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1、使用GRADEpro评价证据质量,武汉大学公共卫生学院流行病教研室2011年11月,GRADE系统简介,GRADE（Grading of Recommendations Assessment, Development and Evaluation）是由2000年建立的GRADE工作组提出的一套评级系统。GRADE系统使用易于理解的方式评价证据质量和推荐等级，目前已被世界卫生组织（WHO）、Cochrane协作网等一批著名机构所采用。,GRADE系统较之其他系统的优势,由一个具有广泛代表性的国际指南制定小组制定明确界定了证据质量和推荐强度清楚评价了不同治疗方案的重要结局对不同级别证据的升级与降级
2、有明确、综合的标准从证据到推荐全过程透明明确承认价值观和意愿就推荐意见的强弱，分别从临床医生、患者、政策制定者角度做了明确实用的诠释适用于制作系统评价、卫生技术评估及指南,证据质量（GRADEpro）,为达到透明和简化的目标， GRADE系统将证据质量分为高、 中、 低、 极低 4 级。一些使用GRADE系统的组织甚至把低和极低归为一级。,推荐等级,使用GRADE系统时，指南小组用“强推荐”表示他们确信相关的干预措施利大于弊。用“弱推荐”表示干预措施有可能利大于弊，但他们把握不大。,GRADE中的证据质量和推荐等级,关键步骤一 导入RevMan文件,关键步骤二 判断结局的重要程度,GRADE
3、系统建议采用 9 级分级判断结局的重要程度:13：不重要结局（NOT IMPORTANT）46：重要结局（IMPORTANT）79：关键结局（CRITICAL）,关键步骤三 选择研究设计类型,按研究设计方法划分随机试验质量等级最高，为高；观察性研究 （包括队列研究、病例 - 对照研究、病例 - 历史对照研究）质量等级低，为低；病例报告、病例分析等其他研究质量等级非常低，为极低。,关键步骤四 评价证据质量,基于研究设计可因5 条降级因素和 4 条升级因素上升或下降级别。,决定证据质量的因素,可能降低证据质量的因素研究的局限性结果不一致间接证据精确度不够发表偏倚可能增加证据质量的因素效应值很大可能
4、的混杂因素会降低疗效剂量-效应关系,研究设计与证据质量,高：为不降级的随机试验和升 2 级的观察性研究； 中：为降级的随机试验和升 1 级的观察性研究； 低：降 2 级的随机试验和没有升降级的观察性研究； 非常低：降3级的随机试验、 降1级的观察性研究、 病例分析/病例报告。,帮助教程要点,研究的局限性（Risk of bias）,这些局限性包括（RCTs）隐藏分组缺失盲法缺失（特别是结局指标为主观性指标且对其的评估极易受偏倚影响时）失访过多未进行意向性分析、观察到疗效就过早终止试验或未报道结果（通常是未观察到疗效的一些研究）,To rate study limitations:,If you
5、 think any limitations were negligible choose no If you think there were serious limitations choose serious this will downgrade the quality of evidence for this outcome by 1 level If you think there were very serious limitations choose very serious this will downgrade the quality of evidence for thi
6、s outcome by 2 levels,结果不一致（ Inconsistency）,Inconsistency may arise from differences in:populations (e.g. drugs may have larger relative effects in sicker populations) interventions (e.g. larger effects with higher drug doses) outcomes (e.g. diminishing treatment effect with time)差异可能源于人群（如药物对重症人群的疗
7、效可能相对显著）、干预措施（如较高药物剂量会使疗效更显著）或结局指标（如随时间推移疗效降低）。,I2,One set of criteria would say that an I2 of less than 40% is low3060% may be moderate5090% may be substantial75100% is considerable,To rate inconsistency:,If you think any inconsistency was negligible choose no If you think there was serious inconsi
8、stency choose serious this will downgrade the quality of evidence for this outcome by 1 level If you think there was very serious inconsistency choose very serious this will downgrade the quality of evidence for this outcome by 2 levels,间接证据（ Indirectness),There are two types of indirectness:1. Indi
9、rect comparison2. Indirect populationinterventioncomparatoroutcome,To rate indirectness:,If you think the evidence is direct choose no If you have serious doubts about directness choose serious this will downgrade the evidence for this outcome by 1 level If you have very serious doubts about directn
10、ess choose very serious this will downgrade the evidence for this outcome by 2 levels,精确度不够（Imprecision ）,当研究纳入的患者和观察事件相对较少而致可信区间较宽时，指南小组将降低该研究的证据质量。A threshold rule-of-thumb valueTotal number of events is less than 300（dichotomous）Total population size is less than 400（continuous）,To rate imprecisi
11、on:,If you think the results were precise choose no If there was serious imprecision choose serious this will downgrade the quality of evidence for this outcome by 1 level If there was very serious imprecision choose very serious this will downgrade the quality of evidence for this outcome by 2 leve
12、ls,发表偏倚（ Publication bias ）,Publication bias arises when investigators fail to report studies they have undertaken (typically those that show no effect). Methods to detect the possibility of publication bias in systematic reviews exist, although authors of the reviews and guideline panels must often
13、 guess about the likelihood of publication bias. A prototypical situation that should elicit suspicion of publication bias occurs when published evidence is limited to a small number of trials, all of which are showing benefits of the studied intervention.若研究者未能发表研究（通常是阴性结果的研究）时，证据质量亦会减弱。典型情况是当公开的证据
14、仅局限于少数试验而这些试验全部由企业赞助，此时不得不质疑存在发表偏倚。,Funnel Plot,To rate probability of the publication bias:,If you think there is no evidence of publication bias choose unlikely If there is high probability of publication bias choose likely this will downgrade the quality of evidence for this outcome by 1 level If
15、 there is very high probability of publication bias choose very likely this will downgrade the quality of evidence for this outcome by 2 levels,效应值很大（Large effect）,疗效越显著，证据越有力。,To rate magnitude of the effect:,If the effect was not large (RR between 0.5 and 2.0) choose no If the effect was large (RR
16、 either 2.0 or 2 or 5.0 or 5 or 0.2this will upgrade the quality of evidence for this outcome by 2 levels,可能的混杂因素会降低疗效（Plausible confounding would change the effect）,On occasion, all plausible confounding from observational studies or randomised trials may be working to reduce the demonstrated effec
17、t or increase the effect if no effect was observed.For example, if only sicker patients receive an experimental intervention or exposure, yet they still fare better, it is likely that the actual intervention or exposure effect is larger than the data suggest.,To rate the effect of all plausible resi
18、dual confounding:,If there is no evidence that the influence of all plausible confounding would reduce a demonstrated effect or suggest a spurious effect when results show no effect choose no If there is evidence that the influence of all plausible confounding would reduce a demonstrated effect or s
19、uggest a spurious effect when results show no effect choose yesthis will upgrade the quality of evidence for this outcome by 1 level,剂量-效应关系（Dose-response gradi）,The presence of a dose-response gradient may increase our confidence in the findings of observational studies and thereby increase the qua
20、lity of evidence.,To rate the presence of dose-response gradient:,If there is no evidence of dose-response gradient choose no If there is evidence of dose-response gradient choose yesthis will upgrade the quality of evidence for this outcome by 1 level,评级流程,关键步骤五 完善数据,关键步骤六 生成表格,Evidence Profile vs.
21、 Summary of Findings Table,GRADE Evidence profileParticularly useful for guideline developersPresents information about the body of evidence (e.g. number of studies), the judgments about the underlying quality of evidence, key statistical results, and a grade for the quality of evidence for each out
22、comeSummary of Findings TableMost relevant to (and designed for use in) Cochrane reviewsPresent the main findings of a systematic review in a transparent and simple tabular formatProvides key information concerning the quality of evidence, the magnitude of effect of the interventions examined, and the sum of available data on most important outcomes.,SoF Table,There are 3 key components of a SoF table: Information about the review Summary of the statistical results Grade of the quality of evidence.,关键步骤七 导出文件到RevMan,Meta分析（RevMan）,证据等级（GRADEpro）,推荐等级,系统综述流程图,
