Investigation on physical restraint use in hospital: health responsibility, ethical and medical legal considerations.

Background: The issue of restraint has long been considered a difficult political and social situation, affecting both healthcare wor-kers and facilities. The practice of restraint is still widespread in many public and private care settings, but there is a lack of systemic studies capable of monitoring the phenomenon. The framing of the question essentially concerns the right to personal freedom, guaranteed by the Italian Constitution. Materials and Methods: An anonymous questionnaire was developed containing questions on knowledge of the regulations on restraints, how, ways, and when they are implemented, and general information such as age, gender, educational qualification, qualification, O.Us. to which they belong. The collected data were statistically processed (Chi-square test) with the Epi Info 7.1.5 program (CDC-Atlanta- USA). A total of 1002 questionnaires were completed. The stratification of the sample by structure shows that 73.9% were public facilities. The indicative figure is represented by the 23.8% of respondents who say that "the restraint is not noted in the medical record". Conclusions: Restraint could be a real risk for the healthcare worker, encroaching on the issue of health liability. It is therefore important to raise awareness among healthcare professionals and top management of the need to structure, at company level, procedures that comply with the "Recommendations on physical restraint" to overcome the use of restraint through the improvement of care pathways in compliance with organizational and risk management standards.

A case of suicide of psychiatric patient in the Sicilian hospital: accidental or professional liability of "top management"?

Background: In the hospital environment, any liability for organizational inadequacy and/or inefficiency, or again for defects in the facilities, or inadequacy of health equipment may be found in the work of the apex professional figures: Medical Director, the General Manager, and/or others. The responsibility for the internal organization of the department falls on the figure of the Director of the Complex Structure where the deficiencies have not been promptly and adequately reported to the top figures. Case Report: A woman 61-year-old, was admitted on a voluntary basis to the Department of Psychiatry. On the third day, in the early morning hours, the patient was found on the ground floor, lying on the floor near the entrance door of the ward with a lacerated contusion wound to the head. The woman underwent total body CT examination with findings of fractured polytrauma as well as subarachnoid hemorrhage and complete fracture of the spleen, which was surgically removed. Three days later, despite the care given, death occurred. The injuries ascertained were consistent with voluntary precipitation from the second-floor stairwell window. The investigations conducted by the police and the checks carried out by the head of the Internal Prevention and Protection Service and the company's Risk Manager, highlighted multiple critical issues. Conclusion: The case allows for numerous considerations relating to liability profiles in the determinism of the patient's death, the hospital's company failure to implement measures to prevent the patient's suicide in the hospital was influential.

Case of tracheal rupture after endotracheal intubation: clinical risk management and medico-legal considerations.

Background: Tracheal injury may be a rare complication of the endotracheal intubation procedure. Incidence and determinant factors are not well known, nevertheless a greater incidence have been recognized with a difficult maneuver or the use of nitrogen peroxide. The therapeutic approach can be conservative or surgical, depending on the characteristics of the lesion and of the patient and therefore the outcomes of medico-legal interest can be different. Case description: It is a case of alleged medical liability regarding a 70-year-old woman, that during the intubation procedure was pouncing on the right. Furthermore, nitrous oxide was used as an anaesthetic. A few hours after the operation the patient showed swelling on the right half of the face and on the right lateral region of the neck. The emergency chest CT scan highlighted subcutaneous emphysema and pneumomediastinum. In the operating room, fibrobronchoscopy was performed with a double-lumen bronchial tube which confirmed the hypotheses lesion; then, right posterolateral thoracotomy was perfor-med followed by suturing of the tracheal lesion. Subsequently, the patient was discharged in good clinical conditions but with a scar in the region of the right hemithorax. Conclusions: Iatrogenic tracheal injury is a rare and fearful complication of the orotracheal intubation procedure. Although risk factors that increase the probability of its onset have been recognized, in most cases it is not possible to identify the cause. From a medico-legal point of view, tracheal injury after intubation is unpredictable and inevitable, so in the case reported it was decided to proceed with a conciliatory solution.

Analysis of the contentious relating to medical liability for healthcare-associated infections (HAI) in a Sicilian hospital.

Background: Since 2012, the Sicilian regional government, in view of the increase in malpractice claims, has adopted a "self-insurance system" The claims management activities have been delegated to the Claims Management Committees (CMCs), the importance of which was also emphasized by Law No. 24/2017. This study aims to describe the experience of Sicilian Hospital CMC and analyze the claims' features, especially for contentious HAIs. Healthcare-associated infections (HAIs) continue to be a major public health concern. The contraction of infection during hospitalization generally results in a significant worsening of the patient's quality of life and prolongation of his or her stay. Still, it is also responsible for an increase in costs that burden the hospital and the entire Health System. Material and Methods: The study investigates the analysis of claims received by a Messina Hospital Company between January 2015 and December 2023 even though for events that occurred in earlier years. From the database, cases in which the Company was sued for HAIs were extrapolated and analyzed, distinguishing them by year and by Department. The data collected were statistically processed with the Epi Info 7.1.5 program (CDC - Atlanta - USA). Conclusion: The CMC experience highlighted a statistically significant increase in complaints especially for those relating to HAI, without differences by Department. In most cases, the CMC admitted the hospital's liability, and an attempt at conciliation was promoted and moreover risk management initiatives were adopted. This is important when considering the recent ruling 6386/2023 of March 3, 2023.

A Southern addiction evaluation project: investigating the impact of addiction through a survey HBSC based.

Background: Adolescence is a critical phase of development characterized by numerous physical, psychological and social changes. During this stage, individuals may engage in experimentation and risky behavior, leading to increased vulnerability to addiction. This article aims to present the results of a survey based on the HBSC (Health Behavior in School-aged Children) surveillance model in a province of Southern Italy for primary and secondary school students. Methods: We conducted a prospective study from March 2020 to April 2023 through the administration of a questionnaire to students of the healthcare faculties of the University of Messina and primary and secondary school students, composed of 19 items and based on HBSC surveillance. Results: We collected a total of 664 questionnaires. We found that smoking habits increase with age: approximately 31% of secondary school students declare they are real smokers compared to 40% of HCP students. At least once, in the three study groups, students experienced alcohol consumption at different rates, with younger students having a greater propensity to drink than older students. Fortunately, in our sample, no middle school students had tried cannabis. At the same time there is a surprising decrease in gambling in all categories compared to national data. Conclusions: The presence of addictive behaviors in our sample was found to be widespread despite being in line with the national trend. Furthermore, we have observed a reduction in recent years which needs to be investigated to assess the reasons. Primary prevention is probably the main weapon in the hands of politicians and must be applied early in school and community settings to reduce prevalence.

Mortality and prognostic factors in patients with bullous pemphigoid: a retrospective multicenter Italian study.

INTRODUCTION: Bullous pemphigoid is the most common autoimmune bullous dermatosis. In recent years several studies have tried to identify the main factors of the disease related with an increased risk of death. The aim of this multicenter Italian study was to assess the risk score of death considering epidemiologic, clinical, immunological, and therapeutic factors in a cohort of patients affected by bullous pemphigoid and try to identify the cumulative survival up to 120 months. METHODS: We retrospectively reviewed the medical records of patients with bullous pemphigoid who were diagnosed between 2005 and 2020 in the 12 Italian centers. Data collected included sex, age at the time of diagnosis, laboratory findings, severity of disease, time at death/censoring, treatment, and multimorbidity. RESULTS: A total of 572 patients were included in the study. The crude mortality rate was 20.6%, with an incidence mortality rate of 5.9 × 100 person/year. The mortality rate at 1, 3, 5, and 10 years was 3.2%, 18.2%, 27.4% and 51.9%, respectively. Multivariate model results showed that the risk of death was significantly higher in patients older than 78 years, in presence of multimorbidity, anti-BP180 autoantibodies >72 U/mL, or anti-BP230 > 3 U/mL at diagnosis. The variables jointly included provided an accuracy (Harrel's Index) of 77% for predicting mortality. CONCLUSION: This study represents the first nationwide Italian study to have retrospectively investigated the mortality rates and prognostic factors in patients with bullous pemphigoid. A novel finding emerged in our study is that a risk prediction rule based on simple risk factors (age, multimorbidity, steroid-sparing drugs, prednisone use, and disease severity) jointly considered with two biomarkers routinely measured in clinical practice (anti-BP230 and anti-BP180 autoantibodies) provided about 80% accuracy for predicting mortality in large series of patients with this disease.

Clinical and serological predictors of relapse in pemphigus: a study of 143 patients.

BACKGROUND: Pemphigus is an autoimmune bullous disease mediated by autoantibodies targeting epithelial cell-cell adhesion molecules. Predictors of relapse have not yet been clearly identified. AIMS: To identify factors at diagnosis and during follow-up that could be predictors of relapse. METHODS: Clinical and immunopathological data at diagnosis, clinical remission and first relapse from patients with pemphigus vulgaris or foliaceus and at least a 36-month follow-up were collected retrospectively. Based on the autoantibody profile at diagnosis, three serological patient subsets were devised: (i) anti-desmoglein (Dsg)1-positive and anti-Dsg3-negative; (iii) anti-Dsg1-negative and anti-Dsg3-positive; and (iii) anti-Dsg1-positive and anti-Dsg3-positive. RESULTS: Data from 143 patients were collected. No significant differences were found between relapsers (n = 90) and nonrelapsers (n = 53) for time to remission or for anti-Dsg1 and anti-Dsg3 titres at diagnosis and remission. In the analysis of all patients, a higher risk of relapse was found for a body surface area (BSA) score of 3 compared with BSA < 3 (OR = 3.30, 95% CI 1.17-9.28; P = 0.02) and for a positive titre of either anti-Dsg1 or anti-Dsg3 autoantibodies at remission compared with both being negative (OR = 2.42, 95% CI 1.21-4.85, P = 0.01). In patients who were anti-Dsg3-positive and anti-Dsg1-negative at diagnosis, failure to achieve anti-Dsg3 negativity at clinical remission was a significant predictor of relapse (OR = 7.89, 95% CI 2.06-30.21; P < 0.01). Similarly, failure to achieve anti-Dsg1 negativity at clinical remission was a significant predictor of relapse in patients with both anti-Dsg1 and anti-Dsg3 positivity at diagnosis (OR = 5.74, 95% CI 1.15-28.61; P = 0.03), but not in those who were anti-Dsg1-positive/anti-Dsg3-negative at diagnosis (OR = 1.08, 95% CI 0.27-4.30; P = 0.91). CONCLUSION: Regardless of pemphigus subtype, autoantibody titre negativity at clinical remission in patients classified based on their anti-Dsg1 and anti-Dsg3 profile at diagnosis and BSA were useful tools in predicting relapse.

European guidelines (S3) on diagnosis and management of mucous membrane pemphigoid, initiated by the European Academy of Dermatology and Venereology - Part I.

This guideline on mucous membrane pemphigoid (MMP) has been elaborated by the Task Force for Autoimmune Blistering Diseases of the European Academy of Dermatology and Venereology (EADV) with a contribution of physicians from all relevant disciplines and patient organizations. It is a S3 consensus-based guideline encompassing a systematic review of the literature until June 2019 in the MEDLINE and EMBASE databases. This first part covers methodology, the clinical definition of MMP, epidemiology, MMP subtypes, immunopathological characteristics, disease assessment and outcome scores. MMP describes a group of autoimmune skin and mucous membrane blistering diseases, characterized by a chronic course and by predominant involvement of the mucous membranes, such as the oral, ocular, nasal, nasopharyngeal, anogenital, laryngeal and oesophageal mucosa. MMP patients may present with mono- or multisite involvement. Patients' autoantibodies have been shown to be predominantly directed against BP180 (also called BPAG2, type XVII collagen), BP230, laminin 332 and type VII collagen, components of junctional adhesion complexes promoting epithelial stromal attachment in stratified epithelia. Various disease assessment scores are available, including the Mucous Membrane Pemphigoid Disease Area Index (MMPDAI), the Autoimmune Bullous Skin disorder Intensity Score (ABSIS), the 'Cicatrising Conjunctivitis Assessment Tool' and the Oral Disease Severity Score (ODSS). Patient-reported outcome measurements (PROMs), including DLQI, ABQOL and TABQOL, can be used for assessment of quality of life to evaluate the effectiveness of therapeutic interventions and monitor disease course.

European Guidelines (S3) on diagnosis and management of mucous membrane pemphigoid, initiated by the European Academy of Dermatology and Venereology - Part II.

This guideline has been initiated by the task force Autoimmune Blistering Diseases of the European Academy of Dermatology and Venereology, including physicians from all relevant disciplines and patient organizations. It is a S3 consensus-based guideline that systematically reviewed the literature on mucous membrane pemphigoid (MMP) in the MEDLINE and EMBASE databases until June 2019, with no limitations on language. While the first part of this guideline addressed methodology, as well as epidemiology, terminology, aetiology, clinical presentation and outcome measures in MMP, the second part presents the diagnostics and management of MMP. MMP should be suspected in cases with predominant mucosal lesions. Direct immunofluorescence microscopy to detect tissue-bound IgG, IgA and/or complement C3, combined with serological testing for circulating autoantibodies are recommended. In most patients, serum autoantibodies are present only in low levels and in variable proportions, depending on the clinical sites involved. Circulating autoantibodies are determined by indirect IF assays using tissue substrates, or ELISA using different recombinant forms of the target antigens or immunoblotting using different substrates. The major target antigen in MMP is type XVII collagen (BP180), although in 10-25% of patients laminin 332 is recognized. In 25-30% of MMP patients with anti-laminin 332 reactivity, malignancies have been associated. As first-line treatment of mild/moderate MMP, dapsone, methotrexate or tetracyclines and/or topical corticosteroids are recommended. For severe MMP, dapsone and oral or intravenous cyclophosphamide and/or oral corticosteroids are recommended as first-line regimens. Additional recommendations are given, tailored to treatment of single-site MMP such as oral, ocular, laryngeal, oesophageal and genital MMP, as well as the diagnosis of ocular MMP. Treatment recommendations are limited by the complete lack of high-quality randomized controlled trials.

Evidence for a 'window of opportunity' in hidradenitis suppurativa treated with adalimumab: a retrospective, real-life multicentre cohort study.

BACKGROUND: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for moderate-to-severe hidradenitis suppurativa (HS). No predictors of response have been identified so far. OBJECTIVES: To identify clinical parameters predicting response to adalimumab and confirm its efficacy/safety. METHODS: The data of 389 patients with HS treated with adalimumab in 21 Italian centres were reviewed. Sex, age at onset/diagnosis/baseline, body mass index, smoking, phenotype, previous treatments, concomitant antibiotics and 'therapeutic delay', defined as the time from HS onset to adalimumab initiation, were assessed. Response to adalimumab and its impact on quality of life (QoL) were evaluated using the Hidradenitis Suppurativa Clinical Response (HiSCR) and the Dermatology Life Quality Index (DLQI) or the Visual Analogue Scale for pain (VAS pain), respectively. Logistic regression analysis was performed. RESULTS: The therapeutic delay correlated to lack of response to adalimumab at week 16 [odds ratio (OR) 1·92 for therapeutic delay > 10 years; 95% confidence interval (CI) 1·28-2·89; P = 0·0016). HiSCR was achieved in 43·7% and 53·9% patients at week 16 and 52, respectively. Significant reductions in both DLQI and VAS pain were found between week 16 vs. baseline (P < 0·0001 for both) and week 52 vs. baseline (P < 0·0001 for both). Previous immunosuppressants inversely correlated to HiSCR at week 52 (OR = 1·74, 95% CI 1·04-2·91, P = 0·0342). CONCLUSIONS: Inverse correlation between therapeutic delay and clinical response was found, supporting early adalimumab use and providing evidence for a 'window of opportunity' in HS treatment. Adalimumab efficacy and safety were confirmed, along with patients' QoL improvement. Immunosuppressants could negatively influence the response to adalimumab inducing a switch to non-TNF-α-driven pathways.

Cutaneous manifestations in patients with COVID-19: a preliminary review of an emerging issue.

BACKGROUND: The infection caused by the recently identified SARS-CoV-2, called coronavirus disease-19 (COVID-19), has rapidly spread throughout the world. With the exponential increase of patients worldwide, the clinical spectrum of COVID-19 is being better defined and new symptoms are emerging. Numerous reports are documenting the occurrence of different cutaneous manifestations in patients with COVID-19. OBJECTIVES: To provide a brief overview of cutaneous lesions associated with COVID-19. METHODS: A literature search was performed in the PubMed, Scopus and Web of Science databases up to 30 April 2020. This narrative review summarizes the available data regarding the clinical and histological features of COVID-19-associated skin manifestations. RESULTS: The literature reports showed a great heterogeneity in COVID-19-associated cutaneous manifestations, as well as in their latency periods and associated extracutaneous symptoms. Pathogenic mechanisms are unknown, although the roles of a hyperactive immune response, complement activation and microvascular injury have been hypothesized. Based on our experience and the literature data, we subdivided the reported cutaneous lesions into six main clinical patterns: (i) urticarial rash; (ii) confluent erythematous-maculopapular-morbilliform rash; (iii) papulovesicular exanthem; (iv) chilblain-like acral pattern; (v) livedo reticularis-livedo racemosa-like pattern; and (vi) purpuric 'vasculitic' pattern. These six patterns can be merged into two main groups: the first - inflammatory and exanthematous - includes the first three groups listed above, and the second includes the vasculopathic and vasculitic lesions of the last three groups. CONCLUSIONS: The possible presence of cutaneous findings leading to suspect COVID-19 puts dermatologists in a relevant position. Further studies are needed to delineate the diagnostic and prognostic values of such cutaneous manifestations.

Successful treatment of co-existent SAPHO syndrome and hidradenitis suppurativa with adalimumab and methotrexate.

SAPHO syndrome, namely Synovitis, Acne, Pustulosis, Hyperostosis and Osteitis, is a rare autoinflammatory chronic disease presenting with non-infectious inflammatory osteitis, sterile joint inflammation and skin manifestations, including palmoplantar pustulosis and severe acne. The case of a 15-year-old boy affected by SAPHO syndrome and hidradenitis suppurativa (HS) is presented and discussed. Coexistence of these two diseases may represent a therapeutic challenge and this case confirms literature data reporting the efficacy of the combination of methotrexate and adalimumab in SAPHO complicated by HS.

Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients.

BACKGROUND: Chronic spontaneous urticaria (CSU) is defined as spontaneous occurrence of wheals and/or angioedema for ≥6 weeks. Omalizumab is a monoclonal anti-IgE antibody effective in refractory CSU, but its mechanism of action and markers predictive of response remain not completely defined. OBJECTIVES: To correlate baseline levels of two proposed biomarkers, total IgE (bIgE) and d-dimer (bd-dimer), and clinical parameters to omalizumab response and to relapses after drug withdrawal. METHODS: In this retrospective Italian multicentre study, clinical data were collected in 470 CSU patients, and bIgE and bd-dimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 (UAS7) at week 1 and 12 after omalizumab starting. Relapses were evaluated during a 2- and 3-month interval after a first and a second course of treatment, respectively. RESULTS: bIgE correlated to a good response to omalizumab since levels were significantly higher in responders than non-responders (P = 0.0002). Conversely, bd-dimer did not correlate to response. There was no correlation between both bIgE and d-dimer and either first or second relapse. Disease duration was significantly longer in patients who experienced either first or second relapse (P < 0.0001 and P = 0.0105, respectively), while baseline UAS7 correlated only to first relapse (P = 0.0023). CONCLUSIONS: Our study confirms bIgE as a reliable biomarker predicting response to omalizumab in CSU, while it does not support the usefulness of bd-dimer unlike previous findings. CSU duration before omalizumab and baseline UAS7 may be clinical markers of relapse risk.

Autoimmune bullous diseases in non-HIV Kaposi's sarcoma: a retrospective study in a large cohort of patients.

BACKGROUND: Kaposi's sarcoma (KS) is a rare endothelial neoplasm caused by the human herpesvirus 8 (HHV-8). Its risk is increased in immunocompromised patients, including those undergoing immunosuppressive therapy for autoimmune bullous diseases. Conversely, HHV-8 infection has been hypothesized to be a triggering factor of bullous diseases, especially pemphigus. Given the fact that both KS and autoimmune bullous diseases have a low incidence in the general population, it could be expected that the association between these disorders would be exceptional. OBJECTIVES: To assess the frequency of bullous diseases in a large cohort of non-HIV KS patients and to describe our experience concerning the clinical features, natural history and treatment options in this setting. METHODS: We performed a retrospective review of all patients with non-HIV KS in association with bullous disease followed at our department between 1990 and 2016. Medical records were reviewed for demographics, medical history, clinical characteristics and treatment. RESULTS: Among 1362 patients with classic or iatrogenic KS, 14 (1.03%) also suffered from bullous disease. The mean age at diagnosis of both disorders was 85.8 years with a male/female ratio of 9 : 5. Among these 14 cases, nine (0.66%) were associated with bullous pemphigoid (BP), three (0.22%) with localized BP and two (0.15%) with pemphigus vulgaris. Seven had developed a bullous disease after being diagnosed with KS, while in the remaining seven cases, KS developed after the onset of bullous disease. As expected, KS worsened when corticosteroids were used. CONCLUSION: Bullous diseases seem to be more frequent among patients with KS, supporting the hypothesis that HHV-8 may be involved in their pathogenesis. Therapeutic management of these cases should take into account KS-inducing potential of corticosteroids.