Search

Evidences on the absence of risk of sexual transmission of HIV by persons living with HIV/AIDS (PLWHA) with undetectable plasma HIV-RNA (HIV-RNA <200 copies/ml) led to the worldwide campaign "U = U" (undetectable = untransmittable). The purpose of this study was to evaluate the perceived accuracy of this message among PLWHA, HIV-negative people having unprotected sex (PHUS) and infectious diseases' (ID) physicians in Italy. A nationwide survey has been conducted using three different anonymous questionnaires (for ID physicians, PLWHA and PHUS). A total of 1121 participants filled the questionnaires: 397 PLWHA; 90 physicians; 634 PHUS. Awareness of U = U message has been reported in 74%, 92% and 47% of PLWHA, ID physicians and PHUS, respectively. The perception of accuracy of the U = U message among those aware was reported as high in 80.4%, 79.5% and 67.3% of PLWHA, ID physicians and PHUS, respectively. Physicians perceived that 11% of PLWHA have a high rate of perception of U = U, whereas among PLWHA, only 34% reported definitive positive messages from physicians. Discrepancies between awareness and perception of accuracy of the message U = U in PLWHA and physicians have been found, suggesting still low confidence in the community regarding the message itself. [ABSTRACT FROM AUTHOR]

Background: Advanced cutaneous squamous cell carcinoma (aCSCC) represents an area of unmet clinical need, with no standardized treatments until the recent approval of immune checkpoint inhibitors (ICIs). Objectives: The aim of the study was to describe clinical characteristics and therapeutic strategies of a real-life Italian cohort of aCSCC patients managed at the beginning of cemiplimab approval as compassionate use in Italy. Methods: A multicenter retrospective study was performed by 10 Italian centers in the period January 1, 2018–May 31, 2020. Patients aged ≥18 years and diagnosed with aCSCC (locally aCSCC and metastatic CSCC) were eligible for the study. Analysis of patients' characteristics and treatment strategies was performed. Results: 239 patients were initially recruited in the study: 19 patients were excluded due to incomplete data collection, yielding a final cohort of 220 patients, of which 191 and 220 were included for patients' clinical characteristics and therapeutic intervention analysis, respectively. Median age at the time of diagnosis was 81 years (range: 72–86); nodal metastases were detected in 64/220 (29%) patients, and distant metastatic spread was reported in 33/220 (15%) patients. Most of our patients referred chronic occupational and/or recreational sun exposure, experienced ≥1 sunburn during their lifetime, never wore hats or used photoprotective filters, and presented with signs of cumulative sun damage (solar lentigines and/or actinic keratosis). Majority of our cohort received at least one intervention directed to the primary tumor (n = 212, 96.3%); surgery and radiotherapy were the most common therapeutic choices. Immunotherapy was administered to a small number of patients as compassionate use, especially in the metastatic setting. Conclusions: Our study outlines the complex and heterogeneous clinical and therapeutic landscape of aCSCC patients at the beginning of ICI era, highlighting the need of a standardized care for this fragile and high-need patient population. [ABSTRACT FROM AUTHOR]

The article discusses a study conducted in Italy on the use of human immunodeficiency virus (HIV) nucleic acid testing (NAAT) for early detection of HIV infection among high-risk men who have sex with men. It reports the results showed that NAAT detected four acute, one primary, and no chronic HIV infections, and all five individuals were linked to care and had undetectable viral loads within three months.

Background: The cost of topical treatments for actinic keratosis (AK) has historically been evaluated in relation to the number of lesions requiring treatment or simply by the price of a single tube/sachet of the drug used. Objective: To demonstrate a new method of costing topical treatments in AK, which takes into account the actual cancerization area treated. Methods: In order to evaluate the actual cost of each treatment, the official approval status of the drug was used to estimate the amount of cream needed per one cm2. This value was then applied to the hypothetical cancerization area sizes to demonstrate the impact of the size treated on the actual cost of treatment. The price considered was the ex‐factory price in Italy. Results: Areas which could be treated with a single tube/sachet of Metvix®, Picato®, Aldara®, Solaraze® and Zyclara® were 200, 25, 25, 33.3 and 200 cm2, respectively. For the treatment of smaller areas (<100 cm2), treatment with Metvix® was the most costly topical option in Italy. However, for the treatment of cancerization areas larger than 100 cm2, Metvix® was the least expensive treatment option. Treatment with Metvix® was least long, requiring a single day of treatment for an area of up to 200 cm2, compared with up to 224 days of treatment with Aldara® for the treatment of a similar size. Conclusion: Changing treatment costing strategy in the management of multiple AKs towards costing per cancerization area instead of costing per lesion is a much more accurate representation of the 'real world cost' for AK. [ABSTRACT FROM AUTHOR]

The efficacy and safety of dupilumab have been reported previously based on data from controlled clinical trials. The GLOBOSTAD study extends the scope of these trials by providing real-world data. This analysis reports baseline demographics and family disease history in patients with atopic dermatitis (AD) who received treatment with dupilumab in a real-world setting. This 5-year, international, multicentre, non-interventional study (GLOBOSTAD; NCT03992417) included patients ≥12 years old with moderate-to-severe AD (Investigator’s Global Assessment score ≥3) who received dupilumab treatment based on country-specific prescribing criteria. Data reported are for the population at baseline (N=952; data cut-off: March 2022) in 22 countries. In the 952 patients included at baseline, mean (standard deviation) age at AD onset was 11.1 (16.0) years. Male patients represented 57.8% of patients and White patients 65.2%. The majority of patients were enrolled from Italy (17.2%), Japan (12.4%) and Spain (11.3%). Family history of type 2 inflammatory conditions (number of patients [%]) was prevalent, including AD (364 [38.2%]), asthma (238 [25%]), allergic rhinitis (219 [23%]), food allergies (74 [7.8%]), recurrent or chronic urticaria (31 [3.3%]), nasal polyposis (21 [2.2%]), eosinophilic esophagitis (11 [1.2%]) and other atopic/allergic conditions (39 [4.1%]). Most cases of type 2 inflammatory conditions were reported in first-degree relatives. Most patients enrolled in the GLOBOSTAD study developed AD during pre-adolescence. Family history of select type 2 inflammatory conditions, including AD, asthma and allergic rhinitis, was present in a moderate proportion of patients. [ABSTRACT FROM AUTHOR]

Objective Psoriasis is one of the most common forms of chronic dermatitis, affecting 2-3% of the worldwide population. It has a serious effect on the way patients perceive themselves and others, thereby prejudicing their quality of life and giving rise to a significant deterioration in their psycho-physical well-being; it also poses greater difficulties for them in leading a normal social life, including their ability to conduct a normal working life. All the above-mentioned issues imply a cost for the society. This study proposes to evaluate the impact on societal costs for the treatment of chronic plaque psoriasis with biologics (etanercept, infliximab and adalimumab) in the Italian clinical practice. Method A prospective observational study has been conducted in 12 specialized centres of the Psocare network, located throughout Italy. Direct and indirect costs (as well as the health-related quality of life of patients with plaque psoriasis undergoing biologic treatments) have been estimated, while the societal impact has been determined using a cost-utility approach. Results Non-medical and indirect costs account for as much as 44.97% of the total cost prior to treatment and to 6.59% after treatment, with an overall 71.38% decrease. Adopting a societal perspective in the actual clinical practice of the Italian participating centres, the ICER of biologic therapies for treating plaque psoriasis amounted to €18634.40 per QALY gained - a value far from the €28656.30 obtained by adopting a third-party payer perspective. Conclusion Our study confirms that chronic psoriasis subjects patients to a considerable burden, together with their families and caregivers, stressing how important it is to take the societal perspective into consideration during the appraisal process. Besides, using data derived from Italian actual practice, treatment with biologics shows a noteworthy benefit in social terms. [ABSTRACT FROM AUTHOR]

Background and Objectives: Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service's pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate. Methods: To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window. Results: The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to €15,073.7 per year (prior to their enrolment, the same patients cost €2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to €28,656.3. Conclusion: At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies. [ABSTRACT FROM AUTHOR]

Background Changes in financing health care delivery, including the adoption of diagnosis-related groups (DRG), has deeply influenced dermatological practice across Europe. Objective To define the current status of dermatological care in the Lombardy Region, Italy, and compare the status of 2009 to that of 2001. Methods Data were analysed from the annual reports of the Healthcare General Department of the Lombardy Region; legislative and administrative data were taken into consideration. Results Beds for inpatients in Dermatologic Wards decreased from 251.7 (2001) to 49.07 (2009). In 2009, a large proportion of inpatients with skin diseases were admitted to non-dermatological departments. Beds for day-hospital activities increased from 55.9 (2001) to 61.0 (2009), and the proportion of admissions for surgical purposes progressively increased. In addition, the complexity and quality of surgical procedures increased, in view of the need to justify a day-hospital admission. The total number of services for outpatients increased from 1 090 052 (2001) to 1 503 692 (2009); in addition, the weighted numbers (an indicator of complexity) increased from 2 117 000 (2001) to 3 644 032 (2009). The number of dermatologists with unlimited contracts decreased, and the number of low paid scholarship recipients and external consultants increased. Three of six medical faculties currently do not have a university department of Dermatology. Conclusion Over the last decade, the number of patients hospitalized in Dermatological Departments has declined; moreover, patients hospitalized with dermatological disorders have been increasingly admitted to wards with a non-dermatologist attending physician. [ABSTRACT FROM AUTHOR]

Aim: We assessed the efficacy, reliability and cost of an in-home control service, devoted to debilitated patients with pacemakers, during long-term follow up. Methods: We admitted 802 patients (mean age 87.8 ± 6.9 years) with pacemakers into our program, which were monitored periodically during in-home visits by nurses. During these controls, patients underwent a standard electrocardiogram with and without magnet, during which stimulation intervals were measured. In-home pacemaker assessments were performed by a portable programmer only for patients with Biotronik pacemakers. Electrocardiograms and technical data were evaluated at hospital, and a report was sent by mail to the patient. Moreover, we compared the costs for the hospital, patients and society between in-home and ambulatory assessments. Results: During 80 months of follow up, 2418 controls were performed. The monthly average of patients who were followed at home was 283.9 ± 23.9. The mean number of controls per month was 30.2 ± 10 (range 4-51). One hundred and twenty-three pacemakers were replaced due to battery exhaustion, after a mean device longevity of 7.4 years (range 4.9-12.4 years). Four hundred and sixty-eight patients died (8.7% annual mortality). Fifteen patients (annual incidence 0.3%) were invited to in-hospital visits for reprogramming. The cumulative cost for in-home assessment were 20.5% lower than conventional in-hospital controls and 66.5% lower if patients are transported by ambulance. Conclusion: Elderly debilitated patients can be monitored by effective and reliable pacemaker assessments at home, alleviating them and their families from the issues that are associated with their transfer from the home to the hospital and concurrently reducing overall costs. Geriatr Gerontol Int 2012; 12: 30-35. [ABSTRACT FROM AUTHOR]

More than 140 different mutations have been reported in the Cu/Zn superoxide dismutase-1 ( SOD1) gene in patients with amyotrophic lateral sclerosis (ALS), some occurring as founder mutations. Occasionally, specific mutations are associated with a particular phenotype. We evaluated a possible genotype-phenotype correlation and looked for a founder effect in nine patients from six unrelated families with ALS, all carrying the G41S mutation, originating from north-west Tuscany in central Italy. Mutational analysis of the SOD1 gene was carried out by direct sequencing. A haplotype study was carried out using eight polymorphic markers flanking the SOD1 gene. The clinical pattern of the nine familial ALS (FALS) patients was characterized by spinal onset with early upper and lower motor neuron involvement, appearance of bulbar signs within one year, and death a few months later. Mean age at onset was 49.3 years and mean duration of disease was 0.9 years. Genotyping revealed a common haplotype for the G41S allele. We provide the first evidence that the G41S mutation in Italy originates from a common founder. In addition, our findings strengthen the data reported previously and indicate that the G41S mutation is consistently associated with a uniform and dramatic, fast-progressing phenotype. [ABSTRACT FROM AUTHOR]

The cost-effectiveness of biological treatments for psoriasis is not well determined and may vary from country to country. The objectives of this study was to perform a cost-effectiveness analysis of infliximab compared with other anti-tumor necrosis factor-α agents for the treatment of psoriasis in Italy. The incremental cost-effectiveness ratio per patients achieving at least 75% improvement in the psoriasis area and severity index assessed over 24- and 48–50-week periods was calculated. Efficacy data were drawn from randomized controlled trials when available or from open label studies. Considering patients achieving psoriasis area and severity index at week 24 and 48–50, infliximab was dominant (more effective and less costly) over etanercept given at 50 mg twice weekly. In contrast, infliximab was not dominant over etanercept at other dosages or over adalimumab. When considering the impact of therapy on quality of life at Week 12 using the Dermatology Life Quality Index equal to zero, infliximab resulted more effective and less costly than etanercept. Therefore, infliximab seems to be cost-effective in the therapy of psoriasis. Further cost-efficacy evaluations based on head-to-head trials are necessary to address health economic considerations. [ABSTRACT FROM AUTHOR]

Background. Recent studies have demonstrated that there exists a great variation in the lymphatic drainage in patients with malignant melanoma. Some patients have drainage to lymph nodes outside of conventional nodal basins. The lymph nodes that exist between a primary melanoma and its regional nodal basin are defined "interval nodes". Interval node occurs in a small minority of patients with forearm melanoma. We report our experience of the Melanoma Unit of University Hospital Spedali Civili Brescia, Italy. Methods. Lymphatic mapping using cutaneous lymphoscintigraphy (LS) has become a standard preoperative diagnostic procedure to locate the sentinel lymph nodes (SLNs) in cutaneous melanoma. We used LS to identify sentinel lymph nodes biopsy (SLNB) in 480 patients. Results. From over 2100 patients affected by cutaneous melanoma, we identified 2 interval nodes in 480 patients with SLNB . The melanomas were both located in the left forearm. The interval nodes were also both located in the left arm. Conclusion. The combination of preoperative LS and intraoperative hand-held gamma detecting probe plays a remarkable role in identifying these uncommon lymph node locations. Knowledge of the unusual drainage patterns will help to ensure the accuracy and the completeness of sentinel nodes identification. [ABSTRACT FROM AUTHOR]

Background. The clinical presentation of desmoplastic melanoma is often challenging. We report the experience of the Melanoma Unit of Spedali Civili University Hospital of Brescia, Italy. Method. Study subjects were drawn from 1770 patients with histologica confirmed melanoma. Within this group, desmoplastic melanoma developed in 5 patients. For each diagnosed melanoma, histological characteristics, treatment, and outcomes were evaluated. Results. Of the 5 patients described in this study, 2 were males and 3 females. The average age was 62.4 years ranging from 56 to 68 years. Breslow thickness ranged from 2.1 to 12mm with a mean thickness of 5.8 mm. Primary treatment of 5 patients included a wide local excision of their primary lesions. Conclusions. Desmoplastic melanoma is a rare neoplasm which clinically may mimic other tumours or cutaneous infiltrate of uncertain significance. The diagnosis is hiastopathological and radical resection is necessary. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) therapeutic approach calls for a long‐term treatment. Treatment options for AD have recently undergone a revolutionary change by the introduction of the first biologic drug. Availability in daily practice of the last version of international AD guidelines, taking peculiarities of the country into account, can contribute to good clinical practice in Italy. To adapt European Dermatology Forum (EDF) guidelines for AD to the Italian medical–legal context, the EDF guidelines were assessed independently by two independent Italian renowned experts in the field and further integrated with articles published and systematically reviewed before May 2019. The first draft was collegially corrected and updated by the members of the SIDEMAST, ADOI, and SIDAPA. Recommendation levels (A; B; C; D) were graded based on the evidence levels (1–4). The adapted guidelines presented here focus on topical and systemic therapies in AD patients, both children and adults. As opposed to previous Italian guidelines, they include indications about biologics. New relevant evidence available from very recent literature and peculiarities of the Italian medical and legal context have been integrated in the revision process. If compared to general guidelines for AD not adapted to a specific national and cultural context, a revision for specific Italian needs is now available: It comprises the option of implementing the new biologic treatments and is likely to provide an important contribution to the improvement of clinical practice in Italy. Cooperation between patients, dermatologists, allergologists, and pediatricians remains mandatory in AD management. The authors of the present revision recommend an update of the Italian guidelines to be performed at least every second year. [ABSTRACT FROM AUTHOR]

Approximately, 1–4% of all new melanoma cases occur in patients younger than 20 years. The clinical presentation of melanoma in the young is often challenging. We report the experience of the Melanoma Unit of University Hospital Spedali Civili of Brescia, Italy. Study subjects were drawn from 1470 patients with histologically confirmed melanoma. From this group, melanoma developed in 12 patients younger than 19 years. For each melanoma diagnosed, histologic characteristics, treatment, and outcomes were evaluated. Of the 12 patients described in this study, four were men and eight were women. The average age was 15.6 years ranging from 11 to 18 years. Regarding invasive melanomas, Breslow thickness ranged from 0.15 to 0.66 mm with a mean thickness of 0.36 mm. Primary treatment of 12 patients included wide local excision of their primary lesions. In many cases reported in literature lesions are amelanotic, nodular, and resemble pyogenic granuloma. From our case studies it was found that the clinical characteristics detected in melanomas diagnosed in childhood and adolescence have been the same as those described in adults and that the ABCDE clinical criteria may be helpful basics of melanoma. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic has led to lockdowns for much of the world. In Italy, all health procedures not directly related to COVID-19 were reduced or suspended, thus limiting patient access to hospitals. Any delay in cancer treatment presents the additional risk of tumors progressing from being curable to incurable. Specifically, melanoma survival rate strictly depends on tumor thickness, which, in turn, is a function of time. To estimate the impact on melanoma progression caused by the reduction in dermatologic services during the COVID-19 lockdown, a retrospective observational cohort study was conducted. This study was designed to compare the clinical and histologic characteristics of the primary melanomas removed in the first 2 months after the end of the lockdown (May-July 2020) in 12 Italian centers characterized by different COVID-19 case frequencies. The control group was represented by the melanomas removed during the same period in the previous 3 years. Overall, 1,124 melanomas were considered: 237 as part of the study group and 887 from the control group (average, 295), with a 20% reduction. Breslow thickness, as well as high-risk histotypes and melanomas with vertical growth, increased for all melanomas. Ulcerated and high mitotic index melanomas increased, particularly in northern Italy. In Italy, the lockdown led to a significant worsening of melanoma severity, causing a staging jump, with a consequent worsening of outcomes. [ABSTRACT FROM AUTHOR]

Proactive school closures are often considered an effective strategy by policy-makers and the public to limit SARS-CoV-2 transmission. While evidence on the role of students in the spread is debated, the effects of closures on children's well-being are well known. In the light of this, we aimed to assess viral spread in educational settings, by calculating the rate of secondary infections per school class and identifying factors associated with cluster generation. We conducted a combined longitudinal and cross-sectional population-based study between October 2020 and November 2021. Secondary screening was conducted whenever a SARS-CoV-2 positive subject had been in the school environment in 48 h prior to symptoms onset or on the date of swab, if asymptomatic. The effect of selected variables on COVID-19 cluster generation was assessed by logistic regression. We identified 1623 primary COVID-19 cases. Of these, 72.5% resulted in no secondary case, 15.6% in 1, and 11.9% in 2 + . The probability of generating a 2 + cluster was lower when the index case was a student, rather than school staff (AOR = 0.42; 95%CI: 0.29-0.60). The number of clusters per week was in line with COVID-19 incidence trend in the general population., Conclusions: Index cases at school led to no secondary case in about three out of four times and only to a secondary case in about 15%. School environment does not facilitate viral spread, but rather reflects circulation in the community. Appropriate measures and timely monitoring of cases make school a safe place. Given the effects on children's learning and well-being, it is essential to favour school attendance over distance learning., What Is Known: • During the COVID-19 pandemic, most European countries resorted to school closures to counter viral transmission. • Although the scientific debate on the suitability of school closures as a non-pharmaceutical intervention is still open and the role of school children in facilitating the spread of SARS-CoV-2 is not supported by unequivocal evidence, there is now a growing awareness of the impact on children's well-being., What Is New: • The contribution of educational settings and students in facilitating viral spread appears limited, as exposure to a positive individual in the school environment led to no secondary cases among students in 72% of cases and only one secondary case in about 15%. • The likelihood of generating school clusters was approximately halved when the index case was a student compared to teachers or other school personnel., (© 2022. The Author(s).)