Changing lifestyle of persons with multiple sclerosis : development, feasibility and preliminary results of a novel high-impact collaborative intervention in leisure environments

Objective: Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation (MDR) because of poor support, knowledge and motivation. We reasoned that pwMS should be more effectively prepared to increase their adherence. We implemented an innovative collaborative approach, called “brief highimpact preparatory experience” (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS. Methods: B-HIPE integrates physiotherapy, mindfulness, sailing, healthy diet, and cultural activities to be experienced in a convivial form at a beautiful seaside location in Sardinia. Sixteen pwMS participated to 3 successive one-week editions of the b-HIPE, co-sponsored by the Rotary Club of Milan and supported by researchers of our Institute and of partner associations. The feasibility was assessed with structured questionnaires and free reports concerning accommodation, logistics, coordination, social climate and the specific activities proposed. For this pilot study we used a single-group design with repeated measurements at baseline and post-intervention. The SF-36 QoL scale was the main outcome measure, the Fatigue Severity Scale (FSS), the Berg Balance scale (BBS) and the 9 hole peg test (9HPT) were the secondary outcomes. Results: The approach was feasible. Scores on several FS-36 scales and secondary outcomes were significantly improved. Participants’ satisfaction with all aspects of the experience was above expectations. PwMS became more motivated and aware of physical and mental resources, all learned to sail adapted monohulls, strategies to master stress and to modify their diet according to specific recommendations. Conclusion: B-HIPE is safe and feasible. The interplay of multiple factors produced in a very short time the expected changes in participants’ attitude toward a healthier lifestyle. A monitoring program is ongoing to assess long-term effects including adherence to hospital-based MDR.Publisher PDFPeer reviewe

Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis

Introduction Natalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended dosing strategy compared with standard 4-weekly administration in a large Italian MS population. Materials and methods This retrospective multicentre study included patients with relapsing-remitting MS (RR-MS) who received NTZ administrations between the 1 June 2012 and the 15 May 2018 and were followed by the ’Italian MS Register’. All patients with MS were stratified into two groups based on NTZ administration schedule: standard interval dosing (SID) patients who received infusions on average from 28 to 32 days (median 30) and extended interval dosing (EID) including patients who have been infused with interval between 33 and 49 days (median 43). Clinical data were assessed at baseline (before starting NTZ), after 12 (T1) and 24 months (T2) of treatment. Results Out of 5231 patients with RR-MS screened, 2092 (mean age 43.2±12.0, 60.6% women) were enrolled. A total of 1254 (59.9%) received NTZ according to SID, and 838 (40.1%) according to EID. At 12 and 24 months, no differences in terms of annualised relapse rate and disability status were found between the two groups. Progression index and confirmed disability worsening were similar between the two groups. Discussion The use of NTZ with an extended interval schedule showed similar effectiveness compared with SID. Unchanged clinical efficacy of EID schedule may raise the question of a possible advantage in terms of tolerability and safety

COVID-19 Severity in Multiple Sclerosis: Putting Data Into Context

Background and objectives: It is unclear how multiple sclerosis (MS) affects the severity of COVID-19. The aim of this study is to compare COVID-19-related outcomes collected in an Italian cohort of patients with MS with the outcomes expected in the age- and sex-matched Italian population. Methods: Hospitalization, intensive care unit (ICU) admission, and death after COVID-19 diagnosis of 1,362 patients with MS were compared with the age- and sex-matched Italian population in a retrospective observational case-cohort study with population-based control. The observed vs the expected events were compared in the whole MS cohort and in different subgroups (higher risk: Expanded Disability Status Scale [EDSS] score > 3 or at least 1 comorbidity, lower risk: EDSS score ≤ 3 and no comorbidities) by the χ2 test, and the risk excess was quantified by risk ratios (RRs). Results: The risk of severe events was about twice the risk in the age- and sex-matched Italian population: RR = 2.12 for hospitalization (p < 0.001), RR = 2.19 for ICU admission (p < 0.001), and RR = 2.43 for death (p < 0.001). The excess of risk was confined to the higher-risk group (n = 553). In lower-risk patients (n = 809), the rate of events was close to that of the Italian age- and sex-matched population (RR = 1.12 for hospitalization, RR = 1.52 for ICU admission, and RR = 1.19 for death). In the lower-risk group, an increased hospitalization risk was detected in patients on anti-CD20 (RR = 3.03, p = 0.005), whereas a decrease was detected in patients on interferon (0 observed vs 4 expected events, p = 0.04). Discussion: Overall, the MS cohort had a risk of severe events that is twice the risk than the age- and sex-matched Italian population. This excess of risk is mainly explained by the EDSS score and comorbidities, whereas a residual increase of hospitalization risk was observed in patients on anti-CD20 therapies and a decrease in people on interferon

DMTs and Covid-19 severity in MS: a pooled analysis from Italy and France

We evaluated the effect of DMTs on Covid-19 severity in patients with MS, with a pooled-analysis of two large cohorts from Italy and France. The association of baseline characteristics and DMTs with Covid-19 severity was assessed by multivariate ordinal-logistic models and pooled by a fixed-effect meta-analysis. 1066 patients with MS from Italy and 721 from France were included. In the multivariate model, anti-CD20 therapies were significantly associated (OR = 2.05, 95%CI = 1.39–3.02, p < 0.001) with Covid-19 severity, whereas interferon indicated a decreased risk (OR = 0.42, 95%CI = 0.18–0.99, p = 0.047). This pooled-analysis confirms an increased risk of severe Covid-19 in patients on anti-CD20 therapies and supports the protective role of interferon

HOW TO ENHANCE THEORY OF MIND IN MULTIPLE SCLEROSIS? FROM THE LITERATURE TO THE DEVELOPMENT OF A NOVEL CULTURAL INTERVENTION

La Teoria della Mente (ToM), la capacità cognitiva di riuscire a rappresentare ed interpretare gli stati mentali propri e altrui al fine di prevederne in comportamento, risulta essere deficitaria nella Sclerosi Multipla (SM), patologia cronica neurodegenerativa. La messa a punto e l’implementazione di un training di potenziamento di questa abilità sociale in questi pazienti è di rilevante importanza in quanto la ToM è strettamente connessa alla loro qualità della vita. Dato che ad oggi non esistono training di potenziamento della ToM nella SM, obiettivo primario della tesi è stata l’indagine relativa ai training di cognizione sociale attualmente esistenti in altre patologie croniche dell’età adulta. E’ stata effettuata una revisione sistematica ed una meta-analisi dei training attualmente esistenti per i soggetti con schizofrenia dato che questi soggetti presentano caratteristiche demografiche simili ai soggetti con SM. Si è quindi progettato un training di potenziamento della ToM da proporre ad un sample di soggetti con SM; prima di valutarne l’efficacia è stato condotto uno studio di accettabilità del suddetto training, al fine di superare potenziali barriere per la sua fattibilità. Si è infine proceduto all’esecuzione del terzo lavoro scientifico, ovvero la valutazione dell’efficacia del suddetto training sulla ToM in soggetti affetti da SM.Theory of Mind (ToM) is the ability of recognition and mental states' attribution to predict future behaviors. ToM deficit is well recognized in MS; hence, ToM training in this population is relevant because ToM is strictly connected with quality of life of people with multiple sclerosis (pwMS). To our knowledge, there is no training established for the treatment in this population. For this reason, we proposed to investigate the efficacy of social cognition training in other adults with chronic disease. We conducted a systematic review and a meta-analysis of SC training in schizophrenia, given that these subjects present demographic characteristics similar to pwMS. Hence, we design a rehabilitation ToM training for pwMS; before evaluating its efficacy, we conducted an acceptability study to overcome potential barriers for its feasibility. Lastly, we implement this novel rehabilitation training testing its efficacy on ToM in pwMS

Premature ejaculation among men with erectile dysfunction-findings from a real-life cross-sectional study

: Concomitant sexual disorders have progressively shown increased prevalence in men at first outpatient presentation. We sought to i) estimate the prevalence of unreported premature ejaculation (PE) in a homogenous cohort of 1258 men seeking first medical help for erectile dysfunction (ED) as their primary compliant; ii) compare the baseline sociodemographic and clinical characteristics of men with only ED(ED-only) compared to those with ED and PE(ED + PE); and, iii) investigate the likelihood of detecting PE among men self-reporting only ED over a 16-year period at a single tertiary-referral centre. Descriptive statistics compared sociodemographic and clinical characteristics between ED-only patients and those with unreported concomitant primary/secondary PE(ED + PE). Logistic regression models predicted the risk of having ED + PE at baseline. Local polynomial regression models graphically explored the probability of reporting PE among ED men with ≤40 vs. 41-60 vs. >60 years over the analysed timeframe. Of all, 932 (74.1%) were ED-only and 326 (25.9%) ED + PE patients, respectively. ED + PE patients were younger, presented with fewer comorbidities, and lower rates of severe ED (all p ≤ 0.04). At multivariable logistic regression analysis, younger age (OR:0.98) and low sexual desire/interest (OR:1.54) were independently associated with ED + PE at first clinical assessment (all p = 0.03). The likelihood of detecting unreported concomitant primary/secondary PE among patients complaining of only ED at first presentation worrisomely increased among younger and middle-aged men over the last 16 years

Cancer risk for multiple sclerosis patients treated with azathioprine and disease-modifying therapies: an Italian observational study

BACKGROUND: The risk of malignancy associated with sequential disease-modifying therapies (DMTs) for patients with multiple sclerosis (MS) is uncertain. The aim of this study was to analyze the risk of cancer in patients with MS treated with azathioprine (AZA) and the influence of sequential DMTs on the risk.METHOD: We retrospectively enrolled a cohort of AZA-treated MS patients followed in two Italian centers from 1987 to 2019. The ratio between observed and expected cancers in the Italian general population was calculated as standardized incidence ratio (SIR). Associations between AZA and DMTs and cancer were estimated by Cox proportional hazards model.RESULTS: We identified 500 AZA-treated MS patients, followed for a median time of 9.7 (0.1-45.7) years: 61.8% of them were treated with DMTs. We found 22 cases of cancer (4.4%). The SIR was 1.14 (95% CI 0.98-1.29), not significantly increased in comparison with the general population. However, the risk was significantly higher in the quintiles of age 32-45, SIR 1.21 (95% CI 1.21-1.42), and 46-51, SIR 1.11 (95% CI 1.11-1.32) than in older cases. Age at AZA treatment onset was the only covariate significantly related to cancer incidence (HR = 1.049, 95% CI 1.007-1.093). The exposure to other DMTs did not modify the risk.CONCLUSION: The risk of malignancy in MS patients after AZA was similar to that of the general population and did not change with other DMTs sequential treatments. The increased risk in the younger ages should be considered in treatment assessment

PDE5is-naïve versus non-naïve patients at first investigation for erectile dysfunction-findings from a long-term, real-life cross-sectional study

Background Phosphodiesterase 5 inhibitors (PDE5is) represent a first-line pharmacological therapy for erectile dysfunction (ED). Men could obtain PDE5is for recreational purposes without any proper medical prescription. Objective We aimed to analyze clinical characteristics of patients who already used any PDE5i for ED without previous formal medical prescription. Materials and methods Data from 2012 heterosexual, sexually active men seeking first medical help for ED at our outpatient clinic between 2005 and 2022 were analyzed. All patients were assessed with a comprehensive sexual and medical history and completed the International Index of Erectile Function (IIEF) at baseline. Comorbidities were scored with the Charlson comorbidity index (CCI). Thereof, according to exposure to any PDE5i before their first visit, patients were subdivided into: PDE5i-naive and non-PDE5i-naive patients. Descriptive statistics tested the sociodemographic and clinical characteristics of both groups. A logistic regression model predicted the likelihood of being PDE5i-naive at the baseline. Linear regression analysis (LRA) estimated the likelihood of being PDE5i-naive versus non-PDE5i-naive over the analyzed timeframe. Lastly, local polynomial regression models graphically explored the likelihood of being PDE5i-naive at the first clinical assessment over the analyzed timeframe, and the sensitivity analyses tested the probability of being PDE5i-naive at baseline. Results Overall, 1,491 (70.9%) patients were PDE5i-naive and 611 (29.1%) were non-PDE5i-naive at the first assessment. PDE5is-naive patients were younger, with a lower prevalence of CCI >= 1 and of normal erectile function (EF) than non-PDE5i-naive men (all p < 0.05). Multivariable logistic regression found that patients with lower BMI (OR: 0.99), higher IIEF-EF scores (OR: 1.02), lower rates of severe ED (OR: 0.94), and who had been assessed earlier throughout the study timeframe (OR: 1.27) were less likely to be PDE5i-naive at baseline. Univariate LRA revealed that younger patients (Coeff: -0.02), with lower CCI (Coeff: -0.29) and higher alcohol intake per week (Coeff: 0.52) were more likely to be PDE5i-naive over the analyzed timeframe. Moreover, for the same IIEF-EF score, patients with higher CCI had lower probability of being PDE5i-naive. Conclusions Self-prescription of PDE5is is an attitude presents in the general population, despite this phenomenon has decreased overtime. Current data outline the importance to keep promoting educational campaigns to promote PDE5is as effective and safe medicinal products, while avoiding their improper use

The symptomatic burden of Peyronie's disease at presentation according to patient age: A critical analysis of the Peyronie's disease questionnaire (PDQ) domains

Background: Peyronie's disease (PD) has a huge impact on patients' physical and psychological wellbeing. Objectives: To investigate whether patients' age has an impact on PD symptomatic burden at first presentation. Materials and methods: Data from 129 consecutive heterosexual patients seeking first medical attention for PD at a single andrological tertiary-referral centre were collected. All patients completed the International Index for Erectile Function (IIEF) and the PD questionnaire (PDQ). Descriptive statistics were used to compare clinical features between younger (≤40years) and older (>40 years) patients. Multivariable linear model assessed the impact of age, the degree of penile curvature and their impact on PDQ (total scores and its domains), after adjusting for PD duration and IIEF-erectile function domain scores. Results: Of 129, 24 (18.6%) patients were ≤40 years old. Young patients presented with a less severe curvature than older patients (median [interquartile ranges] 20° [15-36] vs. 50° [40-80]; p = 0.04). However, younger age was associated with higher psychological and physical symptoms, PDQ-penile pain and PDQ-symptom bother scores (Coeff -0.11, -0.21 and -0.17, respectively) (all p < 0.05). Moreover, the greater the degree of curvature, the higher the PDQ-psychological and physical symptoms and the PDQ-symptom bother scores (Coeff. 0.21 and 0.22, respectively; all p < 0.05). Conclusion: Around one in five men seeking first medical help for PD is younger than 40 years at presentation in the real-life setting. PD-related distress varies according to patients' age, with younger men presenting with a greater risk of penile pain and symptom bother despite lower curvature