系统综述Meta分析

系统综述/Meta分析的撰写和解读北京大学公共卫生学院北京大学循证医学中心詹思延提纲•为什么要规范撰写和解读•如何撰写：PRISMA•如何解读Meta分析结果备受关注，解读不同常引争议�All trials: RR, 1.02; 95% CI, 0.98-1.06.�In 47 low-bias trials with 180 938 participants, (RR, 1.05;95% CI, 1.02-1.08).�beta carotene (RR, 1.07; 95% CI, 1.02-1.11),�vitamin A (RR, 1.16; 95% CI, 1.10-1.24),�vitamin E (RR, 1.04; 95% CI, 1.01-1.07).�Vitamin C and selenium had no significant effect onmortality.JAMA. 2007;297:842-857 NEJM,2007;356Lancet 2009，373（9678）：1849Meta分析的统计学本质：权重平均Meta分析到底是什么？•Meta分析是对既往针对同一问题的研究结果的回顾，实际上是一种观察性研究设计；•不仅不能排除原始研究中存在的偏倚，当原始研究质量不高时，合并的结果会遭受“垃圾进、垃圾出”的质疑；•而且在文献查找、选择、资料提取和统计分析过程中，如果处理不当，还会引入新的偏倚，导致合并后的结果歪曲了真实的情况。

(Ann Surg 2005;241: 450–459)Results of the QUOROM-based checklist assessment: scoring the quality of reviews on treatment and prevention of breast and colorectal cancers国内Meta分析的质量评价•存在的主要问题：–文献查全率不高–没有列出被排除的试验–病人的特征范围、诊断标准和治疗范围不明确–对资料的可合并性的检验较差–对潜在偏倚的控制和检测不足–统计分析不规范–缺少对原始研究的质量评价–未改变方法进行敏感度分析–缺少对发表偏倚的检测–缺少对结果应用价值的评估 (孙福红,魏水易,2004)�报告不规范，质量有待提高如何撰写系统综述•论文基本结构•系统综述国际PRISMA标准•考科蓝综述的立题、注册、制作和发表•PROSPERO：非考科蓝综述注册平台论文的基本结构（IMRAD）�I ntroduction:研究什么问题？为什么研究这个问题？�M ethods：如何研究的？�R esults：发现了什么？�D iscussion：发现意味着什么？标题•重要性和创新点•包含所有关键词 （检索）•吸引人•用动词、句子摘要•缩写的论文•150－250个词•关键的创新点和意义Abstract•Background •Material and methods •Findings •Interpretation •Background •Objective •Design •Setting •Patients •Interventions •Measurements •Results •Limitations •Conclusions材料与方法•研究是如何设计的•研究是如何实施的（时间、地点）•数据分析•伦理，等结果•系统展示研究发现•结果一般用图表表达•结果撰写按逻辑顺序、不是研究的时间顺序•不要罗列结果，要分析，各结果间有逻辑联系致谢•其他人的帮助•基金资助参考文献•认真（都要看过）•不要弄错论文写作的要求•条理清楚，摆事实、讲道理•语言简单、平实、明确、直接•容易被理解和接受•正确、准确地使用英语•用最少、最短的词采用标准规范的格式撰写总结报告——MOOSE介绍第七讲随机对照试验meta分析的报告规范——QUOROM介绍夏音音詹思延第八讲非劣效性和等效性随机对照试验的报告规范朱成斌詹思延2006.6-2007.8，双月刊出中华流行病学杂志 2006.6-2007.8QUOROM声明•1996 年10 月，由临床流行病学家、临床学家、统计学家、从事meta 分析的研究人员以及来自英国和北美对meta分析感兴趣的编辑共30 人，组成专家小组，对RCT的meta分析报告质量进行了方法学的评价，并提出了统一报告格式。

Lancet 1999; 354: 1896–900/index.htm采用标准规范的格式撰写总结报告SUMMARY(Item2)SUMMARY (Item2)�B ackground;�O bjectives;�Methods�Data sources;�Study eligibility criteria, participants, and interventions;�Study appraisal and synthesis methods;�R esults;�Limitations;�C onclusions and implications of key findings; �Funding for the systematic review;�Systematic review registration number.SUMMARY(Item2)SUMMARY (Item2)•目的：明确描述临床问题The effect of fish oil on heart rate (HR), a major risk factor forsudden death, is not well established. We calculated this effect in a meta-analysis of randomized, double-blind, placebo-controlled trials in humans.•资料来源：列出文献数据库和其他信息来源Randomized trials of fish oil that evaluated HR were identified through MEDLINE (1966 through January 2005), hand-searching ofreferences, and contact with investigators for unpublished results.(Circulation. 2005;112:1945-1952.)SUMMARY(Item2)SUMMARY (Item2)•综述方法：概括研究选择的标准(如对象、干预、结局和研究设计)，详细描述真实性评价、资料提取和数据定量合成的方法，以及研究的特征，使读者能够重复–Two investigators independently extracted trial data.–A pooled estimate was calculated from random-effectsmeta-analysis. Predefined stratified meta-analyses and meta-regression were used to explore potentialheterogeneity.(Circulation. 2005;112:1945-1952.)SUMMARY(Item2)SUMMARY (Item2)•结果：描述纳入与排除的RCT 的特征，给出定性、定量的分析结果(例如点估计值及可信区间) 及亚组分析结果–Of 197 identified articles, 30 met inclusion criteria.–In the overall pooled estimate, fish oil decreased HR by1.6 bpm (95% CI, 0.6 to2.5; P=0.002) compared withplacebo.–Fish oil reduced HR by 2.5 bpm (P<0.001) in trialswith baseline HR≥ 69 bpm (median) but had littleeffect (0.04-bpm reduction; P=0.56) in trials withbaseline HR<69 bpm (P for interaction=0.03).(Circulation. 2005;112:1945-1952.)SUMMARY(Item2)SUMMARY (Item2)•结论：对主要结果加以论述–In randomized controlled trials in humans, fish oilreduces HR, particularly in those with higher baselineHR or longer treatment duration. These findingsprovide firm evidence that fish oil consumption directly or indirectly affects cardiac electrophysiology inhumans. Potential mechanisms such as effects on thesinus node, ventricular efficiency, or autonomicfunction deserve further investigation.(Circulation. 2005;112:1945-1952.)Methods Overview�Should provide the following information in a clear and transparent manner:�Literature Search Strategy and Data Sources�Eligibility Criteria�Specific to study characteristics (e.g., PICOS, length of follow up)�Specific to report characteristics (e.g., years considered, language, publication status)�Data Extraction and Data Items (e.g., variables for which datawere sought, assumptions and simplifications )�Quality Assessment�Synthesis of Results�Grading Strength of Evidence�Additional AnalysesMethods: PROTOCOL ANDREGISTRATION (Item 5) •Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address) and, if available, provide registration information including the registration number.•“Methods of the analysis and inclusion criteria were specified in advance and documented in a protocol.” [37]Methods: ELIGIBILITY CRITERIA (Item 6)�State the processes used to select studies for review:�Screening�Eligibility assessment�Inclusion/exclusion criteria applied for the systematic review/meta-analysis We included trials if the randomization scheme included groups that assigned patients to treatment guided by the PAC [pulmonary artery catheter] ortreatment without the PAC. We only included trials if they reported death and number of days hospitalized or the number of days in the ICU as outcomemeasures. Studies were excluded if the randomization scheme did not specify groups as PAC or no PAC, if patients were not randomized to a conventional PAC, if investigators combined randomized and nonrandomized groups when reporting outcomes, or if there were no outcome data on death orhospitalizations.(Shah MR, et al. JAMA 2005;294:1664-70.)Methods: ELIGIBILITY CRITERIA (Item 6)�Type of studies:Randomised clinical trials studying the administration ofhepatitis B vaccine to CRF [chronic renal failure] patients, with or without dialysis. No language, publication date, or publication status restrictions were imposed.�Types of participants:Participants of any age with CRF or receiving dialysis(haemodialysis or peritoneal dialysis) wereconsidered.…Renal transplant patients were excluded from this review.(Schroth RJ, et al. Cochrane Database Syst Rev 2004;(3):CD003775.)。