The INPULSIS enigma: exacerbations in idiopathic pulmonary fibrosis.
The INPULSIS enigma: exacerbations in idiopathic pulmonary fibrosis.
复制标题
INPULSIS之谜：特发性肺纤维化的恶化。
DOI：
10.1136/thoraxjnl-2014-206598
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发表时间：
2015
期刊：
影响因子：
10
通讯作者：
Ernst,Pierre
中科院分区：
文献类型：
--
作者：
Suissa,Samy;Ernst,Pierre
The recently published INPULSIS studies, two duplicate randomised trials evaluating nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF) over 1 year, reported effectiveness in terms of declining lung function, but inconsistent results on exacerbations of IPF. 1 2 Indeed, in the prespecified pooled analysis of the two trials, the risk of an investigator-reported acute exacerbation was lower by 36% with nintedanib compared with placebo but not statistically significant (HR, 0.64; 95% CI 0.39 to 1.05; p= 0.08). On the other hand, another prespecified analysis found that, after adjudication of these same investigator-reported exacerbations, the risk of a confirmed acute exacerbation was lower by 68% and statistically significant (HR, 0.32; 95% CI 0.16 to 0.65; p= 0.001). Such differences in results for the same outcome may puzzle readers and even possibly arouse suspicion of selective or incorrect reporting, especially when the findings straddle the magic 5% conventional level of statistical significance. We believe such differences have a statistical explanation which shows how one result is biased and the other valid. In this paper, we describe the phenomenon of treatment effect dilution, which can lead to false non-significant effects, using the INPULSIS trials as an illustration. We also provide a contrasting example to this phenomenon using, as an illustration, the case of the risk of pneumonia in trials of inhaled corticosteroids in COPD.
