Three Doses of COVID-19 Vaccines: A Retrospective Study Evaluating the Safety and the Immune Response in Patients with Multiple Sclerosis.

Since the beginning of the mass immunization of patients with multiple sclerosis (MS), many data on the efficacy and safety of COVID-19 vaccines have been produced. Considering that MS is an autoimmune disease and that some disease-modifying therapies (DMTs) could decrease the antibody response against COVID-19 vaccines, we carried out this retrospective study with the aim to evaluate the safety of these vaccines in terms of AEFI occurrence and the antibody response after MS patients had received the third dose. Two hundred and ten patients (64.8% female; mean age: 46 years) received the third dose of the mRNA-based COVID-19 vaccine and were included in the study. Third doses were administered from October 2021 to January 2022. The majority of patients (n = 193) were diagnosed with RRMS and EDSS values were ≤3.0 in 72.4% of them. DMTs most commonly used by included patients were interferon Beta 1-a, dimethyl fumarate, natalizumab and fingolimod. Overall, 160 patients (68.8% female) experienced 294 AEFIs, of which about 90% were classified as short-term, while 9.2% were classified as long-term. The most commonly reported following the booster dose were pain at the injection site, flu-like symptoms, headache, fever and fatigue. Regarding the immune response, consistently with literature data, we found that patients receiving ocrelizumab and fingolimod had lower IgG titer than patients receiving other DMTs.

Validation of an iPad version of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS).

BACKGROUND: The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) is the most widely used screening tool for cognitive impairment in Multiple Sclerosis (MS). However, the administration and scoring procedures of the paper version are time consuming and prone to errors. Aim of our study was to develop a tablet version of BICAMS (iBICAMS), and to assess its reliability compared to the paper version. METHODS: We administered both BICAMS and iBICAMS to 139 MS patients in two different sessions. We compared scores on both versions using a paired t-test. We used a repeated measures ANOVA to test the impact of rater, order of administration and test-retest time on test-retest performances. We used the Intraclass Correlation Coefficient (ICC) to assess the reliability between BICAMS and iBICAMS. RESULTS: All three sub-tests of the BICAMS (SDMT, CVLT-II and BVMT-R) were different between the paper and the tablet versions. Order of administration influenced test-retest performances at the SDMT (p<0.001), CVLT- II (p<0.001) and BVMT-R (p<0.001). Intraclass coefficient correlation (ICC) revealed a high level of agreement between the paper BICAMS and the iPad version for all three tests: SDMT (0.92), CVLT-II (0.83) and BVMT-R (0.82). CONCLUSIONS: We found a high reliability between BICAMS and iBICAMS. Considering the inherent advantages of automated scoring, digital storage of data, standardized timing, the iBICAMS could become a standard in clinical practice.

The Safety Profile of COVID-19 Vaccines in Patients Diagnosed with Multiple Sclerosis: A Retrospective Observational Study.

In the current COVID-19 pandemic, patients diagnosed with multiple sclerosis (MS) are considered to be one of the highest priority categories, being recognized as extremely vulnerable people. For this reason, mRNA-based COVID-19 vaccines are strongly recommended for these patients. Despite encouraging results on the efficacy and safety profile of mRNA-based COVID-19 vaccines, to date, in frail populations, including patients diagnosed with MS, this information is rather limited. We carried out a retrospective observational study with the aim to evaluate the safety profile of mRNA-based COVID-19 vaccines by retrieving real-life data of MS patients who were treated and vaccinated at the Multiple Sclerosis Center of the Hospital A.O.R.N. A. Cardarelli. Three-hundred and ten medical records of MS patients who received the first dose of the mRNA-based COVID-19 vaccine were retrieved (63% female; mean age: 45.9 years). Of these patients, 288 also received the second dose. All patients received the Pfizer-BioNTech vaccine. Relapsing-Remitting Multiple Sclerosis (RRSM) was the most common form of MS. The Expanded Disability Status Scale (EDSS) values were <3.0 in 70% of patients. The majority of patients received a Disease Modifying Therapy (DMT) during the study period, mainly interferon beta 1-a, dimethyl fumarate, and natalizumab and fingolimod. Overall, 913 AEFIs were identified, of which 539 were after the first dose of the vaccine and 374 after the second dose. The majority of these AEFIs were classified as short-term since they occurred within the first 72 h. The most common identified adverse events were pain at injection site, flu-like symptoms, and headache. Fever was reported more frequently after the second dose than after the first dose. SARS-CoV-2 infection occurred in 3 patients after the first dose. Using historical data of previous years (2017−2020), the relapses' rate during 2021 was found to be lower. Lastly, the results of the multivariable analysis that assessed factors associated with the occurrence of AEFIs revealed a statistical significance for age, sex, and therapy with ocrelizumab (p < 0.05). In conclusion, our results indicated that Pfizer-BioNTech vaccine was safe for MS patients, being associated with AEFIs already detected in the general population. Larger observational studies with longer follow-up and epidemiological studies are strongly needed.

Sea piracy sequelae: assessment according to the Diagnostic and Statistical Manual of Mental Disorders-5.

BACKGROUND: Our previous studies have investigated the psychological consequences of kidnapping in a group of Italian seafarers assaulted by sea pirates and held in captivity and in their family members by the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-4. These studies have shown that both the victims and the family members showed significant psychological disturbances, corresponding to a chronic Post-Traumatic Stress Disorder (PTSD), in the victims, and a pattern of anxiety and depression in their family members. After publication of these studies, an updated edition of the DSM became available, namely, the DSM-5. The DSM-5 redefines some diagnostic criteria, including those related to the PTSD. This work was focused on the re-evaluation of the results of our previous studies in the light of the DSM-5 diagnostic criteria. MATERIALS AND METHODS: Sixteen Italians including 4 kidnapped seafarers and 12 family members were examined by a semi-structured interview followed by Clinician-Administered PTSD Scale (CAPS-DX) and the Cognitive Behaviour al Assessment (CBA 2.0) for victims and by State-Trait Anxiety Inventory (STAI) X-1 and X-2 of CBA 2.0 and the Hamilton Depression Rating Scale (HDRS) for family members. Data already obtained were reviewed and re-analysed according to the DSM-5 criteria and the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). RESULTS: The use of the CAPS-5 did not modify the diagnosis for the victims' group: 3 of 4 had a PTSD diagnosis performed through the CAPS-5. Seven of 12 family members had PTSD diagnosis performed through the CAPS-5, with negative cognitions and mood symptoms being those obtaining the highest score. CONCLUSIONS: Using DSM-5 criteria, the diagnosis of PTSD in the direct victims of piracy was confirmed. The same diagnosis could apply to a group of their family members. Besides anxiety and fear, in fact, we found in 7 out 12 subjects the presence of symptoms included by the DSM-5 in the PTSD spectrum. These symptoms were: avoidance, negative alterations in mood and cognition, blame of self or others. The use of updated diagnostic criteria may enable more correct assessment of the consequences of piracy acts. This may be also useful for establishing proper compensations for the damage suffered by seafarers, depending on the degree of disability resulting from the criminal acts they suffered.

Caregiver burden and coping strategies in caregivers of patients with Alzheimer's disease.

BACKGROUND: Alzheimer's disease (AD) causes considerable distress in caregivers who are continuously required to deal with requests from patients. Coping strategies play a fundamental role in modulating the psychologic impact of the disease, although their role is still debated. The present study aims to evaluate the burden and anxiety experienced by caregivers, the effectiveness of adopted coping strategies, and their relationships with burden and anxiety. METHODS: Eighty-six caregivers received the Caregiver Burden Inventory (CBI) and the State-Trait Anxiety Inventory (STAI Y-1 and Y-2). The coping strategies were assessed by means of the Coping Inventory for Stressful Situations (CISS), according to the model proposed by Endler and Parker in 1990. RESULTS: The CBI scores (overall and single sections) were extremely high and correlated with dementia severity. Women, as well as older caregivers, showed higher scores. The trait anxiety (STAI-Y-2) correlated with the CBI overall score. The CISS showed that caregivers mainly adopted task-focused strategies. Women mainly adopted emotion-focused strategies and this style was related to a higher level of distress. CONCLUSION: AD is associated with high distress among caregivers. The burden strongly correlates with dementia severity and is higher in women and in elderly subjects. Chronic anxiety affects caregivers who mainly rely on emotion-oriented coping strategies. The findings suggest providing support to families of patients with AD through tailored strategies aimed to reshape the dysfunctional coping styles.

Psychological distress in families of victims of maritime piracy - the Italian experience.

BACKGROUND: This work has investigated the psychological status of family members of kidnapped seafarers, 5 months after their release. AIM: The goal of this study was to assess if relatives of victims of maritime piracy showed signs of psychological distress, to diagnose eventual pathologies and to measure their severity. MATERIALS AND METHODS: Twelve family members (8 females and 4 males) of 4 kidnapped seafarers were examined. They were first interviewed by a semi-structured approach and then examined using the self-report questionnaire State-Trait Anxiety Inventory (STAI-Y), and the Hamilton Depression Rating Scale (HDRS). RESULTS: Five months after the relatives had been released, 42% of the family members of kidnapped seafarers obtained pathological scores in the STAI-Y questionnaire, and 33% showed depression according to the HDRS. CONCLUSIONS: Family members of kidnapped seafarers show significant psychopathological symptoms 5 months after relatives have been released. Symptoms may be severe enough to interfere with daily life in about one half of them. Kidnapping is a changing life experience and both victims and relatives require attention and support.

Psychological consequences in victims of maritime piracy: the Italian experience.

BACKGROUND AND AIM: Maritime piracy is a worrying phenomenon. Its recurrence in the last few years iscausing several problems to the safety of maritime routes. In spite of the number of seafarers kidnappedand maintained in captivity, psychological/mental disorders developed in victims of these criminal actshave not been investigated. This study has assessed psychological consequences of kidnapping in a groupof Italian seafarers held in captivity from 7 to 10 months. MATERIALS AND METHODS: Four Italian seafarers were examined at the 5th month after release. An initial, semi-structured interview was followed by 2 structured clinical evaluations for assessing the possible presence of psychopathological disorders. Instruments used were the Cognitive Behavioural Assessment (CBA 2.0) and the Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS-DX). RESULTS: All victims showed high scores of state anxiety (56.00 ± 3.36) and social adjustment disorder (12.75 ± 2.21) to CBA 2.0. Moreover, 3 of them revealed traits of anxiety (58.75 ± 8.50) and emotionalinstability (8.25 ± 2.50). Two of them had somatic disorders (63.25 ± 15.94), depression (17.25 ± 4.78) and phobic problems (91.00 ± 7.02). In 3 of 4 victims examined, a PTSD diagnosis was made. Symptomsof recall resulted in higher CAPS-DX (13.00 ± 4.05) scores. CONCLUSIONS: Traumatic experiences such as being kept in captivity by pirates could entail relevant psychopathological disorders in victims and their families. Quality care interventions, aimed to develop paradigms for resilience training, represent a priority. An international partnerships and collaboration between institutions, clinicians and seafarer organisations can be useful to evaluate psychological conditions of these workers.

Late and early onset dementia: what is the role of vascular factors? A retrospective study.

BACKGROUND: Neuropathology of Alzheimer's disease (AD) demonstrates that the common occurrence of vascular lesions and vascular factors is suggested to contribute significantly to the clinical progression of the disease. This study has assessed the presence of vascular brain lesions and risk factors in subjects with diagnosis of AD and their influence on the disease course both in Late Onset Dementia (LOD) and in Early Onset Dementia (EOD). METHODS: MRI scans of 374 LOD and of 67 EOD patients were evaluated for the presence of vascular associated lesions and rated according to the age-related white matter changes (ARWMC) scale as "pure degenerative", "mixed" and "vascular" cases of dementia. Vascular risk factors burden (hypertension, diabetes, dyslipidemia, myocardial infarction) and disease progression were also assessed. RESULTS: 44% of LOD cases and 46% of EOD were classified as "mixed dementia cases". The vascular risk factors burden showed an increase from the pure degenerative to the pure vascular forms. Disease progression, calculated in two years using the Mini Mental State Evaluation (MMSE), Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scores, did not reveal differences among the three different classes of dementias. CONCLUSIONS: Vascular lesions are found in the majority of LOD cases and in about one half of EOD. This observation is consistent with the hypothesis of a synergistic effect of the degenerative and vascular factors on the development of cognitive dysfunction. The linear increase of the vascular burden supports the idea of a continuum spectrum between the pure degenerative and the pure vascular forms of adult-onset dementia disorders.