2nd Department of Internal Medicine, Jagiellonian University School of Medicine, Skawinska 8, 31-066 Krakow, Poland.
J Clin Epidemiol. 2013 Mar;66(3):286-95. doi: 10.1016/j.jclinepi.2012.10.005.
To compare methodological characteristics of randomized controlled trials (RCTs) published in higher vs. lower impact Core Clinical Journals.
We searched MEDLINE for RCTs published in 2007 in Core Clinical Journals. We randomly sampled 1,140 study reports in a 1:1 ratio in higher (five general medicine journals with the highest total citations in 2007) and lower impact journals.
Four hundred sixty-nine RCTs proved eligible: 219 in higher and 250 in lower impact journals. RCTs in higher vs. lower impact journals had larger sample sizes (median, 285 vs. 39), were more likely to receive industry funding (53% vs. 28%), declare concealment of allocation (66% vs. 36%), declare blinding of health care providers (53% vs. 41%) and outcome adjudicators (72% vs. 54%), report a patient-important primary outcome (69% vs. 50%), report subgroup analyses (64% vs. 26%), prespecify subgroup hypotheses (42% vs. 20%), and report a test for interaction (54% vs. 27%); P < 0.05 for all differences.
RCTs published in higher impact journals were more likely to report methodological safeguards against bias and patient-important outcomes than those published in lower impact journals. However, sufficient limitations remain such that publication in a higher impact journal does not ensure low risk of bias.
比较发表在高影响力核心临床期刊和低影响力核心临床期刊上的随机对照试验(RCT)的方法学特征。
我们在 MEDLINE 中检索了 2007 年发表在核心临床期刊上的 RCT。我们以 1:1 的比例随机抽取了高影响力(2007 年总引用次数最高的五本普通医学期刊)和低影响力期刊中各 1140 份研究报告。
469 项 RCT 被证明符合条件:219 项来自高影响力期刊,250 项来自低影响力期刊。与低影响力期刊相比,高影响力期刊中的 RCT 样本量更大(中位数为 285 对 39),更有可能获得产业资助(53%对 28%),报告分配隐匿(66%对 36%),报告医护人员盲法(53%对 41%)和结局评估者盲法(72%对 54%),报告患者重要的主要结局(69%对 50%),报告亚组分析(64%对 26%),预先指定亚组假设(42%对 20%),并报告交互检验(54%对 27%);所有差异均 P<0.05。
与发表在低影响力期刊上的 RCT 相比,发表在高影响力期刊上的 RCT 更有可能报告针对偏倚和患者重要结局的方法学保障措施。然而,仍然存在足够的局限性,因此在高影响力期刊上发表并不能确保低风险的偏倚。