Economic analysis of remote monitoring in patients with implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators in the Trento area, Italy.

Introduction: Remote monitoring (RM) technologies have the potential to improve patient care by increasing compliance, providing early indications of heart failure (HF), and potentially allowing for therapy optimization to prevent HF admissions. The aim of this retrospective study was to assess the clinical and economic consequences of RM vs. standard monitoring (SM) through in-office cardiology visits, in patients carrying a cardiac implantable electronic device (CIED). Methods: Clinical and resource consumption data were extracted from the Electrophysiology Registry of the Trento Cardiology Unit, which has been systemically collecting patient information from January 2011 to February 2022. From a clinical standpoint, survival analysis was conducted, and incidence of cardiovascular (CV) related hospitalizations was measured. From an economic standpoint, direct costs of RM and SM were collected to compare the cost per treated patient over a 2-year time horizon. Propensity score matching (PSM) was used to reduce the effect of confounding biases and the unbalance of patient characteristics at baseline. Results: In the enrollment period, N = 402 CIED patients met the inclusion criteria and were included in the analysis (N = 189 patients followed through SM; N = 213 patients followed through RM). After PSM, comparison was limited to N = 191 patients in each arm. After 2-years follow-up since CIED implantation, mortality rate for any cause was 1.6% in the RM group and 19.9% in the SM group (log-rank test, p < 0.0001). Also, a lower proportion of patients in the RM group (25.1%) were hospitalized for CV-related reasons, compared to the SM group (51.3%; p < 0.0001, two-sample test for proportions). Overall, the implementation of the RM program in the Trento territory was cost-saving in both payer and hospital perspectives. The investment required to fund RM (a fee for service in the payer perspective, and staffing costs for hospitals), was more than offset by the lower rate of hospitalizations for CV-related disease. RM adoption generated savings of -€4,771 and -€6,752 per patient in 2 years, in the payer and hospital perspective, respectively. Conclusion: RM of patients carrying CIED improves short-term (2-years) morbidity and mortality risks, compared to SM and reduces direct management costs for both hospitals and healthcare services.

Risk of Symptomatic Infection During a Second Coronavirus Disease 2019 Wave in Severe Acute Respiratory Syndrome Coronavirus 2-Seropositive Individuals.

We analyzed 221 coronavirus disease 2019 cases identified between June 2020 and January 2021 in 6074 individuals screened for immunoglobulin G antibodies in May 2020, representing 77% of residents of 5 Italian municipalities. The relative risk of developing symptomatic infection in seropositive participants was 0.055 (95% confidence interval, .014-.220).

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.

Correction: Cazzoletti et al. Risk Factors Associated with Nursing Home COVID-19 Outbreaks: A Retrospective Cohort Study. Int. J. Environ. Res. Public Health 2021, 18, 8434.

The authors would like to make the following corrections to this paper [...].

Risk Factors Associated with Nursing Home COVID-19 Outbreaks: A Retrospective Cohort Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic had a devastating impact on nursing homes/long-term care facilities. This study examined the relationship between geography, size, design, organizational characteristics, and implementation of infection prevention and control (IPC) measures and the extent of COVID-19 outbreaks in nursing homes in the Autonomous Province of Trento (Italy) during the time frame of March-May 2020. METHODS: The analysis included 57 nursing homes (5145 beds). The association between median cumulative incidence of COVID-19 cases among residents and characteristics of nursing homes was assessed by Mann-Whitney U test, Kruskal-Wallis test or Spearman rho. To evaluate the potential confounding of geographical area, a 2-level random intercept logistic model was fitted, with level 1 units (patients in nursing homes) nested into level 2 units (nursing homes), and "being a COVID-19 case" as the dependent variable. RESULTS: Median cumulative incidence was not significantly associated with any of the variables, except for geographical region (p = 0.002). COVID-19 cases clustered in the part of the province bordering the Italian region most affected by the pandemic (Lombardy) (45.2% median cumulative incidence). CONCLUSIONS: Structural/organizational factors and standard IPC measures may not predict the epidemiology of COVID-19 outbreaks and be sufficient alone to protect nursing homes against them.

The negative effects of COVID-19 and national lockdown on emergency surgery morbidity due to delayed access.

BACKGROUND: The aim of this retrospective comparative study was to assess the impact of COVID-19 and delayed emergency department access on emergency surgery outcomes, by comparing the main clinical outcomes in the period March-May 2019 (group 1) with the same period during the national COVID-19 lockdown in Italy (March-May 2020, group 2). METHODS: A comparison (groups 1 versus 2) and subgroup analysis were performed between patients' demographic, medical history, surgical, clinical and management characteristics. RESULTS: Two-hundred forty-six patients were included, 137 in group 1 and 109 in group 2 (p = 0.03). No significant differences were observed in the peri-operative characteristics of the two groups. A declared delay in access to hospital and preoperative SARS-CoV-2 infection rates were 15.5% and 5.8%, respectively in group 2. The overall morbidity (OR = 2.22, 95% CI 1.08-4.55, p = 0.03) and 30-day mortality (OR = 1.34, 95% CI 0.33-5.50, =0.68) were significantly higher in group 2. The delayed access cohort showed a close correlation with increased morbidity (OR = 3.19, 95% CI 0.89-11.44, p = 0.07), blood transfusion (OR = 5.13, 95% CI 1.05-25.15, p = 0.04) and 30-day mortality risk (OR = 8.00, 95% CI 1.01-63.23, p = 0.05). SARS-CoV-2-positive patients had higher risk of blood transfusion (20% vs 7.8%, p = 0.37) and ICU admissions (20% vs 2.6%, p = 0.17) and a longer median LOS (9 days vs 4 days, p = 0.11). CONCLUSIONS: This article provides enhanced understanding of the effects of the COVID-19 pandemic on patient access to emergency surgical care. Our findings suggest that COVID-19 changed the quality of surgical care with poorer prognosis and higher morbidity rates. Delayed emergency department access and a "filter effect" induced by a fear of COVID-19 infection in the population resulted in only the most severe cases reaching the emergency department in time.

Impact of COVID-19 pandemic waves on changes in surgical urgency volumes and severity in the regional hospital network of Trento (Northern Italy): a descriptive epidemiological analysis.

OBJECTIVES: to analyse both direct and indirect impacts on surgical admissions, surgical rates, and clinical picture severity of the two COVID-19 pandemic waves in a hospital network covering an entire province (Trento, located in Trentino-Alto Adige Region, Northern Italy). DESIGN: retrospective epidemiological study. SETTING AND PARTICIPANTS: data regarding the patient load of the Surgical Urgencies/Emergencies flows (SUEs) of the Local Health Authority of the Autonomous Province of Trento derived from the Hospital Discharge Record (HDR) information flow. The population in study was that of patients hospitalized in the entire Province of Trento. This study compares the volume and characteristics of urgent/emergency surgery during the 2020 COVID-19 pandemic with the homologous period in 2019, subdividing the analysed pandemic period in 3 separated groups: • phase I (March-May 2020); • phase II (June-August 2020); • phase III (October-December 2020). The 3 groups represent, respectively: the 1st pandemic wave proclamation of national lockdown from 9 March to 18 May; the summer pandemic remission; the 2nd pandemic wave with partial restrictions on circulation and commercial activities. Clinical and surgical records of SUE population among these 3 periods (March-May; June-August; October-December) of both 2020 and 2019 were analyzed and compared. MAIN OUTCOME MEASURES: the overall number of admissions and surgical rates for SUEs in the study periods were chosen as primary outcomes. The same outcomes were analysed for the most represented diagnoses in the SUEs population: diverticulitis, intestinal obstruction, appendicitis, cholecystitis, gastrointestinal (GI) perforations, pancreatitis, traumas. To assess the degree of clinical picture severity, variables coming from the hospital discharging charts, commonly associated to worst outcomes in term of mortality and morbidity, such as age, length of hospital stay, DRG weight, and patients not discharged at home were extrapolated from the electronic database. A numerical weight was then assigned to each variable, obtaining a scoring system from 0 to 15 (severity index). RESULTS: the number of admissions for SUEs in the studied period showed a sinusoidal trend, with a dramatic decrease in phase I and III (-46.6% and -31.6%, respectively). This trend was also observed even by stratifying admissions for the most frequent pathologies, except for gastrointestinal perforations and pancreatitis. The surgical rate among hospitalised patients for SUEs was 35.2% in phase, significantly higher than that of 2019 (25.6%). Considering the most frequent diagnoses individually, some had a progressive increase in the surgical rate in phases I and II (diverticulitis, bowel obstructions, cholecystitis), others showed an initial decrease and then settled on values ​​not far from those of 2019 (GI perforations and appendicitis), others again had an initial significant increase and then gradually returned to values ​​similar to those of 2019 in phase III (traumas). The mean patients age was significantly higher in phase I than in 2019 (p-value <0.001) and in phase II (p-value <0.05). Consistently with the trend of the number of urgent admissions, even the severity index calculated on the SUEs population showed a sinusoidal trend with and evident increase during the two pandemic waves. CONCLUSIONS: the effect of the COVID-19 pandemic on SUEs was mainly indirect, manifesting itself with a significant reduction in surgical admissions, particularly in phases I and III. Conversely, in the same phases, the surgical rate showed a significant increase compared to 2019. The stratified analysis confirmed these findings for the most frequent diagnoses except for GI perforations and pancreatitis. The clinical pictures were more severe in the two pandemic waves than in the reference period of 2019. Although with a slight numerical attenuation, in general, the second pandemic wave confirmed the first one findings.

Anti-SARS-CoV-2 antibodies persistence after natural infection: a repeated serosurvey in Northern Italy.

INTRODUCTION: To evaluate the decline of antibodies induced by SARS-CoV-2 infection, the individuals resident in 5 municipalities of the Autonomous Province of Trento, Northern Italy, who resulted IgG positive for anti-SARS-CoV-2 nucleocapsid (NC) in May 2020, were tested four months later. METHODS: Anti-SARS-CoV-2 NC antibodies were detected using the Abbott SARS-CoV-2 IgG assay. Samples that gave a negative result were re-tested using the Liaison SARS-CoV-2 IgG assay to assess anti-spike (S) S1/S2 antibodies. The fifty-percent tissue culture infective dose (TCID50) neutralizing assay was performed on a subgroup of formerly positive sera. Statistical analysis was performed by STATA version 16.1 (STATA Corp., College Station, Texas, USA). RESULTS: Overall, 480 out of 1159 participants became seronegative for anti-NC IgG antibodies. Age above 70 years and cough were associated with persistent anti-NC IgG levels. Most anti-NC IgG negative sera were positive for anti-S IgG (77.9%). The neutralization assay showed high concordance with anti-S antibodies positivity. CONCLUSION: In conclusion, a decline of anti-NC IgG values was recorded four months after the first evaluation. A high proportion of anti-NC seronegative individuals were positive for anti-spike IgG antibodies, which appear to persist longer and to better correlate with neutralization activity.

Parental trust and beliefs after the discovery of a six-year-long failure to vaccinate.

BACKGROUND: In Italy vaccine hesitancy worsened after a failure to vaccinate episode that took place in Friuli Venezia-Giulia Region until early 2017 which undermined herd immunity by leaving unprotected more than 5,444 children. METHODS: Between May and June 2017, 2,557 parents were surveyed at the local vaccination clinic where they were invited within the subsequent extraordinary vaccination campaign. The aim of the survey was to evaluate whether the multi-channel extraordinary vaccination campaign had reached the target population and to know parental beliefs and trusted sources of information after the failure to vaccinate event. RESULTS: While 279 parents were non-hesitant (10.9%) and 1,491 hesitant acceptors (58.3%), just 38 (1.5%) refused to have their children revaccinated. Overall, the most consulted sources of information were print media (18.8%), physicians (16.0%), relatives and friends (12.1%). The majority of parents considered vaccination as a fundamental practice (73.9%), but many were worried about potential side effects (38.8%) or doubtful about the effectiveness of some vaccines (11.0%). According to parents, 19.7% of them (57) changed their opinion about vaccines after the Codroipo case. CONCLUSIONS: After the Codroipo case, most parents chose to have their children re-vaccinated and just a little proportion refused the re-administration of vaccines. More studies are needed to confirm the importance of a coherent multi-channel communication strategy using both traditional and new media in order to counteract vaccine hesitancy.

Prevalence of SARS-CoV-2 IgG antibodies in an area of northeastern Italy with a high incidence of COVID-19 cases: a population-based study.

OBJECTIVES: A seroprevalence study of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was conducted in a high-incidence area located in northeastern Italy. METHODS: All citizens above 10 years of age resident in five municipalities of the Autonomous Province of Trento, with the highest incidence of coronavirus disease 2019 (COVID-19) cases, were invited to participate in the study. Among 6098 participants, 6075 sera and a standardized questionnaire administered face-to-face were collected between 5 May and 15 May 2020 and examined. Symptomatic individuals and their family contacts were tested by RT-PCR. Anti-SARS-CoV-2 antibodies were detected using an Abbott SARS-CoV-2 IgG assay, which was performed on the Abbott Architect i2000SR automated analyser. Seroprevalence was calculated as the proportion of positive results among the total number tested. A multivariable logistic regression model was performed to assess the relationship between seropositive versus seronegative individuals for a set of explanatory variables. RESULTS: A total of 1402 participants were positive for IgG antibodies against SARS-CoV-2, with a prevalence of 23.1% (1402/6075). The highest prevalence was found in the age class 40-49 years. Overall, 34.4% (2096/6098) of the participants reported at least one symptom. The ratio between reported cases identified by molecular test and those with seropositive results was 1:3, with a maximum ratio of about 1:7 in the age group <20 years and a minimum around 1:1 in those >70 years old. The infection fatality rate was 2.5% (35/1402). Among the symptoms, anosmia and ageusia were strongly associated with seropositivity. CONCLUSIONS: The estimated seroprevalence of 23% was three-fold higher than the number of cases reported in the COVID-19 Integrated Surveillance data in the study area. This may be explained in part by a relatively high number of individuals presenting mild or no illness, especially those of younger age, and people who did not seek medical care or testing, but who may contribute to virus transmission in the community.

Short-term outcome associated with remote evaluation (telecardiology) of patients with cardiovascular diseases during the COVID-19 pandemic.

INTRODUCTION: During the recent COVID-19 outbreak, Italian health authorities mandated to replace in-person outpatient evaluations with remote evaluations. METHODS: From March 16th 2020 to April 22th 2020, all outpatients scheduled for in-person cardiac evaluations were instead evaluated by phone. We aimed to report the short-term follow-up of 345 patients evaluated remotely and to compare it with a cohort of patients evaluated in-person during the same period in 2019. RESULTS: During a mean follow-up of 54 ± 11 days, a significantly higher proportion of patients evaluated in-person in 2019 visited the emergency department or died for any cause (39/391, 10% versus 13/345 3.7%, p = 0.001) and visited the emergency department for cardiovascular causes (19/391, 4.9% versus 7/345, 2.0%, p = 0.04) compared to 2020. No cardiovascular death was recorded in the two periods. To an evaluation with a satisfaction questionnaire 49% of patients would like to continue using remote controls in addition to traditional ones. CONCLUSION: These findings may have important implications for the management of patients during the current COVID-19 pandemic because they suggest that remote cardiovascular evaluations may replace in-hospital visits for a limited period.

Management of reduced vaccine coverage due to 6 years of failure to vaccinate: The Codroipo case, Italy.

During 2017 an alert was raised in relation to a possible vaccination failure occurred in Friuli Venezia Giulia Region (Italy) between 2009 and 2015, exposing multiple cohorts of children and the entire community to vaccine preventable diseases outbreak risk. The Codroipo case resulted in 20,441 vaccine doses being in doubt, thus prompting the healthcare system to react in order to revaccinate 5444 children through planning and implementing network actions and multiple channels of communication.

Prevention of congenital malformations and other adverse pregnancy outcomes with 4.0 mg of folic acid: community-based randomized clinical trial in Italy and the Netherlands.

BACKGROUND: In 2010 a Cochrane review confirmed that folic acid (FA) supplementation prevents the first- and second-time occurrence of neural tube defects (NTDs). At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations (CMs) or the risk of a specific and selected group of them, namely cardiac defects and oral clefts. Furthermore, the effects on the prevention of prematurity, foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take 0.4 mg/day, the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs. Other aims include the promotion of pre-conceptional counselling, comparing rates of selected CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age, abruptio placentae. METHODS/DESIGN: This project is a joint effort by research groups in Italy and the Netherlands. Women of childbearing age, who intend to become pregnant within 12 months are eligible for the studies. Women are randomly assigned to receive 4 mg of FA (treatment in study) or 0.4 mg of FA (referent treatment) daily. Information on pregnancy outcomes are derived from women-and-physician information.We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point (e.g.: CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age). A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8%. Since the sample size needed for studying outcomes separately is large, this project also promotes an international prospective meta-analysis. DISCUSSION: The rationale of these randomized clinical trials (RCTs) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs, other CMs and other adverse pregnancy outcomes. Our hope is that these trials will act as catalysers, and lead to other large RCTs studying the effects of this supplementation on CMs and other infant and maternal outcomes. TRIAL REGISTRATION: Italian trial: ClinicalTrials.gov Identifier: NCT01244347.Dutch trial: Dutch Trial Register ID: NTR3161.

The initiative on hip fractures of the Veneto Region.

OBJECTIVE: to assess the prevalence of the most relevant environmental and individual risk factors in subjects with a recent hip fracture was the aim of this observational study promoted by the Health Authorities of the Regione Veneto (Italy). METHODS: patients aged > 60 years of both genders with a recent hip fracture not associated with malignancies, were administered questionnaires on dietary habits, sun exposure, disability score. A complete family, pharmacological and pathology history was collected together with previous falls, details of the fracture index, anthropometric data. In a subgroup of patients blood was taken for the measurements of serum 25 hydroxy-vitamin D (25OHD). RESULTS: the study includes 704 patients (573 women and 131 men). Mean age was 81±8 years (range 60-102). Severe pre-fracture disability was a common feature (58%) associated with multiple co-morbidities (84%), more frequently cardiovascular and neurological diseases, and specific medications. In a large proportion (86%) of the patients environmental or individual risk factors for falling were found. Vitamin D insufficiency was quite common, particularly in the regional Health Districts were strategies for preventing vitamin D deficiency were not implemented. Only a small proportion (17%) of the study population had been evaluate and treated for osteoporosis. CONCLUSIONS: in senile patients with a recent hip fracture pre-existing disability, multiple co-morbidities, high risk of falling and inadequate intake of calcium and vitamin D was quite common. Community and case-finding interventions are highly warranted.

Development and implementation of an automatic system for verification, validation and delivery of laboratory test results.

BACKGROUND: The verification/validation of laboratory test results is one of the most critical aspects of the total testing process, which may produce conflicts between competencies and duties at the point of professional crossroads. This process has centered for decades on the human component, with positive effects as well as potential adverse consequences (postanalytical errors). Manual validation of data is a time-consuming activity, is inherently subjective and arbitrary, and requires the constant presence of postgraduate physicians or biologists within the laboratory with adverse economical and organizational impacts. To overcome these inherent limitations, we have developed and implemented in our stat department an automatic system for verification, validation and delivery of laboratory results. METHODS: The procedure is based on automatic validation of test results by an expert system, coupled with remote wireless connection, which allows the laboratory professional "on call" to access, visualize, analyze, validate and deliver alert values (suspect, erroneous or critical) using a small laptop. This system also provides five phases where preanalytical and analytical errors can be identified and handled. RESULTS AND CONCLUSIONS: Six months following implementation of this innovative system, which can be customized to facilitate a wide variety of laboratory workflow models, the reporting efficiency of our stat laboratory has greatly improved, reducing manual data entry, and increasing the timeliness and utility of test results.

[The validation of a nursing caseload score of home care patients]. / Validazione di un punteggio di gravosità assistenziale infermieristica per i pazienti delle cure domiciliari.

UNLABELLED: Identifying a measure of community nurses' workload is complicated due to the difficulty of capturing and standardizing the nature of community nursing across health care settings. AIM: Aim of this paper is to validate a workload/caseload nursing score for home care patients. METHODS: Patients of health care districts of Veneto region with at least two home care visits per month and a multi-dimensional and professional assessment were assesses with instruments used in routine care, adapted to the scope (a multidimensional assessment scale for frail elderly, that includes assessment of cognitive function, social support, mobility, functional status, health care needs); a list of patients needs. Time required for home care visits (excluded travelling time) was voluntarily registered in 5/8 districts. Uni and multivariate analyses were performed and a robust logistic regression accounting for skewed values. A tree regression analysis with CART Package model to identify conceptual nodes of the proposed classification was used. RESULTS: A group of 1298 of home care patients of 9 Districts were assessed and in 639 patients the time needed for home care visits was registered. The predictive value of the model on home care visits over 3 months was 44% while 59% for the time needed for nursing home care visits (number and length of nurses visits). CONCLUSION: A caseload score allows allocating nursing resources. The role of the family and of the overall environment should be accounted for. Patients need to be regularly re-assessed to capture any changes in their overall situation and needs.