Design, conduct, analysis, and reporting of therapeutic efficacy studies in visceral leishmaniasis: A systematic review of published reports, 2000–2021

by Dahal P, Singh-Phulgenda S, Naylor C, Brack M, Chatterjee M, Alves F, Guerin PJ, Stepniewska K. American Journal of Tropical Medicine and Hygiene 2024. doi: 10.4269/ajtmh.23-0458

Summary: Syntheses of evidence from clinical studies on the efficacy of treatments for visceral leishmaniasis have usually focused on describing the patient population enrolled, heterogeneity in treatment regimens, and drug efficacy and safety, however, the scale and impact of methodological variation in these studies is largely unknown. The authors of this systematic review present the landscape of the design, conduct, analysis, and reporting of 89 visceral leishmaniais efficacy studies published between 2000 and 2021 and indexed in the Infectious Diseases Data Observatory VL library of clinical studies. This review highlights substantial variations in definitions adopted for disease diagnosis and therapeutic outcomes, suggesting a need for a harmonized trials protocol.

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