A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery
A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery
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DOI：
10.1097/01.prs.0000475767.61031.d1
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发表时间：
2016-02-01
影响因子：
3.6
通讯作者：
Bhandari, Mohit
中科院分区：
文献类型：
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作者：
Voineskos, Sophocles H.;Coroneos, Christopher J.;Bhandari, Mohit
背景：作者研究了整形外科随机对照试验中的行业支持、利益冲突和样本量，比较了手术干预。他们假设，行业资助的试验更经常显示出统计上显著的结果，而小样本量的随机对照试验更经常报告统计上显著的结果。方法：通过电子检索检索2000年至2013年发表的随机对照试验。独立审稿人评估稿件并进行数据提取。考察了研究的资金来源、利益冲突、主要结果方向和样本量。分析采用卡方检验和独立样本t检验。结果：检索确定了173个随机对照试验，其中100个（58%）没有承认资助状态。没有观察到资金来源与试验结果方向之间的关系。随着时间的推移，资金状况和利益冲突报告都有所改善。只有24%（25个中的6个）的行业资助的随机对照试验报告作者对数据和手稿内容有独立的控制。每项试验随机分配的平均患者数为73例（中位数为43例，最小值为3例，最大值为936例）。小型试验的阳性结果并不比大型试验多（p = 0.87）。结论：小样本量随机对照试验较为常见；然而，这为该领域开展进一步合作并进行更大规模、更明确的试验提供了很好的机会。关于试验经费和利益冲突的报告历来很少，但在研究期间有了很大改善。在评估资金来源和试验结果之间的关系时，作者和期刊水平的低报仍然是一个限制。改进报告和稿件控制应该是作者和期刊都能积极实现的目标。
Background: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently.Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis.Results: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87).Conclusions: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.