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

Werneck 2014 BRA.

Methods Trial design: Cluster‐RCT.
Unit of randomization: Geographic area.
Number of clusters: 40 geographic areas.
Entomological data collection: Not done.
Clinical data collection: Conversion of the Montenegro skin test (MST) at 18 months of follow‐up.
Length of follow‐up: 18 months.
Analysis: Analysed at cluster level.
Participants Ten localities in 7 neighbourhoods of the city of Teresina (Brazil) were divided into blocks, each containing an average of 60 residences. For each locality, 4 blocks were selected to minimize the risk of cross‐contamination of interventions. Eligible participants were residents of selected blocks aged 1 year or above with no history of VL. The 40 geographic areas (blocks) randomly allocated to the 4 types of interventions (697 subjects MST‐).
Endemic disease: VL caused by L. chagasi (L. infantum).
Interventions
  1. Spraying households and residential annexes with insecticide.

  2. Elimination of infected dogs.

  3. Combination of spraying and eliminating infected dogs.

  4. No intervention.


Description of spraying: performed according to the routine of the VL Control Program of the Zoonosis Control Center of the Teresina City Health Department. Interventions were delivered in the selected blocks every 6 months, for three times, beginning just after each household visit. The elimination of infected dogs was decided if indirect immunofluorescence test was more or equalled 1:40.
Outcomes
  1. Cases of infection by L. infantum at 18 months determined by conversion of the MST (MST‐ at the beginning) or diagnosis of active VL.

Notes Country: Brazil (Teresina, Itararé quarter).
Trial dates: January 2004 to December 2006.
Trial sponsor: Funded by Health Surveillance Unit from the Brazilian Ministry of Health. One author was partially funded by the Brazilian Research Council (CNPq 306267/2010‐1 and 202088/2012‐0). The founders had no role in trial design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors have declared that no competing interests exist.
Sample size: Calculated.
Compliance assessment: Not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Allocation was performed as follows: (a) for each locality, a number was assigned to each block, (b) the intervention schemes were ordered as described above, and (c) using the command "sample" in Stata, the first block sampled was allocated to intervention (i), the second to intervention (ii) and so on. At the end, each intervention scheme was allocated to a total of ten blocks throughout the ten selected localities."
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 Unclear risk No information on loss of clusters. "Losses to follow‐up varied from 35.7% to 40.7% between intervention groups, but no statistically significant difference was found comparing each intervention group with the control group (all P values >0.3)."
Selective reporting (reporting bias) High risk The trial authors' original plan was to use IFAT test at 6 and 12 months, but due to operational problems, data on IFAT results were not considered valid for the analysis, and serology was not used as a marker of infection in the trial. Problems with serology were poor sensitivity and reproducibility ("For instance, among the 951 subjects for which an IFAT result was available at baseline, only 16 (1.68%) were positive"). The authors decided not to use IFAT results in the trial and relied on conversion of the MST at 18 months of follow‐up as the only outcome measure, since no clinical cases of VL were detected among the studied population.
Baseline measurements Unclear risk A table shows the distribution of selected baseline socio‐demographic and environmental characteristics for each intervention group. The dog culling groups showed "higher mean years of living in the residence and a smaller percentage of households with a chicken shed in the peri‐domestic environment as compared to the control group (P < 0.015 and P < 0.046, respectively). No other statistically significant difference with any variables or groups was detected."
Statistical adjustment for clustering Low risk "Using Poisson population‐average models from generalized estimating equations with robust variance, an exchangeable correlation model, and designating each block as the clustering level".
Other bias Low risk Trial authors declared no competing interests. The trial was funded by Health Surveillance Unit from the Brazilian Ministry of Health. GLW was partially funded by the Brazilian Research Council (CNPq 306267/2010‐1 and 202088/2012‐0). The founders had no role in trial design, data collection and analysis, decision to publish, or preparation of the manuscript.