Comparative study on informed consent regulation in health care among Italy, France, United Kingdom, Nordic Countries, Germany, and Spain.

The information and subsequent expression of will, so-called informed consent, have become the essential element of health right, understood as the right to autonomous choice in health, based on the fiduciary relationship between physician and patient. This gradually leads European Countries to adopt special legislations and to issue frequent judgments on the subject. However, new challenges in daily clinical practice call for further study of legal solutions. The authors analyse and compare the regulations on informed consent in health care of Italy, France, the United Kingdom, the Nordic Countries, Germany, and Spain. The health and legal contexts, existence of special regulations on informed consent and their characteristics are discussed. Informed consent resulted a mandatory requirement. Clear communication about treatment, therapeutic alternatives, and major risks, discussed in conversation, but preferably documented in writing, are agreed upon. The possibility of dissent and withdrawal of consent are also included. There is a growing interest in involving and regulating the entire health team in information and consent. Lowering the age of consent for minors or analysing the maturity of minors are attempts to increase their participation in health decisions. On another side, the protection of adult incapables persons requires greater involvement of family and fiduciaries to better adapt to changing health needs. Health policy must take responsibility for training health professionals and citizens about the value of health information and communication as a shared choice in care planning, to strengthen the bond of trust with the healthcare system and users.

Lipschütz ulcers due to SARS-CoV-2 infection: a neglected diagnosis in emergency room.

Background: Primary acute genital ulcers, or Lipschütz ulcers (LU), are nonsexually transmitted, painful, self-limiting, nonrecurrent vulvar ulcers with unclear pathogenesis, representing a challenging diagnosis in emergency setting. LU have recently been described in association with severe acute respiratory syndrome coronaVirus 2 (SARS-CoV-2) infection and vaccination. Objective: The aim of this study is to describe 2 cases of LU due to SARS-CoV-2 infection, highlighting the diagnostic process, differential diagnosis, disease course, and management options. Methods: We describe 2 young females (12 and 9 years old) who presented to pediatric emergency room with the sudden onset of well-demarcated, painful, vulvar ulcers with fibrinous necrotic center. Results: Both patients tested positive to SARS-CoV-2 nasal swab, and, at physical examination, no other lesions were found in other cutaneous or mucosal sites. Sexual abuse was excluded in both cases, as well as infectious and autoimmune diseases. Supportive analgesic therapy was administered, and complete remission of lesions was observed at follow-up visits without evidence of scarring. Limitations: The main limitation of this work is represented by the small number of cases described. Conclusion: Even though extremely rare, LU related to COVID-19 are an emerging entity to be considered in the diagnosis of acute genital ulcerations. Multidisciplinary diagnostic workup of genital ulcers must be established in order to exclude sexual child abuse, to ensure patient safety, and to avoid unnecessary treatment and familial anxiety.

Healthcare-Associated-Infections: preliminary results from a real-time reporting system of an Italian neurologic research hospital.

Background: Healthcare-Associated-Infections are a critical concern in healthcare settings, posing serious threats to patient safety and causing significant morbidity, mortality, and financial strain. This study aims to calculate healthcare-associated-infections trends in the hospital setting through an automatic reporting system. Study design: The study is a descriptive analysis of automatically generated trends of an innovative digital tool based on existing hospital information flows. Methods: An algorithm was developed within a Clinical Information System to create a suite of quality indicators for monitoring healthcare-associated-infections trends. The algorithm used criteria related to admission, laboratory tests and antimicrobial administrations. A descriptive analysis was conducted for patients aged 18 or older, admitted to a neurological or to a neuro-rehabilitation department of a neurologic hospital from 2019 to 2022. Results: The results showed fluctuations in healthcare-associated-infections prevalence from 2.9% to 5.6% and hospital infec-tions prevalence from 4.5% to 10.9%, with notable increases in 2020 and 2021. The majority (70.3%) of healthcare associated infections identified by the tool were confirmed to be potentially hospital-acquired, according to the European Centre of Disease Prevention and Control's definition. Discussion and Conclusions: The study posits the algorithm as a vital tool for automatically monitoring hospital infections, providing valuable preliminary results for improving care quality and guiding the infections' prevention and control strategies, with plans to benchmark the algorithm against a gold standard in the future.

Preventing Healthcare-Associated Infections: Hand Disinfection Monitoring Using an Automated System in an Italian Neurological Hospital.

Hand hygiene plays a pivotal role in preventing Healthcare-Associated Infections (HAIs). Nevertheless, the quality of hand disinfection techniques remains suboptimal, and the reliability of assessment methodologies is notably lacking. This study aimed to evaluate hand disinfection techniques using an automated system in an Italian research hospital. Hospital employees underwent automated hand-disinfection technique assessment, according to the World Health Organization's six-step protocol, at a basal time and two further times. Detection was carried out with a scanner that evaluated the effective hand disinfectant coverage through a fluorescent dye present in the hydro-alcoholic gel rub. The hand-hygiene technique of 222 employees was analyzed by HandInScan®. At the initial assessment of hand coverage with the hydro-alcoholic gel, the mean palm coverage was 82.2%, mean back coverage was 66.8%, and overall mean hand coverage was 74.5%. Then, two measurements were performed in June (t1) and December 2022 (t2). The third measurement showed an increase in hand coverage, with a mean palm coverage of 97.2%, a mean back coverage of 91.8%, and a mean hand coverage of 94.5% (p < 0.05). Moreover, the mean coverage of the hand-back was lower than that of the hand-palm at all times (p < 0.001). The automated scanner provided evidence supporting its effectiveness in enhancing hand hygiene among hospital employees. These findings have motivated researchers to conduct long-term studies, given the potential effects on HAI prevention-including their impact on HAI trends.

Survey on health students' knowledge and perception on body donation for scientific research, education, and training after specific Italian law no. 10/2020.

BACKGROUND: Practicing on the human body was considered extremely relevant for health professionals' education, but a drastic reduction was observed due to an increase in alternative virtual and multimedia means, and, in Italy, also due to a lack of regulation. Italian Law 10/2020 regulates body donation for research and training through an advanced directive for post-mortem body donation. METHODS: A cross-sectional study was carried out to investigate the law knowledge and body donation perception of health students of any degree courses enrolled at the University of Pavia, Italy, in 2021, through ad hoc web questionnaire. RESULTS: 485 students participated to this survey; median age was of 21 years (25th-75th percentiles, 20-23), 73.2% were females, and 62.5% were medical students. Among them 14.9% knew the Italian law 10/2020. Age was the only variable associated with students' knowledge of the law. Further, 8.3% reported the current availability of cadaveric practice, 85.6% of health students acknowledged usefulness of cadaveric practice, with a significant difference between medical and non-medical students (71.4% vs 28.6%, p < 0.001). Overall, 59.7% would donate their body, rising to 62.7% with reference to specific law regulation, with 30.5% and 28.7% undecided, respectively. 51.3% of participants answered not practicing religious faith, 82.9% with Catholic families, without significance on the knowledge of the law. CONCLUSIONS: Poor knowledge of the law compared with great interest and acknowledged cadaveric practice usefulness highlighted the need for better information, especially among health students, where critical discussion could be more valuable. Then, there arises the urgent need to fill the gaps within university studies and syllabuses, to relaunch the central role that cadaveric practice and research had in the education of health professionals. Consequences on basic and specific health students' skills, on health education quality in general, and further on health professionals' expertise must be carefully considered.

Healthcare-acquired Sars-Cov-2 infection: A viable legal category?

In the context of the Sars-Cov-2 pandemic, according to the various periods of emergency and the rate of infections, hospitalized subjects also contracted the infection within the ward, sometimes with the development of disease (COVID-19) and sometimes with permanent damage. The authors wondered if Sars-Cov-2 infection should be considered on a par with other infections acquired in the healthcare setting. The non-diversified diffusion between the health and non-health sectors, the ubiquity of the virus and the high contagiousness, together with the factual inability to prevent it by the health structures, despite the adoption of entry control, practices of isolation of positive subjects, and staff surveillance, lead to consider COVID-19 in a different way, in order to otherwise burden health structures in the face of unmanageable risks, clearly also dependent on exogenous and uncontrollable factors. The guarantee of care safety must, in the pandemic, be able to compare with the real capacity for intervention according to the asset of the current health service, requesting State intervention with alternative instruments, such as una tantum compensation, for COVID-19 damage reparation occurred in the health sector.

New Synthetic Cathinones and Phenylethylamine Derivatives Analysis in Hair: A Review.

The analysis of psychoactive substances in hair is of great importance for both clinical and forensic toxicologists since it allows one to evaluate past and continuative exposure to xenobiotics. In particular, a new challenge is represented by new psychoactive substances: Among this new class of drugs of abuse, synthetic cathinone and phenethylamine derivatives are often detected in biological samples. Hence, there is a growing need to develop new analytical procedures or improve old ones in order to conduct evaluations of these emerging substances. This study is a systematic review of all the instrumental and experimental data available in the literature. A total of 32 articles were included in the review. Acidic solvents proved to be the most reliable solutions for extraction. Gas chromatography and liquid chromatography coupled to tandem mass spectrometric and high-resolution mass spectrometric systems represent the majority of the involved instrumental techniques. Sensitivity must be maintained at the pg/mg level to detect any occurrences up to occasional consumption. In total, 23 out of 32 articles reported real positive samples. The most frequently detected substance in hair was mephedrone, followed by butylone, methylone, MDPV, and α-pyrrolidinophenone-type substances.

New insights on fibrodysplasia ossificans progressiva: discussion of an autoptic case report and brief literature review.

Fibrodysplasia ossificans progressiva (FOP) is a rare genetic condition with soft tissue progressive ossification, leading to severe disability. We describe a 27-years-old female affected by FOP who died after a fall. An autopsy was performed. Upper and lower extremities resulted in fixed flexion, with kyphoscoliosis of the spine and chest wall deformity. Moreover, a cranial fracture was pointed out. At histology, atypical abundance of corpora amylacea in gray matter was observed. In a sample of macroscopically non-affected muscular tissue, small areas with necrosis of myocytes and hyperplasia of fibroblasts were seen in light microscopy, with intracellular inorganic dystrophic inclusions in transmission electron microscopy. Thyroid gland histology showed diffuse lymphocytic infiltration. Postmortem examination of FOP patients provided precious information about involvement of other tissues, suggesting an initial and widespread inflammatory/dystrophic phase, to be further investigated, because it might reveal new insights about a FOP mutation cascade.

Psoriasis and Diabetes, a Dangerous Association: Evaluation of Insulin Resistance, Lipid Abnormalities, and Cardiovascular Risk Biomarkers.

Aims: Psoriasis is an immune-mediated dermatosis with cardio-metabolic comorbidities. The aim of this study was to assess insulin-resistance, lipid abnormalities, and cardiovascular risk biomarkers in psoriatic patients with or without type 2 diabetes mellitus (T2DM). Methods and materials: We enrolled 425 patients: 86 psoriatics, 69 psoriatics with T2DM, 120 T2DM patients, and 150 healthy subjects. We measured the Psoriasis Area and Severity Index (PASI), body mass index (BMI), insulin-resistance parameters [glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI), and with homeostasis model assessment index (HOMA index)], lipidic panel, plasminogen activator inhibitor-1 (PAI-1), homocysteine, soluble adhesion molecules, matrix metalloproteinase, and adipocytokines. Results: FPG, HbA1c, and HOMA-IR were higher in diabetics with psoriasis (p < 0.0001) than in psoriatics. FPI levels were higher in diabetics with psoriasis than in diabetics and psoriatics (p < 0.0001), and higher in psoriatics than controls (p < 0.0001). Psoriatics and diabetics with psoriasis showed higher triglyceride and LDL-C levels (p < 0.0001) than diabetics. Homocysteine was higher in psoriatics and diabetics with psoriasis (p < 0.0001) than in diabetics. PAI-1 was higher in diabetics with psoriasis than diabetics (p < 0.01). sICAM-1 and sVCAM-1 were higher in diabetics with psoriasis than diabetics (p < 0.001 and p < 0.01) and psoriatics (p < 0.001 and p < 0.0001). Visfatin and resistin were lower in psoriatics (p < 0.0001) and in diabetics with psoriasis (p < 0.001 and p < 0.0001, respectively) than diabetics. Conclusions: A limitation of this study is that there is a significant difference in mean age between controls and other study groups: the lack of matching between case and control groups may interfere with the external validity of the study findings. Despite this, the study highlights a pathogenetic link between psoriasis, considered a pre-diabetic condition, and diabetes. Insulin-resistance seems to be the keystone of psoriasis comorbidities. Psoriasis reinforces diabetes, causing a greater cardiometabolic risk.

Neuropathological Alzheimer's Disease Lesions in Nasu-Hakola Disease with TREM2 Mutation: Atypical Distribution of Neurofibrillary Changes.

Nasu-Hakola disease is a rare autosomal recessive disorder associated to mutations in TREM2 and DAP12 genes, neuropathologically characterized by leukoencephalopathy with axonal spheroids. We report the neuropathologic findings of a 51-year-old female with a homozygous mutation (Q33X) of TREM2 gene. Beside severe cerebral atrophy and hallmarks of Nasu-Hakola disease, significant Alzheimer's disease lesions were present. Neurofibrillary changes showed an atypical topographic distribution being severe at spots in the neocortex while sparing the mesial temporal structures. Our finding suggests that TREM2 genetic defects may favor Alzheimer's disease pathology with neurofibrillary changes not following the hierarchical staging of cortical involvement identified by Braak.

Sézary Syndrome: a clinico-pathological study of 9 cases.

BACKGROUND: Sézary Syndrome (SS) is a rare and aggressive variant of cutaneous T-cell lymphoma characterized by erythroderma, generalized lymphadenopathy and atypical lymphocytes in peripheral blood. The aim of the study is to describe our experience with SS patients. METHODS: Nine SS patients were retrospectively identified within 288 patients with cutaneous T-cell lymphomas (CTCLs) followed from 1977 to 2017 in the Unit of Dermatology, IRCCS Policlinico San Matteo Foundation, Pavia, Italy. RESULTS: Nine SS patients were described: 5 males and 4 females, mean age at diagnosis 66.1 years (49-87 y), overall survival (OS) after SS diagnosis was 2.6 years (31.5 ms). All the patients showed erythroderma, pruritus and lymphadenopathy. Palmo-plantar hyperkeratosis, nail lesions, alopecia and ectropion were also present. One patient was excluded for significative differences in management. Three lines treatment -extracorporeal photopheresis plus immunomodulator/s plus photo-photochemotherapy- was the most used first-line option for induction of remission, reached in 4 patients out of 8: 3 with Complete Remission (CR), 1 with Partial Remission (PR). Prognostic variables were investigated by univariate analysis: hypereosinophilia, highly elevated ß2µglobulin >3500 µg/L, male sex and highly elevated LDH>450 U/L resulted with statistical power. CONCLUSIONS: The improved comprehension of SS pathogenesis is progressively increasing the still poor survival: 38.5 months (3.2 years) considering only the 6 patients followed in the last five years, versus overall 31.5 months (2.6 years). The correct identification of SS patients remains determinant for the proper overall management. Among unfavorable prognostic markers, levels of ß2µglobulin allow stratification of patients.

Psoriatic patients undergoing long-term therapy with biologics: Impact of residual localization of psoriasis on quality of life in an Italian clinical setting.

Residual psoriasis characterizes body sites resistant to biologic drugs. Some affected body sites exert disproportionate impact on patients' quality of life. The aim was to localize residual psoriasis in patients treated with biologics for at least 6 months, and to study the correlation between lesional localization and patients' quality of life. Current Psoriasis Area and Severity Index (PASI) and Nail Psoriasis Severity Index (NAPSI) were assessed. Quality of life was obtained by measuring Dermatology Life Quality Index (DLQI). An observational retrospective study was designed. Seventy-five psoriatic patients were included (59 males, 78.67%, mean age 52.45 ± 11.83 years). The overall median current PASI was 0 (Interquartile Range IQR 0-4). The overall median current NAPSI was 0 (IQR 0-0) and DLQI was 0 (IQR 0-1). The commonest sites of residual psoriasis were elbows (41.33%; 95% confidence interval [CI]: 2.502-38.9), followed by anterior lower legs (33.33%; 95% CI 2.097-23.8) and forearms (29.33%; 95% CI 1.019-10.1). Statistical significance between DLQI and forearm, dorsal hand and abdomen was observed. Sites traditionally regarded as difficult-to-treat were rarely affected by residual lesions and showed relatively limited impact on quality of life.

Reduced Efficacy of Biological Drugs in Psoriatic Patients with HLA-A Bw4-80I KIR Ligands.

BACKGROUND: Biological drugs (biologics) are a highly effective therapy for the moderate to severe form of psoriasis, an immune-mediated dermatosis with a strong immunogenetic component. The interaction between human leukocyte antigen (HLA) class I ligands and killer immunoglobulin-like receptors (KIR) has a functional significance in the education of natural killer (NK) cells, and can thus influence the response to biologics. OBJECTIVE: In this study, we investigated the impact of HLA-A and -B KIR ligands in the response to biologics in a cohort of psoriatic patients. METHODS: Eighty-five patients with moderate to severe psoriasis treated with biologics (adalimumab, etanercept, infliximab, ustekinumab and secukinumab) were enrolled in the study. Clinical response was evaluated as patients attaining 50%, 75% or 90% reduction in the Psoriasis Area and Severity Index (PASI) (PASI 50, 75 or 90, respectively) over 6 months' follow-up. Poor response was defined as PASI 50, and in this case patients shifted to treatment with a different biologic. Fifty-two patients (61.2%) showed excellent response (PASI 90) to the first biologic, while 33 patients (38.8%), needed two or more biologics before reaching an excellent response (PASI 90) and were considered difficult to treat. RESULTS: Only HLA-A Bw4-80I ligands were associated with the response to biologics; in particular, they were linked with reduced response both at univariable analysis (odds ratio [OR] 3.11, 95% confidence interval [CI] 1.19-8.07; p = 0.019) and multivariable analysis (OR 5.02, 95% CI 1.40-17.97; p = 0.013). CONCLUSION: We suggest that the HLA-A Bw4-80I epitope could be a marker of reduced responsiveness to biologics. The possible reason for this is an increase of tumour necrosis factor (TNF)-α and the silencing of NK cells through the predominant interaction with the KIR3DL/S pair. HLA-KIR affinities might lead to a more efficient way to prescribe biologics.

Neonatal vesiculopustular eruption in Down syndrome and transient myeloproliferative disorder: A case report and review of the literature.

Transient myeloproliferative disorder (TMD) is a spontaneously resolving clonal myeloid proliferation characterized by circulating megakaryoblasts in the peripheral blood that is restricted to neonates with Down syndrome (DS) or those with trisomy 21 mosaicism. Cutaneous manifestations of TMD are observed in only 5% of affected neonates and present as a diffuse eruption of erythematous, crusted papules, papulovesicles, and pustules, often with prominent and initial facial involvement. We describe the case of a male infant with DS and TMD, associated with a vesiculopustular eruption, which appeared on day 36 of life, and review previous cases.

Photo-photochemotherapy in Juvenile-onset Mycosis Fungoides: A Retrospective Study on 9 Patients.

Mycosis fungoides (MF) is a rare disease and is considered the most common form of cutaneous T-cell lymphoma. Given the infrequent incidence of MF in patients under the age of 20, there are no established guidelines for the treatment of these patients; the overwhelming majority have an early-stage disease and progression to more advanced stages is very rare. This study presents the safety and effectiveness of photo-photochemotherapy as a first-line approach in the treatment of an early-stage MF even in young patients.