Data were used from studies collected in the WWARN data repository, this included 92 studies conducted between 19, accounting for 31,379 patients. In the next study, comparison of the two methods was applied to real datasets. The Kaplan-Meier approach overestimated failure (underestimated the efficacy) and the degree of overestimation in treatment failure reached as high as 3% when the drug efficacy fell to 90%. The simulation study showed substantial differences in the derived estimates of drug efficacy between the two methods in areas of high malaria transmission. In the first instance, simulation studies were carried out for different scenarios of existing drug efficacy in areas of high and low malaria transmission intensity. The Cumulative Incidence Function (CIF) provides an alternative approach for estimating efficacy by accounting for competing risk events.Īuthors set out to comprehensively investigate how the choice of analytical method can impact the derived estimates and interpretation of drug efficacy data in antimalarial clinical studies. The Kaplan-Meier (K-M) method is currently recommended by the World Health Organization (WHO) for estimating the efficacy of antimalarial treatments but does not account for competing risk events. Such events are considered as competing risk events in statistical literature. This gives rise to a scenario where the new infection masks or outcompetes the recrudescent infection. Recrudescent infection can be potentially pre-empted when the number of parasites of the newly acquired infection outnumbers those of the existing infection, or if the new infection is due to a more resistant parasite strain. falciparum or another species of malaria parasite. Recurrent infection can however occur as a result of a new infection with P. In clinical studies looking at the efficacy of antimalarial treatments for uncomplicated Plasmodium falciparum malaria, the primary measurement in determining efficacy is the level of recurrence of parasites which are genetically identical to parasites in the initial infection i.e.
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