Implementation of community health care services to counter the SARS-CoV2 pandemic.

BACKGROUND: The COVID-19 pandemic has ravaged many countries worldwide since December 2019. The high infection rates, and the need for health care assistance for individuals with comorbidities, strained the national health care systems around the world. Outbreak peaks increased the burden on hospitals that where perceived as high-risk places by people, who often decided to cancel or defer hospital visits. Thus, Italian Local Health Authorities had to develop new organizational models to meet the increased health care needs of the population. The aim of this study is to assess the impact of strengthened community health services on the hospital burden. METHODS: We analysed the number of Emergency Department access at the Hospital De Lellis covered by the Local Health Authority in Rieti, from March 2020 to November 2021. We then assessed the effects of community health services: the Special District Continuing Care Units (SDCUs) and the the COVID hub, on the COVID-19-related ED access, admission and mortality rates. A Chi-squared test for trend and three multivariable logistic regression models were used to investigate the trends and the possible predictors of COVID ED access, COVID hospital admissions, and deaths. RESULTS: Being male (OR = 1.41, CI95% 1.05-1.90; p = 0.022) and older age (OR = 1.03, CI95% 1.02-1.04; p < 0.0001) increase the likelihood of hospitalisation for Sars-CoV-2. The implementation of the nursing and medical SDCUs contributed to reducing COVID-19-related deaths (OR = 0.09, CI95% 0.03-0.29; p < 0.0001). The simultaneous implementation of the COVID hub and of the nursing SDCUs had a synergistic effect in reducing the likelihood of hospitalisation (OR = 0.24, CI95% 0.09-0.65; p = 0.005). The subsequent implementation of the medical SDCUS has further contributed to lowering the admission rates. These protective effects persisted also after potential cofounders, such as age, sex, clinical condition on admission, and the immunisation status, were adjusted. CONCLUSIONS: These measures have helped in the management of patients in a complex context such as that of a pandemic by reducing the hospital load and playing an important role in the management of the pandemic. Further studies could assess the transferability of this model in a non-pandemic context.

Trichinella spp. detection in hunted wild boar (Sus scrofa) diaphragm biopsies in Central Italy.

Trichinellosis is a globally diffused foodborne parasitic disease caused by nematodes of the Trichinella complex. During evolution, guided by ecological interactions, natural selection, and biochemical "intelligence", these parasites developed admirable strategies to infect the host's organism. One of the most fascinating is represented by the nurse cell formation in muscular tissue (e.g., diaphragm, skeletal muscle, extrinsic ocular muscles, etc.). This strategy allowed the parasite to adapt and conquer the wider host species spectrum, including ungulates and humans. Consumption of undercooked meat from infected wild ungulates constitutes the most important source of infection for the human species. In this study, we show the prevalence of Trichinella spp. in hunted wild boars (Sus scrofa) in Central Italy. During the hunting season 2021/2022 in the province of Rieti, 554 wild boar diaphragm biopsies were collected for Trichinella spp. screening, in accordance with Regulation EU 1375/2015. An artificial digestion method was used for the detection of Trichinella spp. larval forms. The results revealed a positivity of 0.18% (1/554), and molecular biology identification demonstrated the presence of Trichinella britovi in the positive sample. This species is the most diffused in wild ungulate populations in Central Italy and the most frequently isolated in human patients with trichinellosis from this area, showing a close epidemiological relation between Homo sapiens and Sus scrofa for Trichinella spp. diffusion in an ecosystem. Epidemiological surveillance, in receptive animal species destined for human consumption and at any One Health level, represents the main "winning" strategy in the control of this worldwide, widespread foodborne parasitic disease.

Biofilm Production by Carbapenem-Resistant Klebsiella pneumoniae Significantly Increases the Risk of Death in Oncological Patients.

Carbapenem-resistant Klebsiella pneumoniae (CRKP) is a prominent cause of nosocomial infections associated with high rates of morbidity and mortality, particularly in oncological patients. The hypermucoviscous (HMV) phenotype and biofilm production are key factors for CRKP colonization and persistence in the host. This study aims at exploring the impact of CRKP virulence factors on morbidity and mortality in oncological patients. A total of 86 CRKP were collected between January 2015 and December 2019. Carbapenem resistance-associated genes, antibiotic susceptibility, the HMV phenotype, and biofilm production were evaluated. The median age of the patients was 71 years (range 40-96 years). Clinically infected patients were 53 (61.6%), while CRKP colonized individuals were 33 (38.4%). The most common infectious manifestations were sepsis (43.4%) and pneumonia (18.9%), while rectal surveillance swabs were the most common site of CRKP isolation (81.8%) in colonized patients. The leading mechanism of carbapenem resistance was sustained by the KPC gene (96.5%), followed by OXA-48 (2.3%) and VIM (1.2%). Phenotypic CRKP characterization indicated that 55.8% of the isolates were strong biofilm-producers equally distributed between infected (54.2%) and colonized (45.8%) patients. The HMV phenotype was found in 22.1% of the isolates, which showed a significant (P<0.0001) decrease in biofilm production as compared to non-HMV strains. The overall mortality rate calculated on the group of infected patients was 35.8%. In univariate analysis, pneumoniae significantly correlated with death (OR 5.09; CI 95% 1.08-24.02; P=0.04). The non-HMV phenotype (OR 4.67; CI 95% 1.13-19.24; P=0.03) and strong biofilm-producing strains (OR 5.04; CI95% 1.39-18.25; P=0.01) were also associated with increased CRKP infection-related mortality. Notably, the multivariate analysis showed that infection with strong biofilm-producing CRKP was an independent predictor of mortality (OR 6.30; CI 95% 1.392-18.248; P=0.004). CRKP infection presents a high risk of death among oncological patients, particularly when pneumoniae and sepsis are present. In infected patients, the presence of strong biofilm-producing CRKP significantly increases the risk of death. Thus, the assessment of biofilm production may provide a key element in supporting the clinical management of high-risk oncological patients with CRKP infection.

Reorganization of Istituti Fisioterapici Ospitalieri, an oncological and dermatological clinical and research center, to face the coronavirus health emergency: adopted measures and metrics of success to achieve and keep a COVID-19-free status.

BACKGROUND: A pronounced polarization of healthcare resources and workforce towards the prevention of the rapid spread of SARS-CoV-2 occurred at the expenses of the majority of chronic diseases and cancer, thus jeopardizing continuity of care and therapy outcomes. In this challenging and overwhelming scenario, our Institute confirmed its mission to provide expert cancer care. Here, we provide a report of strategic decisions made and of articulated measures developed to limit virus spreading while striving to make our hospital closer to patients. CONCLUSIONS: We hope our experience may serve as a resource to inform clinical care models in case of future epidemiological outbreaks.

Breast cancer surgery during the Covid-19 pandemic: a monocentre experience from the Regina Elena National Cancer Institute of Rome.

The Covid-19 pandemic has challenged hard the national health systems worldwide. According to the national policy issued in March 2020 in response to the evolving Covid-19 pandemic, several hospitals were re-configured as Covid-19 centers and elective surgery procedures were rescheduled according to the most recent recommendations. In addition, Covid-19 protected cancer hubs were established, including the Regina Elena National Cancer Institute of Rome, Central Italy. At our Institute, the Breast Surgery Department continued working under the sign of a multidisciplinary approach. The number of professional figures involved in case evaluation was reduced to a minimum and interactions took place in the full respect of the required safety measures. Treatments for benign disease, pure prophylactic surgery and elective reconstructive procedures were all postponed and priority was assigned to the histologically-proven malignant breast tumors and highly suspicious lesions. From March 15th though April 30th 2020, we treated a total of 79 patients. This number is fully consistent with the average quantitative standards reached by our Department under ordinary circumstances. Patients were mostly discharged the day after surgery and none was readmitted due to surgery-related late complications. More generally, post-operative complications rates were unexpectedly low, particularly in light of the relatively high number of reconstructive procedures performed in this emergency situation. A strict follow up was performed based on the close contact with the surgical staff by telephone, messaging apps and telemedicine.Patients ascertainment for their Covid-19 status prior to hospital admission and hospital discharge allowed to maintain the "no-Covid-19" status at our Institution. In addition, during the aforementioned time window, none of the care providers developed SARS-CoV-2 infection or disease, as shown by the results of anti-SARS-CoV-2 immunoglobulin M and G profiling. In conclusions, elective breast cancer surgery procedures were successfully performed in a lockdown situation due to a novel viral pandemic. The well-coordinated regional and hospital efforts in terms of medical resource re-allocation and definition of clinical priorities allowed to maintain high quality standards of breast cancer care while ensuring safety to the cancer patients and care providers involved.

Reorganization Tips from a Sarcoma Unit at Time of the COVID-19 Pandemic in Italy: Early Experience from a Regional Referral Oncologic Center.

Since the World Health Organization declared the novel coronavirus outbreak a global health emergency, Italy's lockdown was declared on 9 March 2020. Elective orthopedic surgery was forced to stop to allow the healthcare system to face the emergency. However, many orthopedic oncology cases could not be postponed. The aim of this study was to report the experience in managing sarcoma patients and the reorganization of a cancer center in an attempt to maintain it free from COVID-19. A Coronavirus Crisis Unit was established by the health directorate coordination in order to adopt specific procedures. General rules of screening and social distancing were applied in different health settings (entrance check point, hospital inward, outpatient clinic, operative room). Regarding oncologic orthopedics, priority was given to bone and soft tissue sarcomas, metastases and aggressive benign tumors at risk of impending or pathologic fracture. Precise indications were followed to manage first outpatient visits, patients undergoing surgery and follow-up. Meticulous adherence to rules among patients and personnel and collaboration between leadership and medical staff in order to continue to perform multidisciplinary treatment protocols, maintain the availability of infrastructural spaces and source protective equipment, swabs and screening samples have been successful in the aim towards a safe cure for cancer patients.

Screening for Tuberculosis in Health Care Workers: Experience in an Italian Teaching Hospital.

Health care workers (HCW) are particularly at risk of acquiring tuberculosis (TB), even in countries with low TB incidence. Therefore, TB screening in HCW is a useful prevention strategy in countries with both low and high TB incidence. Tuberculin skin test (TST) is widely used although it suffers of low specificity; on the contrary, the in vitro enzyme immunoassay tests (IGRA) show superior specificity and sensitivity but are more expensive. The present study reports the results of a three-year TB surveillance among HCW in a large teaching hospital in Rome, using TST (by standard Mantoux technique) and IGRA (by QuantiFERON-TB) as first- and second-level screening tests, respectively. Out of 2290 HCW enrolled, 141 (6.1%) had a positive TST; among them, 99 (70.2%) underwent the IGRA and 16 tested positive (16.1%). The frequency of HCW tested positive for TB seems not far from other experiences in low incidence countries. Our results confirm the higher specificity of IGRA, but, due to its higher cost, TST can be considered a good first level screening test, whose positive results should be further confirmed by IGRA before the patients undergo X-ray diagnosis and/or chemotherapy.

H2020 and Beyond: Skip Discrepancy between Theory and Practice of Personalized Medicine. A Position Paper by the Italian Society of Personalized Medicine.

Many unsolved practical issues, from technical and scientific to ethical, legal and economic topics, are slowing down the translation of Personalized Medicine principles into medical practice. The Italian Society of Personalized Medicine exposes here its point of view, based on the real-world practice of precision medicine carried-out in Italian healthcare structures.

The use of Cincinnati Prehospital Stroke Scale during telephone dispatch interview increases the accuracy in identifying stroke and transient ischemic attack symptoms.

BACKGROUND: Timely and appropriate hospital treatment of acute cerebrovascular diseases (stroke and Transient Ischemic Attacks - TIA) improves patient outcomes. Emergency Medical Service (EMS) dispatchers who can identify cerebrovascular disease symptoms during telephone requests for emergency service also contribute to these improved outcomes. The Italian Ministry of Health issued guidelines on the management of AC patients in pre-hospital emergency service, including Cincinnati Prehospital Stroke Scale (CPSS) use.We measured the sensitivity and Positive Predictive Value (PPV) of EMS dispatchers' ability to recognize stroke/TIA symptoms and evaluated whether the CPSS improves accuracy. METHODS: A cross-sectional multicentre study was conducted to collect data from 38 Italian emergency operative centres on all cases identified with stroke/TIA symptoms at the time of dispatch and all cases with stroke/TIA symptoms identified on the scene by the ambulance personnel from November 2010 to May 2011. RESULTS: The study included 21760 cases: 18231 with stroke/TIA symptoms at dispatch and 9791 with symptoms confirmed on the scene. The PPV of the dispatch stroke/TIA symptoms identification was 34.3% (95% CI 33.7-35.0; 6262/18231) and the sensitivity was 64.0% (95% CI 63.0-64.9; 6262/9791). Centres using CPSS more often (>10% of cases) had both higher PPV (56%; CI 95% 57-60 vs 18%; CI 95% 17-19) and higher sensitivity (71%; CI 95% 87-89 vs 52%; CI 95% 51-54).In the multivariate regression a centre's CPSS use was associated with PPV (beta 0.48 p = 0.014) and negatively associated with sensitivity (beta -0.36; p = 0.063); centre sensitivity was associated with CPSS (beta 0.32; p = 0.002), adjusting for PPV. CONCLUSIONS: Centres that use CPSS more frequently during phone dispatch showed greater agreement with on-the-scene prehospital assessments, both in correctly identifying more cases with stroke/TIA symptoms and in giving fewer false positives for non-stroke/TIA cases. Our study shows an extreme variability in the performance among OCs, highlighting that form many centres there is room for improvement in both sensitivity and positive predictive value of the dispatch. Our results should be used for benchmarking proposals in the effort to identify best practices across the country.

Development of the Italian version of the National Institutes of Health Stroke Scale: It-NIHSS.

BACKGROUND AND PURPOSE: The National Institutes of Health Stroke Scale (NIHSS) is a basic component of the assessment of patients with acute stroke. To foster and standardize the use of the NIHSS among Italian health professionals, we translated the scale, dubbed into Italian the training and test videotapes devised by the National Institutes of Health researchers, and conducted a series of certification courses using the translated videos. METHODS: Translation, text adaptation, video dubbing, and editing of the Italian NIHSS videotapes relied on a team of bilingual stroke neurologists. Three waves of training courses were organized for mixed classes of medical and nonmedical health professionals. The certification test was based on the usual set of 5 videotaped patients. Scoring rules were those provided by the National Institutes of Neurological Disorders and Stroke. Reliability of the Italian NIHSS was assessed using kappa statistics and compared with that of the original NIHSS. RESULTS: During 3 years, 850 nurses, 460 nonneurologist physicians, and 246 neurologists were trained. Pass rates were respectively 44%, 75%, and 87%, respectively. Overall, 80% of scale items showed moderate to excellent reliability. Independent significant predictors of test failure at multivariate logistic regression were nurse profession (OR, 5.41; 95% CI, 4.07 to 7.20), older age (OR, 1.03; 95% CI, 1.02 to 1.05), and first edition of the course (OR, 3.13; 95% CI, 2.43 to 4.05). The agreement across all items between NIHSS and the Italian NIHSS was 80% (kappa=0.70+/-0.18, z<0.001). CONCLUSIONS: The Italian translation, supervised by experienced vascular neurologists, did not influence the clinimetric characteristics of the NIHSS. Our findings support the implementation of NIHSS video training in languages other than English.

An emergency clinical pathway for stroke patients--results of a cluster randomised trial (isrctn41456865).

BACKGROUND: Emergency Clinical Pathways (ECP) for stroke have never been tested in randomized controlled trials (RCTs). OBJECTIVE: To evaluate the effectiveness of an ECP for stroke patients in Latium (Italy) emergency system. METHODS: cluster-RCT designed to compare stroke patient referrals by Emergency Medical Service (EMS) and Emergency Room (ER) health professionals trained in the ECP, with those of non-trained EMS and ER controls. Primary outcome measure was the proportion of eligible (aged

Continuing medical education and evidence-based clinical pathways. Training emergency health workers in Latium, Italy.

BACKGROUND: In recent decades, studies that evaluate training programmes have shown that continuing education for physicians is not very effective in improving performance and behavioural changes. One of our goals was to create a Continuing Medical Education Programme (CMEP) that would result in changing the behaviour of health professionals. In early 2005, a new CMEP was offered to emergency medical services and emergency room professionals to introduce an Emergency Critical Pathway (ECP) for the management of acute stroke patients. This paper illustrates the main characteristics of the educational model and the strategies and activities adopted to realize it. METHODS: The training programme was planned and organized applying the concepts and tools of experiential learning. It was organised in three successive phases: 1) interviews with health professionals to identify their learning needs; 2) training the ECP coordinators/facilitators in a residential setting; and 3) on-site training in small groups of health professionals (6-8), led by a coordinator/facilitator. RESULTS: The CME involved 324 emergency health professionals. Participants positively evaluated both the educational programme and the clinical indications of the protocols. Over six months of the ECP training, health professionals treated 657 stroke patients: 153 (23.3%) were transferred to the stroke unit where 15 (9.8%) were thrombolysed. In the same period of the previous year, the professionals treated 638 patients: 99 (15.5%) were transferred to the stroke unit and no patients were thrombolysed. CONCLUSION: The application of the new educational methodology has contributed to improved management of stroke patients in Latium.

[Implementation of an emergency clinical pathway for ST-elevation myocardial infarction in the Lazio Region: results of a pilot study]. / Implementazione di un percorso clinico-assistenziale per la gestione dei pazienti con infarto miocardico con sopraslivellamento del tratto ST nella rete dell'emergenza del Lazio: risultati di uno studio pilota.

BACKGROUND: Timely reperfusion therapies (primary angioplasty and pre-hospital thrombolysis) remain a key component in improving the survival of patients with ST-segment elevation myocardial infarction (STEMI). The Lazio Region emergency organization has a complex mixed logistic (the large city of Rome, presence of complex orography), therefore the use of telemedicine technologies by the emergency medical system (EMS) is mandatory. Emergency clinical pathways (ECP) for the management of STEMI patients were designed, focusing on early pre-hospital diagnosis and best appropriate treatment through the ECG transmission and teleconsultation among EMS and cardiologists in coronary care units (CCU). METHODS: To evaluate the effectiveness of ECP-STEMI in the current practice, a prospective observational cohort study of ambulance-transported patients with cardiovascular symptoms was conducted in a selected area of the Lazio Region during a 6-month period. The implementation of the ECP was carried out by educational activities for the EMS personnel based on the "experiential learning" methods. RESULTS: From October 2005 to March 2006, 287 patients were enrolled in the study and a pre-hospital ECG was performed in 66% of them. One hundred and fifty-two patients were referred to hospital and only 34 had discharged diagnosis of acute myocardial infarction, of whom 23 were STEMI. In the 34 acute myocardial infarction patients the medium time from "call to the EMS" to "arrival to the hospital" was 41 min (range 29-63 min) and 3 had their ECG telematically transmitted from the ambulance to the CCU. All of these cases were STEMI. Twenty-eight acute myocardial infarctions were discharged alive, 2 were transferred in other hospitals, 4 died. No patients received pre-hospital thrombolysis. Prior to the ECP implementation the ECG for STEMI patients has never been transmitted by EMS to the CCU in the Lazio Region. CONCLUSIONS: Our study suggests that adherence to ECP improved the appropriateness of STEMI patient referral and treatment in the CCU in the Lazio Region. The EMS personnel, during the study, showed a high interest in the protocol trying to change their current practice. The Regional Administration plans to expand the utilization of ECP to all regional emergency network (EMS and Emergency Departments) and to improve its use.

Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients?--Study protocol of a cluster randomised trial [ISRCTN41456865].

BACKGROUND: Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways. We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT), the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865--implementation of pre-hospital emergency pathway for stroke--a cluster randomised trial. METHODS/DESIGN: Two-arm cluster-randomised trial (C-RCT). 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline), or to arm 2 (no intervention, current practice). Arm 1 participants (152 physicians, 280 nurses, 50 drivers) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses. Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the intervention. We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to: 1) promptness of interventions for hyperacute ischaemic stroke; 2) promptness of interventions for hyperacute haemorrhagic stroke 3) appropriate diagnosis. Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset < or = 6 hour admitted to the stroke unit. DISCUSSION: The fields in which this trial will play are usually neglected by randomised controlled trial (RCT). We have chosen the cluster-randomised controlled trial (C-RCT) to address the issues of contamination, adherence to real practice, and community dimension of the intervention, with a complex definition of clusters and an extensive use of routine data to collect the outcomes.

Temporal trend of HIV infection: an update of the HIV surveillance system in Lazio, Italy, 1985-2000.

BACKGROUND: After the introduction of the highly active antiretroviral therapies, data from AIDS surveillance systems are less useful to describe the HIV epidemic, while HIV surveillance could give more detailed information to provide data for HIV prevention and care programmes. We report the results of the HIV surveillance system update in Lazio, Italy, from 1985 through 2000. METHODS: New diagnoses of HIV infection were identified through a linkage procedure on the total reports, and underreporting was estimated through a link between the HIV surveillance system and the Hospital Information System of Lazio. RESULTS: As of December 2000, 20,912 new diagnoses of HIV occurred in Lazio. New diagnoses have decreased steadily since 1992. The male/female ratio decreased during the study period, while the number of foreign-born cases increased. Sexual transmission became the main modality of exposure for men in 1996 and for women in 1992. In 2000 the proportion of men infected by sexual transmission reached 54.0% versus 15.2% of those infected by intravenous drug use, whereas the proportion of women was 58.9% and 8.6% respectively. The sensitivity of the system has slightly decreased. CONCLUSION: HIV infection is increasing in women and immigrants; people are being infected more frequently by sexual transmission than intravenous drug use.

[Underreporting of AIDS cases in Lazio, Italy]. / Sottonotifica dei casi di AIDS nel sistema di sorveglianza del Lazio.

One of the most important aspect of any surveillance system is completeness. We conducted an evaluation of the completeness of the AIDS surveillance system (SSAIDS) of Lazio region. We estimated the underreporting of AIDS cases in SSAIDS of Lazio in the period 1996-1998 through a linkage with the regional Hospital Information System (HIS) for the same years. A logistic regression model was used to estimate the relative risk (Odds Ratios--OR) of being unreported by demographic and clinical characteristics. A total of 56 cases had not been reported in the period 1996-1998, corresponding to 3.6% of underreporting. The risk of not being reported was associated with undetermined value of CD4 at diagnosis of AIDS (OR 15.40), unknown modality of exposure (OR 3.15) and with AIDS defining illness at diagnosis (ADI) as mycobacteriosis (OR 11.65), encephalopaties (OR 4.47) and toxoplasmosis (OR 8.67). Differences were also observed by clinical centre of diagnosis. In conclusion, the degree of underreporting is lower in our region than in other countries and the SSAIDS has a high completeness in Lazio. In agreement with other studies, underreporting is more frequent for cases with undermined value of CD4 at diagnosis of AIDS and unknown modality of exposure. The results regarding ADI need further investigation.