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

Abstract

Introduction: A randomized control trial (RCT) is considered to be the highest level in the Evidence-Based Medicine (EBM) pyramid. While EBM is essential to make a practical tool such as a prognostic guideline, it has been unclear how many patients in the real world can be eligible for a randomized control trial (RCT). Patients and method: This study was performed to clarify if there is a difference in patients’ profiles and clinical outcomes between the patients eligible and not eligible for any RCT. We reviewed all IE patients at our institute between 2007 and 2019. The patients were divided into two groups: those eligible for RCTs (RCT appropriate group) and those who were not (RCT inappropriate group). Exclusion criteria for clinical trials were set based on previous clinical trials. Results: A total of 66 patients were enrolled in the study. The median age was 70 years (range 18 to 87 years), and 46 (70%) were male. Seventeen (26%) of the patients were eligible for RCTs. Comparing the two groups, patients in the RCT appropriate group were younger and had fewer comorbidities. The disease severity was milder in the RCT appropriate groups than in the RCT inappropriate groups. Patients in the RCT appropriate group showed significantly longer overall survival times than those in the RCT inappropriate group (Log-Rank test, p < 0.001). Conclusions: We found a significant gap in patients’ characteristics and clinical outcomes between the groups. Physicians should be aware that RCT can never reflect the real-world population.

Adherence to 2015 ESC Guidelines for the Treatment of Infective Endocarditis: A Retrospective Multicentre Study (LEIOT Study)

“…The authors highlighted a certain “gap” between patients eligible for randomised clinical trials on EI and patients not eligible. The latter group consisted of older patients with more comorbidities and a more severe IE [ 24 ]. These findings could contribute to at least partially explaining deviations from the guidelines.…”

The Disruptive Force of Real-World Evidence

“…This appears, unfortunately, not to be the case. For example, Asai et al [ 4 ] recently analyzed to what extent real-world patients with infective endocarditis would be included in RCTs. Only every fourth patient (26%) fulfilled the eligibility criteria for RCTs.…”