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Il lavoro presenta l'esperienza di digitalizzazione dell'ASL4 della Liguria, realizzata attraverso l'implementazione del progetto "Tigullio, luogo di salute", nato come idea strategica di sperimentazione di un nuovo modello di sanità di prossimità territoriale. Il caso evidenzia le modalità di sviluppo di servizi innovativi attraverso la telemedicina e i processi organizzativi che l'azienda ha realizzato per coglierne tutte le potenzialità.I risultati mostrano come il percorso intrapreso, attraverso la digitalizzazione, possa essere interpretato come un percorso di change management. Tale percorso non si limita a creare una nuova offerta di servizi, attraverso la telemedicina, ma ha l'obiettivo più ambizioso di realizzare un cambiamento aziendale guidato dai bisogni del paziente e basato sulla cooperazione tra professionisti e sulla rivisitazione dei percorsi di cura.

The use of three-dimensional (3D) printed patient-specific anatomical models is nowadays a viable strategy for improving surgical outcome in medicine. In adult surgery, 3D printing technology is commonly studied, but its use in paediatric surgery is still under development. This work presents the implementation of 3D printing technology in Orthopaedic department of the paediatric hospital “Santobono-Pausilipon” in Naples by producing 3D printed anatomical models of paediatric patients. The 3D printed models produced were used for the training of the surgical team during the preoperative planning and for carrying out a surgical simulation. The anatomical models are designed in compliance with the current European Medical Devices regulation and following the already existing guidelines in literature. The impact of the 3D printed anatomical models used, a total of seven printed anatomical models based on four patients, is then evaluated throughout a questionnaire proposed to the surgical team, composed by eight paediatric orthopaedic surgeons. Surgeons answered to a total of ten questions, six scale-based questions and four free-text questions. Results obtained from the questionnaires highlighted how 3D printed anatomical models can lead to a better understating of the treated pathologies, carrying relevant improvements in both the surgical team training and the surgical outcome.

The clinical use of 3D printed patient specific orthopaedic cast is of wide interest. However, design and production have problems such as production time, which can take up to 35 h, and standardized procedure considering that there are medical devices that must comply mandatory and/or voluntary standards. Moreover, the proposed procedures do not fully consider the traceability of this innovative medical device design to comply with standards and industrial proposes. The aim of this work is to propose a semi-automatic workflow for the production of the 3D printed orthopaedic casts. The procedure is oriented towards a reduction time in different phases (as scan setting, designing technique, printing orientation) of the production flow. The workflow is compliant with recognized quality standards for the production of additive manufactured medical devices. This approach offers the possibility to introduce new 3D printed medical devices in clinical practice as well as to design an optimized industrial workflow.

Patients affected by severe atresia auris (AA) can be a challenge during hearing restoration surgery due to the abnormal position of vascular and nervous structures in the bone. A 3D reconstruction model of malformed temporal bones can be helpful for planning surgery and optimizing intra-, peri-, and post-operative results. A 5-year-old girl with severe AA on the right side was implanted with a Bonebridge transcutaneous bone conduction implant (tBCI). 3D printing was used to reproduce the malformed temporal bone, find a good position for the tBCI and plan out the surgical details in advance. Hearing tests were performed before and after surgery and information about intra-, peri-, and post-operative outcomes were collected. The patient did not show any negative outcomes and, thanks to the Bonebridge, completely recovered hearing on the right side. 3D printing is a useful tool for planning surgery in AA patients and for preventing possible risks related to the unknown malformed anatomy.

Patient mobility represents a proxy measure to assess the quality and availability of hospital services, especially in decentralized health systems. Different studies have been focused on the interregional mobility in Italy to capture factors influencing this phenomenon. Among them, hospital capacity is generally captured through the number of beds per population. However, this indicator does not consider the distance to hospitals and the accessibility of extra-regional beds, in particular for patients living at the regional borders. The aim of this paper is to analyse the effect of extra-regional spatial accessibility component on patient mobility among the Italian regions. This can help to capture the level of equity in the provision of services across the country providing a snapshot of the distribution of beds over the territory. Moreover, this study contributes to gain a deeper understanding of the allocation of health resources providing input for policy makers on the basis of the principles of service accessibility.

The high demand of hospitalization in the intensive care units (ICUs) during the first wave of the COVID-19 outbreak brought out the critical issues of the limited capacity of the regional systems to deal with high patient inflows in a short period of time. In this view, a rapid and efficient reallocation of resources is one of the main challenges to be addressed by regional systems to prevent overload and saturation. Aim of this study is to assess the spatial accessibility of ICU beds in the 20 Italian regions to capture the equity distribution of critical care services across the country. This analysis may contribute to gain a deeper understanding of the allocation of health resources. It can provide input for policy makers in view of a possible reorganization of the national system in terms of both its preparedness for emergency period and routine capability.

During COVID-19 emergency the majority of health structures in Europe saturated or nearly saturated their availabilities already in the first weeks of the epidemic period especially in some regions of Italy and Spain. The aim of this study is to analyse the efficiency in the management of hospital beds before the COVID-19 outbreak at regional level in France, Germany, Italy and Spain. This analysis can indicate a reference point for future analysis on resource management in emergency periods and help hospital managers, emergency planners as well as policy makers to put in place a rapid and effective response to an emergency situation. The results of this study clearly underline that France and Germany could rely on the robust structural components of the hospital system, compared to Italy and Spain. Presumably, this might have had an impact on the efficacy in the management of the COVID-19 diffusion. In particular, the high availability of beds in the majority of the France regions paired with the low occupancy rate and high turnover interval led these regions to have a high number of available beds. Consider also that this country generally manages complex cases. A similar structural component is present in the German regions where the number of available beds is significantly higher than in the other countries. The impact of the COVID-19 was completely different in Italy and Spain that had to deal with a relevant large number of patients relying on a reduced number of both hospital beds and professionals. A further critical factor compared to France and Germany concerns the dissimilar distribution of cases across regions. Even if in these countries the hospital beds were efficiently managed, the concentration of hospitalized patients and the scarcity of beds have put pressure on the hospital systems.

As the Italian health system is regionally based, COVID-19 emergency actions are based on a general lockdown imposed by national authority and then management at local level by 21 regional authorities. Therefore, the pandemic response plan developed by each region led to different approaches. The aim of this paper is to analyze whether differences in patient management may have influenced the local course of the epidemic. The analysis on the 21 Italian regions considers the strategies adopted in terms of hospitalization, treatment in the ICU and at home. Moreover, an in-depth analysis was carried out on: Lombardia, which adopted a hospitalization approach, Veneto, which tended to confine patients at home, and Emilia Romagna, which adopted a mixed hospitalization-home based approach. The majority of regions implemented a home-based approach, while the hospital approach was followed in three regions (Lombardia, Piemonte, and Lazio), mainly limited to the first period of the outbreak. All regions in the later phases tended to reduce hospitalization, preferring to confine patients at home. This comparison, highlighting the different phases of the pandemic, outlined that the adoption of home-based practices contributed to limiting infection rates among patients and health professionals as well as decreasing the number of deaths.

The study of the Reaching movements, since their significant importance for independence in daily living activities, is increasingly proposed in rehabilitation programs of several disorders of upper limbs. Robotic rehabilitation programs represent a valid approach to this issue, as they are well-matched to realize an rigorous, task-oriented motor training as part of an combined rehabilitation program, counting also non-robotic approaches. However, there is a lack of information showing progresses on parameters related to activities of daily living (ADL), and some experimental studies indicates that to date robotic training fails to transfer the obtained improvements on the functional level. This may be since most of the existing robotic devices are based on the repetition of stereotypical movements rather than of applying more appropriated principles of motor learning. This work proposes a new quantitative kinematic index to assess the kinematic quality of upper arm reaching movements based from the mathematical minimum jerk theory. The results showed as the indexes are close to the ideal ones in according with the mathematica model, making them suitable in a clinical contest for the valuation of the ADL performance during the rehabilitation of upper limb reaching movements from several diseases.

Increasingly, medication is being administered at home by family and friends of the care-recipient. This study aims to identify and analyse risks associated with potential drug administration errors made by informal carers at home. We mapped medication administration at home with a multidisciplinary team that included carers, health care professionals and patients. Evidence-based risk-analysis methodologies were applied: Healthcare Failure Modes and Effect Analysis (HFMEA), Systematic Human Error Reduction and Prediction Analysis (SHERPA) and Systems-Theoretic Accident Model and Processes (STAMP). The process of administration comprises seven sub-processes. Thirty-four possible failure modes were identified and six of these were rated as high risk. These highlighted that medications may be given with a wrong dose, stored incorrectly, not discontinued as instructed, not recorded, or not ordered on time, and often caused by communication and support problems. Combined risk analyses contributed unique information helpful to better understand the medication administration risks and causes within homecare. Practitioner Summary: Increasingly, medication is being administered at home by family and friends of the care-recipient. This study identifies risks associated with potential drug administration errors made by informal carers at home through consensus-based quantitative techniques. The different analyses contribute unique information helpful to better understand the administration risks and causes.

Walking may be defined as the forward displacement of the body requiring coordination between alternate successions of the swing phase and the stance phase. In literature it is known that, looking at the relationship between external moments and relative angles at lower limb joints during human walking is a new way of analyzing the biomechanical behavior of a joint (stiffness concept). Numerous studies show that the concept of quasi-stiffness applies particularly well to major loading phases of the lower extremity joints during stance phase. This study represents the first attempt to quantify the joint quasi-stiffness during the swing phase of gait over rehabilitation sessions performed by a child with cerebral palsy with the Lokomat system. The obtained results, albeit preliminarily, demonstrate the sensitivity of this new method in evaluating the degree of resistance offered by the patient over the rehabilitation sessions.

The aim of this study is to implement the clinical use of the three-dimensional (3D) design and printing technology in pediatric pathologies requiring immobilization. We describe the manufacturing process of the 3D device in place of the plaster cast usually applied to a child 48/72 h after the access to the Trauma Center Traumatology Hub. This procedure had already been performed at Level II, Trauma Center, Campania Region, Orthopaedic Division of Santobono Children's Hospital, Naples, Italy. The operative phase was performed by two 3D printers and a scanner in the bioengineering laboratory of the hospital's outpatient area. The phase of software elaboration requires close cooperation among physicians and engineers. We decided to use a model with a double-shell design and holes varying in width to ensure complete ventilation and lightness of the device. We chose to treat nondisplaced metaphyseal distal fractures of the radius in 18 patients enrolled from January 2017 to November 2017. The flow chart includes clinical and radiological examinations of every enrolled child, collecting information required by the program and its elaboration by bioengineers, and then transfer of the results to 3D printers. The child, immobilized by a temporary splint, wore his 3D device after 12/24 h. Then, he underwent serial check-ups in which the effectiveness and appropriateness of the treatment were clinically monitored and evaluated using subjective scales: visual analogue scale and patient-rated wrist evaluation. All the fractures consolidated both radiologically and clinically after the treatment, with no complications reported. Only one partial breakage of the device happened because of an accidental fall. The statistical analysis of the visual analogue scale and patient-rated wrist evaluation data shows that children's activities of everyday life improved during the immobilization thanks to this treatment. This first study shows that using a 3D device instead of a traditional plaster cast can be an effective alternative approach in the treatment of pediatric nondisplaced metaphyseal distal radius fractures, with high overall patient satisfaction. We believe that 3D technology could be extended to the treatment of more complex fractures; this will be the subject of our second study.

This extended abstract sets up the scene of the KONFIDO project in a clear way. In particular, it: i) defines KONFIDO objectives and draws KONFIDO boundaries; ii) identifies KONFIDO users and beneficiaries; iii) describes the environment where KONFIDO is embedded; iv) provides a bird's eye view of the KONFIDO technologies and how they will be deployed in the pilot studies of the project; and v) presents the approach that the KONFIDO consortium will take to prove that the proposed solutions work. KONFIDO addresses one of the top three priorities of the European Commission regarding the digital transformation of health and care in the Digital Single Market, i.e. citizens' secure access to their health data, also across borders. To make sure that KONFIDO has a high-impact, its results are exposed to the wide public by developing three substantial pilots in three distinct European countries (namely Denmark, Italy, and Spain).

For cross-border collaborative healthcare delivery, data protection legislation seems to be increasingly obstructive. In extreme cases, this may compromise the quality of care a patient receives and at the same time prevent clinicians practicing and developing their medical skills to their full potential. A dilemma develops whereby the fundamental rights of patient and clinician are constrained by the very legal instruments designed to make delivery of healthcare easier. The contention between patient and clinician expectations, or tussles, may pose a threat to future healthcare delivery. Compromising healthcare delivery in this way has wider implications for community trust. The concept of tussles in technology infrastructures suggests an actor-network approach involving the patient and clinician relationship within the context of community response to their interactions to offer an innovative perspective on the problem of tussles in healthcare. In this paper, we develop such an approach and discuss an initial validation based on cross-border healthcare scenarios illustrating the contention between fundamental ethical rights and actor-network compliance.

Background: The increase of healthcare digitalization comes along with potential information security risks. Thus, the EU H2020 KONFIDO project aimed to provide a toolkit supporting secure cross-border health data exchange. Methods: KONFIDO focused on the so-called “User Goals”, while also identifying barriers and facilitators regarding eHealth acceptance. Key user scenarios were elaborated both in terms of threat analysis and legal challenges. Moreover, KONFIDO developed a toolkit aiming to enhance the security of OpenNCP, the reference implementation framework. Results: The main project outcomes are highlighted and the “Lessons Learned,” the technical challenges and the EU context are detailed. Conclusions: The main “Lessons Learned” are summarized and a set of recommendations is provided, presenting the position of the KONFIDO consortium toward a robust EU-wide health data exchange infrastructure. To this end, the lack of infrastructure and technical capacity is highlighted, legal and policy challenges are identified and the need to focus on usability and semantic interoperability is emphasized. Regarding technical issues, an emphasis on transparent and standards-based development processes is recommended, especially for landmark software projects. Finally, promoting mentality change and knowledge dissemination is also identified as key step toward the development of secure cross-border health data exchange services.

Background Increased digitalization of healthcare comes along with the cost of cybercrime proliferation. This results to patients’ and healthcare providers' skepticism to adopt Health Information Technologies (HIT). In Europe, this shortcoming hampers efficient cross-border health data exchange, which requires a holistic, secure and interoperable framework. This study aimed to provide the foundations for designing a secure and interoperable toolkit for cross-border health data exchange within the European Union (EU), conducted in the scope of the KONFIDO project. Particularly, we present our user requirements engineering methodology and the obtained results, driving the technical design of the KONFIDO toolkit. Methods Our methodology relied on four pillars: (a) a gap analysis study, reviewing a range of relevant projects/initiatives, technologies as well as cybersecurity strategies for HIT interoperability and cybersecurity; (b) the definition of user scenarios with major focus on cross-border health data exchange in the three pilot countries of the project; (c) a user requirements elicitation phase containing a threat analysis of the business processes entailed in the user scenarios, and (d) surveying and discussing with key stakeholders, aiming to validate the obtained outcomes and identify barriers and facilitators for HIT adoption linked with cybersecurity and interoperability. Results According to the gap analysis outcomes, full adherence with information security standards is currently not universally met. Sustainability plans shall be defined for adapting existing/evolving frameworks to the state-of-the-art. Overall, lack of integration in a holistic security approach was clearly identified. For each user scenario, we concluded with a comprehensive workflow, highlighting challenges and open issues for their application in our pilot sites. The threat analysis resulted in a set of 30 user goals in total, documented in detail. Finally, indicative barriers of HIT acceptance include lack of awareness regarding HIT risks and legislations, lack of a security-oriented culture and management commitment, as well as usability constraints, while important facilitators concern the adoption of standards and current efforts for a common EU legislation framework. Conclusions Our study provides important insights to address secure and interoperable health data exchange, while our methodological framework constitutes a paradigm for investigating diverse cybersecurity-related risks in the health sector. Electronic supplementary material The online version of this article (10.1186/s12911-018-0664-0) contains supplementary material, which is available to authorized users.

Hospitals are complex systems in which different departments interact with each other. Systemic analytical models use systematic representations to facilitate the understanding of a complex process. The models are simulated with an imitation of the operations of a system and its internal processes, usually over time, and in appropriate detail. Simulation is used to study the performance of new systems as well as predict the effect of changes. Since Emergency Departments (ED) are unpredictable and frontline of healthcare service delivery, their detailed description and analysis are highly needed in order to design improvement actions. In this study, we will present the simulation of the ED a pediatric hospital which admits more than 100 k/year patients. The simulation tool is SIMIO®.

Many cervical spine pathologies involve degeneration of the stabilizing mechanisms of vertebrae segments and often cause pain. Abnormal intervertebral motion is an indication for surgery. Currently, spinal fusion surgery is widely adopted to fix the instable vertebral segments but recently, disk arthroplasty is more and more adopted as an alternative to restore normal kinematics and biomechanics of the sick segment and to reduce development of symptomatic adjacent-level degeneration. This study aims to measure intervertebral kinematics by means of image processing of X-ray fluoroscopy videos, which are able to screen patient's neck spontaneous movements of flexion-extension. Vertebrae trajectories are estimated by using image template matching techniques. Then, continuous-time intervertebral kinematics is computed by using spline interpolation. The results, obtained by using real fluoroscopy videos, reveal the possibility of obtaining in vivo information about the continuous evolution of motion of the implanted prosthesis and adjacent segments.

The costs associated with the healthcare system have risen dramatically in recent years. Healthcare decision-makers, especially in areas of hospital management, are rarely fortunate enough to have all necessary information made available to them at once. In this work we propose a stochastic model for the dynamics of the number of patients in a hospital department with the objective to improve the allocation of resources. The solution is based on a stochastic dynamic programming approach where the control variable is the number of admissions in the department. We use the dataset provided by one of the biggest Italian Intensive Care Units to test the application of our model. We propose also a comparison between the optimal policy of admissions and an empirical policy which describes the effective medical practice in the department. The method allows also to reduce the variability of the length of stay.

The present study illustrates an approach aimed at evaluating the performance of post operative intensive care units (ICUs) in terms of quality of healthcare. The starting point is the recognition of a conceptual model suitable to describe the multifaceted healthcare system. The model plays a fundamental role in the identification of suitable performance indicators, which are intended both to evaluate quality of healthcare and assist system diagnostics and troubleshooting tasks. The evaluation is then accomplished by means of a measurement method that involves the collection and processing of data related to the structure, the process, and the clinical outcomes. The method is inspired to the define-measure-analyze-improve-control (DMAIC) strategy that is largely employed in the industry; in fact, it adopts techniques and tools that are usually utilized to perform statistical process controls. A case study shows the effectiveness of the proposed approach at evaluating ICUs and its capability of recognizing the causes of inefficiencies within the organizational model of the same ICU.

Health data exchange is a major challenge due to the sensitive information and the privacy issues entailed. Considering the European context, in which health data must be exchanged between different European Union (EU) Member States, each having a different national regulatory framework as well as different national healthcare structures, the challenge appears even greater. Europe has tried to address this challenge via the epSOS ("Smart Open Services for European Patients") project in 2008, a European large-scale pilot on cross-border sharing of specific health data and services. The adoption of the framework is an ongoing activity, with most Member States planning its implementation by 2020. Yet, this framework is quite generic and leaves a wide space to each EU Member State regarding the definition of roles, processes, workflows and especially the specific integration with the National Infrastructures for eHealth. The aim of this paper is to present the current landscape of the evolving eHealth infrastructure for cross-border health data exchange in Europe, as a result of past and ongoing initiatives, and illustrate challenges, open issues and limitations through a specific case study describing how Italy is approaching its adoption and accommodates the identified barriers. To this end, the paper discusses ethical, regulatory and organizational issues, also focusing on technical aspects, such as interoperability and cybersecurity. Regarding cybersecurity aspects per se, we present the approach of the KONFIDO EU-funded project, which aims to reinforce trust and security in European cross-border health data exchange by leveraging novel approaches and cutting-edge technologies, such as homomorphic encryption, photonic Physical Unclonable Functions (p-PUF), a Security Information and Event Management (SIEM) system, and blockchain-based auditing. In particular, we explain how KONFIDO will test its outcomes through a dedicated pilot based on a realistic scenario, in which Italy is involved in health data exchange with other European countries. ispartof: JOURNAL OF BIOMEDICAL INFORMATICS vol:94 ispartof: location:United States status: published

The objective of this work was to study the use of electrical impedance spectroscopy (EIS) measurement to characterize muscle electrical properties in different conditions. In vivo EIS measurements were carried out in the range 1-60 kHz on 32 forearm flexor muscles of healthy volunteers. Each subject underwent to a protocol consisting of three trials: rest condition, isometric contraction, 4 min relaxation. Measured data were fitted with Cole-Cole equivalent electrical circuit using the complex nonlinear least square method. Finally, the relative variations from the steady state of the electrical parameters of the equivalent electrical circuit were estimated. Results obtained are in agreement with the hypothesis that, in the frequency range considered, the current preferentially flows through the extracellular fluid, being the component of intracellular resistance negligible. Among circuital parameters, in fact, the relative variations from steady state of R0 changed highly significant (p < 0.001) both during contraction and after 4 min relaxation.