Table 4.

Statistical methods used by therapeutic efficacy studies from sub-Saharan Africa for molecular correction

	n	N	%
Study references WHO protocol for classification of treatment outcome	233	279	84
Explicitly cites 2003 protocol	126	279	45
Explicitly cites 2009 protocol	80	279	29
Study presents the Kaplan–Meier survival analysis for corrected efficacy*	79	221	36
Study presents per-protocol analysis for corrected efficacy*	200	221	90
Explicitly describes how new infections were considered in the per-protocol analysis†	39	197	20
How new infections were considered in per-protocol analysis, as verified retrospectively by abstractors†
Excludes new infections (consistent with WHO recommendations for per-protocol analysis)	53	197	27
New infections coded as adequate clinical and parasitological response	118	197	60
Does not provide clear enough description	26	197	13
Study presents analysis consistent with WHO recommendations (Kaplan–Meier or per-protocol excluding new infections)	99	221	45

N = number of articles assessed; n = number of articles with a finding.

^*Among studies reporting therapeutic efficacy outcome with molecular correction.

^†Denominator excludes one study where definitions differed by site and two studies with no new infections.