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.
Population Medicine considers the following types of articles:• Research Papers -reports of data from original research or secondary dataset analyses.• Review Papers -comprehensive, authoritative, reviews within the journal's scope.These include both systematic reviews and narrative reviews.• Short Reports -brief reports of data from original research.• Policy Case Studies -brief articles on policy development at a regional or national level.• Study Protocols -articles describing a research protocol of a study.• Methodology Papers -papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.• Methodology Papers -papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.
Introduction:Bleedings can result from insufficient blood coagulation and represent a relevant clinical aspect in medical practice. In most cases, these are genetically determined disorders that persist throughout a person's life, leapractice. In most cases, these are genetically determined disorders that persist throughout a person's life, leading to a significant financial burden on the National Health System and affecting the patient's quality of life.On the other hand, the bleeding phenomenon can be influenced in its potential complications by various factors such as pharmacological therapies, autoantibodies, clinical situations, lifestyle, and other factors related to possible genetic predispositions. These undesirable effects pose a diagnostic and therapeutic challenge that often presents characteristics of urgency and severity due to disruptions in the patient's hemostatic balance.Pharmacological therapy with anticoagulants, whether they are heparin-based or NOACs, can affect the duration and quantity of bleeding. Therefore, it is essential to always inform the surgeon and the general practitioner before any procedure if the patient is on these medications. The replacement or discontinuation of these drugs should only be carried out under medical guidance, even if it's for preparing for minor or major surgical interventions. Stopping bleeding is an essential medical procedure, both in the operating room and in outpatient settings. The choice of hemostatic drug or device to use is based on the type of bleeding to be treated and can be a lifesaver for the patient, expediting the recovery process. Making the most appropriate choice promptly can lead to significant economic savings, making it an effective and efficient practice without wasteful decisions. Materials and Methods: The study is observational and multicentric, spanning over 36 months, with data collected from a cohort of 75,000 patients treated at the departments and clinics of the San Giuliano Hospital within the territory of ASL Napoli 2 Nord in the northern area of the Campania capital. The degree of bleeding from the lesions was classified based on a scale validated by the FDA, dividing the phenomenon into grades ranging from 0 to 4. Grade 0 refers to blood loss <1.0 mL/min, Grade 1 to bleeding between 1.0 < mL/min > 5.0, Grade 2 to bleeding between 5.0 < mL/min > 10.0, Grade 3 to bleeding between 10.0 < mL/min > 50.0, and Grade 4 to bleeding with blood loss > 50 mL/min. This division corresponds to a severity threshold and relative life-threatening risk based on the quantity of bleeding. Medical professionals who intervened or were responsible for follow-up visits were given a mini-questionnaire in which they were asked to classify the outcome success rate based on the percentage, assessing the cessation of bleeding considering the initial severity according to the FDA scale. The obtained responses were classified as perfect, good, sufficient, or failed based on the achieved outcome, also correlated with the type of hemostatic device and/or drug used for each individual treatment. The considered therapies involving hemostatic devices and/or drugs were evaluated for total cost. Responses that initially failed were subsequently reclassified as at least sufficient, in order to understand the economic impact of less consistent choices in the treated cases and the related financial expenditure. Within the costs assessed for therapies from sufficient to perfect, all costs related to cases where therapy needed to be modified to improve the outcome were already included. Results: During the 36 months of the study, the outcomes of the 75,000 cases were collected, and each of them was attributed to a grade on the FDA scale. Considering the outcomes, the observed responses were effective, with just under 7% of the total not reaching the levels from perfect to sufficient. The threshold for a failed outcome was intentionally set very high (positive outcome less than 49%) to maintain high performance levels to ensure a good average success rate of the therapies. It is worth noting that out of the 7% of failed responses, only 2% yielded a positive outcome of less than 22%, indicating a significant deviation from the average positivity standards achieved. The outcomes are influenced by the choices made during the bleeding treatment phase, particularly when considering the total for each group. This allowed for the identification of the best therapeutic choices for each grade on the FDA scale. Thus, adhesive sealants were classified as Perfect for Grade 0 cases with only Blood Loss, hemostatic patches for Grade 2, and surgical adjuvants with thrombin and coagulation factor for Grade 4 cases where the patient's life is seriously at risk. Hemostatic powders and dressings were classified as Sufficient for Grade 1 cases, while the hemostatic matrix performed well for Grade 3 cases.When considering the percentage impact on the total cost of the individual observed responses, it was revealed that perfect responses account for 43%, while failed responses account for 10%. In conclusion, the average costs of treatments resulting in a failed response were approximately €135,000. The costs related to the change of therapy to improve the initially obtained response were also calculated. Conclusions: The appropriate classification of the type of bleeding allows for swift intervention and a higher accuracy in selecting the appropriate medical device and/or medication. By using the FDA-validated bleeding scale, optimal results for the patient's life can be achieved quickly, which is highly significant for their recovery.Simultaneously, making the correct choice regarding the use of medication and/or devices to stop bleeding leads to continuous cost monitoring for the corresponding therapies, achieving efficiency and effectiveness while containing costs. The total costs of the 75,000 observed therapies conducted over 36 months in the departments, including the Emergency Room and outpatient clinics of San Giuliano Hospital to address hemorrhages, amounted to approximately €1,500,000. Out of this, around €150,000 could have been saved with a targeted and appropriate choice of the most suitable therapy.
Introduction: Pregnancy termination (IG) is a widely practiced clinical procedure and can be therapeutic (IGT), pharmacological (IGF), or surgical (IGS). The analysis of total costs associated with different methods is useful to highlight advantages and disadvantages for the patient and to enable decision-makers to intervene in a precise manner on company policies supported by concrete data. The relevant legislation governing pregnancy termination is Law 194/78, with specific reference to voluntary termination, permitted within the first 90 days of gestation. This deadline can only be exceeded in special cases, such as severe risk to the mother or fetal malformation. The Law 194/78 aims to ensure that the process of voluntary termination (IVG) is guaranteed, and in this sense, family planning clinics serve as a reference service for many women and couples. The organization of IVG services must be such that there is enough professional figures to provide women with access to voluntary pregnancy termination. From the latest reports published by the Ministry, there is a noticeable decrease in voluntary pregnancy terminations, a trend also observed among foreign women. This is undoubtedly influenced by the increased use of emergency contraception – Levonorgestrel (morning-after pill) and Ulipristal acetate (5-day after pill). On the other hand, due to the more frequent use of pharmacological termination (using Mifepristone+Prostaglandins), there is an increased access to termination within the first 8 weeks of gestation, which represents the deadline for undergoing this variant of the procedure. Materials and Methods: The study is retrospective and uncentered, with an evaluation of data from questionnaires administered to patients who underwent Pregnancy Terminations in the years 2020, 2021, and 2022 at San Giuliano Hospital in Giugliano in Campania (Na), which falls within the territory of the Local Health Authority Napoli 2 Nord.From the analysis of the questionnaires, it is possible to reconstruct sensitive patient data, including place and date of birth, residence, domicile, age, origin, education level, as well as all clinical data related to the patient and pregnancy in general. Surgical pregnancy termination compared to pharmacological termination appears to be less common in all three periods considered. The pharmacological method involves taking an antiprogesterone hormone (Mifepristone) followed by an analogue of prostaglandins (Misoprostol). From a cost analysis perspective, the starting point was the Diagnosis Related Group (DRG) of pharmacological and surgical pregnancy terminations in the Campania Region for each method considered. Results: The laboratory tests which the patient must undergo in the preliminary phase are the same in all abortion (IG) procedures. In the surgical treatment, the patient is admitted to the day hospital, and under anaesthesia, the gestational sac is removed (an invasive procedure with associated risks). In the pharmacological procedure, the patient makes three hospital visits for the administration of two tablets with different active ingredients and at least one follow-up. Conclusions: Although there is a minimal difference between two Diagnosis-Related Groups (DRGs), only 40 euros, the total expenditure is higher in the case of IGF, which prevails significantly in terms of the number of cases compared to IGC. On the other hand, the involvement of professional figures, technical and logistical infrastructure, is inconsistent in IGF, whereas it is much greater in the case of IGC. With IGF, the patient does not undergo any anaesthesia evaluation or surgical intervention, with recovery times estimated to be a few hours and, above all, exposing the patient to fewer risks than the surgical procedure. Additionally, medical and healthcare staff and the operating room structure with all intervention techniques are engaged to a lesser extent in IGF compared to IGC, generating potentially higher company marginality in IGF, especially considering the actual cost of the drugs used. It is worth noting that the DRG falls under regional jurisdiction and may not be the same across the entire national territory. In fact, the Campania Region's case may be different in other regions, resulting in a higher reimbursement amount for IGC treatment compared to IGF.
Introduction: Chronic Pain has been recognized by the World Health Organization as one of the major global public health issues. The condition has debilitating consequences from physical, psychological, and socio-relational perspectives due to its highly disabling nature. Spinal Cord Stimulation (SCS) involves the placement of one or more electrodes in the epidural space through surgical means, connected to a fully implantable battery that electrically stimulates the spinal nerve structures. This treatment is indicated for patients suffering from intractable chronic pain in the trunk and limbs, particularly demonstrating efficacy in treating neuropathic pain. This method has been in use since the mid-1970s. The study lasted 24 months, with the initial 8 months involving patient recruitment and the subsequent 16 months devoted to the follow-up period. Its purpose was to evaluate the cost-benefit ratio of SCS in patients with chronic pain, treated at the Pain Therapy Hub of San Giuliano Hospital, ASL Napoli 2 Nord. The primary goal was to assess the effectiveness of Spinal Cord Neurostimulation (SCS) when applied to these patients. By conducting a comparative assessment 16 months after the implantation, the study evaluated the reduction in pain and disability among patients treated with SCS. Additionally, the study analysed the costs incurred by the National Health Service (SSN) and the corresponding benefits achieved in treating patients with chronic pain using SCS. The study is aimed to assess the effectiveness of this treatment in terms of improving patients' health status and quality of life. Materials and Methods: The observational study is retrospective and single cantered, conducted at the regional Pain Therapy Hub of San Giuliano Hospital, ASL Napoli 2 Nord. The study lasted for 24 months, with the initial 8 months dedicated to patient recruitment and the subsequent 16 months for the follow-up period.A total of 39 adult patients capable of managing or tolerating the devices used in SCS were recruited. These patients had a diagnosis of chronic back and/or leg pain and were non-responders to pharmacological therapy and other therapeutic treatments. The patients were provided with information about this study.Sixteen patients were excluded due to psychological or psychiatric disorders, progressive neurological conditions, or being recipients of an intrathecal pump for pain-relief drug infusion or an IPG. The remaining 23 patients received the implantation of a pulse generator and two electrode catheters. This group constituted our cohort, to which questionnaires were administered to evaluate the level of disability using the Oswestry Disability Index (ODI) and pain measurement using the Visual Analog Scale (VAS). Data were collected at Time 0 (T0) and during the subsequent 16 months from the start of treatment (Follow Up). Only 4 out of the 23 patients removed the neurostimulator before the 16-month term due to incompatibility. Quality of life data related to health status were collected through parameters used to measure how health impacts physical, psychological, and emotional well-being (HRQoL). Additional informative sheets, in addition to the ODI, were administered both at Time 0 and at the Follow-Up point, with the intent to verify if changes in ODI corresponded to changes in HRQoL parameters. Furthermore, quantification of data on resource consumption attributable to costs borne by the National Health Service was conducted, related to the treatment of individuals with chronic pain. These costs were divided into costs related to hospitalization, materials and devices used during the implantation procedure, and instrumental and professional resources employed to carry out the procedure (direct costs), as well as those linked to specialist visits, medication use, instrumental and diagnostic analyses (indirect costs). Regarding direct costs at Time 0, the average costs of daily hospitalization in Campania were considered, along with the average costs of tools, equipment, instrumental and pharmacological resources for an SCS implantation procedure. The gross costs associated with professional resources involved in the procedure, with an average duration of two hours (anaesthesiologist, radiological technician, operating physician, and nurse), were also considered. Lastly, non-medical costs generated by personal habits of patients with chronic pain and their care and management were considered. These costs vary depending on the patient's general conditions. Generally, these are individuals with limited autonomy, leading to increased specialized care needs and subsequent rising costs, including decreased productivity due to absences from work and those temporarily dedicated as caregivers. All medical and non-medical costs were assessed one year before and 16 months after the implantation procedure, the latter being normalized to a 12-month period for equal evaluation periods. Results: The study examined 23 out of 39 eligible patients, evaluating the cost-effectiveness and cost-utility ratio of SCS over a period of 12 months before the implantation and 16 months after the spinal cord neurostimulator implantation. Among the 23 recruited patients, 4 did not reach the 16-month follow-up as they had their spinal cord neurostimulator removed. Two patients removed it due to infection, while the remaining two patients could not tolerate the implanted device. Out of the 19 patients included in the analysis, those who had shown poor quality of life and low health levels in the twelve months prior to the device implantation displayed a significant increase in clinical outcomes at the 16-month mark after SCS intervention. Analysing data related to the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) between T0 and Follow-Up, variations in disability levels for different groups were identified. The decrease in disability and pain perception corresponds to an increased quality of life for the patient and a reduction in the social costs of the disease. The utility index Eq-5D increased from 0.45 to 0.68, and a noticeable improvement began to be observed after six months post-intervention.In terms of economic aspects, analysing monthly and annual medical and non-medical costs incurred by patients with chronic pain in conjunction with the direct and indirect costs of the SSN intervention shed light on the substantial expense to support therapies for this condition, borne by both the SSN and the patient. Nonetheless, these costs are to be considered one-time expenditures, such as those related to the implanted device and its procedure, or significantly reduced, like specialist visits and medication usage, due to the patient's improved health condition. Comparing costs one year before and 16 months after the intervention borne by the SSN highlighted reductions in certain categories in the final amount. Specifically, the number of diagnostic tests and tutoring expenses dropped to zero, while check-up visits reduced on average to two per year.Similarly, when comparing non-medical costs incurred by the patient one year before and 16 months after the intervention, a significant decrease in the final amount was recorded, correlating with the overall improvement in health status and the resulting reduction in the frequency and costs of accessing individual requested services. A notable increase in SSN expenditure was observed within the first 6 months after the neurostimulator implantation, primarily attributed to the device's cost and related implantation procedures. By 9 months post-implantation, a reduction in SSN expenses compared to the pre-implantation months could already be observed.
Introduction: The Coronavirus SARS-CoV-2 pandemic has altered the perception of the current National Health Service (SSN). On one hand, the importance of a free and always accessible SSN for everyone has been strengthened. On the other hand, the fragility of a system with a too specialized and hospital-centered approach has become evident. In the pandemic context, the need to reverse the model by focusing on the needs of the community has become clear, with the main aim of promoting home-based management as much as possible for both chronic and acute conditions. This can be achieved through the creation of an integrated network involving all stakeholders in the care and assistance process, utilizing new technologies and telemedicine systems.Materials and Methods: The aim of this activity was to delve into an integrated network model for home care of Covid patients, within ASL Napoli 2 Nord. This model utilizes interconnected and functionally integrated structures and nodes, with defined pathways and operational procedures based on dedicated telemedicine platforms. These platforms facilitate the comprehensive management and care of Covid-19 patients by all network stakeholders. Results were monitored using specific and dedicated indicators, collecting and analysing data from the period when the care of positive Covid patients began (November 2020), whose management did not require hospitalization.Results: From November 2020 to December 2021, the number of patients living in the ASL Napoli 2 Nord territory under home management included Home Health Care Units (USCA), non-ambulatory residential facilities undergoing non-pharmacological therapy (TNF), non-ambulatory vaccinated individuals receiving home vaccination, and vaccinated individuals in residential facilities, amounted to 38,223. Among these, 37.8% (14,476) tested positive for Covid.The total number of accesses during this period was approximately 94,000, encompassing various types of care provided (TNF at home, TNF in facilities, home management of Covid+ patients, vaccinations in facilities, vaccinations at home for non-ambulatory patients). The shift has been significant, transitioning from managing the entirety of patients in hospitals to slightly over 4.5% of the total managed from December 2020 to December 2021. Conclusions: The sensitivity of healthcare managers during the pandemic period translated into the realization that the focus of the National Health System (SSN) and the Regional Health System (SSR) needed to shift, directing efforts increasingly towards the implementation of local healthcare policies.The high number of hospitalizations recorded was not solely due to the increased number of infections, but also to the challenges faced in providing home care. Creating, developing, and continually implementing an interdisciplinary and interprofessional network, coupled with the development of technological infrastructures and more, ensured the ability to address the emergency. This guaranteed that all citizens received the necessary care and assistance to navigate this historically critical and unexpected moment.The reproducibility of this system assures the possibility of further network implementation, not only in emergencies but also for the daily management of chronic patients. Moreover, in a time when, among other things, Mission 6 of the National Recovery and Resilience Plan (PNRR) has allocated resources amounting to 15.63 billion euros to be invested in the healthcare sector, most of which are dedicated to revolutionizing our SSN and ensuring its greater efficiency and effectiveness in the territor.
Introduction: Bacterial infections associated with implanted biomaterials represent the most significant complication in orthopedics, and they constitute the primary reason for the failure of primary hip and knee prostheses.The prevention of infections associated with implanted biomaterials should simultaneously focus on at least two objectives: inhibition of biofilm formation and minimization of suppression of the local immune response.Some of the technologies proposed for this purpose in clinical practice have already shown strong evidence of antibacterial effectiveness, safety, and resistance. The time is ripe for further development and experimentation of these technologies in a clinical context. Material and Methods: The study was conducted by observing wounds within 6 months following the treatments, and the purpose of the work was to evaluate the cost and benefit aspects in patients treated with defensive antibacterial gels during orthopedic prosthetic and/or synthesis surgeries at the P.O. San Giuliano ASL Napoli 2 Nord. The aim was to assess the effectiveness of the treatment applied to patients who underwent orthopedic prosthetic and/or synthesis surgeries. The wound conditions of treated patients and untreated patients were compared at 6 months after orthopedic surgery. Simultaneously, the costs incurred by the National Health Service (SSN) and the related benefits obtained for the treated patients and untreated patients were also analyzed. This observational and retrospective study was conducted over 6 months on a cohort of 60 patients from the orthopedic department and outpatient clinic of P.O. San Giuliano ASL Napoli 2, who underwent post-traumatic interventions. The cohort was divided into two groups: Group A (gA) included 30 operated patients whose wounds and/or devices used were treated with gels designed for decontamination, aiming to prevent infections; Group B (gB) consisted of 30 operated patients who were not treated with any such device. The study involved a 6-month observation of both groups, evaluating the possible onset of infections, their duration (until complete healing, including potential complications), and the average cost of the necessary treatment (monitoring the use of drugs, medical supplies, and devices).A value scale was established based on the average cost incurred and the average treatment duration for each of the 4 levels on the scale. Results: At the end of the study period, 30 patients from the cohort were observed in group gA, and 30 in group gB.Within group gA, 2 patients experienced infections that positioned them in the first two levels of the scale, while in group gB, 8 patients required treatment for infections that placed them at different levels of the scale based on the treatment received and its associated cost. The economic impact is significant and variable, depending on the extent of usage indications (e.g., applying the device alone or as a carrier in combination with antibiotics in all subjects undergoing primary and revision arthroplasty surgeries, or fracture osteosynthesis, or only in a subset of them, e.g., patients selected at risk of infections, subjects undergoing prosthesis reimplantation, osteosynthesis of open traumatic fractures, etc.). Conclusions:The management of an infection that develops after orthopedic prosthetic and/or synthesis surgery leads the patient to seek and rely on long-term medical follow-up visits and specialized nursing assistance. The total costs for the care of the 10 infected patients show that the overall expenditure related to the 8 patients in group gB is much higher than that of the total 2 patients in group gA, both because of the fivefold difference in terms of number, which demonstrates how treatment with antibacterial gel reduces the incidence of infections, and also because the infections that occurred in the case of the 2 patients in group gA are milder and more manageable. Also considering the costs related to the use of antibacterial gel on wounds and/or prosthetic/osteosynthesis devices, the economic savings are still significant considering the cost of pharmacological treatments for infections and those for their potential complications.
All'inizio del periodo pandemico, si e verificata una forte polarizzazione delle risorse sanitarie e dei professionisti verso la prevenzione della rapida diffusione del SARS-CoV-2, riducendo l'attenzione alle malattie croniche e alla cura oncologica, compromettendo cosi la continuita terapeutica e gli esiti dei trattamenti. In questo scenario avvincente e travolgente, gli IFO sono rimasti ancorati alla propria missione di fornire cure specialistiche ai pazienti oncologici, dermatologici e con malattie rare. Qui, si presenta una sintesi delle decisioni strategiche assunte e dei piani sviluppati per ridurre la diffusione del virus, mentre ci si sforzava di avvicinare l'ospedale ai pazienti. Si spera che questa esperienza possa servire da risorsa per informare i modelli di assistenza in caso di futuri focolai epidemiologici.
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.
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. Main body of the abstract: 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.
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.
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.
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.
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.
Background The Hospital practices the Clinical Governance approach to ensure high standards of care and to continuously improve the quality of services. One purpose is to produce and to apply Organizational and Clinical Procedures (OCP), based on the best available evidence and the local contest and organization, to manage critical patients in the Emergency Department (ED). Annually, about 50.000 patients arrived to the ED, where 18% have urgent and 2% life-threatening conditions. These last cases receive a multidisciplinary treatment (emergency physicians, anaesthesiologists) and after stabilization of main symptoms are delivered to the Intensive Care Unit (ICU). The emergency physician is in the permanent staff of the ED while the anaesthesiologist of the ICU is on call. Until 2011, the anaesthesiologist was called by the emergency physician after his first intervention on the critical patient’s ED needed resuscitation treatment with consequent delay of patient’s delivery to the ICU. In 2012, to reduce the time of intervention of the anaesthesiologist in the ED, a group was constituted by health personnel of the ED and ICU, health direction, Quality Unit. The group detected the causes of the delay through the study of available data extracted by the ED electronic data sheet and of the organization of the ED. The group decided to provide an OCP to manage patients with life-threatening emergency conditions in the ED (OCP-ED). Materials and methods To reduce obstacles to the implementation and acceptance of organizational change, the emergency physicians and anaesthesiologists were educated to use OCP-ED applying the concepts and tools of experiential learning. Periodically, health direction organized meetings with personnel to disseminate the results of OCP-ED’s implementation and to discuss the possible problems and to find the solutions to overcome them. The effects of OCP-ED are measured through the indicators and the periodical audit on cases. The process indicators are calculated on data extracted by health database of the ED.
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.
Emergency Clinical Pathways (ECP) for stroke have never been tested in randomized controlled trials (RCTs).
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.
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.