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本文引用的文献

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Full publication of results initially presented in abstracts.最初以摘要形式呈现的研究结果的完整发表。
Cochrane Database Syst Rev. 2007 Apr 18(2):MR000005. doi: 10.1002/14651858.MR000005.pub3.
2
Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors.识别PubMed上随机试验中的结果报告偏倚:出版物综述与作者调查
BMJ. 2005 Apr 2;330(7494):753. doi: 10.1136/bmj.38356.424606.8F. Epub 2005 Jan 28.
3
Issues in the reporting of epidemiological studies: a survey of recent practice.流行病学研究报告中的问题:近期实践调查
BMJ. 2004 Oct 16;329(7471):883. doi: 10.1136/bmj.38250.571088.55. Epub 2004 Oct 6.
4
Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.由加拿大卫生研究院资助的随机试验中的结果报告偏倚。
CMAJ. 2004 Sep 28;171(7):735-40. doi: 10.1503/cmaj.1041086.
5
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.随机试验中结果选择性报告的实证证据:方案与已发表文章的比较。
JAMA. 2004 May 26;291(20):2457-65. doi: 10.1001/jama.291.20.2457.
6
Data dredging, bias, or confounding.数据挖掘、偏差或混杂因素。
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7
Citation bias of hepato-biliary randomized clinical trials.肝胆随机临床试验的引用偏倚
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8
Sifting the evidence-what's wrong with significance tests?筛选证据——显著性检验存在哪些问题?
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9
Subgroup analysis and other (mis)uses of baseline data in clinical trials.临床试验中基线数据的亚组分析及其他(不当)用途。
Lancet. 2000 Mar 25;355(9209):1064-9. doi: 10.1016/S0140-6736(00)02039-0.
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Sample size of randomized double-blind trials 1976-1991.1976 - 1991年随机双盲试验的样本量
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摘要中相对风险和比值比的可信度:横断面研究

Believability of relative risks and odds ratios in abstracts: cross sectional study.

作者信息

Gøtzsche Peter C

机构信息

Nordic Cochrane Centre, H:S Rigshospitalet, DK-2100 Copenhagen Ø, Denmark,.

出版信息

BMJ. 2006 Jul 29;333(7561):231-4. doi: 10.1136/bmj.38895.410451.79. Epub 2006 Jul 19.

DOI:10.1136/bmj.38895.410451.79
PMID:16854948
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1523498/
Abstract

OBJECTIVE

To compare the distribution of P values in abstracts of randomised controlled trials with that in observational studies, and to check P values between 0.04 and 0.06.

DESIGN

Cross sectional study of all 260 abstracts in PubMed of articles published in 2003 that contained "relative risk" or "odds ratio" and reported results from a randomised trial, and random samples of 130 abstracts from cohort studies and 130 from case-control studies. P values were noted or calculated if unreported.

MAIN OUTCOME MEASURES

Prevalence of significant P values in abstracts and distribution of P values between 0.04 and 0.06.

RESULTS

The first result in the abstract was statistically significant in 70% of the trials, 84% of cohort studies, and 84% of case-control studies. Although many of these results were derived from subgroup or secondary analyses, or biased selection of results, they were presented without reservations in 98% of the trials. P values were more extreme in observational studies (P < 0.001) and in cohort studies than in case-control studies (P = 0.04). The distribution of P values around P = 0.05 was extremely skewed. Only five trials had 0.05 < or = P < 0.06, whereas 29 trials had 0.04 < or = P < 0.05. I could check the calculations for 27 of these trials. One of four non-significant results was significant. Four of the 23 significant results were wrong, five were doubtful, and four could be discussed. Nine cohort studies and eight case-control studies reported P values between 0.04 and 0.06, but in all 17 cases P < 0.05. Because the analyses had been adjusted for confounders, these results could not be checked.

CONCLUSIONS

Significant results in abstracts are common but should generally be disbelieved.

摘要

目的

比较随机对照试验摘要中P值的分布与观察性研究摘要中P值的分布,并检查0.04至0.06之间的P值。

设计

对2003年发表在PubMed上的所有260篇包含“相对风险”或“比值比”并报告随机试验结果的文章摘要进行横断面研究,以及从队列研究中随机抽取130篇摘要和从病例对照研究中随机抽取130篇摘要。若P值未报告,则进行记录或计算。

主要观察指标

摘要中显著P值的患病率以及0.04至0.06之间P值的分布。

结果

摘要中的首个结果在70%的试验、84%的队列研究和84%的病例对照研究中具有统计学显著性。尽管这些结果中有许多来自亚组分析或二次分析,或存在结果偏倚选择,但在98%的试验中这些结果都毫无保留地呈现了出来。观察性研究(P<0.001)和队列研究中的P值比病例对照研究中的P值更极端(P=0.04)。P值在P=0.05附近的分布极度不对称。只有5项试验的0.05≤P<0.06,而29项试验的0.04≤P<0.05。我可以检查其中27项试验的计算结果。四项非显著性结果中有一项具有显著性。23项显著性结果中有四项错误,五项存疑,四项有待讨论。九项队列研究和八项病例对照研究报告的P值在0.04至0.06之间,但在所有17例中P<0.05。由于分析已对混杂因素进行了校正,因此无法检查这些结果。

结论

摘要中的显著性结果很常见,但通常不应轻信。