Soto 1995.
Methods | RCT Duration of the trial: 3 to 5 weeks followed by 4 weeks' follow‐up |
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Participants | Colombian Army members stationed in endemic areas | |
Interventions | Insecticide treated clothing versus placebo Treatment arms: ‐ ITC ‒ 86 individuals; ‐ Placebo ‒ 86 individuals. |
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Outcomes | ‐ Participants with clinical malaria confirmed through blood smears or rapid diagnostic tests (P. falciparum or P. vivax); and ‐ Recorded adverse events. |
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Notes | Trial was conducted in the Colombian Amazon. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The randomization process is not described. Quote “troops were randomly assigned to receive either permethrin‐impregnated or non‐impregnated uniforms” |
Allocation concealment (selection bias) | Unclear risk | Poorly described. |
Blinding of participants and personnel (performance bias) Clinical malaria | Low risk | Medical attendants and soldiers were blinded to the intervention. |
Blinding of participants and personnel (performance bias) Adverse events | Low risk | Medical attendants and soldiers were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Adverse events | Low risk | Medical attendants and soldiers were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Clinical malaria | Low risk | Medical attendants and soldiers were blinded to the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed the study and there were no losses to follow‐up, no treatment withdrawals, no trial group changes and no major adverse events. Adherence to instructions (wearing clothes) was not monitored so not possible to assess whether soldiers were compliant. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available and the corresponding author failed to communicate. |
Other bias | Unclear risk | Baseline imbalance Both study arms recruited similar number of soldiers and deployed them to the same endemic area. However, the number of weeks soldiers in each study arm were deployed in the field was not reported per arm. "Each soldier was in the area of endemicity for 3‐8 weeks." |