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

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

Learning from organisational changes in the management of breast cancer patients during the COVID-19 pandemic: Preparing for a second wave at a breast unit in northern Italy.

Italy was the first western country to be hit by the initial wave of severe adult respiratory syndrome coronavirus 2 pandemic, which has been more widespread in the country's northern regions. Early reports showing that cancer patients are more susceptible to the infection posed a particular challenge that has guided our Breast Unit at Hub Hospital in Trento to making a number of stepwise operational changes. New internal guidelines and treatment selection criteria were drawn up by a virtual multidisciplinary tumour board that took into account the risks and benefits of treatment, and distinguished the patients requiring immediate treatment from those whose treatment could be delayed. A second wave of the pandemic is expected in the autumn as gatherings in closed places increase. We will take advantage of the gained experience and organisational changes implemented during the first wave in order to improve further, and continue to offer breast cancer management and treatment to our vulnerable patient population.

Higher heparin dosages reduce thromboembolic complications in patients with COVID-19 pneumonia.

Coronavirus disease 2019 (COVID-19) is a new viral disease complicating with acute thrombophylic conditions, probably also via an inflammatory burden. Anticoagulants are efficacious, but their optimal preventive doses are unknown. The present study was aimed to compare different enoxaparin doses/kg of body weight in the prevention of clot complications in COVID-19 pneumonia. Retrospective data from a cohort of adult patients hospitalized for COVID-19 pneumonia, never underwent to oropharyngeal intubation before admission, were collected in an Internal Medicine environments equipped for non-invasive ventilation. Unfavorable outcomes were considered as: deep venous thrombosis, myocardial infarction, stroke, pulmonary embolism, cardiovascular death. Fourteen clinical thromboembolic events among 42 hospitalized patients were observed. Patients were divided into two group on the basis of median heparin dose (0.5 mg-or 50 IU-for kg). The decision about heparin dosing was patient by patient. Higher enoxaparin therapy (mean 0.62±0.16 mg/kg) showed a better thromboprophylactic action (HR=0.2, p=0.04) with respect to lower doses (mean 0.42±0.06 mg/kg), independently from the clinical presentation of the disease. Therefore, COVID-19 pneumonia might request higher enoxaparin doses to reduce thromboembolic events in hospitalized patients, even if outside intensive care units.

Early-stage predictors of the acute phase duration in uncomplicated COVID-19 pneumonia.

OBJECTIVE: In this study, we aimed to highlight the common early-stage clinical and laboratory variables independently related to the acute phase duration in patients with uncomplicated coronavirus disease (COVID-19) pneumonia. METHODS: In hospitalized patients, the acute phase disease duration was followed using the Brescia-COVID respiratory severity scale. Noninvasive ventilation was administered based on clinical judgment. Patients requiring oropharyngeal intubation were excluded from the study. For parameters to be measured at the hospital entrance, age, clinical history, National Early Warning Score 2 (a multiparametric score system), partial pressure of oxygen in arterial blood/fraction of inspired oxygen (P/F ratio), C-reactive protein, and blood cell count were selected. RESULTS: In 64 patients, age (direct relationship), P/F, and platelet number (inverse relationship) independently accounted for 43% of the acute phase duration of the disease (P < .001). CONCLUSIONS: For the first time, the present results revealed that the acute phase duration of noncomplicated pneumonia, resulting from severe acute respiratory syndrome coronavirus 2, is independently predicted from a patient's age, as well as based on the hospital entrance values of P/F ratio and peripheral blood platelet count.

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

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

Early Guillain-Barré syndrome in coronavirus disease 2019 (COVID-19): a case report from an Italian COVID-hospital.

Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy associated with dysimmune processes, often related to a previous infectious exposure. During Italian severe acute respiratory syndrome coronavirus-2 outbreak, a woman presented with a rapidly progressive flaccid paralysis with unilateral facial neuropathy after a few days of mild respiratory symptoms. Coronavirus was detected by nasopharyngeal swab, but there was no evidence of its presence in her cerebrospinal fluid, which confirmed the typical albumin-cytological dissociation of GBS, along with consistent neurophysiological data. Despite immunoglobulin infusions and intensive supportive care, her clinical picture worsened simultaneously both from the respiratory and neurological point of view, as if reflecting different aspects of the same systemic inflammatory response. Similar early complications have already been observed in patients with para-infectious GBS related to Zika virus, but pathological mechanisms have yet to be established.

[Doctors' and nurses' perceptions of the spending review in the autonomous province of Trento (Italy)]. / La spending review percepita da medici e infermieri. Il caso dell'APSS di Trento.

The national expenditure limits set by the spending review has required reorganization and streamlining measures. The present study was conducted in 2015, among 2,020 nurses and 861 doctors in the autonomous province of Trento (Italy), to describe their perceptions of the containment measures introduced in healthcare spending, following the spending review. Results show that nurses and doctors were most affected by the measures regarding staff management (staff turnover rate, reducing overtime and changes in training). These measures, however, cannot be adopted for a long period of time without leading to negative effects on organization and quality of care.

Survival and time-to-transplantation of peritoneal dialysis versus hemodialysis for end-stage renal disease patients: competing-risks regression model in a single Italian center experience.

AIMS: Despite several studies reporting similar outcomes for peritoneal dialysis (PD) and hemodialysis (HD), the former is underused worldwide, with a PD prevalence of 15% in Italy. In 2008, the Unit of Nephrology and Dialysis of the Healthcare Trust of the Autonomous Province of Trento implemented a successful PD program which has increased the proportion of PD incident patients from 7 to 47%. We aimed to assess the effect of this extensive use of PD by comparing HD and PD in terms of survival and time-to-transplantation. METHODS: A total of 334 HD and 153 PD incident patients were enrolled between January 2008 and December 2014. After screening for exclusion criteria and propensity score matching, 279 HD and 132 PD patients were analyzed. Survival and time-to-transplantation were assessed by competing-risks regression models, using death and transplantation as primary and competing events. RESULTS: Crude and adjusted regression models for survival revealed the absence of significant differences between HD and PD cumulative incidence functions (subhazard ratio: 1.09, p = 0.62 and 1.34, p = 0.10, respectively). Differently, crude and adjusted regression models for transplantation revealed a lower time-to-transplantation for PD versus HD patients (subhazard ratio: 2.34, p < 0.01, and 2.57, p < 0.01, respectively). The waiting time for placement in the transplant waiting list was longer in HD than PD patients (330 vs. 224 days, p < 0.01). CONCLUSIONS: The extensive use of PD did not lead to any statistically significant difference in mortality. Furthermore, PD was associated with lower time to transplantation. PD may be a viable option for large-scale dialytic treatment in the advanced chronic kidney disease population.

An EFQM excellence model for integrated healthcare governance.

PURPOSE: The purpose of this paper is to account for a ten-year experience with the European Foundation for Quality Management (EFQM) Excellence Model implemented in the Trento Healthcare Trust. DESIGN/METHODOLOGY/APPROACH: Since 2000, the EFQM Excellence Model provided an overarching framework to streamline business process governance, to support and improve its enablers and results. From 2000 to 2009, staff performed four internal (self) and four external EFQM-based assessments that provided guidance for an integrated management system. Over the years, key controls and assurances improved service quality through business planning, learning and practice cycles. FINDINGS: Rising assessment ratings and improving results characterized the journey. The average self-assessment score (on a 1,000 points scale) was 290 in 2001, which increased to 610 in 2008. Since 2006, the Trust has been Recognized for Excellence (four stars). The organization improved significantly on customer satisfaction, people results and key service delivery and outcomes. PRACTICAL IMPLICATIONS: The EFQM Model can act as an effective tool to meet governance demands and promote system-level results. The approach to integrated governance discussed here may support similar change processes in comparable organizations. ORIGINALITY/VALUE: The paper describes a unique experience when implementing EFQM within a large Italian healthcare system, which had a broader reach and lasted longer than any experience in Italian healthcare.

[The implementation of the week surgery in an orthopedic and urology ward and assessment of its impact]. / L'introduzione della week surgery in urologia e ortopedia e valutazione dell'impatto.

SUMMARY: The implementation of the week surgery in an orthopedic and urology ward and the assessment of its impact. INTRODUCTION: The week surgery (WS) is one of the models organized according the intensity of care that allows the improvement of the appropriateness of the hospital admissions. AIM: To describe the implementation and the impact of the WS on costs and levels of care. METHODS: The WS was gradually implemented in an orthopedic and urology ward. The planning of the surgeries was modified, the wards where patients would have been transferred during the week-end where identified, the nurses were supported by expert nurses to learn new skills and clinical pathways were implemented. The periods January-June 2012 and 2013 were compared identifying a set of indicators according to the health technology assessment method. RESULTS: The nurses were able to take vacations according to schedule; the cost of outsourcing services were reduced (-4.953 Euros) as well as those of consumables. The nursing care could be guaranteed employing less (-5) full-time nurses; the global clinical performance of the ward did not vary. Unfortunately several urology patients could not be discharged during the week-ends. CONCLUSIONS: A good planning of the surgeries according to the patients' length of staying, together with interventions to increase the staff-skill mix, and the clinical pathways allowed an effective and efficient implementation of the WS model without jeopardizing patients' safety.

Health technology assessment in Italy.

OBJECTIVES: The aim of this study was to review the history of health technology assessment (HTA) in Italy. METHODS: Founded in 1978, the Italian National Health Service (NHS) has been strongly regionalized mainly after a constitutional reform, which started a devolution process. HTA started in the 1980s at the National Institute of Health and in a few University Hospitals, with a focus on big ticket technology: that process was driven by clinical engineers. RESULTS: In recent years, HTA is becoming an important tool for decision-making processes at central, regional, and local levels. In particular, the National Agency for Regional Health Services (AGENAS) and five regions (of twenty-one) are strongly committed to develop HTA initiatives connected with the planning process. CONCLUSIONS: At the local level, the hospital-based HTA activity is probably the most important peculiarity of the country and the real driver of the HTA movement.

Sterility and microbiological assessment of reused single-use cardiac electrophysiology catheters.

OBJECTIVE: To assess the performance and limitations of a reprocessing protocol for nonlumen electrophysiology catheters by testing the sterility of reprocessed devices and defining the maximum number of reprocessing cycles sustainable by the device in hygienically safe conditions. DESIGN: Simulated use, reprocessing, and testing of the catheters. SETTING: Microbiology and virology department of a public health diagnostic laboratory. INTERVENTIONS: Seventy-three catheters were collected after clinical use on patients. The first group of devices was tested for sterility after 1 cycle of reprocessing. By the repetition of simulated use (blood inoculated with bacteria) and reprocessing (decontamination, cleaning, and hydrogen peroxide gas plasma sterilization), we obtained 39 sample devices reprocessed 2 times, 26 reprocessed 3 times, 28 reprocessed 4 times, 36 reprocessed 5 times, and 22 reprocessed 6 times. Devices were cultured for 28 days in trypticase soy broth. RESULTS: We tested 208 catheters with 6 cycles of reprocessing and 4 inoculated bacteria species. No devices tested positive for the inoculated strains until the fourth cycle of reprocessing. One of 35 catheters showed the growth of the inoculated strain Bacillus subtilis after 5 cycles of reprocessing, and 1 of 22 catheters showed growth of this organism 6 cycles. After the second reprocessing, 7 of 36 devices showed growth of gram-negative bacteria other than the strain inoculated. CONCLUSIONS: Reprocessing according to the reprocessing protocol was insufficient to guarantee device sterility after 5 reuses. Cleaning with enzymatic solution revealed good cleaning properties with efficient bioburden reduction. Storage intervals of longer than 24 hours during reprocessing should be avoided to limit contamination or bacterial overgrowth. Technical considerations suggest the introduction of reprocessing procedures only in hospitals with considerable workloads.

Efficiency in endotoxin removal by a reprocessing protocol for electrophysiology catheters based on hydrogen peroxide plasma sterilization.

Electrophysiology and ablation cardiac catheters, which come in contact with blood during clinical use, are required to be non-pyrogenic (<20 endotoxin units (EU)/device). This study aimed to quantify the residual endotoxin load in reprocessed devices as a mandatory step to guarantee safe reuse. We monitored the pyrogenic status of the device (n=61) in three fundamental steps of the reprocessing protocol: after clinical use, after decontamination-cleaning treatments and after complete reprocessing, including sterilization by hydrogen peroxide gas plasma. Finally, a depyrogenation test was produced for evaluating the depyrogenation efficiency of the sole hydrogen peroxide sterilization treatment. Results showed that standard clinical use did not represent a source for endotoxin contamination, while the use of tap water and manual cleaning processing could increase the pyrogenic load in a significant way. The introduction of the sterilization by hydrogen peroxide gas plasma resulted in effective reduction of the endotoxin contamination and in safe reprocessing of 15 of 15 clinically used catheters. In addition, tests conducted on in vitro spiked catheters showed that initial pyrogenic loads of 40, 80, 200EU/device were reduced to less than 11EU/device. Depyrogenation testing demonstrated efficiency in endotoxin reduction of more than 62 times (1.8log). These results show the determining role of hydrogen peroxide gas-plasma sterilization in the reduction of pyrogenic load on medical devices. Considering actual hygienic requirements at single-use device reprocessing, hydrogen peroxide gas-plasma sterilization can be considered as an efficient treatment at non-lumen cardiac electrophysiology catheter reprocessing.

Functional properties and performance of new and reprocessed coronary angioplasty balloon catheters.

The need of health costs control has prompted the reuse of devices originally manufactured for single use only. To assess reprocessing feasibility of disposable medical devices, hygienic, technical, and functional aspects must be taken into account in addition to economical, ethical, and legal implications. This study aims to characterize coronary angioplasty catheters and to evaluate performance changes induced by reprocessing. Multiple analysis including crossing profile, slipperiness, compliance, mechanical, and burst pressure tests were performed at different steps of the protocol on 25 catheters reprocessed up to two times. The results highlighted that both use and reprocessing can affect the features of angioplasty catheters. Mechanical stress caused by clinical inflation and thermal-chemical stress undergone by polymers during cleaning and sterilization procedures caused partial modifications of material properties, inducing an overall shrinking effect on balloons. Compliance tests reported a maximum variation of 6.2% from nominal values, showing the conformity of reprocessed devices with manufacturers' original specifications (+/-10%). The burst pressure of reprocessed devices was 80% higher than the rated burst pressure certified by manufacturers, thus reducing concerns of breakage during reuse. A strict dependence on device model in the behavior of catheters was found, especially for balloons crossing profile and slipperiness. Main changes occurred after the first reprocessing cycle, while a second cleaning and sterilization did not introduce further significant alterations. On the whole, the magnitude of modifications introduced up to two reprocessing cycles did not compromise catheters performance.