Pickering 2015 MLI.
| Methods | Cluster RCT | |
| Participants | Number: 6319 children aged < 5 years at end of study (4031 HHs) (after 11.1% LTFU) Inclusion criteria: HHs with ≥ 1 child aged < 10 years |
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| Interventions | Interventions (60 villages, 2365 HHs): CLTS which used participatory methods to eliminate the practice of open defecation in rural HHs and promote building of toilets. No hardware or subsidies was provided to HHs. Control (61 villages, 2167 HHs ): no intervention |
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| Outcomes | Diarrhoea (2‐day and 2‐week prevalence): ≥ 3 loose or watery stools per 24 hours Symptoms: loose stool by chart, blood in stool, vomit, fever, cough, congestion, difficulty breathing, earache, and bruising (negative controls) Anthropometry (height for age, weight for age) Self‐reported all‐cause and cause‐specific mortality Sanitation access and defecation behaviours (including open defecation by children and use of potty) Drinking water quality Hand hygiene |
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| Notes | Location: 121 villages in Koulikoro district, Mali Length of study: 24 months (April 2011 to May 2013) Publication status: published |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "One of the study investigators (MLA) used a computer‐generated algorithm that randomly assigned villages (1:1) to treatment and control groups." |
| Allocation concealment (selection bias) | Low risk | Quote: "The algorithm generated a random number for each village, which was then used to sort villages and assigned the first 60 to the intervention group and the remaining 61 to the control group." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Masking of participants was not possible because of the nature of the intervention." |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Field staff were not informed of village treatment status, but could have inferred this during the follow‐up from the presence of signage showing village certification of an open defecation free status." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar percentage LTFU (11.8% of HHs in control group and 10.4% in intervention group). |
| Selective reporting (reporting bias) | Low risk | All outcomes prespecified in methods were reported. |
| 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 | Low risk | The participants were unaware whether they were randomized to CLTS or control villages. |
| Baseline imbalance | Low risk | No substantial differences in baseline characteristics were observed. Quote: "access to sanitation and an improved water source were similar across groups. Baseline diarrhoeal and respiratory illness symptoms were at higher prevalence in villages assigned to the CLTS intervention." |
| Loss of clusters | Low risk | No loss of villages reported. |
| Incorrect analysis | Low risk | In the analysis used (quote) "robust standard errors (the Huber‐White Sandwich estimator) to account for correlated outcomes at the village level." |