Inserm U738, Paris, France.
Joint Bone Spine. 2012 May;79(3):262-7. doi: 10.1016/j.jbspin.2011.05.008. Epub 2011 Jul 5.
Readers of scientific articles often read only the abstract and its conclusions because of lack of time or of access to the full-length articles.
To assess the prevalence of misleading conclusions in abstracts of randomized controlled trials (RCTs) in rheumatology, determine whether trials are registered and whether abstract conclusions are based on the primary outcome (PO), and identify the predictors of misleading abstract conclusions.
We searched Medline, Embase and the Cochrane Collaboration for reports of RCTs assessing rheumatoid arthritis, osteoarthritis or spondylarthropathies published between January 2006 and April 2008. Abstract conclusions were misleading if: the PO was not reported in the conclusion; the conclusions were based on only a secondary outcome or subgroup results; the results and conclusions were in disagreement; negative results were suggested as equivalent, or if there was no discussion of benefits and risks in cases of serious adverse events.
Of the 144 reports selected, we focused on the 105 articles containing a clear PO. Twenty-four reports (23%) contained misleading conclusions. Lack of PO reporting (n=10) and conclusions disagreeing with article results (n=7) were the most frequent reasons. Nineteen out of 144 (13.2%) declared study registration with clear and similar registered and published POs and no misleading abstract conclusions. Reports of negative results showed a higher frequency of misleading conclusions as did those assessing osteoarthritis. On multivariable analysis, only negative results predicted misleading abstract conclusions (OR=9.58 [3.20-28.70]).
Almost one-quarter of these RCT in rheumatology had misleading conclusions in the abstract, especially those with negative results.
由于缺乏时间或无法获取全文,读者经常只阅读科学文章的摘要及其结论。
评估风湿病学中随机对照试验(RCT)摘要中误导性结论的流行程度,确定试验是否已注册以及摘要结论是否基于主要结局(PO),并识别误导性摘要结论的预测因素。
我们在 Medline、Embase 和 Cochrane 协作数据库中搜索了 2006 年 1 月至 2008 年 4 月期间发表的评估类风湿关节炎、骨关节炎或脊柱关节病的 RCT 报告。如果摘要结论具有以下特征,则被认为是误导性的:PO 未在结论中报告;结论仅基于次要结局或亚组结果;结果和结论不一致;阴性结果被认为等效,或者在严重不良事件的情况下没有讨论获益和风险。
在 144 篇报告中,我们重点关注了 105 篇包含明确 PO 的文章。24 篇报告(23%)包含误导性结论。最常见的原因是缺乏 PO 报告(n=10)和结论与文章结果不一致(n=7)。144 篇报告中有 19 篇(13.2%)声明了研究注册,具有明确且相似的注册和发表的 PO,且没有误导性的摘要结论。阴性结果报告显示出更高频率的误导性结论,而评估骨关节炎的报告也是如此。多变量分析表明,只有阴性结果预测了误导性的摘要结论(OR=9.58 [3.20-28.70])。
这些风湿病学 RCT 中近四分之一的摘要存在误导性结论,尤其是那些报告阴性结果的 RCT。