Digital Health Service for Identification of Frailty Risk Factors in Community-Dwelling Older Adults: The SUNFRAIL+ Study Protocol.

This article reports the study protocol of a nationwide multicentric study in seven Italian regions aimed at assessing the effectiveness of a digitally supported approach for the early screening of frailty risk factors in community-dwelling older adults. SUNFRAIL+ is a prospective observational cohort study aimed at carrying out a multidimensional assessment of community-dwelling older adults through an IT platform, which allows to connect the items of the SUNFRAIL frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. Seven centers in seven Italian regions will administer the SUNFRAIL questionnaire to 100 older adults. According to the answers provided by older adults, they will be subjected to one or more validated in-depth scale tests in order to perform further diagnostic or dimensional evaluations. The study aims to contribute to the implementation and validation of a multiprofessional and multistakeholder service model for the screening of frailty in community-dwelling older adult population.

Overcrowding analysis in emergency department through indexes: a single center study.

INTRODUCTION: Overcrowding in the Emergency Department (ED) is one of the major issues that must be addressed in order to improve the services provided in emergency circumstances and to optimize their quality. As a result, in order to help the patients and professionals engaged, hospital organizations must implement remedial and preventative measures. Overcrowding has a number of consequences, including inadequate treatment and longer hospital stays; as a result, mortality and the average duration of stay in critical care units both rise. In the literature, a number of indicators have been used to measure ED congestion. EDWIN, NEDOCS and READI scales are considered the most efficient ones, each of which is based on different parameters regarding the patient management in the ED. METHODS: In this work, EDWIN Index and NEDOCS Index have been calculated every hour for a month period from February 9th to March 9th, 2020 and for a month period from March 10th to April 9th, 2020. The choice of the period is related to the date of the establishment of the lockdown in Italy due to the spread of Coronavirus; in fact on 9 March 2020 the Italian government issued the first decree regarding the urgent provisions in relation to the COVID-19 emergency. Besides, the Pearson correlation coefficient has been used to evaluate how much the EDWIN and NEDOCS indexes are linearly dependent. RESULTS: EDWIN index follows a trend consistent with the situation of the first lockdown period in Italy, defined by extreme limitations imposed by Covid-19 pandemic. The 8:00-20:00 time frame was the most congested, with peak values between 8:00 and 12:00. on the contrary, in NEDOCS index doesn't show a trend similar to the EDWIN one, resulting less reliable. The Pearson correlation coefficient between the two scales is 0,317. CONCLUSION: In this study, the EDWIN Index and the NEDOCS Index were compared and correlated in order to assess their efficacy, applying them to the case study of the Emergency Department of "San Giovanni di Dio e Ruggi d'Aragona" University Hospital during the Covid-19 pandemic. The EDWIN scale turned out to be the most realistic model in relation to the actual crowding of the ED subject of our study. Besides, the two scales didn't show a significant correlation value.

COVID-19 Post-Exposure Evaluation (COPE) Study: Assessing the Role of Socio-Economic Factors in Household SARS-CoV-2 Transmission within Campania Region (Southern Italy).

Campania is the sixth poorest region of Italy, and it is the region with the highest income inequality. The secondary attack rates of SARS-CoV-2 among households are found to be substantially heterogeneous among published studies and are influenced by socio-economic factors. We conducted a retrospective study to describe the role of socio-economic factors in the household transmission of SARS-CoV-2 among patients living in Campania Region and referring to "Federico II" Hospital. We interviewed 413 subjects followed-up for COVID-19 between the 8 March 2020 and the 24 May 2021 with the aim to collect demographic, clinical, economic, and social data regarding their household and the index cases. The variables associated with SARS-CoV-2 attack rate higher than 50% among households were higher age (p = 0.023) and higher Charlson Comorbidity Index of the index case (p = 0.023) and, for household characteristics, higher number of families per house (p = 0.02), location of the houses in Naples' suburbs (Chi2 = 5.3, p = 0.02) and in Caserta City area (Chi2 = 4, p = 0.04), and renting the house compared to owning it (Chi2 = 5.83, p = 0.01). This study confirms the finding described by other authors that household transmission of SARS-CoV-2 is correlated with the income inequality of the analyzed geographical area as well as with the indicators of health and economic wealth of the families, and this correlation also applies to the Campania Region.

Association between COVID-19 and Sick Leave for Healthcare Workers in a Large Academic Hospital in Southern Italy: An Observational Study.

Studies have shown that the pandemic has led to an increase in sick leave periods among healthcare workers (HCWs); however, this might have changed over time considering increase in vaccination coverage and change in COVID-19 variant predominance. Therefore, we conducted an observational study to evaluate whether the type of symptoms and the duration of sick leave period for healthcare workers working in a large university hospital in the South of Italy changed between January 2021 and January 2022; 398 cases of COVID-19 were identified for a total of 382 subjects involved. A total of 191 subjects answered the questionnaire about symptoms; of these, 79 had COVID-19 during the period from March 2020 until February 2022. The results showed a decrease of about 1.2 days in sick leave period for each quarter without finding significant differences in the perception of symptoms. It is possible to hypothesize a contribution from the Omicron variant to the decrease in sick leave period in the last quarter, from vaccination coverage, from optimization of COVID-19 management, and from change in the regulations for the assessment of positivity.

Machine Learning and Lean Six Sigma to Assess How COVID-19 Has Changed the Patient Management of the Complex Operative Unit of Neurology and Stroke Unit: A Single Center Study.

Background: In health, it is important to promote the effectiveness, efficiency and adequacy of the services provided; these concepts become even more important in the era of the COVID-19 pandemic, where efforts to manage the disease have absorbed all hospital resources. The COVID-19 emergency led to a profound restructuring-in a very short time-of the Italian hospital system. Some factors that impose higher costs on hospitals are inappropriate hospitalization and length of stay (LOS). The length of stay (LOS) is a very useful parameter for the management of services within the hospital and is an index evaluated for the management of costs. Methods: This study analyzed how COVID-19 changed the activity of the Complex Operative Unit (COU) of the Neurology and Stroke Unit of the San Giovanni di Dio e Ruggi d'Aragona University Hospital of Salerno (Italy). The methodology used in this study was Lean Six Sigma. Problem solving in Lean Six Sigma is the DMAIC roadmap, characterized by five operational phases. To add even more value to the processing, a single clinical case, represented by stroke patients, was investigated to verify the specific impact of the pandemic. Results: The results obtained show a reduction in LOS for stroke patients and an increase in the value of the diagnosis related group relative weight. Conclusions: This work has shown how, thanks to the implementation of protocols for the management of the COU of the Neurology and Stroke Unit, the work of doctors has improved, and this is evident from the values of the parameters taken into consideration.

Lean Management Approach for Reengineering the Hospital Cardiology Consultation Process: A Report from AORN "A. Cardarelli" of Naples.

BACKGROUND: Consultations with specialists are essential for safe and high-quality care for all patients. Cardiology consultations, due to a progressive increase in cardiology comorbidities, are becoming more common in hospitals prior to any type of treatment. The appropriateness and correctness of the request, the waiting time for delivery and the duration of the visit are just a few of the elements that can affect the quality of the process. METHODS: In this work, a Lean approach and Telemedicine are used to optimize the cardiology consultancy process provided by the Cardiology Unit of "Antonio Cardarelli" Hospital of Naples (Italy), the largest hospital in the southern Italy. RESULTS: The application of corrective actions, with the introduction of portable devices and telemedicine, led to a reduction in the percentage of waiting for counseling from 29.6% to 18.3% and an increase in the number of patients treated. CONCLUSIONS: The peculiarity of the study is to apply an innovative methodology such as Lean Thinking in optimizing the cardiology consultancy process, currently little studied in literature, with benefits for both patients and medical staff.

Durability of Humoral Immune Responses to SARS-CoV-2 in Citizens of Ariano Irpino (Campania, Italy): A Longitudinal Observational Study With an 11.5-Month Follow-Up.

As of November 17, 2021, SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2), the causative agent of COVID-19 (COronaVIrus Disease 19), has infected ~250 million people worldwide, causing around five million deaths. Titers of anti-SARS-CoV-2 neutralizing antibodies were relatively stable for at least 9 months in a population-based study conducted in Wuhan, China, both in symptomatic and in asymptomatic individuals. In the mass screening campaign conducted in the town of Ariano Irpino (Avellino, Italy) in May, 2020, 5.7% (95% CI: 5.3-6-1) of the 13,444 asymptomatic citizens screened were positive for anti-nucleocapsid antibodies against SARS-CoV-2. Among these, 422 citizens were re-tested for anti SARS-CoV-2 antibodies in January, 2021 and/or in April, 2021 and enrolled in this longitudinal observational study. Median (interquartile range) age of the study cohort was 46 years (29-59), with 47 (11.1%) participants of minor age, while 217 (51.4%) participants were females. There was no evidence of re-infection in any of the subjects included. Presence of anti-nuclear antibodies antibodies (Elecysis, Roche) was reported in 95.7 and 93.7% of evaluable participants in January and April, 2021. Multiple logistic regression analysis used to explore associations between age, sex and seroprevalence showed that adults vs. minors had significantly lower odds of having anti-S1 antibodies (Biorad) both in January, 2021 and in April, 2021. Our findings showed that antibodies remained detectable at least 11.5 months after infection in >90% of never symptomatic cases. Further investigation is required to establish duration of immunity against SARS-CoV-2.

Digitally Enabled Health Service for the Integrated Management of Hypertension: A Participatory User-Centred Design Process.

This article describes a user-centred approach taken by a group of five procurers to set specifications for the procurement of value-based research and development services for IT-supported integrated hypertension management. The approach considered the unmet needs of patients and health systems of the involved regions. The procurers established a framework for requirements and a solution design consisting of nine building blocks, divided into three domains: service delivery, devices and integration, and health care organisation. The approach included the development of questionnaires, capturing patients' and professionals' views on possible system functionalities, and a template collecting information about the organisation of healthcare, professionals involved and existing IT systems at the procurers' premises. A total of 28 patients diagnosed with hypertension and 26 professionals were interviewed. The interviewees identified 98 functional requirements, grouped in the nine building blocks. A total of nine use cases and their corresponding process models were defined by the procurers' working group. As result, a digitally enabled integrated approach to hypertension has been designed to allow citizens to learn how to prevent the development of hypertension and lead a healthy lifestyle, and to receive comprehensive, individualised treatment in close collaboration with healthcare professionals.

Health Communication in COVID-19 Era: Experiences from the Italian VaccinarSì Network Websites.

In 2013, in a bid to combat Vaccine Hesitancy (VH) and provide information on vaccines by communicating with the general public and the health community (e.g., healthcare workers and public health operators), the Italian Society of Hygiene and Preventive Medicine (S.It.I.) published the national website "VaccinarSì". The project was subsequently extended to ten Italian Regions. This led to the creation of the VaccinarSì Network, whose websites are publicly owned. The aim of this work was to present the framework of the websites of the VaccinarSì Network and to analyse user behaviour in the pre-COVID-19-era (dating from each website's publication until 31 January 2020) and in the COVID-19-era (from 1 February 2020 to 31 January 2021). Some metrics such as the number of visits to the site (sessions, number of users and average session duration), user behaviour (pages viewed, bounce rate and organic search) and the session acquisition path (direct traffic, referrals and social traffic) were searched, extrapolated and processed with Google Analytics. Qualitative and normally distributed quantitative variables were summarised with their absolute (relative) frequencies and means. Statistical differences between the means of the two periods were evaluated through paired t-test. A two-tailed p-value less than 0.05 was considered to be statistically significant. When the total values recorded over the period were compared, an overall increase in metrics was observed-the number of individual users, visits and individual pageviews rose in a statistically significant way. Our study aimed to highlight how combining disciplines such as health education and digital communication via Information and Communication Technologies (ICT) represents the best strategy to support citizens. This approach gives them the tools to become independent and responsible players that are capable of voluntarily and consciously choosing to adhere to vaccination programs. The VaccinarSì Network's goal for the future is to reach an even wider audience. By building each user's critical knowledge, this network enables users to be active components of a wider, more empowered community.

Seroprevalence of SARS-CoV-2 Assessed by Four Chemiluminescence Immunoassays and One Immunocromatography Test for SARS-Cov-2.

The onset of the new SARS-CoV-2 coronavirus encouraged the development of new serologic tests that could be additional and complementary to real-time RT-PCR-based assays. In such a context, the study of performances of available tests is urgently needed, as their use has just been initiated for seroprevalence assessment. The aim of this study was to compare four chemiluminescence immunoassays and one immunochromatography test for SARS-Cov-2 antibodies for the evaluation of the degree of diffusion of SARS-CoV-2 infection in Salerno Province (Campania Region, Italy). A total of 3,185 specimens from citizens were tested for anti-SARS-CoV-2 antibodies as part of a screening program. Four automated immunoassays (Abbott and Liaison SARS-CoV-2 CLIA IgG and Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays) and one lateral flow immunoassay (LFIA Technogenetics IgG-IgM COVID-19) were used. Seroprevalence in the entire cohort was 2.41, 2.10, 1.82, and 1.85% according to the Liaison IgG, Abbott IgG, Siemens, and Roche total Ig tests, respectively. When we explored the agreement among the rapid tests and the serologic assays, we reported good agreement for Abbott, Siemens, and Roche (Cohen's Kappa coefficient 0.69, 0.67, and 0.67, respectively), whereas we found moderate agreement for Liaison (Cohen's kappa coefficient 0.58). Our study showed that Abbott and Liaison SARS-CoV-2 CLIA IgG, Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays, and LFIA Technogenetics IgG-IgM COVID-19 have good agreement in seroprevalence assessment. In addition, our findings indicate that the prevalence of IgG and total Ig antibodies against SARS-CoV-2 at the time of the study was as low as around 3%, likely explaining the amplitude of the current second wave.

Smoke Evacuation During Laparoscopic Surgery: A Problem Beyond the COVID-19 Period. A Quantitative Analysis of CO2 Environmental Dispersion Using Different Devices.

Background. The COVID-19 pandemic leads to several debates regarding the possible risk for healthcare professionals during surgery. SAGES and EAES raised the issue of the transmission of infection through the surgical smoke during laparoscopy. They recommended the use of smoke evacuation devices (SEDs) with CO2 filtering systems. The aim of the present study is to compare the efficacy of different SEDs evaluating the CO2 environmental dispersion in the operating theater. Methods. We prospectively evaluated the data of 4 group of patients on which we used different SEDs or standard trocars: AIRSEAL system (S1 group), a homemade device (S2 group), an AIRSEAL system + homemade device (S3 group), and with standard trocars and without SED (S4 group). Quantitative analysis of CO2 environmental dispersion was carried out associated to the following data in order to evaluate the pneumoperitoneum variations: a preset insufflation pressure, real intraoperative pneumoperitoneum pressure, operative time, total volume of insufflated CO2, and flow rate index. Results. 16 patients were prospectively enrolled. The [CO2] mean value was 711 ppm, 641 ppm, 593 ppm, and 761 ppm in S1, S2, S3, and S4 groups, respectively. The comparison between data of all groups showed statistically significant differences in the measured ambient CO2 concentration. Conclusion. All tested SEDs seem to be useful to reduce the CO2 environmental dispersion respect to the use of standard trocars. The association of AIRSEAL system and a homemade device seems to be the best solution combining an adequate smoke evacuation and a stable pneumoperitoneum during laparoscopic surgery.

Evaluation of a fully closed real time PCR platform for the detection of SARS-CoV-2 in nasopharyngeal swabs: a pilot study.

AIMS: To date, reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs is the 'gold standard' approach for the diagnosis of COVID-19. The need to develop easy to use, rapid, robust and with minimal hands-on time approaches are warranted. In this setting, the Idylla SARS-CoV-2 Test may be a valuable option. The aim of our study is to evaluate the analytical and clinical performance of this assay on previously tested SARS-CoV-2 people by conventional RT-PCR based approach in different settings, including initial diagnosis and clinical follow-up. METHODS: To evaluate the sensitivity and specificity of the Idylla SARS-CoV-2 Test, we retrieved 55 nasopharyngeal swabs, previously analysed by a fully validated assay, from symptomatic patients or from people who have been in close contact with COVID-19 positive cases. Discordant or high discrepant cases were further analysed by a third technique. In addition, a second subset of 14 nasopharyngeal swab samples with uncertain results (cycle threshold between 37 and 40), by using the fully validated assay, from patients with viral infection beyond day 21, were retrieved. RESULTS: Overall, Idylla showed a sensitivity of 93.9% and a specificity of 100.0%. In addition, in the additional 14 nasopharyngeal swab samples, only five (35.7%) featured a positive result by the Idylla SARS-CoV-2 Test. CONCLUSIONS: We demonstrated that the Idylla SARS-CoV-2 Test may represent a valid, fast, highly sensitive and specific RT-PCR test for the identification of SARS-CoV-2 infection.

Optical Coherence Tomography Angiography Features in Post-COVID-19 Pneumonia Patients: A Pilot Study.

PURPOSE: This study investigated changes in retinal vessel density in macular and papillary regions in post-SARS-CoV-2 pneumonia patients by means of optical coherence tomography angiography (OCTA). DESIGN: Prospective, observational, cohort study. METHODS: Forty eyes of 40 patients (mean age: 49.7 ± 12.6 years old) post-SARS-CoV-2 infection and 40 healthy subjects were enrolled in this study. COVID-19 patients had to be fully recovered from COVID-19 pneumonia and were evaluated 6 months after COVID-19 infection. The primary outcome resulted from OCTA studies of the following vascular structures: vessel density (VD) in the retinal superficial capillary plexus (SCP), deep capillary plexus (DCP), and radial peripapillary capillaries (RPC) compared to those of controls. Structural spectral domain (SD)-OCT parameters were also evaluated: ganglion cell complex (GCC) and retinal nerve fiber layer (RNFL). RESULTS: The patients showed a significant reduction in VD of the SCP in whole images and in the DCP in all sectors compared to those in healthy subjects (P <.05). COVID-19 patients featured a reduced VD of the RPC compared to that in controls (P <.001). No differences were found in the GCC, whereas the RNFL was reduced in the COVID-19 group compared to that in controls (P = .012). Significant correlations were found between the RNFL and VD of the SCP, DCP, RPC, and FAZ area in the COVID-19 group (P <.05). CONCLUSIONS: OCTA showed retinal vascular changes in subjects fully recovered from COVID-19 pneumonia. These findings could be a consequence of a thrombotic microangiopathy that affected retinal structures as well as other systemic organs. OCTA could represent a valid, noninvasive biomarker of early vascular dysfunction after SARS-CoV-2 infection.

Seroprevalence of SARS-CoV-2-specific antibodies in the town of Ariano Irpino (Avellino, Campania, Italy): a population-based study.

The Italian municipality of Ariano Irpino (Avellino, Campania, Italy) was locked down by the regional authorities from March until April 2020 after several citizens tested positive for SARS coronavirus 2 (SARS-CoV-2). A serological mass screening campaign targeting the Ariano Irpino population using the Roche Cobas Elecsys anti-SARS-CoV-2 assay was organized by the Zoo-Prophylactic Institute of Southern Italy (Portici, Italy) and conducted in cooperation with the Local Health Unit (Azienda Sanitaria Locale - ASL - Avellino, Avellino, Italy), the Department of Public Health of University Federico II (Naples, Italy) and Department of Health Services of Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital (Naples, Italy) in May 2020. A total of 13,218 asymptomatic individuals were reviewed in this analysis. A total of 738 citizens tested positive for anti-SARS-CoV-2 antibodies (398 females, 340 males). The overall prevalence in the sample was 5.6% (95% CI: 5.2-6.0). Among seropositive citizens, 101 cases tested positive on RT-PCR (0.76% of the overall population). Among citizens aged 14-18, 18-65 and >65 years, the seroprevalence was equal to 6.1 (95% CI: 4.1-8.7), 5.6 (95% CI: 5.1-6.1) and 4% (95% CI: 3.3-4.8), respectively. In the pediatric cohort (<14 years old), seroprevalence was 13% (95% CI: 10.2-16.2). A serological-based screening strategy could be a cost-effective public health intervention to tackle the COVID-19 pandemic.

Prevalence of SARS-CoV-2 Antibodies in Multiple Sclerosis: The Hidden Part of the Iceberg.

BACKGROUND: We compared the prevalence of SARS-CoV-2 IgG/IgM in multiple sclerosis (MS), low-risk, and high-risk populations and explored possible clinical correlates. METHODS: In this cross-sectional study, we recruited MS patients, low-risk (university staff from non-clinical departments), and high-risk individuals (healthcare staff from COVID-19 wards) from 11 May to 15 June 2020. We used lateral flow immunoassay to detect SARS-CoV-2 IgG and IgM. We used t-test, Fisher's exact test, chi square test, or McNemar's test, as appropriate, to evaluate between-group differences. RESULTS: We recruited 310 MS patients (42.3 ± 12.4 years; females 67.1%), 862 low-risk individuals (42.9 ± 13.3 years; females 47.8%), and 235 high-risk individuals (39.4 ± 10.9 years; females 54.5%). The prevalence of SARS-CoV-2 IgG/IgM in MS patients (n = 9, 2.9%) was significantly lower than in the high-risk population (n = 25, 10.6%) (p < 0.001), and similar to the low-risk population (n = 11, 1.3%) (p = 0.057); these results were also confirmed after random matching by age and sex (1:1:1). No significant differences were found in demographic, clinical, treatment, and laboratory features. Among MS patients positive to SARS-CoV-2 IgG/IgM (n = 9), only two patients retrospectively reported mild and short-lasting COVID-19 symptoms. CONCLUSIONS: MS patients have similar risk of SARS-CoV-2 infection to the general population, and can be asymptomatic from COVID-19, also if using treatments with systemic immunosuppression.

COVID-19 prevention and multiple sclerosis management: The SAFE pathway for the post-peak.

BACKGROUND: We hereby report on our experience from Naples (South Italy), where the peak of coronavirus disease 2019 (COVID-19) has already passed. METHODS: Assuming that COVID-19 will be circulating until vaccination and/or herd immunity is achieved (possibly not earlier than 2021), we have developed a protocol for the long-term management of multiple sclerosis (MS). RESULTS: We have defined a pathway for the access to the MS Centre with logistic, preventative and clinical recommendations, and have also included 14-day self-isolation and COVID-19 testing before some disease modifying treatments. DISCUSSION: Overall, we believe our experience could be helpful for MS management in the upcoming months.