Fuller 2012.
| Methods | Design: stepped‐wedge cluster‐randomised trial Study period: Campagin rolled out in all centres between December 2004‐June 2005; data were collected from October 1, 2006‐December 31, 2009. 36 month trial overall, with units added to intervention at different periods in time UK |
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| Participants | Healthcare workers in acute care and ICU: 60 wards in 16 hospitals | |
| Interventions | Feedback and personalised action planning plus National 'Clean Your Hands' campaign Control: 'Clean Your Hands' campaign only |
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| Outcomes | Observation of hand hygiene compliance | |
| Notes | Appropriate analysis for stepped wedge Funding source: Patient Safety Research Programme and Trustees of the Royal Free Hospital Declaration of interest: Cookson and Stone have received consultancy fees from GoJo industries |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Hospitals were given a number, then the numbers were randomly allocated to arm using a research randomiser website |
| Allocation concealment (selection bias) | Low risk | Unit of allocation was the ward and was done at the start of the study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included feedback and personalised action planning so participants aware of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes were assessed blindly |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data (missed opportunities) unlikely to be very different in different arms Difficult to compare loss to follow‐up in both groups because of their different composition of types of units |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. Only 12 wards participated in MRSA swabbing but all participated in hand hygiene assessment |
| Other bias | Low risk | No evidence |
| Baseline outcomes | Unclear risk | Baseline hand hygiene not reported; they reported relative changes from baseline with baseline as reference point |
| Baseline characteristics | High risk | No baseline characteristics presented |
| Protection from contamination | Low risk | Individualised unit‐based intervention so even if control units heard about it, they could not have the intervention |