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

Zomer 2012 NED.

Methods Cluster‐RCT
Allocation sequence: unclear
Allocation concealment: not described
Blinding: open
Inclusion of participants in the analysis: adequate
Length of follow‐up: November 2011 to March 2012
Cluster‐adjustment method: adjusted
Participants Number: 71 day‐care centres (DCC) (intervention 36; control 35) with 545 children (278 from 34 intervention DCC and 267 from 35 control DCC)
Inclusion criteria: children attended the DCC at least two days a week, aged between 6 months and 3 to 5 years, intended to attend the DCC throughout the trial period, if their parents consented, were Dutch speaking and had access to e‐mail or regular post.
Exclusion criteria: if the child had chronic illness, if the child was on medication that predisposed him/her to infection and if was sibling is taking part in the trial (one per child per family participant)
Age: children between 6 months to 60 months
Interventions Intervention (see Table 5 for detailed description):
  1. Hand hygiene products provided free of charge.

  2. Training on Dutch Hand Hygiene guidelines with booklet on its content distributed.

  3. Training sessions aimed at goal setting and formulating specific hand hygiene improvement activities.

  4. Provision of posters and stickers to children and caregivers as reminders and cue to action.


Control:
  1. No intervention (They continued their usual hand hygiene practice).

Outcomes
  1. Incidence of gastrointestinal infections (incidence of diarrhoea specifically).

  2. Caregivers hand hygiene compliance.


Not used in this review:
  • Incidence of respiratory infections

Notes Location: Rotterdam‐Rijnmond, Gouda and Leiden regions of Netherlands
Duration: September 2011 to April 2012 (7 months)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stratified randomized allocation.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not described.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 553 children included in the trial; 545 included in the analysis.
Selective reporting (reporting bias) Unclear risk Not observed.
Other bias High risk There were some differences in baseline characteristics between intervention and control group.
"...the crude incidence of diarrhoeal episodes differed between intervention and control DCCs at baseline..."

aSee Table 5; Table 6; and Table 7 for a detailed description of the interventions.