High-energy devices in different surgical settings: lessons learnt from a full health technology assessment report developed by SICE (Società Italiana di Chirurgia Endoscopica).

BACKGROUND: The present paper aims at evaluating the potential benefits of high-energy devices (HEDs) in the Italian surgical practice, defining the comparative efficacy and safety profiles, as well as the potential economic and organizational advantages for hospitals and patients, with respect to standard monopolar or bipolar devices. METHODS: A Health Technology Assessment was conducted in 2021 assuming the hospital perspective, comparing HEDs and standard monopolar/bipolar devices, within eleven surgical settings: appendectomy, hepatic resections, colorectal resections, cholecystectomy, splenectomy, hemorrhoidectomy, thyroidectomy, esophago-gastrectomy, breast surgery, adrenalectomy, and pancreatectomy. The nine EUnetHTA Core Model dimensions were deployed considering a multi-methods approach. Both qualitative and quantitative methods were used: (1) a systematic literature review for the definition of the comparative efficacy and safety data; (2) administration of qualitative questionnaires, completed by 23 healthcare professionals (according to 7-item Likert scale, ranging from - 3 to + 3); and (3) health-economics tools, useful for the economic evaluation of the clinical pathway and budget impact analysis, and for the definition of the organizational and accessibility advantages, in terms of time or procedures' savings. RESULTS: The literature declared a decrease in operating time and length of stay in using HEDs in most surgical settings. While HEDs would lead to a marginal investment for the conduction of 178,619 surgeries on annual basis, their routinely implementation would generate significant organizational savings. A decrease equal to - 5.25/-9.02% of operating room time and to - 5.03/-30.73% of length of stay emerged. An advantage in accessibility to surgery could be hypothesized in a 9% of increase, due to the gaining in operatory slots. Professionals' perceptions crystallized and confirmed literature evidence, declaring a better safety and effectiveness profile. An improvement in both patients and caregivers' quality-of-life emerged. CONCLUSIONS: The results have demonstrated the strategic relevance related to HEDs introduction, their economic sustainability, and feasibility, as well as the potentialities in process improvement.

Why laparoscopists may opt for three-dimensional view: a summary of the full HTA report on 3D versus 2D laparoscopy by S.I.C.E. (Società Italiana di Chirurgia Endoscopica e Nuove Tecnologie).

BACKGROUND: Three-dimensional view in laparoscopic general, gynaecologic and urologic surgery is an efficient, safe and sustainable innovation. The present paper is an extract taken from a full health technology assessment report on three-dimensional vision technology compared with standard two-dimensional laparoscopic systems. METHODS: A health technology assessment approach was implemented in order to investigate all the economic, social, ethical and organisational implications related to the adoption of the innovative three-dimensional view. With the support of a multi-disciplinary team, composed of eight experts working in Italian hospitals and Universities, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaire and self-reported interviews, applying a final MCDA quantitative approach, and considering the dimensions resulting from the EUnetHTA Core Model. RESULTS: From systematic search of literature, we retrieved the following studies: 9 on general surgery, 35 on gynaecology and urology, both concerning clinical setting. Considering simulated setting we included: 8 studies regarding pitfalls and drawbacks, 44 on teaching, 12 on surgeons' confidence and comfort and 34 on surgeons' performances. Three-dimensional laparoscopy was shown to have advantages for both the patients and the surgeons, and is confirmed to be a safe, efficacious and sustainable vision technology. CONCLUSIONS: The objective of the present paper, under the patronage of Italian Society of Endoscopic Surgery, was achieved in that there has now been produced a scientific report, based on a HTA approach, that may be placed in the hands of surgeons and used to support the decision-making process of the health providers.

The integrated OR Efficiency and effectiveness evaluation after two years use, a pilot study.

OBJECTIVES: Technology evaluation of integrated/digital OR is needed since very little literature has been published on the subject. The integrated OR is a technological solution intended for minimally invasive surgery where the surgeons have complete control of the environment, devices and image distribution. Before such an investment, Health Technology Assessment can be used as a method to evaluate what vendors' state, i.e. the fact that the integrated OR is a very effective and efficient solution. Then a follow-up evaluation could be useful after the installation to test the users' satisfaction and give suggestions to the community about real- experienced integrated OR advantage. METHODS: A multiple answer questionnaire has been handed to 17 surgeons and 9 scrub nurses form Varese Town and University Hospital to evaluate the degree of satisfaction after 2 years of use of integrated ORs. RESULTS: Surgeons and scrub nurses agree that the integrated OR can be very effective in increasing quality, risk reduction and surgery time reduction through the use of digitalized video acquisition system, boom-mounted devices and multiple displays. Scrub nurses are a little bit more confident than surgeons that medical device control could reduce the confusion inside the OR and reduce the number of setting errors. A very positive judgment was given to the system's teaching capabilities, but both surgeons and scrub nurses agree that a great degree of education and a cultural change are needed to use the system in a correct and complete way. CONCLUSIONS: Results show that there is a deep appreciation of the system which proved to be efficient (reducing surgery time and enhancing surgical quality) and effective. This is a pilot study based on few collected data, but the questionnaire could be handed to many hospitals where integrated ORs are present, in order to achieve a significant degree of assessment and find common topics to be considered fundamental especially in the evaluating phase.

Budgeting and health technology assessment: first evidence obtained from proposal forms used to submit the adoption of new technology.

OBJECTIVES: The aim of this study was to benchmark the proposal forms used by a sample of Italian hospitals to inform the budget process for the adoption of new technology to understand the relationship with the guidelines provided by the Health Technology Assessment (HTA) literature. METHODS: A literature review was first undertaken to identify the frameworks developed to support decision making regarding new technology at a hospital level. A checklist of criteria drawn up according to five main perspectives (technology, patient, organization, economics, and level of evidence) has been formalized to review and compare the collected proposal forms. RESULTS: The "technology" perspective appears to have been broadly covered. The "patient" perspective has focused to clinical issues and partially neglects other dimensions such as patient satisfaction and potential adverse events. The "organization" dimension has paid little attention to change management. The "economics" dimension has been broadly covered, even though a sensitivity analysis has not been considered. The "level of evidence" that is required for submitting the proposal form is little. CONCLUSIONS: The proposal forms used to inform the budget process regarding the adoption of new technology are accountable for a limited set of dimensions from among those proposed in literature. Further research is required to understand how to render technology assessment multidimensional, multidisciplinary, evidence-based, and accountable at a hospital level.