[A global core outcome measurement set for snakebite clinical trials].

Autor:	Abouyannis M; Centre for Snakebite Research and Interventions, Liverpool School of Tropical Medicine, Liverpool, Royaume-Uni.; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Esmail H; Medical Research Council Clinical Trials Unit at UCL, University College London, Londres, Royaume-Uni.; Institute for Global Health, University College London, Londres, Royaume-Uni., Hamaluba M; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya.; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, Oxford, Royaume-Uni., Ngama M; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Mwangudzah H; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Mumba N; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Yeri BK; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Mwalukore S; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Alphan HJ; Kenya Medical Research Institute (KEMRI) - Wellcome Research Programme, Kilifi, Kenya., Aggarwal D; Department of Medicine, University of Cambridge, Royaume-Uni., Alcoba G; Service de médecine, Médecins Sans Frontières, Genève, Suisse.; Service de médecine tropicale et humanitaire, Hôpitaux universitaires de Genève, Genève, Suisse., Cammack N; Wellcome Trust, Londres, Royaume-Uni., Chippaux JP; Université Paris Cité, Institut de Recherche pour le Développement (IRD), Unité « Mère et enfant en milieu tropical : pathogènes, système de santé et transition épidémiologique » (MERIT), Paris, France., Coldiron ME; Epicentre, Paris, France., Gutiérrez JM; Instituto Clodomiro Picado, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa Rica., Habib AG; Bayero University Department of Infectious and Tropical Diseases, Kano, Nigéria., Harrison RA; Centre for Snakebite Research and Interventions, Liverpool School of Tropical Medicine, Liverpool, Royaume-Uni., Isbister GK; Clinical Toxicology Research Group, University of Newcastle, Newcastle, NSW, Australie., Lavonas EJ; Department of Emergency Medicine, Denver Health and Hospital Authority, Denver, Colorado; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, États-Unis., Martins D; Wellcome Trust, Londres, Royaume-Uni., Ribeiro I; Drugs for Neglected Diseases Initiative, Genève, Suisse., Watson JA; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, Oxford, Royaume-Uni.; Mahidol Oxford Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thaïlande., Williams DJ; Regulation and Prequalification Department, Access to Medicines and Health Products Division, Organisation mondiale de la Santé, Genève, Suisse Auteur correspondant : jean-philippe.chippaux@ird.fr., Casewell NR; Centre for Snakebite Research and Interventions, Liverpool School of Tropical Medicine, Liverpool, Royaume-Uni., Walker SA; Medical Research Council Clinical Trials Unit at UCL, University College London, Londres, Royaume-Uni., Lalloo DG; Centre for Snakebite Research and Interventions, Liverpool School of Tropical Medicine, Liverpool, Royaume-Uni.
Jazyk:	francouzština
Zdroj:	Medecine tropicale et sante internationale [Med Trop Sante Int] 2023 Sep 05; Vol. 3 (3). Date of Electronic Publication: 2023 Sep 05 (Print Publication: 2023).
DOI:	10.48327/mtsi.v3i3.2023.421
Abstrakt:	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. (Copyright © 2023 SFMTSI.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu