Cameron 2013 INA.
Methods | Cluster RCT | |
Participants | Number: 2500 HHs at end of study Inclusion criteria: HHs with children aged < 2 years (and HH with children aged < 5 years where too few HH with aged < 2 years found) |
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Interventions | Intervention (80 subvillages): TSSM which included CLTS to stop open defecation, social sanitation marketing to increase availability of products and services and strengthening the enabling environment at policy and institutional levels. Control (80 subvillages): no intervention |
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Outcomes | Changes in perceptions of consequences of poor sanitation Sanitation improvements (toilet construction and access to improved sanitation) Open defecation practices Diarrhoea prevalence (2‐, 7‐, or 14‐day recall): ≥ 3 stools per day and the stools were loose or watery, or blood or mucous (or both) visible in stool Symptoms: nausea, vomiting, water or soft stools, mucous or blood in stool, refusal to eat, bruising, abrasion, itchy skin or scalp Intestinal parasite infections (Ascaris, Trichuris, hookworm infections) Anthropometry (stunting and wasting) Iron‐deficiency anaemia Cognitive and motor development (communication skills, mobility skills, and social‐personal skills for age) Water source Handwashing practices ARIs |
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Notes | Location: 160 rural subvillages, East Java, Indonesia Length of study: 30 months (August 2008 to February 2011) Publication status: report |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Using a random number generator in STATA, the IE [impact evaluation] team randomly selected 10 treatment and 10 control villages in each district." |
Allocation concealment (selection bias) | Low risk | Quote: "Once the IE team received the sub‐village lists from the district offices for all 20 villages, they told district offices which villages were in the treatment group and which were in the control group." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "179 could not be contacted (86 households in the control group and 93 households in the treatment group)" (8.5% LTFU). |
Selective reporting (reporting bias) | Low risk | Reported all outcomes specified in methods. |
Other bias | Unclear risk | — |
Similarity of baseline outcome measurements | Unclear risk | NA |
Similarity of baseline characteristics | Unclear risk | NA |
Adequate allocation of intervention concealment during the study | Unclear risk | NA |
Adequate protection against contamination | Unclear risk | NA |
Confounders adequately adjusted for in analysis/design | Unclear risk | NA |
Recruitment bias | High risk | Seemed the baseline data collection occurred after assignment to intervention and control. |
Baseline imbalance | Low risk | Quotes: "For the key outcome variables (household water and sanitation condition, as well as children's health variables), balance is achieved." "demographic and socio‐economic characteristics are also similar across treatment and control groups." |
Loss of clusters | Low risk | No loss of clusters reported. |
Incorrect analysis | Low risk | In multivariate analysis adjust for clustering. |