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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-9964769 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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