HCV spread among female incarcerated population and treatment pathways to viral elimination in Italian prison settings: clinical perspectives and medico legal aspects.

BACKGROUND: Hepatitis C virus (HCV) infection is more frequent among incarcerated people than in general population. In the DAAs era, the short schedules and the low risk of adverse reactions, increased the number of HCV treatments. However, the most part of literature reports lack of incarcerated women inclusion in studies on field. Our aim is to assess the screening execution, HCV prevalence, and DAAs treatment among incarcerated women. A focused insight on quick vs standard diagnosis and staging approach will be also provided. METHODS: Incarcerated women from 4 Italian regions' penitentiary institutes were included. HCV screening was executed with HCV saliva test (QuickOral Test®) or phlebotomy. Stage of liver fibrosis was evaluated with FIB-4 value or fibroscan®, based on physicians' decision. Treatment prescription followed national protocols. RESULTS: We included 156 women, 89 (57%) were Italian, mean age was 41 ± 10 years, and 28 (17.9%) were people who inject drugs (PWIDs). Overall, the HCV seroprevalence was 20.5%. Being PWID and on opioid substitution therapy (OST) were significantly associated with serological status (p-value < 0.001). Of them, the 75.5% of patients had active infection, the most frequent genotype was 3a (50%). Among them, 4 (16.6%) and 6 (25%) had psychosis or alcohol abuse history. The 62.5%, 25% and 12.5% had low, intermediate, and advanced fibrosis, respectively. Out of the 24 HCV-RNA positive patients, the 75% underwent to DAAs treatment. The sustained virological response (SVR12) was achieved in 88.8% of cases. When evaluating the influence of quick diagnosis and staging methods vs standard phlebotomy and fibroscan® on SVR12, FIB-4 use showed higher performance for retainment in treatment during prison staying (p = 0.015), while the use of quick saliva test had no influence on the outcome (p = 0.22). CONCLUSION: HCV seroprevalence and active infections are very high among incarcerated women. More tailored interventions should be focused on HCV diagnosis and treatment in female prison population. The use of quick staging methods (FIB-4) is useful to increase SVR12 achievement without delays caused by the fibroscan® awaiting.

Physician autonomy and patient rights: lessons from an enforced blood transfusion and the role of patient blood management.

This article provides an ethical and medico-legal analysis of ruling no. 465 of 30 May 2018 issued by the Court of Termini Imerese (Palermo) and confirmed on appeal on 11 November 2020, which, in the absence of similar historical precedents in Europe, convicted a medical doctor of a crime of violent assault for having ordered the administration of a blood transfusion to a patient specifically declining blood transfusion on religious grounds. We analyse the Court's decision regarding the identification of assault in performing the blood transfusion and its decision not to accept exculpatory urgent 'necessity' as a defence. In addition, we present an updated revision of the current standard of care in transfusion medicine as well as the ethical principles governing the patient's declining of transfusion. In doing so, we highlight that respect for the patient's self-determination in declining transfusions and respect for the professional autonomy of the doctor protecting the safety and life of the patient could be equally satisfied by applying the current peer-reviewed evidence.

Medico-legal assessment of personal damage in older people: report from a multidisciplinary consensus conference.

Ageing of the global population represents a challenge for national healthcare systems and healthcare professionals, including medico-legal experts, who assess personal damage in an increasing number of older people. Personal damage evaluation in older people is complex, and the scarcity of evidence is hindering the development of formal guidelines on the subject. The main objectives of the first multidisciplinary Consensus Conference on Medico-Legal Assessment of Personal Damage in Older People were to increase knowledge on the subject and establish standard procedures in this field. The conference, organized according to the guidelines issued by the Italian National Institute of Health (ISS), was held in Bologna (Italy) on June 8, 2019 with the support of national scientific societies, professional organizations, and stakeholders. The Scientific Technical Committee prepared 16 questions on 4 thematic areas: (1) differences in injury outcomes in older people compared to younger people and their relevance in personal damage assessment; (2) pre-existing status reconstruction and evaluation; (3) medico-legal examination procedures; (4) multidimensional assessment and scales. The Scientific Secretariat reviewed relevant literature and documents, rated their quality, and summarized evidence. During conference plenary public sessions, 4 pairs of experts reported on each thematic area. After the last session, a multidisciplinary Jury Panel (15 members) drafted the consensus statements. The present report describes Conference methods and results, including a summary of evidence supporting each statement, and areas requiring further investigation. The methodological recommendations issued during the Conference may be useful in several contexts of damage assessment, or to other medico-legal evaluation fields.

Patient blood management: The best approach to transfusion medicine risk management.

In advanced health systems it is increasingly important to offer effective medical services that have high quality and safety standards. We present an overview of the direct hazards and the indirect hazards associated with blood transfusions. Our aim is to focus on the potential medico-legal impacts of these hazards in the context of clinical risk management, incorporating the accumulating evidence from Patient Blood Management programs. The direct or deterministic hazards of transfusion refer to scenarios where the mechanisms for post transfusion damage are clearly traceable to the blood transfused in a 1:1 cause and effect manner. The indirect hazards can be defined as probabilistic and are associated with transfusion through epidemiological studies. The implementation of Patient Blood Management programs demonstrates that the use of a blood transfusion is not always necessary or unavoidable but can be considered modifiable. Review of the literature confirms that transfusion should not be the default option to manage anemia or blood loss. Instead, accumulating evidence demonstrates that a patient-centred, proactive approach to managing a patient's own blood is the new standard of care. It thus follows, an adverse transfusion event, where the transfusion was avoidable through the application of patient blood management, may constitute a profile for medical professional medical negligence. In an effort to maximise patient safety, transfusion medicine practice culture needs to shift towards a patient blood management approach, with hospitals implementing it as an important tool to minimize the risks of allogeneic blood transfusion.

Patient blood management implementation in light of new Italian laws on patient's safety.

The present work aims to analyze the impact - from legal and medical perspective - of the recent Italian legislative provisions on the subject of healthcare safety, and how these affect current transfusion practices, also in light of the accumulation of evidence deriving from the implementation of the Patient Blood Management (PBM) program. The scientific evidence shows that PBM is a bundle of care that improves patient outcomes including mortality and morbidity, improves the quality of life of patients and the population, reduces healthcare costs and decreases consumption of blood components. These aspects should be largely sufficient to carry out an urgent implementation of PBM in Italian hospitals. However, it is now also possible to indicate a further incentive for implementation which is made up of medico-legal aspects and is characterized by the need to decrease the intrinsic risks of the use of blood products so as to protect doctors and hospitals from possible future medico-legal disputes regarding adverse transfusion events that could be effectively avoided.

Is the Italian consent to transfusion really informed? A medico-legal analysis between old ghosts and new evidence.

In healthcare systems of developed countries, obtaining informed consent is a necessary and fundamental requirement for the administration of any medical treatment. In Italy, for the administration of the recipient's informed consent for a blood transfusion, a pre-printed form is used in line with the Decree of the Ministry of Health dated 2 November 2015. This paper aims to analyse this form in light of the European legal provisions and following the enactment of Italian Law No. 219 of 2017 on informed consent and advance treatment directives. Our review shows that the structure of the form can be improved in light of the new direction provided by Italian law, the scientific advancement on transfusion risks, and the potential to reduce the use of blood components. Revising this form could be the opportune time to include written information on Patient Blood Management strategies. Though not exhaustive, this proposal may stimulate debate on the point and produce further contributions.

The contribution of legal medicine in clinical risk management.

BACKGROUND: In advanced health services, a main objective is to promote the culture of safety and clinical risk management. In this regard, the reporting of sentinel events fits within a perspective of error analysis, attempting to propose solutions aimed at preventing a new occurrence of the harmful event. The purpose of this study is to analyze the contribution of medico-legal litigation in the management of clinical risk and to propose an organizational model so as to coordinate the intervention of clinical risk management and medico-legal services. METHODS: Retrospective review of 206 cases of medico-legal litigation, settled against a Hospital of a North-eastern city in Italy from January 1, 2014 and December 31, 2015. RESULTS: Approximately 20% of cases, that are classifiable as "sentinel events", were not reported due to various factors. The reason that these events are under-reported is mainly due to the latency between the event itself and its manifestation as a serious damage to health as well as the discomfort in reporting the events of this kind, which is still widespread among healthcare workers. The systematic research of the available documentation for medico-legal purposes permits the acquisition of more information concerning the clinical event, thereby increasing the number and accuracy of the reports to the clinical risk unit. CONCLUSION: The analysis of medico-legal litigation is a valid tool to enhance the reporting of "sentinel events". One possible proposal is the implementation of an organizational model to establish a rapid procedure for the reporting of sentinel events during the evaluation of medico-legal litigations.

Shortage of plasma-derived medicinal products: what is next? narrative literature review on its causes and counteracting policies in Italy.

Introduction: This paper describes the peculiarities of the plasma-derived medicinal product (PDMP) market and illustrates the results of a review of the literature on policies aimed at counteracting the shortage of PDMPs. Characteristics of PDMPs: Plasma is primarily used for the industrial production of blood products (80%). The demand for PDMPs, particularly immunoglobulins (IGs), is increasing. However, the production of PDMPs is complex, long (7-12 months), and expensive, accounting, according to US estimates, for 57% of the total costs of PDMPs compared to 14% for small molecules. PDMP market: Unexpected increases in clinical need cannot be addressed in the short term. Once the demand for some diseases is satisfied, the collection and fractionation of plasma will only be used to supply some specific patients. Hence, the full weight of the marginal costs, which remain constant, are borne by a few products. According to last liter economics, the industry stops producing when the marginal revenue equals the marginal cost, thereby reducing the convenience of producing the most commonly used PDMPs (albumin and IG). The imbalance between the demand and supply of PDMPs was exacerbated by the COVID-19 pandemic, which further increased the cost of plasma collection. Shortage issue and possible solutions: Policies to counteract this imbalance have also been discussed. If the demand is inappropriate, it should be reduced. If the demand is appropriate and supply cannot be increased, the demand should be prioritized for patients for whom PDMPs are the only available treatment. If the shortage depends on insufficient supply and technical and allocative efficiency, both production and supply should be improved, together with incentives for all stakeholders involved in the PDMP market to increase the sustainability of production/supply. The paper is focused on this second issue, that is supply-driven unbalance.

[Medico-legal and management issues in patient blood management era.] / Aspetti medico-legali e organizzativi nell'era del Patient blood management.

In recent decades, the approach to blood transfusion has changed radically around the world. In the past, transfusion represented the only solution for anemia, today the paradigm has changed: through the implementation of the Patient blood management (Pbm) program it is possible to manage the patient's own blood in order to reduce and, in many cases, eliminate the administration of blood components for transfusion. This approach increases patient safety by reducing clinical risks as well as costs. The implementation of the PBM program in Australia has demonstrated that the use of blood is not strictly necessary but, on the contrary, is largely avoidable. Through change management the traditional attitude of doctors and healthcare facilities can be modified. Law no. 24/2017 focuses on the safety of care by encouraging the necessary implementation of Pbm in hospital settings; the failure to adopt an organized Pbm program may constitute, in the event of an adverse transfusion event, a clear profile of health responsibility on the part of the management and clinicians.

Women Living with HIV in Italian Prison Settings: Results from the Gender-Specific ROSE Network.

BACKGROUND: Incarcerated women are a minority in the Italian prison population. The lack of prevention and awareness of HIV infection and the lack of access to treatment make the treatment path difficult. METHODS: we conducted a multi-center study including incarcerated women living with HIV (WLWH). RESULTS: The study included 85 WLWH with a mean age of 41.7 ± 8.7 years, and 58.8% (50/85) of them were Italian. Principally, HIV transmission was related to sexual intercourse, 47% of all patients were PWIDs, and 62.5% of them were on opioid substitution therapy (OST). Overall, 56.4% of the included patients had a CD4+ cell count of >500 cells/mmc. Among the participants, 92.9% were on antiretroviral therapy, 87.3% had treatment before incarceration, and 83.5% were virologically suppressed. Among the 13 non-virally-suppressed patients, 53.8% were unaware of their serological status before incarceration and had started HAART but were still not virologically suppressed; 46.2% (6/13) had a lack of compliance or had suspended the treatment before incarceration and restarted it after admission. All patients with chronic hepatitis C underwent treatment with direct-acting antivirals and reached a sustained virological response. CONCLUSIONS: the detention of these women could represent an occasion for the patients' healthcare provision and use, and the creation of a gender-specific network can be an effective strategy for reaching this population.

Guiding Principles for Surgical Pathways: A Tool for Improving Outcomes and Patient Safety.

Surgical activity is an important aspect for the management of health and safety processes and from an organizational perspective is one of the most complex activities performed in hospitals. It is often a defining and high value feature for any healthcare facility while being one of the most high-risk procedures for patients with the highest number of avoidable adverse events. To ensure effective management of surgical pathways, they need to be considered from the perspective of clinical governance which takes a global approach to planning and management with the goal of improving safety and quality for patients. This paper contains the main features of this objective outlined within the document issued subsequent to the State-Regional Italian Government conference. This regulatory effort includes effective recommendations to make surgical pathways safer and more efficient with particular reference to lean management, patient blood management and patient safety.

Health and Economic Impact of Atrial Fibrillation of Workers in Italy: Social Security Benefits.

BACKGROUND: The aim of this research was to analyze trends in social security applications in Italy as a result of the onset of atrial fibrillation, analyzing data pertaining to the classification of professions and assessing the economic impact on the social security system. METHODS: We analyzed all applications for invalidity allowances and invalidity pensions throughout Italy over a 10-year period from 01.01.2009 to 31.12.2019, giving specific attention to all reports indicating atrial fibrillation as the principal diagnosis (Cod. ICD-9-CM 427.31). We then extracted the relative expenditure data for said benefits. The results of all analyses have been collated in tables. RESULTS: Over the period in question, a total of 3468 applications for assistance were filed throughout Italy indicating a diagnosis of atrial fibrillation, of which 58% were rejected, 41% qualified for an invalidity allowance, and only 1.1% qualified for a pension. On average, every year, 1100 workers received social security benefits as a result of a diagnosis of atrial fibrillation, which equates to an average annual expenditure of EUR 10 million. A comparison of the data from the first observation year (2009) with data from the last (2019) shows a rising trend in the number of beneficiaries and consequently in expenses. CONCLUSIONS: The social security assistance provided by the Italian government by means of the National Institute of Social Security is fundamental to social cohesion and to those who are either permanently disabled from working or those with a significantly diminished earning capacity. This assistance is associated with a significant financial cost, which requires careful monitoring.

Protection of Prisoners with Mental Health Disorders in Italy: Lights and Shadows after the Abolition of Judicial Psychiatric Hospitals.

In Italy, a person suffering from a mental disorder who commits a crime will be given a custodial security order and serve the period of admission at a Residenza per la esecuzione delle misure di sicurezza (REMS) (Residence for the Execution of Security Measures, hereinafter "REMS"). These institutions have been established recently and though equipped with the necessary safety measures, the focus is on psychiatric therapy. Despite being present on a national scale, access is very limited in terms of capacity. Immediate remedial measures are needed, so much so that the European Court of Human Rights recently condemned Italy for this very reason. This article, through a review of the constitutive principles of these institutions, shows how they have very positive aspects such as the attention to necessary psychotherapy in order to protect the right to health and the real taking charge of the fragility of the subjects; however, it is seen how there are many negative aspects linked above all to the scarce availability of places in these structures. The article provides suggestions on a more comprehensive strategy for facilities for detainees with mental disorders.

Main Predictors of COVID-19 Vaccination Uptake among Italian Healthcare Workers in Relation to Variable Degrees of Hesitancy: Result from a Cross-Sectional Online Survey.

Background: Hesitancy remains one of the major hurdles to vaccination, regardless of the fact that vaccines are indisputable preventive measures against many infectious diseases. Nevertheless, vaccine hesitancy or refusal is a growing phenomenon in the general population as well as among healthcare workers (HCWs). Many different factors can contribute to hesitancy to COVID-19 vaccination in the HCWs population, including socio-demographic characteristics (female gender, low socio-economical status, lower age), individual beliefs regarding vaccine efficacy and safety, as well as other factors (occupation, knowledge about COVID-19, etc.). Understanding the determinants of accepting or refusing the COVID-19 vaccination is crucial to plan specific interventions in order to increase the rate of vaccine coverage among health care workers. Methods: We conducted a cross-sectional online survey on HCWs in seventeen Italian regions, between 30 June and 4 July 2021, in order to collect information about potential factors related to vaccine acceptance and hesitancy. Results: We found an overall vaccine uptake rate of 96.4% in our sample. Acceptance was significantly related to job task, with physicians showing the highest rate of uptake compared to other occupations. At univariate analysis, the HCWs population's vaccine hesitancy was significantly positively associated with fear of vaccination side effects (p < 0.01), and negatively related to confidence in the safety and efficacy of the vaccine (p < 0.01). Through multivariate analysis, we found that only the fear of possible vaccination side effects (OR: 4.631, p < 0.01) and the confidence in vaccine safety and effectiveness (OR: 0.35 p < 0.05) remained significantly associated with hesitancy. Conclusion: Action to improve operator confidence in the efficacy and safety of the vaccine should improve the acceptance rate among operators.

The potential lethality of caput medusae.

While gastro-oesophageal varices commonly complicate portal hypertension and may be a life-threatening condition, fatal haemorrhaging from cirrhosis-related caput medusae has seldom been described in the scientific literature. This article documents a rare death due to the rupture of a varix in the umbilical area. This case raises a number of points for medico-legal discussion, such as the negative consequences of an erroneous cause of death in evaluating medical malpractice cases and the importance of a thorough external examination of the body in order to ensure this type of vascular lesion is not overlooked.

Proposal for the Application of a Quality Indicator to Medico-legal Consultations in the Field of Medical Liability.

INTRODUCTION: In recent decades, the number of professional liability disputes has increased, especially in the civil sector. In these liability assessments, medico-legal experts have become the linchpin. Law No. 24/2017, concerning professional liability in Italy, requires that guidelines and best practices be established to identify the necessary elements for writing expert reports in the legal sector. MATERIALS AND METHODS: The authors have created a numerical indicator to be applied to 150 legal expert reports on professional liability, enabling them to evaluate the methodological quality of those reports. The results are then compared with the outcome of the legal proceedings in order to establish the suitability of this quality index for evaluating the work of medico-legal experts. RESULTS: Of the 150 reports considered, 14 were scored inadequate, 75 adequate and 31 good. These inadequate (according to the indicator) reports presented a higher probability of being scored inadequate in court proceedings, compared to the risk of inadequacy of all the reports; OR 4.6 (95% CI 1.25-16.90). This probability significantly increased on comparing the inadequate reports with the adequate; OR 5.6 (95% CI 1.28-24.41), and the inadequate with the good; OR 7.73 (95% CI 1.50- 39.87). DISCUSSION: Application of the proposed indicator is simple and produces a high-quality result, thus ensuring an accurate and tenable appraisal of methodological quality. CONCLUSION: The indicator proposed serves as a useful starting point for creating the necessary methodological standards for medico-legal experts in the field of professional liability as recommended by Law No. 24/2017.

Seventeen-Year Medical Professional Liability Experience in a Level III University Hospital.

INTRODUCTION: In recent decades, the number of medical professional liability disputes has grown exponentially, becoming a well-studied aspect of public healthcare. Legal medicine is an essential tool in managing this phenomenon. METHODS: This article reports the results of the analysis of disputes for medical professional liability in a Level III University Hospital in Italy. The study covers the time period from 01.01.2003 to 31.12.2019. RESULTS: About 33% of claims have been compensated. Those claims fall within the following categories: 37% in the surgical field, 17% in the field of internal medicine, and 35% in the emergency care field. As for the types of a medical mistake, compensation was awarded in 30% of diagnostic error cases, 26% of therapeutic error cases, 47% of execution error cases, and 55% of organizational deficiency cases. DISCUSSION: The difference in the rate of compensation between the various medical fields or types of error depends on specific medico-legal characteristics. The aim of advanced healthcare systems is to prevent medical liability disputes by analyzing this phenomenon and improving clinical risk management programs. In particular, according to our study, events related to organizational deficiencies are the most preventable. In addition, through the use of a dedicated reporting procedure, medico-legal analysis of malpractice cases may be the key to risk reduction. CONCLUSION: Every major hospital should set up a medico-legal watchdog responsible for collecting and analyzing information on professional medical liability disputes in order to prevent and manage such events.

Organizational Strategies for the Management of Intravenous Iron Therapy in Non-Hospitalized Settings: A Safe Opportunity to Implement Patient Blood Management in Italy.

This article analyzes the recommendations issued by the Emilia Romagna region in July 2020 on "Organizational strategies for the safe management of intravenous iron therapy in patients in non-hospitalized settings". The objective of these recommendations is to set up safe intravenous iron administration sites outside the hospital environment across the national territory. The document facilitates the organization of methods for intravenous iron infusion that are safe for the patient and correct from a medico-legal perspective. In addition, it opens the way for the widespread use of iron infusion in the field, providing benefits to patient quality of life. This program prevents unnecessary transfusions, reduces costs, prevents overcrowding in hospitals in the event of a pandemic, and enables patient treatment in the field, thus, saving on the use of personnel.

Pharmacological Abortion in a Pandemic: An Italian Medico-Legal Perspective.

The limitations caused by the spread of the SARS-CoV2 virus have had repercussions on the voluntary termination of pregnancy. During the pandemic, Italy issued updated guidelines regarding voluntary termination of pregnancy by means of mifepristone and prostaglandin. This included news concerning the time limit and location in which this procedure could be accessed: updates partially recognize women's needs, and they are into line with the European parliament's recent exhortations. However, these updates do not change the previously provided responsibilities that lie with doctors. This article aimed to compare regulations concerning medical abortion in Italy and other countries, with a focus on recent Italian updates in the context of pandemic.

Health in Prison: Does Penitentiary Medicine in Italy Still Exist?

Despite the detailed legislative developments that have occurred within the context of prison medicine in Italy, problems of a management nature continue to affect prisoner health and management, which in turn impact the prison system's ability to offer prisoners a real opportunity for rehabilitation. Certain behavioral aspects reported in prisons may alter and negatively impact the normal doctor-patient relationship, including elements that hinder the therapeutic alliance and impede proper clinical risk prevention and management. However, practical steps may be taken in connection with the analysis of flows and healthcare services that may enable prison administrations to bring about a true, modern restructure of the prison system.