Azor‐Martinez 2018.
| Study characteristics | ||
| Methods | A cluster‐RCT, controlled, and open study of 911 children aged 0 to 3 years attending 24 DCCs in Almería, Spain, with an 8‐month follow‐up. 2 intervention groups of DCC families performed educational and hand hygiene measures, 1 with soap and water (n = 274), another with hand sanitiser (n = 339), and the control group followed usual hand‐washing procedures (n = 298). Respiratory infection (RI) episode rates were compared through multilevel Poisson regression models. The percentage of days missed were compared with Poisson exact tests. | |
| Participants | A total of 911 children attending 24 DCCs in Almería (Spain). Inclusion criteria: children between 0 and 3 years old enrolled in DCCs and attending for at least 15 hours per week whose parents or guardians had signed an informed consent Exclusion criteria: children with chronic illness or medication that could affect their likelihood of contracting an infection Data were analysed for 911 participants: hand sanitiser group (n = 339), soap and water group (n = 274), and control group (n = 298). |
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| Interventions | 2 intervention groups. 1 group used soap and water, another used hand sanitiser, whilst the control group followed usual hand‐washing procedures. Groups received 1‐hour hand hygiene workshop. See Table 4 for details. | |
| Outcomes | Primary: RI incidence rate Secondary: (1) the presence or absence of at least 1 antibiotic prescription for each new RI episode during the study period (topical antibiotics were excluded), and (2) the percentage of RI absenteeism days in the 3 groups calculated as the ratio of RI absenteeism days to all possible days of attendance DCC absenteeism episode was defined as when a child failed to attend a DCC because of an RI. Respiratory illness was defined as the presence of 2 of the following symptoms during 1 day or the presence of 1 of the symptoms for 2 consecutive days: (1) runny nose, (2) stuffy or blocked nose or noisy breathing, (3) cough, (4) feeling hot or feverish or having chills, (5) sore throat, or (6) sneezing. No safety outcomes reported. |
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| Notes | Government funded | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer randomisation using statistical software for the sequence |
| Allocation concealment (selection bias) | Low risk | Clusters assigned prior to recruitment. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded study |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition minimal and similar in 3 groups |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |