乳腺癌患者不同健康效用值測(cè)量方式的比較研究
本文選題:乳腺癌 + 健康效用值。 參考:《山東大學(xué)》2015年碩士論文
【摘要】:研究背景乳腺癌是危害婦女健康的最常見(jiàn)惡性腫瘤,每年中國(guó)乳腺癌新發(fā)數(shù)量和死亡數(shù)量分別占全世界的12.2%和9.6%。乳腺癌不僅給患者帶來(lái)嚴(yán)重的疾病負(fù)擔(dān),也造成了很大的社會(huì)損失與經(jīng)濟(jì)負(fù)擔(dān)。衛(wèi)生經(jīng)濟(jì)學(xué)評(píng)價(jià)是衛(wèi)生經(jīng)濟(jì)學(xué)的一種重要方法或研究工具,成本-效用分析作為衛(wèi)生經(jīng)濟(jì)學(xué)評(píng)價(jià)的主要方法之一,已得到認(rèn)可并被廣泛應(yīng)用。在衛(wèi)生領(lǐng)域,效用是指衛(wèi)生服務(wù)方案滿(mǎn)足人們獲得健康這一需要或欲望的能力,代表了社會(huì)或個(gè)人某種價(jià)值觀念的取向,也可以理解為對(duì)某種健康狀態(tài)所賦予的權(quán)重,即健康效用值。對(duì)健康狀態(tài)的測(cè)量可分為非基于偏好和基于偏好兩大類(lèi),而非基于偏好的健康狀態(tài)測(cè)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。健康效用值是反映個(gè)體健康狀況的綜合指數(shù),是人們對(duì)某種健康狀態(tài)的偏好程度,取值在0(死亡)和1(完全健康)之間。國(guó)際上常用的測(cè)量方法大致可分為直接測(cè)量法與間接測(cè)量法兩類(lèi),直接測(cè)量法是根據(jù)患者自身的健康偏好,間接測(cè)量法是基于普通人群的健康偏好。國(guó)際上已在多種慢性疾病中開(kāi)展效用值的測(cè)量研究,不少研究均同時(shí)采用了直接測(cè)量法與間接測(cè)量法,并對(duì)兩類(lèi)測(cè)量方式進(jìn)行比較研究,但在乳腺癌領(lǐng)域,這方面的研究仍較為少見(jiàn)。目前,國(guó)內(nèi)多采用乳腺癌癌癥專(zhuān)用測(cè)量量表以及國(guó)際上通用的生命質(zhì)量測(cè)量量表(如SF-36、EQ-5D等量表)對(duì)乳腺癌患者進(jìn)行生命質(zhì)量的評(píng)價(jià)研究的研究較多,較少涉及到效用值的測(cè)量研究。目前,中國(guó)大陸尚無(wú)乳腺癌健康效用值的測(cè)量文獻(xiàn)報(bào)道和中國(guó)人群的相關(guān)數(shù)據(jù),因此,開(kāi)展我國(guó)乳腺癌患者健康效用值的測(cè)量研究,尋求適合我國(guó)乳腺癌患者實(shí)際狀況的健康效用值測(cè)量方法,可使我國(guó)乳腺癌診療服務(wù)的臨床決策機(jī)制更加合理,同時(shí)為今后開(kāi)展乳腺癌臨床治療的成本-效用分析提供方法借鑒和基礎(chǔ)數(shù)據(jù)支持。研究目的本研究采用直接測(cè)量法和間接測(cè)量法來(lái)測(cè)量我國(guó)乳腺癌患者的健康效用值,分析其相關(guān)影響因素,并比較分析不同方法之間的一致性,找出更加符合我國(guó)乳腺癌患者實(shí)際狀況的健康效用值測(cè)量工具,并為今后開(kāi)展衛(wèi)生經(jīng)濟(jì)學(xué)評(píng)價(jià)研究提供支持。1.采用TTO.EQ-5D-5L量表和SF-6D量表測(cè)量我國(guó)乳腺癌患者的健康效用值;2.探索影響我國(guó)乳腺癌患者健康效用值的主要影響因素;3.比較SF-6D、TTO、EQ-5D-5L三種測(cè)量方法的一致性,找出適合我國(guó)乳腺癌患者的健康效用值測(cè)量工具。資料來(lái)源與方法本研究資料來(lái)源包括兩方面:一是對(duì)現(xiàn)有文獻(xiàn)資料的收集整理,二是對(duì)于2014年11月~2015年2月在青島市立醫(yī)院乳腺科就診、住院治療的621名乳腺癌患者進(jìn)行問(wèn)卷調(diào)查,收集被調(diào)查者的個(gè)人基本信息和臨床信息,通過(guò)SF-6D量表、時(shí)間權(quán)衡法、EQ-5D-5L量表三種測(cè)量方法測(cè)量被調(diào)查者的健康效用值。乳腺癌分期標(biāo)準(zhǔn)采用目前國(guó)際TNM分期方法,SF-6D量表、EQ-5D-5L量表已獲得相應(yīng)研發(fā)機(jī)構(gòu)授權(quán)使用,時(shí)間權(quán)衡法問(wèn)題的設(shè)計(jì)參閱國(guó)際上相關(guān)文獻(xiàn),結(jié)合我國(guó)乳腺癌疾病特點(diǎn)進(jìn)行設(shè)計(jì)完成。最終在被調(diào)查者知情同意的情況下,由經(jīng)過(guò)專(zhuān)業(yè)培訓(xùn)的調(diào)查人員完成調(diào)查。本研究采用分析方法包括:(1)描述性分析,包括樣本的均數(shù)(標(biāo)準(zhǔn)差)、95%可信區(qū)間、中位數(shù)等統(tǒng)計(jì)指標(biāo);(2)單因素分析,采用兩個(gè)獨(dú)立樣本的秩和檢驗(yàn)和多個(gè)獨(dú)立樣本的秩和檢驗(yàn)進(jìn)行分析;(3)多因素分析,采用二分類(lèi)logistics回歸進(jìn)行分析;(4)SF-6D量表、時(shí)間權(quán)衡法、EQ-5D-5L量表三種測(cè)量方式的一致性檢驗(yàn)采用組內(nèi)相關(guān)系數(shù)(ICC)和Bland-A1tman法。研究結(jié)果被調(diào)查者的基本情況:本研究共計(jì)調(diào)查符合條件的乳腺癌患者621名,其中13份原始問(wèn)卷由于信息不完整未能納入最終分析。被調(diào)查者平均年齡48.0±9.6歲,平均病程38.2+40.9月;被調(diào)查者的文化程度偏低,小學(xué)文化程度和文盲占近三分之一;企業(yè)職工(工人)所占比例超過(guò)三分之一,農(nóng)民/農(nóng)民工約占四分之一;88.7%的被調(diào)查者為已婚;家庭平均年收入以3-8萬(wàn)元所占比例最高(43.1%);被調(diào)查者的醫(yī)療保障形式以城鎮(zhèn)職工醫(yī)療保險(xiǎn)和新農(nóng)合為主,分別占到47.2%和43.3%;III期的患者約占三分之一,Ⅳ期患者所占比例最低(12.0%);近一半的患者接受單純化療;雌激素受體蛋白/孕激素受體(ER/PR)陽(yáng)性患者占54.1%,陰性占26.0%;被調(diào)查者中絕經(jīng)者占到一半以上(54.9%);從疾病狀態(tài)看,原發(fā)性乳腺癌或復(fù)發(fā)超過(guò)一年及以上的患者所占比例最高(40.3%),乳腺癌復(fù)發(fā)年及以?xún)?nèi)的患者所占比例最低(10.7%)。EQ-5D-5L量表所測(cè)健康效用值:用EQ-5D-5L量表測(cè)量的乳腺癌患者的平均健康效用值為0.83±0.16(95%可信區(qū)間0.82~0.85,中位數(shù)為0.87)。單因素分析顯示,被調(diào)查患者的健康效用值在居住地、婚姻狀況、職業(yè)、教育程度、醫(yī)療保障形式、家庭收入以及病程、臨床分期、治療方案和疾病狀態(tài)分類(lèi)不同亞組之間的差異均具有統(tǒng)計(jì)學(xué)意義(P0.05)。多因素分析顯示,被調(diào)查患者的居住地、職業(yè)、教育程度、醫(yī)療保障形式、家庭收入以及治療方案會(huì)對(duì)健康效用值產(chǎn)生一定影響。SF-6D量表所測(cè)健康效用值:用SF-6D量表測(cè)量的樣本人群平均健康效用值為0.65±0.13,(95%可信區(qū)間0.64~0.66,中位數(shù)為0.62)。單因素分析顯示,被調(diào)查者的健康效用值在婚姻狀況、職業(yè)、教育程度、醫(yī)療保障形式、家庭收入、治療方案以及疾病狀態(tài)分類(lèi)的不同亞組之間的差異均具有統(tǒng)計(jì)學(xué)意義(P0.05);多因素分析顯示,被調(diào)查者的職業(yè)、教育程度、醫(yī)療保障形式、家庭收入、主要治療方案會(huì)對(duì)其健康效用值產(chǎn)生一定的影響。時(shí)間權(quán)衡法所測(cè)健康效用值:本研究利用時(shí)間權(quán)衡法測(cè)量的樣本人群的平均健康效用值為0.80±0.25(95%可信區(qū)間0.77~0.82,中位數(shù)為0.90)。單因素分析顯示,被調(diào)查者的健康效用值在婚姻狀況、教育程度、家庭收入、治療方式以及疾病狀態(tài)不同亞組之間的差異均具有統(tǒng)計(jì)學(xué)意義(P0.05);多因素分析顯示,被調(diào)查者的教育程度、家庭收入以及病理診斷信息會(huì)對(duì)其健康效用值產(chǎn)生一定的影響。EQ-5D-5L量表、SF-6D量表與時(shí)間權(quán)衡法的比較:EQ-5D-5L量表、SF-6D量表與TTO三種測(cè)量方式比較顯示,EQ-5D-5L量表存在較高的天花板效應(yīng)(28.62%),而TTO存在一定的地板效應(yīng)(4.44%)。EQ-5D-5L量表、SF-6D量表與TTO所測(cè)樣本人群的健康效用值的組間相關(guān)系數(shù)(ICC)為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量表與TTO之間基本不一致。Bland-Altman法顯示,EQ-5D-5L量表和時(shí)間權(quán)衡法所測(cè)量的健康效用值差值的均值為0.04,EQ-5D-5L量表和SF-6D量表所測(cè)量的健康效用值均值的差異為0.19,SF-6D量表和時(shí)間權(quán)衡法所測(cè)量的健康效用值差值的均值為0.04,三種測(cè)量方式之間均不一致。結(jié)論本研究采用EQ-5D-5L量表、SF-6D量表與TTO所測(cè)608名被調(diào)查者的健康效用值有所不同,比較顯示三者之間存在中度一致性,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會(huì)受多種因素的影響,包括教育程度、疾病狀態(tài)等。另外,本研究認(rèn)為,SF-6D量表更適用于我國(guó)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.
【學(xué)位授予單位】:山東大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2015
【分類(lèi)號(hào)】:R737.9
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