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. 2015 Sep 8;2015(9):CD004265. doi: 10.1002/14651858.CD004265.pub3

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
Participants Number: 534 households (267 intervention, 267 control) with 534 children (267 intervention, 267 control)
Inclusion criteria:
  • at least one child aged 6 to 35 months living in the home

  • using wood or solid fuel as main energy source for cooking

  • not being connected to public sewage

  • tenants planning to stay in their home for the next 12 months


Exclusion criteria:
  • the child had any congenital abnormalities or suffered from a chronic debilitating illness

  • families that had two or more households in different geographical areas with migration within sites that lasted more than 6 months during the year (mainly for migratory agriculture practices)


Age: 6 to 35 months
Interventions Intervention (see Table 5 for detailed description):
  1. Hygiene education with small and large group meetings

  2. 51 community clusters received integrated home‐hygiene intervention package


Control:
  1. Psychomotor‐stimulation package

Outcomes
  1. Diarrheal episodes


Not used in this review:
  • Prevalence of cough and fever

  • Duration of days spent ill

  • Average number of days for health care seeking

  • Child growth outcomes (stunting, wasting and underweight)

Notes Location: San Marcos province, Cajamarca region, Peru
Duration of trial: March 2008 to January 2010 (23 months)
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.