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临床试验、流行病学与公众信心。

Clinical trials, epidemiology, and public confidence.

作者信息

Seigel Daniel

出版信息

Stat Med. 2003 Nov 15;22(21):3419-25. doi: 10.1002/sim.1641.

Abstract

Critics in the media have become wary of exaggerated research claims from clinical trials and epidemiological studies. Closer to home, reviews of published studies find a high frequency of poor quality in research methods, including those used for statistical analysis. The statistical literature has long recognized that questionable research findings can occur when investigators fail to set aside their own outcome preferences as they analyse and interpret data. These preferences can be related to financial interests, a concern for patients, peer recognition, and commitment to a hypothesis. Several analyses of published papers provide evidence of an association between financial conflicts of interest and reported results. If we are to regain professional and lay confidence in research findings some changes are required. Clinical journals need to develop more competence in the review of analytic methods and provide space for thorough discussion of published papers whose results are challenged. Graduate schools need to prepare students for the conflicting interests that surround the practice of statistics. Above all, each of us must recognize our responsibility to use analytic procedures that illuminate the research issues rather than those serving special interests.

摘要

媒体中的批评者已开始对临床试验和流行病学研究中夸大的研究主张持谨慎态度。在国内,对已发表研究的审查发现研究方法质量低下的情况很常见,包括用于统计分析的方法。统计文献早就认识到,当研究人员在分析和解释数据时未能抛开自己对结果的偏好,就可能出现有问题的研究结果。这些偏好可能与经济利益、对患者的关心、同行认可以及对某个假设的执着有关。对已发表论文的多项分析提供了经济利益冲突与报告结果之间存在关联的证据。如果我们要重新赢得专业人士和公众对研究结果的信任,就需要做出一些改变。临床期刊需要在分析方法审查方面提高能力,并为对其结果受到质疑的已发表论文进行深入讨论留出空间。研究生院校需要让学生为围绕统计学实践的利益冲突做好准备。最重要的是,我们每个人都必须认识到自己有责任使用能够阐明研究问题的分析程序,而不是服务于特殊利益的程序。

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