Hartinger 2010 PER.
Methods | Cluster‐RCT Allocation sequence: unclear Allocation concealment: unclear Blinding: participants and assessors Inclusion of participants in the analysis: unclear Length of follow‐up: 12 months Cluster‐adjustment method: unclear |
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Participants | Number: 534 households (267 intervention, 267 control) with 534 children (267 intervention, 267 control) Inclusion criteria:
Exclusion criteria:
Age: 6 to 35 months |
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Interventions | Intervention (see Table 5 for detailed description):
Control:
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Outcomes |
Not used in this review:
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Notes | Location: San Marcos province, Cajamarca region, Peru Duration of trial: March 2008 to January 2010 (23 months) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized "...using covariate‐based constrained randomization as proposed by Moulton (2004)". Researchers went to extra lengths to ensure integrity of the randomizations. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "As a strategy to reduce non‐blinding bias, a child psychomotor development intervention was implemented in the control arm as an equivalent to the IHIP in the intervention arm". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "...and data collection was done by an independent team of field workers, which was not part of the initial education and re‐enforcement of the interventions during the follow‐up period". We consider this an attempt to blinding outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Researchers presented a detailed account of the randomization and follow‐up in a PRISMA flow diagram. |
Selective reporting (reporting bias) | Low risk | None observed. |
Other bias | Low risk | None observed. |