COVID-19 response: effectiveness of weekly rapid risk assessments, Italy.

PROBLEM: After Italy's first national restriction measures in 2020, a robust approach was needed to monitor the emerging epidemic of coronavirus disease 2019 (COVID-19) at subnational level and provide data to inform the strengthening or easing of epidemic control measures. APPROACH: We adapted the European Centre for Disease Prevention and Control rapid risk assessment tool by including quantitative and qualitative indicators from existing national surveillance systems. We defined COVID-19 risk as a combination of the probability of uncontrolled transmission of severe acute respiratory syndrome coronavirus 2 and of an unsustainable impact of COVID-19 cases on hospital services, adjusted in relation to the health system's resilience. The monitoring system was implemented with no additional cost in May 2020. LOCAL SETTING: The infectious diseases surveillance system in Italy uses consistent data collection methods across the country's decentralized regions and autonomous provinces. RELEVANT CHANGES: Weekly risk assessments using this approach were sustainable in monitoring the epidemic at regional level from 4 May 2020 to 24 September 2021. The tool provided reliable assessments of when and where a rapid increase in demand for health-care services would occur if control or mitigation measures were not increased in the following 3 weeks. LESSONS LEARNT: Although the system worked well, framing the risk assessment tool in a legal decree hampered its flexibility, as indicators could not be changed without changing the law. The relative complexity of the tool, the impossibility of real-time validation and its use for the definition of restrictions posed communication challenges.

Accelerating the health literacy agenda in Europe.

Health literacy can be defined as the knowledge, motivation and competence to access, understand, appraise and apply information to make decisions in terms of healthcare, disease prevention and health promotion. Health literacy is a European public health challenge that has to be taken seriously by policy-makers. It constitutes an emerging field for policy, research and practice. However, recent research has shown that health literacy advancement is still at its infancy in Europe, as reflected in the scarce scientific health literacy literature published by European authors. From a total of 569 articles published until 2011 on this subject, the first author of only 15% of them is from Europe. This article conveys recommendations of different European stakeholders on how to accelerate the health literacy agenda in Europe. A general introduction on the current status of health literacy is provided, followed by two cases applying health literacy in the areas of prevention of communicable diseases and promotion of digital health. The current EU strategies integrating health literacy are listed, followed by examples of challenges threatening the further development of health literacy in Europe. Recommendations as to how European stakeholders involved in research, policy, practice and education can promote health literacy are given. It is vital that the European Commission as well as European Union Member States take the necessary steps to increase health literacy at individual, organizational, community, regional and national levels.

Telemonitoring of Type 2 Diabetes Mellitus in Italy.

BACKGROUND: Type 2 diabetes mellitus (DM) affects 382 million people worldwide. INTRODUCTION: This study aimed at assessing whether telemonitoring (TM) of DM patients improves health-related quality of life (HRQoL). MATERIALS AND METHODS: As part of the RENEWING HEALTH project, 299 DM patients with HbA1c >7.0% were enrolled in a randomized controlled trial, with 208 patients in the TM group and 91 patients in the usual-care group. TM electronically transmitted glucose measurements to physicians during a 12-month follow-up. The SF-36v2 questionnaire was used to assess HRQoL. RESULTS: In a total of 243 patients analyzed, the study did not identify any clinically important improvement in HRQoL, our primary endpoint. There was no statistically significant difference in HbA1c between the two groups; however, outpatient visits and planned hospitalizations were significantly reduced in the TM group (p < 0.0001 and p = 0.02). DISCUSSION: The results regarding HRQoL might be, at least in part, an artifact stemming from the criteria used to select patients. TM reduced ambulatory visits and planned hospital admissions, an important result that plausibly reflects the fact that clinicians can strictly monitor their patients' health status without face-to-face contacts. CONCLUSIONS: Enhancement of HRQoL should represent the most critical goal of DM healthcare delivery. Effects of TM on HRQoL of diabetic patients should be studied further.

A one-to-one telestroke network: the first Italian study of a web-based telemedicine system for thrombolysis delivery and patient monitoring.

Over 10 years after European approval, thrombolysis is still limited by a restricted time window and non-optimal territorial coverage. Implementation of telestroke can give a growing number of patients access to treatment. We hereby present the first Italian telemedicine study applied to both the acute and the monitoring phase of stroke care. From January 2011 to December 2013, we tested a web-based, drip, and treat interaction model, connecting the cerebrovascular specialist of one hub center to the Emergency Department of a Spoke center. We then compared thrombolysis delivered using the telestroke model with thrombolysis provided at the Hub Stroke Unit at the time when the telemedicine program was activated. Telethrombolysis data were then compared with data from the two main international telestroke projects (TEMPiS and REACH), and other European telestroke studies performed at the time of writing. We collected a total of 131 thrombolysis procedures (25 telethrombolysis and 106 thrombolysis patients at the Stroke Unit). Statistical analysis with the t test yielded no statistically significant differences between the two populations in door-to-scan, door-to-needle (DTN), and onset-to-treatment times (OTT). Our OTT and DTN pathway times were longer than the TEMPiS and REACH studies but comparable with other European telemedicine trials, despite different models of interaction and number of centers. Our study in a northeastern province of Italy confirms the potential of applying telemedicine to a cerebrovascular pathology.

Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

BACKGROUND: Although a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services. METHODS: A 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual's normal range. The study's primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths. RESULTS: Three hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79-1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 - 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19-0.98); p = 0.01 and 0.46 (95% CI 0.24-0.89); p = 0.01, respectively]. CONCLUSION: Study results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission. TRIAL REGISTRATION: Retrospectively registered on January 2012, ClinicalTrials.gov Identifier: NCT01513980 .

The neurosurgical telecounseling network in the Veneto Region: 4 years of experience of HEALTH OPTIMUM.

BACKGROUND: Neurosurgery is a highly specialized service that, because of high costs, is often centralized. Since 2005, a neurosurgical telecounseling service was defined and then deployed in the Veneto Region. It was aimed at creating the same range of services for head trauma by using standardized protocols at regional levels and at rationalizing the use of human and technological resources by providing a network of services that manages patients at the local level. The main objective of the study was to evaluate the use of this service. MATERIALS AND METHODS: Interoperability and flexibility were granted by creating a technological framework based on international standards. Physicians of local hospitals electronically transmit patients' clinical data and images to neurosurgeons located at a central hospital. These physicians respond to the requesting physicians by providing all the necessary recommendations. RESULTS: The outcomes were collected over a period of 41 months. The service is now available in 34 hospitals. Every year 3,181 telecounselings are conducted for patients with an average age of 65.5 years (55% male, 45% female) whose health status is mainly not serious. Within 30 min from the request of telecounseling, 49% of responses are sent. In 84% of cases the patient was not moved. The overall appreciation of clinicians is positive (4.3/5). Intervention time was reduced, and resources were optimized. CONCLUSIONS: The service brought remarkable benefits at the organizational level. The reorganization of the processes and patient management leads to rationalization of both human and technological resources.

Mathematical Modeling and Robustness Analysis to Unravel COVID-19 Transmission Dynamics: The Italy Case.

This study started from the request of providing predictions on hospitalization and Intensive Care Unit (ICU) rates that are caused by COVID-19 for the Umbria region in Italy. To this purpose, we propose the application of a computational framework to a SEIR-type (Susceptible, Exposed, Infected, Removed) epidemiological model describing the different stages of COVID-19 infection. The model discriminates between asymptomatic and symptomatic cases and it takes into account possible intervention measures in order to reduce the probability of transmission. As case studies, we analyze not only the epidemic situation in Umbria but also in Italy, in order to capture the evolution of the pandemic at a national level. First of all, we estimate model parameters through a Bayesian calibration method, called Conditional Robust Calibration (CRC), while using the official COVID-19 data of the Italian Civil Protection. Subsequently, Conditional Robustness Analysis (CRA) on the calibrated model is carried out in order to quantify the influence of epidemiological and intervention parameters on the hospitalization rates. The proposed pipeline properly describes the COVID-19 spread during the lock-down phase. It also reveals the underestimation of new positive cases and the need of promptly isolating asymptomatic and presymptomatic cases. The results emphasize the importance of the lock-down timeliness and provide accurate predictions on the current evolution of the pandemic.

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

BACKGROUND: Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. OBJECTIVE: The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. METHODS: A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. RESULTS: In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per patient per year were detected within a mean (SD) time of 1.18 (2.08) days. Mean time spent by physicians to treat a patient was lower in the I-group compared to the U-group (-4.1 minutes PM; -13.7 minutes ICD). Organizational analysis showed that remote monitoring implementation was rather haphazard and fragmented. From a health care system perspective, the economic analysis showed statistically significant gains (P<.001) for the I-group using PM. CONCLUSIONS: This study contributes to build solid evidence regarding the usefulness of RM in detecting and managing clinical and technical events with limited use of manpower and other health care resources. To fully gain the benefits of RM of PM/ICD, it is vital that organizational processes be streamlined and standardized within an overarching strategy.

Assessment of Patients' Perception of Telemedicine Services Using the Service User Technology Acceptability Questionnaire.

INTRODUCTION: The purpose of this paper is to assess if similar telemedicine services integrated in the management of different chronic diseases are acceptable and well perceived by patients or if there are any negative perceptions. THEORY AND METHODS: Participants suffering from different chronic diseases were enrolled in Veneto Region and gathered into clusters. Each cluster received a similar telemedicine service equipped with different disease-specific measuring devices. Participants were patients with diabetes (n = 163), chronic obstructive pulmonary disease (n = 180), congestive heart failure (n = 140) and Cardiac Implantable Electronic Devices (n = 1635). The Service User Technology Acceptability Questionnaire (SUTAQ) was initially translated, culturally adapted and pretested and subsequently used to assess patients' perception of telemedicine. Data were collected after 3 months and after 12 months from the beginning of the intervention. Data for patients with implantable devices was collected only at 12 months. RESULTS: Results at 12 months for all clusters are similar and assessed a positive perception of telemedicine. The SUTAQ results for clusters 2 (diabetes), 5 (COPD) and 7 (CHF) after 3 months of intervention were confirmed after 12 months. CONCLUSIONS: Telemedicine was perceived as a viable addition to usual care. A positive perception for telemedicine services isn't a transitory effect, but extends over the course of time.

Adverse event reporting and patient safety at a University Hospital: Mapping, correlating and associating events for a data-based patient risk management.

BACKGROUND: Reporting adverse events (AE) with a bearing on patient safety is fundamentally important to the identification and mitigation of potential clinical risks. OBJECTIVE: The aim of this study was to analyze the AE reporting systems adopted at a university hospital for the purpose of enhancing the learning potential afforded by these systems. RESEARCH DESIGN: Retrospective cohort study METHODS: Data were collected from different information flows (reports of incidents and falls, patients' claims and complaints, and cases of hospital-acquired infection [HAI]) at an university hospital. A composite risk indicator was developed to combine the data from the different flows. Spearman's nonparametric test was applied to investigate the correlation between the AE rates and a Poisson regression analysis to verify the association among characteristics of the wards and AE rates. SUBJECTS: Sixty-four wards at a University Hospital. RESULTS: There was a marked variability among wards AE rates. Correlations emerged between patients' claims with complaints and the number of incidents reported. Falls were positively associated with average length of hospital stay, number of beds, patients' mean age, and type of ward, and they were negatively associated with the average Cost Weight of the Diagnosis-related group (DRG) of patients on a given ward. Claims and complaints were associated directly with the average DRG weight of a ward's patient admissions. CONCLUSIONS: This study attempted to learn something useful from an analysis of the mandatory (but often little used) data flows generated on adverse events occurring at an university hospital with a view to managing the associated clinical risk to patients.

Ebola: lessons learned and future challenges for Europe.

The Ebola virus epidemic has topped media and political agendas for months; several countries in west Africa have faced the worst Ebola epidemic in history. At the beginning of the disease outbreak, European Union (EU) policies were notably absent regarding how to respond to the crisis. Although the epidemic is now receding from public view, this crisis has undoubtedly changed the European public perception of Ebola virus disease, which is no longer regarded as a bizarre entity confined in some unknown corner in Africa. Policy makers and researchers in Europe now have an opportunity to consider the lessons learned. In this Personal View, we discuss the EU's response to the Ebola crisis in west Africa. Unfortunately, although ample resources and opportunities for humanitarian and medical action existed, the EU did not use them to promote a rapid and well coordinated response to the Ebola crisis. Lessons learned from this crisis should be used to improve the role of the EU in similar situations in the future, ensuring that European aid can be effectively deployed to set up an improved emergency response system, and supporting the establishment of sustainable health-care services in west Africa.

Health protection in times of economic crisis: challenges and opportunities for Europe.

STOA, the European Parliament's technology assessment body, and the European Observatory on Health Systems and Policies recently organised a workshop on the impacts of the economic crisis on European health systems. Evidence of the impact of the recent financial crisis on health outcomes is only just beginning to emerge. Data suggests that this latest recession has led to more frequent poor health status, rising incidence of some communicable diseases, and higher suicide rates. Further, available data are likely to underestimate the broader mental health crisis linked to increased rates of stress, anxiety, and depression among the economically vulnerable. Not only does recession affect factors that determine health, but it also affects the financial capacity to respond. Many European governments have reduced public expenditure on health services during the financial crisis, while introducing or increasing user charges. The recession has driven structural reforms, and has affected the priority given to public policies that could be used to help protect population health. The current economic climate, while challenging, presents an opportunity for reforming and restructuring health promotion actions and taking a long-term perspective.