30 version 2.0), and evaluate its psychometric properties. The translation process included independent translation, back translation, a pilot test with gynecological cancer patients, and a review and approval by the original developers. Participants in the major study included gestational trophoblastic disease patients (n = 68), ovarian cancer patients (n = 105), and other types of gynecological cancer patients (n = 18). The average completion time of the Standard Chinese version was 8.1 ± 2.9 min. All item-subscale correlation coefficients exceeded the criterion of item-convergent validity (r > 0.40) except item 1, 5, 20, and 25, and all items correlated significantly higher with their own subscale than with other subscales except item 1, 20, and 25. The correlation coefficients among all subscales were significant but modest (r = 0.40–0.70). Seven out of nine subscales met the minimal standards of reliability (Cronbach's > 0.70). In conclusion, the Standard Chinese version of the EORTC QLQ-C30 is a valid instrument overall in assessing the QOL of Chinese gynecological cancer patients.     

Quality of life scores: An independent prognostic variable in a general population of cancer patients receiving chemotherapy

This report examines the prognostic associations between QOL scores measured by the EORTC QLQ-C30 and survival in a large heterogeneous population of cancer patients. Eight hundred and fifty-one cancer patients who were to receive chemotherapy were enrolled in two National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) antiemetic trials. All patients completed the EORTC QLQ-C30 immediately prior to their first chemotherapy. Survival data were available and obtained for 474 of 639 patients (74%). Cox's proportional hazards model was used to assess the independent impact of QOL and demographic variables on survival. Presence of metastatic disease, diagnosis of lung or ovarian cancer, ECOG performance status, global quality of life and emotional functioning were significantly associated with survival. Global QOL was predictive in all patients, in subgroups of patients with metastatic disease, with breast and lung cancer and other tumour types. In patients with low global quality of life scores, patients with low emotional functioning ratings lived longer than did patients with high emotional functioning ratings. Patients with high global QOL live significantly longer than do patients with low global QOL. The relationship between emotional functioning in patients with low global QOL and survival needs confirmation.     

Translation and validation of Korean Functional Assessment of Cancer Therapy-Esophageal (FACT-E) scale with squamous cell carcinoma and chemoradiation-only patients

Purpose

The Functional Assessment of Cancer Therapy-Esophageal (FACT-E) Scale version 4 has been used to assess quality of life in patients with squamous cell carcinoma undergoing chemoradiation. We sought to determine whether this scale can be used to assess quality of life in Korean patients with esophageal cancer undergoing chemoradiation.

Methods

The FACT-E scale version 4 was cross-culturally translated into Korean. Its reliability and validity were assessed in a group of 146 esophageal cancer patients who were scheduled for neoadjuvant chemoradiation (CRT). This procedure was followed by esophagectomy that took place between 2007 and 2010 at Asan Medical Center. All patients completed the FACT-E, Hospital Anxiety and Depression Scale (HADS) and Functional Living Index-Cancer (FLIC) questionnaires at baseline (pre-treatment) and 1?month after two cycles of induction chemotherapy followed by CRT.

Results

In validating the FACT-E, we found high internal consistency coefficients ranging from 0.72 to 0.91. Good convergent and divergent validities were demonstrated by the FLIC and HADS scales. The FACT-E showed good clinical validity and effectively differentiated between patient groups with different performance status ratings and stages. Changes in clinical status were reflected by changes in FACT-E scores, demonstrating responsiveness to neoadjuvant CRT.

Conclusion

The FACT-E has been shown to be a reliable and valid instrument that can now be used to prospectively evaluate the quality of life of Korean patients with esophageal cancer.     

Cultural adaptation and application of the IBS–QOL in China: a disease-specific quality-of-life questionnaire

Background Irritable bowel syndrome (IBS) is a chronic and episodic illness characterized by altered bowel habits and associated abdominal pain. At present, IBS is one of the most common functional gastrointestinal and motility disorders affecting countries around the world. Surveys have found that patients with IBS have a significantly lower health-related quality of life. Objectives The aim of this study was to translate and examine the validity of the Irritable Bowel Syndrome–Quality of Life questionnaire (IBS–QOL) in patients suffering from IBS in China. Methods A structured procedure was used for the translation and cultural adaptation of the original English IBS–QOL into Chinese. The questionnaire was administered to 73 clinical patients with IBS and␣70 healthy individuals. Psychometric testing for reliability, validity and responsiveness followed standardized procedures. Test–retest reliability (10–20 hours) was assessed using the clinical patients. Follow-up (4 weeks) was collected for 61 clinical patients. All enrolled patients also completed the Short Form-36 Health Survey (SF-36) at the baseline visit. Responsiveness to treatment (Venlafaxine and traditional Chinese herbal medicine) was assessed by one-way ANOVA methods. Results The average length of time required to complete the questionnaire was short (5.63 min for IBS patients and 5.54 min for healthy subjects by self-administration). Internal consistency (Cronbach’s alpha) values ranged from 0.722 to 0.914 for the Chinese IBS–QOL subscales and test–retest reliability coefficients were higher than 0.920 on all subscales. The convergent and discriminate validity results comparing the Chinese translation of the IBS–QOL overall score and the SF-36 subscales confirmed our predicted hypotheses. The Chinese IBS–QOL scores are more highly correlated with social functioning, vitality and general health (SF-36) and show weaker associations with physical functioning, role physical, mental health, and bodily pain (SF-36). The Chinese translation of the IBS–QOL was responsive to treatment. Conclusion In general, the Chinese translation of the IBS–QOL, after cultural adaptation and revision, possesses good reliability, validity and responsiveness. It is a reliable and valid instrument to assess the quality of life in Chinese patients suffering from IBS and is an appropriate measure to use in further clinical trials or for related research projects in China.     

Testing psychometric properties of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30)

BACKGROUND: Because cancer is now the first and second leading causes of death in both of urban and suburban area in China, there are increasing demands for measurement tools to assess quality of life in Chinese cancer patients. The objective of this study was to evaluate the psychometric properties of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30, version 3.0). METHODS: The questionnaire was administered before, during, and after treatment of 143 patients with breast, gynecological, or lung cancer in six hospitals in China. RESULTS: Cronbach's alpha coefficients for multi-item scales were greater than 0.70 before and during treatment, except for the cognitive functioning scale. Multitrait scaling analysis showed that most of the item-scale correlation coefficients met the standards of convergent and discriminant validity. All scales and items exhibited good reproducibility, criterion-related validity, and construct validity. Score changes over time were observed in the following scales: physical, role, and social functioning; global quality of life; fatigue; nausea/vomiting. Score changes were also observed in the appetite loss item. CONCLUSION: The standard Chinese version of the EORTC QLQ-C30 is overall a valid instrument to assess the quality of life of Chinese cancer patients.