Data extraction and risk of bias assessment
One reviewer independently extracted the main characteristics of eligible studies (study design, patient population, mean age, follow up, and outcomes of interest), and a second reviewer checked for accuracy. If needed, authors of included studies were contacted to provide additional data. The Cochrane Risk of Bias tool for randomised trials was used to assess the risk of bias (ROB) of the included studies (15). The ROB was judged as low, high or unclear for each domain: random sequence generation, allocation concealment, blinding of participants and personnel, blinding for outcome assessment, incomplete outcome data, and selective reporting (figure S1) (16,17,18).
For the health economics analysis, two reviewers extracted the main characteristics of included studies (type of economic evaluation, perspective, time horizon, discounting, sources of information, model type), relevant outcomes (costs, ICERs, sensitivity analyses results), sources of funding, and conflict of interest. Methodological limitations of the economic evaluations were evaluated by two reviewers using the consensus on health economics criteria checklist (CHEC) (19). Transferability to the European context was assessed using the European Network of Health Economic Evaluation Databases (EURONHEED) checklist (20,21).