Investigating the generalizability of Economic Evaluations conducted in Italy: a critical review

bstract: Aim. To assess the methodological quality of Italian HEEs and their generalizability or transferability to different settings. Methods. A literature search was performed on Pubmed search engine to identify trial-based, non- experimental prospective studies or model-based full economic evaluations, carried out in Italy from 1995 to 2013. The studies were randomly assigned to four reviewers who applied a detailed checklist to assess the generalizability and the quality of reporting. The review process followed a three-step blinded procedure. The reviewers who carried out the data extraction were blind as to the name of the author(s) of each study. Second, after the first review, articles were re-assigned through a second blind randomization to a second reviewer. Finally, any disagreement between the first two reviews was solved by a senior researcher. Results. One-hundred fifty-one economic evaluations eventually met the inclusion criteria. Over time, we observed an increasing transparency of methods and a greater generalizability of results, along with a wider and more representative sample in trials and a larger adoption of transition-Markov models. On the other hand, often context-specific economic evaluations are carried out and not enough effort is done to assure the transferability of their results to other contexts. In recent studies, Cost- Effectiveness Analyses and the use of the Incremental Cost-Effectiveness Ratio were preferred. Conclusion. Despite a quite positive temporal trend, generalizability of results still appears as an unsolved question, even if some indication of improvement within Italian studies has been observed