A global core outcome measurement set for snakebite clinical trials.

Abouyannis M Esmail H Hamaluba M Ngama M Mwangudzah H Mumba N Yeri BK Mwalukore S Alphan HJ Aggarwal D Alcoba G Cammack N Chippaux JP Coldiron ME Gutiérrez JM Habib AG Harrison RA Isbister GK Lavonas EJ Martins D Ribeiro I Watson JA Williams DJ Casewell NR Walker SA Lalloo DG
The Lancet. Global health 2023 Feb ; 11(2); . doi: 10.1016/S2214-109X(22)00479-X. Epub 2023 01 25


Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. A globally representative group of key stakeholders came together to reach consensus on a globally relevant set of core outcome measurements. Outcome domains and outcome measurement instruments were identified through searching the literature and a systematic review of snakebite clinical trials. Outcome domains were shortlisted by use of a questionnaire and consensus was reached among stakeholders and the patient group through facilitated discussions and voting. Five universal core outcome measures should be included in all future snakebite clinical trials-mortality, WHO disability assessment scale, patient-specific functional scale, acute allergic reaction by Brown criteria, and serum sickness by formal criteria. Additional syndrome-specific core outcome measures should be used depending on the biting species. This core outcome measurement set provides global standardisation, supports the priorities of patients and clinicians, enables meta-analysis, and is appropriate for use in low-income and middle-income settings.

Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.