Chowdhury 2011 BGD.
Methods | Trial design: Cluster‐RCT. Unit of randomization: 5 households. Number of clusters: 6. Entomological data collection: Adult sandfly density was determined in households sampled monthly by counts of vectors either landing rates on exposed body parts of humans acting as baits or collected resting inside buildings (for example, walls). Clinical data collection: Not done. Length of follow‐up: 12 months. Analysis: Analysed at household level. |
|
Participants | Four villages were divided into six geographical areas with high, intermediate or low density of phlebotomine sandflies. Five households were selected from each of the density areas by simple random sampling, yielding a subset of (24 X 5) 120 households that participated in the trial. The assignment to intervention arms was stratified by the average vector density to provide comparable vector density distribution in each arm. Endemic disease: VL caused by L. donovani. |
|
Interventions |
|
|
Outcomes |
|
|
Notes | Country: Bangladesh (Fulbaria subdistrict, Mymensingh district). Trial dates: October 2006 to September 2007. Unclear timing and duration of interventions. Trial sponsor: Funded by a grant from the Centers for Disease Control and Prevention (CDC) Emerging Infections Initiative and by the Special Programme for Research and Training in Tropical Diseases, WHO. Sample size: Calculated. Compliance assessment: Done. Houses were visited monthly to encourage compliance. This trial is 1 of 4 parallel trials in India, Nepal, and Bangladesh that used similar methods and design (Joshi 2009 ASIA). |
|
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. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) participants | Unclear risk | People 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 on loss of clusters. Individual participants were not followed up. |
Selective reporting (reporting bias) | Low risk | All outcome mentioned in the methods were reported in the results. |
Baseline measurements | Low risk | Assignment to intervention arms were stratified by vector density. |
Statistical adjustment for clustering | Low risk | The outcome was rates of phlebotomine sandflies trapped, and the statistical model used a random effect which accounted for clustering within households. |
Other bias | Unclear risk | Trial authors did not provide a conflict of interest declaration. |