A global core outcome measurement set for snakebite clinical trials
Issued Date
2023-09-30
Resource Type
eISSN
27782034
Scopus ID
2-s2.0-85179773355
Pubmed ID
38094484
Journal Title
Medecine tropicale et sante internationale
Volume
3
Issue
3
Rights Holder(s)
SCOPUS
Bibliographic Citation
Medecine tropicale et sante internationale Vol.3 No.3 (2023)
Suggested Citation
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., Gutiérrez 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. A global core outcome measurement set for snakebite clinical trials. Medecine tropicale et sante internationale Vol.3 No.3 (2023). doi:10.48327/mtsi.v3i3.2023.421 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/95646
Title
A global core outcome measurement set for snakebite clinical trials
Author(s)
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.
Gutiérrez 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.
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.
Gutiérrez 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.
Author's Affiliation
Mère et Enfant en Milieu Tropical : Pathogènes, Système de Santé et Transition Epidémiologique
Mahidol Oxford Tropical Medicine Research Unit
Department of Medicine
Universidad de Costa Rica
Kenya Medical Research Institute
Denver Health
Organisation Mondiale de la Santé
University College London
Liverpool School of Tropical Medicine
Epicentre
Hôpitaux Universitaires de Genève
Nuffield Department of Medicine
Medecins Sans Frontieres
Newcastle University
Bayero University
Wellcome Trust
Drugs for Neglected Diseases Initiative
Mahidol Oxford Tropical Medicine Research Unit
Department of Medicine
Universidad de Costa Rica
Kenya Medical Research Institute
Denver Health
Organisation Mondiale de la Santé
University College London
Liverpool School of Tropical Medicine
Epicentre
Hôpitaux Universitaires de Genève
Nuffield Department of Medicine
Medecins Sans Frontieres
Newcastle University
Bayero University
Wellcome Trust
Drugs for Neglected Diseases Initiative
Corresponding Author(s)
Other Contributor(s)
Abstract
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.