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Common misunderstandings of evidence-based medicine

Currently, most evidence assessments in guidelines or health technology assessments (HTAs) rely on the assumption that a randomized controlled trial (RCT) is always the best source of evidence. However, if the outcome in a control group is certain, e.g. death within a short time with an almost 100%...

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Autores principales: Semrau, Frank, Aidelsburger, Pamela, Israel, Carsten Walter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Medizin 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10462562/
https://www.ncbi.nlm.nih.gov/pubmed/37548688
http://dx.doi.org/10.1007/s00399-023-00957-0
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author Semrau, Frank
Aidelsburger, Pamela
Israel, Carsten Walter
author_facet Semrau, Frank
Aidelsburger, Pamela
Israel, Carsten Walter
author_sort Semrau, Frank
collection PubMed
description Currently, most evidence assessments in guidelines or health technology assessments (HTAs) rely on the assumption that a randomized controlled trial (RCT) is always the best source of evidence. However, if the outcome in a control group is certain, e.g. death within a short time with an almost 100% chance, or if an event can only occur in the treatment group, there is no need for a randomized control group; the evidence cannot be improved by a control group, nor by an RCT design. If a cause–effect relationship is certain (“primary or direct evidence”), a therapeutic effect can be diluted in the population of an RCT by cross-over, etc. This can lead to serious misinterpretations of the effect. While experts such as the GRADE group or Cochrane institutes recommend using all available evidence, the leading approach in many guidelines and HTAs is assessing “the best available trials”, i.e. RCTs. But since RCTs only deliver probabilities of cause–effect relationships, it is not appropriate to demand RCTs for certain effects. A control group can only diminish the net value of a treatment since the outcome in the control group is subtracted from the outcome in the treatment group. Therefore, under identical circumstances, an RCT will always show lower effect rates compared to a single arm study of the same quality, for desired as well as for adverse effects. Considering these inconsistencies in evidence-based medicine interpretation, the evidence pyramid with RCTs at the top is not always a reliable indicator for the best quality of evidence.
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spelling pubmed-104625622023-08-30 Common misunderstandings of evidence-based medicine Semrau, Frank Aidelsburger, Pamela Israel, Carsten Walter Herzschrittmacherther Elektrophysiol Original Contribution Currently, most evidence assessments in guidelines or health technology assessments (HTAs) rely on the assumption that a randomized controlled trial (RCT) is always the best source of evidence. However, if the outcome in a control group is certain, e.g. death within a short time with an almost 100% chance, or if an event can only occur in the treatment group, there is no need for a randomized control group; the evidence cannot be improved by a control group, nor by an RCT design. If a cause–effect relationship is certain (“primary or direct evidence”), a therapeutic effect can be diluted in the population of an RCT by cross-over, etc. This can lead to serious misinterpretations of the effect. While experts such as the GRADE group or Cochrane institutes recommend using all available evidence, the leading approach in many guidelines and HTAs is assessing “the best available trials”, i.e. RCTs. But since RCTs only deliver probabilities of cause–effect relationships, it is not appropriate to demand RCTs for certain effects. A control group can only diminish the net value of a treatment since the outcome in the control group is subtracted from the outcome in the treatment group. Therefore, under identical circumstances, an RCT will always show lower effect rates compared to a single arm study of the same quality, for desired as well as for adverse effects. Considering these inconsistencies in evidence-based medicine interpretation, the evidence pyramid with RCTs at the top is not always a reliable indicator for the best quality of evidence. Springer Medizin 2023-08-07 2023 /pmc/articles/PMC10462562/ /pubmed/37548688 http://dx.doi.org/10.1007/s00399-023-00957-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Contribution
Semrau, Frank
Aidelsburger, Pamela
Israel, Carsten Walter
Common misunderstandings of evidence-based medicine
title Common misunderstandings of evidence-based medicine
title_full Common misunderstandings of evidence-based medicine
title_fullStr Common misunderstandings of evidence-based medicine
title_full_unstemmed Common misunderstandings of evidence-based medicine
title_short Common misunderstandings of evidence-based medicine
title_sort common misunderstandings of evidence-based medicine
topic Original Contribution
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10462562/
https://www.ncbi.nlm.nih.gov/pubmed/37548688
http://dx.doi.org/10.1007/s00399-023-00957-0
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