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

Hill 2007.

Methods Cluster‐RCT
Unit of randomization: household
ICC was not reported.
Trial duration: 6 months from March to September 2003.
Participants Adults or children living in malaria‐endemic area
Interventions Topical repellent lotion containing 30% PMD versus placebo lotion.
Co‐interventions: LLINs
Treatment arms:
‐ Repellent arm (30% PMD) + LLINs: 424 households (1967 individuals)
‐ Placebo arm + LLINs: 436 households (2041 individuals)
Outcomes ‐ Participants with malaria parasitaemia confirmed through mRDTs (specific to P. falciparum);
‐ All‐cause fever;
‐ Self‐reported adherence to regular usage of the intervention; and
‐ Recorded adverse events.
Notes Conducted in the Bolivian Amazon, Vaca Diez and Pando Provinces
Trial registration number: NCT00144716
Funded by Gates Malaria Partnership grant from London School of Hygiene and Tropical Medicine
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Sequence generation was not random.
“Field staff followed the strict inclusion criteria to randomise participants at the household level following a basic sequential alternate A/B/A/B regimen. Field staff and study participants were blind to the group allocation.”
Allocation concealment (selection bias) High risk Sequence generation was alternated. Personnel knew which treatment was given next.
“Field staff followed the strict inclusion criteria to randomise participants at the household level following a basic sequential alternate A/B/A/B regimen. Field staff and study participants were blind to the group allocation.”
Blinding of participants and personnel (performance bias) 
 Parasitaemia Low risk Field staff and participants were blinded to the treatment allocation.
Blinding of participants and personnel (performance bias) 
 All‐cause fever Low risk Field staff and participants were blinded to the treatment allocation.
Blinding of participants and personnel (performance bias) 
 Compliance Low risk Field staff and participants were blinded to the treatment allocation.
Blinding of participants and personnel (performance bias) 
 Adverse events Low risk Field staff and participants were blinded to the treatment allocation.
Blinding of outcome assessment (detection bias) 
 Parasitaemia Low risk Primary outcome is objective (mRDT result), so although it is not described if the outcome assessor is blinded, lack of blinding was unlikely to bias the results.
Blinding of outcome assessment (detection bias) 
 Compliance Unclear risk Blinding of outcome assessment for adherence to intervention is unclear.
Blinding of outcome assessment (detection bias) 
 All‐cause fever Unclear risk Blinding of outcome assessment for all‐cause fever is unclear.
Blinding of outcome assessment (detection bias) 
 Adverse events Unclear risk Blinding of outcome assessment for adverse events is unclear.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The number of participants lost to follow‐up was similar between treatment arms.
Selective reporting (reporting bias) Low risk All the outcomes set to be measured were reported.
Other bias High risk Baseline imbalance
“There were no significant differences in most household characteristics (number of household members, roof material, water source, heating source, or possession of electricity, fridge, and radio) between the two groups (data not shown), but households allocated to the repellent group were slightly more likely to own a television than those allocated to the placebo group (P=0.056) (table 1). There were also no significant differences in age or sex between the groups but at baseline more participants in the repellent group were positive for P. falciparum (P=0.065) (table 1).”