Integrated HTA and FMECA methodology for the evaluation of robotic surgery

Robotic surgery has been strongly improved since the beginning of the twenty-first century and chased important level of technical and clinical performances. Within the robotic area, the most worldwide used surgical robot is the da Vinci® system made by Intuitive Surgical Inc. The aim of this study was to evaluate at the hospital scale the robotic surgery (Hospital –Based Health Technology Assessment) in comparison to the open and laparoscopic procedures yet combining a FMECA analysis to accurately assess all those aspects involving patient and staff safety. The total number of robotic procedures directly observed by the surgical department and reported in the following study was 44, including 28 urology interventions and 16 general surgeries. The study confirmed clinical benefits carried out with the robot but bigger complexity in managing the whole surgical system in terms of structural needs, staff and technology. For the future, further steps regard the necessity to dispose of a wider number of robotic procedures in order to strength the analysis reliability and complete the socio-economic assessment with medium and long terms observation. Finally a new FMECA application will be essential to monitor the real effects of the suggested actions on the evaluated risks according to the already known and new failure modes

Practice of HB-HTA on the study of HIFU technology for the treatment of prostate cancer and uterine fibroma

The aim of the study has been the development of a Hospital Based - Health Technology Assessment, study directed to analyze the clinical, social and financial aspects derived from the use of the HIFU method for the treatment of prostate cancer and uterine fibroma in comparison with the traditional therapeutic approaches. A systematic literature review was carried out inspecting the treatment of prostate cancer through the use of HIFU technology as well as its use for the treatment of uterine fibroma. At a later stage, clinical, social and financial indicators (gathered from EUnetHTA Core Model as well as from scientific literature) were defined and evaluated and a single benefit index was drawn in the end to have a rapid and direct comparison among the various treatment methods. For the treatment of prostate cancer, HIFU reaches good results in the clinical setting obtaining 78% of negative biopsy results post-surgery and a 68% disease-free survival rate at 5 years. It also proves efficient in the social setting and equal to traditional surgeries. For the treatment of uterine fibroma, HIFU presents an improvement of post-surgery symptomology in 80% of cases, revealing a good clinical efficacy and showing particularly convenient in the patient quality of life. Even though the traditional techniques represent the current gold standard, the initial results for the treatment of prostate cancer, exclusive to low risk of illness, and of uterine fibroma through the use of HIFU appear positive and, therefore, encouraging for the immediate future even though it remains fundamental to have greater availability of evidence especially in the long run

A simulation based model for planning operating theater activity in complex hospitals: Case study in orthopedics

Operating theaters (OT) in hospitals represent some of the highest sources of economic expenditures since their high complexity in terms of technology equipment (integration of different complex devices and specific technical requirements), organization (multi-personnel area with complex patients flow) and usage (optimum planning between regular activity and emergency management). For the above reasons, it is essential to understand and plan the whole surgical path (patient and personnel) by avoiding foreseeable inefficiencies, delays and risks. Hence, the aim of this study is fully modeling a generic orthopedics OT in order to support hospital decision makers in OT design and activity planning for both regular and emergency scenarios. In order to do that and due to the complexity of the OT system, a simulation approach is fundamental for properly understanding the whole process and for clearly controlling and analyzing all the factors involved (surgical durations, types, working times and rooms availability, etc..). Discrete event models have been found reliable and accurate to simulate complex health systems (e.g. emergency management, beds management, logistic and assets estimation, etc.). Finally, after selecting the most appropriate type of model, and using past surgical data and experts’ opinions from the hospital for its development and implementation, a more precise and reliable clinical validation of the model is currently in progress, by concluding a data verification that needs a period of on-site data collection. © Springer International Publishing Switzerland 2015