1、实验流行病学文献评阅曾芳芳流行病学教研室A. Description of the evidence 证据的描述l What was the study design and how to collect data we need?l What was the study population?l What was the exposure?l What was the outcome?l What was the main result?B. Internal validity consideration of non-causal explanations 内部真实性 考虑是否有非因果解释
2、v Are the results likely to be affected by selection bias? 是否由于选择偏移所致v Are the results likely to be affected by observation bias? 是否由于观察偏移所致v Are the results likely to be affected by confounding? 是否由混杂偏移所致v Are the results likely to be affected by chance variation? 是否出于偶然因素C. Internal validity consi
3、deration of positive features of causation内部真实性 因果关系阳性特征的考虑1. Is there a correct time relationship? 是否存在前因后果的时间关系2. Is the relationship strong? 联系强度3. Is there a dose-response relationship? 是否存在剂量反应关系？v Are the results consistent within the study? 不同的相关研究指标结果是否一致5. Is there any specificity within th
4、e study? 研究是否存在特异性？D. External validitygeneralization of the results外部特异性 结果能否外推v Can the study results be applied to the eligible population? 结果能否适用于合格研究人群v Can the study results be applied to the source population? 结果能否适用于源人群v Can the study results be applied to other relevant populations?结果是否适用于其
5、他相关人群E. Comparison of the results with other evidence 与其它证据的比较1. Are the results consist with other evidence, particularly evidence from studies of similar or more powerful study design? 研究结果是否与其它研究 (尤其是设计更好，证据更强的 )结果相似或一致？2. Does the total evidence suggest any specificity? 研究结果是否存在特异性？3. Are the re
6、sults plausible, in terms of a biological mechanism? 研究结果是否合理，能否用生物学机制解释4. If a major effect is shown, is it coherent with the distribution of the exposure and the outcome? 如果存在联系，该联系与人群的暴露与结局分布是否一致？The Revised CONSORT Statement for Reporting Randomized Trials:Explanation and ElaborationAnn Intern M
7、ed. 2001 Apr 17;134(8):663-94.INCOMPLETE AND INACCURATE EPORTINGl information on whether assessment of outcomes* was blinded was reported in only 30% of 67 trial reports in four leading journals in 1979 and 1980l only 27% of 45 reports published in 1985 defined a primary end point* (14), and only 43
8、% of 37 trials with negative findings published in 1990 reported a sample size* calculationlOf 119 reports stating that all participants* were included in the analysis in the groups to which they were originally assigned (intention-to-treat* analysis), 15 (13%) excluded patients or did not analyze all patients as allocatedChecklist of Items To Include When Reporting a Randomized Trial
