Discussion
infection
INFECTION
The CLEEN study is a large cluster randomised controlled trial conducted in an Australian tertiary hospital. The study represents the first randomised controlled study in the world to provide level 1 evidence on the impact of additional cleaning of shared equipment on rates of HAIs (5). The advantages of the study design include a simple and feasible intervention, with strategies built in to ensure adherence and fidelity. Unlike pragmatic trial designs, which may use existing resources of PSAs, we are able to ensure that the intervention is delivered through additional resources being provided specifically for the purpose of delivering the intervention. The stepped wedge design is another strength of the research design, as each ward will act as its own control. This negates issues associated with differing patient case mix, individual ward culture, operational issues and local practices. This study will provide evidence to inform the development of a future service delivery model, national guidelines and local policy with respect to roles and responsibilities and the importance of cleaning of shared medical equipment.Limitations to the study may include issues such as hospital changes in policy or practice that may influence the outcomes being observed. However, the hospital is committed to ensuring that there will be no significant changes to the hospital cleaning policy during the trial period unless absolutely necessary. Other aspects of infection prevention control policy such as hand hygiene and antimicrobial usage will be monitored, and we will be able to document/identify changes in other policies that may influence the outcomes of this study. Further potential disadvantages of the trial may include that the intervention will only be delivered 5 days of 7, due to physical and financial constraints. Given the intervention is being delivered over the vast majority of the working week, the burden and risk in the environment will still likely be significantly reduced. Environmental swabbing of the environment was considered; however, due to poor positive predictive value, it was not included in the current study design (17). In a related study in the same participating hospital, we intend to use targeted whole genome sequencing to evaluate potential transmission pathways through shared medical equipment.