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系统评价、Meta-分析设计与实施方法

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系统评价、Meta-分析设计与实施方法

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《系统评价、Meta-分析设计与实施方法》系统评价、Meta分析是循证医学重要的研究方法和最佳证据的重要来源之一,是当前临床医学各专业使用最频繁的研究工具之一。掌握系统评价方法还有助于提高临床研究设计的质量及发表高水平学术论文的能力。特别是Cochrane系统评价于2007年被SCI收录,2008年其影响因子达4.6,国内各高校医学研究生、博士生对学习系统评价制作方法热情高涨,学员对该知识的需求大。中国循证医学中心应全国各地学员要求,编写一本针对性强的参考书,以指导其具体研究。每一章开头增加精选案例引入本章,结尾给出本章的具体应用案例,内容有
Catalogue

绪论
第一章 系统评价基本知识及制作前准备
第一节 系统评价的概念、起源、发展和作用
第二节 系统评价与meta-分析的关系
第三节 Cochrane系统评价制作所需条件及注册过程
第四节 Cochrane系统评价制作、保存、发表和更新原则
第五节 Cochrane系统评价在循证医学中的作用

第二章 系统评价选题
第一节 系统评价选题原则
第二节 系统评价问题的主要组成部分
第三节 系统评价选题常见问题及注意事项

第三章 系统评价计划书撰写
第一节 概述
第二节 Cochrane系统评价计划书撰写内容与流程
第三节 计划书撰写注意事项与相关资源

第四章 临床研究检索与常用数据库介绍
第一节 循证医学证据概述
第二节 临床研究检索方法与检索策略制定
第三节 常用中英文数据库介绍
第四节 常用文献管理软件简介

第五章 临床研究选择和纳入
第一节 临床研究选择和纳入的重要性
第二节 临床研究选择和纳入标准流程
第三节 临床研究选择和纳入基本步骤
第四节 临床研究选择和纳入基本原则
第五节 临床研究选择和纳入注意事项
第六节 临床研究选择和纳入表格模板

第六章 纳入研究的偏倚评价
第一节 基本概念
第二节 随机对照试验系统评价纳入研究的偏倚风险评价
第三节 非随机研究系统评价纳入研究的偏倚风险评价
第四节 诊断性试验系统评价纳入研究的偏倚风险评价
第五节 纳人研究偏倚风险评价的注意事项
第六节 研究文献的质量评价在系统评价中的作用

第七章 数据提取
第一节 数据来源及提取基本原则
第二节 数据提取基本步骤
第三节 数据提取表的设计
第四节 数据提取过程中的特殊问题
第五节 数据提取表格模板

第八章 meta-分析和系统评价常用统计指标及方法
第一节 meta-分析中的统计学过程
第二节 常用统计指标及可信区间

第九章 结果
第一节 结果报告原则和要点
第二节 制作结果汇总表
第三节 报告偏倚的概念与评价
第四节 不良反应

第十章 结果解释(讨论)与结论
第一节 结果解释的要点
第二节 结果的统计学意义与临床意义
第三节 证据质量分级及其影响因素
第四节 正确解释证据适用性
第五节 如何得出结论

第十一章 RevMan软件介绍
第一节 RevMan软件基本内容与主要功能
第二节 RevMan软件操作流程及注意事项

第十二章 系统评价与meta-分析特别主题
第一节 不良反应的系统评价
第二节 经济学证据整合
第三? 患者报告的结局
第四节 个体患者系统评价
第五节 前瞻性meta-分析
第六节 动物实验系统评价

第十三章 Cochrane系统评价汇总评价
第一节 Cochrane系统评价汇总评价的基本概念
第二节 Cochrane系统评价汇总评价的主要内容

第十四章 系统评价的临床应用
第一节 系统评价是目前临床循证论证强度最高的证据之一
第二节 运用最佳证据进行临床实践决策
第三节 应用系统评价指导临床循证决策应注意的问题
附录
附录1 Cochrane系统评价常用术语中英文对照
附录2 Cochrane协作网52个系统评价专业组联系方式
附录3 常用Cochrane系统评价与meta-分析制作及循证医学应用相关参考资源
附录4 其他系统评价与meta-分析方法学常用参考资源
附录5 国际社会学系统评价研究、药物经济学评价与安全性相关资源网
Book Abstract

(四)研究类型
某些研究设计(design)比另外一些研究设计更适合回答某些问题。因此,在纳入标准的设计中,系统评价的作者还需要考虑什么样的研究设计能提供更可靠的数据来回答系统评价所关注的问题。
因为Cochrane系统评价关注的临床问题常常是关于防治性医疗措施的效果,所以,随机对照试验是回答此类问题的主要研究类型。随机是在不同干预组之间,防止已知和未知混杂因素引起研究对象的基线特征出现系统性偏差的唯一方法。对于临床干预措施而言,谁接受干预措施,谁不接受干预措施受很多因素包括许多预后因素的影响。一般而言,非随机研究与随机研究相比,其观察到的医疗干预的阳性结果更多,受偏倚的影响更大,而且偏倚的程度甚至方向都是很难估计和预测的。因此,许多Cochrane系统评价只纳入随机试验,其纳入随机试验的方法也并不适用于纳入其他类型的研究。而如果纳入随机研究以外的其他类型的研究,系统评价本身可能需要一些额外的努力来保持系统评价持续更新,也由此可能增加了系统评价的结果被发表偏倚影响的危险。
有时,尽管系统评价只限于纳入随机试验,研究设计的某些特殊的方面也应该被考虑。比如:是否需要纳入簇状随机试验和交叉试验,是否使用了安慰剂,对于结果的评估是否使用了盲法,随访的最短时间是多少等。还需要衡量严格的研究设计和不严格的研究设计之间的不同,前者可能纳入了低度偏倚的研究文献,但是通常研究样本量较小;后者可能纳入了偏倚较高的文献,但是样本量更大。
三、获取更多信息
有时,我们可以发现,即使获得了研究文献的全文,仍然没有我们所需要的信息。比如,可能文献并没有表明该研究是怎样进行随机分配的;也可能文献没有写清楚参与者的类型如何;有时,甚至发现文献没有提供我们所需要的结局指标。当文献研究的相关信息不全或不清楚时,需要进一步获取相关信息。有时可以从文章中合理地推断出所需要的信息。比如,有研究表明其纳入的是60岁以上的妇女,此时,可以假设所有纳入的女性都是绝经后妇女,而不需要就此问题去询问作者。如果不能推导出相关信息,就需要寻找进一步的资料。一个方法是去检索同一研究的其他相关报道,其有可能包含了更多的信息;另一个方法是联系文献的作者以获得进一步的信息。
第四节 临床研究选择和纳入基本原则
在制作系统评价全文时,临床试验研究的选择和纳入是一个主观判断过程,难免会发生偏倚和人为的错误。尤其是有时需要对上百,甚至上万篇检索出的文献研究进行筛选,决定是否纳入时,如何保证文献选择和纳入的准确可靠,尽可能减少偏倚和人为错误,同时又节省时间呢?掌握文献研究选择和纳入的基本原则就非常重要。以下就系统评价中,对文献选择和纳入的基本原则进行讨论。
……

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