湖南省肺结核病经济负担及其影响因素研究
摘要
一、研究背景
中国是全球22个结核病高负担国家之一,结核病患者数位居全世界第2位。在我国传染病疫情网络报告中,肺结核发病和死亡数始终位居甲乙类传染病之首,发病人群中2/3集中于15～54岁生产能力最强的年龄组,其中80%以上为农村患者,且80%的患者家庭年人均收入低于当地人均水平。结核病多发生在贫困人群,是导致我国贫困人群“因贫致病”和“因病致贫”的主要原因之一。湖南省为全国结核病高疫情区,2004年经WHO专家和国家结核病专家联合评估,湖南省涂阳肺结核发病率为59/10万,比全国平均涂阳肺结核发病率(46/10万)高28.3%。全省每年发现和治疗管理活动性肺结核患者近5万例,其中传染性肺结核患者3万余例,充分说明结核病是危害我国和我省民众健康和生命的重大传染性疾病,对个人、家庭和社会均可造成巨大的经济负担。
1992年以来,我国政府利用世界银行贷款,在13个省开展结核病控制项目,全面推行结核病控制策略(DOTS),对发现的所有传染性肺结核患者(痰检涂片阳性者)实行统一免费的全程督导短程化疗。至2005年,我国达到了WHO要求的涂阳肺结核发现率70%和治愈率85%目标,结核病控制工作取得了阶段性成果。为了达到2015年全国结核病患病率和死亡率在1990年的基础上各下降50%的联合国千年发展目标(MDG),我国政府积极推行和实施全球遏制结核病策略,包括进一步加强结核病防治服务体系建设;扩展和加强DOTS实施质量;对所有活动性肺结核患者实现免费诊治政策;应对以TB/HIV双重感染、流动人口结核病管理和耐多药结核病防治(MDR-TB)为主及其它特殊挑战(贫困人口、羁押人群、学校等);病人和社区全面动员、全社会参与结核病控制,确保以病人为中心的质量管理等。为了验证和评价政府实现结核病控制目标的程度,需要从患者、家庭、社会和政府的层面综合研究肺结核病造成的经济负担。
近十多年来,尽管对结核病的经济学研究已有了一些可贵的探索,如有用住院样本计算结核病住院费用的;有基于当地卫生统计年鉴资料,从患者角度计算结核病医疗花费的;也有从社会角度计算DALY(伤残调整寿命年)损失以评价结核病负担的。不同的研究、不同的研究人群、不同的研究方法其结果不同,且多限于患者个体的角度,围绕着患者的诊治费用,或死亡、失能以评价结核病经济负担。对肺结核经济负担的评价至今仍无统一的认识和测量方法,其研究框架有待进一步完善。事实上,肺结核病对患者、家庭、政府和社会的经济影响,不仅限于患者和家庭因病求治所致的医疗费、交通住宿费和营养费等直接经济负担,还应包括当年政府为防治结核病的投入;患者本人因病休工和家属陪护误工所致的家庭间接经济损失;因病失能、因病早亡而减少了为社会创造财富的社会间接经济负担等,将损失的健康寿命年转换成货币,应作为疾病经济负担研究不可缺少的内容之一。与此同时,很少有研究涉及肺结核病对整个家庭经济收入和支出情况的改变,科学、全面地评估肺结核病造成的社会经济负担,对政府制定结核病防治控制政策具有重要的价值和意义。
二、研究目的
1.构建肺结核病经济负担的研究框架,为今后开展相关研究打下技术基础;
2.从患者家庭、政府和社会的层面,系统测算湖南省因肺结核病所致的经济负担,掌握肺结核病经济负担现况和分布特征,分析政府结核病控制目标实施中所存在的问题;
3.了解肺结核病对患者本人和家庭社会经济的影响,构建肺结核病家庭经济负担指数;
4.分析肺结核病疾病经济负担的主要影响因素,探讨减轻患者家庭肺结核病疾病经济负担的有效途径;
5.根据研究结果,结合全省实情,为结核病防治可持续发展规划的制定提供决策依据。
三、研究方法
1.主要研究指标及其操作性定义
(1)肺结核病直接经济负担:是指直接用于预防和治疗肺结核病的1年的总费用,包括患者家庭和政府用于肺结核病的诊断、治疗、康复以及预防过程中直接消耗的各种费用。分为直接医疗费用(门诊、住院及辅助检查、药品和保健、康复等)和直接非医疗费用(患者和陪护所支付的交通费、营养食宿等费)两部分。
①家庭直接经济负担:家庭用于肺结核病的诊治、康复过程中直接消耗的各种费用,包括门诊诊治费、住院费、药品保健费等直接医疗费与患者及陪护交通费、食宿费和营养费等直接非医疗费用之和。
②政府直接经济负担:各级政府和外援结核病项目为肺结核患者(需方)提供的免费检查、诊断和抗结核病药品等直接医疗费用与为结核病防治机构(供方)提供的结核病健康教育、人员培训、结核病人的督导、追踪与访视、药品运输等直接非医疗费之和。
③社会直接经济负担:例均社会直接经济负担×当地人口数×发病率。
例均社会直接经济负担=例均家庭直接经济负担+政府直接经济负担。
(2)肺结核病间接经济负担:是指因肺结核病的发生而间接地给家庭和社会带来的经济负担,包括经济损失和健康损失两部分,是将因肺结核病损失的时间和寿命年货币化,计量分析肺结核病的危害和损失的大小。
①家庭间接经济负担:患者因病休工和家属陪护误工所致的家庭生产或收入损失。
②社会间接经济负担:是将健康寿命货币化,间接测量患者因病失能或早亡造成健康寿命损失所致的创造社会财富和价值的损失。
(3)肺结核病总经济负担:指直接经济负担与间接经济负担之和。
(4)家庭疾病负担指数(disease burden index,DBI):这是本研究新创立的一个评价指标,指患者家庭直接经济负担占家庭年纯收入之比,即:
肺结核家庭疾病负担指数=(患病后1年家庭直接经济负担)/(当年家庭年纯收入)
也可以理解为患者家庭需要多长时间(年)的纯收入来支付患者因疾病导致的直接经济损失。负担指数越大,家庭经济补偿所需要的时间越长。本研究计算的肺结核患者家庭疾病负担指数,将来还可用于不同疾病之间家庭经济负担的比较。
2.资料来源
(1)现场调查
采取分层随机整群抽样方法,分别在湖南省国家级扶贫重点县、省级扶贫重点县和非扶贫县各随机抽2个县作为研究现场,所确定的样本县区分别为湘潭市的湘潭县和邵阳市的邵东县(非扶贫县);常德市的石门县和张家界市的永定区(省级扶贫重点县区)及岳阳市的平江县和益阳市的安化县(国家级扶贫重点县)。以年龄≥15岁,自2005年7月～9月到6所样本县区结核病防治所就诊并确诊的连续新发活动性肺结核患者为现场调查对象。样本量的估算以因病卧床为失能依据。前期研究结果表明,肺结核患者中22.5%因病卧床(失能),按照样本量计算公式:N=1.96~2×p(1-P)/D~2,设容许误差D=0.2×P,得出N=345。预设15%的失访和不应答,即至少需要397例确诊的肺结核患者样本。对所有调查对象,采用自制的结核病社会经济学调查问卷,在知情同意的前提下,分别在确诊时和疗程结束后2次入户访谈,收集患者病后的失能程度、诊治经过和医疗费用以及患病前后1年个人和家庭经济收入、支出等相关资料和信息。
以6个样本县区2005年度所有新登记的肺结核患者为观察对象,队列观察1年,分析其治疗结局。根据样本县区每例因肺结核病死亡者的年龄、性别信息计算样本县区因肺结核病早亡所致的健康寿命年损失(YLL)。
(2)统计数据来源:
①2005年、2006年全省和样本县区人口数、性别比、人均纯收入、人均GDP等信息分别来源于《湖南统计年鉴-2006》和《湖南统计年鉴-2007》;
②2005年肺结核发病率来源于2007年WHO结核病控制年度报告;
③全省和各样本县区肺结核登记病例数以及治疗转归结果来源于2005年～2006年结核病防治规划实施的季度报表和肺结核病信息管理系统;
④制作2000年标准期望寿命表所用的标准人口来源于2000年湖南省人口普查资料;
⑤各级政府和国外援助项目对结核病防治的投入经费来源于湖南省和样本县区结核病防治规划(2001～2010年)中期评估资料以及全省各项目执行单位的资金下拨计划表。
3.主要研究内容
(1)肺结核病直接经济负担
①家庭直接经济负担=直接医疗费+直接非医疗费
直接医疗费=门诊费(挂号费+检查费+药品费等)+住院费
直接非医疗费=患者交通费+陪护人员交通费+患者食宿费+陪护人员食宿费+其他费(营养保健和偏方等)
通过现场收集肺结核病患者诊治相关的医疗费用,采用分类汇总求和的方法计算患者家庭的直接经济负担和例均直接经济负担
②政府直接经济负担=政府结核病防治落实的配套经费+外援结核病项目经费。
根据全省及6样本县区结核病防治规划(2001～2010年)中期评估资料,查阅当年各级政府结核病防治专项经费和配套经费到账额度,各样本县区外援结核病项目的资金到位额度,计算例均政府直接经济负担。
③社会直接经济负担=例均社会直接经济负担×当地人口数×发病率。
例均社会直接经济负担=例均家庭直接经济负担+例均政府直接经济负担
(2)肺结核病间接经济负担:
①家庭肺结核病间接负担=(患者因病休工天数+陪护误工天数)×日均劳动力收入。采用人力资本法,根据患者休工和陪护误工天数,结合当年当地农民纯收入折算成日均劳动力收入,计算家庭肺结核布浣泳盟鹗А?
②社会间接经济负担=DALYs×人均GDP×生产力权重
社会DALY损失值=直接DALY损失值+间接DALY损失值
直接DALY损失值:根据调查样本测得直接例均DALY损失,计算全省已发现治疗患者的社会直接DALY损失值;
间接DALY损失值:根据化疗前时代的早期结核病流行病学研究结果,即病死率和平均死亡年龄,计算年DALY损失,再按调查样本的平均就诊延误时间(从肺结核病症状出现到首次就诊的时间间隔),折算在当前DOTS策略下的未发现患者的间接例均DALY损失,推算全省未发现治疗患者的社会间接DALY损失值。
采用人力资本法和DALY相结合的方法,结合样本县区和全省登记治疗肺结核患者的加权年龄权重和当年当地人均GDP,计算得全省肺结核病社会间接经济负担。
(3)肺结核病社会总经济负担=社会直接经济负担+社会间接经济负担
(4)通过肺结核病对患者日常生活和社会功能受限程度以及患病前后1年个人医疗开支和收入的变化,分析肺结核病对患者本人的社会经济影响;通过患病前后1年家庭纯收入和开支的变化,了解家庭对肺结核病直接经济负担的应对措施;并通过家庭肺结核病直接经济负担占家庭年纯收入的比例,构建家庭肺结核病经济负担指数。
(5)分别从社会人口学、疾病的严重程度、医疗服务利用以及患者本人和家庭经济收入等4个维度,运用有序logistic回归对家庭肺结核病直接经济负担影响因素进行单因素和多因素分析。
4.统计分析方法
采用EpiData 3.0建立统一数据库后对数据资料进行双录入,导入SPSS12.0统计学软件包建立数据库。采用有序logistic回归多因素分析家庭肺结核病经济负担影响因素。采用EXCEL(2003)作相关的统计表和统计图。
DALY的计算,采用GBD的计算公式和各参数的固定取值,期望寿命采用2000年湖南省标准期望寿命表,失能的取值以GBD失能分级及其权重为基础,结合农村居民的生活习惯和肺结核病的特点作了适当修改。
四、研究结果
1.样本人群特征:
(1)现场调查共纳入354例患者,其中男性258例(72.9%),女性96例(27.1%),平均年龄为43.2±15.4岁,平均受正规教育中位年限为9年。19.2%的患者未婚,66.9%的初婚,6.8%的再婚和7.1%的离婚、丧偶独居。共有57.1%的患者以农业生产为职业,26.6%外出务工,10.2%的从事批零、餐饮和运输等商业和服务业和5.6%的无正式职业。患者家庭户均人口3.4人,户均劳动力1.95人。年龄分布中有91.3%的调查患者在15～59岁这一最具生产能力的人群。
(2)6个样本县区2005年共登记、治疗活动性肺结核患者3652例,队列观察1年,其中成功治疗共3349例(91.7%);死亡156例(4.3%),其中因结核病死亡76例(非结核病死亡80例),病死率2.1%;丢失122例(3.3%);失败11例(0.3%)和其他14例。
(3)2005年全省共登记活动性肺结核患者47440例,新登记率为70.5/10~5,肺结核病发病率100/10~5。
2.因肺结核病导致的直接经济负担
(1)家庭例均直接经济负担1459.8元,中位直接经济负担为1045元(360～11046);其中例均直接医疗费为1267.3元,中位直接医疗费为902元(115～10174),例均直接非医疗费为192.6元,中位直接非医疗费为152元(15～1306);确诊前家庭例均经济负担为850.3元,中位389元(0～9570);确诊后例均经济负担为609.6元,中位583元(192～1654)。全省家庭总直接经济负担共为6925.3万元。
(2)政府例均直接经济负担为927.9元,全省各级政府和外援结核病防治项目总投入共为4402万元。
(3)社会例均直接经济负担为2387.7元,全省社会总直接经济负担共为1.61亿元。
3.因肺结核病导致的间接经济负担
(1)例均家庭间接经济负担为887.5元,全省家庭总间接经济负担共为5947.7万元。
(2)例均社会间接经济负担为4409.1元,全省社会总间接经济负担共为2.97亿元。
4.因肺结核病导致的总经济负担
(1)例均家庭总经济负担为2347.3元,全省家庭总经济负担共为1.29亿元。
(2)例均政府总经济负担为927.9元,全省各级政府和外援结核病防治项目实际总投入共为4402万元(计划应投入4562万元)。
(3)例均社会总经济负担为6796.8元,全省社会总经济负担共为4.58亿元。
5.因肺结核病导致DALY损失
(1)直接例均DALLY损失0.57人年(其中例均YLL为0.26,例均YLD为0.31),社会直接DALY损失共27246健康寿命人年。
(2)间接例均DALY损失0.88人年,社会间接DALY损失共17495健康寿命人年。
(3)社会总DALY损失共44741健康寿命人年。
(4)湖南省全人群肺结核病DALY损失率为40.5/10~5,其中男性为58.0/10~5,女性为21.1/10~5。
6.肺结核病对患者个人社会功能和家庭经济损失
(1)患者例均肺结核症状持续118.8天(中位98天);例均休工95.7天(中位93天);例均家人陪护误工8.2天(中位5天)。
(2)患者年人均收入占家庭总年收入的比例由病前1年的53.1%降至病后1年的37.2%;患者例均年收入减少1700.6元(中位1000元);
(3)家庭年人均收入低于当地年人均收入水平的比例由病前1年的64.4%上升到病后1年的76%;病后70.7%的家庭年人均收入低于患病前;病后家庭人均年收入减少358.6元(中位200元)。
(4)病前1年26.3%的家庭总经济收入低于当年支出(收不抵支),户均年节余226.7元(中位287元);患病后1年收不抵支的家庭增加到69.5%,户均年超支429.2元(中位539元)。病后1年家庭户均收入减少1235.6元(中位625元)。
(5)肺结核患者家庭例均直接经济负担占家庭总经济开支的20.4%,占家庭总医疗开支的89.6%。直接经济负担中,63.8%的是来源自费,19.1%的是向亲友借钱,6.2%的是子女或父母负担,5.8%的是变卖家产,而医疗保险或新型农村合作医疗支付比例仅1%。家庭应对肺结核病直接经济负担的措施还有改变年度开支计划,包括削减16.4%的生活开支和4.6%的文化、教育和娱乐通讯开支等。
7.家庭疾病负担指数
肺结核病患者户均家庭经济负担指数为0.33年,中位负担指数为0.16年(0.14～10.3)。
8.影响家庭经济负担的因素
多因素有序Logitic回归分析显示:因病住院(OR=423.266,95%CI=71.236～2514.929)、症状持续天数长(OR=4.175,95%CI=2.519～6.917)、休工天数长(OR=4.166,95%CI=1.203～14.426)、确诊前3次及以上就诊次数(OR=2.083,95%CI=1.261～3.442)和有就诊延误(OR=2.610,95%CI=1.319～5.186)等因素加重了肺结核患者和家庭经济负担;而高的文化程度(OR=0.233,95%CI=0.069～0.786)、高的患者个人收入(OR=0.431,95%CI＝0.202～0.920)以及首诊选择结防机构就诊(OR=0.140,95%CI＝0.051～0.386)可降低肺结核患者和家庭的经济负担。
五、本研究的意义与主要结论
本研究通过现场调查并基于大量流行病学数据,构建了肺结核病经济负担研究框架;从患者家庭、政府和社会等各层面系统研究了湖南省肺结核病的经济损失和健康损失的测算以及肺结核病的经济负担。采用湖南省标准期望寿命,测算了全省登记治疗的肺结核患者的直接DALY损失,并基于调查样本的平均就诊延误时间以及未经治疗患者的病死率和平均死亡年龄,间接推算了在目前DOTS下未发现肺结核患者的例均社会间接DALY损失。为了更确切地分析肺结核病对家庭经济的损失情况,本研究建立了肺结核病家庭疾病负担指数,即家庭肺结核病的直接经济负担占家庭年纯收入比例,进一步说明肺结核对社会经济发展的影响,并为结核病防治政策的制定提供决策依据和建议。
主要结论如下:
1.肺结核病给患者、家庭、政府和社会均带来了沉重的经济负担,而且给社会造成的损失要大于患者家庭在一段时间内所造成的经济损失。
2.除了使绝大多数患者不同程度的社会功能受限外,肺结核病造成例均损失0.57个健康寿命年。肺结核病减少了患者和家庭的收入,家庭户均要以约4个月(家庭疾病负担系数0.33年)的纯收入来补偿肺结核病给家庭带来的经济损失。为了应对肺结核病的经济负担,家庭削减了生活和教育开支,降低了生活水平。肺结核病不仅导致了约70%的家庭收不抵支、因病致贫,也使一些贫困的家庭变得更加穷困。
3.政府为肺结核病提供的免费检查和抗结核病药品,虽在一定程度上缓解了家庭肺结核病的经济负担,但患者确诊后肝肾功能检查、基本保肝和对症辅助药品以及往返交通、食宿费等仍使广大患者及家庭的经济能力难以承受。
4.减轻肺结核病家庭经济负担的主要责任应归于政府,需要进一步加强政府承诺和政府责任,建立长效的结核病防治可持续发展计划和筹资机制,扩大结核病服务免费范围。如果将患者确诊后的直接经济负担609.6元/例列为肺结核患者确诊后的免费检查项目,政府需额外筹资2892万元。
5.家庭肺结核病经济负担与卫生服务提供者密切相关,加强结核病防治服务体系建设,改善结核病服务质量,以减少患者因住院,减少患者确诊前就诊次数,可提高结核病患者的可及性与可获得性而减轻家庭经济负担。
6.肺结核病特殊病种的医疗保障体系不完善,特别是农村地区。只有微乎其微的农村参合肺结核病住院患者享受了政府提供的补贴以及相应的医疗保障(报销额度仅占家庭直接经济负担的1%),需要将国家未纳入免费范围的肺结核病的诊治(住院和门诊)费用部分在医疗保险和新型农村合作医疗统筹考虑,纳入相关医疗保障制度的补偿范围。
Background
China is currently one of the 22 countries with highest burden of tuberculosis with the number of PTB patient ranked No.2 all over the world.Based on the official disease control information website (http://202.106.123.35/).the cases of notification and death are always on the top among all infectious disease.Two-thirds of the new cases are aged from 15 to 54 years old with more than 80%in rural area,80%of the household with the net income per capita are less than that of local level. TB always occur in poverty populations,it is one of the main reasons that makes patients and households more poverty.TB epidemic situation in Hunan is severe.The incidence of smear positive tuberculosis was estimated to be 0.059%in 2004,and 28.3%higher than the average level in the nationwide.Every year more than 50,000 active pulmonary tuberculosis(PTB) are detected out and treated in the whole province, while 30,000 of them are infectious PTB.TB is the major infectious diseases that severely threatens the health and life of the people and brings heavy economic burden to the patient household and society.Since 1992,Chinese government has carried out the World Bank loan TB control program in sixteen provinces,extensively implemented the DOTS(directly observed treatment,short course) strategy,and had reached the global target of that at least 70%of incident smear-positive cases should be detected and treated in DOTS and that at least 85%of those cases should be successfully treated.In order to achieve the targets for MDG(Millennium development goal) global TB control,that TB prevalence and death rates should be halved by 2015 compared with their level in 1990,Chinese government are implementing and carrying out the Global TB control Strategy positively,including further strengthening the service system,expanding and improving the quality of DOTS,free charge of diagnosing and treating for PTB,coping with the challenge of TB/HIV co-infection,management of floating population TB,multi-drug resistant tuberculosis control and other special issues(poverty population, prison,school,and others),mobilizing patients,communities and whole society to take part in the TB control and ensuring the quality management and take the patient-oriented measures.To verify and evaluate the extent of government commitment,the economic burden of PTB should be evaluated and estimated based on the point of view of patient household,society and government respectively.
Over the past decades,we have got some valuable explore on the economic study of TB,such as calculating the TB hospitalization expenditures using inpatient sample,computing the medical cost from the point of patients basing on the local health statistics yearbook,estimating DALY from the point of view of society to assess the TB burden. Different studies,different subjects and different methods lead to different results,and most of them focused on patients individual,There is no unified identification and measure method to assess the TB economic burden.In fact,the TB economic impacts to patient individual, household,government and society include not only the direct economic burden such as medical cost,fee for traffic,accommodating and nutrition, but also the fund such as government input to TB control and foreign aid TB program.loss of DALY due to disability and premature death,loss of income because of absence from work both of patient and his/her family members,decreasing the social wealth created by patient.Converting the loss of healthy life years into money should be a indispensable part of the study on disease economic burden.In addition,few study referred to the change of the household income and expenditure due to PTB.Assessing the PTB economic burden scientifically and comprehensively is valuable and significant for the government to make TB control strategy.
Objectives
1.To establish a frame to assess PTB economic burden,to lay the technical foundation for reseach of disease economic burden in the future.
2.To Estimate and evaluate the PTB economic burden in Hunan Province by the way of PTB patient and household,government and society.To describe the current status and distribution characteristics of PTB economic burden.Analyses the extent and problems of the TB control implementation at government level.
3.To investigate the impacts of PTB to patient individual and household,establish the disease burden index of PTB household.
4.To analyses the main influencing factors to PTB economic
burden.Explore approaches effective enough to relieve the economic burden for the patient household.
5.To make some strategic suggestion for TB control based on the research results and the fact of our province.
Methods
1.Main study indications and the operational definition
(1) PTB direct economic burden:total cost for prevention,treatment and recovery paid by patient family,government and society,including direct medical cost(clinic treatment,hospitalization,assistant tests,drugs, health care and recovery) and direct non-medical cost(fee for traffic, acommandation room and board and nutrition consummated by patient and accompany).
①Patient household direct economic burden:the various fees and charges for the diagnosis and treatment of TB an d the rehabilitation process paid by family directly,including direct medical cost(clinic treatment,hospitalization,drugs,health care,etc.) and direct non-medical cost(fee for patients and companies traffic,room and board and nutrition).
②Government direct economic burden:including direct medical cost offered by governments at all levels and other foreign aid TB control programme for free tests,diagnosis and anti-TB drugs for patients,and direct non-medical cost for TB health education,training,supervision, case-tracing,following up and visiting to patients,etc.
③Total direct economic burden:the sum of patient household and government direct economic burden.
(2) Indirect economic burden:refer to the economic burden due to disability or premature death,including absenteeism in workplace of patients individual and family members and loss of health life years. Converting the loss of time and life years into currency,quantitatively analysis the loss indirectly.
①Family indirect economic burden:the loss of family production or income because of absence work or unemployed due to PTB both the patients and family members.
②Society indirect economic burden:convert healthy life year into money,measure the loss of social wealth created by the patients due to disability or premature death indirectly.
(3) PTB economic burden:the sum of direct and indirect social economic burden
(4) The disease burden index of household(DBI):this is the creative new indication It is the ratio of the direct economic burden on household with the total household annual net income.DBI refers how many years' net income it will take for the patients' family to pay for the direct economic loss caused by the disease.The more the index is,the long time it will take to make up the loss.DBI could be used to not only PTB but also other diseases and could be compared between different diseases.
2.Sources of data and methods
(1) Field survey
Using stratified cluster sampling,randomly choose two counties from national-level poverty support counties,provincial-level poverty support counties,and non-poverty counties respectively.They are Xiangtan and Shaodong(non-poverty),Shimen and Yongding(provincial-level poverty counties),and Pingjiang and Anhua(national-level poverty counties). Subjects are new active PTB patients in these six sample counties from July to September in 2005 with the age more than 15 years old.From the former research,the rate of being in sickbed(referring to disability) in PTB patients is 22.5%,the sample should be 345(basing on the formula:N=1.96~2×P(1-P) / D~2,δ=0.2P).Take into account of 15% dropping off and non-response,397 consecutive subjects should be involved in the project at least.Interview all the cases and family members with a structured questionnaire at the time of diagnosis and at the end of treatment duration respectively with the informed consent. Collecting data on patients' extent of disability due to PTB,process of diagnosis and treatment,medical cost,income and expenses both of patient and family members one year before and after being sick.
Recruit all the new registered cases in the six counties,follow up one year,analyses the outcome.Estimating the DALY due to PTB respectively basing the death age and gender.
(2) Statistical data sources:
①The population,sex ratio,per capita net income,per capita GDP in the whole province and sample counties in 2005 and 2006 were got from Hunan Statistical Yearbook 2006 and 2007.
②TB incidence in 2005 came from the WHO's annual report of TB control in 2007.
③The registered cases and their outcome in the whole province and the six sample counties came from the quarterly report in TB control planning and information management system for TB in 2005-2006.
④Census data in Hunan 2000 were used to be a standard population for the standard life expectancy table.
⑤The numbers of funds offered by governments and other foreign aid TB programme were got from the Mid-term evaluation data of TB control planning(2001-2010) in Hunan Province and sample counties and the funds allocated schedule in the project implementation units all over the province.
3.Main study content
(1) PTB direct economic burden:
①Family direct economic burden = direct medical cost + direct non-medical cost.
The data and information is collected by interviewing the patients and family members from household by household.Estimating the classifying sum of the patient household direct economic burden and the average level.
②Government direct economic burden = supporting funds from government for TB control + aided funds from foreign aid TB control programmes.
Basing on the Mid-term evaluation data of TB control planning (2001-2010) in Hunan Province and sample counties,government funds invested on TB control was defined as the government direct economic burden in the project.
③Social direct economic burden = Social direct economic burden per case×population×incidence of PTB
Social direct economic burden per case = household direct economic burden per case + government direct economic burden per case
(2) PTB indirect economic burden:
①Household indirect economic burden =(PTB patients absence work days + the family members absence from work days)×labour force income per day
Using human capital method,basing on the number of absent work days both of patients and family members,converting the net income of local farmers to daily average labor income,estimating the family indirect economic burden.
②Social indirect economic burden = DALYs×GDP×weight of productivity
Social loss of DALY = direct loss of DALY + indirect loss of DALY
Direct loss of DALY:basing on the direct loss of DALY per case got from the survey sample,calculate the total direct DALY loss of all the registered and treated PTB cases in Hunan Province in 2005.
Indirect loss of DALY:basing on the fatality and mean death age got from the early epidemiology studies(in the pre-drug era),calculating the annual loss of DALY,then basing on the average diagnostic delay days(time interval between the appearance of PTB symptoms and the first time to seeking health service),estimating the average indirect loss of DALY of the unregistered and undetected cases under the current DOTS,then assess the total indirect social loss of DALY of the unregistered cases in the province.
Using human capital method and DALY,combining the weight of age for registered patients in the province and sample counties and local annual GDP per capita,we can get the total social indirect economic burden in the province.
(3) PTB total social economic burden = direct social economic burden + indirect social economic burden.
(4) Analyses the social economic influence of PTB to patients,in the aspects of daily life,extent of social function limitation,changes of patients' medical cost and income before and after being sick.Realize the financing methods of PTB direct economic burden and changing in household consumption patterns,Calculate the family burden of disease index(the ratio of the direct economic burden on patients' family with the total household annual net income).
(5) Multivariate analysis on factors impacting the patient household economic burden from the points of social demography,severity of illness, utilization of medical service and economic income of patients and their families by ordinal logistic regression.
4.Statistic Analysis
All data derived from the questionnaires were processed using EpiData 3.0 and SPSS software package(version 11.0) for univariate analysis and multivariate analysis.Non-parametric tests were used when comparing means or proportions because of the asymmetric distributions of values.Statistic tables and charts were drawn from EXCEL(2003).
Calculate DALY using formula of GBD and fixed values of parameters.Life expectancy were got from the standard life expectancy table in Hunan 2000.The value of disability was based on the GBD disability grade and its weight,and corrected properly by the life habits of rural residents and the characteristics of TB.
Results
1.Characteristics of the sample population:
(1) A total of 354 PTB cases were recruited in the study with 258 male(72.9%) and 96 female(27.1%).The average age was 43.2±15.4 years old and the median of the education year was 9.66.9%of the subjects were first married,while 19.2%unmarried,6.8%remarried, 7.1%divorced or loss of spouse.The occupation of the patients were farmers(57.1%),working out(26.6%),commerce and service(10.2%) and unemployed and no fixed job(5.6%).Averagely there were 3.4 persons in a patient's family,1.95 of them are work force.91.3%of them were in the age group of 16-59 when it's the most productive.
(2) Total of 3652 active PTB patients were registered and treated in the six sample counties in 2005 and cohort followed up for one year, 3349(91.7%) cases of them were successfully cured.156(4.3%) cases died with 76 for PTB and 80 for other diseases or reasons,the the fatality was 2.1%.122(3.3%) cases were default.11(0.3%) cases failed,while 14 were with other outcome.
(3) Totally 47440 active PTB patients were registered in the whole province in 2005.The new register rate of PTB was 70.5/10~5,and the incidence rate of TB was 100/10~5.
2.The direct economic burden due to PTB
(1) The direct economic burden per household was 1459.8 yuan RMB,with the median 1045 RMB.While the direct medical cost per case was 1267.3 yuan RMB(median 902),and the non-medical cost was 192.6 yuan RMB(median 152).The total family direct economic burden in the whole province was 69 million yuan RMB.
(2) The government direct economic burden per case was 927.9 yuan RMB.The funds offered by governments and foreign aided programmes were 44.02 million yuan RMB.
(3) The social direct economic burden per case was 2387.7 yuan RMB,The total in the province was 161 million RMB.
3.The indirect economic burden due to PTB
(1) The family indirect economic burden per case was 887.5 yuan RMB.The total in the whole province was 59.48 million yuan RMB.
(2) The social indirect economic burden per case was 4409.1 yuan RMB.The total in the province was 297 million yuan RMB.
4.The total economic burden due to PTB
(1) The total economic burden on family per case was 2347.3 yuan RMB,while the total of the whole province was 129 million yuan RMB.
(2) The total economic burden on government per case was 927.9 yuan RMB,while the total funds offered by governments and foreign aided programmes actually were 44.02 million yuan RMB(47 million yuan RMB planned).
(3) The total economic burden on society per case was 6796.8 yuan RMB,while the total of the whole province was 458 million yuan RMB.
5.The loss of DALY due to PTB
(1) The average direct loss of DALY was 0.57 person-year,with the YLL 0.26 and YLD 0.31,while the total loss of DALY on society was 27,246 healthy-life years.
(2) The average indirect loss of DALY was 0.88 person-year,with the total loss of DALY on society was 17,495 healthy-life years.
(3) The total loss of DALY on society was 44,741 healthy-life years.
(4) The loss rate of DALY all of the TB patients was 40.5/10~5 with male 58.0/10~5and female 21.1/10~5.
6.The social and economic impacts of PTB to patient individual and household
(1) The average duration of symptoms lasting was 118.8 days (median 98 days).The average absence work time was 95.7 days(median 93 days).The average absence work days of family members due to PTB was 8.2 days(median 5 days).
(2) The ratio of household annual income reduction from 53.1%to 37.2%before and after being illness.The reduction of net income per case was 1700.6 RMB(median 1000 RMB) per case.
(3) The proportion of per capita annual net income less than that of local level increased from 64.4%to 76%before and after being illness. Per capita annual revenue of household in 70.7%families was less than before being illness year.The average reduction of annual revenue of per household was 358.6 yuan RMB(median 200 RMB).
(4) The proportion of household overspending the annual revenue was increased from 26.3%to 69.5%before and after being illness,with overspending per household of 429.2 yuan RMB(median 625 RMB).
(5) Illness-related costs affected patients and their families.The direct economic burden for each household due to PTB amounted to 20.4%of annual household expenditure,and 89.6%of the family's total medial expenses.Of the patient household financing methods,63.8%of direct economic burden was most frequently financed from household savings (out of pocket),19.1%transfer payments from community members and relatives,6.2%of them offered by parents or children,5.8%sold part of their property and only 1%paid by medical insurance or new rural cooperative medical system.To cope with illness-related expenditures and income reductions,the patent household had to change the annual consumption patterns,including cutting down 16.4%of the living expenditure,and 4.6%expenses for cultural,educational,and recreational and communication,etc.
7.The diseases burden index of household(DBI)
The average DBI of PTB household was 0.33 years,and the median was 0.16 years(0.14-10.3).
8.Factors impacting the family economic burden
Ordinal Logistic regression shows that factors significantly contributed to patient household economic burden are hospitalization (OR=423.266,95%CI 71.236-2514.929),a long lasting duration of PTB symptoms(OR=4.175,95%CI 2.519-6.917),a long duration of absence of work(OR=4.166,95%CI 1.203-14.426),3 times or more for encounter before diagnosis(OR=2.083,95%CI 1.261-3.442) and diagnostic delay(OR=2.610,95%CI 1.319-5.186)..while highly educated(OR=0.233,95%CI 0.069-0.786),high income of the patient(OR=0.431,95%CI 0.202-0.920) and visiting TB control agent directly when PTB symptoms onset(OR=0.140,95%CI 0.051-0.386) could alleviate the patient household economic burden.
Significance and conclusion
This research established the frame for the study of PTB economic burden,basing on field survey and a great deal of epidemiologic data. Investigate the measurement of the economic burden and loss of health life year due to PTB and calculate the economic burden in Hunan Province from the viewpoint of patients,household,government and society.Using the standard lift expectancy in Hunan population,calculate the direct loss of DALY due to the all registered and treated PTB patients in the whole province.Assess the average social indirect loss of DALY of patients who were not been detected and found under the DOTS strategy implementation,basing on the average days of delay to diagnosis and the fatality and average death age of patients without treatment.To analyses the family economic loss due to PTB more accurately,a new indicator (DBI) was created to measure the illness-related economic loss of patient household,that is the ratio of patient househould direct economic burden due to TB with the annual revenue of household.Main conclusion are as follows:
1.PTB brings heavy economic burden to patients,families, government and society.The economic loss to society is much greater than that to patients household for a period.
2.PTB not only lead to constraining of social functions to most of patients,but also loss 0.57 healthy-life year for each case.The disease reduces the income of patients and their families.It takes near 4 months annual revenue of patient household to make up the economic loss due to PTB,with the DBI of 0.33 year.To cope with illness-related expenditures and income reductions,the patients household have to cut down living and educational expenditure pattern.PTB makes about 70%of the patient household overspend the annual revenue and poor families become more impoverished.
3.Free charge of TB medical service offered by government can relief the patient household burden at some extent,but it only cover the basic diagnostic items including sputum examination,X ray chest film and anti-TB drugs et al.the expenditure on liver function and kidney function tests before and after confirmed diagnosis,basic liver-protective agent and allopathic treatment,traffic,room and board is difficult to bear for the patient household.
4.The responsibility is seems to lie with government rather than patients to alleviate their burden,government commitment should be further enhance.A long sustainable development plan and financing mechanism for TB control should be established urgently.If the patient household direct economic burden of patients after diagnosis(609.6 RMB per capita) is involved in free of charge,government level by level has to raise fund another 28.92 million RMB.
5.The patient household economic burden is closely related to the health care provider.Strengthen the service system establishment and improve the quality of service is needed currently,so as to reduce the hospitalization expenditure and encounter times before the diagnosis. Improving the accessibility and availability of TB service among TB patients and their household is also a way to significantly reduce PTB economic burden.
6.The medical security system for TB is not yet perfect,especially in rural countryside.Only a little TB inpatients who take part in the new rural cooperative medical system could get the allowance offered by government and the corresponding medical security,which take only 1% of the patient household direct economic burden.It is suggested that some illness-related expenditure of PTB should plan as a whole in currently health insurance system.Parts of expenditure including hospitalization and clinic not offered by government yet should be taken into the medical insurance and new rural cooperative medical system,and the free charge service items for TB patients and TB suspects should be enlarged and increased.
中国是全球22个结核病高负担国家之一,结核病患者数位居全世界第2位。在我国传染病疫情网络报告中,肺结核发病和死亡数始终位居甲乙类传染病之首,发病人群中2/3集中于15～54岁生产能力最强的年龄组,其中80%以上为农村患者,且80%的患者家庭年人均收入低于当地人均水平。结核病多发生在贫困人群,是导致我国贫困人群“因贫致病”和“因病致贫”的主要原因之一。湖南省为全国结核病高疫情区,2004年经WHO专家和国家结核病专家联合评估,湖南省涂阳肺结核发病率为59/10万,比全国平均涂阳肺结核发病率(46/10万)高28.3%。全省每年发现和治疗管理活动性肺结核患者近5万例,其中传染性肺结核患者3万余例,充分说明结核病是危害我国和我省民众健康和生命的重大传染性疾病,对个人、家庭和社会均可造成巨大的经济负担。
1992年以来,我国政府利用世界银行贷款,在13个省开展结核病控制项目,全面推行结核病控制策略(DOTS),对发现的所有传染性肺结核患者(痰检涂片阳性者)实行统一免费的全程督导短程化疗。至2005年,我国达到了WHO要求的涂阳肺结核发现率70%和治愈率85%目标,结核病控制工作取得了阶段性成果。为了达到2015年全国结核病患病率和死亡率在1990年的基础上各下降50%的联合国千年发展目标(MDG),我国政府积极推行和实施全球遏制结核病策略,包括进一步加强结核病防治服务体系建设;扩展和加强DOTS实施质量;对所有活动性肺结核患者实现免费诊治政策;应对以TB/HIV双重感染、流动人口结核病管理和耐多药结核病防治(MDR-TB)为主及其它特殊挑战(贫困人口、羁押人群、学校等);病人和社区全面动员、全社会参与结核病控制,确保以病人为中心的质量管理等。为了验证和评价政府实现结核病控制目标的程度,需要从患者、家庭、社会和政府的层面综合研究肺结核病造成的经济负担。
近十多年来,尽管对结核病的经济学研究已有了一些可贵的探索,如有用住院样本计算结核病住院费用的;有基于当地卫生统计年鉴资料,从患者角度计算结核病医疗花费的;也有从社会角度计算DALY(伤残调整寿命年)损失以评价结核病负担的。不同的研究、不同的研究人群、不同的研究方法其结果不同,且多限于患者个体的角度,围绕着患者的诊治费用,或死亡、失能以评价结核病经济负担。对肺结核经济负担的评价至今仍无统一的认识和测量方法,其研究框架有待进一步完善。事实上,肺结核病对患者、家庭、政府和社会的经济影响,不仅限于患者和家庭因病求治所致的医疗费、交通住宿费和营养费等直接经济负担,还应包括当年政府为防治结核病的投入;患者本人因病休工和家属陪护误工所致的家庭间接经济损失;因病失能、因病早亡而减少了为社会创造财富的社会间接经济负担等,将损失的健康寿命年转换成货币,应作为疾病经济负担研究不可缺少的内容之一。与此同时,很少有研究涉及肺结核病对整个家庭经济收入和支出情况的改变,科学、全面地评估肺结核病造成的社会经济负担,对政府制定结核病防治控制政策具有重要的价值和意义。
二、研究目的
1.构建肺结核病经济负担的研究框架,为今后开展相关研究打下技术基础;
2.从患者家庭、政府和社会的层面,系统测算湖南省因肺结核病所致的经济负担,掌握肺结核病经济负担现况和分布特征,分析政府结核病控制目标实施中所存在的问题;
3.了解肺结核病对患者本人和家庭社会经济的影响,构建肺结核病家庭经济负担指数;
4.分析肺结核病疾病经济负担的主要影响因素,探讨减轻患者家庭肺结核病疾病经济负担的有效途径;
5.根据研究结果,结合全省实情,为结核病防治可持续发展规划的制定提供决策依据。
三、研究方法
1.主要研究指标及其操作性定义
(1)肺结核病直接经济负担:是指直接用于预防和治疗肺结核病的1年的总费用,包括患者家庭和政府用于肺结核病的诊断、治疗、康复以及预防过程中直接消耗的各种费用。分为直接医疗费用(门诊、住院及辅助检查、药品和保健、康复等)和直接非医疗费用(患者和陪护所支付的交通费、营养食宿等费)两部分。
①家庭直接经济负担:家庭用于肺结核病的诊治、康复过程中直接消耗的各种费用,包括门诊诊治费、住院费、药品保健费等直接医疗费与患者及陪护交通费、食宿费和营养费等直接非医疗费用之和。
②政府直接经济负担:各级政府和外援结核病项目为肺结核患者(需方)提供的免费检查、诊断和抗结核病药品等直接医疗费用与为结核病防治机构(供方)提供的结核病健康教育、人员培训、结核病人的督导、追踪与访视、药品运输等直接非医疗费之和。
③社会直接经济负担:例均社会直接经济负担×当地人口数×发病率。
例均社会直接经济负担=例均家庭直接经济负担+政府直接经济负担。
(2)肺结核病间接经济负担:是指因肺结核病的发生而间接地给家庭和社会带来的经济负担,包括经济损失和健康损失两部分,是将因肺结核病损失的时间和寿命年货币化,计量分析肺结核病的危害和损失的大小。
①家庭间接经济负担:患者因病休工和家属陪护误工所致的家庭生产或收入损失。
②社会间接经济负担:是将健康寿命货币化,间接测量患者因病失能或早亡造成健康寿命损失所致的创造社会财富和价值的损失。
(3)肺结核病总经济负担:指直接经济负担与间接经济负担之和。
(4)家庭疾病负担指数(disease burden index,DBI):这是本研究新创立的一个评价指标,指患者家庭直接经济负担占家庭年纯收入之比,即:
肺结核家庭疾病负担指数=(患病后1年家庭直接经济负担)/(当年家庭年纯收入)
也可以理解为患者家庭需要多长时间(年)的纯收入来支付患者因疾病导致的直接经济损失。负担指数越大,家庭经济补偿所需要的时间越长。本研究计算的肺结核患者家庭疾病负担指数,将来还可用于不同疾病之间家庭经济负担的比较。
2.资料来源
(1)现场调查
采取分层随机整群抽样方法,分别在湖南省国家级扶贫重点县、省级扶贫重点县和非扶贫县各随机抽2个县作为研究现场,所确定的样本县区分别为湘潭市的湘潭县和邵阳市的邵东县(非扶贫县);常德市的石门县和张家界市的永定区(省级扶贫重点县区)及岳阳市的平江县和益阳市的安化县(国家级扶贫重点县)。以年龄≥15岁,自2005年7月～9月到6所样本县区结核病防治所就诊并确诊的连续新发活动性肺结核患者为现场调查对象。样本量的估算以因病卧床为失能依据。前期研究结果表明,肺结核患者中22.5%因病卧床(失能),按照样本量计算公式:N=1.96~2×p(1-P)/D~2,设容许误差D=0.2×P,得出N=345。预设15%的失访和不应答,即至少需要397例确诊的肺结核患者样本。对所有调查对象,采用自制的结核病社会经济学调查问卷,在知情同意的前提下,分别在确诊时和疗程结束后2次入户访谈,收集患者病后的失能程度、诊治经过和医疗费用以及患病前后1年个人和家庭经济收入、支出等相关资料和信息。
以6个样本县区2005年度所有新登记的肺结核患者为观察对象,队列观察1年,分析其治疗结局。根据样本县区每例因肺结核病死亡者的年龄、性别信息计算样本县区因肺结核病早亡所致的健康寿命年损失(YLL)。
(2)统计数据来源:
①2005年、2006年全省和样本县区人口数、性别比、人均纯收入、人均GDP等信息分别来源于《湖南统计年鉴-2006》和《湖南统计年鉴-2007》;
②2005年肺结核发病率来源于2007年WHO结核病控制年度报告;
③全省和各样本县区肺结核登记病例数以及治疗转归结果来源于2005年～2006年结核病防治规划实施的季度报表和肺结核病信息管理系统;
④制作2000年标准期望寿命表所用的标准人口来源于2000年湖南省人口普查资料;
⑤各级政府和国外援助项目对结核病防治的投入经费来源于湖南省和样本县区结核病防治规划(2001～2010年)中期评估资料以及全省各项目执行单位的资金下拨计划表。
3.主要研究内容
(1)肺结核病直接经济负担
①家庭直接经济负担=直接医疗费+直接非医疗费
直接医疗费=门诊费(挂号费+检查费+药品费等)+住院费
直接非医疗费=患者交通费+陪护人员交通费+患者食宿费+陪护人员食宿费+其他费(营养保健和偏方等)
通过现场收集肺结核病患者诊治相关的医疗费用,采用分类汇总求和的方法计算患者家庭的直接经济负担和例均直接经济负担
②政府直接经济负担=政府结核病防治落实的配套经费+外援结核病项目经费。
根据全省及6样本县区结核病防治规划(2001～2010年)中期评估资料,查阅当年各级政府结核病防治专项经费和配套经费到账额度,各样本县区外援结核病项目的资金到位额度,计算例均政府直接经济负担。
③社会直接经济负担=例均社会直接经济负担×当地人口数×发病率。
例均社会直接经济负担=例均家庭直接经济负担+例均政府直接经济负担
(2)肺结核病间接经济负担:
①家庭肺结核病间接负担=(患者因病休工天数+陪护误工天数)×日均劳动力收入。采用人力资本法,根据患者休工和陪护误工天数,结合当年当地农民纯收入折算成日均劳动力收入,计算家庭肺结核布浣泳盟鹗А?
②社会间接经济负担=DALYs×人均GDP×生产力权重
社会DALY损失值=直接DALY损失值+间接DALY损失值
直接DALY损失值:根据调查样本测得直接例均DALY损失,计算全省已发现治疗患者的社会直接DALY损失值;
间接DALY损失值:根据化疗前时代的早期结核病流行病学研究结果,即病死率和平均死亡年龄,计算年DALY损失,再按调查样本的平均就诊延误时间(从肺结核病症状出现到首次就诊的时间间隔),折算在当前DOTS策略下的未发现患者的间接例均DALY损失,推算全省未发现治疗患者的社会间接DALY损失值。
采用人力资本法和DALY相结合的方法,结合样本县区和全省登记治疗肺结核患者的加权年龄权重和当年当地人均GDP,计算得全省肺结核病社会间接经济负担。
(3)肺结核病社会总经济负担=社会直接经济负担+社会间接经济负担
(4)通过肺结核病对患者日常生活和社会功能受限程度以及患病前后1年个人医疗开支和收入的变化,分析肺结核病对患者本人的社会经济影响;通过患病前后1年家庭纯收入和开支的变化,了解家庭对肺结核病直接经济负担的应对措施;并通过家庭肺结核病直接经济负担占家庭年纯收入的比例,构建家庭肺结核病经济负担指数。
(5)分别从社会人口学、疾病的严重程度、医疗服务利用以及患者本人和家庭经济收入等4个维度,运用有序logistic回归对家庭肺结核病直接经济负担影响因素进行单因素和多因素分析。
4.统计分析方法
采用EpiData 3.0建立统一数据库后对数据资料进行双录入,导入SPSS12.0统计学软件包建立数据库。采用有序logistic回归多因素分析家庭肺结核病经济负担影响因素。采用EXCEL(2003)作相关的统计表和统计图。
DALY的计算,采用GBD的计算公式和各参数的固定取值,期望寿命采用2000年湖南省标准期望寿命表,失能的取值以GBD失能分级及其权重为基础,结合农村居民的生活习惯和肺结核病的特点作了适当修改。
四、研究结果
1.样本人群特征:
(1)现场调查共纳入354例患者,其中男性258例(72.9%),女性96例(27.1%),平均年龄为43.2±15.4岁,平均受正规教育中位年限为9年。19.2%的患者未婚,66.9%的初婚,6.8%的再婚和7.1%的离婚、丧偶独居。共有57.1%的患者以农业生产为职业,26.6%外出务工,10.2%的从事批零、餐饮和运输等商业和服务业和5.6%的无正式职业。患者家庭户均人口3.4人,户均劳动力1.95人。年龄分布中有91.3%的调查患者在15～59岁这一最具生产能力的人群。
(2)6个样本县区2005年共登记、治疗活动性肺结核患者3652例,队列观察1年,其中成功治疗共3349例(91.7%);死亡156例(4.3%),其中因结核病死亡76例(非结核病死亡80例),病死率2.1%;丢失122例(3.3%);失败11例(0.3%)和其他14例。
(3)2005年全省共登记活动性肺结核患者47440例,新登记率为70.5/10~5,肺结核病发病率100/10~5。
2.因肺结核病导致的直接经济负担
(1)家庭例均直接经济负担1459.8元,中位直接经济负担为1045元(360～11046);其中例均直接医疗费为1267.3元,中位直接医疗费为902元(115～10174),例均直接非医疗费为192.6元,中位直接非医疗费为152元(15～1306);确诊前家庭例均经济负担为850.3元,中位389元(0～9570);确诊后例均经济负担为609.6元,中位583元(192～1654)。全省家庭总直接经济负担共为6925.3万元。
(2)政府例均直接经济负担为927.9元,全省各级政府和外援结核病防治项目总投入共为4402万元。
(3)社会例均直接经济负担为2387.7元,全省社会总直接经济负担共为1.61亿元。
3.因肺结核病导致的间接经济负担
(1)例均家庭间接经济负担为887.5元,全省家庭总间接经济负担共为5947.7万元。
(2)例均社会间接经济负担为4409.1元,全省社会总间接经济负担共为2.97亿元。
4.因肺结核病导致的总经济负担
(1)例均家庭总经济负担为2347.3元,全省家庭总经济负担共为1.29亿元。
(2)例均政府总经济负担为927.9元,全省各级政府和外援结核病防治项目实际总投入共为4402万元(计划应投入4562万元)。
(3)例均社会总经济负担为6796.8元,全省社会总经济负担共为4.58亿元。
5.因肺结核病导致DALY损失
(1)直接例均DALLY损失0.57人年(其中例均YLL为0.26,例均YLD为0.31),社会直接DALY损失共27246健康寿命人年。
(2)间接例均DALY损失0.88人年,社会间接DALY损失共17495健康寿命人年。
(3)社会总DALY损失共44741健康寿命人年。
(4)湖南省全人群肺结核病DALY损失率为40.5/10~5,其中男性为58.0/10~5,女性为21.1/10~5。
6.肺结核病对患者个人社会功能和家庭经济损失
(1)患者例均肺结核症状持续118.8天(中位98天);例均休工95.7天(中位93天);例均家人陪护误工8.2天(中位5天)。
(2)患者年人均收入占家庭总年收入的比例由病前1年的53.1%降至病后1年的37.2%;患者例均年收入减少1700.6元(中位1000元);
(3)家庭年人均收入低于当地年人均收入水平的比例由病前1年的64.4%上升到病后1年的76%;病后70.7%的家庭年人均收入低于患病前;病后家庭人均年收入减少358.6元(中位200元)。
(4)病前1年26.3%的家庭总经济收入低于当年支出(收不抵支),户均年节余226.7元(中位287元);患病后1年收不抵支的家庭增加到69.5%,户均年超支429.2元(中位539元)。病后1年家庭户均收入减少1235.6元(中位625元)。
(5)肺结核患者家庭例均直接经济负担占家庭总经济开支的20.4%,占家庭总医疗开支的89.6%。直接经济负担中,63.8%的是来源自费,19.1%的是向亲友借钱,6.2%的是子女或父母负担,5.8%的是变卖家产,而医疗保险或新型农村合作医疗支付比例仅1%。家庭应对肺结核病直接经济负担的措施还有改变年度开支计划,包括削减16.4%的生活开支和4.6%的文化、教育和娱乐通讯开支等。
7.家庭疾病负担指数
肺结核病患者户均家庭经济负担指数为0.33年,中位负担指数为0.16年(0.14～10.3)。
8.影响家庭经济负担的因素
多因素有序Logitic回归分析显示:因病住院(OR=423.266,95%CI=71.236～2514.929)、症状持续天数长(OR=4.175,95%CI=2.519～6.917)、休工天数长(OR=4.166,95%CI=1.203～14.426)、确诊前3次及以上就诊次数(OR=2.083,95%CI=1.261～3.442)和有就诊延误(OR=2.610,95%CI=1.319～5.186)等因素加重了肺结核患者和家庭经济负担;而高的文化程度(OR=0.233,95%CI=0.069～0.786)、高的患者个人收入(OR=0.431,95%CI＝0.202～0.920)以及首诊选择结防机构就诊(OR=0.140,95%CI＝0.051～0.386)可降低肺结核患者和家庭的经济负担。
五、本研究的意义与主要结论
本研究通过现场调查并基于大量流行病学数据,构建了肺结核病经济负担研究框架;从患者家庭、政府和社会等各层面系统研究了湖南省肺结核病的经济损失和健康损失的测算以及肺结核病的经济负担。采用湖南省标准期望寿命,测算了全省登记治疗的肺结核患者的直接DALY损失,并基于调查样本的平均就诊延误时间以及未经治疗患者的病死率和平均死亡年龄,间接推算了在目前DOTS下未发现肺结核患者的例均社会间接DALY损失。为了更确切地分析肺结核病对家庭经济的损失情况,本研究建立了肺结核病家庭疾病负担指数,即家庭肺结核病的直接经济负担占家庭年纯收入比例,进一步说明肺结核对社会经济发展的影响,并为结核病防治政策的制定提供决策依据和建议。
主要结论如下:
1.肺结核病给患者、家庭、政府和社会均带来了沉重的经济负担,而且给社会造成的损失要大于患者家庭在一段时间内所造成的经济损失。
2.除了使绝大多数患者不同程度的社会功能受限外,肺结核病造成例均损失0.57个健康寿命年。肺结核病减少了患者和家庭的收入,家庭户均要以约4个月(家庭疾病负担系数0.33年)的纯收入来补偿肺结核病给家庭带来的经济损失。为了应对肺结核病的经济负担,家庭削减了生活和教育开支,降低了生活水平。肺结核病不仅导致了约70%的家庭收不抵支、因病致贫,也使一些贫困的家庭变得更加穷困。
3.政府为肺结核病提供的免费检查和抗结核病药品,虽在一定程度上缓解了家庭肺结核病的经济负担,但患者确诊后肝肾功能检查、基本保肝和对症辅助药品以及往返交通、食宿费等仍使广大患者及家庭的经济能力难以承受。
4.减轻肺结核病家庭经济负担的主要责任应归于政府,需要进一步加强政府承诺和政府责任,建立长效的结核病防治可持续发展计划和筹资机制,扩大结核病服务免费范围。如果将患者确诊后的直接经济负担609.6元/例列为肺结核患者确诊后的免费检查项目,政府需额外筹资2892万元。
5.家庭肺结核病经济负担与卫生服务提供者密切相关,加强结核病防治服务体系建设,改善结核病服务质量,以减少患者因住院,减少患者确诊前就诊次数,可提高结核病患者的可及性与可获得性而减轻家庭经济负担。
6.肺结核病特殊病种的医疗保障体系不完善,特别是农村地区。只有微乎其微的农村参合肺结核病住院患者享受了政府提供的补贴以及相应的医疗保障(报销额度仅占家庭直接经济负担的1%),需要将国家未纳入免费范围的肺结核病的诊治(住院和门诊)费用部分在医疗保险和新型农村合作医疗统筹考虑,纳入相关医疗保障制度的补偿范围。
Background
China is currently one of the 22 countries with highest burden of tuberculosis with the number of PTB patient ranked No.2 all over the world.Based on the official disease control information website (http://202.106.123.35/).the cases of notification and death are always on the top among all infectious disease.Two-thirds of the new cases are aged from 15 to 54 years old with more than 80%in rural area,80%of the household with the net income per capita are less than that of local level. TB always occur in poverty populations,it is one of the main reasons that makes patients and households more poverty.TB epidemic situation in Hunan is severe.The incidence of smear positive tuberculosis was estimated to be 0.059%in 2004,and 28.3%higher than the average level in the nationwide.Every year more than 50,000 active pulmonary tuberculosis(PTB) are detected out and treated in the whole province, while 30,000 of them are infectious PTB.TB is the major infectious diseases that severely threatens the health and life of the people and brings heavy economic burden to the patient household and society.Since 1992,Chinese government has carried out the World Bank loan TB control program in sixteen provinces,extensively implemented the DOTS(directly observed treatment,short course) strategy,and had reached the global target of that at least 70%of incident smear-positive cases should be detected and treated in DOTS and that at least 85%of those cases should be successfully treated.In order to achieve the targets for MDG(Millennium development goal) global TB control,that TB prevalence and death rates should be halved by 2015 compared with their level in 1990,Chinese government are implementing and carrying out the Global TB control Strategy positively,including further strengthening the service system,expanding and improving the quality of DOTS,free charge of diagnosing and treating for PTB,coping with the challenge of TB/HIV co-infection,management of floating population TB,multi-drug resistant tuberculosis control and other special issues(poverty population, prison,school,and others),mobilizing patients,communities and whole society to take part in the TB control and ensuring the quality management and take the patient-oriented measures.To verify and evaluate the extent of government commitment,the economic burden of PTB should be evaluated and estimated based on the point of view of patient household,society and government respectively.
Over the past decades,we have got some valuable explore on the economic study of TB,such as calculating the TB hospitalization expenditures using inpatient sample,computing the medical cost from the point of patients basing on the local health statistics yearbook,estimating DALY from the point of view of society to assess the TB burden. Different studies,different subjects and different methods lead to different results,and most of them focused on patients individual,There is no unified identification and measure method to assess the TB economic burden.In fact,the TB economic impacts to patient individual, household,government and society include not only the direct economic burden such as medical cost,fee for traffic,accommodating and nutrition, but also the fund such as government input to TB control and foreign aid TB program.loss of DALY due to disability and premature death,loss of income because of absence from work both of patient and his/her family members,decreasing the social wealth created by patient.Converting the loss of healthy life years into money should be a indispensable part of the study on disease economic burden.In addition,few study referred to the change of the household income and expenditure due to PTB.Assessing the PTB economic burden scientifically and comprehensively is valuable and significant for the government to make TB control strategy.
Objectives
1.To establish a frame to assess PTB economic burden,to lay the technical foundation for reseach of disease economic burden in the future.
2.To Estimate and evaluate the PTB economic burden in Hunan Province by the way of PTB patient and household,government and society.To describe the current status and distribution characteristics of PTB economic burden.Analyses the extent and problems of the TB control implementation at government level.
3.To investigate the impacts of PTB to patient individual and household,establish the disease burden index of PTB household.
4.To analyses the main influencing factors to PTB economic
burden.Explore approaches effective enough to relieve the economic burden for the patient household.
5.To make some strategic suggestion for TB control based on the research results and the fact of our province.
Methods
1.Main study indications and the operational definition
(1) PTB direct economic burden:total cost for prevention,treatment and recovery paid by patient family,government and society,including direct medical cost(clinic treatment,hospitalization,assistant tests,drugs, health care and recovery) and direct non-medical cost(fee for traffic, acommandation room and board and nutrition consummated by patient and accompany).
①Patient household direct economic burden:the various fees and charges for the diagnosis and treatment of TB an d the rehabilitation process paid by family directly,including direct medical cost(clinic treatment,hospitalization,drugs,health care,etc.) and direct non-medical cost(fee for patients and companies traffic,room and board and nutrition).
②Government direct economic burden:including direct medical cost offered by governments at all levels and other foreign aid TB control programme for free tests,diagnosis and anti-TB drugs for patients,and direct non-medical cost for TB health education,training,supervision, case-tracing,following up and visiting to patients,etc.
③Total direct economic burden:the sum of patient household and government direct economic burden.
(2) Indirect economic burden:refer to the economic burden due to disability or premature death,including absenteeism in workplace of patients individual and family members and loss of health life years. Converting the loss of time and life years into currency,quantitatively analysis the loss indirectly.
①Family indirect economic burden:the loss of family production or income because of absence work or unemployed due to PTB both the patients and family members.
②Society indirect economic burden:convert healthy life year into money,measure the loss of social wealth created by the patients due to disability or premature death indirectly.
(3) PTB economic burden:the sum of direct and indirect social economic burden
(4) The disease burden index of household(DBI):this is the creative new indication It is the ratio of the direct economic burden on household with the total household annual net income.DBI refers how many years' net income it will take for the patients' family to pay for the direct economic loss caused by the disease.The more the index is,the long time it will take to make up the loss.DBI could be used to not only PTB but also other diseases and could be compared between different diseases.
2.Sources of data and methods
(1) Field survey
Using stratified cluster sampling,randomly choose two counties from national-level poverty support counties,provincial-level poverty support counties,and non-poverty counties respectively.They are Xiangtan and Shaodong(non-poverty),Shimen and Yongding(provincial-level poverty counties),and Pingjiang and Anhua(national-level poverty counties). Subjects are new active PTB patients in these six sample counties from July to September in 2005 with the age more than 15 years old.From the former research,the rate of being in sickbed(referring to disability) in PTB patients is 22.5%,the sample should be 345(basing on the formula:N=1.96~2×P(1-P) / D~2,δ=0.2P).Take into account of 15% dropping off and non-response,397 consecutive subjects should be involved in the project at least.Interview all the cases and family members with a structured questionnaire at the time of diagnosis and at the end of treatment duration respectively with the informed consent. Collecting data on patients' extent of disability due to PTB,process of diagnosis and treatment,medical cost,income and expenses both of patient and family members one year before and after being sick.
Recruit all the new registered cases in the six counties,follow up one year,analyses the outcome.Estimating the DALY due to PTB respectively basing the death age and gender.
(2) Statistical data sources:
①The population,sex ratio,per capita net income,per capita GDP in the whole province and sample counties in 2005 and 2006 were got from Hunan Statistical Yearbook 2006 and 2007.
②TB incidence in 2005 came from the WHO's annual report of TB control in 2007.
③The registered cases and their outcome in the whole province and the six sample counties came from the quarterly report in TB control planning and information management system for TB in 2005-2006.
④Census data in Hunan 2000 were used to be a standard population for the standard life expectancy table.
⑤The numbers of funds offered by governments and other foreign aid TB programme were got from the Mid-term evaluation data of TB control planning(2001-2010) in Hunan Province and sample counties and the funds allocated schedule in the project implementation units all over the province.
3.Main study content
(1) PTB direct economic burden:
①Family direct economic burden = direct medical cost + direct non-medical cost.
The data and information is collected by interviewing the patients and family members from household by household.Estimating the classifying sum of the patient household direct economic burden and the average level.
②Government direct economic burden = supporting funds from government for TB control + aided funds from foreign aid TB control programmes.
Basing on the Mid-term evaluation data of TB control planning (2001-2010) in Hunan Province and sample counties,government funds invested on TB control was defined as the government direct economic burden in the project.
③Social direct economic burden = Social direct economic burden per case×population×incidence of PTB
Social direct economic burden per case = household direct economic burden per case + government direct economic burden per case
(2) PTB indirect economic burden:
①Household indirect economic burden =(PTB patients absence work days + the family members absence from work days)×labour force income per day
Using human capital method,basing on the number of absent work days both of patients and family members,converting the net income of local farmers to daily average labor income,estimating the family indirect economic burden.
②Social indirect economic burden = DALYs×GDP×weight of productivity
Social loss of DALY = direct loss of DALY + indirect loss of DALY
Direct loss of DALY:basing on the direct loss of DALY per case got from the survey sample,calculate the total direct DALY loss of all the registered and treated PTB cases in Hunan Province in 2005.
Indirect loss of DALY:basing on the fatality and mean death age got from the early epidemiology studies(in the pre-drug era),calculating the annual loss of DALY,then basing on the average diagnostic delay days(time interval between the appearance of PTB symptoms and the first time to seeking health service),estimating the average indirect loss of DALY of the unregistered and undetected cases under the current DOTS,then assess the total indirect social loss of DALY of the unregistered cases in the province.
Using human capital method and DALY,combining the weight of age for registered patients in the province and sample counties and local annual GDP per capita,we can get the total social indirect economic burden in the province.
(3) PTB total social economic burden = direct social economic burden + indirect social economic burden.
(4) Analyses the social economic influence of PTB to patients,in the aspects of daily life,extent of social function limitation,changes of patients' medical cost and income before and after being sick.Realize the financing methods of PTB direct economic burden and changing in household consumption patterns,Calculate the family burden of disease index(the ratio of the direct economic burden on patients' family with the total household annual net income).
(5) Multivariate analysis on factors impacting the patient household economic burden from the points of social demography,severity of illness, utilization of medical service and economic income of patients and their families by ordinal logistic regression.
4.Statistic Analysis
All data derived from the questionnaires were processed using EpiData 3.0 and SPSS software package(version 11.0) for univariate analysis and multivariate analysis.Non-parametric tests were used when comparing means or proportions because of the asymmetric distributions of values.Statistic tables and charts were drawn from EXCEL(2003).
Calculate DALY using formula of GBD and fixed values of parameters.Life expectancy were got from the standard life expectancy table in Hunan 2000.The value of disability was based on the GBD disability grade and its weight,and corrected properly by the life habits of rural residents and the characteristics of TB.
Results
1.Characteristics of the sample population:
(1) A total of 354 PTB cases were recruited in the study with 258 male(72.9%) and 96 female(27.1%).The average age was 43.2±15.4 years old and the median of the education year was 9.66.9%of the subjects were first married,while 19.2%unmarried,6.8%remarried, 7.1%divorced or loss of spouse.The occupation of the patients were farmers(57.1%),working out(26.6%),commerce and service(10.2%) and unemployed and no fixed job(5.6%).Averagely there were 3.4 persons in a patient's family,1.95 of them are work force.91.3%of them were in the age group of 16-59 when it's the most productive.
(2) Total of 3652 active PTB patients were registered and treated in the six sample counties in 2005 and cohort followed up for one year, 3349(91.7%) cases of them were successfully cured.156(4.3%) cases died with 76 for PTB and 80 for other diseases or reasons,the the fatality was 2.1%.122(3.3%) cases were default.11(0.3%) cases failed,while 14 were with other outcome.
(3) Totally 47440 active PTB patients were registered in the whole province in 2005.The new register rate of PTB was 70.5/10~5,and the incidence rate of TB was 100/10~5.
2.The direct economic burden due to PTB
(1) The direct economic burden per household was 1459.8 yuan RMB,with the median 1045 RMB.While the direct medical cost per case was 1267.3 yuan RMB(median 902),and the non-medical cost was 192.6 yuan RMB(median 152).The total family direct economic burden in the whole province was 69 million yuan RMB.
(2) The government direct economic burden per case was 927.9 yuan RMB.The funds offered by governments and foreign aided programmes were 44.02 million yuan RMB.
(3) The social direct economic burden per case was 2387.7 yuan RMB,The total in the province was 161 million RMB.
3.The indirect economic burden due to PTB
(1) The family indirect economic burden per case was 887.5 yuan RMB.The total in the whole province was 59.48 million yuan RMB.
(2) The social indirect economic burden per case was 4409.1 yuan RMB.The total in the province was 297 million yuan RMB.
4.The total economic burden due to PTB
(1) The total economic burden on family per case was 2347.3 yuan RMB,while the total of the whole province was 129 million yuan RMB.
(2) The total economic burden on government per case was 927.9 yuan RMB,while the total funds offered by governments and foreign aided programmes actually were 44.02 million yuan RMB(47 million yuan RMB planned).
(3) The total economic burden on society per case was 6796.8 yuan RMB,while the total of the whole province was 458 million yuan RMB.
5.The loss of DALY due to PTB
(1) The average direct loss of DALY was 0.57 person-year,with the YLL 0.26 and YLD 0.31,while the total loss of DALY on society was 27,246 healthy-life years.
(2) The average indirect loss of DALY was 0.88 person-year,with the total loss of DALY on society was 17,495 healthy-life years.
(3) The total loss of DALY on society was 44,741 healthy-life years.
(4) The loss rate of DALY all of the TB patients was 40.5/10~5 with male 58.0/10~5and female 21.1/10~5.
6.The social and economic impacts of PTB to patient individual and household
(1) The average duration of symptoms lasting was 118.8 days (median 98 days).The average absence work time was 95.7 days(median 93 days).The average absence work days of family members due to PTB was 8.2 days(median 5 days).
(2) The ratio of household annual income reduction from 53.1%to 37.2%before and after being illness.The reduction of net income per case was 1700.6 RMB(median 1000 RMB) per case.
(3) The proportion of per capita annual net income less than that of local level increased from 64.4%to 76%before and after being illness. Per capita annual revenue of household in 70.7%families was less than before being illness year.The average reduction of annual revenue of per household was 358.6 yuan RMB(median 200 RMB).
(4) The proportion of household overspending the annual revenue was increased from 26.3%to 69.5%before and after being illness,with overspending per household of 429.2 yuan RMB(median 625 RMB).
(5) Illness-related costs affected patients and their families.The direct economic burden for each household due to PTB amounted to 20.4%of annual household expenditure,and 89.6%of the family's total medial expenses.Of the patient household financing methods,63.8%of direct economic burden was most frequently financed from household savings (out of pocket),19.1%transfer payments from community members and relatives,6.2%of them offered by parents or children,5.8%sold part of their property and only 1%paid by medical insurance or new rural cooperative medical system.To cope with illness-related expenditures and income reductions,the patent household had to change the annual consumption patterns,including cutting down 16.4%of the living expenditure,and 4.6%expenses for cultural,educational,and recreational and communication,etc.
7.The diseases burden index of household(DBI)
The average DBI of PTB household was 0.33 years,and the median was 0.16 years(0.14-10.3).
8.Factors impacting the family economic burden
Ordinal Logistic regression shows that factors significantly contributed to patient household economic burden are hospitalization (OR=423.266,95%CI 71.236-2514.929),a long lasting duration of PTB symptoms(OR=4.175,95%CI 2.519-6.917),a long duration of absence of work(OR=4.166,95%CI 1.203-14.426),3 times or more for encounter before diagnosis(OR=2.083,95%CI 1.261-3.442) and diagnostic delay(OR=2.610,95%CI 1.319-5.186)..while highly educated(OR=0.233,95%CI 0.069-0.786),high income of the patient(OR=0.431,95%CI 0.202-0.920) and visiting TB control agent directly when PTB symptoms onset(OR=0.140,95%CI 0.051-0.386) could alleviate the patient household economic burden.
Significance and conclusion
This research established the frame for the study of PTB economic burden,basing on field survey and a great deal of epidemiologic data. Investigate the measurement of the economic burden and loss of health life year due to PTB and calculate the economic burden in Hunan Province from the viewpoint of patients,household,government and society.Using the standard lift expectancy in Hunan population,calculate the direct loss of DALY due to the all registered and treated PTB patients in the whole province.Assess the average social indirect loss of DALY of patients who were not been detected and found under the DOTS strategy implementation,basing on the average days of delay to diagnosis and the fatality and average death age of patients without treatment.To analyses the family economic loss due to PTB more accurately,a new indicator (DBI) was created to measure the illness-related economic loss of patient household,that is the ratio of patient househould direct economic burden due to TB with the annual revenue of household.Main conclusion are as follows:
1.PTB brings heavy economic burden to patients,families, government and society.The economic loss to society is much greater than that to patients household for a period.
2.PTB not only lead to constraining of social functions to most of patients,but also loss 0.57 healthy-life year for each case.The disease reduces the income of patients and their families.It takes near 4 months annual revenue of patient household to make up the economic loss due to PTB,with the DBI of 0.33 year.To cope with illness-related expenditures and income reductions,the patients household have to cut down living and educational expenditure pattern.PTB makes about 70%of the patient household overspend the annual revenue and poor families become more impoverished.
3.Free charge of TB medical service offered by government can relief the patient household burden at some extent,but it only cover the basic diagnostic items including sputum examination,X ray chest film and anti-TB drugs et al.the expenditure on liver function and kidney function tests before and after confirmed diagnosis,basic liver-protective agent and allopathic treatment,traffic,room and board is difficult to bear for the patient household.
4.The responsibility is seems to lie with government rather than patients to alleviate their burden,government commitment should be further enhance.A long sustainable development plan and financing mechanism for TB control should be established urgently.If the patient household direct economic burden of patients after diagnosis(609.6 RMB per capita) is involved in free of charge,government level by level has to raise fund another 28.92 million RMB.
5.The patient household economic burden is closely related to the health care provider.Strengthen the service system establishment and improve the quality of service is needed currently,so as to reduce the hospitalization expenditure and encounter times before the diagnosis. Improving the accessibility and availability of TB service among TB patients and their household is also a way to significantly reduce PTB economic burden.
6.The medical security system for TB is not yet perfect,especially in rural countryside.Only a little TB inpatients who take part in the new rural cooperative medical system could get the allowance offered by government and the corresponding medical security,which take only 1% of the patient household direct economic burden.It is suggested that some illness-related expenditure of PTB should plan as a whole in currently health insurance system.Parts of expenditure including hospitalization and clinic not offered by government yet should be taken into the medical insurance and new rural cooperative medical system,and the free charge service items for TB patients and TB suspects should be enlarged and increased.
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