Rowland 1999.
Methods | Cluster‐RCT Unit of randomization: household ICC was not reported. Trial duration: 16 weeks from July to November 1996 |
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Participants | Adults or children living in malaria‐endemic regions Participants were not screened at start for P. vivax. |
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Interventions | Treated clothing in the form of chaddars (permethrin 0.1 mg/cm²) versus placebo Co‐interventions: none Treatment arms: ‐ Treated chaddar arm: 51 households (438 individuals) ‐ Placebo arm: 51 households (387 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 with Afghan refugees in Adizai settlement in north‐western Pakistan. Funded by HealthNet International’s Malaria and Leishmaniasis control and research programme. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generator used against list of health centre family registration cards. “To achieve this sample size, 20% of refugee households were selected using a random number generator against the list of health centre family registration cards.” |
Allocation concealment (selection bias) | Unclear risk | Not described. “Selected households were randomly divided into intervention and placebo groups, and if more than one family lived in a single house all families therein were allocated to the same treatment group.” |
Blinding of participants and personnel (performance bias) Clinical malaria | Low risk | Participants and staff were blinded. “Field workers were under the assumption that both placebo and permethrin were effective. Health centre staff did not know which families were in which group.” |
Blinding of participants and personnel (performance bias) Adverse events | Low risk | Participants and staff were blinded. “Field workers were under the assumption that both placebo and permethrin were effective. Health centre staff did not know which families were in which group.” |
Blinding of outcome assessment (detection bias) Adverse events | Low risk | “Health centre staff did not know which families were in which group" |
Blinding of outcome assessment (detection bias) Clinical malaria | Low risk | “Health centre staff did not know which families were in which group" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated how many people were lost to follow‐up, or how/if this was measured. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available and author failed to communicate with the review team. |
Other bias | Low risk | Baseline imbalance Study arms had similar baseline characteristics. |