【作者】 邱红燕；

【导师】 程怡民； 吴尚纯；

【作者基本信息】 北京协和医学院 ， 流行病与卫生统计学， 2011， 博士

【摘要】 研究背景：在以长效避孕措施为主的避孕模式下,面对如此种类繁多的避孕方法,如何对其进行评估将是生殖健康领域研究者们面临的一个重要议题。传统的对避孕方法进行评估的方法,多是从服务提供者的角度出发,侧重于避孕方法的临床效果的评估,即基于生物医学模式,仅仅强调生物学效应,关注有效性与安全性两个维度,而且多是有效性和安全性的独立评价。由于各种避孕节育方法各具特点,而且使用者、服务提供者和管理者的观点、态度也各异,使人们对某种产品的评价可能有很大不同,甚至可能是矛盾的。而且实际上避孕节育方法的推广应用可能还受到服务对象的可接受性、服务提供等很多因素的影响。因此,有必要在广泛进行的临床研究的基础上,综合计划生育服务领域中服务管理者、服务提供者及服务利用者三方的观点,从多个方面,采用科学的方法对避孕节育技术产品进行综合评价。本课题基于现代“生物-心理-社会医学模式”与计划生育优质服务(知情选择)的理念,采用多维多目标评价,不仅考虑有效性、安全性生物学效应指标,还引入心理学、经济学、满意度与可接受性等指标,对相关综合评价方法进行探索和应用。目的：在课题前期工作基础上,本研究采用德尔菲(Delphi)法对已初步建立的避孕节育技术／产品综合评价指标体系进行调整,确立长效避孕节育方法的综合评价体系；采用TOPSIS法、密切值法、功效系数法、加权综合指数法及秩和比法对元宫铜300、TCu380A、活性165宫内节育器(IUD)、抽芯近端包埋法、银夹法输卵管绝育术和直视钳穿法输精管结扎术三类六种避孕节育方法进行综合评价；采用等级相关、组合评价和聚类分析对评价结果进行评估,筛选适宜长效避孕节育方法综合评价的统计方法。方法：在初步建立的避孕节育技术／产品综合评价指标体系基础上,按照Delphi法原理,对副高级以上职称、对生殖健康领域研究感兴趣且在各自领域具有权威的计划生育、妇产科和公共卫生学专家进行两轮咨询,总结归纳反馈意见,计算相关参数,调整确立长效避孕节育方法的综合评价体系,用直接评分法和Satty’s赋权法确定各指标权重。资料来源：应用国家“十一五”科技支撑项目开展的月经间期放置三种IUD(元宫铜300、TCu380A、活性165)的随机对照研究、两种女性绝育方法(抽芯近端包埋法和银夹法输卵管绝育术)临床对比研究和直视钳穿输精管结扎术前瞻性临床观察研究的临床资料、SF-36生活质量健康状况调查资料,获得综合评价指标体系中的有效性、安全性及可接受性等相关指标的数值；应用同步对相应计划生育服务机构开展的卫生经济学调查研究资料,获得综合评价指标体系中的成本-效果指标数值。应用各项指标数值,采用TOPSIS法、密切值法、功效系数法、加权综合指数法和秩和比法运行长效避孕节育方法的综合评价体系,对三类六种长效避孕节育方法进行综合评价,获得五种方法的综合评价结果；采用等级相关系数法对五种评价结果进行相关性检验,进一步采用组合评价法评估适宜方法的评价结果,并采用聚类分析对三类六种长效避孕节育方法划分等级,筛选适宜长效避孕节育方法综合评价的统计方法。数据录入和统计分析使用EpiData3.0、Excel 2003、SPSS13.0、WHO LTA2.0 and SAS9.1软件。结果：1.长效避孕节育方法的综合评价体系的构成如下表所示：2. TOPSIS法、密切值法、功效系数法、加权综合指数法和秩和比法对三类六种避孕节育方法综合评价的评价值及排序结果如下表所示：3.用模糊Borda法对五种综合评价结果进行组合,得到三类六种避孕节育方法的Borda得分值及排序：包埋法Borda得分值为192.44,排序第一；男绝为68.60,排序第二；元宫铜300 IUD为16.11,排序第三；银夹法为15.15,排序第四；活性165 IUD为14.38,排序第五；TCu380A IUD为5.16,排序第六。4.对三类六种避孕节育方法五种综合评价结果进行聚类分析,第一类为包埋法、男绝；第二类为银夹法、元宫铜300 IUD；第三类为TCu38OA IUD、活性165 IUD。5.五种基础综合评价的结果与组合评价的结果进行Spearman等级相关分析,r16=0.9856大于临界值(0.886),表明TOPSIS法与组合评价的结果关系最为密切,评价结果均有一致性。结论：1.构建了由3个一级指标,6个二级指标,13个三级指标及其权重组成的长效避孕节育方法综合评价体系。2. TOPSIS法的评价结果与组合评价结果的相关性最为密切,因此长效避孕方法的综合评价,建议优先选择TOPSIS法。3.组合评价与聚类分析结果一致,近端抽芯包埋法和直视钳穿输精管结扎法的综合评价效果最好,其次为元宫铜300和银夹法,再次为TCu380A和活性165。政策建议：综合评价方法作为一种综合多方面、多维度、量化的评估体系对于评估避孕方法很有意义,可以作为临床研究或流行病学研究数据统计的一部分纳入统计分析。更多还原

【Abstract】 Background:With the mode of long-acting contraceptions and such a wide variety of contraceptive methods, how to evaluate them, which is an important topic to the researchers in the reproductive health field. The traditional evaluation methods focused on the clinical effect of contraceptive methods, emphasized the biological effect, especially paying attention to the efficacy and safety independently. While with various features of each contraceptions and different view and attitude of service providers and managers’, the evaluation result of the contraception was different, or possibly even contradictory. And in fact the popularization and application of contraceptive methods may also influenced by the acceptability of service objects, service provision and many other factors. Therefore, based on widely clinical studies, it is necessary to integrate the viewpoints of management, providers and objects in the family planning field to evaluate contraceptive technology and products. According to the modern "biological-psychological-social medical model" and family planning service (informed choice) idea, the multidimensional and multi-objective evaluation was used. The relevant evaluation methods was explorated and applicated. It was not only consider efficacy, safety, also introduced biological effects indexes of psychology, economics, satisfaction and acceptability, etc.Objective:With the initially established comprehensive evaluation index system of contraceptive methods, the Delphi method was used to adjust and radicate the comprehensive evaluation index system for long-acting contraceptive methods. The comprehensive statistic methods of TOPSIS, osculating value, efficacy coefficient, weighted composite Index and RSR were used respectively to evaluate intrauterine devices (IUD) including Yuan Gong Copper 300, TCu380A and activity 165, female tubal sterilization including the modified Uchida technique and the application of silver clips) and vasectomy. Finally, the adaptive statistic methods of comprehensive evaluation for long-acting contraception are identified with Spearman rank correlation coefficient, Borda method and Clustering analysis.Methods: Based on the previous work, according to the principles of Delphi method, we consulted family planning, epidemiological, gynecological and obstetrical experts who were anthoritative in their respective fields. AfterTwo rounds of consulting were proceeded, we concluded the feedback opinions and calculated relevant parameters. Finaly, the comprehensive evaluation index system of long-acting contraceptive methods was adjusted and radicated. Specialist-score method and Satty’s score weighting method were adopted to determine the weight of each index.Data resource:Based on the previous research findings, this study used indexes value of effectiveness, side effects and acceptability obtained from the questionnaires of healthy life quality (SF-36) and prospective clinical trials of three types of IUD placement during intermenstruum (Yuan Gong Copper 300、TCu380A and activity 165), two female tubal sterilization methods (the modified Uchida technique and the application of silver clips) and vasectomy. Cost-effect value in the evaluation system of the long-acting comprehensive methods was obtained from the health economics research of those family planning services agencies. The prospective clinical trials and health economics research were supported by the National Key Technology Program of "Eleventh Five-Year".With above data, TOPSIS, osculating value, efficacy coefficient, weighted Composite Index and RSR were used respectively to evaluate the 6 above contraceptive methods, Borda method was used to evaluate the results of adaptive statistic methods and the 6 contraceptions were classified with Clustering analysis. Compared with Borda method, Spearman rank correlation coefficient was used to identify the consistency of the results of 5 statistic methods. EpiData3.0, Excel 2003, SPSS13.0, WHO LTA2.0 and SAS 9.1 statistical software were used for data management and analysis.Results:1. The structure of evaluation system of the long-acting comprehensive methods was lied in the following table: 2. The values and orders of TOPSIS, osculating value, efficacy coefficient, weighted Composite Index and RSR for 3 types of IUD and 3 kinds of sterilization were lied in the following table.3. Borda method was used to organize the above 5 results of TOPSIS, osculating value, efficacy coefficient, weighted Composite Index and RSR methods. The Board values and orders for 3 types of IUD and 3 kinds of sterilization were 192.44 for the modified Uchida technique ranking first; 68.60 for vasectomy ranking second,16.11 for Yuan Gong Copper 300 IUD ranking third,15.15 for silver clips ranking the fourth, 14.38 for activity 165 IUD ranking fifth, and 5.16 for TCu380A IUD ranking sixth.4. Clustering analysis was used to classify the 3 types of IUD and 3 kinds of sterilization into three categories. The first category included the modified Uchida technique and vasectomy. The second category included silver clips and Yuan Gong Copper 300 IUD. The third category included TCu380A IUD and activity 165 IUD.5. Spearman correlation coefficient method was used to analysis the results of TOPSIS, osculating value, efficacy coefficient, weighted Composite Index, RSR and Borda method. The Spearman correlation coefficient between TOPSIS and Borda method was 0.9856 (>rs=0.886). The results of TOPSIS was conformed with that of Borda method.Conclusion:1. With 3 first-level indicators,6 second-level indicators,13 third-level indicators and weighty for each indicators, the comprehensive evaluation system for long-acting comprehensive methods was established.2. The results of TOPSIS was conformed with that of Borda method. TOPSIS method was identified as the most suitable comprehensive evaluation methods for long-acting contraception.3. The result of Borda method and Clustering analysis was conformed with each other. Comprehensive effects of the modified Uchida technique and vasectomy were the best, then the Yuan Gong Copper 300 IUD and silver clips, TCu380A and activity 165 IUD were the last.Suggestion:With consideration of many factors on many aspects, the comprehensive evaluation method is a significative system for contraceptions. It shoule be suggested to bring into clinic study and epidemiology as a part of statistic analysis.更多还原