Health Technology Assessment of Intensive Care Ventilators for Pediatric Patients.

This paper is aimed at addressing all the critical aspects linked to the implementation of intensive care ventilators in a pediatric setting, highlighting the most relevant technical features and describing the methodology to conduct health technology assessment (HTA) for supporting the decision-making process. Four ventilator models were included in the assessment process. A decision-making support tool (DoHTA method) was applied. Twenty-eight Key Performance Indicators (KPIs) were identified, defining the safety, clinical effectiveness, organizational, technical, and economic aspects. The Performance scores of each ventilator have been measured with respect to KPIs integrated with the total cost of ownership analysis, leading to a final rank of the four possible technological solutions. The final technologies' performance scores reflected a deliver valued, contextualized, and shared outputs, detecting the most performant technological solution for the specific hospital context. HTA results had informed and supported the pediatric hospital decision-making process. This study, critically identifying the pros and cons of innovative features of ventilators and the evaluation criteria and aspects to be taken into account during HTA, can be considered as a valuable proof of evidence as well as a reliable and transferable method for conducting decision-making processes in a hospital context.

Correction to: Clinical needs and technical requirements for ventilators for COVID-19 treatment critical patients: an evidence-based comparison for adult and pediatric age.

[This corrects the article DOI: 10.1007/s12553-020-00467-w.].

Clinical needs and technical requirements for ventilators for COVID-19 treatment critical patients: an evidence-based comparison for adult and pediatric age.

The spread of severe acute respiratory syndrome coronavirus 2, taking on pandemic proportions, is placing extraordinary and unprecedented demands on healthcare systems worldwide. The increasing number of critical patients who, experiencing respiratory failure from acute respiratory distress syndrome, need respiratory support, has been leading countries to race against time in arranging new Intensive Care Units (ICUs) and in finding affordable and practical solutions to manage patients in each stage of the disease. The simultaneous worldwide emergency caused serious problems for mechanical ventilators supply. This chaotic scenario generated, indeed, a frenetic race to buy life-saving ventilators. However, the variety of mechanical ventilators designs, together with the limitations in time and resources, make the decision-making processes on ventilators procurement crucial and not counterbalanced by the evaluation of devices quality. This paper aimed at offering an overview of how evidence-based approach for health technologies evaluation, might provide support during Corona Virus Disease 2019 (COVID-19) pandemic in ICUs management and critical equipment supply. We compared and combined all the publicly available indications on the essential requirements that ICU ventilators might meet to be considered acceptable for treating COVID-19 patients in severe to critical illnesses. We hope that the critical analysis of these data might help readers to understand how structured decision-making processes based on evidence, evaluating the safety and effectiveness of a given medical device and the effects of its introduction in a healthcare setting, are able to optimize time and resources allocation that should be considered essential, especially during pandemic period.

Semiautomated external defibrillators for in-hospital early defibrillation: a comparative study.

OBJECTIVES: Semiautomated external defibrillators (AEDs) should be considered as a means to facilitate in-hospital early defibrillation (IHED) in areas where advanced life support rescuers are not readily available. In this study, we aimed to develop a checklist and a measurement protocol to evaluate and compare AEDs by assessing factors that may affect IHED. METHODS: A clinical and technical comparison of six AEDs was performed. Technical specifications were analyzed, while an emergency team evaluated ergonomics and appropriateness for IHED at Bambino Gesù Children's Hospital. A measurement protocol was implemented, which aimed to assess the ability of defibrillators to recognize shockable and nonshockable rhythms, accuracy of delivered energy, and charging time. RESULTS: Designs of AEDs differed in several features which influence their appropriateness for IHED. Some units showed poor ergonomics and instructions/feedback for cardiopulmonary resuscitation. Differences between defibrillators in recognizing shockable and nonshockable rhythms emerged for polymorphic ventricular tachycardia waveforms and when the frequency and amplitude of input signals varied. Tests for accuracy revealed poor performances at low and high impedance levels for most AEDs. Notably, differences greater than 20 seconds were found in the time from power-on to "ready for discharge." CONCLUSIONS: The approach we used to assess AEDs allowed us to evaluate their appropriateness with respect to the organizational context, to measure their parameters, and to compare models. Results showed that ergonomics and/or performances (timing and accuracy) could be improved in each device.

Brain network involved in visual processing of movement stimuli used in upper limb robotic training: an fMRI study.

BACKGROUND: The potential of robot-mediated therapy and virtual reality in neurorehabilitation is becoming of increasing importance. However, there is limited information, using neuroimaging, on the neural networks involved in training with these technologies. This study was intended to detect the brain network involved in the visual processing of movement during robotic training. The main aim was to investigate the existence of a common cerebral network able to assimilate biological (human upper limb) and non-biological (abstract object) movements, hence testing the suitability of the visual non-biological feedback provided by the InMotion2 Robot. METHODS: A visual functional Magnetic Resonance Imaging (fMRI) task was administered to 22 healthy subjects. The task required observation and retrieval of motor gestures and of the visual feedback used in robotic training. Functional activations of both biological and non-biological movements were examined to identify areas activated in both conditions, along with differential activity in upper limb vs. abstract object trials. Control of response was also tested by administering trials with congruent and incongruent reaching movements. RESULTS: The observation of upper limb and abstract object movements elicited similar patterns of activations according to a caudo-rostral pathway for the visual processing of movements (including specific areas of the occipital, temporal, parietal, and frontal lobes). Similarly, overlapping activations were found for the subsequent retrieval of the observed movement. Furthermore, activations of frontal cortical areas were associated with congruent trials more than with the incongruent ones. CONCLUSIONS: This study identified the neural pathway associated with visual processing of movement stimuli used in upper limb robot-mediated training and investigated the brain's ability to assimilate abstract object movements with human motor gestures. In both conditions, activations were elicited in cerebral areas involved in visual perception, sensory integration, recognition of movement, re-mapping on the somatosensory and motor cortex, storage in memory, and response control. Results from the congruent vs. incongruent trials revealed greater activity for the former condition than the latter in a network including cingulate cortex, right inferior and middle frontal gyrus that are involved in the go-signal and in decision control. Results on healthy subjects would suggest the appropriateness of an abstract visual feedback provided during motor training. The task contributes to highlight the potential of fMRI in improving the understanding of visual motor processes and may also be useful in detecting brain reorganisation during training.

Gray matter decrease distribution in the early stages of Anorexia Nervosa restrictive type in adolescents.

Few studies have used Voxel-Based Morphometry (VBM) to examine brain structure in Anorexia Nervosa patients. The purpose of the present study was to investigate a sample of Anorexia Nervosa restrictive type (AN-r) adolescent patients in the early stages of the illness, using VBM in order to characterize morphometric gray matter (GM) changes. Participants were 16 AN-r female patients (with no other psychiatric disorders) whose AN-r had been in progress for less than 12 months and 16 age-matched healthy female subjects. High-resolution T1-weighted magnetic resonance images were preprocessed according to the optimized VBM method, and statistically analyzed. The analyses revealed a significant global GM decrease in the AN-r patients; furthermore, a significant region-specific decrease in GM volume was found bilaterally in the middle cingulate cortex, the precuneus, and the inferior and superior parietal lobules. The significant early GM decrease in the aforementioned regions in AN-r adolescent patients suggests that there might be a region-specific GM vulnerability that could play a role in the pathophysiology of the disease. Given that these regions are also involved in the manipulation of mental images and the mental representation of the self, this might explain the presence of a distorted body image in these patients.