BackgroundSnakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation.MethodA 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.ResultsFive 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.ConclusionThis 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.
09/2023
3
Centre for Snakebite Research and Interventions, Liverpool School of Tropical Medicine, Liverpool, Royaume-Uni.
Humans, Snake Bites, Disability Evaluation, Consensus, Surveys and Questionnaires, Outcome Assessment, Health Care