ROBINS-I tool: This is a risk of bias tool to assess non-randomized studies of interventions, currently available for cohort designs with adaptions underway for other study types such as case control and interrupted time series. This tool assesses these types of studies against a hypothetical pragmatic ‘target randomised trial’. Signalling questions are again a key feature that assist with identifying relevant information and reaching judgements. The bias domains included in ROBINS-I overlap with the ‘Risk of bias’ 2.0 tool but include 3 additional domains: confounding, selection of participants into the study and classification at intervention. An overall bias judgement is made. The tool is available for use, however, an online version is also in development. The tool is not currently integrated into RevMan. Using ROBINS-I will require substantive expertise in epidemiology and the conduct and analysis of non-randomized studies. Click here to read more about the tool.

Cochrane Scientific Committee recommendation: ROBINS-I is the preferred tool to be used in Cochrane Reviews for non-randomized studies of interventions, although it is not mandatory, and will require author teams to have sufficient knowledge and experience to apply the tool. An alternative option is the Newcastle-Ottawa Scale. Please await further announcements on guidance and support to implement this tool. (Full statement)