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. |
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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. |
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Interventions |
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Outcomes |
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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. |
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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. |