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. 2018 Feb 6;2018(2):CD011595. doi: 10.1002/14651858.CD011595.pub2

Sluydts 2016.

Methods Cluster‐RCT
Unit of randomization: cluster of houses
ICC was calculated per survey; survey 4 ICC was 0.0294.
Trial duration: approximately 20 months from April 2012 until November 2013 inclusive.
Participants Adults and children living in malaria‐endemic regions.
Participants were not screened at start for P. vivax.
Interventions Picaridin KBR3023 (topical repellent) versus no treatment
Picaridin 10% for children < 10 years and Picaridin 20% in individuals < 10 years
Co‐interventions: LLINs
Treatment arms:
‐ Picaridin KBR3023 arm ‒ 49 clusters from 57 villages (5642 households, 25,051 individuals)
‐ No treatment arm ‒ 49 clusters from 56 villages (5287 households, 23,787 individuals)
Outcomes ‐ Participants with clinical malaria confirmed through blood smears or rapid diagnostic tests (P. falciparum or P. vivax);
‐ Participants with malaria parasitaemia confirmed through thick or thin blood smears, mRDTs or PCR (P. falciparum or P.vivax);
‐ Adherence to regular usage of the intervention through self‐reporting and observational studies; and
‐ Recorded adverse events.
Notes Trial was conducted in Ratanakiri province, Cambodia.
Trial registration number: NCT01663831
Funded by the Bill and Melinda Gates Foundation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random sequence, calculation of restriction factor, and validity matrix was carried out in R using “onemillion_random.RData”.
Allocation concealment (selection bias) Low risk All clusters were allocated a treatment at start using a computer generated random sequence.
Blinding of participants and personnel (performance bias) 
 Parasitaemia High risk There was no placebo given to control group.
Blinding of participants and personnel (performance bias) 
 Clinical malaria High risk There was no placebo given to control group.
Blinding of participants and personnel (performance bias) 
 Compliance High risk There was no placebo given to control group so it is unclear how compliance might have been affected. Control group was given LLIN and intervention group was given a topical repellent in addition to the LLIN. It is possible that participants felt they would be protected by the repellent and so would choose not to use their bed net.
Blinding of participants and personnel (performance bias) 
 Adverse events High risk There was no placebo given to control so those given repellent lotions might have felt more likely to suffer adverse effects.
Blinding of outcome assessment (detection bias) 
 Parasitaemia Low risk Parasitaemia was measured by PCR which is an objective test.
Blinding of outcome assessment (detection bias) 
 Compliance Unclear risk Compliance was only measured in the treatment arm because there was no placebo.
Blinding of outcome assessment (detection bias) 
 Adverse events High risk Adverse effects were self‐reported and could have been influenced by the participant knowing that he/she had been given a fully effective mosquito repellent.
Blinding of outcome assessment (detection bias) 
 Clinical malaria Unclear risk The trial was not placebo‐controlled: individuals that received the repellent could have mentioned this to medical staff and influenced their diagnosis of clinical malaria.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition was similar between groups.
Selective reporting (reporting bias) Low risk Reporting was done according to protocol.
Other bias Low risk Baseline imbalance.
Restrained randomization controlled for baseline imbalances