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).