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Pre-referral rectal artesunate is no “magic bullet” in weak health systems

Severe malaria is a potentially fatal condition that requires urgent treatment. In a clinical trial, a sub-group of children treated with rectal artesunate (RAS) before being referred to a health facility had an increased chance of survival. We recently published in BMC Medicine results of the CARAM...

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Autores principales: Hetzel, Manuel W., Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Awor, Phyllis, Signorell, Aita, Kwiatkowski, Marek, Lambiris, Mark J., Visser, Theodoor, Cohen, Justin M., Buj, Valentina, Burri, Christian, Lengeler, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10060914/
https://www.ncbi.nlm.nih.gov/pubmed/36991404
http://dx.doi.org/10.1186/s12916-023-02777-y
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author Hetzel, Manuel W.
Okitawutshu, Jean
Tshefu, Antoinette
Omoluabi, Elizabeth
Awor, Phyllis
Signorell, Aita
Kwiatkowski, Marek
Lambiris, Mark J.
Visser, Theodoor
Cohen, Justin M.
Buj, Valentina
Burri, Christian
Lengeler, Christian
author_facet Hetzel, Manuel W.
Okitawutshu, Jean
Tshefu, Antoinette
Omoluabi, Elizabeth
Awor, Phyllis
Signorell, Aita
Kwiatkowski, Marek
Lambiris, Mark J.
Visser, Theodoor
Cohen, Justin M.
Buj, Valentina
Burri, Christian
Lengeler, Christian
author_sort Hetzel, Manuel W.
collection PubMed
description Severe malaria is a potentially fatal condition that requires urgent treatment. In a clinical trial, a sub-group of children treated with rectal artesunate (RAS) before being referred to a health facility had an increased chance of survival. We recently published in BMC Medicine results of the CARAMAL Project that did not find the same protective effect of pre-referral RAS implemented at scale under real-world conditions in three African countries. Instead, CARAMAL identified serious health system shortfalls that impacted the entire continuum of care, constraining the effectiveness of RAS. Correspondence to the article criticized the observational study design and the alleged interpretation and consequences of our findings. Here, we clarify that we do not dispute the life-saving potential of RAS, and discuss the methodological criticism. We acknowledge the potential for confounding in observational studies. Nevertheless, the totality of CARAMAL evidence is in full support of our conclusion that the conditions under which RAS can be beneficial were not met in our settings, as children often failed to complete referral and post-referral treatment was inadequate. The criticism did not appear to acknowledge the realities of highly malarious settings documented in detail in the CARAMAL project. Suggesting that trial-demonstrated efficacy is sufficient to warrant large-scale deployment of pre-referral RAS ignores the paramount importance of functioning health systems for its delivery, for completing post-referral treatment, and for achieving complete cure. Presenting RAS as a “magic bullet” distracts from the most urgent priority: fixing health systems so they can provide a functioning continuum of care and save the lives of sick children. The data underlying our publication is freely accessible on Zenodo.
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spelling pubmed-100609142023-03-30 Pre-referral rectal artesunate is no “magic bullet” in weak health systems Hetzel, Manuel W. Okitawutshu, Jean Tshefu, Antoinette Omoluabi, Elizabeth Awor, Phyllis Signorell, Aita Kwiatkowski, Marek Lambiris, Mark J. Visser, Theodoor Cohen, Justin M. Buj, Valentina Burri, Christian Lengeler, Christian BMC Med Correspondence Severe malaria is a potentially fatal condition that requires urgent treatment. In a clinical trial, a sub-group of children treated with rectal artesunate (RAS) before being referred to a health facility had an increased chance of survival. We recently published in BMC Medicine results of the CARAMAL Project that did not find the same protective effect of pre-referral RAS implemented at scale under real-world conditions in three African countries. Instead, CARAMAL identified serious health system shortfalls that impacted the entire continuum of care, constraining the effectiveness of RAS. Correspondence to the article criticized the observational study design and the alleged interpretation and consequences of our findings. Here, we clarify that we do not dispute the life-saving potential of RAS, and discuss the methodological criticism. We acknowledge the potential for confounding in observational studies. Nevertheless, the totality of CARAMAL evidence is in full support of our conclusion that the conditions under which RAS can be beneficial were not met in our settings, as children often failed to complete referral and post-referral treatment was inadequate. The criticism did not appear to acknowledge the realities of highly malarious settings documented in detail in the CARAMAL project. Suggesting that trial-demonstrated efficacy is sufficient to warrant large-scale deployment of pre-referral RAS ignores the paramount importance of functioning health systems for its delivery, for completing post-referral treatment, and for achieving complete cure. Presenting RAS as a “magic bullet” distracts from the most urgent priority: fixing health systems so they can provide a functioning continuum of care and save the lives of sick children. The data underlying our publication is freely accessible on Zenodo. BioMed Central 2023-03-30 /pmc/articles/PMC10060914/ /pubmed/36991404 http://dx.doi.org/10.1186/s12916-023-02777-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis 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/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Correspondence
Hetzel, Manuel W.
Okitawutshu, Jean
Tshefu, Antoinette
Omoluabi, Elizabeth
Awor, Phyllis
Signorell, Aita
Kwiatkowski, Marek
Lambiris, Mark J.
Visser, Theodoor
Cohen, Justin M.
Buj, Valentina
Burri, Christian
Lengeler, Christian
Pre-referral rectal artesunate is no “magic bullet” in weak health systems
title Pre-referral rectal artesunate is no “magic bullet” in weak health systems
title_full Pre-referral rectal artesunate is no “magic bullet” in weak health systems
title_fullStr Pre-referral rectal artesunate is no “magic bullet” in weak health systems
title_full_unstemmed Pre-referral rectal artesunate is no “magic bullet” in weak health systems
title_short Pre-referral rectal artesunate is no “magic bullet” in weak health systems
title_sort pre-referral rectal artesunate is no “magic bullet” in weak health systems
topic Correspondence
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10060914/
https://www.ncbi.nlm.nih.gov/pubmed/36991404
http://dx.doi.org/10.1186/s12916-023-02777-y
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