Journal article
Dealing with indeterminate outcomes in antimalarial drug efficacy trials: A comparison between complete case analysis, multiple imputation and inverse probability weighting
P Dahal, K Stepniewska, PJ Guerin, U D'Alessandro, RN Price, JA Simpson
BMC Medical Research Methodology | BMC | Published : 2019
Abstract
Background: Antimalarial clinical efficacy studies for uncomplicated Plasmodium falciparum malaria frequently encounter situations in which molecular genotyping is unable to discriminate between parasitic recurrence, either new infection or recrudescence. The current WHO guideline recommends excluding these individuals with indeterminate outcomes in a complete case (CC) analysis. Data from the four artemisinin-based combination (4ABC) trial was used to compare the performance of multiple imputation (MI) and inverse probability weighting (IPW) against the standard CC analysis for dealing with indeterminate recurrences. Methods: 3369 study participants from the multicentre study (4ABC trial) w..
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Funding Acknowledgements
PD is funded by Tropical Network Fund, Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford. PD is a Susan and George Brownlee Junior Research Fellow at Linacre College, University of Oxford. The WorldWide Antimalarial Resistance Network (PD, KS, RNP, and PJG) is funded by a Bill and Melinda Gates Foundation grant and the ExxonMobil Foundation. JAS is an Australian National Health and Medical Research Council Senior Research Fellow (1104975). RNP is a Wellcome Trust Senior Fellow in Clinical Science (200909). This work was supported in part by the Australian Centre of Research Excellence on Malaria Elimination (ID#1134989). The funders did not participate in the study development, the writing of the paper, decision to publish, or preparation of the manuscript