Abstract

[A global core outcome measurement set for snakebite clinical trials]

Abouyannis, M. Esmail, H. Hamaluba, M. Ngama, M. Mwangudzah, H. Mumba, N. Yeri, B. K. Mwalukore, S. Alphan, H. J. Aggarwal, D. Alcoba, G. Cammack, N. Chippaux, J. P. Coldiron, M. E. Gutierrez, J. M. Habib, A. G. Harrison, R. A. Isbister, G. K. Lavonas, E. J. Martins, D. Ribeiro, I. Watson, J. A. Williams, D. J. Casewell, N. R. Walker, S. A. Lalloo, D. G.
Med Trop Sante Int. 2023; 3

Permanent descriptor

https://doi.org/10.48327/mtsi.v3i3.2023.421

BACKGROUND: Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. METHOD: 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. RESULTS: 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. CONCLUSION: 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.