Department of Anesthesiology, Medicine, and Surgery, University of Colorado, School of Medicine, Anschutz Medical Campus, 12401 E. 17th Ave., Leprino Office Building, 7th Floor, MS B-113, Aurora, CO, 80045, USA.
Adult and Child Center for Health Outcomes and Delivery Science, University of Colorado, School of Medicine, Aurora, Colorado, USA.
BMC Med Res Methodol. 2018 Jul 5;18(1):71. doi: 10.1186/s12874-018-0526-6.
Limited translational success in critical care medicine is thought to be in part due to inadequate methodology, study design, and reporting in preclinical studies. The purpose of this study was to compare reporting of core features of experimental rigor: blinding, randomization, and power calculations in critical care medicine animal experimental research. We hypothesized that these study design characteristics were more frequently reported in 2015 versus 2005.
We performed an observational bibliometric study to grade manuscripts on blinding, randomization, and power calculations. Chi-square tests and logistic regression were used for analysis. Inter-rater agreement was assessed using kappa and Gwet's AC1.
A total of 825 articles from seven journals were included. In 2005, power estimations were reported in 2%, randomization in 35%, and blinding in 20% (n = 482). In 2015, these metrics were included in 9, 47, and 36% of articles (n = 343). The increase in proportion for the metrics tested was statistically significant (p < 0.001, p = 0.002, and p < 0.001).
Only a minority of published manuscripts in critical care medicine journals reported on recommended study design steps to increase rigor. Routine justification for the presence or absence of blinding, randomization, and power calculations should be considered to better enable readers to assess potential sources of bias.
人们认为，重症监护医学中的转化研究成功率有限，部分原因是临床前研究中的方法学、研究设计和报告存在不足。本研究旨在比较重症监护医学动物实验研究中实验严谨性的核心特征（即盲法、随机化和效能分析）的报告情况。我们假设这些研究设计特征在 2015 年比 2005 年报告得更频繁。
我们进行了一项观察性的文献计量学研究，对盲法、随机化和效能分析进行了分级。使用卡方检验和逻辑回归进行分析。使用 Kappa 和 Gwet 的 AC1 评估组内一致性。
共纳入来自七种期刊的 825 篇文章。2005 年，有 2%的文章报告了效能估计，35%的文章报告了随机化，20%的文章报告了盲法（n=482）。2015 年，这些指标分别包含在 9%、47%和 36%的文章中（n=343）。所测试指标的比例增加具有统计学意义（p<0.001、p=0.002 和 p<0.001）。
重症监护医学期刊发表的论文中，只有少数报告了增加严谨性的推荐研究设计步骤。应考虑常规说明盲法、随机化和效能分析的存在或缺失的理由，以便读者更好地评估潜在的偏倚来源。
