A Large Gap in Patients’ Characteristics and Outcomes between the Real-World and Clinical Trial Settings in Community-Acquired Pneumonia and Healthcare-Associated Pneumonia

Abstract

(1) Introduction: Evidence-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 questions on whether the results of clinical trials reflect the real world of medical practice. (2) Methods: To examine how many patients could join any randomized clinical trials for the treatment of community-acquired pneumonia (CAP) and healthcare-associated pneumonia (HCAP). 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. (3) 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). (4) 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 facts and the limits of the clinical trials.

A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World

“…Moreover, patients in the RCT inappropriate group showed significantly lower OSs than those in the RCT appropriate group. This remarkable trend was reproducible in previous studies [ 2 , 18 ]. In terms of mortality among IE patients, the mortality rate in RCT was much lower than our cohort, showing 2.9–18% of in-hospital mortality rate [ 17 , 19 , 20 ].…”

“…Since EBM is considered to be the highest level of medical practice, physicians tend to prioritize it in general practice, and some are overconfident in RCTs. As the data showed, EBM based on RCT is very limited in scope, and EBM has never reflected the real world as previous studies have already reported [ 2 , 18 ].” IE patients in the real world are quite different from those who can be enrolled in a clinical trial, showing an unfavorable outcome. Only 26% (17 of the 66) of patients were appropriate for RCT enrollment.…”