Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinic setting: study protocol for a randomised controlled trial targeting type 2 diabetes individuals with non-ideal glycaemic values (Telemechron study).

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the twenty-first century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. smartphone application-App) in the health field has progressively increased as it has been proved to be effective in helping individuals manage their long-term diseases. Therefore, it has the potential to reduce the use of health service and its related costs. The objective of this study is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organisational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy. METHODS: This trial was designed as a multi-centre, open-label, randomised, superiority study with two parallel groups and a 1:1 allocation ratio. Individuals regularly attending outpatient diabetes clinics, providing informed consent, are randomised to be prescribed TreC Diabete platform as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis. DISCUSSION: This trial is the first conducted in the PAT area for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organisational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed. TRIAL REGISTRATION: ClinicalTrials.gov NCT05629221. Registered on November 29, 2022, prior start of inclusion.

A novel smartphone App to support the clinical practice of pediatric ophthalmology and strabismus: the validation of visual acuity tests.

This study is aimed at describing the TreC Oculistica novel smartphone App that facilitated the clinical practice of pediatric ophthalmology and strabismus during the COVID-19 pandemic and at reporting on the validation of visual acuity tests in a home setting. The Trec Oculistica smartphone App was prescribed to eligible patients at the Pediatric Ophthalmology and Strabismus Clinic, Ophthalmology Unit of Rovereto Hospital, between September 2020 and March 2022. Four key indicators were identified for monitoring visual and visuo-motor functions remotely: visual acuity, ocular motility, head posture, and color vision. Clinicians selected few mobile applications (iOS, Android) and printable materials within the Trec Oculistica App: the Snellen Chart Visual Acuity App, the 9Gaze App, the eyeTilt App, the Color Blind test App, the LEA Symbols pdf, and the Snellen Chart pdf. All patients, aged 4 and older, were screened at home for visual acuity at 3 m and later in the clinic (LEA Symbols cabinet or Snellen computerized optotype). The 9Gaze, the eyeTilt, and the Color Blind test Apps were only recommended to a subset of patients based on clinical suspicion or diagnosis. The Wilcoxon signed rank sum test and weighted Cohen's kappa coefficient were applied to compare pairs of scores from different settings. The Trec Oculistica App was downloaded and activated by 97 patients or their caregiver. 40 patients were tested at home using the 9Gaze App, 7 used the eyeTilt App, and 11 used the Color-Blind test App. Families reported that all the Apps were easy and intuitive to use; clinicians reported that measurements were reliable. 82 eyes of 41 patients (mean age 5.2 years, SD ± 0.4, range 4.4-6.1) were tested for visual acuity using the self-administered LEA Symbols pdf. 92 eyes of 46 patients (mean age 11.6 years, SD ± 5.2, range 6-35) were evaluated using the self-administered Snellen Chart Visual Acuity App or the Snellen Chart pdf. Home median visual acuity score was statistically different from that registered in clinical setting for both the LEA Symbols pdf (P-value = 0.0074) and the Snellen Chart App and pdf (P-value = 0.0001). The strength of agreement was 0.12 (slight) for the LEA Symbols pdf, 0.50 (moderate) for the Snellen Chart Visual Acuity App, and 0.69 (substantial) for the Snellen Chart pdf. CONCLUSION: The novel TreC Oculistica smartphone App was a useful tool for facilitating the clinical practice of pediatric ophthalmology and strabismus during the COVID-19 pandemic. In the follow-up of strabismus patients and patients with suspected inherited retinal diseases, the 9Gaze, eyeTilt, and Color Blind test applications were deemed to be intuitive and easy to use by families and were considered reliable by clinicians. In a home setting, visual acuity tested by means of Snellen Charts was moderately congruent with the in-office examination. On the contrary, agreement was poor in younger children tested with the LEA Symbols pdf. WHAT IS KNOWN: • Teleophthalmology enables clinicians to evaluate patients' ocular diseases remotely and various tools are helpful for screening, follow-ups and treatment. • Smartphones can currently be used to obtain ocular images and vision measurements of patients' eyes and this information can be shared with the ophthalmologist for further evaluations and medical management (mhealth). WHAT IS NEW: • Smartphone Apps can be successfully used in a hybrid teleophthalmology service concerning first visits and follow-ups. • Apps and printable materials are easy, intuitive to use for patients and  also reliable for  clinicians.

Patient-Reported Outcomes After Swallowing (SWOARs)-Sparing IMRT in Head and Neck Cancers: Primary Results from a Prospective Study Endorsed by the Head and Neck Study Group (HNSG) of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

OBJECTIVES: To prospectively investigate changes in M.D. Anderson Dysphagia Inventory (MDADI) scores in patients affected by naso- and oropharynx cancer after definitive radiochemotherapy (ChemoRT) using swallowing organs at risk (SWOARs)-sparing IMRT. METHODS: MDADI questionnaires were collected at baseline and at 6 and 12 months after treatment. MDADI scores were categorized as follows: ≥ 80 "optimal," 80-60 "adequate," < 60 "poor" deglutition-related quality of life (QoL) group, and dichotomized as "optimal" vs "adequate/poor" for the analysis. A mean MDADI composite (MDADI-C) change of 10 points was considered as minimal clinically important difference (MCID). RESULTS: Sixty-three patients were enrolled of which 47 were considered for the analysis. At baseline, 26 (55%) were "optimal" and 21 (45%) were "adequate/poor." The mean baseline MDADI-C score was 93.6 dropping to 81 at 6 months (p = 0.013) and slightly rising to 85.5 at 12 months (p = 0.321) for the "optimal" group. Indeed, the mean baseline MDADI-C score was 64.3 rising to 77.5 at 6 months (p = 0.006) and stabilizing at 76 at 12 months (p = 0.999) for the "adequate/poor" group. A statistically significant but not clinically relevant worsening of the MDADI-C score was reported for the "optimal" group, whereas both a statistically significant and clinically meaningful improvement of the MDADI-C score were reported for the "adequate/poor" group from before to post-treatment. CONCLUSION: Our results suggest a doubly clinical benefit of dose optimization to SWOARs to minimize the RT sequalae in patients with a baseline "optimal" deglutition-related QoL and to recover from cancer dysphagia in those with a baseline "adequate/poor" deglutition-related QoL.

Digital Technologies and the Role of Health Care Professionals: Scoping Review Exploring Nurses' Skills in the Digital Era and in the Light of the COVID-19 Pandemic.

BACKGROUND: The nursing role significantly changed following reforms in the nurse training process. Nowadays, nurses are increasingly trained to promote and improve the quality of clinical practice and to provide support in the assistance of patients and communities. Opportunities and threats are emerging as a consequence of the introduction of new disruptive technologies in public health, which requires the health care staff to develop new digital skills. OBJECTIVE: The aim of this paper is to review and define the role of nurses and the skills they are asked to master in terms of new methodological approaches and digital knowledge in a continuously evolving health care scenario that relies increasingly more on technology and digital solutions. METHODS: This scoping review was conducted using a thematic summary of previous studies. Authors collected publications through a cross-database search (PubMed, Web of Science, Google Scholar) related to new telemedicine approaches impacting the nurses' role, considering the time span of 2011-2021 and therefore including experiences and publications related to the first phase of the COVID-19 pandemic. RESULTS: The assessment was completed between April and July 2021. After a cross-database search, authors reviewed a selection of 60 studies. The results obtained were organized into 5 emerging macro areas: (1) leadership (nurses are expected to show leadership capabilities when introducing new technologies in health care practices, considering their pivotal role in coordinating various professional figures and the patient), (2) soft skills (new communication skills, adaptiveness, and problem solving are needed to adapt the interaction to the level of digital skills and digital knowledge of the patient), (3) training (specific subjects need to be added to nursing training to boost the adoption of new communication and technological skills, enabling health care professionals to largely and effectively use new digital tools), (4) remote management of COVID-19 or chronic patients during the pandemic (a role that has proved to be fundamental is the community and family nurse and health care systems are adopting novel assistance models to support patients at home and to enable decentralization of services from hospitals to the territory), and (5) management of interpersonal relationships with patients through telemedicine (a person-centered approach with an open and sensitive attitude seems to be even more important in the framework of telemedicine where a face-to-face session is not possible and therefore nonverbal indicators are more problematic to be noticed). CONCLUSIONS: Further advancing nurses' readiness in adopting telemedicine requires an integrated approach, including combination of technical knowledge, management abilities, soft skills, and communication skills. This scoping review provides a wide-ranging and general-albeit valuable-starting point to identify these core competences and better understand their implications in terms of present and future health care professionals' roles.

Novel Harmonization Method for Multi-Centric Radiomic Studies in Non-Small Cell Lung Cancer.

The purpose of this multi-centric work was to investigate the relationship between radiomic features extracted from pre-treatment computed tomography (CT), positron emission tomography (PET) imaging, and clinical outcomes for stereotactic body radiation therapy (SBRT) in early-stage non-small cell lung cancer (NSCLC). One-hundred and seventeen patients who received SBRT for early-stage NSCLC were retrospectively identified from seven Italian centers. The tumor was identified on pre-treatment free-breathing CT and PET images, from which we extracted 3004 quantitative radiomic features. The primary outcome was 24-month progression-free-survival (PFS) based on cancer recurrence (local/non-local) following SBRT. A harmonization technique was proposed for CT features considering lesion and contralateral healthy lung tissues using the LASSO algorithm as a feature selector. Models with harmonized CT features (B models) demonstrated better performances compared to the ones using only original CT features (C models). A linear support vector machine (SVM) with harmonized CT and PET features (A1 model) showed an area under the curve (AUC) of 0.77 (0.63-0.85) for predicting the primary outcome in an external validation cohort. The addition of clinical features did not enhance the model performance. This study provided the basis for validating our novel CT data harmonization strategy, involving delta radiomics. The harmonized radiomic models demonstrated the capability to properly predict patient prognosis.

Role of magnetic resonance imaging following postoperative radiotherapy in clinical decision-making of patients with high-grade glioma.

OBJECTIVES: The present study aims to investigate the role of the first magnetic resonances (MRI) following radio-chemotherapy (RT-CT) in patients diagnosed with high-grade glioma. METHODS: We retrospectively recorded radiological evaluations following RT-CT, symptoms related to disease progression (avoiding any sign due to radiotherapy or chemotherapy) and the change of therapeutic strategy. RESULTS: In March 2021, at data analysis, the data of 149 patients diagnosed with high-grade glioma and treated between May 2013 and July 2020 were retrieved for the present analysis. Two out of 122 (1.6%), 5 out of 106 (4.7%) and 8 out of 92 (8.6%) asymptomatic patients received the diagnosis of disease recurrence at the time of the first, second and third MRI, respectively. Otherwise, 16 out of 27 (59.2%), 16 out of 24 (66.6%) and 13 out of 16 (82.2%) symptomatic patients changed their therapy after the first, second and third MRI, respectively. Among patients that experienced radiological signs of distant progression, 10 out of 14 were symptomatic and changed their therapy. CONCLUSIONS: MRIs performed by 6 months after the end of RT-CT lead to change treatment strategy mostly in symptomatic patients.

Impact of recurrence pattern in patients undergoing a second surgery for recurrent glioblastoma.

The impact of different patterns of glioblastoma (GBM) recurrence has not yet been fully established in patients suitable for a second surgery. Through the present observational study carried out at Pisa University Hospital, we aimed to investigate how different patterns of GBM failure influence second surgery outcomes. Overall survival (OS) and post-recurrence survival (PRS) were assessed according to clinical characteristics, including pattern of recurrence, in a prospective cohort of recurrent GBM patients. Survival curves were calculated using the Kaplan-Meier method and the log-rank test was applied to evaluate the differences between curves. Patients with local recurrence had better OS than patients with non-local one, 24.1 versus 18.2 months, respectively [P = 0.015, HR = 1.856 (1.130-3.050)]. The second surgery conferred an advantage in OS respect to non-operated patients, however, this advantage was more evident in patients with local recurrence [P = 0.002 with HR 0.212 (95% CI 0.081-0.552) and P = 0.029 with HR = 0.522 (95% CI 0.291-0.936), respectively]. The recurrence pattern can influence the outcome of patients with recurrent GBM suitable for a second surgery.

Implementation of tele visit healthcare services triggered by the COVID-19 emergency: the Trentino Province experience.

AIM: In response to the SARS-CoV-2 emergency, the Competence Centre on digital health 'TrentinoSalute4.0' has developed TreC_Televisita, a tele visit solution that meets the needs of the Trentino healthcare system and maintains high-quality patient-doctor interactions while respecting social distancing. This paper highlights how 'TreC_Televisita' was integrated into the Trentino healthcare system and its potential to become a structural and durable solution for the future local healthcare service provisioning. SUBJECT AND METHODS: This paper presents the multifactorial context that TreC_Televisita has faced for its implementation and the strategies adopted for its structural integration into the healthcare system. The analysis focuses on the main issues faced for the integration of the tele visits (e.g. privacy, payments) and how the context of TrentinoSalute4.0 permitted responding quickly to its implementation during the pandemic. It also describes how TreC_Televisita fits into the healthcare continuum from the organisational and technological standpoint, the end-user perspective and the barriers that could hamper the solution scalability. RESULTS: TreC_Televisita has demonstrated to be a technological solution that can be contextualised for different clinical domains beyond SARS-CoV-2. Moreover, it has shown its potential to scale up the solution beyond the COVID-19 emergency to the whole healthcare provisioning system in the long term. CONCLUSION: Being a positive experience in the first months of its implementation, the long-term goal is to transform TreC_Televisita into a structural pillar of the Trentino healthcare system, setting the bases for a sustainable, win-win situation for all the stakeholders involved in healthcare service provisioning.

Enabling teleophthalmology during the COVID-19 pandemic in the Province of Trento, Italy: Design and implementation of a mHealth solution.

BACKGROUND: Due to the many restrictions imposed during the COVID-19 emergency, the normal clinical activities have been stopped abruptly in view of limiting the circulation of the virus. The extraordinary containment measures have had a dramatic impact on the undertaking and follow-up of ophthalmic outpatients. OBJECTIVE: In order to guarantee proper monitoring and routine care, the Pediatric Ophthalmology equipe of Rovereto Hospital (North-East of Italy) supported by the Competence Center on Digital Health TrentinoSalute4.0, designed and implemented a digital platform, TreC Oculistica, enabling teleophthalmology. We report our innovative-albeit restricted-experience aiming at testing and maximizing the efficacy of remote ophthalmic and orthoptic visits. METHODS: A multidisciplinary team created the TreC Oculistica platform and defined a teleophthalmology protocol. The system consists of a clinician web interface and a patient mobile application. Clinicians can prescribe outpatients with the App and some preliminary measurements to be self-collected before the televisit. The App conveys the clinician's requests (i.e. measurements) and eases the share of the collected information in a secure digital environment, promoting a new health care workflow. RESULTS: Four clinicians took part in the testing phase (2 ophthalmologists and 2 orthoptists) and recruited 37 patients (mostly pediatric) in 3 months. Thanks to a continuous feedback between the testing and the technical implementation, it has been possible to identify pros and cons of the implemented functionalities, considering possible improvements. Digital solutions such as TreC Oculistica advance the digitalization of the Italian health care system, promoting a structured and effective reorganization of the workload supported by digital systems. CONCLUSIONS: The study tested an innovative digital solution in the teleophthalmology context and represented the first experience within the Italian healthcare system. This solution opens up new possibilities and scenarios that can be effective not only during the pandemic, but also in the traditional management of public health services.

Neural encoding and functional interactions underlying pantomimed movements.

Pantomimes are a unique movement category which can convey complex information about our intentions in the absence of any interaction with real objects. Indeed, we can pretend to use the same tool to perform different actions or to achieve the same goal adopting different tools. Nevertheless, how our brain implements pantomimed movements is still poorly understood. In our study, we explored the neural encoding and functional interactions underlying pantomimes adopting multivariate pattern analysis (MVPA) and connectivity analysis of fMRI data. Participants performed pantomimed movements, either grasp-to-move or grasp-to-use, as if they were interacting with two different tools (scissors or axe). These tools share the possibility to achieve the same goal. We adopted MVPA to investigate two levels of representation during the planning and execution of pantomimes: (1) distinguishing different actions performed with the same tool, (2) representing the same final goal irrespective of the adopted tool. We described widespread encoding of action information within regions of the so-called "tool" network. Several nodes of the network-comprising regions within the ventral and the dorsal stream-also represented goal information. The spatial distribution of goal information changed from planning-comprising posterior regions (i.e. parietal and temporal)-to execution-including also anterior regions (i.e. premotor cortex). Moreover, connectivity analysis provided evidence for task-specific bidirectional coupling between the ventral stream and parieto-frontal motor networks. Overall, we showed that pantomimes were characterized by specific patterns of action and goal encoding and by task-dependent cortical interactions.

Use of eHealth Platforms and Apps to Support Monitoring and Management of Home-Quarantined Patients With COVID-19 in the Province of Trento, Italy: App Development and Implementation.

BACKGROUND: Italy was the first country to largely experience the COVID-19 epidemic among other Western countries during the so-called first wave of the COVID-19 pandemic. Proper management of an increasing number of home-quarantined individuals created a significant challenge for health care authorities and professionals. This was especially true when considering the importance of remote surveillance to detect signs of disease progression and consequently regulate access to hospitals and intensive care units on a priority basis. OBJECTIVE: In this paper, we report on an initiative promoted to cope with the first wave of the COVID-19 epidemic in the Spring/Summer of 2020, in the Autonomous Province of Trento, Italy. A purposefully built app named TreCovid19 was designed to provide dedicated health care staff with a ready-to-use tool for remotely monitoring patients with progressive symptoms of COVID-19, who were home-quarantined during the first wave of the epidemic, and to focus on those patients who, based on their self-reported clinical data, required a quick response from health care professionals. METHODS: TreCovid19 was rapidly developed to facilitate the monitoring of a selected number of home-quarantined patients with COVID-19 during the very first epidemic wave. The app was built on top of an existing eHealth platform, already in use by the local health authority to provide home care, with the following functionalities: (1) to securely collect and link demographic and clinical information related to the patients and (2) to provide a two-way communication between a multidisciplinary health care team and home-quarantined patients. The system supported patients to self-assess their condition and update the multidisciplinary team on their health status. The system was used between March and June 2020 in the province of Trento. RESULTS: A dedicated multidisciplinary group of health care professionals adopted the platform over a period of approximately 3 months (from March-end to June 2020) to monitor a total of 170 patients with confirmed COVID-19 during home quarantine. All patients used the system until the end of the initiative. The TreCovid19 system has provided useful insights of possible viability and impact of a technological-organizational asset to manage a potentially critical workload for the health care staff involved in the periodic monitoring of a relevant number of quarantined patients, notwithstanding its limitations given the rapid implementation of the whole initiative. CONCLUSIONS: The technological and organizational model adopted in response to the COVID-19 pandemic was developed and finalized in a relatively short period during the initial few weeks of the epidemic. The system successfully supported the health care staff involved in the periodic monitoring of an increasing number of home-quarantined patients and provided valuable data in terms of disease surveillance.

Decoding motor imagery and action planning in the early visual cortex: Overlapping but distinct neural mechanisms.

Recent evidence points to a role of the primary visual cortex that goes beyond visual processing into high-level cognitive and motor-related functions, including action planning, even in absence of feedforward visual information. It has been proposed that, at the neural level, motor imagery is a simulation based on motor representations, and neuroimaging studies have shown overlapping and shared activity patterns for motor imagery and action execution in frontal and parietal cortices. Yet, the role of the early visual cortex in motor imagery remains unclear. Here we used multivoxel pattern analyses on functional magnetic resonance imaging (fMRI) data to examine whether the content of motor imagery and action intention can be reliably decoded from the activity patterns in the retinotopic location of the target object in the early visual cortex. Further, we investigated whether the discrimination between specific actions generalizes across imagined and intended movements. Eighteen right-handed human participants (11 females) imagined or performed delayed hand actions towards a centrally located object composed of a small shape attached on a large shape. Actions consisted of grasping the large or small shape, and reaching to the center of the object. We found that despite comparable fMRI signal amplitude for different planned and imagined movements, activity patterns in the early visual cortex, as well as dorsal premotor and anterior intraparietal cortex, accurately represented action plans and action imagery. However, movement content is similar irrespective of whether actions are actively planned or covertly imagined in parietal but not early visual or premotor cortex, suggesting a generalized motor representation only in regions that are highly specialized in object directed grasping actions and movement goals. In sum, action planning and imagery have overlapping but non identical neural mechanisms in the cortical action network.

Predictive coding of action intentions in dorsal and ventral visual stream is based on visual anticipations, memory-based information and motor preparation.

Predictions of upcoming movements are based on several types of neural signals that span the visual, somatosensory, motor and cognitive system. Thus far, pre-movement signals have been investigated while participants viewed the object to be acted upon. Here, we studied the contribution of information other than vision to the classification of preparatory signals for action, even in the absence of online visual information. We used functional magnetic resonance imaging (fMRI) and multivoxel pattern analysis (MVPA) to test whether the neural signals evoked by visual, memory-based and somato-motor information can be reliably used to predict upcoming actions in areas of the dorsal and ventral visual stream during the preparatory phase preceding the action, while participants were lying still. Nineteen human participants (nine women) performed one of two actions towards an object with their eyes open or closed. Despite the well-known role of ventral stream areas in visual recognition tasks and the specialization of dorsal stream areas in somato-motor processes, we decoded action intention in areas of both streams based on visual, memory-based and somato-motor signals. Interestingly, we could reliably decode action intention in absence of visual information based on neural activity evoked when visual information was available and vice versa. Our results show a similar visual, memory and somato-motor representation of action planning in dorsal and ventral visual stream areas that allows predicting action intention across domains, regardless of the availability of visual information.

Common spatiotemporal processing of visual features shapes object representation.

Biological vision relies on representations of the physical world at different levels of complexity. Relevant features span from simple low-level properties, as contrast and spatial frequencies, to object-based attributes, as shape and category. However, how these features are integrated into coherent percepts is still debated. Moreover, these dimensions often share common biases: for instance, stimuli from the same category (e.g., tools) may have similar shapes. Here, using magnetoencephalography, we revealed the temporal dynamics of feature processing in human subjects attending to objects from six semantic categories. By employing Relative Weights Analysis, we mitigated collinearity between model-based descriptions of stimuli and showed that low-level properties (contrast and spatial frequencies), shape (medial-axis) and category are represented within the same spatial locations early in time: 100-150 ms after stimulus onset. This fast and overlapping processing may result from independent parallel computations, with categorical representation emerging later than the onset of low-level feature processing, yet before shape coding. Categorical information is represented both before and after shape, suggesting a role for this feature in the refinement of categorical matching.