Study of the excess mortality associated with the SARS-CoV-2 pandemic in the Local Health Authorities and Districts of the Autonomous Region of Sardinia - quinquennium 2017-2021.

Background: Based on the indications of the Italian National Recovery and Resilience Plan and the Ministerial Decree n°77/2022, detecting specific populations' social-welfare needs is essential to reorganize the national and regional health service. The present analysis studies the impact of pandemic and pre-pandemic conditions in terms of mortality on Sardinian health service organizational subunits to indirectly investigate the need for specific social and health interventions. Design: Retrospective observational mortality study on the Sardinian resident population, surveyed by the Italian National Institute of Statistics (Istat) from 2017 to 2021. Methods: The database was built by crossing demographic data from the Istat divided into 21 five-year age groups (0-4 to 100+). Mortality and excess mortality were calculated with a focus on local health authorities and districts. The analysis were made considering three age groups (0-64, ≥ 65, 0-100+) and comparing the individual years 2020 and 2021 with the pre-pandemic triennium 2017-2019. To better understand the phenomenon of excess mortality, the old age index was calculated for the Local Health Authority and District for each year of the quinquennium considered. Results: Standardized mortality ratios increased in the biennium of the SARS-CoV-2 pandemic compared to the baseline 2017-2019. A global increaseof the Standardized mortality ratios in all districts (2021) was measured, including those with Standardized mortality ratios already increasing in 2020. Notably, the Standardized mortality ratios (2020 and 2021) were often increased by the 0-64 age group. The regional excess mortality (0-100+) confirmed an increase in mortality compared to the baseline, with a slight decrease from 2020 to 2021. Conclusions: Sardinia presents peculiar demographic and geographical characteristics. Monitoring mortality rates and excess mortality confirms to be crucial to constantly re-modulating health interventions and planning of the supply of services, including the equitable allocation of resources based on actual health needs. Sardinia should embrace the concept of "age-friendly community" and create communities designed to promote active aging and social participation.

The impact of MDQ positivity on quality of life impairment: Does it support the hypothesis of "Dysregulation of Mood, Energy, and Social Rhythms Syndrome" (DYMERS)?

Background: DSM-5 separates bipolar (BD) from depressive disorders, but some experts consider BD as part of a spectrum of mood disorders. The interpretation of numerous false positives of BD screened by the Mood Disorders Questionnaire (MDQ) is part of this debate. Recent study results suggest that the worsening of health-related quality of life (H-Qol) associated with MDQ positivity does not depend solely on mood disorders. This study aims to clarify whether the impairment may be due to other concomitant disorders, unrelated to mood disorders, leading to a worsening of H-Qol. Additionally, the study aims to explore if MDQ positivity itself observe clinical significance. Design and methods: The study involved pairs of cases (MDQ+) and controls (MDQ-) matched for sex, age, and absence of DSM-IV psychiatric comorbidity. The impact of MDQ positivity on the quality of life in a sample of MDQ+ comorbid with MDD was measured and compared to impact of MDD in other chronic disorders. Results: The H-Qol was significantly worse in MDQ+ than in controls (both groups without any psychiatric co-morbidity). The worsening was similar to severe chronic disorders The burden of worsening quality of life due to MDD was mild in another sample of MDQ positives with comorbid MDD. Conclusion: The study hypothesizes that MDQ positivity may be related to hyperactivation and dysregulation of rhythms typical of stress disorders. In fact, MDQ+ was found strongly related to sleep disturbances. Future studies could verify if a "Dysregulation of Mood, Energy, and Social Rhythms Syndrome" (DYMERS), causes worsening the H-Qol in MDQ+.

Recurrent nasal basal cell carcinoma treated with standard surgery excision: evaluation of volume ratio.

BACKGROUND: Basal cell carcinoma (BCC) is the most common malignant skin tumor. Although it rarely evolves into a metastatic disease, BCC can lead to a significant morbidity due to local invasion. The risk of lesion recurrence depends on clinical and histopathological factors as described by the Nation Comprehensive Cancer Network (NCCN). The surgical excision margins have a well-known role: there is a close relationship between high recurrence rate of BCC and the tumor proximity to the surgical margins. Aim of our study was to assess whether there is a significative correlation between recurring BCC and volume ratio (VRb/t), defined as ratio between excisional biopsy volume and tumor volume, and if VRb/t is a useful parameter to assess the risk of recurrence of BCC. METHODS: Retrospective case-control study in 80 patients with history of recurrent basal cell carcinoma of the nose (cases), and 43 patients with history of basal cell carcinoma of the nose with no evidence of relapse (controls) in the following 8 years. RESULTS: Surgical excision margins, histological subtype, ulceration, depth of invasion and volume ratio (VRb/t) were evaluated in case and controls. The evaluation of VRb/t evidenced a significant difference between recurrent BCC and non-recurrent BCC. The mean values of VRb/t were 6.17 for cases and 11.94 for controls. The Binomial Logistic Regression has displayed, for values of VRb/t around 7, a probability of 75% to identify BCCs belonging to the recurrent group. CONCLUSIONS: Our data show a significant correlation between recurrent BCCs and VRb/t. VRb/t can help in the assessment of recurrence risk, used together with others prognostic factor. For values of VRb/t close to 7 it should be recommended a close follow-up to promptly identify a possible recurrence.

Does the Response to a Stressful Condition in Older Adults with Life Rhythm Dysregulations Provide Evidence of the Existence of the "Dysregulation of Mood, Energy, and Social Rhythms Syndrome"?

OBJECTIVE: The COVID-19 lockdown periods have given rise to the "Dysregulation of Mood, Energy, and Social Rhythms Syndrome" (DYMERS). This syndrome is characterized by a poor regulation of biological, social, and behavioral rhythms, including sleep, nutrition, and social contacts. The purpose of this cohort study was to examine whether older adults with pre-existing DYMERS had a more negative perception of their health-related quality of life (H-QoL) during the COVID-19 pandemic lockdown, regardless of the presence of concurrent mood disorders. METHOD: The entire study population (N = 93; age > 65 year) was categorized based on whether they exhibited dysregulated rhythms at the outset of the study. A comparison was made between DYMERS-positive individuals and DYMERS-negative individuals, and we assessed their H-QoL at the conclusion of the study. We also compared the H-QoL of individuals in the cohort who did not have a positive depression score to understand the impact of the rhythm dysregulation alone. RESULTS: The frequency of individuals with a critical health-related quality of life score (SF12 < 25) was higher in the cohort with pre-existing DYMERS during lockdown (33.33% vs. 6.17%). This difference remained significant even when only individuals without depressive symptomatology were considered (27.27% vs. 2.60%). CONCLUSION: The results of this study indicate that DYMERS can exert a substantial influence on health-related quality of life (H-QoL), even when mood disturbances are not present. Additional research is required to investigate the relationship between DYMERS and other psychiatric conditions as well as its nature as a standalone disorder.

Differences in lethality and diffusion of Covid-19 in countries using different kinds of vaccines.

To verify if lethality and diffusivity of Covid-19 correlated with percentage of people vaccinated in different countries and whether results on these indicators were comparable under different types of vaccines. A linear regression analysis was conducted between vaccines/inhabitant, new cases/inhabitants and ratio deaths/cases. A comparison between the three indicators was carried out in countries subdivided by kind of vaccine. The proportion of vaccinations/inhabitants correlates negatively with proportion of deaths × 100 cases (R = -3.90, p < 0.0001), but didn't on incidence of new cases. Countries with prevalence of mRNA vaccines were similar to others on incidence of new cases; but a lower lethality of Sars-Cov2 was found than in countries with prevalence of viral vehicle vaccines (F = 6.064, p = 0.0174) but didn't against countries with prevalence of inactivated vaccines. The higher is the proportion of vaccine/inhabitant in a given country, the less is the fraction of infected people who die.

The perception of professionals and users of the quality of care and respect for human rights in four outpatient care facilities of an Italian hospital during the Covid-19 pandemic.

Background: During the Covid-19 pandemic, delays in providing medical services, dissatisfaction, criticism toward health workers (HW) and the risk of burnout of HW in Italy have been documented. No studies have contrasted the point of view of HW and users on the quality of care and respect for human rights in health facilities. Objective: To compare the perception of users of their satisfaction with the care provided with the perception of HW of their satisfaction with work as well as the perception of the respect of HW "s and users" human rights. Methods: The "Well-Being at work and respect for human rights questionnaire" (WWRR) was administered on a sample of users (142) and HW (154) in four outpatient health care facilities of a hospital in Sardinia, Italy. Results: Users showed higher scores than HW on their satisfaction with the care received (p < 0.0001), the perception of respect for their human rights (p < 0.0001), and availability of resources for care (p < 0.0001). The HW scores were higher than 50% of the maximum in all items, but a relatively low score was reported on the HW's satisfaction of the resources and the respect for their rights. Conclusion: The satisfaction for care and respect for human rights in the outpatient health services was higher than expected. The relatively low score by the HWs in relation to the satisfaction with the resources and perception of respect for their human rights could be a wake-up call. The study does not involve emergency rooms, wards, or Covid units.

Effect of a Low-Moderate Exercise Program on Dysmetabolism in Older Adults: Results of a Randomized Controlled Trial.

Physical exercise has been shown to improve dysmetabolism in older adults, reducing cardiovascular risk, while its role in preventing dysmetabolism is less known. Moreover, most of the trials use exercise programs that are difficult to put into daily practice. The purpose of this Randomized Controlled Trial (RCT) was to evaluate the effectiveness of a 3-month moderate exercise program in improving or preventing dysmetabolism in 120 older adults, randomly selected for the exercise program (experimental group) or cultural activities (control group). None of the subjects were following a hypocaloric diet, and all of them reported healthy eating habits. Anthropometric (Body Mass Index (BMI) and Waist Circumference (WC)) and metabolic variables (fasting plasma glucose (FPG), High-Density Lipoprotein Cholesterol (HDL-C), and triglycerides (TG)) were assessed at baseline (T0) and at the end of the trial (T1). Dysmetabolism was defined by the presence of an increased WC plus at least two metabolic alterations. At T0, the two groups did not differ by sex, age, education, BMI, WC, FPG, HDL-C levels, and prevalence of dysmetabolism. The mean BMI value indicated overweight, and WC values were higher than the cut-off. At T1, a slight reduction in the number of people with dysmetabolism was found only in the experimental group. However, none of the individuals without dysmetabolism at T0 in the experimental group developed it at T1, while 11.4% developed it in the control group (p = 0.032). This study highlights that a moderate exercise program, accessible in daily practice, can prevent dysmetabolism in older adults, even while being overweight, while if dysmetabolism is already present, more prolonged combined nutritional and exercise interventions will be needed.

An Objective Comparison of Vedolizumab and Ustekinumab Effectiveness in Crohn's Disease Patients' Failure to TNF-Alpha Inhibitors.

INTRODUCTION: The use of ustekinumab and vedolizumab as second-line therapies in patients with Crohn's disease (CD) in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of this study was to compare, in a large multicenter observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second-line therapies, as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging. METHODS: Clinical response, remission, and steroid-free remission at weeks 26 and 52 were evaluated in a retrospective propensity score-weighted and propensity score-matched cohort of patients in which TNFi failed. Objective response and remission were evaluated by 1 or more techniques among endoscopy, magnetic resonance/computed tomography enteroclysis, and small bowel ultrasound. RESULTS: A total of 470 patients with CD (239 treated with ustekinumab and 231 treated with vedolizumab) were included in the study. At week 26, clinical outcomes were similar between the 2 groups. At week 52, clinical remission (ustekinumab 42.5% vs vedolizumab 55.5%, P = 0.01) and steroid-free remission (ustekinumab 40.6% vs vedolizumab 51.1%, P = 0.038) rates were significantly higher in vedolizumab-treated patients. Three hundred two patients (hundred thirty-five treated with ustekinumab and hundred sixty-seven treated with vedolizumab) had an objective evaluation of disease activity at baseline and week 52. At week 52, objective response and remission rates were similar between the 2 groups. Clinical response at week 26 predicted steroid-free remission at week 52 in both ustekinumab-treated and vedolizumab-treated patients. Safety profiles were similar between the 2 groups. DISCUSSION: In patients with CD in which TNFi failed, both ustekinumab and vedolizumab showed similar clinical effectiveness after 26 weeks of treatment. At 1 year, vedolizumab was associated with a higher rate of clinical remission when compared with ustekinumab. However, no difference was observed between the 2 groups when objective outcomes were investigated at this time point.

Covid-19 vaccines work but other factors play a relevant role: a data analysis on spread and mortality in 24 countries.

BACKGROUND: The aim was to outline a methodology to monitor the impact of vaccinations in different countries comparing at two different times within countries and between countries the frequency of new cases and Covid-19 related deaths and the percentage of vaccinations conducted. DESIGN AND METHODS: The 25 countries with the largest increase in SARS-CoV-2 cases on 8 August 2021 were evaluated. In each nation was calculated the proportion of Covid-19 deaths divided per new cases x 100 and the proportion of new cases per 1.000 inhabitants on 10 January 2021 (before vaccinations' distribution) and 8 August 2021 (when large percentage of the population had been vaccinated in many countries). RESULTS: The study shows that in the countries with the highest number of cases as of 8 August 2021, the proportion of vaccinations carried out in the population correlates negatively with both the proportion between Covid-19 dead people x100 infected people and with the rate of new cases. However, the proportion of vaccinations does not correlate with the differences in the two same indicators considered in the weeks observed, thus additional factors seem to play an important role. CONCLUSIONS: This work indicates that mass vaccination is associated with a lower spread of the pandemic and, to greater extent, with a lowering of mortality in infected people.

Previous functional social and behavioral rhythms affect resilience to COVID-19-related stress among old adults.

BACKGROUND: Functioning of Social Behavioral Rhythms (SBRs) may affect resilience toward stressful events across different age groups. However, the impact of SBRs on the coronavirus disease of 2019 (COVID-19) in elder people is yet to ascertain, representing the aim of the present report. DESIGN AND METHODS: Follow-up of a peer-reviewed randomized controlled trial on exercise on old adults (³65 years), concurrent to the onset of the pandemic-related lockdown. Post-RCT evaluations occurred after further 12 and 36 weeks since the beginning of the lockdown phase. People with Major Depressive Episode (MDE) at week-48 (follow-up endpoint) were deemed as cases, people without such condition were considered controls. MDE was ascertained using the Patient Health Questionnaire-9 (PHQ-9); SBRs functioning at week 12 onward, through the Brief Symptom Rating Scale (BSRS). RESULTS: Seventy-nine individuals (53.2%, females) entered the RCT-follow-up phase. The frequency of MDE did not significantly change before versus during lockdown (OR 2.60, CI95%=0.87-9.13). People with BSRS>1 standard deviation of the whole sample score at week-12 had an inflated risk of DE during lockdown (OR=5.6, 95%CI: 1.5-21.4) compared to those with lower BSRS scores. Such odd hold after excluding individuals with MDD at week-12. The post-hoc analysis could be potentially affected by selection bias. CONCLUSIONS: Overall, older adults were resilient during the first phase of the pandemic when functioning of pre-lockdown was still preserved, in contrast to the subsequent evaluations when the impairment of daily rhythms was associated with impaired reliance.

Exercise in Older Adults to Prevent Depressive Symptoms at the Time of Covid-19: Results of a Randomized Controlled Trial with Follow-Up.

Background: This study aimed to verify, through a randomized controlled trial, whether a medium-intensity mixing/aerobic/anaerobic exercise (accessible to older adults even with mild chronic diseases) can effectively counteract depressive episodes. A characteristic of the trial was that the follow-up coincided (unscheduled) with the lockdown due to Covid-19. Methods: Participants (N=120) were randomized into an intervention group, performing physical exercise, and a control group. Participants, aged 65 years and older, belonged to both genders, living at home, and cleared a medical examination, were evaluated with a screening tool to detect depressive episodes, the PHQ9, at pre-treatment, end of the trial (12-week), and follow-up (48-week). Results: A decrease in the frequency of depressive episodes after the trial (T1) was found in both groups; however, a statistically significant difference was observed only in the control group (p=0.0039). From T1 to follow-up (conducted during the lockdown), the frequency of depressive episodes increased in the control group, reaching a frequency equal to the time of study entry (p=0.788). In the experimental group, the frequency of depressive episodes did not change at the end of the trial but reached a statistically significant difference compared to the start of the study (p = 0.004) and was higher than the control group (p=0.028). Conclusion: Moderate-intensity physical exercise can be conducted safely, benefitting older adults even suffering from mild chronic disorders. Physical exercise seems to guarantee a long-term preventive effect towards depressive symptoms, especially in serious stressful situations such as the lockdown due to the Covid-19 pandemic.

Moderate Exercise Improves Cognitive Function in Healthy Elderly People: Results of a Randomized Controlled Trial.

BACKGROUND: Physical activity in the elderly is recommended by international guidelines to protect against cognitive decline and functional impairment. OBJECTIVE: This Randomized Controlled Trial (RCT) was set up to verify whether medium-intensity physical activity in elderly people living in the community is effective in improving cognitive performance. DESIGN: RCT with parallel and balanced large groups. SETTING: Academic university hospital and Olympic gyms. SUBJECTS: People aged 65 years old and older of both genders living at home holding a medical certificate for suitability in non-competitive physical activity. METHODS: Participants were randomized to a 12-week, 3 sessions per week moderate physical activity program or to a control condition focused on cultural and recreational activities in groups of the same size and timing as the active intervention group. The active phase integrated a mixture of aerobic and anaerobic exercises, including drills of "life movements", strength and balance. The primary outcome was: any change in Addenbrooke's Cognitive Examination Revised (ACE-R) and its subscales. RESULTS: At the end of the trial, 52 people completed the active intervention, and 53 people completed the control condition. People in the active intervention improved on the ACE-R (ANOVA: F(1;102)=4.32, p=0.040), and also showed better performances on the memory (F(1;102)=5.40 p=0.022) and visual-space skills subscales of the ACE-R (F(1;102)=4.09 p=0.046). CONCLUSION: A moderate-intensity exercise administered for a relatively short period of 12 weeks is capable of improving cognitive performance in a sample of elderly people who live independently in their homes.Clinical Trials Registration No: NCT03858114.

Principal Component Analysis of the Social and Behavioral Rhythms Scale in elderly.

BACKGROUND: Changes in social and behavioral rhythms (SBR) in the elderly are related to health status. Nevertheless, there is no data on factor analysis of the Brief Social Rhythm Scale (BSRS) an internationally well-known tool in this field. The aim was to analyze, in the elderly, the factorial structure of the Italian version of BSRS.  Design and methods: Principal Component Analysis of the BSRS carried out in elderly living at home. RESULTS: Sample of 141 participants (83 Females, 58,9%), aged 72.3±4.8. All the items of the questionnaire were related and could compose a single factor, explaining 56% of variance. A solution adopting two factors, the first (including items 1,2,3,4,9,10), the second (including items 5,6,7,8), covered cumulatively 78.8% of the variance. CONCLUSIONS: The study confirms that the BSRS is consistent with the idea for which it was built and can be useful for the study of the regularity of SBR in old adults.

Gender Differences among Sardinians with Alcohol Use Disorder.

Sardinia is an Italian island in the Mediterranean characterized by secular isolation and the singular genetic characteristics of its inhabitants. Findings obtained in populations with diverse genetic make-up and cultural background indicate gender differences and/or similarities in drinking characteristics of patients with alcohol use disorder (AUD). Knowledge of these characteristics in AUD patients is useful to improve access to treatments. This paper investigated the drinking characteristics of 66 female and 282 male outpatients with AUD, born from 1937 to 1991, living in Sardinia, and compared their characteristics with those of AUD patients living in other countries. Most Sardinian patients were men, approximately 3 years younger than women; women consumed lower amounts of alcohol than men but did not differ from men in the severity of AUD. Men were more often single than women, while a higher proportion of women reported that their mother or spouse was affected by AUD. Anxiety and depression were more prevalent among women while a higher proportion of men were affected by substance use disorders. Women were older than men at the age of first drink, regular drinking, and onset of AUD, and progressed faster than men from regular use to AUD onset. Women did not differ from men in age at first request for care, and in the lapse from AUD onset to first request for care. Women and men waited for more than 8 and 9 years, respectively, before receiving medical treatment. Gender differences progressively decreased among younger patients. Although the scarce number of women in some cohorts limits the strength of these findings, drinking characteristics of Sardinian patients did not vary significantly from those of AUD patients living in other countries. These results suggest that the number of Sardinian women with AUD is increasing and services for treatment of AUD should (a) consider women's specific needs, and (b) realize effective policies to reduce latency prior to accessing medical treatment for both men and women with AUD.

Exercise improves long-term social and behavioral rhythms in older adults: Did it play a role during the COVID-19 lockdown?

The study aimed to verify whether exercise training in older adults can improve social behavioral rhythms (SBR) and if any modification is maintained over time. Older adults (n=120) from a previous randomized controlled trial, were randomly allocated to either a moderate-intensity exercise group or a control group. SBR was evaluated at t0, t26, and t48 weeks (during the COVID-19 lockdown), using the brief social rhythms scale (BSRS). Seventy-nine participants completed the follow-up (age 72.3±4.7, women 55.3%). An improvement in the BSRS score was found in the exercise group at 26 weeks (p=0.035) when the exercise program was concluded, and it was maintained at 48 weeks (p=0.013). No improvements were observed in the control group. To conclude, SBR, previously found as a resilience factor in older adults during COVID-19, appear to improve after a moderate 12 weeks exercise program, and the improvement persisted even after stopping exercise during the COVID-19 lockdown.

The COVID-19 incidence in Italian regions correlates with low temperature, mobility and PM10 pollution but lethality only with low temperature.

BACKGROUND: The aim was to verify whether the density of particulate matter (PM10), the climate, and the mobility of people can influence the pandemic in the 19 regions and in the two autonomous Italian provinces as incidence rate and lethality. DESIGN AND METHODS: The incidence rates per 100,000 inhabitants and the case fatality ratio (CFR) (dependent variables) in all Italian regions were calculated in January 2021 at John Hopkins University Coronavirus Center. The independent variables were: Minimum average temperatures in the same month (January) of 2020; average pollution of PM10 in the air in each region in the last year available reported on a 0-10 scale to 0 = total absence of PM10 to 10 maximum pollutions; number of places in hotels occupied per inhabitants in 2020. Linear regression and Multiple Regression Analysis were carried out. RESULTS: The spread of the COVID-19 in the Italian regions seems to be related to pollution of PM10, the number of beds occupied in hotels (as an index of mobility and temperature (indirect correlation). On the contrary, the CFR correlates inversely with temperature but not with pollution. Measuring the concomitant effect of two independent variables by means of Multiple Regression Analysis, temperature and pollution show a synergistic effect on COVID-19 incidence. CONCLUSIONS: The study seems to confirm the literature on the influence of temperature on the lethality of COVID-19 but adds the new results of an inverse relationship between the spread of the virus and low temperature in regions between the Mediterranean area (which includes southern Italy and Sicily and Sardinia islands) and the cold European temperate zone which includes the northern regions under the Alps. A new date also concerns the summation effect of the risk between cold weather and PM10 air pollution was found. Due to several methodic weaknesses, the study has an exploratory than conclusive relevance.

Active elderly and health-can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial.

BACKGROUND: Aging is marked by a progressive rise in chronic diseases with an impact on social and healthcare costs. Physical activity (PA) may soothe the inconveniences related to chronic diseases, has positive effects on the quality of life and biological rhythms, and can prevent the decline in motor functions and the consequent falls, which are associated with early death and disability in older adults. METHODS: We randomized 120 over-65 males and females into groups of similar size and timing and will give each either moderate physical activity or cultural and recreational activities. Being younger than 65 years, inability to participate in physical activity for any medical reason, and involvement in a massive program of physical exercise are the exclusion criteria. The primary outcome measures are: quality of life, walking speed, and postural sway. Participants are tested at baseline, post-treatment, and 6-month (24 weeks) and 12-month (48 weeks) follow-ups. DISCUSSION: This study aims at improving the quality of life, wellness, and cognitive functioning in the elderly through a low-cost affordable program of moderate physical activity. Given the growing aging of the world population and the social and economic burden of disability in the elderly, our results might have a major impact on future practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT03858114 . Registered on 28 February 2019.

The effect of sucralfate-containing ointment on quality of life in people with symptoms associated with haemorrhoidal disease and its complications: the results of the EMOCARE survey.

BACKGROUND AND AIM: A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy. METHODS: EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores. RESULTS: Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (-11.13 [95%CI -12.95, -9.30] for physical disorders, -6.14 [95%CI -7.42, -4.85] for psychology, -18.79 [95% CI -21.67, -15.90] for defaecation, and -6.46 [95%CI -8.40, -4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05). CONCLUSIONS: After a mean 13 days of treatment  the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.

Community pharmacist's professional adaptation amid Covid-19 emergency: a national survey on Italian pharmacists.

Background Italy has been the first non-Asian country affected by Coronavirus Disease 19 (COVID-19) pandemic. Community pharmacies are essential services authorized to continue their activity during the emergency. To date, a clear image is lacking of the critical issues Italian community pharmacists had to face and of how they responded in their daily work.. Objective To describe procedures and critical logistical-organizational issues encountered by Italian community pharmacists and to collect the main requests reported by patients to pharmacists. Setting A national survey on Italian community pharmacists. Method A cross-sectional survey using a reasoned questionnaire was sent during the pandemic peak to Italian pharmacies, divided in two groups according to the incidence of COVID-19: "Red Zones" and "non-Red Zones". Main outcome measure Exploring the most frequently adopted measures by the pharmacists. Results 169 community Pharmacists answered the questionnaire. The most frequently adopted measures were the use of gloves, surgical masks and protective barriers at the drug counter. Most implemented services for customers were: booking of prescriptions, delivery of medications and implementation of phone consultations. Overall, the questionnaire highlighted an increase in the number of health-related consultations and requests by customers. In Red Zones, there was a higher use of FFP2 and FFP3 masks by pharmacists, where customers were mainly interested in gaining information about specific classes of medications. Conclusion Community pharmacists adapted to lockdown measures by implementing a number of measures. There was an overall increase in pharmacists' personal protective equipment in Red Zones possibly linked to increased risk perception.

Broad Spectrum project: factors determining the quality of antibiotic use in primary care: an observational study protocol from Italy.

INTRODUCTION: The overuse of antibiotics is causing worldwide spread of antimicrobial resistance (AMR). Compared with other countries, Italy has both high antibiotic consumption rates and high rates of AMR. Due to the fact that around 90% of antibiotics are prescribed by general practitioners (GPs), this study aims to measure the impact of knowledge, attitudes and sociodemographic and workplace-related factors on the quality of antibiotic prescriptions filled by GPs in the Italian Region of Sardinia. METHODS AND ANALYSIS: Knowledge, attitude, sociodemographic and workplace-related factors deemed to influence physicians prescribing behaviour will be evaluated in a cross-sectional study conducted among all GPs of the Italian Region of Sardinia (n=1200). A knowledge and attitudes questionnaire (Knowledge and Attitudes on Antibiotics and Resistance - Italian version: ITA-KAAR) accompanied by a sociodemographic form will be linked to drug prescription data reimbursed by the National Health System. European Surveillance of Antibiotic Consumption quality indicators for outpatient antibiotic use will be calculated from drug prescription records. Every GP will be deemed to have demonstrated an adequate quality of prescriptions of antibiotics if half of the indicator score plus one is better than the median of the region. A multivariate Poisson regression model with robust variance estimation will be used to evaluate the impact of the determinants of antibiotic prescriptions on the actual prescribing quality of each physician. ETHICS AND DISSEMINATION: The project has been approved by the ethics committee of the Regional Health Trust of Sardinia (176/2019/CE, 24 September 2019). The results will be useful to inform evidence-based interventions to tackle irrational antibiotic use in the community.