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.

Assessing stress variations in children during the strange situation procedure: comparison of three widely used respiratory sinus arrhythmia estimation methods.

Objective.The respiratory sinus arrhythmia (RSA) is a well-known marker of vagal activity that can be exploited to measure stress changes. RSA is usually estimated from heart rate variability (HRV). This study aims to compare the RSA obtained with three widely adopted methods showing their strengths and potential pitfalls.Approach.The three methods are tested on 69 healthy preschoolers undergoing a stressful protocol, the strange situation procedure (SSP). We compare the RSA estimated by the Porges method, the univariate autoregressive (AR) spectral analysis of the HRV signal, and the bivariate AR spectral analysis of HRV and respirogram signals. We examine RSA differences detected across the SSP episodes and correlation between the estimates provided by each method.Main results.The Porges and the bivariate AR approaches both detected significant differences (i.e. stress variations) in the RSA measured across the SSP. However, the latter method showed higher sensitivity to stress changes induced by the procedure, with the mean RSA variation between baseline and first separation from the mother (the most stressful condition) being significantly different among methods: Porges, -17.5%; univariate AR, -18.3%; bivariate AR, -23.7%. Moreover, the performances of the Porges algorithm were found strictly dependent on the applied preprocessing.Significance.Our findings confirm the bivariate AR analysis of the HRV and respiratory signals as a robust stress assessment tool that does not require any population-specific preprocessing of the signals and warn about using RSA estimates that neglect breath information in more natural experiments, such as those involving children, in which respiratory frequency changes are extremely likely.