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利益冲突与研究结果之间的关系。

Relationship between conflicts of interest and research results.

作者信息

Friedman Lee S, Richter Elihu D

机构信息

The Social Policy Research Institute, Skokie, Illinois 60076, USA.

出版信息

J Gen Intern Med. 2004 Jan;19(1):51-6. doi: 10.1111/j.1525-1497.2004.30617.x.

Abstract

CONTEXT

To date, research regarding the influence of conflicts of interest on the presentation of findings by researchers has been limited.

OBJECTIVE

To evaluate the sources of funding for published manuscripts, and association between reported findings and conflicts of interest.

METHODS

Data from both print and electronic issues of The New England Journal of Medicine (NEJM) and The Journal of the American Medical Association (JAMA) were analyzed for sources of funding, areas of investigation, conflict of interest (COI), and presentation of results. We reviewed all original manuscripts published during the year 2001 within NEJM (N = 193) and JAMA (N = 205). We use 3 definitions for COI in this paper: a broadly defined criterion, the criterion used by The International Council of Medical Journal Editors (ICMJE), and a criterion defined by the authors.

RESULTS

Depending on the COI criteria used, 16.6% to 32.6% of manuscripts had 1 or more author with COI. Based on ICMJE criterion, 38.7% of studies investigating drug treatments had authors with COI. We observed a strong association between those studies whose authors had COI and reported positive findings (P <.001). When controlling for sample size, study design, and country of primary authors, we observed a strong association between positive results and COI (ICMJE definition) among all treatment studies (adjusted odds ratio [OR], 2.35; 95% confidence interval [CI], 1.08 to 5.09) and drug studies alone (OR, 2.64; 95% CI, 1.09 to 6.39).

CONCLUSION

COI is widespread among the authors of published manuscripts and these authors are more likely to present positive findings.

摘要

背景

迄今为止,关于利益冲突对研究人员研究结果呈现的影响的研究有限。

目的

评估已发表手稿的资金来源,以及报告的研究结果与利益冲突之间的关联。

方法

分析《新英格兰医学杂志》(NEJM)和《美国医学会杂志》(JAMA)印刷版和电子版的数据,以获取资金来源、研究领域、利益冲突(COI)和结果呈现情况。我们回顾了2001年在NEJM(N = 193)和JAMA(N = 205)上发表的所有原创手稿。本文中我们使用了3种利益冲突的定义:一个广义定义的标准、国际医学期刊编辑委员会(ICMJE)使用的标准以及作者定义的标准。

结果

根据所使用的利益冲突标准,16.6%至32.6%的手稿有1名或多名作者存在利益冲突。根据ICMJE标准,研究药物治疗的研究中有38.7%的研究作者存在利益冲突。我们观察到作者存在利益冲突的研究与报告阳性结果之间存在很强的关联(P <.001)。在控制样本量、研究设计和第一作者所在国家后,我们在所有治疗研究(调整后的优势比[OR],2.35;95%置信区间[CI],1.08至5.09)以及仅药物研究(OR,2.64;95%CI,1.09至6.39)中观察到阳性结果与利益冲突(ICMJE定义)之间存在很强的关联。

结论

利益冲突在已发表手稿的作者中普遍存在,并且这些作者更有可能呈现阳性结果。

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