【作者】 刘世炜；

【导师】 杨功焕；

【作者基本信息】 中国协和医科大学 ， 流行病与卫生统计学， 2009， 博士

【摘要】 研究背景自1971年首次报道二手烟草烟雾的健康危害以来,大量流行病学研究表明二手烟草烟雾会导致成人癌症、心血管疾病、呼吸系统疾病和呼吸道症状等的发生。影响胎儿生长发育,导致新生儿猝死综合症和儿童呼吸系统疾病。危害女性生殖健康,导致宫颈癌、乳腺癌的发生增加。归因于二手烟草烟雾的疾病负担非常沉重,我国每年死于二手烟草烟雾的人数超过10万。我国二手烟草烟雾暴露严重,特别是儿童和妇女,而且持续不降,人群中遭受二手烟草烟雾危害的人数高达5.4亿。有充分的证据证明,诸如吸烟这样的不健康生活方式是完全可以通过有效干预来改变的,而且最具成本效益。国内外控烟干预项目不断增加,控烟项目的干预对象从个体到人群,干预措施从简单到复杂,综合控烟干预项目的开展无疑给项目干预效果的评价带来了极大的挑战。查阅国内文献发现,二手烟草烟雾控制综合干预项目在我国开展很少,对其干预效果评价存在不足,表现在(1)效果评价方法不科学,没有一套科学的过程评价指标体系,对干预活动进行合理量化,并结合健康促进项目干预措施和效果因果联系的判断规则进行效果评价;(2)评价指标的选择随意,而且比较单一,很难适应综合干预项目的评价要求;(3)尚没有利用干预引起未来发病或死亡的减少作为项目干预效果评价内容,这给不同的项目之间进行效果比较和成本效果分析带来一定困难。由美国国立卫生研究院支持的“中国烟草控制流行病学、监测和干预能力建设项目”(Fogarty项目),以及彭博全球控烟基金支持的“迈向无烟中国”(Bloomberg项目)于2008年年底结束。作为我国二手烟草烟雾暴露控制综合干预项目的第一阶段,Fogarty项目以健康促进理论为基础,以减少非吸烟人群的二手烟草烟雾暴露为主要目标,在我国3省6县实施干预。Bloomberg项目作为综合干预项目的第二阶段,参考第一阶段形成的干预模式在我国20个省(自治区、直辖市)的40个项目市、县(区、旗)进行推广。二手烟草烟雾暴露控制综合干预项目在我国的实施是否取得了预期效果?效果是否真正由项目的干预措施引起?有必要对其进行综合效果评价,并对效果评价方法作深入探讨。目的1对Fogarty项目进行效果评价,论证二手烟草烟雾暴露控制综合干预措施是否有效。对Bloomberg项目进行效果评价,通过效果与干预强度间的关联性分析,进一步验证二手烟草烟雾暴露控制综合干预措施的效果。2结合健康促进项目干预措施与效果因果联系判断规则,判断二手烟草烟雾暴露控制综合干预模式在我国的实施是否实用、有效,效果是否真正由项目干预引起。3利用归因死亡数、伤残调整寿命年(DALY)预测项目干预的远期效果,供相似控烟项目或不同公共卫生干预项目间的效果比较,为确定政策优先权提供参考。4对二手烟草烟雾控制综合干预项目效果评价方法进行深入探讨,供相似干预项目的效果评价参考。方法1采用有平行对照的前后比较法对Fogarty项目进行效果评价,论证二手烟草烟雾暴露控制综合干预措施是否有效。2根据二手烟草烟雾暴露控制综合干预项目五大干预策略,经查阅文献、专家咨询和小组讨论,形成一套针对各项策略活动的过程评价指标体系,并用这套指标体系对Bloomberg项目点的干预活动进行过程评价。3通过专家评分法,对形成的过程评价指标体系进行权重,对Bloomberg项目过程评价结果进行赋值,量化干预措施,获得干预强度。对Bloomberg项目进行效果评价,对效果与干预强度进行简单相关和混合效应线性模型分析,验证二手烟草烟雾暴露控制综合干预措施的效果。4通过对Fogarty项目和Bloomberg项目的效果评价,结合健康促进项目干预措施与效果因果联系判断规则,判断二手烟草烟雾暴露控制综合干预模式是否适用、有效,效果是否真正由项目干预引起。5采用人群健康综合测量的危险因素归因法对项目干预效果可能引起未来归因死亡的减少进行预测,在归因死亡估算的基础上,采用世界卫生组织(WHO)疾病负担研究方法,进一步预测项目干预效果可能引起DALY值的挽救,并进行不确定性和敏感性分析。结果1 Fogarty项目效果评价结果显示:1.1由于项目的干预措施,Fogarty项目江西省干预县二手烟暴露率下降了4.90%,男性现在吸烟率下降了12.25%。河南省干预县二手烟暴露率下降了1.43%。1.2通过项目干预,干预县居民对二手烟危害知识,即二手烟暴露的人更容易得心脏病、丈夫是吸烟者的女性比其他女性更容易得肺癌、和吸烟者生活的孩子更容易得哮喘或呼吸道疾病、二手烟暴露对健康有严重危害,以及避免二手烟暴露的认识,即吸烟者不应该当着别人的面吸烟、吸烟者不应该在室内吸烟和家里来客不应该敬烟的知晓率明显提高。1.3江西省干预县居民对各大公共/工作场所应该完全禁止吸烟的赞同率均有升高,河南省干预县则有所下降,但与非干预县比较仍然有效。各场所中对餐馆和卡拉ok厅等娱乐场所应该完全禁止吸烟的赞同率要低于其他场所。江西省干预县对在公共场所禁止吸烟来保护不吸烟者的健康、应该禁止所有卷烟广告的赞同率升高,河南省干预县则没有变化,但比例很高。两省干预县认为医生和教师任何时间都不应该吸烟的比例均没有变化,但比例很高。无烟社区创建对各种政策的赞同率均有升高,无烟医院创建对各种政策的赞同率均高于非干预医院。1.4干预县居民吸烟和避免二手烟暴露的相关行为得到了明显的提高和改善,劝阻室外吸烟的比例升高,非现在吸烟者的敬烟比例下降。干预县居民在各公共场所吸烟的比例显著下降,但在家吸烟的比例依然严重,非吸烟者在家受到二手烟暴露的比例依然很高。现在吸烟者在家里来客人时吸烟的比例很高,接近100%,江西省干预县在家吸烟没有任何限制的比例下降,河南省则有所升高。2 Bloomberg项目效果评价结果显示:2.1在调整下一级效果指标、因变量的基线效果指标、调查人群性别、年龄、学历、在婚比例和省份的影响后,干预市县总干预强度与近期、中期和终期结果均显示有统计学意义的正关联性(P值分别为0.0327、0.0245和0.0431),即总干预强度越大,近期、中期和终期结果越好。2.2将总干预强度分解成各大策略干预强度后与各期结果进行关联性分析发现效果不明显,干预效果体现的是综合干预的结果。2.3无论是终期、中期,还是近期结果,其基线结果越差,干预效果越好。2.4重点干预社区和重点干预医院的干预效果不如干预市县明显,但趋势是一致的。重点干预社区总干预强度与近期结果存在正关联性(P=0.0132)。重点干预医院总干预强度与近期和中期结果存在正关联性(P值分别为0.0327和0.0104)。3由于Fogarty项目的实施,推算江西省干预县将减少大概1656(1332-1920)例死亡,按3%的贴现率,将挽救25438(20386-29545)个健康生命年;河南省干预县将减少大概184(108-242)例死亡,按3%的贴现率,将挽救2923(1663-3859)个健康生命年。结论1二手烟草烟雾暴露控制综合干预模式在我国是适用、有效的。项目效果需要作进一步的流行病学监测。2我国居民二手烟暴露依然严重,特别是家庭内暴露,以烟待客的比例依然很高,移风易俗依然艰难,各级政府和非政府组织应该立即采取行动,加大力度,遏制我国烟草的流行。3本研究采用的二手烟草烟雾暴露控制综合干预项目效果评价方法可以为相似项目效果评价提供借鉴,过程评价指标与效果评价指标尚需进一步完善。更多还原

【Abstract】 BackgroundSince the health hazard of Environmental Tobacco Smoke (ETS) has been firstly reported in 1971, the large number of epidemiological studies showed that ETS would cause adult cancers, cardiovascular diseases, respiratory diseases and respiratory symptoms et al. ETS would also stunt fetal growth and development, cause neonatal sudden death syndrome and respiratory diseases of children, as well as harm to women’s reproductive health, and increase the incidence of cervical cancer and breast cancer. The disease burdens attributable to ETS are serious in China with more than 100,000 deaths per year. Unfortunately the ETS exposure is still severe and maintains at high level in China, especially among women and children. Approximately 540 million pepole are exposed to ETS in China.There is ample evidence that unhealthy lifestyles such as smoking could be changed through effective intervention, and it is the most cost-effective. Tobacco control programs are continually increased all around the world, which target subjects selected from individual to population, and the intervention measures taken from simple to complex. The development of comprehensive programs of ETS prevention undoubtedly posts a great challenge on the effectiveness evaluation. To date, few literatures have been reported in China on the comprehensive programs of ETS prevention and the effectiveness evaluation has several shortcomings as follows: (1) Evaluation methodology was not scientific. There has not a practical process evaluation index, which could rationally quantify the intervention activities, and evaluated the effectiveness of the health promotion programs according to the rules and principles to judge the causal association between intervention measures and effectiveness; (2) The evaluation indexes were selected arbitrarily and simply, which was difficult to adapt the evaluation requirement of comprehensive intervention programs; (3) There were not objective indicators, such as the reduced morbidity and mortality caused by the program intervention, to predict the long-term effect, which would bring a big difficulty on the effectiveness comparison and cost-effectiveness analysis between different programs.China tobacco control epidemiology, surveillance and intervention capacity building supported by NIH’s Fogarty International Center (Fogarty program), and Towards a smoke-free China supported by Bloomberg global tobacco control fund (Bloomberg program) have been finished by the end of 2008. Fogarty program, as the first stage of comprehensive program of ETS prevention in China, was conducted at six counties of three provinces, which complied with the health promotion theory and aimed to reduce no-smokers’ exposure to ETS. Bloomberg program, as the second stage of comprehensive program of ETS prevention, was expanded to 40 intervention sites of 14 provinces, 2 autonomous regions and 3 Municipalities, which based on the intervention model developed by Fogarty program. Is the comprehensive program of ETS prevention implemented in China effective? Does the effectiveness be actually caused by the intervention measures? It is necessary to synthetically evaluate their effectiveness, and conduct in depth research on effectiveness evaluation methods.Objectives1 To demonstrate whether the comprehensive program of ETS prevention is effective through effectiveness evaluation on Fogarty program. Take effectiveness evaluation on Bloomberg program to further validate the effectiveness of comprehensive program of ETS prevention in China through the association analysis on effectiveness and intervention intensity.2 To determine whether the intervention model of comprehensive program of ETS prevention in China is practical and effective combining the rules and principles to judge the causal association between intervention measures and effectiveness, and identify whether the effectiveness is really caused by the program intervention.3 To quantitatively predict the long-term effect using some comparable indicators such as Attributable Deaths and Disability Adjusted Life Years (DALY), which could be applied to the effectiveness comparison among similar programs, and provide reference for policy priority.4 To conduct in-depth research on effectiveness evaluation methods of comprehensive program of ETS prevention, and provide references for other similar intervention programs.Methods1 Evaluating the intervention effectiveness of Fogarty program using pre- and post-comparison method with parallel control design, to demonstrate whether the comprehensive intervention measures of ETS prevention program is effective.2 Developing a process evaluation index, based on five intervention strategies of comprehensive program of ETS prevention, literature review, expert consultation, and panel discussion, to evaluate the intervention activities of each Bloomberg program site.3 Weighting the process evaluation index with experts grading method, and quantifying the intervention measures after the quantification of the process evaluation results of Bloomberg program. Evaluating the intervention effectiveness of Bloomberg program, Pearson correlation analysis and mixed-effect linear model were conducted to explore the association of effectiveness and intervention intensity, and further validate the effectiveness of comprehensive intervention measures of ETS prevention program in China.4 Determining whether the intervention model of comprehensive program of ETS prevention in China is practical and effective, and identifying whether the effectiveness is really caused by the program interventions, based on the effectiveness evaluation of Fogarty program and Bloomberg program, combining the rules and principles to judge the causal association between intervention measures and effectiveness.5 Predicting the possible reduction of attributed deaths in the future caused by program interventions with Attributable Fraction method of summary measures of population. Further predicting the possible DALY saves with disease burden method developed by WHO based on the estimation of attributed deaths, uncertainty and sensitivity analysis were considered.Results1 The results of effectiveness evaluation on Fogarty program showed:1.1 As a result of Fogarty program interventions, the prevalence of secondhand smoke decreased by 4.90%, and the prevalence of current smoking among male decreased by 12.25% in intervention county of Jiangxi province. While the prevalence of secondhand smoke decreased by 1.43% in intervention county of Henan province.1.2 Because of the program interventions, the prevalence of knowing the health hazards of ETS has been much improved which include: knowing ETS is more likely to have heart disease, knowing wife of a smoker is more likely to have lung cancer, knowing child having smoking parents is more likely to have asthma or respiratory disease, and knowing ETS has serious health hazards. The prevalence of awareness of avoiding the exposure of ETS has also been obviously improved, which include: recognizing no smoking in public places, recognizing no smoking in front of other people, and recognizing do not offer cigarettes during social interactions.1.3 The prevalence of approving to completely ban smoking at each public/work place has been increased in intervention county of Jiangxi province, and decreased in intervention county of Henan province, though it is also effective comparing with non intervention county. The prevalence of approving to completely ban smoking at restaurants and karaoke ok offices were lower than that at other places. The prevalence of approving to protect the health of no-smokers by prohibiting smoking at public places, and ban all cigarette advertising have been increased in intervention county of Jiangxi province, and no changes in intervention county of Henan province, but maintained at high level. The proportion of doctor and teacher should not smoke at any time have no changes, but maintained at high level in all intervention counties. The proportion of approving to tobacco control policies has been improved in the intervention communities, and it was higher in intervention hospitals than that in no-intervention hospitals.1.4 The behaviors related to smoking and avoiding ETS have been improved, the proportion of persuading to smoke outdoor increased, and the proportion of offering cigarette among no-smokers decreased in intervention counties. The proportion of smoking at public places has been decreased significantly, but it was also very serious to smoke at home, and the proportion of exposure to ETS at home was still very high. The proportion of smoking at home when guest visited was very high, which was close to 100%. The proportion of smoking at home without any restrictions has been declined in intervention county of Jiangxi province, but increased in Henan province.2 The results of effectiveness evaluation on Bloomberg program showed:2.1 The positive association between total intervention intensity of county/city level and initial, intermediate, final outcome all showed statistical significance (P = 0.0327, 0.0245 and 0.0431) under adjusting the effect of the lower level outcome index, baseline value of outcome index, the gender, age, education level, marriage status of survey population, and the impact of province cluster. The greater the total intensity, the better the initial, intermediate, and final outcome would be.2.2 The results of association analysis showed that the effect was not obvious after divided the total intervention intensity into several intervention intensity according to the five strategies. The effectiveness was reflected in the results of comprehensive intervention.2.3 Whether it was the final, intermediate, or the initial outcome, the worse the baseline value of effectiveness index, the better the intervention effectiveness.2.4 The intervention effectiveness in intervention community and hospital as demonstration were not as good as that of intervention county/city, but the trend was consistent. The total intervention intensity in intervention community as demonstration showed statistically significant association with initial outcome (P =0.0132). The total intervention intensity in intervention hospital as demonstration showed statistically significant association with initial and intermediate outcome (P =0.0327 and 0.0104).3 It was estimated that 1,656 (1,332-1,920) premature deaths, and 25,438 (20,386-29,545) DALYs with 3% discount rate would be saved in intervention county of Jiangxi Province. The number was 184 (108-242) and 2923 (1,663-3,859) respectively in Henan.Conclusions1 The intervention model developed by comprehensive program of ETS prevention in China is practical and effective. The intervention effectiveness should be further epidemiologically surveilled.2 The situation of exposure to ETS is still serious in China, especially at home. The proportion of offering cigarette to guest remains very high, and it is still very difficult to change the customs and traditions related to smoking. Both the government and non-governmental organizations should take immediate actions to strengthen their efforts to curb the tobacco epidemic in China.3 The effectiveness evaluation methods of comprehensive program of ETS prevention developed in this study can be used in other similar programs for reference. The indexes of process evaluation and effectiveness evaluation need to be further improved.更多还原