Martin‐Madrazo 2012.
| Methods | Design: Cluster‐randomised trial Study period: January 2009 to December 2009 3‐month baseline (first observation) then follow‐up (second observation) 6 months after intervention, although duration of data collection in the latter period was not specified Spain |
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| Participants | Healthcare workers in 11 primary healthcare centres | |
| Interventions | Multimodal strategy based on WHO: posters, education sessions, and availability of ABHR Control: no intervention |
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| Outcomes | Hand hygiene compliance, defined as number of hand hygiene opportunities taken by number of opportunities observed | |
| Notes | Unit of analysis error: analysed by healthcare worker type, not cluster, and inappropriate correction for missing data 10 opportunities were observed for each healthcare worker at each observation period Unlikely observer effect as participants did not know what outcome was being measured Funding source: Istituto de Salud Carlos III, Ministry of Health of Spain Declaration of interest: None |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | EPIDAT3 program used to randomly select centres for each arm (reported in previous article listed in references) |
| Allocation concealment (selection bias) | Low risk | Unit of allocation was the centre and performed at the start of study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included reminder posters so participants aware of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Observer was blinded (reported in discussion) and participants were unaware hand hygiene was being observed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data (missed opportunities) unlikely to be very different in different arms Similar loss to follow‐up in both groups |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | High risk | Additional measures taken for H1N1 |
| Baseline outcomes | Low risk | Similar hand hygiene compliance at baseline |
| Baseline characteristics | High risk | Similar types of healthcare workers but types of patients seen at the centres not reported and baseline characteristics of the units were not reported |
| Protection from contamination | Low risk | Intervention was by centre |