Table 1 Standardized antimalarial therapeutic efficacy reporting (STARTER)
From: STARTER checklist for antimalarial therapeutic efficacy reporting
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 |