實(shí)驗(yàn)流行病學(xué)文獻(xiàn)評(píng)閱

1、實(shí)驗(yàn)流行病學(xué)文獻(xiàn)評(píng)閱,曾芳芳流行病學(xué)教研室,A. Description of the evidence 證據(jù)的描述,What was the study design and how to collect data we need?What was the study population?What was the exposure?What was the outcome?What was the main result?

2、,B. Internal validity — consideration of non-causal explanations 內(nèi)部真實(shí)性——考慮是否有非因果解釋,Are the results likely to be affected by selection bias? 是否由于選擇偏移所致Are the results likely to be affected by observation bias? 是否由于觀察偏移

3、所致Are the results likely to be affected by confounding? 是否由混雜偏移所致Are the results likely to be affected by chance variation? 是否出于偶然因素,C. Internal validity— consideration of positive features of causation內(nèi)部真實(shí)性——因果關(guān)系陽(yáng)性特征的

4、考慮,1. Is there a correct time relationship? 是否存在前因后果的時(shí)間關(guān)系2. Is the relationship strong? 聯(lián)系強(qiáng)度3. Is there a dose-response relationship? 是否存在劑量反應(yīng)關(guān)系？Are the results consistent within the study? 不同的相關(guān)研究指標(biāo)結(jié)果是否一致5. I

5、s there any specificity within the study? 研究是否存在特異性？,D. External validity—generalization of the results外部特異性—結(jié)果能否外推,Can the study results be applied to the eligible population? 結(jié)果能否適用于合格研究人群Can the study results be

6、 applied to the source population? 結(jié)果能否適用于源人群Can the study results be applied to other relevant populations?結(jié)果是否適用于其他相關(guān)人群,E. Comparison of the results with other evidence 與其它證據(jù)的比較,1. Are the results consist with oth

7、er evidence, particularly evidence from studies of similar or more powerful study design? 研究結(jié)果是否與其它研究(尤其是設(shè)計(jì)更好，證據(jù)更強(qiáng)的)結(jié)果相似或一致？2. Does the total evidence suggest any specificity? 研究結(jié)果是否存在特異性？3. Are the results plausible,

8、in terms of a biological mechanism? 研究結(jié)果是否合理，能否用生物學(xué)機(jī)制解釋4. If a major effect is shown, is it coherent with the distribution of the exposure and the outcome? 如果存在聯(lián)系，該聯(lián)系與人群的暴露與結(jié)局分布是否一致？,The Revised CONSORT Statement for Re

9、porting Randomized Trials:Explanation and Elaboration,Ann Intern Med. 2001 Apr 17;134(8):663-94.,INCOMPLETE AND INACCURATE EPORTING,information on whether assessment of outcomes* was blinded was reported in only 30% of

10、67 trial reports in four leading journals in 1979 and 1980only 27% of 45 reports published in 1985 defined a primary end point* (14), and only 43% of 37 trials with negative findings published in 1990 reported a sample

11、size* calculation,,Of 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 an

12、alyze all patients as allocated,Checklist of Items To Include When Reporting a Randomized Trial,Title and Abstract,How participants were allocated to interventions (e.g., “random allocation,” “randomized,” or “randomly a

13、ssigned”).,Introduction,Scientific background and explanation of rationale,Methods--Participants,Eligibility criteria for participantsThe settings and locations where the data were collected,Methods-- Interventions,Prec

14、ise details of the interventions intended for each group and how and when they were actually administered.,Methods-- Objectives,Specific objectives and hypotheses.,Methods-- Outcomes,Clearly defined primary and secondary

15、 outcome measures.When applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).,Methods-- Sample size,How sample size was determinedWhen applicable, exp

16、lanation of any interim analyses and stopping rules.,Methods-- Randomization,Method used to generate the random allocation sequenceDetails of any restriction [of randomization] (e.g., blocking, stratification)Method us

17、ed to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.,,Who generated the allocation sequence, wh

18、o enrolled participants, and who ssigned participants to their groups.,Methods-- Blinding (masking),Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to gr

19、oup assignment.If done, how the success of blinding was evaluated.,Methods-- Statistical methods,Statistical methods used to compare groups for primary outcome(s).Methods for additional analyses, such as subgroup analy

20、ses and adjusted analyses.,Results--Participant flow,Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receivi

21、ng intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.,Results--Recruitment,Dates defining the periods of re

22、cruitment and follow-up.,Results--Baseline data,Baseline demographic and clinical characteristics of each group,Results--Numbers analyzed,Number of participants (denominator) in each group included in each analysis and w

23、hether the analysis was by “intention to treat.” State the results in absolute numbers when feasible (e.g., 10 of 20, not 50%).,Results--Outcomes and estimation,For each primary and secondary outcome, a summary of result

24、s for each group and the estimated effect size and its precision (e.g., 95% confidence interval).,Results--Ancillary analyses,Address multiplicity by reporting any other analyses performed, including subgroup analyses an

25、d adjusted analyses, indicating those prespecified and those exploratory.,Results-- Adverse events,All important adverse events or side effects in each intervention group.,Discussion--Interpretation,Interpretation of the

26、 results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes.,Discussion--Generalizability,Generalizability (external val