OBJECTIVES : The aim of the study is to show potential approaches and usefulness of early Health Technology Assessment exemplifying the case study of the Video and Optical See-Through Augmented Reality Surgical System (VOSTARS), an advanced navigation tool for non-endoscopic surgeries, recently developed, also thanks to funding from H2020 programme.

METHODS : Surgeons in potential fields of application were surveyed about current practice, potential application of the system, perceived usefulness, intention to use, organizational issues, etc.. Those data, data from in vitro and in vivo tests and inputs from literature were used to inform early evaluation of different HTA dimensions comprising also cost-effectiveness (CEA) and budget impact analysis (BIA).

RESULTS : A total of 99 surgeons were surveyed. About the possibility to use the VOSTARS system, 39 surgeons (41%) declared they will absolutely or probably use it (45%). Positive feedbacks were also obtained for both the potential usefulness and the possibility of the system to improve performance of work (about 80% of surgeons). High degree of variability emerged about the opportunity to enhance job effectiveness and improve operating time, anyway surgeons offered insight into potential limits and benefits of the system, related to the possibility of personalized approach. Surgeons also informed the identification of specific surgical fields and interventions for which the system could allow satisfy unmet need (ie, neurosurgery and maxillofacial surgery). Although variability of results, CEA showed potential savings for the Italian National Health System (INHS) in both neurosurgery and maxillofacial surgery, when compared to freehand approach. The BIA highlighted 3-year savings of -1,269€ for a local HS performing about 50 procedures per year.

CONCLUSIONS : Despite the evaluation underlined high degree of uncertainty about the economic implications, end users involvement helped highlighting technical issues to be solved, offered insight to better target the technology, assess fact related to acceptability and also design the potential market