03177nas a2200865 4500000000100000008004100001260001600042653002100058100001700079700001300096700001500109700001200124700001700136700001200153700001200165700001600177700001400193700001500207700001300222700001400235700001500249700001600264700001800280700001300298700001600311700001600327700001500343700001400358700001400372700001400386700001600400700001600416700001400432700001400446700001700460700001500477700001300492700001400505700001400519700001600533700001500549700001600564700001300580700001800593700001300611700001500624700001600639700001600655700001400671700001500685700001400700700001200714700001600726700001700742700001200759700001400771700001400785700001400799700001600813700001200829700001700841700001400858700001500872700001600887700001100903700001300914700001500927700001600942245007200958856007501030300001401105490000701119520117101126022001402297 2023 d bElsevier BV10aGeneral Medicine1 aAbouyannis M1 aEsmail H1 aHamaluba M1 aNgama M1 aMwangudzah H1 aMumba N1 aYeri BK1 aMwalukore S1 aAlphan HJ1 aAggarwal D1 aAlcoba G1 aCammack N1 aChippaux J1 aColdiron ME1 aGutiérrez JM1 aHabib AG1 aHarrison RA1 aIsbister GK1 aLavonas EJ1 aMartins D1 aRibeiro I1 aWatson JA1 aWilliams DJ1 aCasewell NR1 aWalker SA1 aLalloo DG1 aAbouyannis M1 aAggarwal D1 aAlcoba G1 aAlphan HJ1 aCammack N1 aCasewell NR1 aChippaux J1 aColdiron ME1 aEsmail H1 aGutiérrez JM1 aHabib AG1 aHamaluba M1 aHarrison RA1 aIsbister GK1 aLalloo DG1 aLavonas EJ1 aMartins D1 aMumba N1 aMwalukore S1 aMwangudzah H1 aNgama M1 aRibeiro I1 aWalker AS1 aWatson JA1 aWilliams DJ1 aYeri BK1 aBammigatti C1 aCarter RW1 aGerardo CJ1 ade Silva HJ1 aLamb T1 aLewin MR1 aMonteiro W1 aStienstra Y00aA global core outcome measurement set for snakebite clinical trials uhttps://www.thelancet.com/action/showPdf?pii=S2214-109X%2822%2900479-X ae296-e3000 v113 a

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.

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