Table 1.

Standardized antimalarial therapeutic efficacy reporting (STARTER)

Section	Item no.	Recommendation
Introduction	1	(a) Describe current policy for the treatment of malaria
Study design and data collection methods
Summary	2	(a) Provide dates and location(s) of study. For locations, include details at the district and city/village level, if available
		(b) Specify target sample size and power calculation
		(c) Define arms by site and drug
		(d) Describe any randomization or blinding procedures
Antimalarial studied and dosing specifics	3	(a) Specify antimalarial manufacturer
		(b) Describe source of medicine and/or quality control measures
		(c) Provide age or weight bands used for dosing
		(d) State whether doses were given with or without food
		(e) State timing of doses and whether all doses (or which doses) were directly observed
Inclusion and exclusion criteria	4	(a) Provide age range
		(b) Specify how fever (or history of fever) was measured and defined
		(c) Present parasite density range for inclusion (if any)
		(d) Specify minimum acceptable hemoglobin value (if any)
Patient follow-up	5	(a) List days participants were followed up and approximate time windows
		(b) Specify treatment of patients in the case of early or late treatment failure
		(c) Describe clinical and laboratory assessments performed at each follow-up visit
Outcome definition	6	(a) Define early and late treatment failure
		(b) Define adequate clinical and parasitological response
		(c) Specify primary efficacy indicator and how it was calculated
		(d) State how new infections, loss to follow-up, protocol violation, and indeterminate results were figured in primary efficacy calculations (e.g., censored, excluded)
Laboratory methods
Microscopy	7	(a) State how slides were prepared
		(b) State how many microscopists read each slide
		(c) State how discrepancies were defined and resolved
		(d) State how parasite density was calculated
Molecular correction (recrudescence vs new infection)	8	(a) Specify markers used for genotyping
		(b) State whether all markers were assessed for all samples
		(c) Describe criteria used to determine new infection vs recrudescence, including both the definition of a match at each marker and the overall definition of recrudescence considering all markers
		For fragment-length polymorphic markers (e.g., msp1, msp2, microsatellites)
		(d) Specify range of fragment size differences that qualified as a match for each marker
		(e) Provide cut-off settings for PCR artefacts and stutter peaks
		(f) State how fragment lengths were measured (e.g., capillary electrophoresis or gel)
		For non-fragment-length polymorphic markers (e.g., SNP-barcodes, amplicon sequencing)
		(g) Describe sequencing methodology
		(h) Provide sequencing depth and cut-offs
		(i) Cite bioinformatics software and workflow
Data and results
Patients reaching study outcomes	9	(a) Provide number of participants enrolled, lost to follow-up, withdrawn, and excluded
		(b) State reasons for exclusion
Participant composition by arm	10	Describe age, sex, initial parasite density, and initial hemoglobin
Outcome by arm	11	(a) Provide % slide positivity amongst patients seen on Day 3 (with Day 0 defined as first day of treatment)
		(b) List number of late treatment failures classified as new infections, recrudescences, or indeterminate
		(c) List number of participants with adequate clinical and parasitological response
		(d) Report day 28 results for arms with follow up ≥ 28 days
		(e) Report day 42 results for all arms with follow up ≥ 42 days
		(f) Provide Kaplan–Meier estimates of efficacy, where new infections and cases with loss to follow up are censored
		(g) Provide estimates and confidence intervals of both uncorrected and PCR-corrected results
		(h) Disaggregate all outcomes by study arm (site, drug, and species)
		(i) Only calculate p-values if study was specifically designed and powered to detect a difference between arms
Genotyping data	12	Provide table or supplementary table of paired full genotyping data (observed alleles at each locus) and classification for each late treatment failure

Essential items to be included in reports of therapeutic efficacy of antimalarials for uncomplicated malaria

Please refer to WHO guidance for antimalarial efficacy monitoring, molecular techniques, and distinguishing reinfection from recrudescence after therapy [2–4]. Commonly found errors in therapeutic efficacy reports have been characterized recently [1, 5].