Essential headaches in developmental age: What is changed before, during and after the lockdown for COVID-19 pandemic. Clinical study.

Introduction: Essential headache is one of the main causes of pain in children, and has an important impact on their quality of life. In children with essential headaches play an important role in both triggers like stress, excessive use of video terminals, or physical fatigue but also comorbidities like anxiety, depression, and sleep disturbances. CoViD-19 Pandemic was very stressful, especially for children, and amplified all headache triggers and comorbidities. Study objective: In this work, we studied the aspects concerning the headache,lifestyle, habits, and mental health of children before, during, and after the lockdown and the differences between some categories (selected by age, gender, and headache status before the lockdown). Methods: This study was conducted on 90 patients with primary headaches followed at the AOUP Neuropediatrics Clinic from January 2018 to March 2022. Participants answered a questionnaire of 21 questions. For every question, the answer was divided into three periods: before, during, or after the lockdown. All dates have been converted and inserted into a database and we used SPSS technology for statistical analysis. Results: In our study, 51,1% were females and 48,9% were males and there was a prevalence of adolescents (56,7%) compared to children from 5 to 11 years (43,3%). Regarding the headache onset, 77,7% of patients started to suffer from headaches before 10 years, moreover, 68,9% had familiarity with the headache. Using Cohen's K- Concordance Test, we performed a Concordance Analysis, studying the questions in the three periods above mentioned: considering headache characteristics there is poor concordance about the trend of headache; modest concordance (K: 0,2-0,4) about the frequency and the type (migraine or tension headache); moderate concordance (K: 0,41-0,61) about the acute use of analgesic. Analyzing lifestyle the lockdown had a significant impact on sports (practiced much less) and on the use of video terminals (used much more). Conclusion: The pandemic and lockdown aren't events that led to strong and unidirectional responses in patients, there is great variability in the answers about headache, lifestyle, and psychology, and each patient had individualized reactions. However, these considerations are not applied to physical activity and the use of video terminals, because both have been inevitably modified by the pandemic situations and so were not affected by subjective influence.

Evaluation of the Anti-Spike (RDB) IgG Titer among Workers Employed at the University of Pisa Vaccinated with Different Types of SARS-CoV-2 Vaccines.

With the development of SARS-CoV-2 vaccines, many authors started evaluating the immunization efficacy of the available vaccines mainly through sero-positivity tests or by a quantitative assessment of the IgG against the spike protein of SARS-CoV-2 virus in vaccinated subjects. In this work, we compared the titers resulting from vaccination and tried to understand the potential factors affecting the immune response to the available SARS-CoV-2 vaccines. This study was conducted on 670 volunteers employed at the University of Pisa and undergoing a health surveillance program at the University Hospital of Pisa. For each participant, 10 mL of blood, information about contacts with confirmed cases of COVID-19, age, sex, SARS-CoV-2 vaccination status, previous SARS-CoV-2 infection and symptoms, type of vaccine and the date of administration were collected. In the multivariate analysis, the type of vaccine, the presence of symptoms in SARS-CoV-2 positive individuals, and the distance from the second dose significantly affected the antibody titer; the combined vaccination resulted in a faster decay over time compared with the other types of vaccination. No significant differences were observed between Spikevax and Comirnaty (p > 0.05), while the antibody levels remain more stable in subjects undergoing Vaxzevria vaccination (p < 0.01) compared with mRNA-based ones.

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. PATIENTS AND METHODS: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27-87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. RESULTS: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. CONCLUSIONS: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

A real-life experience as a proof of Guselkumab effectiveness and safety in patients with moderate to severe psoriasis.

Psoriasis is a skin disorder characterized by chronic inflammation driven by different immunologic pathways, among which the IL-23/Th17 axis plays a pivotal role. For this reason, the use of IL23p19 inhibitors in psoriasis treatment has been evaluated over the years. Guselkumab, a totally human IgG1 lambda monoclonal antibody, that selectively blocks the p 19 subunit of IL- 23 has demonstrated high efficacy and safety throughout several, randomized, double-blind phase III trials (VOYAGE 1 and 2, NAVIGATE and ECLIPSE). We designed a single-center retrospective cohort study in a population consisting of 46 patients followed from December 2018 to April 2021. After a diagnosis of moderate to severe psoriasis, all the patients were considered suitable to receive treatment with Guselkumab. In our population, among those who achieved clinical improvement in terms of Psoriasis Area Severity Index (PASI), PASI 75, 90, and 100 were achieved on average on weeks 14, 19, 21 respectively. We then analyzed a subgroup of our population, consisting of 35 patients, who had an identical follow-up time of 28 weeks, thus observing the trend in mean PASI at subsequent assessments and the number of patients who had reached PASI 75, PASI 90, and PASI 100 at week 4 (10; 3; 1), week 12 (12; 13; 11), week 20 (7; 6; 2), and week 28 (1; 4; 6), respectively. The results obtained are in line with those obtained from previous studies, thus confirming that Guselkumab is an excellent choice in terms of security, long-term efficacy, and overall tolerance.

Laparoscopic bariatric surgery is safe during phase 2-3 of COVID-19 pandemic in Italy: A multicenter, prospective, observational study.

BACKGROUND: Sars-Cov-2 epidemic in Italy caused one of the greatest 2020 European outbreaks, with suspension of elective bariatric/metabolic surgery (BMS). From May 2020 a significant decline of the epidemic has been observed (phase 2); National Health Service protocols permitted elective BMS' resumption. A new, more severe COVID-19 surge, the "second wave", started on October 2020 (phase 3). AIM: The primary end point was to analyze the outcomes of any Sars-Cov-2 infection and related morbidity/mortality within 30 POD after laparoscopic BMS during phase 2-3; secondary end points were readmission and reoperation rates. METHODS: Study design prospective, multicenter, observational. SETTING: Eight Italian high-volume bariatric centers. All patients undergoing BMS from July 2020 through January 2021 were enrolled according to the following criteria: no Sars-Cov-2 infection; primary procedures; no concomitant procedure; age > 18 < 60 years; compensated comorbidities; informed consent including COVID-19 addendum; adherence to specific admission, in-hospital and follow-up protocols. Data were collected in a prospective database. Patients undergone BMS during July-December 2019 were considered a control group. RESULTS: 1258 patients were enrolled and compared with 1451 operated on in 2019, with no differences for demographics, complications, readmission, and reintervention rates. Eight patients (0·6%) tested positive for Sars-Cov-2 infection after discharge, as well as and 15 healthcare professionals, with no related complications or mortality. CONCLUSIONS: Introduction of strict COVID-19 protocols concerning the protection of patients and health-care professionals guaranteed a safe resumption of elective BMS in Italy. The safety profile was, also, maintained during the second wave of outbreak, thus allowing access to a cure for the obese population.

Psycho-social impact of social distancing and isolation due to the COVID-19 containment measures on patients with physical disabilities.

BACKGROUND: While the COVID-19 pandemic was spreading worldwide, the Italian government stated lockdown, with a drastic reorganization of healthcare systems. The psychological and social effects of the pandemic and the restrictions of freedom could have had a detrimental impact on people with physical disabilities, for whom well-being depends strongly on their social environment. AIM: Our main aim was to describe the overall impact of the pandemic on mental health, social condition and illness perception among patients with disabilities, to provide early interventions for this particularly vulnerable population. For this purpose, we performed a specific screening protocol to detect the prevalence of any psychological distress. DESIGN: Cross-sectional observational study. SETTING: Telephonic interview administered to patients and their caregivers attending the Unit of Neurorehabilitation at the University Hospital of Pisa. POPULATION: 134 patients with physical disability related to neurological disorders, who had their outpatient appointment cancelled, because of the government dispositions, were enrolled. METHODS: A specific questionnaire (COVID19-q) was designed to test patients' psycho-social state, including a section addressed to the caregiver. Moreover, a standardized psychological evaluation, using the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), was also performed. RESULTS: Results show a different impact in our study population compared to the general population on psychological aspect. Patients did not manifest any clinically relevant distress, as assessed with CORE-OM. However, patients with higher disability degree reported a statistically lower outcome in the social function, in the well-being domains and an increase in risk behavior. Results from COVID19-q show that most of our patients reported none or mild change in their psycho-social habits and perception of illness during lockdown. However, reduction of family cohesion and lack of healthcare support are two important aspects that people with disability had to face with during the pandemic emergency. CONCLUSIONS: People with physical disabilities surprisingly shown milder effects of the pandemic on their psychological state and good coping skills in facing social isolation, manifesting resilience resources. However, the is a need to give concrete support to healthcare and social care, especially in the management of severe disability. CLINICAL REHABILITATION IMPACT: This unexpected and reassuring result may reveal a worrying scenario regarding-the social participation and quality of life of people with disabilities: were they already in lockdown?

Prevalence and impact of COVID-19 in Parkinson's disease: evidence from a multi-center survey in Tuscany region.

BACKGROUND: If Parkinson's Disease (PD) may represent a risk factor for Coronavirus disease 2019 (COVID-19) is debated and there are few data on the direct and indirect effects of this pandemic in PD patients. OBJECTIVE: In the current study we evaluated the prevalence, mortality and case-fatality of COVID-19 in a PD cohort, also exploring possible risk factors. We also aimed to investigate the effect of lockdown on motor/non-motor symptoms in PD patients as well as their acceptability/accessibility to telemedicine. METHOD: A case-controlled survey about COVID-19 and other clinical features in PD patients living in Tuscany was conducted. In non-COVID-19 PD patients motor/non-motor symptoms subjective worsening during the lockdown as well as feasibility of telemedicine were explored. RESULTS: Out of 740 PD patients interviewed, 7 (0.9%) were affected by COVID-19, with 0.13% mortality and 14% case-fatality. COVID-19 PD patients presented a higher presence of hypertension (p < 0.001) and diabetes (p = 0.049) compared to non-COVID-19. In non-COVID-19 PD population (n = 733) about 70% did not experience a subjective worsening of motor symptoms or mood, anxiety or insomnia. In our population 75.2% of patients was favorable to use technology to perform scheduled visits, however facilities for telemedicine were available only for 51.2% of cases. CONCLUSION: A higher prevalence of COVID-19 respect to prevalence in Tuscany and Italy was found in the PD population. Hypertension and diabetes, as for general population, were identified as risk factors for COVID-19 in PD. PD patients did not experience a subjective worsening of symptoms during lockdown period and they were also favorable to telemedicine, albeit we reported a reduced availability to perform it.