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

Nobuhiro Asai,Mao Hagihara,Hiroyuki Suematsu,Hiroshige Mikamo,Daisuke Sakanashi,Hideo Kato,Yuka Yamagishi,Yuichi Shibata

doi:10.3390/jcm11020297

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.

Highlights

This study focused on to what degree community-acquired pneumonia (CAP) and healthcare-associated pneumonia (HCAP) patients are eligible for clinical trials, to investigate whether antibiotic therapy is effective and/or tolerable for these patients
For the purpose of how many community-onset pneumonia patients in our institute could join any randomized clinical trials for an antibiotic treatment among pneumonia patients, we reviewed all CAP and HCAP patients who were admitted to our hospital between September 2014 and May 2017
We already reported that only 24% of candidemia patients could participate in a clinical trial

Summary

Introduction

Evidence-based medicine (EBM) aims to assist physicians in making rational decisions in general practices. As EBM is established according to the results of clinical trials, clinical trials are considered one of the essential undertakings and are put at the top of priority among physicians in constructing therapeutic strategies [1]. A randomized control trial (RCT) evaluates the efficacy and tolerability of a new antibiotic treatment, and EBM guidelines/recommendations are made based on those results. There is no room for doubt that current medicine is based on EBM. We skeptically think about that when we consider eligibility of pneumonia patients for EBM guidelines or recommendations in actual practice. Entry criteria for any clinical trial are generally very strict, and most patients might not be suitable for the studies. It is reasonable to doubt whether the results of clinical trials reflect the real world in general practice.

Methods

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Discussion

Conclusion