To what degree could clinical trials in evidence based medicine reflect reality in the treatment of candidemia?
Copyright © 2020. Published by Elsevier B.V..
INTRODUCTION: Evidenced based medicine (EBM) is necessary to standardize or treatment for infection since EBM is established based on the results of clinical trials. Entry criteria for clinical trials are very strict, and many patients have difficulties in being enrolled in any clinical trials regarding candidemia. It is questionable if the results of clinical trials reflect the real world of general medicine in this case.
PATIENTS AND METHODS: For the purpose of examining how many patients could join any randomized clinical trials for the treatment of candidemia, we reviewed all the candidemia patients in our institute during 2014-2018. 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.
RESULTS: A total of 70 patients was enrolled in this study. The median age was 73 years (range 36-93 years). Of these, 41 patients (59%) were male. As for site of infections, catheter related blood stream infection was most frequently seen in 37 (53%). Seventeen patients (24%) were classified as participation possible group and 53 patients (76%) were participation impossible group. Comparing the two groups, participation possible group patients have much better performance status, have less comorbidities and have longer overall survival times than participation impossible group patients.
CONCLUSION: Only 24% of candidemia patients were eligible for the clinical trials. Thus, we can see that clinical trials might not correctly reflect the real world among candidemia patients.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:55 |
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| Enthalten in: |
Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi - 55(2022), 1 vom: 15. Feb., Seite 147-153 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Asai, Nobuhiro [VerfasserIn] |
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| Links: |
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| Themen: |
Cancer |
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| Anmerkungen: |
Date Completed 22.02.2022 Date Revised 22.02.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jmii.2020.11.003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM319046478 |
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| 500 | |a Date Revised 22.02.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020. Published by Elsevier B.V. | ||
| 520 | |a INTRODUCTION: Evidenced based medicine (EBM) is necessary to standardize or treatment for infection since EBM is established based on the results of clinical trials. Entry criteria for clinical trials are very strict, and many patients have difficulties in being enrolled in any clinical trials regarding candidemia. It is questionable if the results of clinical trials reflect the real world of general medicine in this case | ||
| 520 | |a PATIENTS AND METHODS: For the purpose of examining how many patients could join any randomized clinical trials for the treatment of candidemia, we reviewed all the candidemia patients in our institute during 2014-2018. 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 | ||
| 520 | |a RESULTS: A total of 70 patients was enrolled in this study. The median age was 73 years (range 36-93 years). Of these, 41 patients (59%) were male. As for site of infections, catheter related blood stream infection was most frequently seen in 37 (53%). Seventeen patients (24%) were classified as participation possible group and 53 patients (76%) were participation impossible group. Comparing the two groups, participation possible group patients have much better performance status, have less comorbidities and have longer overall survival times than participation impossible group patients | ||
| 520 | |a CONCLUSION: Only 24% of candidemia patients were eligible for the clinical trials. Thus, we can see that clinical trials might not correctly reflect the real world among candidemia patients | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cancer | |
| 650 | 4 | |a Candidemia | |
| 650 | 4 | |a Chemotherapy | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Evidence based medicine | |
| 650 | 4 | |a Palliative medicine | |
| 700 | 1 | |a Sakanashi, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Suematsu, Hiroyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Kato, Hideo |e verfasserin |4 aut | |
| 700 | 1 | |a Hagihara, Mao |e verfasserin |4 aut | |
| 700 | 1 | |a Shiota, Arufumi |e verfasserin |4 aut | |
| 700 | 1 | |a Koizumi, Yusuke |e verfasserin |4 aut | |
| 700 | 1 | |a Yamagishi, Yuka |e verfasserin |4 aut | |
| 700 | 1 | |a Mikamo, Hiroshige |e verfasserin |4 aut | |
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