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.
ContributorsMichael Abouyannis, Hanif Esmail, Mainga Hamaluba, Mwanajuma Ngama, Hope Mwangudzah, Noni Mumba, Betty K Yeri, Salim Mwalukore, Hassan J Alphan, Dinesh Aggarwal, Gabriel Alcoba, Nick Cammack, Jean-Philippe Chippaux, Matthew E Coldiron, José M Gutiérrez, Abdulrazaq G Habib, Robert A Harrison, Geoffrey K Isbister, Eric J Lavonas, Diogo Martins, Isabela Ribeiro, James A Watson, David J Williams, Nicholas R Casewell, Sarah A Walker, David G Lalloo; Snakebite Global Core Outcome Set Study Group
Disease Category: Public health
Disease Name: Snakebite
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Drug
- Clinical experts
- Consumers (patients)
- Families
- Funders
- Methodologists
- Policy makers
- Statisticians
- COS for clinical trials or clinical research
- Literature review
- Semi structured discussion
- Systematic review
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