Variation in Calculating and Reporting Antimalarial Efficacy against Plasmodium falciparum in Sub-Saharan Africa: A Systematic Review of Published Reports

Plucinski, Mateusz M., Hastings, Ian ORCID: https://orcid.org/0000-0002-1332-742X, Moriarty, Leah F., Venkatesan, Meera, Felger, Ingrid and Halsey, Eric S. (2021) 'Variation in Calculating and Reporting Antimalarial Efficacy against Plasmodium falciparum in Sub-Saharan Africa: A Systematic Review of Published Reports'. American Journal of Tropical Medicine and Hygiene, Vol 104, Issue 5, pp. 1820-1829.

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Abstract

Antimalarials, in particular artemisinin-based combination therapies (ACTs), are critical tools in reducing
the global burden of malaria, which is concentrated in sub-Saharan Africa. Performing and reporting antimalarial
efficacy studies in a transparent and standardized fashion permit comparison of efficacy outcomes across countries
and time periods. This systematic review summarizes study compliance with WHO laboratory and reporting guidance
pertaining to antimalarial therapeutic efficacy studies and evaluates how well studies from sub-Saharan Africa adhered
to these guidelines. We included all published studies (January 2020 or before) performed in sub-Saharan Africawhere
ACT efficacy for treatment of uncomplicated Plasmodium falciparum infectionwas reported. The primary outcomewas
a composite indicator for study methodology consistent with WHO guidelines for statistical analysis of corrected
efficacy, defined as an article presenting a Kaplan–Meier survival analysis of corrected efficacy or reporting a perprotocol
analysis where new infections were excluded from the numerator and denominator. Of 581 articles screened,
we identified 279 for the review. Molecular correction was used in 83% (232/279) to distinguish new infections from
recrudescences in subjects experiencing recurrent parasitemia. Only 45% (99/221) of articles with therapeutic efficacy
as a primary outcome and performing molecular correction reported corrected efficacy outcomes calculated in a way
consistent with WHO recommendations. These results indicate a widespread lack of compliance with WHOrecommendedmethods
of analysis, whichmay result in biases in how antimalarial effectiveness is being measured and
reported from sub-Saharan Africa.

Item Type:	Article
Subjects:	QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 256 Antimalarials QX Parasitology > Protozoa > QX 135 Plasmodia WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
Faculty: Department:	Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):	https://doi.org/10.4269/ajtmh.20-1481
Depositing User:	Cathy Waldron
Date Deposited:	25 Mar 2021 10:32
Last Modified:	16 Mar 2022 02:02
URI:	https://archive.lstmed.ac.uk/id/eprint/17296

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