Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation.

This article's authors delve into, and comment on, some of the key provisions within law no. 219, passed in 2017, which came into full effect in 2018. The legislation presents several innovative aspects: (a) communication time is equated to care; (b) patients may turn down lifesaving treatments, yet doctors must put in place all suitable support processes, from a psychological standpoint as well, in order to make sure that patients make informed decisions in full awareness; (c) refusal to treatment may be expressed prior to the onset of the disease making the patient incapable, as long as the advance directive is laid out by a mentally capable adult who has been provided with all relevant medical information available as to the consequence of a refusal to undergo a given treatment; (d) artificial nutrition and hydration are tantamount to treatment; thus, they may not be carried out and kept in place in absence of valid consent; (e) patients may appoint a healthcare proxy holder, tasked with interacting with doctors and caregivers and expressing consent or refusal; (f) patient will, whether current or advance, must be complied with even under emergency or urgency conditions, provided that clinical conditions and circumstances make it possible to acquire it; (g) doctors may disregard advance directives only when specifically provided for by the law; (h) patients may not demand treatment deemed to be illegal or running counter to ethical codes or scientific evidence. The new legislation, therefore, is meant to uphold the right to exercise self-determination as well as the patient's quality of life, yet ensuring that doctors remain fully capable of making the decisions that they are best positioned to. Summary: The Italian Parliament has for the first time regulated the issue of consent and refusal of healthcare treatments, whether currently expressed or advance. This article elaborates on recent Italian legislation that details a patient's right to consent to or refuse treatment in advance, including refusal of artificial nutrition and hydration, the duty of doctors in the event of an emergency, the shared planning treatment, the role of durable power of attorney, and advance healthcare directives.

Budget impact of implementing platelet pathogen reduction into the Italian blood transfusion system.

BACKGROUND: Despite improvements in blood donor selection and screening procedures, transfusion recipients can still develop complications related to infections by known and emerging pathogens. Pathogen reduction technologies (PRT) have been developed to reduce such risks. The present study, developed whithin a wider health technology assessment (HTA) process, was undertaken to estimate the costs of the continuing increase in the use of platelet PRT in Italy. MATERIALS AND METHODS: A multidisciplinary team was established to perform the HTA and conduct a budget impact analysis. Quantitative data on platelet use were derived from the 2015 national blood transfusion report and from the Italian Platelets Transfusion Assessment Study (IPTAS). The current national fee of 60 Euro per platelet PRT procedure was used to quantify the costs to the Italian National Health Service (INHS). The analysis adopts a 3-year time-frame. In order to identify the impact on budget we compared a scenario representing an increased use of PRT platelets over time with a control scenario in which standard platelets are used. RESULTS: Progressive implementation of PRT for 20%, 40% and 66% of annual adult platelet doses could generate an increase in annual costs for the INHS amounting to approximately 7, 14 and 23 million Euros, respectively. Use of kits and devices suitable for the treatment of multiple adult platelet doses in one PRT procedure could lower costs. DISCUSSION: In order to fully evaluate the societal perspective of implementing platelet PRT, the increase in costs must be balanced against the expected benefits (prevention of transfusion-transmissible infections, white cell inactivation, extension of platelet storage, discontinuation of pathogen detection testing). Further studies based on actual numbers of platelet transfusion complications and their societal cost at a local level are needed to see the full cost to benefit ratio of platelet PRT implementation in Italy, and to promote equal treatment for all citizens.

A review of illicit psychoactive drug use in elective surgery patients: Detection, effects, and policy.

Limited information is present in literature regarding detection of illicit drug users visiting physicians when planning elective surgery; also, there is no update manuscript that is illustrating the effects of illicit drugs use that require reconstructive surgery interventions. Aims of this manuscript are: 1) to summarize existing knowledge, and give surgeons information how to detect patients who might possible use illicit drugs; 2) to review the effects of illicit drug use that specifically require reconstructive surgery interventions; 3) to assess on existing policies on asymptomatic illicit drug users when planning elective surgery. Studies were identified by searching systematically in the electronic databases PubMed, Medline, The Cochrane Library and SveMed+. Because of the nature of research questions to be investigated (drug policy and surgery), a "systematic review" was not possible. In spite of some existing policies to detect illicit drug use in specific situations such as workplaces or acute trauma patients, there is a lack of data and lack of information, and subsequently no policy has ever been made, for detection and management of illicit drug use asymptomatic patients requesting or referred for plastic surgery interventions. This manuscript poses questions for further ethical evaluations and future policy.

A Proposed Road Map for the Ethical Evaluation of Sham (Placebo) Surgery.

OBJECTIVE: The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice. BACKGROUND: Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group. The use of sham surgery is controversial from an ethical point of view. METHODS: This evaluation system is set up according to ICH/GCP, World Medical Association Declaration of Helsinki, CONSORT 2010 standards. The proposed roadmap is based on the following 4 steps/levels: safety/clinical indications; adequacy of trial methodology/design adopted for a sham surgery CT; specific informed consent, and economic issues. RESULTS: A flowchart is proposed which can be used at two levels: as a basic guideline for the design of a surgical protocol representing a benchmark level of care; and a multiaxial assessment considering the first two sources of morality of human acts according to Aristotelian ethics: the object of the act (step 1) and some of its circumstances (steps 2-4). CONCLUSIONS: The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.

Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use.

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed.

”FOCUS ON PRACTICE”: CLINICAL ETHICS CONSULTATION ON AN ORTHOTOPIC LIVER TRANSPLANT CASE / "CENTRARSE EN LA PRÁCTICA": ÉTICA CLÍNICA DE CONSULTA EN UN CASO DE TRASPLANTE HEPÁTICO ORTOTÓPICO / "CENTRALIZAR-SE NA PRÁTICA": ETICA CLÍNICA DE CONSULTA NUM CASO DE TRANSPLANTE HEPÁTICO ORTOTÓPICO

The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the "Agostino Gemelli" School of Medicine of the Università Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient's prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery.

El artículo presenta un caso clínico, dirigido en el año 2011 por el equipo de servicio de consulta ética clínica del Instituto de Bioética y Humanidades Médicas de la Facultad "Agostino Gemelli" de Medicina de la Universidad Católica del Sacro Cuore en Roma (Italia). El caso clínico se refiere a los dilemas éticos sobre las perspectivas del paciente para recibir un trasplante hepático ortotópico porque no era residente del país y carecía de un cuidador para asistirlo durante el periodo de seguimiento, así como de un lugar para quedarse después de la cirugía.

Este artigo apresenta um caso clínico dirigido em 2011 pela equipe de serviço de consulta ética clínica do Instituto de Bioética e Humanidades Médicas da Faculdade de Medicina Agostino Gemelli, da Università Cattolica del Sacro Cuore (Roma, Itália). O caso clínico se refere aos dilemas éticos sobre as perspectivas da paciente para receber um transplante hepático ortotópico porque não era residente do país, carecia de um cuidador para assisti-la durante o período de observação e de um lugar para ficar depois da respectiva cirurgia.

[Pneumothorax following dry needling treatment: legal and ethical aspects]. / Pneumotorace successivo a trattamento riabilitativo con tecnica "dry needling": aspetti medico legali e etico-deontologici.

Trigger point "dry needling" is a technique used to treat myofascial pain. It involves using filiform needles which are inserted into muscles to give local pain relief. Few cases of serious adverse events following this treatment have been reported in the literature. In this paper we describe the case of a professional swimmer who developed pneumothorax after dry needling treatment and discuss the medicolegal and ethical aspects related to competencies and responsibilities of medical doctors and physiotherapists performing the procedure.

Evaluación de la investigación: El caso de la bioética académica italiana / Reserach evaluation: The case of Italian academic bioethics

Un nuevo sistema para evaluar los resultados de la investigación ha sido introducido en Italia, bajo la Ley nº 240 del 30 de Diciembre de 2010, la así llamada "Reforma Gelmini". Este sistema tiene su fundamento en la separación entre la evaluación de resultados de investigacion con referencia a las ciencias experimentales y la evaluación de resultados de investigación con referencia a las humanidades y ciencias sociales. La primera se basa en criterios bibliometricos, la segunda utiliza criterios no-bibliometricos. El artículo trata del impacto de este nuevo sistema en la bioetica academica italiana

A new system for evaluating production of research has been introduced in Italy by the Law of 30 December 2010 no. 240 (also called Gelmini’s Reform). This system is based on a strict distinction between the evaluation of "academic production" concerning "hard sciences" and evaluation of "academic production" concerning "humanities and social sciences". The first evaluation uses bibliometric criteria, while the second one uses non-bibliometric criteria. The article deals with the impact of this new system on Italian academic bioethics

Suicidal or homicidal sharp force injuries? A review and critical analysis of the heterogeneity in the forensic literature.

The differential diagnosis between self-inflicted and nonself-inflicted, suicidal and homicidal, injuries is difficult or impossible in many cases and, above all, cannot be made on the basis of information obtained solely from the autopsy or the medicolegal clinical examination. The purpose of this study is to analyze the literature on suicidal and homicidal sharp force injuries and identify the relevant parameters that may help differentiate between suicidal and homicidal deaths. To achieve this goal, a review of 595 potentially relevant articles was performed. After excluding the nonrelevant papers by screening the titles, all abstracts were reviewed, and articles meeting the inclusion criteria underwent a full-text review. The following parameters were compiled into a table: number of cases, localization of the injuries, and number of injuries. The data were statistically analyzed and compared with those available in the forensic literature. On the basis of the heterogeneity of data revealed by the present review, a simple and short checklist of the parameters that should be included when reporting suicides and homicides by sharp force has been proposed.

An unusual case showing fatal rupture of a gastric ulcer or gastromalacia? The importance/role of histology for differential diagnosis.

Gastromalacia is the acute autolytic erosion of the gastric wall. It generally occurs postmortem, and it appears as a slimy brownish black region of the wall which occurs principally in the gastric fundus. A 59-year-old woman died in the Emergency Department following a 2-day period of mild abdominal pain, vomiting, and diarrhea. A forensic autopsy was performed which revealed a rupture of the gastric fundus that had caused leakage of gastric content into the abdominal cavity. There was no macroscopic evidence of peritonitis, and the stomach wall adjacent to the rupture site showed marked thinning. The gross appearance was typical of gastromalacia. In contrast, histological observations revealed the presence of an ulcer at the site of perforation and a severe acute inflammatory reaction indicating a robust reaction with an antemortem rupture.

Ethical assessment of hepatitis C virus treatment: The lesson from first generation protease inhibitors.

Since chronic hepatitis C has mostly become curable, issues concerning choice and allocation of treatment are of major concern. We assessed the foremost ethical issues in hepatitis C virus therapy with 1st generation protease inhibitors using the personalist ethical framework within the health technology assessment methodology. Our aim was to identify values at stake/in conflict and to support both the physicians' choices in hepatitis C therapy and social (macro-) allocation decision-making. The ethical assessment indicates that: (1) safety/effectiveness profile of treatment is guaranteed if its use is restricted to the patients subgroups who may benefit from it; (2) patients should be carefully informed, particularly on treatment deferral, and widespread information on these therapies should be implemented; (3) since treatment was proven to be cost-effective, its use is acceptable respecting resource macro-allocation. Concerning individual (micro-) location criteria: (a) criteria for eligibility to treatment should be clearly identified and updated periodically; (b) information on criteria for eligibility/deferral to treatment for specific patients' subgroups should be made widely known. Interferon-based regimens will disappear from use within the next year, with the introduction of highly effective/tolerable combination regimens of direct-acting antivirals, thus profoundly changing social choices. Nonetheless, our model could support future ethical assessment since the evaluation pertaining ethical domains remains generally applicable.

Cerebral venous sinus thrombosis due to spontaneous, progressive, and retrograde jugular vein thrombosis causing sudden death in a young woman.

Cerebral venous sinus thrombosis (CVST) is a rare cerebrovascular condition that affects approximately 5 per 1 million people annually, and develops in 0.5% of all stroke patients. Herein we report a case involving a 31-year-old woman with CVST. She initially presented with a 2-month history of intermittent headaches at the nape of her neck with cervical pain. Other than these symptoms, she was in apparently good health and was a nonsmoker. She had no children and did not take contraceptives. She became comatose with unequal pupil size and CVST was diagnosed. An autopsy revealed CVST that extended from the confluence of the sinuses to the transverse sinuses and tip of the superior sagittal sinus, as well as a thrombus that obstructed the right internal jugular vein. A correct and early diagnosis of CVST combined with heparin-based therapy and/or interventional endovascular strategies may be of benefit by preventing intracerebral extension of jugular venous thrombosis and subsequent serious or even fatal neurological sequelae.

Research ethics committee auditing: the experience of a university hospital.

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.

Outlining ethical issues in nanotechnologies.

Nanotechnologies are an expression of the human ability to control and manipulate matter on a very small scale. Their use will enable an even and constant monitoring of human organisms, in a new and perhaps less invasive way. Debates at all levels--national, European and international--have pointed out the common difficulty of giving a complete, clear definition of nanotechnologies. This is primarily due to the variety of their components, to the fact that there is not just one technology but several. The most significant medical applications of nanotechnologies are in the diagnostic and the therapeutic fields, eg biosensors and molecular imaging, providing diagnosis and drug delivery with no invasive methods involved. Like any other emerging field, such technologies imply new possibilities for improving health but, on the other hand, they are still at an experimental stage and therefore should be implemented under rigorous safety testing before going on general release. For this purpose, the ethical, legal and social implications (ELSI) of nanotechnologies have been elaborated by study groups, in order to develop solutions before the results of the tests are diffused into medical practice. The aim of this paper is to define some of the ethical issues concerning biomedical applications and to evaluate whether there is a need for new or additional guidelines and regulations.