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. |
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Participants | Adults and children living in malaria‐endemic regions. Participants were not screened at start for P. vivax. |
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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) |
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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. |
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Notes | Trial was conducted in Ratanakiri province, Cambodia. Trial registration number: NCT01663831 Funded by the Bill and Melinda Gates Foundation. |
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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 |