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In these times of global crisis caused by COVID-19, there is an urgent need to address the topic of nature-based experiences in education: the pandemic has strongly highlighted both the interdependence between human beings and nature, and the need for mending the dichotomic vision that keeps them separate. Experiential education in natural contexts within an ecological framework might have a strategic role in this crucial period to develop anthropologic, civic, and dialogic conscience (Morin, 2001). Through this study, CEFEO Research Center had the objective of investigating the socio-economic impact of COVID-19 on Italian nature-based programs in the educational, therapeutic, training, and leisure areas. From 28 May to 19 June 2020, an online questionnaire was distributed with the purpose of understanding the socio-economic impact of the pandemic on nature-based programs during the lockdown period and during the period of first reopening, and the related needs and new opportunities for the future. The results highlight a paradox: the COVID-19 crisis has caused more problems for a sector which was already suffering from a lack of funding and of social and institutional acknowledgment. Many agencies working in the field lost months of income and numerous working days, and they are uncertain about the future: they are having difficulties surviving in a moment when we need them more.

Background: Nature-based therapeutic approaches have largely centered on the significance of nature, as a unique setting. This article focuses on an additional perspective, that of nature as actively influencing the therapeutic process, providing significant content. Purpose: The main objective of this study was to shed light on how practitioners experience, perceive, and work with nature to serve therapeutic goals. Methodology/Approach: Grounded theory inquiry was implemented. Data included in-depth interviews conducted with 26 nature-based practitioners with different professional backgrounds from five countries and field observations of six nature-based workshops. Findings/Conclusions: Four major categories emerged--(a) A basic belief among practitioners that nature is actively influencing the therapeutic process, providing significant and relevant personal information; (b) the practitioners' relationship with nature and its role in the therapeutic process; (c) the practice of working with nature so nature's input is acknowledged and integrated intentionally; (d) creating the conditions for the clients' engagement with nature as a resource via five themes. Implications: This study expands on common notions of nature-based facilitation, illuminating the possibilities and potential of integrating nature's input as beneficial and relevant to the therapeutic process by working with nature. The operational and practical steps for working with nature are delineated.

Based on behavioral science assumptions, the main purpose of this study is to validate a theoretical model of the relationship between serious game play, patient empowerment and health-related behaviors. We first hypothesized that serious games for health enhanced patients' empowerment-related education; second, we expected that gender may influence such an educational model. To test our hypotheses, 124 Italian young diabetics (Mean age = 14.12 years old, SD = 2.14; 59.67% female) were involved in the research study named "Tako Dojo". After participating to a training session about the use of the serious game for diabetes, they filled in a questionnaire that included several scales of game experience, patient empowerment and adherence-related behaviors. Multiple regression analysis partially confirmed our hypotheses. First, it pointed out that serious game for health directly supported the patients' empowerment and their therapeutic adherence indirectly. Then, it showed that patients' gender influenced the game-based patient empowerment. To conclude, some relevant theoretical issues concerning the game-based patient education and practical implications about the game design in the healthcare contexts were highlighted.

Creativity is considered to be one of the most important characteristics that humans possess. It emerges from fundamental cognitive operations and the activation of specific brain regions. In several neurological disorders, such as frontotemporal dementia (FTD) and Parkinson's disease (PD), creativity plays an important role in diagnosis and rehabilitation strategies. This study examined the link between creativity and pathology in a sample of neurological patients (idiopathic PD, n = 17; FTD, n = 11 with behavioural or semantic variants), and 15 healthy subjects (Mini Mental State Examination score = 20; age range, 45 to 85 years) using the Divergent Thinking Test. The FTD group exhibited lower scores than the PD and control groups. Furthermore, PD patients performed significantly better on the single DTT factor, "originality," than controls. These results are discussed in relation to neurological mechanisms that may influence creative strategies in dementia. Finally, it has been proposed creativity therapy as a cognitive rehabilitation approach, which may help patients enhance and maintain cognitive functions, reduce the severity of emotional disorders, and promote social interactions.

Collaboration with families and communities has been identified as one of six overarching principles to speech and language therapists' (SLTs') engagement in culturally competent practice (Verdon et al., 2015a). The aim of this study was to describe SLTs' collaboration with families and communities when engaging in practice to support the speech, language and communication of children from culturally and linguistically diverse backgrounds. The study also aimed to identify the benefits and tensions related to such collaborations and to describe opportunities for SLTs to enhance their cultural competence through collaborative practice. The current study drew upon three data sources collected during the "Embracing Diversity--Creating Equality" study: field notes, narrative reflections by the researcher, and semi-structured interviews with SLTs. This study was conducted in 14 international sites across five countries (Brazil, Canada, Hong Kong, Italy and the USA), representing a diverse range of cultural and practice contexts. Cultural-Historical Activity Theory (CHAT, Engeström, 1987) was used as both an heuristic framework through which the study was conceptualized and as a tool for analysis to describe the varied nature of collaboration in different cultural contexts, the benefits of collaborating with families and communities, and the tensions that can arise when engaging in collaborative practice. The results illuminate the importance of SLTs' collaboration with families in order to gain an understanding of different cultural expectations and approaches to family involvement, and to build partnerships with families to work towards common goals. Collaboration with communities was highlighted for its ability to both facilitate understanding of children's cultural context and build respectful, reciprocal relationships that can act as a bridge to overcome often unspoken or invisible tensions arising in cross-cultural practice. The findings of this study highlight opportunities for professionals to enhance the cultural competence of their practice through engagement with families and communities.

The aim of the present study was to compare the effectiveness of cognitive-behavioural (CBT) and psychodynamic (PDT) therapies in the treatment of anxiety among university students. To this aim, the Symptom Questionnaire (SQ) was completed by 30 students assigned to CBT and by 24 students assigned to PDT, both at the beginning and at the end of treatment. The main problem presented by all patients was anxiety. Except for one sub-scale, we observed significant differences in the scores of all sub-scales and scales of SQ, with lower scores at the end of the therapy, indicating lower distress, regardless of the type of treatment. The present findings suggest that both therapies are effective in the treatment of anxiety among university students.

Background: People with schizophrenia show impairments in metacognitive function, including awareness and monitoring of one's mental processes (Self-Reflectivity (SR)), recognition of the fallibility of one's thoughts, and the ability to infer others' emotions and intentions (Theory of Mind (ToM)). The aim of the present study was to explore whether SR and ToM play a key role in influencing the global functioning of persons affected by schizophrenia. Methods: Twenty persons with schizophrenia were recruited before hospital discharge and compared with 17 controls. Clinical, neurocognitive, and global functioning assessments were performed. The Beck Cognitive Insight Scale was used to assess: (1) Self-Reflectiveness, which allows subjects with psychosis to objectively observe their cognitive distortions, and (2) Self-Certainty, which reflects rigid confidence in their own beliefs (over-confidence). ToM assessment included verbal and non-verbal measures. Results: Our study confirms the semi-independent nature of the metacognitive functions of ToM abilities and the cognitive insight domain. In fact, by multiple regression model analyses, only the Self-Reflectiveness deficit was found to be the best predictor of low global functioning in schizophrenia and represents a target for rehabilitation interventions to remediate the processes that cause fallible interpretations of daily events. Conclusions: Our results encourage a new trend in the cognitive-behaviour therapy of schizophrenia to be complemented with metacognitive approaches. (Contains 3 tables.)

Background: The Picture Exchange Communication System (PECS) is a common treatment choice for non-verbal children with autism. However, little empirical evidence is available on the usefulness of PECS in treating social-communication impairments in autism. Aims: To test the effects of PECS on social-communicative skills in children with autism, concurrently taking into account standardized psychometric data, standardized functional assessment of adaptive behaviour, and information on social-communicative variables coded in an unstructured setting. Methods & Procedures: Eighteen preschool children (mean age = 38.78 months) were assigned to two intervention approaches, i.e. PECS and Conventional Language Therapy (CLT). Both PECS (Phases I-IV) and CLT were delivered three times per week, in 30-min sessions, for 6 months. Outcome measures were the following: Autism Diagnostic Observation Schedule (ADOS) domain scores for Communication and Reciprocal Social Interaction; Language and Personal-Social subscales of the Griffiths' Mental Developmental Scales (GMDS); Communication and Social Abilities domains of the Vineland Adaptive Behavior Scales (VABS); and several social-communicative variables coded in an unstructured setting. Outcomes & Results: Results demonstrated that the two groups did not differ at Time 1 (pre-treatment assessment), whereas at Time 2 (post-test) the PECS group showed a significant improvement with respect to the CLT group on the VABS social domain score and on almost all the social-communicative abilities coded in the unstructured setting (i.e. joint attention, request, initiation, cooperative play, but not eye contact). Conclusions & Implications: These findings showed that PECS intervention (Phases I-IV) can improve social-communicative skills in children with autism. This improvement is especially evident in standardized measures of adaptive behaviour and measures derived from the observation of children in an unstructured setting. (Contains 5 tables.)

As the availability of new communication technologies increases, mental health professionals have incorporated these innovations into their practice and research. Up to now several studies have presented promising results in using the power and convenience of the Internet for clinical care. While multiple contributions focus on the potential and the advantages of therapies delivered through the Internet, mental health practitioners may take into account new technological opportunities to improve their practice. Mobile phone diffusion is expanding worldwide at breath-taking speed. In fewer than 20 years, mobile phones have gone from being rare and expensive pieces of equipment used primarily by the business elite, to a pervasive low-cost personal item. In many countries, mobile phones now outnumber land-line telephones, with most adults and many children now owning mobile phones. With high levels of mobile telephone penetration, a mobile culture has evolved, where the phone becomes a key social and cultural tool. The purpose of this paper is to explore the potentialities that mobile phones may offer in clinical care. The paper will investigate in which areas of clinical interventions mobile phones have already been successfully applied. Moreover, the paper will discuss these opportunities by presenting the results of two different studies based on the use of the mobile phone for anxiety management. (Contains 2 tables and 4 figures.)

The training models of two schools of family therapy in Italy are compared on the basis of the logical level of intervention practiced at each school. The relational context in each program, the therapeutic style taught, and selected characteristics of each clinical method are examined. (Author)

Simple Summary: Actinic keratosis (AK) is a premalignant skin lesion caused by chronic sun damage, which usually arises in older people on chronically sun-exposed areas of the body, such as the face, scalp, ears, neck, back of the forearms and hands. Actinic keratosis rarely occurs as a single lesion; most often it can involve multiple lesions in a field of cancerization. Since the AKs may progress to invasive squamous cell carcinoma, treatment of any AK regardless of clinical severity is strongly recommended. The goals of AK therapy are to eradicate clinical and subclinical lesions, prevent the progression into invasive squamous cell carcinoma, provide a good cosmetic outcome and reduce the risk of relapses. Multiple treatment options are available for this condition; however, no gold standard therapy has been established. A novel formulation of 4% 5-Fluorouracil with once daily application proved to be a highly effective and safe treatment for multiple actinic keratoses. Background: Actinic keratosis (AK) is one of the most common skin diseases, with a low risk of progression into invasive squamous cell carcinoma. We aim to assess efficacy and safety of a novel formulation of 5-Fluorouracil (5-FU) 4% with once daily application for the treatment of multiple AKs. Methods: A pilot study was performed on 30 patients with a clinical and dermoscopic diagnosis of multiple AKs, enrolled between September 2021 and May 2022 at the Dermatology Departments of two Italian hospitals. Patients were treated with 5-FU 4% cream once daily for 30 consecutive days. The Actinic Keratosis Area and Severity Index (AKASI) was calculated before starting therapy, and at each follow-up, to assess objective clinical response. Results: The cohort analyzed included 14 (47%) males and 16 (53%) females (mean age: 71 ± 12 years). A significant decrease in AKASI score at both 6 and 12 weeks (p < 0.0001) was observed. Only three patients (10%) discontinued therapy, and 13 patients (43%) did not report any adverse reactions; no unexpected adverse events were observed. Conclusions: In the setting of topical chemotherapy and immunotherapy, the new formulation of 5-FU 4% proved to be a highly effective treatment for AKs and field cancerization. [ABSTRACT FROM AUTHOR]

Background: Chronic respiratory diseases (CRDs) are common diseases with a heterogeneous distribution worldwide. Due to their impact on disability, weight assistance and pharmaceutical spending, they represent an important global burden for national health systems. However, few studies have investigated the use and consumption of inhaled drugs in real life in patients with CRDs. Objective: This study aimed to investigate the real-life consumption of health care resources of main CRDs through an analysis of the administrative databases of the local health authority (ASL) in the Puglia region (Italy). Methods: The present study is an observational study that longitudinally reviewed the administrative and health databases associated with patients' consumption of health resources between 2017 and 2018. Results: The first important finding is a marked underestimation of the true incidence of CRDs despite the search for disease-specific exemption codes. Another important result is that the real-life consumption of inhaled drugs among these patients is well below the minimum acceptable values for adherence. The most commonly used inhaled drugs, for which at least one pack was withdrawn, were inhaled steroids (61.6%), followed by the ICS/LABA combination (43.7%) and LABAs (32.4%). However, less than one-third of patients (31%) withdrew at least three packages of ICS or ICS/LABA during the year, while the percentage was reduced to less than 15% for other combinations. Another alarming finding is that only 8.4% of patients taking CRDs drugs reported at least one spirometry during the study period. Conclusions: The wide availability of computerized systems may be an important tool for increasing therapeutic adherence and optimizing the resources of health systems in the diagnosis, treatment and management of patients with CRDs. [ABSTRACT FROM AUTHOR]

Background: Children with medical complexity need complex assistance, that considerably affects caregivers’ quality of life. They often need multiple medications, with a consequent relevant risk of errors or poor compliance. Galenic (or compounded) drugs are blended in the pharmacy’s laboratory worldwide according to different rules and tailoring the patient’s needs. While their use may sometimes simplify these therapies, little is known about parents’ attitude about this issue. Aim: This study aimed at investigating the complexity of the daily therapy management and exploring the parents’ opinions about galenic compounds. Design: Parents were interviewed by using a structured questionnaire. Setting: Children followed by the Pediatric Palliative Care Network in Friuli Venezia Giulia, Italy, were included from November 2021 to April 2022. Those diagnosed with malignancies were excluded, since therapies are mainly administered through a central venous catheter. Results: Thirty-four parents were interviewed. Fourteen patients took drugs orally, one via nasogastric tube (NGT), 18 via gastrostomy, and one orally + NGT. The mean number of drugs taken every day was six (2–14), in mean 10 (3–18) administrations, that overall required a mean of 44 (8–180) minutes to be delivered. Twenty-eight parents used galenic compounds, and 24 reported relevant advantages, because of a ready-to-use and safe formulation. Conclusions: The therapy management of children with medical complexity relies on parents. Galenic compounds may improve both patients’ and caregivers’ quality of life, either in terms of shorter time of administration or smaller risk of errors. Therefore, their use should be encouraged worldwide, according to the different reference rules. [ABSTRACT FROM AUTHOR]

Background: Subclinical hypothyroidism (SH) management in neonatal age opens important questions. We aimed to describe the evolution over time of subclinical hypothyroidism diagnosed in the first three months of life in a population of full-term neonates. Methods: A single-center longitudinal retrospective cohort study in a tertiary care center was conducted. We recruited 32 subjects with SH diagnosed within the first three months of life. We collected clinical, biochemical, and ultrasound data for every subject at the first examination and every six months until four years of age. Results: A total of 43.8% of subjects showed stimulating thyroid hormone (TSH) levels over the limit of 10 mUI/L and underwent treatment (Group 1). Eleven subjects started therapy at the first visit, while three subjects started it after a period of observation; 15.6% (Group 2A) showed a trend of TSH decrease and were finally discharged from the follow-up, while 40.6% (Group 2B) showed a TSH level slightly increased, changeless over time. Conclusions: We demonstrated that more than half of newborns with hyperthyrotropinemia did not require substitutive therapy showing a positive trend toward normalization or a remaining slight increase compared to normal levels. Moreover, our study suggests the need for a follow-up over time to check the TSH levels course. [ABSTRACT FROM AUTHOR]

Doxycilicine is the second‐line treatment of choice for infectious syphilis when treatment with penicillin G is not feasible. To date, difficulties in the penicillin supply chain make it necessary to evaluate and resort to antibiotic therapies which are currently considered a second‐line choice. Moreover, systematic studies comparing the two treatments in affected patients are still few, and many do not consider late and indeterminate latent infections. The objective of this study was to assess the differences in the serological response of the treatment of syphilis infections with benzathine penicillin compared with doxycycline. We built an in‐house database with all patients diagnosed with syphilis infection from January 2010 to January 2020 in the STD Centre of the S.Orsola‐Malpighi Polyclinic of the University of Bologna, located in the North‐east of Italy. We recorded all the principal independent (demographic, social status, reinfection rare, HIV infections, comorbidities, sexual behaviors, and initial TPHA values) and dependent variables (RPR values). We then extrapolated all patients treated with doxycycline (100 mg of doxycycline twice daily for 14 days for infections diagnosed within the first year and a 28 days course for infections older than 1 year or undetermined) and matched in 1:1 ratio numbers with a homogeneous group of patients treated with penicillin G (2.4 million units in a single dose intramuscularly for infections diagnosed within the first year and a cycle consisting in of 2.4 million units administered in a single dose per week for 3 weeks for infections older than 1 year or undetermined) We then analyzed the serological trends and outcomes in the primary, secondary and early latent groups versus late latent and undetermined infections. We retrieved 41 patients for each group with homogeneous initial characteristics. At the end of the 24‐month observation period, a slight difference in a valid RPR reduction rate emerged, with a greater success rate emerged in patients receiving penicillin than those with doxycycline (26 vs. 22, p 0.615). Indeed, patients with latent or indeterminate syphilis treated with doxycycline appear to have a higher rate of serofast than those treated with penicillin. Linear regression analysis showed no strong correlation between the analyzed independent variables and the observed outcomes. Doxycycline had a slightly lower, though not statistically different, success rate when compared with penicillin in treating primary syphilis, but appeared to have a reduced success rate in attaining resolution in late and undetermined syphilis infection. [ABSTRACT FROM AUTHOR]

Background: The reason why some multiple sclerosis (MS) patients show disease activity after alemtuzumab (ALM) is still unclear, but ocrelizumab (OCR) could represent an interesting sequential therapeutic approach., Objectives: To investigate safety and efficacy of OCR in MS patients with disease activity after two ALM courses., Methods: Observational retrospective multi-centers Italian cohort study., Results: Seventy-two subjects were included. Mean follow-up (FU) was 2.4 (±1) years. Forty-five patients (62.5%) experienced at least one adverse event (AE), with infections accounting for 96.7% of cases. A reduction in total lymphocytes was observed between OCR start and 6 months FU, driven by BCD19+ lymphocytes depletion ( p < 0.001). Immunoglobulin M (IgM) levels decreased between OCR start and 6 months FU ( p < 0.001). At 2-year FU, relapse, magnetic resonance imaging (MRI) activity and disability worsening-free survival were 92.1%, 90.8%, and 89.2%. The evidence of inflammatory activity between the two ALM courses was associated with higher risk of relapse, MRI activity, and NEDA-3 status loss in relapsing-remitting multiple sclerosis (RRMS; p = 0.02, p = 0.05, p = 0.01, respectively)., Conclusions: OCR after two ALM courses seemed to be safe and effective. Early IgM hypogammaglobulinemia occurred in a high proportion of patients. The evidence of inflammatory activity between ALM courses seemed to increase the risk of MS re-activation on OCR treatment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: C. Lapucci has received honoraria for speaking, travel grants, and for participating in the advisory board from Merck, Sanofi, Novartis, Roche, Alexion. J. Frau served on scientific advisory boards for Biogen and Genzyme, and has received honoraria as a speaker from Merck Serono, Genzyme, Biogen, and Teva. E. Cocco reported grants, personal fees, and non-financial support from Biogen and Merck; personal fees and non-financial support from Novartis; grants from Roche; and personal fees from Genzyme. G. Coghe received honoraria for consultancy or speaking from Biogen, Novartis, Sanofi, Genzyme, Serono, Teva, and Almirall. M. Petracca has received travel/meeting expenses from Novartis, Janssen, Roche, and Merck; speaking honoraria from HEALTH&LIFE S.r.l., AIM Education S.r.l., Biogen, Novartis, and FARECOMUNICAZIONE E20; honoraria for consulting services and advisory board participation from Biogen; research grants from Baroni Foundation and the Italian Ministry of University and Research. R. Lanzillo has received honoraria from Biogen, Merck, Novartis, Roche, and Teva. V. Brescia Morra has received research grants from the Italian MS Society and Roche, and honoraria from Bayer, Biogen, Merck, Mylan, Novartis, Roche, Sanofi-Genzyme, and Teva. C.G. Nicoletti received travel funding from Biogen, Merck Serono, Sanofi-Genzyme, Roche, Teva, Novartis, Bristol Mayer Squibb, Janssen, Almirall and consultation fees from Sanofi, Almirall, Merck- Serono, Roche, Novartis, and Biogen. She is a sub-investigator in clinical trials being conducted for Biogen, Merck Serono, Roche, Biogen, Sanofi, Novartis, Teva, Bristol Mayer Squibb. D. Landi has received travel funding from Biogen, Merck Serono, Sanofi, Teva, Bristol Myers Squibb, Mylan; speaking or consultations fees from Sanofi, Merck Serono, Teva, Biogen, Roche, Novartis, Bristol Myers Squibb, BayerSchering. G. Marfia has received travel funding, speaking or consultation fees from Almirall, Bayer-Schering, Biogen, Sanofi, Merck Serono, Novartis, Teva, Mylan, Bristol Mayers Squibb and research grants from Roche and Biogen. M. Vercellino has received congress grants, speaker fees and advisory board fees from Merck-Serono, Novartis, Roche, Biogen, Sanofi Genzyme. P. Cavalla has received honoraria as speaker or travel grants to attend national and international conferences or consultation for advisory boards from Alexion, Almirall, Bayer Schering, Biogen, Cellgene-BMS, Merck-Serono, Teva, Roche, Novartis, Sanof-Genzyme, and Janssen. A. Bianco has received honoraria for speaking, advisory board/consulting from Biogen, Novartis, Merck Serono, Roche, Sanofi Genzyme. M. Mirabella has received honoraria for speaking, advisory board/consulting from Biogen, Novartis, Merck Serono, Roche, Almirall, Sanofi Genzyme, Janssen, Bristol-Myers Squibb, Viatris, Alexion. He is principal investigator in clinical trials for Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, CSL Behring, Ultragenix, Argenx. V. Torri Clerici acted as an Advisory Board member of Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Almirall, Lundbeck and Bristol Myers Squibb; she received funding for traveling and honoraria for speaking or writing from Novartis, Sanofi Genzyme, Horizon, Merck Serono, Roche, Bristol Myers Squibb, Janssen and Almirall. She received support for research project by Almirall. E. Tomas received funding for work contract from Roche. M.T. Ferrò has received consultancy fees or speaker compensation from Sanofi, Bristol, Biogen Idec, and Novartis. L. Moiola has received honoraria for speaking and for participating in advisory board from Merck, Celgene, Biogen, Sanofi, Novartis, Roche, Alexion. M. Zaffaroni has received advisory board membership, speakers honoraria, travel support, research grants, consulting fees or clinical trial support from Actelion, Almirall, Bayer Schering, Biogen, Celgene, Excemed, Genzyme, Merck, Novartis, Sanofi, Roche, Teva. M. Ronzoni has received travel grants for congresses participation from Biogen, Genzyme, Novartis e Merck. G. Novi has received speaker honoraria from Merck, Novartis, Roche, Alexion. M. Cellerino has received consulting fees from Novartis, Genzyme, Teva and Zambon. A. Uccelli has received grants (to his institution) from FISM, Biogen, Roche, Alexion, and Merck Serono and has participated on a data safety monitoring board or advisory board (to his institution) for BD, Biogen, Iqvia, Sanofi, Roche, Alexion, and Bristol Myers Squibb. M. Inglese received grants from NIH, NMSS, and FISM; received fees for consultation from BMS, Janssen, Roche, Genzyme, Merck, Biogen and Novartis. P. Grossi, A. Nozzolillo, and F. Pinardi have nothing to disclose.

Hidradenitis Suppurativa (HS) often causes severe impairment of the quality of life of patients affected, as it is characterized by recurrent relapses of inflammation and predisposes to retractive scars, with severe alteration of anatomy of the affected regions. Adalimumab is currently the only approved long-term biological therapy for this disease. We retrospectively review the data of HS patients treated with Adalimumab at the 'Hidradenitis Suppurativa Clinic', University of Ferrara, Italy since the drug was first available to October 2020. The aim is to describe our real-life experience in a clinical outpatient service. We assessed the main demographic features, therapy duration, reasons of suspension and efficacy (evaluated by HiSCR – Hidradenitis Score) in relation to surgical procedures, hospitalization, number of areas involved by the disease and BMI > 30. We also assessed the aspects related to the use of adalimumab's biosimilar. Data on 76 patients, with a mean age of 38.26 ± 14.74 years and mean BMI 28.10 ± 5.92 were collected. Most of the treated patients had Hurley stage III (58/76); mean Sartorius score was 115.5 ± 55.86, mean IHS4 was 76.1 ± 44.3. A statistically significant correlation between hospitalization and cessation of adalimumab, the loss of the achievement of the HiSCR, and surgery was found. No need to do surgery was a protective factor against the failure of adalimumab treatment, meaning that the most severe cases are more likely to fail the biological therapy. New scenarios are opening up in clinical practice: the arrival of biosimilars allow greater sustainability of expenditure, while the anti-IL17 allow the patient who has failed therapy with adalimumab a valid and safe therapeutic option to be undertaken. A comprehensive care including hospitalization, a specific antibiotic therapy and surgical treatment is often mandatory to achieve a satisfactory control of the disease. [ABSTRACT FROM AUTHOR]

The aim of this study is to present a series of case studies on the real-life use of pegvaliase in Italy in managing patients affected by phenylketonuria (PKU) and provide practical insight and support to healthcare professionals currently approaching and facing this novel enzyme substitution therapy. A panel of 11 PKU experts from seven leading Italian treatment centers attended online virtual meetings with the aim of reviewing their clinical and practical experiences with pegvaliase based on occurred cases. In selecting the cases, specific consideration was given to the nationwide representation of the centers involved and to the number of patients with PKU managed. Cases were thoroughly reviewed, with comprehensive discussions enabling the identification of key take-home messages regarding pegvaliase therapy. The panel discussed 18 cases, 11 males and 7 females (age range 17–43 years). At the last follow-up (up to 111 weeks after pegvaliase initiation), 11 out of 18 patients (61%) reached Phe levels below 600 μmol/l. Outcomes varied significantly across cases. All cases underscore the potential of pegvaliase in reducing Phe levels, enhancing the quality of life, and promoting social skills and independence. Additionally, the cases highlight the challenges associated with pegvaliase therapy, including managing adverse events and ensuring patient motivation and adherence. This is the first report about the Italian experience of managing patients affected by PKU with pegvaliase. Given the limited real-world data on the use of pegvaliase in PKU management, this case series offers valuable insights into the practical implementation and management of pegvaliase therapy in this Country. Continued research and data collection will be crucial to confirm and progress with this treatment. Despite potential challenges, pegvaliase therapy represents a substantial promise in managing PKU in Italy. Patient education, personalized treatment approaches, and careful monitoring are important to ensure optimal patient outcomes. [ABSTRACT FROM AUTHOR]

Background: In adult population, Growth Hormone Deficiency (GHD) is a complex clinical condition with heterogeneity of causes and duration. Growth Hormone (GH) replacement therapy has beneficial effects entailing a chronic and expensive use. Therefore, entity, appropriateness and standardization of GHD treatment need to be accurately analysed. In Italy, the epidemiological surveillance on somatropin therapy is entrusted to the National Register of Growth Hormone Therapy (Registro Nazionale degli Assuntori dell'Ormone della Crescita-RNAOC) by the Italian Regulation, in accordance of which the RNAOC-database is collecting the notifications of somatropin prescriptions. Methods: Aim of this study is to analyse data on somatropin-treated adult population communicated to the RNAOC by the specialist centres of 15 Italian regions and 2 autonomous provinces. Results: From 2011 to 2019, the somatropin-treated adults were 970 with 4061 examinations (1.21 ± 0.33 visits/year). The diagnoses were: hypopituitarism (n = 579); hypophysectomy (n = 383); and congenital GHD (n = 3). Five subjects were addressed with diagnoses not included in the regulation. The starting posology of somatropin was 0.320 (± 0.212) mg/day, 0.292 (± 0.167) mg/day in male and 0.360 (± 0.258) in female patients, with 7 administrations/week in 70.31% of the prescriptions. The differences in posology by gender persisted at 10th year of the follow-up. Starting dosage was higher in patients diagnosed with adult GHD before the age of 30 (0.420 ± 0.225 mg/day), with a progressive decrease of the dosage during the follow-up. Conclusions: This is the first report on adult GH treatment, describing numbers, diagnoses, and pharmaceutical prescriptions associated to somatropin therapy in a large cohort of Italian GHD-adults. [ABSTRACT FROM AUTHOR]

Background: Non-tuberculous mycobacteria (NTM) are generally free-living organism, widely distributed in the environment, with sporadic potential to infect. In recent years, there has been a significant increase in the global incidence of NTM-related disease, spanning across all continents and an increased mortality after the diagnosis has been reported. The decisions on whether to treat or not and which drugs to use are complex and require a multidisciplinary approach as well as patients' involvement in the decision process., Methods and Results: This review aims at describing the drugs used for treating NTM-associated diseases emphasizing the efficacy, tolerability, optimization strategies as well as possible drugs that might be used in case of intolerance or resistance. We also reviewed data on newer compounds highlighting the lack of randomised clinical trials for many drugs but also encouraging preliminary data for others. We also focused on non-pharmacological interventions that need to be adopted during care of individuals with NTM-associated diseases CONCLUSIONS: Despite insufficient efficacy and poor tolerability this review emphasizes the improvement in patients' care and the needs for future studies in the field of anti-NTM treatments., (© 2024. The Author(s).)

Objective: This study aimed to assess the long-term outcome of patients with acromegaly., Design: This is a multicenter, retrospective, observational study which extends the mean observation period of a previously reported cohort of Italian patients with acromegaly to 15 years of follow-up., Methods: Only patients from the centers that provided information on the life status of at least 95% of their original cohorts were included. Life status information was collected either from clinical records or from the municipal registry offices. Standardized mortality ratios (SMRs) were computed comparing data with those of the general Italian population., Results: A total of 811 patients were included. There were 153 deaths, with 90 expected and an SMR of 1.7 (95% CI 1.4-2.0, p < 0.001). Death occurred after a median of 15 (women) or 16 (men) years from the diagnosis, without gender differences. Mortality remained elevated in the patients with control of disease (SMR 1.3, 95% CI 1.1-1.6). In the multivariable analysis, only older age and high IGF1 concentrations at last available follow-up visit were predictors of mortality. The oncological causes of death outweighed the cardiovascular ones, bordering on statistical significance with respect to the general population., Conclusions: Mortality remains significantly high in patients with acromegaly, irrespectively of disease status, as long as the follow-up is sufficiently long with a low rate of patients lost to follow-up. Therapy strategy including radiotherapy does not have an impact on mortality. Oncological causes of death currently outweigh the cardiovascular causes., (© 2024. The Author(s).)

Introduction: This cross-sectional study was aimed at estimating the number of Italian incident cancer patients in 2020 eligible for, and respondent to, immune checkpoint inhibitors (ICI)., Methods: The study is based on publicly available data: the ICI approved until August 2022 by the Italian Medicines Agency (AIFA) with their specific indications and overall observed responses, rther details can be found in the Online Supplementary Materi cancer incidence estimates at 2020 and observed cancer deaths, and published papers with estimates on the frequency of different cancer stage/histology/markers etc. corresponding to AIFA authorizations., Results: In the analyzed period, a total of seven ICI were authorized in Italy for 20 cancer types. The estimated number of ICI-eligible patients in 2020 was 48,400, 14.3% of those tumors (including skin epitheliomas) that may fit AIFA-indications, and 10.5% of all the incident malignant tumors, including skin epitheliomas. The number of patients who may benefit from ICI therapy was 24,052, 49.7% of the ICI-eligible ones, or 5.2% of the overall estimated incident cancers in 2020., Conclusions: In conclusion, although the number of ICI-eligible patients is a relatively small proportion of the yearly burden of cancers, about half of them may respond to ICI-treatment., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Dimethyl fumarate (DMF) is a fumaric acid esters derivate approved for plaque psoriasis as first‐line systemic therapy. It has been available in Italy since 2017 and an increasing number of patients are treated with this drug. To evaluate DMF effectiveness, side effects and drug survival in a dermatological real‐life setting. We performed a retrospective multi‐center study in five dermatologic clinics in Emilia‐Romagna, Northern Italy, which included all consecutive patients affected by moderate–severe psoriasis treated with DMF. We assessed effectiveness (in terms of PASI50 and PASI75 in an intention to treat observation) and safety (occurrence of side effects) of DMF and their association with demographic and disease characteristics, mean daily dose taken and treatment discontinuation. We included 103 patients, 78 (75.72%) had at least one comorbidity including 19 (18.44%) with a history of cancer; the mean treatment duration was 23.61 ± 17.99 weeks (min 4, max 130) and the mean daily dose was 262.13 ± 190.94 mg. Twenty‐four patients (23.30%) reached PASI75 at week 12, while a further 18 patients (17.47%) reached it at week 26. Side effects occurred in 63 patients (61.16%), the most frequent were diarrhea, epigastric discomfort, nausea, and flushing. Sixteen patients (15.53%) showed an alteration of laboratory tests. In some cases side effects were transitory, while in 53 patients (51.45%) they led to cessation of therapy. The median daily dose showed a direct association with PASI50 achievement and an indirect association with treatment discontinuation. Our study shows the peculiarities of DMF in a real‐world setting: effectiveness is often reached after 12 weeks of treatment and side effects could limit the continuation of the therapy but, at the same time, DMF has no major contraindications and, due to the wide range of dosage, it can allow both to manage side effects and to personalize the prescription for each patient. [ABSTRACT FROM AUTHOR]

The aim of this pilot, feasibility study was to assess health improvements in 16 institutionalized older people with Alzheimer's disease, after the Biodanza intervention, a nonpharmacological dance movement-based treatment. Biodanza significantly decreased agitated and neuropsychiatric behaviors. Effectiveness studies will be performed in order to assess the implication of such interventions. [ABSTRACT FROM AUTHOR]

Although chronic lymphocytic leukemia (CLL) predominantly affects the elderly, limited data exists about the outcomes of over 80-year-old patients, usually underrepresented in clinical trials. We conducted a multicenter study enrolling 79 consecutive CLL patients ≥80 years at the time of frontline therapy, all treated with ibrutinib. Nearly 48% of cases exhibited unmutated IGHV genes, 32% 17p deletion, and 39.2% TP53 mutations; 63.3% displayed a cumulative illness rating scale (CIRS) > 6. The overall response rate on ibrutinib, computed in 74/79 patients (5 patients excluded for early withdrawal), was 89.9%. After a median follow-up of 28.9 months, the median progression-free survival (PFS) and overall survival (OS) were 42.5 and 51.8 months, respectively. CIRS>6 and temporary discontinuation of ibrutinib lasting for 7-30 days were the only parameters associated with a significantly shorter PFS and were both relevant in predicting a shorter PFS compared to patients with CIRS≤6 and therapy discontinuation ≤7 days. The most common grade≥3 adverse events were infections (25.5%), neutropenia (10.1%), and anemia (2.5%). Eighteen patients (22.8%) experienced a cardiovascular event, including grade-2 atrial fibrillation (n = 9; 11%), grade-2 hypertension (n = 5; 6%), heart failure (n = 3; 3%), and acute coronary syndrome (n = 1; 1%). Mild bleeding events were observed in 27 patients (34.2%). Ibrutinib was permanently discontinued in 26 patients due to progressive disease (n = 11, including 5 Richter's syndromes), secondary malignancies (n = 6), infections (n = 3), cardiac failure (n = 3), severe bleeding (n = 2), and sudden death (n = 1). In conclusion, our analyses confirmed the overall effectiveness and favorable safety profile of the ibrutinib-single agent therapeutic approach in CLL patients ≥80 years., (© 2024 The Authors. Hematological Oncology published by John Wiley & Sons Ltd.)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19), which has rapidly become epidemic in Italy and other European countries. The disease spectrum ranges from asymptomatic/mildly symptomatic presentations to acute respiratory failure. At the present time the absolute number of severe cases requiring ventilator support is reaching or even surpassing the intensive care unit bed capacity in the most affected regions and countries. To narratively summarize the available literature on the management of COVID-19 in order to combine current evidence and frontline opinions and to provide balanced answers to pressing clinical questions. Inductive PubMed search for publications relevant to the topic. The available literature and the authors' frontline-based opinion are summarized in brief narrative answers to selected clinical questions, with a conclusive statement provided for each answer. Many off-label antiviral and anti-inflammatory drugs are currently being administered to patients with COVID-19. Physicians must be aware that, as they are not supported by high-level evidence, these treatments may often be ethically justifiable only in those worsening patients unlikely to improve only with supportive care, and who cannot be enrolled onto randomized clinical trials. Access to well-designed randomized controlled trials should be expanded as much as possible because it is the most secure way to change for the better our approach to COVID-19 patients. [ABSTRACT FROM AUTHOR]

Introduction: A real-world study was performed to describe the clinical characteristics of patients who received dapagliflozin to better understand differences when initiating dapagliflozin in various countries and different prescribing settings. Methods: We assessed pooled data from observational studies carried out in Italy (n = 2484), Spain (n = 564) and Greece (n = 87). The primary objective was to compare the clinical profile of patients initiating dapagliflozin in the three countries. We also evaluated the percentage of patients who received dapagliflozin in clinical practice who satisfied DECLARE-TIMI 58 enrolment criteria. Results: In Italy and Spain, around 90% of patients were receiving metformin vs. 66% in Greece (p < 0.0001). Patients in Greece had lower levels of estimated glomerular filtration rate and lower prevalence rates of retinopathy, prior stroke, acute myocardial infarction, peripheral arterial disease and atherosclerotic cardiovascular disease. Grouping the cohorts by prescribing setting (primary vs. specialist care), baseline HbA1c was lower in primary care (8.4 ± 1.7 vs. 8.7 ± 1.5, respectively; p < 0.0001). Significantly more patients were receiving other medications for concomitant conditions in specialist care. A total of 1416 patients (48%) did not meet DECLARE inclusion criteria, while 1561 (52%) patients met the criteria (Greece 41.05%, Italy 53.19%, Spain 51.35%). Conclusions: Significant differences were seen among patients initiating dapagliflozin in southern Europe. Our results suggest that dapagliflozin was being initiated at different stages of the disease according to the country and prescribing settings. Such geographic heterogeneity may have an impact upon effectiveness of dapagliflozin on glucose lowering, as well as cardiovascular and renal outcomes. [ABSTRACT FROM AUTHOR]

Dance and movement therapy is about the creative use of movement and dancing in a therapeutic alliance. The present study analysis semi-structured interviews from people connected to young people with Down's syndrome. Our subjects practiced dances like ballet, zumba, vals, tango and also therapeutic movement. Some of them proved their skills in events specially organized for people with disabilities, but also in inclusive events, where they danced together with professional dancers, in Romania, Republic of Moldavia and Italy. The effects of dancing include increased selfesteem, relaxation, social inclusion, improved learning skills; they also developed social skills, because they met a lot of people in different social contexts. [ABSTRACT FROM AUTHOR]