Abstract

[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, Guti�rrez JM, Habib AG, Harrison RA, Isbister GK, Lavonas EJ, Martins D, Ribeiro I, Watson JA, Williams DJ, Casewell NR, Walker SA, Lalloo DG
Med Trop Sante Int. 2023;3

Permenent descriptor

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.