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Background Immune checkpoint inhibitors (ICIs) represent an effective cancer immunotherapy yet are associated with immune-related adverse events (irAEs). The aim of this study was to characterize irAEs involving the peripheral nervous system (PNS-irAEs) in a real-world cohort of ICI-treated patients. Methods Cancer patients treated with ICIs between January 2014 and March 2022 were included. Patients with PNS-irAEs were identified and divided into two groups: (1) cranial/peripheral neuropathies and (2) myasthenia gravis (MG) and/or myositis. Clinical characteristics and outcomes, measured with the modified Rankin Scale (mRS), were compared among the two groups. Results Among 920 ICI-treated patients, 20 patients (2.17%) developed a PNS-irAEs. The median latency from ICI exposure was 8.8 weeks and the median time from onset to clinical nadir was 3.5 weeks. Eleven patients developed a neuropathy: polyneuropathy (n = 4), cranial neuropathy (n = 3), small-fiber neuropathy (n = 3), brachial plexopathy (n = 1). Nine patients presented MG and/or myositis: concomitant MG and myositis (n = 6), isolated myositis (n = 2), exacerbation of MG (n = 1). Immunosuppressive treatment and/or ICI withdrawal determined a significant clinical improvement, expressed by a mRS reduction, in the neuropathy group (p = 0.004), but not in the MG/myositis group (p = 0.11). Overall, death due to irAEs occurred in four patients (20%), all with MG/myositis. Compared to patients with neuropathies, those with MG/myositis had a shorter latency onset (p = 0.036), developed more frequently concomitant non-neurologic irAEs (p = 0.028) and showed a higher mortality rate (p = 0.026). Conclusions In our large cohort of ICI-treated patients, 2.17% developed PNS-irAEs. Compared to ir-neuropathies, ir-MG/myositis tend to occur earlier from ICI exposure and present a worse response to treatment and a higher mortality.

Objective: Data on COVID-19 outcomes in persons with epilepsy (PWE) are scarce and inconclusive. We aimed to study the risk of hospitalization and death for COVID-19 in a large cohort of PWE from March 1, 2020 to October 31, 2021. Methods: The historical cohort design (EpiLink Bologna) compared adult PWE grouped into people with focal epilepsy (PFE), idiopathic generalized epilepsy (PIGE), and developmental and/or epileptic encephalopathy (PDEE), and a population cohort matched (ratio 1:10) for age, sex, residence, and comorbidity (assessed with the multisource comorbidity score), living in the local health trust of Bologna (approximately 800 000 residents). Clinical data were linked to health administrative data. Results: In both cohorts (EpiLink: n=1575 subjects, 1128 PFE, 267 PIGE, 148 PDEE, 32 other; controls: n=15 326 subjects), 52% were females, and the mean age was 50 years (SD=18). Hospital admissions for COVID-19 in the whole period were 49 (3.1%) in PWE and 225 (1.5%) in controls. The adjusted hazard ratio (aHR) in PWE was 1.9 (95% confidence interval [CI] = 1.4–2.7). The subgroups at higher risk were PFE (aHR=1.9, 95% CI=1.3–2.8) and PDEE (aHR=3.9, 95% CI=1.7–8.7), whereas PIGE had a risk comparable to the controls (aHR=1.1, 95% CI =.3–3.5). Stratified analyses of the two main epidemic waves (March–May 2020, October 2020–May 2021) disclosed a higher risk of COVID-19-related hospitalization during the first epidemic wave (March–May 2020; aHR=3.8, 95% CI=2.2–6.7). Polytherapy with antiseizure medications contributed to a higher risk of hospital admission. Thirty-day risk of death after hospitalization was 14% in both PWE and controls. Significance: During the first 20 months since the outbreak of COVID-19 in Bologna, PWE had a doubled risk of COVID-19 hospital admission compared to a matched control population. Conversely, epilepsy did not represent a risk factor for COVID-19-related death.

IntroductionMajor haemorrhage after injury is the leading cause of preventable death for trauma patients. Recent advancements in trauma care suggest damage control resuscitation (DCR) should start in the prehospital phase following major trauma. In Italy, Helicopter Emergency Medical Services (HEMS) assist the most complex injuries and deliver the most advanced interventions including DCR. The effect size of DCR delivered prehospitally on survival remains however unclear.Methods and analysisThis is an investigator-initiated, large, national, prospective, observational cohort study aiming to recruit >500 patients in haemorrhagic shock after major trauma. We aim at describing the current practice of hypotensive trauma management as well as propose the creation of a national registry of patients with haemorrhagic shock. Primary objective: the exploration of the effect size of the variation in clinical practice on the mortality of hypotensive trauma patients. The primary outcome measure will be 24 hours, 7-day and 30-day mortality. Secondary outcomes include: association of prehospital factors and survival from injury to hospital admission, hospital length of stay, prehospital and in-hospital complications, hospital outcomes; use of prehospital ultrasound; association of prehospital factors and volume of first 24-hours blood product administration and evaluation of the prevalence of use, appropriateness, haemodynamic, metabolic and effects on mortality of prehospital blood transfusions. Inclusion criteria: age >18 years, traumatic injury attended by a HEMS team including a physician, a systolic blood pressure Ethics and disseminationThe study has been approved by the Ethics committee ‘Comitato Etico di Area Vasta Emilia Centro’. Data will be disseminated to the scientific community by abstracts submitted to international conferences and by original articles submitted to peer-reviewed journals.Trial registration numberNCT04760977.

There is an increasing need of outcome measures for young people suitable to evaluate treatments and routine settings. However, measures must show suitable psychometric characteristics for such use. This is the first psychometric evaluation of the Italian version of the Core Young Person Clinical Outcomes in Routine Evaluation (YP-CORE). Data are reported for a clinical sample, aged 11-17 (n=175) and non-clinical sample, aged 11- 17 (n=206). Analyses included acceptability, confirmatory factor analysis, internal reliability, influence of gender and age on cutoff scores and reliable change. The YP-CORE acceptability was good, with a very high completion rate (98.7% fully completed). Internal consistency was good: the overall Cronbach’s alpha value (α) equal to 0.75 (95% confidence interval=0.69-0.80). The measure was sensitive to change (Cohen dz=1.35). The Italian version of the YP-CORE showed acceptable psychometric properties is suitable for use in services for young people as a change/outcome measure.

Aim To report on the development of an early intervention service in Modena, Italy, with information relevant to the first 4 years of implementation. Methods The 2-year service was offered to people aged 18-35 with psychotic manifestations, within 2 years from psychosis onset/or naive to antipsychotics, by teams placed within community mental health Centres, according to a "specialist within generalist" model. Treatment included pharmacological consultation, psychoeducation and social inclusion programs. Health of the Nation Outcome Scale was administered at baseline and every 6 months. Results One hundred cases accepted the treatment from 1 March 2013 to 31 December 2016. Of these, 71% were male with a median age of 23. Ninety percent were diagnosed with non-affective psychosis, yielding an estimated treated incidence of 19.1/105 . General practitioners (GPs)represented the most frequent referrers to the program (38%), followed by referrals from acute general and psychiatric hospital units (22%) and self-referrals (14%). Meaningful clinical improvement was observed, 6 months after enrolment. Conclusions An early intervention service for psychosis was successfully implemented within existing community outpatient services. GPs represented the main referrals, providing some validation of the "specialist within generalist" model of care. A promising clinical improvement and trend of reduction in duration of untreated psychosis was found, supporting the variety of early detection efforts in the community. The high median age and lack of information about pathways to care underline possible barriers to access for younger patients. These findings will inform refinement of treatments and service models for the Region.

Objective To study the evolution of the Tree Drawing Test (TDT) in a group of Alzheimer’s disease (AD) patients. Methods A total of 33 AD patients were consecutively evaluated by Mini Mental State Evaluation (MMSE) and TDT. The evolution of the TDT parameters, trunk-to-crown (TC) and space occupation (SO) index, were analyzed. Results The median age at first visit was 79 years. Globally, trees drawn by patients showed an evolution characterized by a progressive reduction of the crown compared to the trunk. TC index showed a significant linear growth change (2.52 points per year) while SO index did not significantly increase. No significant associations were found examining the relations between MMSE and TC and SO index. Conclusions TDT could represent a complementary technique to the main neuropsychological screening tests for orienting cognitive impairment diagnosis and an aid in following the evolution of cognitive impairment over time in AD patients.

Background People with psychotic illness suffer from reduced quality of life and often from an insufficient level of social inclusion. These variables are associated with several negative outcomes, such as higher neuro-cognitive deficits, negative symptoms, internalised stigma, increased cardiovascular risk and, most importantly, excess mortality. To date, only a minority of social interventions in psychosis have been investigated. Since 2011, the Department of Mental Health and Substance Abuse in Modena introduced the “Social Point” program, which provides social inclusion interventions to promote active social participation for patients suffering from severe mental illness. The aim of this study was to assess whether a social inclusion intervention is associated with better outcomes in terms of personal and social recovery, with particular reference to the areas of social functioning and activity, and subjective dimensions such as self-esteem, self-stigma and perceived quality of life. Methods A cross-sectional design was adopted to compare 30 subjects, selected at the completion of “Social Point” program, with a group of subjects, matched for socio-demographic and clinical features, selected from a wait list for “Social Point”. All subjects were evaluated by means of instruments assessing: level of disability, level of functioning, severity of psychopathology, self-esteem, internalised stigma and quality of life. Results Overall, the results of the study suggest that social inclusion interventions may be effective in people suffering from non-affective psychosis. A dose-effect relationship was also found between higher number of activities per patient and better outcomes within both social and psychopathological domains. However, due to the cross-sectional design of the study no definitive causality can be inferred. Conclusion Psychosocial interventions promoting social inclusion are likely to represent an effective approach to improve personal and social recovery.

Despite the call by the scientific community for a systematic monitoring of physical health in people with psychiatric illnesses, national and international audits have reported poor quality of cardiovascular risk assessments and management in this vulnerable population. Available evidence indicates that in people affected by mental illness, life expectancy is reduced by 10-20 years, mainly due to cardiovascular accidents and metabolic syndrome (MetS)-related diseases. The primary aim of the present study was to evaluate the accuracy of cardiovascular risk monitoring in an outpatient sample of patients taking second-generation antipsychotics. The sample consisted of 200 patients consecutively recruited from two community mental health centres. A clinical chart review was performed on the following laboratory tests: total cholesterol, high- and low-density lipoprotein, serum triglycerides, fasting blood glucose, γ-glutamyl transpeptidase. Blood pressure and waist circumference were measured. A complete cardiovascular risk assessment was available only in 60 patients out of 200 (33.3%). The only variable associated with laboratory tests for MetS was receiving three or more psychotropic medications, which increased fourfold the probability of metabolic screening. In the subsample of patients with full screening, the prevalence of MetS was 33.3%. Our findings suggest that mental health professionals working in community mental health services should incorporate a more systematic assessment of physical health in their practice, and intervene proactively to reduce the significant cardiovascular burden carried by people with several mental illness.

People with mental disorders show mortality rates up to 22.2 times higher than that of the general population. In spite of progressive increase in life expectancy observed in the general population, the mortality gap of people suffering from mental health problems has gradually widened. The aim of this paper was to study mortality rates in people suffering from mental illness in a cohort of people (16,981 subjects) in the local mental health register of the province of Modena during the decade 2006–2015. Standardized Mortality Ratios (SMRs) were calculated to compare the mortality of people with mental disorders to the mortality of people living in the province of Modena and the excess of mortality was studied in relation to the following variables: gender, age group, diagnosis and causes of death. In addition, Poisson regression analysis was performed to study the association between patient characteristics and mortality. An overall excess mortality of 80% was found in subjects under the care of mental health services as compared to the reference population (SMR = 1.8, 95% CI 1.7–1.9). Subjects in the 15–44 year group presented the highest SMR (9.2, 95% CI 6.9–11.4). The most prevalent cause of death was cancer (28.1% of deaths). At the Poisson regression, the diagnosis “Substance abuse and dependence” showed the highest relative risk (RR) (4.00). Moreover, being male, single, unemployed and with a lower qualification was associated with higher RRs. Our study confirms that subjects with mental illness have higher SMR. Noteworthy, the overall higher risk of mortality was observed in the younger age group.

Background Early interventions services (EIS) for psychosis are not uniformly available in the Italian public mental health care system. In 2012, Region Emilia Romagna funded the implementation of a comprehensive population based program to deliver EIS. These services provide a package of care including psychiatric consultation, family psychoeducation, case management, recovery oriented activities (e.g. supported employment, social inclusion), and physical health monitoring, consistent with international models but embedded within community mental health services (CMHS). We report feasibility, descriptors of enrolled samples, and clinical variables associated with remission. Methods Demographic and clinical data of CMHS users that accepted EIS from January 1st, 2013 to December 31st, 2016 were acquired from paper and electronic health records in each province. Inclusion criteria were: residence in Regione Emilia Romagna, age 18–35, presence of non-organic, affective and non-affective psychotic symptoms within two years of onset. Exclusion criteria included severe intellectual disability and non-fluency in Italian. Remission was defined as a total score of 8 on the Health of Nation Outcome Scale (HoNOS) at 6 months after enrollment. Results Six hundred and eighty-nine patients accepted EIS. Median age was 22, 93% had diagnoses of non-affective psychosis, whereas 7% affective psychosis, with a median duration of untreated psychosis (DUP) of 6 months [IQR=10; 0–120], 41% had comorbid substance use disorders, 31.1% had personality disorders, and 39% had a previous hospitalization. The proportion of migrants (23%) was almost twice that of the entire Region (11.9%). Psychiatric visits represented 44% of total utilization, whereas only 14% received at least one case management visit, 79% a family session, 19% a recovery oriented activity, and 1% physical health monitoring. Of the sample, 460 subjects (67%) improved as presented with significant reduction in the 4 subscales scores of the follow up HoNOS, and 164 (35.7%) showed remission. Shorter DUP and lower HoNOS scores at baseline were associated with an increased likelihood of achieving remission (OR=1.03, p=0.0068, and OR=1.04, p=