“Real-world” endovascular versus surgical arteriovenous fistula economic evaluation: Can clinical outcomes and use of resources be derived from different countries?

In their comparison of endovascular arteriovenous fistula (AVF) versus surgical AVF in incident or prevalent patients receiving hemodialysis, Rognoni et al. ¹ carried out an extensive cost-effectiveness study along with a budget impact analysis. Both were intended from the perspective of the Italian national heath system, and their main domains included: (a) clinical results; (b) consumption of resources; and (c) utility values. These three sources of information were combined through Markov modelling in order to determine standard indexes of cost-effectiveness and budget impact for the comparison of endovascular versus surgical AVF in clinical terms and pharmacoeconomic terms. One strength of the study by Rognoni et al. ¹ is that specific parameters were generated to evaluate the place in therapy of endovascular versus surgical AVF in the Italian national health service. Although the clinical evidence available from original, single-arm studies was limited, the propensity matched analysis provided some useful, though preliminary, results for evaluating this comparison. On the other hand, one limitation of Rognoni’s analysis is that, while their study was claimed to be a “real world” study in the Italian setting, tariffs were the only Italian information because all the remaining data (clinical outcomes, event rates, consumption of resources, utilities) were obtained from non-Italian studies. This raises the (theoretical) question of how much country-specific information is needed to define a study as a “real world” study conducted from the perspective of a specific country.^1,2 It should be noted that this multi-country approach is employed with remarkable frequency in the field of medical devices because comprehensive data generated within a single country for different domains are rarely available. ² In conclusion, the main point is a theoretical one, and focuses on which criteria should be met to attribute the label of “real world” study to an investigation that collects information from different countries.