REFERENCE BIAS IN REPORTS OF DRUG TRIALS
REFERENCE BIAS IN REPORTS OF DRUG TRIALS
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DOI：
10.1136/bmj.295.6599.654
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发表时间：
1987-09-12
影响因子：
105.7
通讯作者：
GOTZSCHE, PC
中科院分区：
文献类型：
--
作者：
GOTZSCHE, PC
对1985年前发表的描述两种或两种以上非类固醇抗炎药治疗类风湿性关节炎的双盲试验的文章进行了检查，以确定他们引用的参考文献中是否存在任何偏见。通过Medline检索和检查检索到的文章的参考文献列表，共找到244篇符合标准的文章。研究中比较的药物被归类为新药或对照药物，试验结果为阳性或非阳性。然后检查所有关于该新药的其他试验的参考文献列表，以确定参考偏倚。如果参考文献列表所包含的对该药物有积极结果的参考文献所占比例高于假定作者可获得的所有文章(比索引文章早发表两年以上的文献)，则判定发生了正偏倚。在244篇文章中，共有133篇因各种原因而被排除--例如，44篇是因为多次发表，19篇是因为没有参考文献。在分析的111篇文章中，有35篇参考文献不可能存在偏见(因为所有的参考文献都给出了相同的结果)；10篇参考文献是中性选择，22篇是负面选择，44篇是正面选择--这是一种显著的正面偏向。这种偏见并不是因为引用的文章比未引用的文章具有更好的科学地位而造成的。因此，通过扫描参考文献列表检索文献可能会产生有偏见的文章样本，参考文献偏倚也可能使一篇文章的结论不太可靠。
Articles published before 1985 describing double blind trials of two or more non-steroidal anti-inflammatory drugs in rheumatoid arthritis were examined to see whether there was any bias in the references they cited. Altogether 244 articles meeting the criteria were found through a Medline search and through examining the reference lists of the articles retrieved. The drugs compared in the studies were classified as a new or as control drugs and the outcome of the trial as positive or not positive. The reference lists of all papers with references to other trials on the new drug were then examined for reference bias. Positive bias was judged to have occurred if the reference list contained a higher proportion of references with a positive outcome for that drug than among all the articles assumed to have been available to the authors (those published more than two years earlier than the index article). Altogether 133 of the 244 articles were excluded for various reasons-for example, 44 because of multiple publication and 19 because they had no references. Among the 111 articles analysed bias was not possible in the references of 35 (because all the references gave the same outcome); 10 had a neutral selection of references, 22 a negative selection, and 44 a positive selection-a significant positive bias. This bias was not caused by better scientific standing of the cited articles over the uncited ones. Thus retrieving literature by scanning reference lists may produce a biased sample of articles, and reference bias may also render the conclusions of an article less reliable.