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Abouyannis, Michael 
ORCID: https://orcid.org/0000-0003-4856-4334, Aggarwal, Dinesh, Lalloo, David ORCID: https://orcid.org/0000-0001-7680-2200, Casewell, Nicholas ORCID: https://orcid.org/0000-0002-8035-4719, Hamaluba, Mainga and Esmail, Hanif
(2021)
'Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review'. PLoS Neglected Tropical Diseases, Vol 15, Issue 8, e0009589.
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Abouyannis et al. - 2021 - Clinical outcomes and outcome measurement tools re.pdf - Updated Version Available under License Creative Commons Attribution. Download (1MB) | Preview |
Abstract
Background
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.
Methods
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.
Results
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.
Discussion
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.
| Item Type: | Article |
|---|---|
| Subjects: | W General Medicine. Health Professions > W 20.5 Biomedical research WD Disorders of Systemic, Metabolic or Environmental Origin, etc > Animal Poisons > WD 410 Reptiles |
| Faculty: Department: | Biological Sciences > Department of Tropical Disease Biology |
| Digital Object Identifer (DOI): | https://doi.org/10.1371/journal.pntd.0009589 |
| Depositing User: | Cathy Waldron |
| Date Deposited: | 02 Sep 2021 15:05 |
| Last Modified: | 16 Jun 2023 10:48 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/18759 |
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