To What Degree Could Clinical Trials in Evidence Based Medicine Reflect The Real World in The Treatment of Pneumonia?

Background: Evidenced based medicine (EBM) is necessary to standardize treatments for infections because EBM　has been established based on the results of clinical trials. Since entry criteria for clinical trials are　very strict, it ​may cause skepticism or question whether the results of clinical trials　reflect the real world ​of medical practice. Methods: To examine how many patients could join any randomized clinical trials for the　treatment of community-onset pneumonia, we reviewed all the pneumonia patients in our institute　during 2014-2017. The patients were divided into two groups: patients who were eligible for clinical　trials (participation possible group), and those who were not (participation impossible group).　Exclusion criteria for clinical trials were set based on previous clinical trials. Results: A total of 406 patients were enrolled in the present study. Fifty-seven (14%) patients were categorized into the participation possible group, while 86% ​of patients belonged to the participation impossible group. Patients in the participation possible group had less comorbidities and ​more favorable outcomes than those with the participation impossible group. As for the outcomes, there were significant differences in the 30-day and in-hospital mortality rates between the two groups. In addition, the participation possible group showed a longer overall survival time than the participation impossible group ( p <0.001 by Log-Rank test). Conclusion: There is a difference in patients’ profile and outcomes between clinical trials and the real world. Though EBM is essential to advance ​medicine, we should acknowledge the fact​s and the limit​s of the clinical trial.