Table 7.
A best-practice checklist identifying the minimum set of essential items to be included in articles reporting therapeutic efficacy of antimalarials for uncomplicated Plasmodium falciparum infection
| 1. Summary of study design and methods |
| 1.1 Summary |
| Dates and location(s) of study |
| Target sample size and rationale |
| 1.2 Antimalarial studied and dosing specifics |
| From which manufacturer |
| Whether the WHO supplied the medicine or if quality control was performed on the antimalarial(s) |
| Dosage details (e.g., in mg/kg) or given as tablet in age or weight bands; if the latter, details of bands |
| With or without food |
| Whether all doses were directly observed |
| How long subject was monitored after dosing |
| What was done in case of vomiting a dose |
| 1.3 Inclusion criteria |
| How malaria was diagnosed at the health facility |
| Age range |
| Fever specifics |
| How measured and defined (site: axillary, oral, etc; number, e.g., > 37.5°C) |
| Parasite density range required for study inclusion |
| Hemoglobin range |
| 1.4 Exclusion criteria |
| 1.5 Patient follow-up |
| Days participants followed up and in what approximate time windows |
| Treatment of patients in the case of early or late treatment failure |
| Laboratory tests performed at each follow-up visit |
| What else was done (e.g., clinical assessment) |
| 1.6 Definition of main outcome measures |
| Early and late failure definitions |
| Adequate clinical parasitological response definition |
| Whether new infections were eliminated from the per-protocol calculation |
| How loss to follow-up, protocol violation, indeterminate results, etc., were figured in per-protocol and Kaplan–Meier calculations |
| Kaplan–Meier methodology described |
| 1.7 Other |
| Data management: Which platform and any other data entry specifics such as double entry, data cleaning, and analysis |
| Human subjects review specifics |
| Consent/assent specifics |
| Funding source |
| Data availability statement |
| 2. Methods |
| 2.1 Microscopy |
| How were slides prepared (e.g., staining, thick, and thin) |
| How were slides read (e.g., how many readings, what defines a discrepancy, and what was done if there was a discrepancy) |
| How was parasite density calculated, including what parameter (e.g., white blood cells) was used and what assumption about density was assumed for that parameter |
| 2.2 Molecular correction (recrudescence vs new infection) description |
| Laboratory methods used to determine the presence of parasitemia in a late failure (e.g., microscopy and PCR) |
| Whether msp1/msp2/glurp, neutral microsatellites, or other markers were used |
| Which specific loci or microsatellites used |
| Whether background allele frequencies were obtained |
| Whether markers were assayed sequentially (e.g., msp1 and msp2 results used to determine whether glurp should be investigated) |
| Laboratory criteria/methods used to determine new infection vs recrudescence |
| Definition for new infection vs. recrudescence |
| Explicit mention of how recrudescence was defined when multiple alleles were present at day 0 or day of failure (i.e., explicitly state that presence of at least one shared allele was sufficient to define a match) |
| Range of fragment size that qualifies as a match for each marker |
| Cutoff settings for PCR artefacts and stutter peaks |
| Whether capillary electrophoresis by an automated sequencer or gels were used (e.g., to determine msp1 fragment length) |
| 3. Data and results |
| 3.1 Number enrolled, lost to follow-up, withdrawn, and protocol violations |
| Missing data and reason |
| 3.2 Participant composition by arm |
| Age, gender, initial parasite density, and initial hemoglobin |
| 3.3 Outcome by arm |
| Slide positivity on day 3 |
| Late treatment failures reported as clinical or parasitological |
| Late treatment failures reported as new infections or recrudescences |
| Adequate clinical and parasitological response |
| If day 42 results are provided (e.g., for dihydroartemisinin–piperaquine or artesunate–pyronaridine), then day 28 results are also reported |
| For per-protocol results, provide numerators and denominators, not just percentages |
| Kaplan–Meier estimates included |
| Two sets of results with confidence intervals, uncorrected, and PCR-corrected |
| Data collected at different sites reported by site and not just aggregated |
| Table or Supplemental Table of raw paired genetic data and classification for each late treatment failure |