乳腺癌患者不同健康效用值测量方式的比较研究

发布时间：2018-05-02 23:28

本文选题：乳腺癌 + 健康效用值　；参考：《山东大学》2015年硕士论文

【摘要】：研究背景乳腺癌是危害妇女健康的最常见恶性肿瘤,每年中国乳腺癌新发数量和死亡数量分别占全世界的12.2%和9.6%。乳腺癌不仅给患者带来严重的疾病负担,也造成了很大的社会损失与经济负担。卫生经济学评价是卫生经济学的一种重要方法或研究工具,成本-效用分析作为卫生经济学评价的主要方法之一,已得到认可并被广泛应用。在卫生领域,效用是指卫生服务方案满足人们获得健康这一需要或欲望的能力,代表了社会或个人某种价值观念的取向,也可以理解为对某种健康状态所赋予的权重,即健康效用值。对健康状态的测量可分为非基于偏好和基于偏好两大类,而非基于偏好的健康状态测量具有一定的局限性,因此,本研究所指健康效用值即是基于偏好的健康效用值研究。健康效用值是反映个体健康状况的综合指数,是人们对某种健康状态的偏好程度,取值在0(死亡)和1(完全健康)之间。国际上常用的测量方法大致可分为直接测量法与间接测量法两类,直接测量法是根据患者自身的健康偏好,间接测量法是基于普通人群的健康偏好。国际上已在多种慢性疾病中开展效用值的测量研究,不少研究均同时采用了直接测量法与间接测量法,并对两类测量方式进行比较研究,但在乳腺癌领域,这方面的研究仍较为少见。目前,国内多采用乳腺癌癌症专用测量量表以及国际上通用的生命质量测量量表(如SF-36、EQ-5D等量表)对乳腺癌患者进行生命质量的评价研究的研究较多,较少涉及到效用值的测量研究。目前,中国大陆尚无乳腺癌健康效用值的测量文献报道和中国人群的相关数据,因此,开展我国乳腺癌患者健康效用值的测量研究,寻求适合我国乳腺癌患者实际状况的健康效用值测量方法,可使我国乳腺癌诊疗服务的临床决策机制更加合理,同时为今后开展乳腺癌临床治疗的成本-效用分析提供方法借鉴和基础数据支持。研究目的本研究采用直接测量法和间接测量法来测量我国乳腺癌患者的健康效用值,分析其相关影响因素,并比较分析不同方法之间的一致性,找出更加符合我国乳腺癌患者实际状况的健康效用值测量工具,并为今后开展卫生经济学评价研究提供支持。1.采用TTO.EQ-5D-5L量表和SF-6D量表测量我国乳腺癌患者的健康效用值；2.探索影响我国乳腺癌患者健康效用值的主要影响因素；3.比较SF-6D、TTO、EQ-5D-5L三种测量方法的一致性,找出适合我国乳腺癌患者的健康效用值测量工具。资料来源与方法本研究资料来源包括两方面：一是对现有文献资料的收集整理,二是对于2014年11月～2015年2月在青岛市立医院乳腺科就诊、住院治疗的621名乳腺癌患者进行问卷调查,收集被调查者的个人基本信息和临床信息,通过SF-6D量表、时间权衡法、EQ-5D-5L量表三种测量方法测量被调查者的健康效用值。乳腺癌分期标准采用目前国际TNM分期方法,SF-6D量表、EQ-5D-5L量表已获得相应研发机构授权使用,时间权衡法问题的设计参阅国际上相关文献,结合我国乳腺癌疾病特点进行设计完成。最终在被调查者知情同意的情况下,由经过专业培训的调查人员完成调查。本研究采用分析方法包括：(1)描述性分析,包括样本的均数(标准差)、95%可信区间、中位数等统计指标；(2)单因素分析,采用两个独立样本的秩和检验和多个独立样本的秩和检验进行分析；(3)多因素分析,采用二分类logistics回归进行分析；(4)SF-6D量表、时间权衡法、EQ-5D-5L量表三种测量方式的一致性检验采用组内相关系数(ICC)和Bland-A1tman法。研究结果被调查者的基本情况：本研究共计调查符合条件的乳腺癌患者621名,其中13份原始问卷由于信息不完整未能纳入最终分析。被调查者平均年龄48.0±9.6岁,平均病程38.2+40.9月；被调查者的文化程度偏低,小学文化程度和文盲占近三分之一；企业职工(工人)所占比例超过三分之一,农民/农民工约占四分之一；88.7%的被调查者为已婚；家庭平均年收入以3-8万元所占比例最高(43.1%)；被调查者的医疗保障形式以城镇职工医疗保险和新农合为主,分别占到47.2%和43.3%；III期的患者约占三分之一,Ⅳ期患者所占比例最低(12.0%)；近一半的患者接受单纯化疗；雌激素受体蛋白/孕激素受体(ER/PR)阳性患者占54.1%,阴性占26.0%；被调查者中绝经者占到一半以上(54.9%)；从疾病状态看,原发性乳腺癌或复发超过一年及以上的患者所占比例最高(40.3%),乳腺癌复发年及以内的患者所占比例最低(10.7%)。EQ-5D-5L量表所测健康效用值：用EQ-5D-5L量表测量的乳腺癌患者的平均健康效用值为0.83±0.16(95%可信区间0.82～0.85,中位数为0.87)。单因素分析显示,被调查患者的健康效用值在居住地、婚姻状况、职业、教育程度、医疗保障形式、家庭收入以及病程、临床分期、治疗方案和疾病状态分类不同亚组之间的差异均具有统计学意义(P0.05)。多因素分析显示,被调查患者的居住地、职业、教育程度、医疗保障形式、家庭收入以及治疗方案会对健康效用值产生一定影响。SF-6D量表所测健康效用值：用SF-6D量表测量的样本人群平均健康效用值为0.65±0.13,(95%可信区间0.64～0.66,中位数为0.62)。单因素分析显示,被调查者的健康效用值在婚姻状况、职业、教育程度、医疗保障形式、家庭收入、治疗方案以及疾病状态分类的不同亚组之间的差异均具有统计学意义(P0.05)；多因素分析显示,被调查者的职业、教育程度、医疗保障形式、家庭收入、主要治疗方案会对其健康效用值产生一定的影响。时间权衡法所测健康效用值：本研究利用时间权衡法测量的样本人群的平均健康效用值为0.80±0.25(95%可信区间0.77～0.82,中位数为0.90)。单因素分析显示,被调查者的健康效用值在婚姻状况、教育程度、家庭收入、治疗方式以及疾病状态不同亚组之间的差异均具有统计学意义(P0.05)；多因素分析显示,被调查者的教育程度、家庭收入以及病理诊断信息会对其健康效用值产生一定的影响。EQ-5D-5L量表、SF-6D量表与时间权衡法的比较：EQ-5D-5L量表、SF-6D量表与TTO三种测量方式比较显示,EQ-5D-5L量表存在较高的天花板效应(28.62%),而TTO存在一定的地板效应(4.44%)。EQ-5D-5L量表、SF-6D量表与TTO所测样本人群的健康效用值的组间相关系数(ICC)为0.46,具有中度一致性。EQ-5D-5L量表和SF-6D量表具有高度一致性；EQ-5D-5L量表和TTO具有一定程度的一致性,SF-6D量表与TTO之间基本不一致。Bland-Altman法显示,EQ-5D-5L量表和时间权衡法所测量的健康效用值差值的均值为0.04,EQ-5D-5L量表和SF-6D量表所测量的健康效用值均值的差异为0.19,SF-6D量表和时间权衡法所测量的健康效用值差值的均值为0.04,三种测量方式之间均不一致。结论本研究采用EQ-5D-5L量表、SF-6D量表与TTO所测608名被调查者的健康效用值有所不同,比较显示三者之间存在中度一致性,其中,EQ-5D-5L量表和SF-6D量表具有高度一致性。乳腺癌患者的健康效用值会受多种因素的影响,包括教育程度、疾病状态等。另外,本研究认为,SF-6D量表更适用于我国乳腺癌人群的健康效用值研究。
[Abstract]:Background breast cancer is the most common malignant tumor that endangers women's health. The number and death number of breast cancer in China, which account for 12.2% and 9.6%. of the world, not only bring serious disease burden to patients, but also cause great social loss and economic burden. Health economics evaluation is a kind of health economics. An important method or research tool, cost utility analysis, as one of the main methods of health economics evaluation, has been recognized and widely used. In the health field, utility is the ability to satisfy people's need or desire for health, representing the orientation of a social or individual value concept, and can also be understood. Health utility values can be divided into two categories, non preference based and based on preference, rather than preference based health measurements. Therefore, the health utility value of this study is based on the study of preferred health utility values. Health utility values are The comprehensive index, which reflects the individual health status, is the people's preference to a certain state of health between 0 (death) and 1 (complete health). The commonly used methods commonly used internationally can be divided into two categories: direct measurement and indirect measurement. Direct measurement is based on the patient's own health preference, and indirect measurement is based on ordinary people. The survey of utility values has been carried out in a variety of chronic diseases. Many studies have simultaneously adopted direct and indirect measurements and compared the two types of measurements. However, in the field of breast cancer, there are still few studies in this field. The scale and the international standard of life quality measurement scale (such as SF-36, EQ-5D isometric scale) for the evaluation of the quality of life of breast cancer patients are more, less involved in the measurement of the value of the utility value. At present, there is no literature on the health utility value of breast cancer in China and the related data of Chinese population. The measurement of health utility value of breast cancer patients in China and the health utility value measurement method suitable for the actual situation of breast cancer patients in China can make the clinical decision-making mechanism of breast cancer diagnosis and treatment service more reasonable in our country, and provide a reference and basic data support for the cost utility analysis of the clinical treatment of breast cancer in the future. The purpose of this study is to use direct measurement and indirect measurement to measure the health utility value of breast cancer patients in China, analyze its related factors, compare and analyze the consistency between different methods, find a healthier utility value measuring tool which is more in line with the actual situation of the breast cancer patients in China, and carry out the health economy for the future. Study evaluation research provides support for.1. using TTO.EQ-5D-5L scale and SF-6D scale to measure the health utility value of breast cancer patients in China; 2. explore the main influencing factors affecting the health utility value of breast cancer patients in China; 3. compare the consistency of three methods of SF-6D, TTO, EQ-5D-5L and find the health utility value suitable for the breast cancer patients in our country. The sources and methods of this study include two aspects: one is the collection of existing documents, and the two is to investigate 621 breast cancer patients in the Oingdao Municipal Hospital from November 2014 to February 2015, and collect the basic information and clinical letters of the respondents. The health utility values of the respondents were measured by the SF-6D scale, the time balance method and the EQ-5D-5L scale. The standard of the staging of breast cancer was adopted by the current international TNM staging method, the SF-6D scale, the EQ-5D-5L scale, and the design of the corresponding R & D organization, and the design of the time tradeoff method was used to refer to the relevant international literature, and to combine with our country. The characteristics of breast cancer were designed. In the end, the investigators completed the investigation under the informed consent of the respondents. The methods of analysis included: (1) descriptive analysis, including the average number of samples (standard deviation), 95% confidence interval, median and so on; (2) single factor analysis, two Analysis of rank sum test of independent samples and rank sum test of multiple independent samples; (3) multi factor analysis and two classification logistics regression analysis; (4) SF-6D scale, time trade-off method, and EQ-5D-5L scale for the consistency test of three measurement methods using intra group correlation coefficient (ICC) and Bland-A1tman method. The results were investigated by investigators. Basic situation: a total of 621 breast cancer patients were investigated in this study, of which 13 original questionnaires were not included in the final analysis due to incomplete information. The average age of the respondents was 48 + 9.6 years old and the average course was 38.2+40.9 months; the educated degree of the respondents was low, the degree of primary school literature and illiteracy accounted for nearly 1/3; The proportion of workers (workers) accounted for more than 1/3, farmers / migrant workers accounted for about 1/4; 88.7% of the respondents were married; the average annual income of the family was the highest (43.1%) of 3-8 yuan (43.1%); the medical insurance forms of the respondents accounted for 47.2% and 43.3% of the urban workers' medical insurance and NCMS respectively; the patients in the III period were approximately the same. The proportion of patients in stage IV was the lowest (12%); nearly half of the patients received chemotherapy alone; estrogen receptor protein / progesterone receptor (ER/PR) positive accounted for 54.1%, and negative accounted for 26%; the menopause accounted for more than half (54.9%) of the respondents; from the condition of disease, primary breast cancer or recurrence was more than one year or more. The proportion of patients was the highest (40.3%), the proportion of patients with breast cancer relapse and within the lowest (10.7%).EQ-5D-5L scale measured health utility value: the average health utility value of the breast cancer patients measured by the EQ-5D-5L scale was 0.83 + 0.16 (95% confidence interval 0.82 to 0.85, the median was 0.87). Health utility value in residence, marital status, occupation, education, medical support form, family income and course of illness, clinical stage, treatment plan and disease status classification of different subgroups were statistically significant (P0.05). Multi factor analysis showed that the residence, occupation, education, medical guarantee form of the patients were investigated. The income of the court and the treatment plan had a certain effect on the health utility value of the health utility value measured by the.SF-6D scale: the average health utility value of the sample population measured by the SF-6D scale was 0.65 + 0.13, (95% confidence interval 0.64 to 0.66, and the median was 0.62). Degree, medical security form, family income, treatment scheme and different subgroups of disease status classification were statistically significant (P0.05); multi factor analysis showed that the occupation, education level, medical security form, family income, and main treatment plan had a certain influence on its health utility value. The health utility values measured by the trade-off method: the average health utility value of the sample population measured by the time trade-off method was 0.80 + 0.25 (95% confidence interval 0.77 ~ 0.82 and median is 0.90). Single factor analysis showed that the health utility value of the respondents was different in marital status, education range, family income, treatment and disease status. The differences between the subgroups were statistically significant (P0.05). The multifactor analysis showed that the degree of education, family income and pathological diagnosis of the respondents had a certain influence on the health utility value of the.EQ-5D-5L scale, the comparison of the SF-6D scale and the time trade-off method: the comparison of the EQ-5D-5L scale, the SF-6D scale and the TTO three measurement methods The EQ-5D-5L scale showed a high ceiling effect (28.62%), while TTO had a certain floor effect (4.44%).EQ-5D-5L scale, and the correlation coefficient (ICC) of the health utility value of the SF-6D scale and TTO sample population was 0.46, and the moderate consistency.EQ-5D-5L scale and SF-6D scale had high consistency; EQ-5D-5L scale and TTO. With a certain degree of consistency, the basic disagreement between the SF-6D and TTO shows that the mean value difference between the health utility value measured by the EQ-5D-5L scale and the time balance method is 0.04, and the difference between the mean of health utility values measured by the EQ-5D-5L scale and the SF-6D scale is 0.19, and the health measured by the SF-6D scale and the time balance method is healthy. The mean value difference value was 0.04, and the three methods were different. Conclusion the EQ-5D-5L scale was used in this study. The health utility values of the 608 people surveyed by the SF-6D scale and TTO were different. The comparison showed that there was a moderate consistency among the three, among them, the EQ-5D-5L scale and the SF-6D scale were highly consistent. The value of health utility is influenced by many factors, including education and disease. In addition, this study suggests that the SF-6D scale is more suitable for the study of health utility value of breast cancer in our country.

【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R737.9

【参考文献】