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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Risk of bias for analysis 2.1 Diagnosis of mental disorders at 7‐24 months.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Tripathy 2010 Low risk of bias 1a.1: PY; 1a.2: Y. Note: Randomization was obtained through the drawing of folded papers in the presence of extrnal observers in order to convince local communities to participate.
1.3: NI. Note: No useful information is reported to evaluate this element
1b.1: N: particpants were recruited after randomization;
1b.2: PN. Note: there is no evidence to suggest that selection of individual participants was affected by knoweldge of the intervention assigned to the cluster;
1b.3:PN. Note: groups were comparable at baseline, the observed differences are compatible with chance in a cluster design.		 Low risk of bias 2.1a: NI; 2.1b: PY; 2.2: PY. Note: No information provided on whether participants knew that they were in a trial, due to the nature of the intervention they (as those delivering the intervention) were aware of intervention allocation.
2.3: PN. Note: No evidence to suggest deviations from the intended intervention that arose because of the trial context
2.4: NA.
2.5: NA.
2.6: Y. Note: Data was analysed on an intention‐to‐treat basis.
2.7: NA.		 Low risk of bias 3.1a: PY. Note: data was available for all clusters; 3.1b: Y. Note: data was available for nearly all participants within clusters, Quote: "All 18 selected clusters
had the intervention. Loss to follow‐up after birth as a result of migration or refusal of interview was 86 (<1%)
of 9770 women in intervention clusters and 173 (2%) of 9260 in control clusters."
3.2: NA.
3.3: NA.		 Some concerns 4.1: PN. Note: The outcome measure is widely established and validated for use across different contexts, included the one of the trial.
4.2: PN. No evidence to suggest that.
4.3a: NI; 4.3b: PY. Note: No information provided on whether participants knew that they were in a trial, participants were most likely aware of the group allocation due to the nature of the intervention
4.4: PY, 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, protocol and final article not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. Further outcomes than those mentioned in the protocol were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods and results were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.