Funding source, trial outcome and reporting quality: are they related? Results of a pilot study.

Funding source, trial outcome and reporting quality: are they related? Results of a pilot study.
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DOI:
10.1186/1472-6963-2-18
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发表时间:
2002-09-04
影响因子:
2.8
通讯作者:
Moher D
Moher D
中科院分区:
医学3区
文献类型:
--
作者:
Clifford TJ;Barrowman NJ;Moher D

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人们越来越关注研究商业化的潜在影响。为了检查资金来源、试验结果和报告质量之间的关系,对最近一期的五本经过同行评审的高影响因子普通医学期刊进行了手工检索,以确定 100 项随机对照试验的样本(20 项试验/期刊)。提取了相关数据,包括资金来源(行业/非营利/混合/未报告)和主要结局的统计显着性(支持新治疗/支持常规治疗/中性/不清楚)。使用 Jadad 量表和分配隐藏的充分性来分配质量分数。百分之六十六的试验获得了一些行业资助。试验结果与资金来源无关 (p= .461)。在已发表的试验中,有大量有利的统计结论,其中 67% 的报告结果支持新疗法,而 6% 的结果支持传统疗法。质量得分与资金来源或试验结果无关。目前尚不清楚资金来源、试验结果和报告质量之间缺乏显着关联是否反映了真正的关联缺失,或者是统计能力不足、依赖自愿披露资金信息、关注最近在顶级医学期刊上发表的试验,还是其中的某种组合的结果。建议继续并扩大对潜在冲突的监控,特别是考虑到 ICMJE 已批准的新披露准则。
There has been increasing concern regarding the potential effects of the commercialization of research. In order to examine the relationships between funding source, trial outcome and reporting quality, recent issues of five peer-reviewed, high impact factor, general medical journals were hand-searched to identify a sample of 100 randomized controlled trials (20 trials/journal). Relevant data, including funding source (industry/not-for-profit/mixed/not reported) and statistical significance of primary outcome (favouring new treatment/favouring conventional treatment/neutral/unclear), were abstracted. Quality scores were assigned using the Jadad scale and the adequacy of allocation concealment. Sixty-six percent of trials received some industry funding. Trial outcome was not associated with funding source (p= .461). There was a preponderance of favourable statistical conclusions among published trials with 67% reporting results that favored a new treatment whereas 6% favoured the conventional treatment. Quality scores were not associated with funding source or trial outcome. It is not known whether the absence of significant associations between funding source, trial outcome and reporting quality reflects a true absence of an association or is an artefact of inadequate statistical power, reliance on voluntary disclosure of funding information, a focus on trials recently published in the top medical journals, or some combination thereof. Continued and expanded monitoring of potential conflicts is recommended, particularly in light of new guidelines for disclosure that have been endorsed by the ICMJE.
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