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

Feliciangeli 2003 VEN.

Methods Trial design: Paired RCT.
Unit of randomization: Houses.
Number of houses: 40.
Entomological data collection: Sandflies were collected by CDC miniature light traps that were suspended from the ceiling at about 2 m from the ground floor and left overnight in the bedrooms of control and sprayed houses.
Clinical data collection: Not done.
Length of follow‐up: 79 days.
Analysis: Analysed at house level.
Participants Included houses were made of mixture of mud and straw supported by a structure of sticks, called "bahareque" in the local colloquial language (24%), concrete blocks (26%) and wood (26%).
Endemic disease: CL caused by L. braziliensis and L. mexicana.
Interventions
  1. IRS using lambdacyhalothrin 10% water‐dispersible powder at a dosage of 25 mg/m². Insecticide application was made using a Hudson X‐Pert hand compression sprayer on the internal wall surface of the houses and on the lower surface of large furniture.

  2. Control group (not described).

Outcomes
  1. Estimates of the density of the vectors assessed at 79 days.

Notes Country: Venezuela (El Ingenio).
Trial dates: December 1996 to February 1997.
Trial sponsor: STD Programme of the Commission of the European Communities (DG: XII: Science, Research and Development) (Contract no. TS3.CT.930247), the Consejo de Desarrollo Cientifico y Humanístico de la Universidad de Carabobo (CDC‐UC, Project FCS‐91‐044), and the Dirección de Malariologia y Saneamiento Ambiental, Ministerio de Salud y Asistencia Social, Maracay, Venezuela. One author of the trial (D. Campbell‐Lendrum) was supported by the Wellcome Trust.
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 details were reported about the method used to generate the allocation sequence. "These were paired according to structure and randomly assigned to the control group (n = 20: B = 7, C = 6, and W = 7) or the group to be sprayed (n = 20: B = 7, C = 7, and W = 6)".
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding (performance bias and detection bias) 
 participants Unclear risk Individual participants not assessed in this trial.
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 if all houses were analysed. Individual participants not assessed.
Selective reporting (reporting bias) Low risk All outcomes mentioned in the methods were reported in the results.
Baseline measurements Unclear risk No baseline information. Questionnaire done, but information not provided.
Statistical adjustment for clustering Unclear risk No adjustment was done, however the outcome was sandfly density and the analysis was conducted at the household level, which is the unit of randomization, thus removing any clustering effects.
Other bias Unclear risk Trial authors did not provide a conflict of interest declaration.