Battaglia Salvatore, Scichilone Nicola
DIBIMIS, University of Palermo, Palermo, Italy.
Respir Res. 2017 Jan 5;18(1):5. doi: 10.1186/s12931-016-0494-5.
Randomized clinical trials (RCTs) are performed to provide evidence to support treatment decisions. Based on the nature of those studies and the need to avoid confounding factors, it has been argued that the population selected in RCTs only partially represents the real-life population. This assumption casts doubts on the applicability of the results provided by RCTs in the management of individuals with an established diagnosis of COPD, and advocates the need for complementary studies with a pragmatic design. Herein, we comment on the recent article published by Halpin and colleagues on the Journal [Halpin et al, Respir Res 17:120, 2016], in which higher rates of inclusions in RCTs for COPD are found compared to previous observations. By analyzing the design of the studies and the end results, we conclude that the accumulating evidence contribute to shed lights on how representative is the outpatient population of real life settings.
进行随机临床试验（RCT）是为了提供证据以支持治疗决策。基于这些研究的性质以及避免混杂因素的需要，有人认为RCT中选择的人群仅部分代表了现实生活中的人群。这一假设使人对RCT结果在慢性阻塞性肺疾病（COPD）确诊患者管理中的适用性产生怀疑，并主张需要进行具有实用设计的补充研究。在此，我们对哈尔平及其同事发表在《呼吸研究》杂志上的最新文章进行评论[哈尔平等人，《呼吸研究》17:120，2016]，该文章发现与之前的观察结果相比，COPD的RCT纳入率更高。通过分析研究设计和最终结果，我们得出结论，越来越多的证据有助于阐明门诊患者人群在现实生活环境中的代表性如何。
