Quality improvement in neonatal care through enhanced patient safety and clinical risk management: a before-and-after study about neonatal sepsis.

Introduction: Neonatal sepsis, classified into early-onset and late-onset based on symptom timing, poses significant risks of morbidity and mortality, especially in low birth weight infants. Effective clinical risk management protocols are crucial in reducing these risks. Methods: This before-and-after study evaluated the impact of a newly implemented clinical risk management protocol in the Neonatology and Neonatal Intensive Care Unit (NICU) at Policlinico Hospital-University of Bari. The study included 399 neonates over three years, comparing pre- and post-protocol outcomes. Data collection focused on maternal and neonatal demographics, infection rates, and hospital stay lengths. Statistical analysis included t-tests, Wilcoxon-Mann-Whitney tests, and logistic regression models. Results: The study found no significant differences in neonatal pathologies or demographics between pre- and post-protocol groups. However, post-protocol implementation showed a notable reduction in umbilical venous catheter (UVC) infections (p = 0.018) and improved hospital stay lengths. Blood and urine cultures did not show significant changes in microbial patterns post-protocol. Discussion: The findings underscore the effectiveness of structured clinical risk management protocols in enhancing neonatal outcomes, particularly in reducing specific infection risks. Despite the study's limitations, including its observational nature and sample size, the results advocate for broader adoption and further research on these protocols in diverse healthcare settings. The positive outcomes highlight the importance of continuous clinical risk management efforts in high-risk neonatal environments.

Dura mater and survival time determination in individuals who died after traumatic brain injury: a preliminary study.

BACKGROUND: Traumatic brain injury (TBI) is one of the major causes of morbidity and mortality among young people and is a matter of concern for forensic pathologists. Many authors have tried to estimate a person's survival time (ST) after TBI using different approaches. OBJECTIVE: The present study aimed to present an innovative workflow to estimate the ST after TBI by observing the inflammatory reaction of the dura mater (DM). METHODS: The authors collected DM samples from 36 cadavers (20 with TBI and 16 with no history or signs of TBI). Each sample was labelled via immunohistochemistry with three different primary antibodies, CD15, CD68, and CD3, yielding 108 slides in total. The slides were digitalized and analysed using QuPath software. RESULTS: The DM is involved in the inflammatory response after TBI. CD15 immunoreactivity allowed us to distinguish between subjects who died immediately after TBI and those with an ST of minutes or hours. CD3 immunoreactivity can be used to differentiate subjects with an ST of days from those with other STs. Moreover, the DM samples showed an acceptable diagnostic yield even in samples with signs of putrefaction.

Measuring the willingness to share personal health information: a systematic review.

Background: In the age of digitalization and big data, personal health information is a key resource for health care and clinical research. This study aimed to analyze the determinants and describe the measurement of the willingness to disclose personal health information. Methods: The study conducted a systematic review of articles assessing willingness to share personal health information as a primary or secondary outcome. The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol. English and Italian peer-reviewed research articles were included with no restrictions for publication years. Findings were narratively synthesized. Results: The search strategy found 1,087 papers, 89 of which passed the screening for title and abstract and the full-text assessment. Conclusion: No validated measurement tool has been developed for willingness to share personal health information. The reviewed papers measured it through surveys, interviews, and questionnaires, which were mutually incomparable. The secondary use of data was the most important determinant of willingness to share, whereas clinical and socioeconomic variables had a slight effect. The main concern discouraging data sharing was privacy, although good data anonymization and the high perceived benefits of sharing may overcome this issue.

Alcohol and Drug Consumption among Drivers before and during the COVID-19 Pandemic: An Observational Study.

Restrictions imposed during the COVID-19 pandemic might have changed recreational habits. In this study, the results of toxicological tests for alcohol and drugs in blood were compared among drivers stopped at roadside checks in the periods before (1 January 2018 to 8 March 2020) and after the lockdown measures (9 March 2020 to 31 December 2021). A total of 123 (20.7%) subjects had a blood alcohol level above the legal limit for driving of 0.5 g/l, 21 (3.9%) subjects tested positive for cocaine, and 29 (5.4%) subjects positive for cannabis. In the COVID-19 period, the mean blood alcohol level was significantly higher than in the previous period. Cannabis use, which was more frequent among younger subjects, was statistically associated with cocaine use. There has also been a quantitative increase in alcohol levels in the population with values above the legal limits, indicative of greater use of alcohol in the population predisposed to its intake.

Digital Health Care, Telemedicine, and Medicolegal Issues in Orthopedics: A Review.

The use of technologies in medicine has great potential to reduce the costs of health care services by making appropriate decisions that provide timely patient care. The evolution of telemedicine poses a series of clinical and medicolegal considerations. However, only a few articles have dealt with telemedicine and orthopedics. This review assesses the ethical and medicolegal issues related to tele-orthopedics. A systematic review was performed including papers published between 2017 and 2021 focusing on the main medicolegal and clinical-governance aspects of tele-orthopedics. Most of the articles were published during the COVID-19 pandemic, confirming the impetus that the pandemic has also given to the spread of telemedicine in the orthopedic field. The areas of interest dealt with in the scientific evidence, almost exclusively produced in the USA, Europe, the UK, and Canada, are quality, patient satisfaction, and safety. The impact of telemedicine in orthopedics has not yet been fully evaluated and studied in terms of the potential medicolegal concerns. Most of the authors performed qualitative studies with poor consistency. Authorizations and accreditations, protection of patient confidentiality, and professional responsibility are issues that will certainly soon emerge.

Italian Legal Euthanasia: Unconstitutionality of the Referendum and Analysis of the "Italian" Problem.

The term "euthanasia" refers to medical interventions that involve the direct administration of a lethal drug to the patient who requests it and meets certain requirements. Currently in Italy euthanasia constitutes a crime and falls within the hypotheses foreseen and punished by Article 579 (Murder of consenting person) or by article 580 (Instigation or aid to suicide) of the penal code. On the contrary, medically assisted suicide in some cases and the suspension of treatment constitute an inviolable right pursuant to art. Thirty two of the Constitution and Law 219/2017. Thanks to the sentence 242/2019 of the Constitutional Court, in Italy it is instead possible to request medically assisted suicide, that is, the indirect help of a doctor to die. There are four conditions required: whoever requests it must be fully capable of understanding and willing, must have an irreversible pathology that is the bearer of severe physical or mental disease, and must survive thanks to life-saving treatments. The Italian referendum "Free until the end" aims to introduce legal euthanasia through the partial repeal of art. 579 c.p. which punishes the murder of the consenting party. The authors analyze the reasons for the referendum in the light of the Italian and European scenario, analyzing the first Italian case of assisted suicide immediately after the referendum which inevitably becomes a starting point for ethical and medico-legal reflection on the issue. On 02.15.2022 the Italian Constitutional Court declared the Referendum on Legal Euthanasia inadmissible.

COVID-19 Vaccination in Italian Children: The Limits of Parental Rights.

SARS-CoV-2 vaccination campaigns initially targeted the adult population. After the authorization of the main agencies, including the EMA (European Medicines Agency), the European Vaccination Plan now involves young people between the ages of 12-17 and 5-11. In assessing the child's "best interests", the refusal of vaccination by parents or guardians, in addition to the increased circulation of the virus, is responsible for the risk of social distancing. This reduction in social contacts, particularly during very sensitive ages such as adolescence, has been linked to the increased incidence of psychiatric illness, a significant reason for extending vaccination against SARS-CoV-2 in these younger children. One may consider that government should issue a law that allows the child to decide on the vaccination plan, even without the consent of the parents or guardians, without the need for a judge's ruling. The availability of the child should be the point of reference, according to the National Bioethics Committee, for consent to vaccination. The authors investigate the subject in depth in order to counteract vaccination hesitation, and promote the dissemination of correct scientific information, using every different possible communication tool, as well as social networks and schools.

Informed consent and biological agents in rheumatology and internal medicine.

BACKGROUND: The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process. METHODS: The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures. RESULTS: No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off-label use of biological agents usually with no obvious attention to informed consent shortcomings. CONCLUSION: The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.

Reporting Incidents in the Psychiatric Intensive Care Unit: A Retrospective Study in an Italian University Hospital.

ABSTRACT: To evaluate the characteristics of the reported workplace violence in a psychiatric intensive care unit (PICU) by analyzing an electronic hospital incident reporting system (IRS). One hundred thirty reports were retrieved from January 2017 to June 2020, referring to assaults committed by patients (71% males) with an average age of 29.8 years (SD, 14.9). The most frequent psychiatric diagnosis was a neurodevelopmental disorder (33%). Physical aggression (84%) was more frequent than the other types of aggression. Nurses and unlicensed assistive personnel were the most frequent victims (65%). Aggressions were more frequent on Friday (18%) and between 4 p.m. and 8 p.m. (35%). A total of 64.9% of the incidents happened in the first 5 days of hospitalization. A significant association between physical aggression and diagnosis of neurodevelopmental disorder emerged. IRS could be helpful to identify high-risk patient groups and develop clinical strategies to reduce adverse events in clinical practice.

Cranio-Mandibular Disorders after Whiplash Injury: A Mono-Institutional Clinical Study on 31 Patients.

BACKGROUND: Whiplash is a consequence of traumatic injuries, mostly related to road accidents, with variable clinical manifestations, also known as Whiplash Associated Disorders, such as neck, head and temporo-cranio-mandibular pain. METHODS: The current study aims to evaluate the onset and evolution of temporomandibular joint pain in people with whiplash in a study group treated with the use of Zimmer Collars (adjustable rigid cervical collars for neck immobilization), as compared to a control group. This prospective study included 31 patients followed by the Dental Prosthesis Department of the University of Bari "Aldo Moro": 20 patients with whiplash (age range: 20-39 years) treated with Zimmer collars and 11 patients with whiplash (age range: 20-33 years) who were not. Immediately after the whiplash occurred, a visual analogue scale (VAS) was used to describe the intensity of pain and to complete the chart of the European Academy of Craniomandibular Disorders. Five out of twenty patients, already treated with a Zimmer collar, wore an occlusal splint as well because of persistent pain reported at the 28-day and 60-day follow-up and were supported by pharmacological therapy with analgesics (paracetamol) and muscle relaxants (thiocolchicoside). RESULTS: During the last follow-up (at six months), three out of five patients displayed a residual VAS score of 3, 4, and 5, respectively, while the remaining two displayed a VAS of 0. In the control group, four out of eleven patients needed to wear an occlusal splint but without muscle relaxants and analgesics pharmacological therapy; these four corresponded to the patients showing a residual painful symptomatology, with VAS reaching value of 2, and also were the oldest patients of the group. Data regarding VAS values and Zimmer collar use, both at the first visit and six months later, were statistically analyzed. CONCLUSION: Our prospective study highlights how whiplash-associated acute disorders are often self-limiting over a period of few months, thus reducing the possibility of symptom chronicity; the latter seems to be strictly related to lesion severity, pre-existence of a craniomandibular dysfunction and patient age, but appears to be independent from Zimmer collar use, as statistically confirmed.

Off-Label Use of Cardiovascular Drugs in the Home Therapy of Children With Congenital or Acquired Heart Disease.

Most medications are not labeled for use in the pediatric population because they have not been formally studied in children. Data on off-label use of cardiovascular (CV) drugs in the home therapy of children with CV disease are scanty. The study included 325 pediatric patients with CV disease and on ≥1 CV medication who underwent ≥1 visit during 2019 at the Pediatric Cardiology outpatient clinic of Giovanni XXIII Pediatric Hospital in Bari, Italy. A total of 287 patients (88.3%) received ≥1 off-label medication, whereas 113 patients (34.7%) received ≥2 off-label medications, and 22 patients (6.7%) ≥3 off-label medications. In CV medications (n = 27) 85% were used off-label in all cases, and 92.5% were used off-label in ≥50% of patients. Adverse events occurred in 8 patients, leading to drug discontinuation in 2 of them. In all 8 cases, medications were used off-label. In multivariate analysis, congenital heart disease patients with single-ventricle physiology (odds ratio 8.4, 95% confidence interval 2.25 to 54.4) and those with heart failure (odds ratio 2.0, 95% confidence interval 1.1 to 3.6) were at higher risk for receiving ≥2 off-label drugs. The off-label use of CV drugs in the home therapy of children with congenital or acquired heart disease is common and adverse events may occur. Patients with congenital heart disease with single-ventricle physiology and those with heart failure have a higher probability to receive ≥2 off-label medications. This study highlights the need for larger safety and efficacy trials in this specific cohort of pediatric patients.

Imaging Appropriateness in Pediatric Radiology during COVID-19 Pandemic: A Retrospective Comparison with No COVID-19 Period.

During the COVID-19 pandemic, the number of accesses to the Pediatric Emergency Department (pED) in Italy sharply decreased by 30%. The purpose of this study is to evaluate how this novel setting impacted on management of children with trauma, and the use and appropriateness of imaging studies in such patients at the pED. All imaging studies performed in patients with trauma at the pED of a tertiary children's Hospital during the first wave of the COVID-19 pandemic (between March and May 2020) were reviewed, in comparison with a control time interval (March to May 2019). In the pre-COVID control era, 669 imaging studies documented bone fractures in 145/568 children (25.5%). In the COVID-era, 79/177 (44.6%) pediatric patients showed bone fractures on 193 imaging studies. Comparative analysis shows a 71% decrease in imaging studies, and the proportion of negative imaging studies (with no evidence of bone fractures) dropped in 2020 by 19% compared to the 2019 control era (p < 0.001). The sharp decrease of negative studies suggests that the rate of appropriateness was higher during COVID-era, suggesting some attitude toward defensive medicine in the previous control year, as a result of some degree of imaging inappropriateness. The impact of a pandemic on emergency medicine may offer a unique opportunity to revisit diagnostic and therapeutic protocols in pediatrics.

Role and Tasks of the Occupational Physician during the COVID-19 Pandemic.

Background and Objectives: The first clusters of SARS-CoV-2 infection were identified in an occupational setting, and to date, a significant portion of the cases may result from occupational exposure; thus, COVID-19 should also be considered a new occupational risk that both directly and indirectly impacts the health of workers. Given the significance of occupational-exposure-related infections and deaths, this study aims to assess the roles and tasks of occupational physicians (OPs) in countering the spread of the infection. Indeed, despite the OP's centrality in risk management in the workplace, its activity in the current epidemic context has rarely been mentioned. Materials and Methods: Three different databases (PubMed, Google Scholar, and Embase) were questioned using the main keywords "COVID-19" and "SARS-CoV-2" that were crossed, according to different needs, with the terms "occupational medicine", "occupational physician", "workplace", and "risk assessment" using, when possible, the MeSH database research. Additionally, a systematic research of the regulatory changes of workplaces health surveillance was performed on reference sites of international, European, and Italian authorities. Results: Fundamental tasks and duties of OPs in the current COVID-19 outbreak are highlighted by examining their clinical activity and technical action. A risk assessment and management workflow is proposed, and medico-legal implications in case of infection at work are also discussed in the light of recent regulatory changes that clearly attribute to OPs an important role in safeguarding public health. Conclusion: The proposed approach can provide new instruments to contrast the spread of the infection as part of a comprehensive system response to the current pandemic, for which OPs are called to assume full responsibility.

Post-mortem persistence of SARS-CoV-2: a preliminary study.

Since the beginning of March 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has been the cause of millions of deaths worldwide. The need to better define the pathogenesis of coronavirus disease 19 (Covid-19) as well as to provide the correct statistical records concerning deaths related to this virus, inevitably involves the role of forensic pathology and routine autopsy practice. Currently, some data on macroscopic and microscopic features in autopsies performed in suspected Covid-19 cases are reported in the literature. The persistence of SARS-CoV-2 in cadavers has not yet been elucidated and only a few reports have emphasized the importance of evaluating the Virus RNA in post-mortem tissues. In this preliminary study, we observed that SARS-CoV-2 survives in multiple cadaver tissues many days after death despite some extreme conditions of post-mortem body preservation. The results of this on-going analysis could help improve the safety of working practices for pathologists as well as understanding the possible interaction between microbiological agents and the cadaver tissue's supravital reactions.

Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective.

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures.

The Diagnosis of Acute Myocarditis in Emergency (DAME) score: improving diagnostics within the emergency department.

PURPOSE: . The final diagnosis of myocarditis is challenging. The aim of our study was to provide the D.A.M.E. (Diagnosis of Acute Myocarditis in Emergency) Score for the fast identification of patients suffering from myocarditis at Emergency Department (ED). METHODS: . This was a multicenter, retrospective study involving three centers. All medical records from January 2010 to December 2014 reporting a final discharge diagnosis of myocarditis were considered. One hundred-four patients (mean age: 40.2±16.5 years) were enrolled. Clinical, biochemical and instrumental data were gathered. Data were analysed by means of logistic regression model and factorial analysis. A validation cohort from a fourth center was enrolled. RESULTS: . The final determinants of the DAME score were six: fever, chest pain, erythrocyte sedimentation rate (ESR) > 20 mm/h, C-reactive protein (hs-CRP) >3 mg/L, troponin serum levels >3 ng/L, and left ventricle ejection fraction < 50%. All of them received a specified score ranging from 0 to 4. A score > 4 was related to 75% probability of myocarditis; a final score ranging between 1 and 4 was related to 57% probability of myocarditis. ROC curve on the validation cohort (289 patients, 27 with myocarditis) demonstrated the best cut-off to be 7: AUC 0.958 (p< 0.001), sensibility: 100%, specificity: 85.11%, PPV: 40.9%, NPV: 100% (LR+: 6.72; LR-: 0.00). Logistic regression analysis revealed Odds Ratio equal to 2.83 (95% CI 1.90 - 4.20, p < 0.0001). CONCLUSIONS: . DAME score can offer a reliable tool in ED setting for the evaluation of patients suffering from suspected myocarditis.