Kotch 2003 USA.
Methods | Cluster‐RCT Allocation sequence: unclear Allocation concealment: not stated Blinding: open Inclusion of participants in the analysis: unclear Length of follow‐up: 7 months (November 2002 to May 2003) Cluster‐adjustment method: unclear |
|
Participants | Number: 46 child‐care centres (23 intervention, 23 control) with 388 infants and toddlers Inclusion criteria:
Exclusion criteria: not stated Age: Infants and toddlers < 36 months |
|
Interventions | Intervention (see Table 5 for detailed description):
Control:
|
|
Outcomes |
Not used in this review:
|
|
Notes | Location: North Carolina, America Duration: September 2002 to May 2003 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Applied different statistical tests for different nature of variables: "No control variables are included in these descriptive comparisons". |
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 described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Attrition form the intervention and control groups during the course of the trial was comparable". |
Selective reporting (reporting bias) | Low risk | None observed. |
Other bias | High risk | "Two significant differences between the 2 trial groups were noted. The total number of children and the number of boys were larger in the intervention classrooms. These differences may have reduced the overall effect of the intervention, because number of children per classroom is a risk factor, and boys tend to stay in diapers longer. In addition, control centres were working hard to get their perceived reward (the free equipment that they were promised at the end of the trial). These 3 factors should have reduced the difference in outcomes between the intervention and control groups, suggesting that the significant differences in illnesses and absences that were found favouring the intervention group are all the more impressive". |