研究资助对头颈部癌症随机临床试验结果的影响。
Influence of study sponsorship on head and neck cancer randomized trial results.
机构信息
Robert Wood Johnson Foundation Clinical Scholars, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan; Department of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
出版信息
Head Neck. 2013 Oct;35(10):1515-20. doi: 10.1002/hed.23151. Epub 2012 Sep 18.
BACKGROUND
The purpose of this study was to identify associations between study sponsorship and the methodological quality and published outcomes of head and neck cancer randomized controlled trials (RCTs).
METHODS
We systematically searched MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials for qualified RCTs, evaluating journal impact factor (IF), Jadad score (measure of study quality), and results favoring or not favoring experimental therapy.
RESULTS
Of 118 RCTs, the most common sponsor was government (38; 32%), followed by nonprofit organizations (30; 25%) and industry (26; 22%). Industry-supported RCTs were associated with publication in journals with higher IF compared with RCTs without industry support (p = .013). Government-supported RCTs were associated with higher mean Jadad score (p = .026) and results favoring experimental therapy (p = .034).
CONCLUSIONS
Government-supported, but not industry-supported, RCTs were significantly associated with positive study results. These findings may be confounded by broadly applied definitions of sponsorship.
背景
本研究旨在确定研究赞助与头颈部癌症随机对照试验（RCT）的方法学质量和发表结果之间的关联。
方法
我们系统地检索了 MEDLINE、EMBASE、CINAHL 和 Cochrane 对照试验中心注册库，以寻找合格的 RCT，评估期刊影响因子（IF）、Jadad 评分（研究质量的衡量标准）以及支持或不支持实验治疗的结果。
结果
在 118 项 RCT 中，最常见的赞助商是政府（38；32%），其次是非营利组织（30；25%）和工业界（26；22%）。与没有工业支持的 RCT 相比，工业支持的 RCT 与发表在 IF 较高的期刊上相关（p =.013）。政府支持的 RCT 与较高的平均 Jadad 评分（p =.026）和支持实验治疗的结果（p =.034）相关。
结论
政府支持的 RCT，但不是工业支持的 RCT，与阳性研究结果显著相关。这些发现可能受到赞助的广泛定义的影响。
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