Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.

<h4>Background</h4>Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Co...

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Autores principales:	Michael Abouyannis, Dinesh Aggarwal, David G Lalloo, Nicholas R Casewell, Mainga Hamaluba, Hanif Esmail
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/3d7b7f8820ce442aa56997cabb3fb555
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spelling	oai:doaj.org-article:3d7b7f8820ce442aa56997cabb3fb5552021-12-02T20:23:43ZClinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.1935-27271935-273510.1371/journal.pntd.0009589https://doaj.org/article/3d7b7f8820ce442aa56997cabb3fb5552021-08-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009589https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite.<h4>Methods</h4>All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160.<h4>Results</h4>This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain ('venom antigenaemia') was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies.<h4>Discussion</h4>Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.Michael AbouyannisDinesh AggarwalDavid G LallooNicholas R CasewellMainga HamalubaHanif EsmailPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 8, p e0009589 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Michael Abouyannis Dinesh Aggarwal David G Lalloo Nicholas R Casewell Mainga Hamaluba Hanif Esmail Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.
description	<h4>Background</h4>Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite.<h4>Methods</h4>All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160.<h4>Results</h4>This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain ('venom antigenaemia') was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies.<h4>Discussion</h4>Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.
format	article
author	Michael Abouyannis Dinesh Aggarwal David G Lalloo Nicholas R Casewell Mainga Hamaluba Hanif Esmail
author_facet	Michael Abouyannis Dinesh Aggarwal David G Lalloo Nicholas R Casewell Mainga Hamaluba Hanif Esmail
author_sort	Michael Abouyannis
title	Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.
title_short	Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.
title_full	Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.
title_fullStr	Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.
title_full_unstemmed	Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.
title_sort	clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: a systematic review.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/3d7b7f8820ce442aa56997cabb3fb555
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Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review.

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