摘要
【研究背景】
以高血压、脑卒中(中风)和冠心病为代表的心脑血管疾病,严重危害人类健康,被称为“人类健康的头号杀手”。脑卒中具有发病急、高死亡率、高致残率和高负担的特点,因此特别强调脑卒中的危险因素的防治。作为一种常见的心血管疾病,同时又是其它心脑血管疾病的主要危险因素,高血压已成为全球范围内的重大公共卫生问题。国外的大量研究结果表明,对以高血压为代表的心脑血管疾病进行社区干预是符合成本效益的干预措施。国内也开展了一系列以高血压管理为代表的脑卒中社区人群防治干预研究,但各地水平参差不齐,策略各异,覆盖面不同。为实现资源的有效配置,有必要对干预措施进行效果评价和卫生经济学评价。虽然脑卒中社区干预的效果得到了国内许多研究的验证,但对其经济学的评价却相对比较少。
上海市新华社区历经十年,开展了以高血压管理为主的脑卒中社区人群防治干预项目。在这种情形下,适时对社区实际的脑卒中的疾病负担进行研究和对社区人群防治干预策略进行经济学评价,发掘科学、客观的证据,不仅有利于识别具有成本效果的干预方案,使卫生管理部门在制定最佳的卫生资源有效配置的相关决策时有据可循,而且有利于解决目前脑卒中人群防治经济学研究的空白点,具有重要的现实意义和研究价值。为此我们应用典型案例分析方法,在上海新华社区开展了脑卒中的疾病负担及人群防治干预策略的经济学评价的研究。
【研究目的】
总目标:
研究新华社区脑卒中的疾病负担,并对人群防治干预策略进行效果评价,在此基础上进行经济学分析,依据结果进行干预模式的探讨,为制定社区心脑血管疾病的防治策略提供依据。
具体目标:
1.研究社区脑卒中的疾病负担:测算社区脑卒中的疾病负担(狭义)和经济负担。
2.评价社区脑卒中人群防治干预策略实施的效果:
◆评价以高血压管理为主的脑卒中社区人群防治策略的干预效果,比较血压水平、高血压患病率、知晓率、治疗率和控制率的变化;
◆比较干预前后的社区脑卒中发病率与死亡率的变化,干预前后脑卒中失能调整生命年的变化;
3.经济学分析,进行成本效果分析,为确定适宜的防治干预措施提供经济学依据。
4.干预模式研究,总结新华社区脑卒中的防治干预模式,探讨可行性和优缺点,为推广和工作的改进提供依据。
【研究方法】
本研究主要采用定量与定性研究相结合的研究方法。
1.疾病负担测算方法:采用上海市死因登记系统和人口学资料,分析新华社区居民1997-2005年间脑卒中的死亡率、死亡所致的寿命损失年(YLLs)和失能调整生命年(DALYs)。
2.经济负担测算方法:对2005年1月—2006年6月新发且于调查时间(2006年7月-8月)仍存活的所有脑卒中患者进行问卷调查,调查内容包括人口社会学资料及疾病情况,因脑卒中门诊和住院花费、以及非医疗的花费(包括自购药费、自购医疗器械费、营养费、交通费等)情况等。采用自下而上法、人力资本法和支付意愿法分别对直接、间接和无形经济负担进行估算。
3.效果评价:以社区脑卒中危险因素的重复横断面调查(repeated survey)为主,结合社区脑卒中的报病监测资料和上海市死因登记资料,进行干预前后的比较研究评价。
4.卫生经济学分析:通过现场调查和文献评阅,获得有关参数信息,建立Markov模型,模拟10000名35岁的社区人50年间在有干预与无干预两种不同策略下的期望健康结局,对社区防治策略进行成本效果分析。
5.定性研究方法:通过个别访谈和文献查阅,总结脑卒中人群防治干预方案实施的管理模式和方案。
【主要研究结果】
1.新华社区脑卒中疾病负担严重。脑卒中死亡占人群总死亡数的19%,35岁以上人群的脑卒中死亡率偏高193.36/10万,标化后为128.07/10万(世界人口)和155.99/10万(上海人口),每千人口脑卒中DALYs损失也偏高,每干人口因患脑卒中损失19.67个YLLs和24.59个DALYs。35.4%脑卒中患者伴有致残;脑卒中患者的人均直接经济负担达到12752元,而患者本人需要支付5283元,占直接经济负担的41%,占人均收入的44%;脑卒中患者的人均间接经济负担为11417元,人均无形经济负担为134143元,人均总经济负担为24169元(包括直接和间接经济负担)。
2.社区以高血压管理为主的脑卒中人群防治干预策略有效。高血压知晓率、治疗率和控制率都显著提高;高血压患者血压和正常人收缩压下降;35岁以上人口的脑卒中标化发病率和死亡率呈缓慢下降的趋势;每千人口脑卒中DALYs损失随着时间呈现下降趋势。高血压知晓率由1995年的23.55%提高到2005年的86.46%,提高了62.91%;高血压治疗率由1998年的66.53%提高到2005年的71.22%,提高了4.69%;高血压控制率由1998年的4.25%提高到2005年的36.86%,提高了32.61%;高血压患者血压值(收缩压和舒张压)下降,收缩压下降了12mmHg,舒张压下降了5.6mmHg;正常人群收缩压下降3mmHg;世界人口标化发病率从1997年的295.86/10万下降到2005年的154.30/10万,下降幅度为47.85%;上海人口标化发病率从1997年的338.96/10万下降到2005年的175.14/10万,下降幅度为48.33%。世界人口标化死亡率从1997年的180.446/10万下降到2005年的108.99/10万,下降幅度为39.60%;上海人口标化死亡率,从1997年的213.97/10万下降到2005年的137.06/10万,下降幅度为35.94%。每千人口DALYs从1997年的28.62下降到2005年的22.66,下降幅度为20.83%。
3.MARKOV模型的经济学分析结果:与无干预策略相比,脑卒中的社区人群防治干预策略可使1万35岁的人在50年里增加6574个生命年,6303个质量生命年,减少998例脑卒中的发生。从效果的角度,应选择高血压人群管理为主的脑卒中社区防治干预策略。单纯从经济学的角度,干预策略每增加1个生命年和1个质量生命年分别需259.25元和261.18元,而无干预时只需230.00元和231.48元,但没有绝对优势。从增量成本效果比来看,干预策略增加投入1297.57元获得1个生命年,增加投入1353.14元获得1个质量生命年和8546.56元减少1例脑卒中,并结合其产生的效果,应选择干预策略,即高血压人群管理为主的脑卒中社区人群防治干预策略值得推荐。
4.经济学分析提示:控制高血压的医疗费用、降低高血压管理的机构成本和减少高血压的发病率是改变和提高高血压管理为主的脑卒中社区人群防治干预策略成本效果的关键因素。
5.新华社区的脑卒中人群防治干预策略是以高血压管理为主,历经十年,结合科研项目和社区卫生服务的日常工作开展,不断进行管理模式的改进,由全科服务团队主要对高血压患者采取综合危险因素干预,形成了以医院为主的社区高血压三级管理模式。科研项目不断为管理提供资金和最新的研究结果,促进新华社区高血压管理的可持续发展和模式的创新。其干预模式可为其他社区提供借鉴,但结合科研项目这一做法的推广还有待商榷。
6.社区高血压管理还需进一步改进。必须加强高血压的第一级预防,应该注重健康者和高危人群的危险因素的综合干预;高血压第二级预防必须关注合理用药和行为干预(非药物治疗措施);加强机构高血压管理的内涵式建设来减少机构成本。
【主要结论】
1.社区脑卒中的疾病负担和经济负担沉重,必须进行社区人群防治干预,预防脑卒中的发生。
2.以高血压管理为主的脑卒中社区人群防治干预策略有效果,经济学分析显示该策略值得推荐。
3.控制高血压的医疗费用、降低高血压管理的机构成本和加强高血压的危险因素干预是改变和提高高血压管理为主的脑卒中社区人群防治策略成本效果的关键因素和主要措施。
【本研究的创新之处】
1.首次用Markov状态转移模型模拟从健康者到高血压到脑卒中的疾病自然史,对脑卒中以高血压管理为主的社区人群防治干预策略的经济学效果进行了决策模型分析,且在分析过程中进行了敏感性分析,为国内慢性病防治的经济学研究提供了参考。
2.本研究选用的是采用时间离散、状态离散的四状态非齐性不可逆Markov模型,该模型充分考虑到慢性病的时变性,各状态转移概率随着队列人群年龄的增加而发生变化。此外,各状态的转移概率来自社区的实际调查,解决了分析中数据来源不同易于自相矛盾的问题。为今后类似的经济学研究提供方法学的借鉴,拓宽了Markov状态转移模型在医学领域的应用范围。
3.在研究中还充分考虑多角度的综合研究。如结合死亡率和DALY指标,对城市社区脑卒中的疾病负担进行了评价;从直接经济负担、间接经济负担和无形经济负担三方面揭示了脑卒中的经济负担;从社会角度出发估算脑卒中社区防治干预策略的成本,不单纯考虑干预成本,而是按照WHO介绍的方法,使项目成本既包括项目干预的直接成本,同时也包括了由于干预活动而使干预地区居民增加的高血压医疗费用的支出,以及脑卒中患者的医疗费用,成本的估算更为科学;将质量调整生命年作为效果指标,便于不同干预措施的比较。
Background
Stroke severely threatens human being's health for its high incidence rate, mortality rate and handicap-causing rate.Enormous studies showed that the primary prevention in communities can effectively decrease the incidence and mortality of stroke.Hypertension is not only a single disease but also an important risk factor of cardiovascular diseases,so the control of hypertension is important to prevent stroke. Studies have indicated that the blood pressure level in population could be declined through developing community-based comprehensive program on prevention of hypertension.To decide whether the intervention programme is worth of implementation,only the effect evaluation is not enough,health economic analyses should also be performed.However,there are few studies in this field in China.
To prevent stroke,the long-term strategy of hypertension management had been taken to control the rise of risk factors among the people in Xinhua Community,in other words,to aim directly at the cause of the diseases,involving community-based strategy and high-risk group strategy.Under this circumstance,it is important and necessary to measure disease burden of stroke and conduct economic evaluation on community-based strategies for stroke and provide scientific evidence,which is helpful not only to identify effective interventions,but also to enrich study of hypertension prevention and control system.
Objectives
General goal of the present study was to evaluate the disease and economic burden of stroke on community-based project for stroke prevention.As a result,it would provide scientific evidence for policy-makers to develop a cost-effective and feasible strategy to prevent stroke.
The specific objectives are as follows:
1.To measure the disease burden and the economic burden of stroke;
2.To evaluate the impact of community-based strategies for stroke;
3.To compare and analyze cost-effectiveness of community-based strategies for stroke by using Markov model.
4.To summarize the experience of this intervention programme for finding suitable methods to further intervention.
Methods
1.Diseases burden methods:Death database from CDC and population data was used to evaluate mortality,years of life lost with premature death(YLLs) and disability adjusted life years(DALYs) in Xinhua Community.
2.Diseases economic burden methods:Researchers investigated in stroke patients in Xinhua Community of Shanghai.The direct economic burden is measured by bottom-up approach,indirect economic burden by the human capital method combining with DALYs,and the intangible burden by 'willingness to pay' method.
3.Impact evaluation:Pre-and post-design was conducted using repeated cross-sectional surveys and monitor data in community and death data from the local center for disease control(CDC).
4.Economic appraisal of community-based strategies for stroke:Cost effectiveness analysis and cost benefit analysis on community-based strategies were conducted through developing a Markov model to simulate expected health outcomes of 10000 people based on the results of field surveys and literature reviews.
5.Qualitative research:Interviewees and literature reviews was adopted to discuss the feasibility of community-based strategies
Main findings
1.Burden of disease of stroke:Proportion of death due to stroke is 19%.The crude and standard mortality rates of stroke per year among people older than 35 years were 193.36/100,000,128.07/100,000(world standard population) and 155.99/100,000(shanghai population),respectively.The average YLLs and DALYs of stroke above 35 years were 19.67 and 24.59 per 1000 persons.35.4% of patients with stroke were disabled.The direct cost per capita in Xinhua Community was￥12752.The payment rates of patients were 41%of the direct cost and 44%of their income.The indirect burden and intangible burden were￥11417 and￥134143,respectively.The total economic burden was estimated￥24169.
2.The comprehensive community prevention approach was effective in the prevention and control of stroke.After long-term intervention,significant improvement was found in the prevalence of awareness,treatment and control of hypertension.The morbidity and mortality of stroke as well as DALYs were significantly decreased.
3.Economic evaluation.Compared with no intervention,6574 life years(LYs) and 6303 quality adjusted life year quality life years(QALYs) were gained with intervention,while 998 persons were free of stroke for the cohort of 10000 people 35 years old over a 50-year period.Markov cohort analysis showed that, the average cost-effectiveness is￥259 per LYs and￥261 per QALYs in community-based strategy,while￥230 per LYs and￥231 per QALYs in no strategy.In order to avoid 1 patient with stroke,community-based strategy will spend￥8547 more than that of no strategy,while it will spend￥1296 per LYs and￥1353 per QALYs more.Community-based strategy should be considered as priority.
4.If greater emphasis was placed on hypertension incidence,the cost of hypertension medication and management could be lowered down,economic effectiveness of community-based strategy will be improved greatly.
5.The long-term strategy of hypertension control in Xinhua Community involving community-based strategy and high-risk group strategy is feasible,but the investment for study program approach is not suited for other community.
6.Greater emphasis should be placed on hypertension's primary prevention, reasonable use of hypertensive's drugs as well as behavior intervention.
Main conclusions
1.The disease and economic burden caused by stroke was dramatically higher. Effective measures of community-based strategy should be taken to reduce and avoid stroke.
2.Community-based strategy was feasible and effective in the prevention and control of stroke,and it should be considered as priority.
3.More attention should be attached to comprehensive factors intervention for hypertension,the lower cost of hypertension medication fee and management cost.
Contributions of this study
1.The study firstly carried out an economic appraisal on community-based strategies for stroke systematically using Markov model in China.
2.Markov time-dependent model was firstly used with community field surveys to make decisions in China.
3.The study conducted cost-effectiveness analysis in community-based stroke prevention with QALYs and costs from social perspective,and it measured the burden of disease with mortality and DALYs,meanwhile measuring economic burden systematically.
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