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. 2015 Aug 6;2015(8):CD008736. doi: 10.1002/14651858.CD008736.pub2

Costa 2007 BRA.

Methods Trial design: Cluster‐RCT.
Unit of randomization: Geographic area.
Number of clusters: 34 geographic areas.
Entomological data collection: Not done.
Clinical data collection: Immunological tests by ELISA in blood samples to detect antigen from Leishmania chagasi, at one year.
Length of follow‐up: 6 to 12 months.
Analysis: Analysed at cluster level.
Participants The central area of Teresina (Brazil) was divided in 34 geographic areas (blocks) randomly allocated to the 4 types of interventions (367 inhabitants; 213 seronegatives/154 seropositives at the beginning).
Endemic disease: VL caused by L. infantum (L. chagasi).
Interventions
  1. Spraying houses and animals pens with insecticide.

  2. Spraying houses and eliminating infected dogs.

  3. Combination of spraying houses and animal pens and eliminating infected dogs.

  4. Spraying houses (considered as no treatment in the publication).


Description of spraying: Pyrethroid insecticide in internal walls (all of 3 m height walls were sprayed) of houses (household spraying) and outdoors close to the houses.
The elimination of infected dogs was decided if indirect immunofluorescence test was more or equalled 1:40.
Outcomes
  1. Cases of seropositivity by ELISA assessed at one year.

Notes Country: Brazil (Teresina, Itararé quarter).
Trial dates: 1995 to 1996.
Trial sponsor: No source of funding reported.
Sample size: Not calculated.
Compliance assessment: Not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail was reported about the method used to generate the allocation sequence. "Os lotes foram alocados aleatoriamente a 4 tipos de intervenção".
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding (performance bias and detection bias) 
 participants Unclear risk Not reported.
Blinding (performance bias and detection bias) 
 investigators Unclear risk Not reported.
Blinding (performance bias and detection bias) 
 Assessors Unclear risk Not reported.
Incomplete outcome data (attrition bias) 
 All outcomes High risk No information on loss of clusters. There were 44% of lost of participants to follow‐up (93/213) although the authors did not specify to which group these people belonged.
Selective reporting (reporting bias) Low risk All outcomes mentioned in the methods were reported in the results.
Baseline measurements High risk The prevalence of seropositivity at baseline were similar in the intervention areas but was significantly lower in the control area (only IRS). Groups were not comparable at baseline. Prevalence of infection was similar within the three treatments, but not between the treatments and the control group (lower prevalence in control group).
Statistical adjustment for clustering Low risk Cluster adjustment was performed as the model considered the effect of aggregation of individuals in batches and used robust variance estimates.
Other bias Unclear risk Trial authors did not provide a conflict of interest declaration.