Patil 2014 IND.

Methods	Cluster RCT
Participants	Number: 3039 HHs (5209 children aged < 5 years) (after 15.3% LTFU) Inclusion criteria: HH with ≥ 1 child aged < 24 months at enrolment. For follow‐up, the HH had to have ≥ 1 child aged 21–45 months and were living in the village at the time of baseline. Mean age: intervention group 21.9 months; control group 22.1 months
Interventions	Intervention (40 villages): India Total Sanitation Campaign (subsidies and promotion of individual HH latrines) and Nirmal Vatika (additional subsidies) and support from WSP through TSSM project, which included creation of enabling environment + capacity building to implement CLTS‐based behaviour change methods. Control (40 villages): no intervention.
Outcomes	Toilet coverage, defecation behaviours (including daily open defecation by children (aged < 5 years), hygienic child faeces disposal) Diarrhoea: ≥ 3 loose or watery stools in 24 hours or a single stool with blood/mucous. 7‐day recall in questionnaire at baseline and at end of study. Highly credible gastrointestinal illness Acute lower respiratory illness Bruising/abrasions and itchy skin/scalp (negative control outcomes) Anthropometry (weight for age, height for age, weight for height, MUAC) Anaemia Water quality Child stool parasitology (including helminth present in stool,Ascaris lumbricoides present in stool)
Notes	Location: 80 rural villages in 2 neighbouring districts in Madhya Pradesh, India Length of study: 23 months (25 May 2009 to 25 April 2011) Publication status: journal
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Used public lottery to assign villages to arms.
Allocation concealment (selection bias)	Low risk	Used public lottery to assign villages to arms.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants possible but outcomes were self‐reported so could have been affected by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Field interviewers were not informed of group assignment, but it was possible for them to identify intervention villages during interviews of Block officers or the village secretary." Comment: incomplete blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition was not differential by randomized group and no missing values for main outcomes.
Selective reporting (reporting bias)	Low risk	Report on main outcomes.
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	Follow‐up data which were the data used for analysis were measured in newly recruited HHs that belonged to either intervention or control arms.
Baseline imbalance	Low risk	No major imbalance and the analysis adjusted for the 3 characteristics that had slight imbalance between groups.
Loss of clusters	Low risk	No loss of clusters.
Incorrect analysis	Low risk	Adjusted for clustering in the analyses.