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. 2019 May 23;2019(5):CD012688. doi: 10.1002/14651858.CD012688.pub2

Keating 2011.

Methods Study design: cRCT with 2 intervention arms
Unit of allocation: clusters (villages)
Number of units: 58 randomized villages in each arm
Outcome assessment/surveillance type: 15 houses within each village were randomly selected to serve as ultimate sampling units, giving 870 houses in each arm of the study. Household residents were given a questionnaire and took a RDT (Carestart) for malaria infection. Positive tests were confirmed by blood smear microscopy.
Length of follow‐up: 3–4 months post spraying (6–15 October 2009)
Adjustment for clustering: yes
Participants Number of participants: 7273 resided in participating houses. In the paper, 5508 total from Table 2 but 5502 stated in results
Population characteristics: the distribution of participants living in houses located in treatment and control villages was similar on sex, age, employment status of the respondent, and education level
Withdrawal and loss to follow‐up: test refusal rates differed between treatment (8.5%) and control (12.7%) arms (P < 0.05)
Interventions Comparison: IRS + ITN versus ITN alone
IRS:
Active ingredient and dosage: DDT 1–2 g/m²
Formulation: wettable powder
Frequency of spraying: once, June–July 2009
Coverage: minimum 80% target (84.8% of households sampled sprayed within 12 months)
Buffer size between clusters: > 5 km between intervention and control villages. in 2 instances whereby a treatment village was too close (< 5 km) to a control village, the closest village > 5 km was selected into the control arm.
ITN: any ITN that was treated at least once in last 11 months, or was an LLIN
Coverage: measured as people living in household owning ≥ 1 ITN: 75.8% (range 74.2% to 77.4%)
Compliance: measured as individuals using ITN in the previous night: 50.7% (range 48.6% to 52.8%)
Control: ITN only as above
Coverage: measured as people living in household owning ≥ 1 ITN: 72.0% (range 70.2% to 73.7%)
Compliance: measured as people using ITN in the previous night: 46.2% (range 43.9% to 48.6%)
Cointerventions: larval habitat management and continued case management
Outcomes Malaria prevalence: parasite infection and febrile illness data from all household residents > 1 month old requiring a positive RDT (Carestart) and a positive thick blood film
Location profile Study location: Gash Barka, West lowlands of Eritrea, mostly rural and agricultural. Altitudes were 1500–3000 m above sea level. 30% of the country's population lived here. Approximately 200 mm per year precipitation. Temperatures were extremely hot and dry climatic conditions with seasonal precipitation, concentrated in the summer months.
Malaria endemicity: season with peak transmission occurring September–November. Smaller malaria season March–April
EIR: study references an estimated annual range of 0–70.6 (Shililu 2004).
Population proximity/density: not reported
Plasmodiumspp:P falciparum with rare reports of P vivax
Vector profile Primary (and secondary) vector species:An arabiensis and An gambiae s.s.
Vector behaviour (nature, stability, adult habitat, peak biting times, exophilic/endophilic, exophagic/endophagic, anthropophilic/zoophilic): not reported
Phenotypic resistance profile: not reported
Genotypic resistance profile: not reported
Method of mosquito collection: no entomological data collected
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Fifty‐eight (58) villages within Gash Barka were randomly…"
Comment: however randomization procedure was not described.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding of participants and personnel (performance bias) 
 Incidence of malaria Low risk Outcome not reported.
Blinding of participants and personnel (performance bias) 
 Prevalence of malaria Low risk Participants and personnel were not blinded to the intervention status; however, the outcome would not be affected by this knowledge.
Blinding of outcome assessment (detection bias) 
 Incidence of malaria Low risk Outcome not reported.
Blinding of outcome assessment (detection bias) 
 Prevalence of malaria Low risk Outcome assessors were not blinded to the intervention status; however, the outcome was measured using an objective tool (Carestart RDT) and would not be affected by this knowledge.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Only one time point used, inapplicable
Selective reporting (reporting bias) Low risk The study only intended to report the relationship between IRS and parasite prevalence and this outcome was provided. Numbers appeared correct, assumed typographical error in table 2, should read 5502.
Recruitment bias Low risk Households for survey were randomly selected.
Baseline imbalance Unclear risk Baseline data were not displayed but due to randomization this should be accounted for.
Loss of clusters Low risk No mention of lost clusters.
Incorrect analysis Low risk Adjustment for clustering was done.
Comparability with RCTs randomizing participants Low risk Because the intervention is expected to have community level impact as well as individual impact, cRCTs are the most appropriate study design to capture this.
Other bias Low risk No other biases.