Missed linkage to care for patients who screened positive for Hepatitis C in a tertiary care centre: Results of the Telepass project.

Italy is one of the countries on track with the WHO's agenda to eliminate hepatitis C virus (HCV) by 2030. Healthcare facilities play a crucial role in seeking patients who are infected but have not yet been treated. We assessed the effectiveness of a recall strategy, named 'Telepass' project, for patients exposed to HCV infection who have not yet been linked to care in a large tertiary care centre. The 'Telepass' project was structured in two phases: (a) a retrospective analysis first identified all anti-HCV-positive subjects among patients who underwent pre-operative assessment in the facility in the course of one year; (b) a following prospective phase, aimed to recall patients in need either of further diagnostic tests (ie HCV-RNA) or treatment. A total of 12246 records of patients tested for HCV antibodies were reviewed. The overall prevalence of anti-HCV-positive subjects was 1.83% (224/12246) with a male/female ratio of 2.07. Out of the 224 anti-HCV-positive patients, 123 (54.91%) did not have documented HCV-RNA tests and were therefore selected for recall. Of these, 123 were reachable and 26 (21.13%) were successfully linked to care. Ten patients (38.46%) tested HCV-RNA positive and initiated treatment with direct-acting antivirals (DAAs). The Telepass study highlights that a recall strategy starting from internal hospital databases can help identify patients with chronic HCV infection who have not yet been linked to care, and provides an epidemiological insight into the prevalence of HCV infection in Italy in the late DAAs era.

[The assessment of the sanitation of surfaces and instruments in the context of hospital refection]. / Idoneità igienico-sanitaria delle superfici e degli strumenti nella ristorazione collettiva: analisi di un'esperienza nella realtà ospedaliera.

The Authors present the results of an experience carried out in a University General Hospital, for the assessment of the sanitation of surfaces and instruments in the context of hospital refection. A specific procedure has been quarterly implemented in order to verify the correct execution of the sanitization procedures. In the time-period September 2016 - March 2020 Petri dishes and tampons were used in order to determine the following microbiological parameters and indicators: total bacterial load at 30 degrees C, Coliforms, Listeria monocytogenes, Salmonella spp, Staphylococcus aureus, Escherichia coli and mycetic load. Only 7 out of 82 sanitized surfaces (8.5% of the total) were found to be not complying, only for total bacterial load at 30 degrees C, mycetic load and Coliforms. The systematic application of this procedure and the results of the survey conducted, comforting as a whole, confirm the attention reserved to the hygienic level of surfaces, tools, equipment and utensils, in the context of the centralized catering service of the hospital, in which the Health Department, sharing with the UOC Hospital Hygiene the specific hygienic procedure, has always been at the forefront of the proposal of interventions, considering the increased susceptibility and vulnerability of the hospitalized patients.

[Hospital foodservice through the Cook Chill system: a two-year experience in a University teaching hospital, Italy]. / La ristorazione in ospedale mediante il sistema "Cook and Chill": un'esperienza di 2 anni in un Policlinico Universitario.

The Authors present their two-year experience regarding an evaluation of the hygienic quality of ready-to-eat foods in a hospital foodservice, both for patients' meals and hospital staff, prepared by using the Cook Chill system. According to the microbiological parameters provided by International Guidelines, 23 of 27 food samples that were collected and analyzed were found to be satisfactory, one was acceptable and only three were unsatisfactory (two for aerobic colony count and one both for aerobic colony count and hygienic procedure). Escherchia coli, Staphylococcus aureus, Salmonella, Listeria monocytogenes, and Clostridium perfringens were absent in all of the analyzed products, The study results are encouraging and confirm the need to always verify that the different phases of production of hospital meals are correctly implemented, even when the foodservice is out-sourced. This has always been considered a priority in the study hospital, where the Health Department is at the forefront both in control and verification of food safety practices and in offering training activities, especially in view of the increased susceptibility of hospitalized patients.

[Use of the Lean methodology in the management of cancer patients in a University Hospital, Italy: First results]. / Applicazione di logiche lean nella gestione del paziente oncologico: primi risultati della sperimentazione in un policlinico universitario.

AIM: The aim of this study was to map a patient's journey along all stages of his daily care path in an Oncology outpatient department, to identify and eliminate "bottleneck" situations that interfere with the patient's flow of care. The main key performance indicators used in the study were: waiting times for each stage of the care process, time required for each activity, and resources used. METHODS: The study was conducted from 17-30 January 2018 at the medical oncology clinic of a large university teaching and research hospital in Italy. We analyzed all the healthcare services provided during the monitoring period, dividing them into: first appointments, therapy, visits for adjustments of the therapeutic plan, visits for i.v. therapy, visits for oral therapy, follow-up visits, other visits (e.g. for positioning of peripherally inserted central catheter). Data collection was performed by administering two questionnaires: a Patient Journey (PJ) questionnaire to patients and a Medical Journey (MJ) questionnaire to clinicians. This project employed Lean principles in order to: view the process and specify value through the patient's point of view, identify waste in processes and eliminate any steps lacking any added value, reduce variation of and leveling workload to improve quality and ?ow of care, engage patients and staff to redesign the process. RESULTS: The response rate in 1351 outpatients who were invited to participate was 63%; for doctors it was 81%. The mean waiting time for first visits and follow up visits performed in a single day was 50 minutes. An audit process was thus performed and a series of quality improvement measures were defined and shared with health professionals. CONCLUSIONS: The Lean methodology could provide a robust framework for improved understanding and management of complex system constraints in outpatient oncology clinics, and could result in improved access to treatment and reduced waiting times for patients.

[Hygienic safety of infant milk powder formulas in hospital setting]. / La sicurezza igienica del latte in polvere per la prima infanzia nella realtà ospedaliera.

The authors present the results of a study whose aim was to assess the hygienic quality of powder and reconstituted milk for early childhood, in a University General Hospital in Rome, Italy. This procedure is an integral part of the systematic verification activities that the hospital Health Management department considers as a priority for patient safety. The absence of contamination in all tested samples confirms the suitability of adopted procedures to ensure a safe product, considering the increased vulnerability of newborns, especially if preterm.

[Resident physicians' participation to the activities of the hospital hygiene unit in a teaching hospital: a pilot study]. / Partecipazione dei medici in formazione specialistica alle attività dell'unità operativa complessa "Igiene ospedaliera" in un policlinico universitario: studio pilota.

INTRODUCTION: The Hospital Hygiene Unit ensures hospital patient safety, through surveillance and control of environmental conditions of risk. In this context, resident physicians in Hygiene and Preventive Medicine of the Catholic University of the Sacred Heart (UCSC) are required to attend the unit to acquire professional skills, for two months (four weeks in the first year of residency and four weeks in the second year). In the initial phase of the rotation, residents are acquainted with the organization and assigned activities. Ongoing meetings with the tutor take place to verify the progress of activities in which they are involved; verification of acquired skills is performed at the end of the period of attendance. The aim of the study was to evaluate resident doctors' opinions about their training experience, in order to assess the perceived quality and pursue continuous improvement of the training program. MATERIALS AND METHODS: A questionnaire was administered to resident physicians attending the first three years of residency; the survey consisted of 11 multiple choice questions on organization, attendance, training and overall satisfaction and 3 open-ended questions on strengths, weaknesses and proposals for improvement. RESULTS: Fourteen of 15 residents (93.3%) completed the questionnaire: seven were male, five were first-year residents, five were second-year and four were third-year residents. Overall, 78% gave a positive assessment of the quality of training; in particular, 11 of 14 residents reported that the experience was very relevant to their training in Hygiene and Preventive Medicine. Responses regarding the training organization were also mostly positive (75%), as were those regarding attendance (57%) and overall satisfaction (67%). Fifty percent reported difficulties in combining this internship with the other activities planned with their tutor. CONCLUSIONS: Positive opinions prevail in all areas of assessment, although there are some aspects that can be improved, including the possibility to extend the period of attendance. Overall, training activities at the Operative Unit of Hospital Hygiene are appreciated by resident physicians, who consider them an important opportunity for professional growth.

[Hygienic suitability of food and food-contact surfaces in a hospital canteen: the experience of a University Hospital in Italy]. / Idoneità igienico-sanitaria di alimenti e superfici in una mensa ospedaliera: un'esperienza in un Policlinico Universitario.

The Authors present the results of a study performed during a time-period of two years, to evaluate the hygienic quality of ready-to-eat foods, prepared and served in a hospital catering service, and the microbiological status of food-contact surfaces. Food hygiene was evaluated using non-pathogenic indicator microorganisms. The study was part of the verification activities that the hospital Health Department considers as a priority in order to guarantee patient safety. Only one of 52 food samples tested was considered unsatisfactory; the examined surfaces were not fully satisfactory in one of four cases. The study results, although encouraging as a whole, especially with respect to the hygienic safety of food prepared and served in the hospital, confirm the need to continuously verify that the appropriate environmental sanitation procedures are applied, even in the case of outsourcing. Considering the increased susceptibility of hospitalized patients, this remains a priority in the hospital where the study was performed.

Does clinical governance influence the appropriateness of hospital stay?

BACKGROUND: Clinical Governance provides a framework for assessing and improving clinical quality through a single coherent program. Organizational appropriateness is aimed at achieving the best health outcomes and the most appropriate use of resources. The goal of the present study is to verify the likely relationship between Clinical Governance and appropriateness of hospital stay. METHODS: A cross-sectional study was conducted in 2012 in an Italian Teaching Hospital. The OPTIGOV(©) (Optimizing Health Care Governance) methodology was used to quantify the level of implementation of Clinical Governance globally and in its main dimensions. Organizational appropriateness was measured retrospectively using the Italian version of the Appropriateness Evaluation Protocol to analyze a random sample of medical records for each clinical unit. Pearson-correlation and multiple linear regression were used to test the relationship between the percentage of inappropriate days of hospital stay and the Clinical Governance implementation levels. RESULTS: 47 Units were assessed. The percentage of inappropriate days of hospital stay showed an inverse correlation with almost all the main Clinical Governance dimensions. Adjusted multiple regression analysis resulted in a significant association between the percentage of inappropriate days and the overall Clinical Governance score (ß = -0.28; p < 0.001; R-squared = 0.8). EBM and Clinical Audit represented the Clinical Governance dimensions which had the strongest association with organizational appropriateness. CONCLUSIONS: This study suggests that the evaluation of both Clinical Governance and organizational appropriateness through standardized and repeatable tools, such as OPTIGOV(©) and AEP, is a key strategy for healthcare quality. The relationship between the two underlines the central role of Clinical Governance, and especially of EBM and Clinical Audit, in determining a rational improvement of appropriateness levels.

[Audit as a tool to assess and promote the quality of medical records and hospital appropriateness: metodology and preliminary results]. / L'audit come strumento per la valutazione e promozione della qualità della documentazione sanitaria e dell'appropriatezza organizzativa dei ricoveri in un policlinico universitario: metodologia e primi risultati.

In the actual economic context, with increasing health needs, efficiency and efficacy represents fundamental keyword to ensure a successful use of the resources and the best health outcomes. Together, the medical record, completely and correctly compiled, is an essential tool in the patient diagnostic and therapeutic path, but it's becoming more and more essential for the administrative reporting and legal claims. Nevertheless, even if the improvement of medical records quality and of hospital stay appropriateness represent priorities for every health organization, they could be difficult to realize. This study aims to present the methodology and the preliminary results of a training and improvement process: it was carried out from the Hospital Management of a third level Italian teaching hospital through audit cycles to actively involve their health professionals. A self assessment process of medical records quality and hospital stay appropriateness (inpatients admission and Day Hospital) was conducted through a retrospective evaluation of medical records. It started in 2012 and a random sample of 2295 medical records was examined: the quality assessment was performed using a 48-item evaluation grid modified from the Lombardy Region manual of the medical record, while the appropriateness of each days was assessed using the Italian version of Appropriateness Evaluation Protocol (AEP) - 2002ed. The overall assessment was presented through departmental audit: the audit were designed according to the indication given by the Italian and English Ministry of Health to share the methodology and the results with all the involved professionals (doctors and nurses) and to implement improvement strategies that are synthesized in this paper. Results from quality and appropriateness assessment show several deficiencies, due to 40% of minimum level of acceptability not completely satisfied and to 30% of inappropriateness between days of hospitalization. Furthermore, there are great discrepancies among departments and among Care Units: the higher problems are centered in DHs, which are generally lacking on both profiles. Finally, our audit model, that could be considered a good project according the NHS (score of 20/25), has allowed to involve in 34 editions 480 professionals of different care Unit which are satisfied and stimulated to keep going in continuous improvement of the quality and appropriateness with these arrangements. The tools used in the project have proven their value for measuring the minimum quality of healthcare documentation and organizational appropriateness: furthermore, the audit has been shown as an effective methodology for their introduction because it ensures their acceptability among the staff and creates the basis for a rapid and quantifiable improvement that, through the promotion of accountability and transparency, could support the risk management activities and ensure greater efficiency in hospitalization.

Hospital Services to Improve Nutritional Intake and Reduce Food Waste: A Systematic Review.

BACKGROUND AND AIMS: Patients' nutritional intake is a crucial issue in modern hospitals, where the high prevalence of disease-related malnutrition may worsen clinical outcomes. On the other hand, food waste raises concerns in terms of sustainability and environmental burden. We conducted a systematic review to ascertain which hospital services could overcome both issues. METHODS: A systematic literature search following PRISMA guidelines was conducted across MEDLINE, Web of Science, and Scopus for randomised controlled trials (RCTs) and observational studies comparing the effect of hospital strategies on energy intake, protein intake, and plate/food waste. The quality of included studies was assessed using the Newcastle-Ottawa Scale for cohort studies and the Cochrane Risk of Bias tool from the Cochrane Handbook for Systematic Reviews of Interventions for RCTs. RESULTS: Nineteen studies were included, assessing as many hospital strategies such as food service systems-including catering and room service-(n = 9), protected mealtimes and volunteer feeding assistance (n = 4), food presentation strategies (n = 3), nutritional counseling and education (n = 2), plant-based proteins meal (n = 1). Given the heterogeneity of the included studies, the results were narratively analysed. CONCLUSIONS: Although the results should be confirmed by prospective and large sample-size studies, the personalisation of the meal and efficient room service may improve nutritional intake while decreasing food waste. Clinical nutritionist staff-especially dietitians-may increase food intake reducing food waste through active monitoring of the patients' nutritional needs.

Flu and COVID-19 Vaccination: What Happens to the Flu Shot When the Campaigns Overlap? Experience from a Large Italian Research Hospital.

Influenza represents a threat to global health and health care workers (HCWs) have an increased risk of contracting the influenza virus in the workplace. The COVID-19 pandemic has brought back the importance of influenza vaccination, as the influenza virus can circulate together with SARS-CoV-2. The aim of this report is to describe the actual flu vaccination coverage among healthcare workers of a research hospital and the trend changes, with respect to the past flu vaccination campaigns, in light of the present pandemic and COVID-19 vaccination. A Pearson's χ2 test was used to test the correlation of flu vaccination coverage, across all professional categories, between the last two years. A linear regression model was adopted to predict the total vaccination coverage of this year. A statistically significant decrease (p < 0.01) was observed in vaccination coverage among all the professional categories with a 50% reduction in vaccination trends between the last two years. Analyzing the data from the previous six flu vaccination campaigns, the expected value, according to the linear regression model, was estimated to be 38.5% while the observed value was 24%. The decrease in vaccination coverage may be due to the fear of the pandemic situation and especially to the uncertainty related to the consequences of a concurrent administration which may overload the immune system or may be more reactogenic. The COVID-19 pandemic represents an opportunity to promote and support large-scale influenza vaccination among HCWs through structured programs, adequate funding, and tailored communication strategies.

Media Fill Test for Validation of Non-Radioactive Kit for Radiopharmaceutical Preparations.

INTRODUCTION: The administration of improperly prepared intravenous fluids might determine healthcare-associated infections. Quality and sterility assurance in radiopharmaceutical manufacturing products must be evaluated by media fill tests that simulate the performance of the aseptic manufacturing procedure. The aim of this study is to show a methodological modification of a specific step of media fill tests, giving an overview of economic and organizational advantages that it might bring. MATERIALS AND METHODS: Media fill tests were conducted to ensure that they reproduce as strictly as possible the routine aseptic production process with all the critical steps described in the internal Standard Operating Procedures. We introduced an innovative modification in step 1: instead of using a completely decayed 99Mo/99mTc generator, we used a99Mo/99mTc generator just before its disposal, eluting it with saline solution aspirated in an empty vacuum vial. RESULTS: A total of 47 production runs were performed, and a total of 799 vials were tested for sterility. Thirteen nuclear medicine technicians were assessed. We found contamination in 1% of the total number of vials analyzed. CONCLUSIONS: The modification proposed shows several advantages: reduction of the costs of the media fill tests, the possibility to manage these without referring to external services, and decreased injuries for technicians who perform the tests.

Malpractice Claims and Incident Reporting: Two Faces of the Same Coin?

Incident reporting is an important method to identify risks because learning from the reports is crucial in developing and implementing effective improvements. A medical malpractice claims analysis is an important tool in any case. Both incident reports and claims show cases of damage caused to patients, despite incident reporting comprising near misses, cases where no event occurred and no-harm events. We therefore compare the two worlds to assess whether they are similar or definitively different. From 1 January 2014 to 31 December 2021, the claims database of Policlinico Universitario A. Gemelli IRCCS collected 843 claims. From 1 January 2020 to 31 December 2021, the incident-reporting database collected 1919 events. In order to compare the two, we used IBNR calculation, usually adopted by the insurance industry to determine loss to a company and to evaluate the real number of adverse events that occurred. Indeed, the number of reported adverse events almost overlapped with the total number of events, which is indicative that incurred-but-not-reported events are practically irrelevant. The distribution of damage events reported as claims in the period from 1 January 2020 to 31 December 2021 and related to incidents that occurred in the months of the same period, grouped by quarter, was then compared with the distribution of damage events reported as adverse events and sentinel events in the same period, grouped by quarter. The analysis of the claims database showed that the claims trend is slightly decreasing. However, the analysis of the reports database showed that, in the period 2020-2021, the reports trend was increasing. In our study, the comparison of the two, malpractice claims and incident reporting, documented many differences and weak areas of overlap. Nevertheless, this contribution represents the first attempt to compare the two and new studies focusing on single types of adverse events are, therefore, desirable.

Effect of Lockdowns on Hospital Staff in a COVID Center: A Retrospective Observational Study.

At the onset of the SARS-CoV-2 pandemic, individual and social measures were strengthened through restrictive non-pharmaceutical interventions, labelled with the term "lockdown". In Italy, there were two lockdowns (9 March 2020−3 May 2020 and 3 November 2020−27 March 2021). As part of preventive measures, healthcare workers and the administrative staff population of Policlinico A. Gemelli underwent nasopharyngeal swab tests from 1 March 2020 to 9 February 2022, a long time interval that includes the two aforementioned lockdowns. The population included 8958 people from 1 March 2020 to 31 December 2020; 8981 people from 1 January 2021 to 31 December 2021; and 8981 people from 1 January 2022 to 9 February 2022. We then analysed pseudo-anonymized data, using a retrospective observational approach to evaluate the impact of the lockdown on the incidence of SARS-CoV-2 infections within the population. Given the 14 day contagious period, the swab positivity rate (SPR) among the staff decreased significantly at the end of the first lockdown, every day prior to 18 May 2020, by 0.093 (p < 0.0001, CI = (−0.138−−0.047)). After the fourteenth day post the end of the first lockdown (18 May 2020), the SPR increased daily at a rate of 0.024 (p < 0.0001, 95% CI = (0.013−0.034)). In addition, the SPR appeared to increase significantly every day prior to 17 November 2020 by 0.024 (p < 0.0001, CI = (0.013−0.034)). After the fourteenth day post the start of the second lockdown (17 November 2020), the SPR decreased daily at a rate of 0.039 (p < 0.0001, 95% CI = (−0.050−−0.027)). These data demonstrate that, in our Institution, the lockdowns helped to both protect healthcare workers and maintain adequate standards of care for COVID and non-COVID patients for the duration of the state of emergency in Italy.

A real-time integrated framework to support clinical decision making for covid-19 patients.

BACKGROUND: The COVID-19 pandemic affected healthcare systems worldwide. Predictive models developed by Artificial Intelligence (AI) and based on timely, centralized and standardized real world patient data could improve management of COVID-19 to achieve better clinical outcomes. The objectives of this manuscript are to describe the structure and technologies used to construct a COVID-19 Data Mart architecture and to present how a large hospital has tackled the challenge of supporting daily management of COVID-19 pandemic emergency, by creating a strong retrospective knowledge base, a real time environment and integrated information dashboard for daily practice and early identification of critical condition at patient level. This framework is also used as an informative, continuously enriched data lake, which is a base for several on-going predictive studies. METHODS: The information technology framework for clinical practice and research was described. It was developed using SAS Institute software analytics tool and SAS® Vyia® environment and Open-Source environment R ® and Python ® for fast prototyping and modeling. The included variables and the source extraction procedures were presented. RESULTS: The Data Mart covers a retrospective cohort of 5528 patients with SARS-CoV-2 infection. People who died were older, had more comorbidities, reported more frequently dyspnea at onset, had higher d-dimer, C-reactive protein and urea nitrogen. The dashboard was developed to support the management of COVID-19 patients at three levels: hospital, single ward and individual care level. INTERPRETATION: The COVID-19 Data Mart based on integration of a large collection of clinical data and an AI-based integrated framework has been developed, based on a set of automated procedures for data mining and retrieval, transformation and integration, and has been embedded in the clinical practice to help managing daily care. Benefits from the availability of a Data Mart include the opportunity to build predictive models with a machine learning approach to identify undescribed clinical phenotypes and to foster hospital networks. A real-time updated dashboard built from the Data Mart may represent a valid tool for a better knowledge of epidemiological and clinical features of COVID-19, especially when multiple waves are observed, as well as for epidemic and pandemic events of the same nature (e. g. with critical clinical conditions leading to severe pulmonary inflammation). Therefore, we believe the approach presented in this paper may find several applications in comparable situations even at region or state levels. Finally, models predicting the course of future waves or new pandemics could largely benefit from network of DataMarts.

Is COVID-19 a Real Incentive for Flu Vaccination? Let the Numbers Speak for Themselves.

Seasonal flu vaccination is one of the most important strategies for preventing influenza. The attitude towards flu vaccination in light of the COVID-19 pandemic has so far been studied in the literature mostly with the help of surveys and questionnaires. Whether a person chooses to be vaccinated or not during the COVID-19 pandemic, however, speaks louder than any declaration of intention. In our teaching hospital, we registered a statistically significant increase in flu vaccination coverage across all professional categories between the 2019/2020 and the 2020/2021 campaign (24.19% vs. 54.56%, p < 0.0001). A linear regression model, based on data from four previous campaigns, predicted for the 2020/2021 campaign a total flu vaccination coverage of 30.35%. A coverage of 54.46% was, instead, observed, with a statistically significant difference from the predicted value (p < 0.0001). The COVID-19 pandemic can, therefore, be considered as an incentive that significantly and dramatically increased adherence to flu vaccination among our healthcare workers.

Evaluation of the Effectiveness and Safety of the BNT162b2 COVID-19 Vaccine in the Vaccination Campaign among the Health Workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study was conducted among health staff working at the FPG. Vaccination data were collected from hospital records. The primary end points were vaccine effectiveness and safety. A total of 6649 health workers were included, of whom 5162 received injections. There were 14 cases of COVID-19 with onset at least 14 days after the second dose among vaccinated health workers and 45 cases among unvaccinated ones. BNT162b2 was 91.5% effective against COVID-19 (95% credible interval, 84.7% to 95.3%). The safety profile of BNT162b2 vaccine consisted of short-term, non-serious events. The promotion and boost of the COVID-19 vaccination campaign represents a key public health measure useful to curb the spread of the pandemic especially in vulnerable contexts, such as hospitals, where health workers carry out a paramount role for the entire community, and requires further protection with a possible booster dose in view of autumn-winter 2021.

Evidence-based of conjunctival COVID-19 positivity: An Italian experience: Gemelli Against COVID Group.

BACKGROUND: The possible transmission of severe acute respiratory coronavirus 2 (SARS-CoV-2) by tears and conjunctiva is still debated. METHODS: Main outcome was to investigate the agreement between nasopharyngeal swab (NPs) and conjunctival swabs (Cs) in patients with SARS-CoV-2 infection. We divided patients into four groups: (1) NPs and Cs both negative (C-NF-), (2) NPs positive and Cs negative (NFs+Cs-), (3) NPs negative and Cs positive (NFs-Cs+), and (4) NPs and Cs both positive (NFs-Cs+). The secondary outcomes were to correlate Cs results with systemic clinical parameters such as: oxygen saturation (SpO2), dyspnea degree (DP), radiologic pulmonary impairment based on chest radiography (XR) or computed tomography (CT), blood chemistry as D-Dimer (D-Dimer), fibrinogen, ferritin, lactate dehydrogenase (LDH), and C-reactive protein (C-RP). RESULTS: A total of 100 conjunctival swabs in 50 patients with SARS-CoV-2 have been enrolled in this interventional clinical trials. Ocular signs (conjunctivitis) were present in five patients (10%). NPs and Cs highlighted a poor level of agreement (0.025; p = 0.404). Median SpO2 levels are the highest in the NF-C- group (98%) and the lowest (90%) in the group NF+C+ (p = 0.001). Pulmonary impairment was statistically significantly different between NFs and Cs groups (p = 0.019). Pulmonary impairment score increased from NFs-Cs- group (3.8 ± 3.9), to NFs+Cs+ group (6.7 ± 4.1). Intensive care unit patients showed higher COVID-19 Cs positivity in conjunctiva (12.5%) against hospitalized ones (5.8%). CONCLUSIONS: In patients hospitalized for SARS-CoV-2 the virus can be detected in conjunctival swab. Intensive care unit patients may reveal a higher COVID-19 presence in the conjunctiva. The most severe pulmonary impairment can be observed in NFs and Cs positivity. TRIAL REGISTRATION: Clinicaltrials.gov registration. ETHICAL COMMITTEE AUTHORIZATION: ID number: 0013008/20.

Contactless: a new personalised telehealth model in chronic pediatric diseases and disability during the COVID-19 era.

BACKGROUND: Suspending ordinary care activities during the COVID-19 pandemic made it necessary to find alternative routes to comply with care recommendations not only for acute health needs but also for patients requiring follow-up and multidisciplinary visits. We present the 'Contactless' model, a comprehensive operational tool including a plurality of services delivered remotely, structured according to a complexity gradient, aimed to cover diagnostic procedures and monitor disease progression in chronic pediatric patients. METHODS: A multidisciplinary and multiprofessional project team was recruited, in collaboration with patients' associations, to map a panel of available Evidence-Based solutions and address individual needs in full respect of the concept of personalized medicine. The solutions include a number of services from videoconsultations to more structure videotraining sessions. RESULTS: A modular framework made up of four three Macro-levels of complexity - Contactless Basic, Intermediate and Advanced - was displayed as an incremental set of services and operational planning establishing each phase, from factors influencing eligibility to the delivery of the most accurate and complex levels of care. CONCLUSION: The multimodal, multidisciplinary 'Contactless' model allowed the inclusion of all Units of our Pediatric Department and families with children with disability or complex chronic conditions. The strengths of this project rely on its replicability outside of pediatrics and in the limited resources needed to practically impact patients, caregivers and professionals involved in the process of care. Its implementation in the future may contribute to reduce the duration of hospital admissions, money and parental absence from work.

A machine-learning parsimonious multivariable predictive model of mortality risk in patients with Covid-19.

The COVID-19 pandemic is impressively challenging the healthcare system. Several prognostic models have been validated but few of them are implemented in daily practice. The objective of the study was to validate a machine-learning risk prediction model using easy-to-obtain parameters to help to identify patients with COVID-19 who are at higher risk of death. The training cohort included all patients admitted to Fondazione Policlinico Gemelli with COVID-19 from March 5, 2020, to November 5, 2020. Afterward, the model was tested on all patients admitted to the same hospital with COVID-19 from November 6, 2020, to February 5, 2021. The primary outcome was in-hospital case-fatality risk. The out-of-sample performance of the model was estimated from the training set in terms of Area under the Receiving Operator Curve (AUROC) and classification matrix statistics by averaging the results of fivefold cross validation repeated 3-times and comparing the results with those obtained on the test set. An explanation analysis of the model, based on the SHapley Additive exPlanations (SHAP), is also presented. To assess the subsequent time evolution, the change in paO2/FiO2 (P/F) at 48 h after the baseline measurement was plotted against its baseline value. Among the 921 patients included in the training cohort, 120 died (13%). Variables selected for the model were age, platelet count, SpO2, blood urea nitrogen (BUN), hemoglobin, C-reactive protein, neutrophil count, and sodium. The results of the fivefold cross-validation repeated 3-times gave AUROC of 0.87, and statistics of the classification matrix to the Youden index as follows: sensitivity 0.840, specificity 0.774, negative predictive value 0.971. Then, the model was tested on a new population (n = 1463) in which the case-fatality rate was 22.6%. The test model showed AUROC 0.818, sensitivity 0.813, specificity 0.650, negative predictive value 0.922. Considering the first quartile of the predicted risk score (low-risk score group), the case-fatality rate was 1.6%, 17.8% in the second and third quartile (high-risk score group) and 53.5% in the fourth quartile (very high-risk score group). The three risk score groups showed good discrimination for the P/F value at admission, and a positive correlation was found for the low-risk class to P/F at 48 h after admission (adjusted R-squared = 0.48). We developed a predictive model of death for people with SARS-CoV-2 infection by including only easy-to-obtain variables (abnormal blood count, BUN, C-reactive protein, sodium and lower SpO2). It demonstrated good accuracy and high power of discrimination. The simplicity of the model makes the risk prediction applicable for patients in the Emergency Department, or during hospitalization. Although it is reasonable to assume that the model is also applicable in not-hospitalized persons, only appropriate studies can assess the accuracy of the model also for persons at home.