Disclosure of Funding Sources and Conflicts of Interest in Phase III Surgical Trials: Survey of Ten General Surgery Journals

Disclosure of Funding Sources and Conflicts of Interest in Phase III Surgical Trials: Survey of Ten General Surgery Journals
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DOI:
10.1007/s00268-014-2580-5
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发表时间:
2014-10-01
影响因子:
2.6
通讯作者:
Tuech, Jean-Jacques
Tuech, Jean-Jacques
中科院分区:
医学3区
文献类型:
--
作者:
Bridoux, Valerie;Moutel, Gregoire;Tuech, Jean-Jacques

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关于在发表的同行评议期刊文章中披露资金来源和利益冲突(COI)的讨论正变得越来越普遍和激烈。本研究的目的是检查发表在主要外科期刊上的随机对照试验(RCTs)是否报告了资金来源和COI。2005年1月至2010年12月发表的所有报告随机对照III期试验的文章被选为10个国际期刊的综述。我们评估了披露的资金来源和COI的数量,以及与这些披露相关的因素。通过对这10种期刊的657项随机对照试验的回顾,我们发现分别有47%(309)和25.1%(165)披露了资金来源和COI的存在或缺失。“国际医学期刊编辑委员会(ICMJE)附属期刊”上的大多数文章没有披露COI。披露资金与期刊影响因子bbb3(51.7比41.6%,p < 0.01)、统计学家/流行病学家参与(64.2比43.7%,p < 0.001)、2008年以后的发表(52.9比41.1%,p < 0.01)以及该期刊是否隶属于icmje(49.3比40%,p < 0.05)相关。利益冲突披露与2008年以后发表的期刊相关(38.7% vs 11.3%, p < 0.001),与未隶属于ICMJE的期刊相关(36.9% vs 21.3%, p < 0.001)。在我们调查的已发表的研究中,超过一半的研究没有披露资金来源(即是否有资金来源),近四分之三的研究没有披露COI是否存在。我们的研究结果表明,为了履行对读者的责任,最终对患者的责任,需要在披露竞争利益方面采取最佳的现行做法。
Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI.All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures.From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor > 3 (51.7 vs 41.6 %; p < 0.01), statistician/epidemiologist involvement (64.2 vs 43.7 %; p < 0.001), publication after 2008 (52.9 vs 41.1 %; p < 0.01), and the journal being ICMJE-affiliated (49.3 vs 40 %; p < 0.05). Conflict of interest disclosure was associated with publication after 2008 (38.7 vs 11.3 %; p < 0.001), and with the journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001).Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.