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

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...

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Autores principales: Asai, Nobuhiro, Shibata, Yuichi, Hirai, Jun, Ohashi, Wataru, Sakanashi, Daisuke, Kato, Hideo, Hagihara, Mao, Suematsu, Hiroyuki, Mikamo, Hiroshige
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9964769/
https://www.ncbi.nlm.nih.gov/pubmed/36836100
http://dx.doi.org/10.3390/jcm12041566
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author Asai, Nobuhiro
Shibata, Yuichi
Hirai, Jun
Ohashi, Wataru
Sakanashi, Daisuke
Kato, Hideo
Hagihara, Mao
Suematsu, Hiroyuki
Mikamo, Hiroshige
author_facet Asai, Nobuhiro
Shibata, Yuichi
Hirai, Jun
Ohashi, Wataru
Sakanashi, Daisuke
Kato, Hideo
Hagihara, Mao
Suematsu, Hiroyuki
Mikamo, Hiroshige
author_sort Asai, Nobuhiro
collection PubMed
description 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.
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spelling pubmed-99647692023-02-26 A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World Asai, Nobuhiro Shibata, Yuichi Hirai, Jun Ohashi, Wataru Sakanashi, Daisuke Kato, Hideo Hagihara, Mao Suematsu, Hiroyuki Mikamo, Hiroshige J Clin Med Article 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. MDPI 2023-02-16 /pmc/articles/PMC9964769/ /pubmed/36836100 http://dx.doi.org/10.3390/jcm12041566 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Asai, Nobuhiro
Shibata, Yuichi
Hirai, Jun
Ohashi, Wataru
Sakanashi, Daisuke
Kato, Hideo
Hagihara, Mao
Suematsu, Hiroyuki
Mikamo, Hiroshige
A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World
title A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World
title_full A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World
title_fullStr A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World
title_full_unstemmed A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World
title_short A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World
title_sort gap of patients with infective endocarditis between clinical trials and the real world
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9964769/
https://www.ncbi.nlm.nih.gov/pubmed/36836100
http://dx.doi.org/10.3390/jcm12041566
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