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临床试验数据的建议统计报告指南。

Suggested statistical reporting guidelines for clinical trials data.

作者信息

Charan Jaykaran, Saxena Deepak

机构信息

Department of Pharmacology, Government Medical College, Surat, India.

出版信息

Indian J Psychol Med. 2012 Jan;34(1):25-9. doi: 10.4103/0253-7176.96152.

Abstract

Statistical methods are widely accepted tools for analyzing data and drawing appropriate conclusions. However, inappropriate statistical methods may lead to unsuitable or false conclusions. Statistical quality of articles published in Indian medical journals presents with statistical fallacies and very few attempts have been done to document it till date. Issues related to inappropriate use of statistic in interpreting clinical trial raises serious doubt about the validity of the results published and there generalization to patient population. Clinical trials are considered to have one of the highest evidences in terms of efficacy of any intervention and hence results reported in these clinical trials help in appropriate decision making in clinical practices. Present manuscript is an attempt to have an insight into issues related to inappropriate use of statistic during clinical trials and suggests possible methods by which such fallacies can be averted.

摘要

统计方法是分析数据和得出恰当结论的广泛认可的工具。然而,不恰当的统计方法可能导致不合适或错误的结论。印度医学期刊上发表的文章的统计质量存在统计谬误,迄今为止很少有人尝试对此进行记录。在解释临床试验时不恰当使用统计数据的相关问题引发了对所发表结果的有效性及其对患者群体的推广性的严重质疑。就任何干预措施的疗效而言,临床试验被认为具有最高的证据之一,因此这些临床试验中报告的结果有助于临床实践中的恰当决策。本手稿旨在深入探讨临床试验期间不恰当使用统计数据的相关问题,并提出避免此类谬误的可能方法。

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