[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 J-P., 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.
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.