The use of C-reactive protein testing and antibiotic prescribing in Italy: A population-based study in primary care.

Testing serum C-reactive protein (CRP) levels can help determine whether there is a need for antibiotics and can limit prescribing of antibiotics for illnesses that are likely viral or non-infectious in origin. Using Health Search, an Italian primary care database, we identified all patients, aged 15 years or older, being registered in the period between 1 January 2000 and 31 December 2019 and newly diagnosed with upper respiratory tract infections (URTIs) or COPD- or asthma-related exacerbations. From the date of these diagnoses, patients were followed up until occurrence of antibiotic prescription (for these indications) up to 31 December 2019. The association between the CRP testing and the outcome was investigated using a nested case-control analysis. In a cohort of 469 684 patients being diagnosed for URTI (83%), COPD- (11%) and asthma (7%)-related exacerbations, 28 688 (6.11%) were prescribed with antibiotics because of the aforementioned indications. Of note, 98% of cases, nominally those prescribed with antibiotics, were not tested with CRP. However, those receiving antibiotics were more likely to have been previously tested for CRP than controls who did not receive antibiotics (833/28 601 [3%] and 4128/277 968 [1.5%]; OR 2.0 [95% CI: 1.8-2.1]). Our findings indicate that most of the antibiotic prescriptions for the investigated conditions were given without any prior CRP testing. A small minority of GPs did properly use CRP to determine whether antibiotics were needed. Further guidance is needed in Italy on the use of CRP in guiding antibiotic prescribing in primary care.

Epidemiology of invasive meningococcal disease and its sequelae: a population-based study in Italian primary care, 2000-2019.

BACKGROUND: Invasive meningococcal disease (IMD) is a severe infectious disease. Although effective preventive and therapeutical strategies are available, the fatality rate remains high in the general population, with an occurrence of meningococcal-related severe sequelae involving 10-20% of survivors. Given the crucial role of general practitioners in recognizing and preventing IMD and its related sequelae, we aim to assess the burden of these conditions in primary care. METHODS: Using an Italian primary care database, the incidence rate of IMD was calculated in the period 2000-2019 by capturing the first diagnosis registered during follow-up. As far as meningococcal-related sequelae are concerned, we identified and clinically evaluated each potential sequela during the first 3 months, from 3 to 12 months, and up to 36 months. RESULTS: Among 508 patients diagnosed with IMD, 403 (incidence rate: 0.24 per 10,000 person-years) comprised those diagnosed with IMD in patients aged 15 years or older. We ascertained 104 sequelae (20.4%); 76% of them occurred in those aged 25 or older; 42, 27, and 35 were assessed as short-, medium-, or long-term sequelae, respectively. Overall, 4.7% of IMD patients reported physical sequelae, while 12.2% and 5.7% of patients reported neurological and psychological sequelae, respectively. CONCLUSION: Our study showed that a substantial proportion of IMD and related sequelae occur in individuals aged over 25, with a non-negligible burden for healthcare systems. As for the paediatric population, effective communication on the relevance of meningococcal vaccination in adults should be proficiently fostered.

A rapid and feasible tool for clinical decision making in community-dwelling patients with COVID-19 and those admitted to emergency departments: the Braden-LDH-HorowITZ Assessment-BLITZ.

There is no univocal standardized strategy to predict outcomes and stratify risk of SARS-CoV-2 infected patients, notably in emergency departments. Our aim is to develop an accurate indicator of adverse outcomes based on a retrospective analysis of a COVID-19 database established at the Emergency Department (ED) of a North-Italian hospital during the first wave of SARS-CoV-2 infection. Laboratory, clinical, psychosocial and functional characteristics including those obtained from the Braden Scale-a standardized scale to quantify the risk of pressure sores which takes into account aspects of sensory perception, activity, mobility and nutrition-from the records of 117 consecutive patients with swab-positive COVID-19 disease admitted to the Emergency Medicine ward between March 1, 2020 and April 15, 2020 were included in the analysis. Adverse outcomes included admission to the Intensive Care Unit (ICU) and in-hospital death. Among the parameters collected, the highest cutoff sensitivity and specificity scores to best predict adverse outcomes were displayed by lactate dehydrogenase (LDH) blood value at admission > 439 U/L, Horowitz Index (P/F Ratio) < 257 and Braden score < 18. The estimation power reached 93.6%. We named the assessment BLITZ (Braden-LDH-HorowITZ). Despite the retrospective and preliminary nature of the data, a multidimensional tool to assess overall functions, not chronological age, produced the highest prediction power for poor outcomes in relation to SARS-CoV-2 infection. Further analyses are now needed to establish meaningful correlations between ventilation therapies and multidimensional frailty as assessed by ad-hoc validated and standardized tools.

Predicting the risk of severe COVID-19 outcomes in primary care: development and validation of a vulnerability index for equitable allocation of effective vaccines.

BACKGROUND: General practitioners (GPs) need a valid, user-friendly tool to identify patients most vulnerable to COVID-19, especially in the hypothesis of a booster vaccine dose. The aim of this study was to develop and validate a GP-friendly prognostic index able to forecast severe COVID-19 outcomes in primary care. Indeed, no such prognostic score is as yet available in Italy. RESEARCH DESIGN AND METHODS: In this retrospective cohort study, a representative sample of 47,868 Italian adults were followed up for 129,000 person-months. The study outcome was COVID-19-related hospitalization and/or death. Candidate predictors were chosen on the basis of systematic evidence and current recommendations. The model was calibrated by using Cox regression. Both internal and external validations were performed. RESULTS: Age, sex and several clinical characteristics were significantly associated with severe outcomes. The final multivariable model explained 60% (95%CI 58-63%) of variance for COVID-19-related hospitalizations and/or deaths. The area under the receiver-operator curve (AUC) was 84% (95% CI: 83-85%). On applying the index to an external cohort, the AUC was 94% (95% CI: 93-95%). CONCLUSIONS: This index is a reliable prognostic tool that can help GPs to prioritize their patients for preventive and therapeutic interventions.

[COVID-Guide: an app for covid-19 triage and self-assessment.] / COVID-Guide: una app per il triage e l'autovalutazione della covid-19.

INTRODUCTION: The unprecedented covid-19 pandemic has shown the weaknesses of health systems and opened new spaces for e-health and telemedicine. Recent literature states that chatbots, if implemented effectively, could be useful tools for quickly sharing information, promoting healthy behaviors, and helping reduce the psychological burden of isolation. The aim of this project is to develop and test a secure and reliable computerized decision support system (CDSS) in web-app and evaluate its use, usability and its outputs in a pre-specified way. METHODS: A multidisciplinary team was recruited to plan and design, based on the SMASS medical CDSS, the scenarios of the COVID-Guide web-app, a self-triage system for patients with suspected covid-19. The output data for the period May-September 2020 from Germany were analyzed. RESULTS: During the period under review, the total number of consultations in Germany was 96,012. 3,415 (3.56%) consultations indicated the need for immediate evaluation, by activating the emergency service (calling an ambulance) - 1,942, equal to 2.02% - or by advising the patient to go to hospital - 1,743, equal to 1.54%. CONCLUSIONS: Data seems to show good usability and a consistent number of consultations carried out. Regular use of COVID-Guide could help collect epidemiological data on the spread of (suspected) covid-19 cases, easily and quickly available in all countries where the tool will be used. Using the SSDC could help reduce the load on operators. Furthermore, the use of anonymous and geolocatable clinical data together with the generation of alerts and indicators produced by COVID-Guide could become a useful tool for epidemiological surveillance in the future phases of the pandemic (Telemedical Syndromic Surveillance).

Reduced effectiveness among ß-lactam antibiotics: a population-based cohort study in primary care in Italy.

BACKGROUND: There are few data comparing the relative effectiveness of the individual ß-lactams. OBJECTIVES: To quantify the reduced effectiveness, defined as switching to a different antibiotic being prescribed for the same indication, among new users of ß-lactam antibiotics in primary care. METHODS: A retrospective cohort study was conducted using the Health Search Database, an Italian primary care data source. Patients newly prescribed with ß-lactams for a specific indication between 1 January 2013 and 31 December 2017 were identified. A switch to a different antibiotic for the same indication occurring during a 30day follow-up was the study outcome. Cox regression was adopted to assess the risk of switching between the different ß-lactams. RESULTS: Among 178 256 patients newly treated with ß-lactam antibiotics, 1172 (0.65%) switched to a different antibiotic. Amoxicillin/clavulanate (co-amoxiclav: n = 104 891) and amoxicillin (n = 21 699) were the most frequently prescribed ß-lactams. The other antibiotics showed significantly higher risk of switching when compared with co-amoxiclav for lower respiratory tract [e.g. ceftriaxone, hazard ratio (HR): 1.6, 95% CI: 1.2-2.0], dental [e.g. amoxicillin, HR: 4.2, 95% CI: 2.9-5.9], and middle ear infections [e.g. amoxicillin, HR: 1.8, 95% CI: 1.1-2.7]. The same results were gathered when parenteral formulations were excluded. CONCLUSIONS: The prevalence of reduced effectiveness of newly prescribed ß-lactam antibiotics was lower than 1%. Specifically, the rate of switch to another antibiotic, when it was prescribed to treat low respiratory tract, dental, and middle ear infections, was lower among users of co-amoxiclav than those prescribed with other ß-lactams.

How to Treat COVID-19 Patients at Home in the Italian Context: An Expert Opinion.

The impact of the coronavirus disease (COVID-19), caused by the novel coronavirus SARS-CoV-2, continues to be widespread, with more than 100 million cases diagnosed in more than 220 countries since the virus was first identified in January 2020. Although patients with mild to moderate forms of COVID-19 could be efficiently managed at home, thus reducing the pressure on the healthcare system and minimizing socio-psychological impact on patients, no trial has been proposed, conducted, or even published on COVID-19 home therapy to date. These expert opinions provide indications on the therapeutical at home management of COVID-19 patients, based on the evidence from the literature and on current guidelines.

An umbrella review of systematic reviews with meta-analyses evaluating positive and negative outcomes of Hydroxychloroquine and chloroquine therapy.

BACKGROUND & AIMS: Hydroxychloroquine (HCQ) and chloroquine (CQ) are anti-malarial drugs frequently used in the rheumatologic field. They were recently identified as potential therapeutic options for Coronavirus Disease (COVID-19). The present study aims to map and grade the diverse health outcomes associated with HCQ/CQ using an umbrella review approach. METHODS: Umbrella review of systematic reviews of observational and intervention studies. For observational studies, random-effects summary effect size, 95% confidence interval, and 95% prediction interval were estimated. We also assessed heterogeneity, evidence for small-study effect, and evidence for excess significance bias. The quality of evidence was then graded using validated criteria from highly convincing to weak. The evidence from randomized controlled trials (RCTs) was graded using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. RESULTS: From 313 articles returned in the literature search, six meta-analyses were included (n = 25 outcomes). Among meta-analyses (MAs) of observational studies, HCQ/CQ are weakly associated with a reduced risk for cardiovascular events and diabetes when used for autoimmune diseases and with spontaneous abortion; they are also associated with a higher risk of death in COVID-19 patients. Among MAs of RCTs, HCQ/CQ are associated with an improvement of articular manifestations of rheumatic diseases. CONCLUSIONS: There is high evidence of the efficacy of HCQ/CQ in the rheumatologic field. The lack of evidence for efficacy and the risk of death associated with the use of HCQ/CQ for COVID-19 indicate the inappropriateness of their inclusion in recent COVID-19 therapy guidelines and the urgent need for RCTs to determine eventual appropriateness as a COVID-19 therapy.

Use of Corticosteroids in Coronavirus Disease 2019 Pneumonia: A Systematic Review of the Literature.

The aim was to investigate the effectiveness of glucocorticoid therapy in patients with COVID-19. A systematic search of the literature across nine databases was conducted from inception until 15th March 2020, following the PRISMA guidelines. Patients with a validated diagnosis of COVID-19 and using corticosteroids were included, considering all health outcomes. Four studies with 542 Chinese participants were included. Two studies reported negative findings regarding the use of corticosteroids in patients with COVID-19, i.e., corticosteroids had a detrimental impact on clinical outcomes. One study reported no significant association between the use of corticosteroids and clinical outcomes. However, one study, on 201 participants with different stages of pneumonia due to COVID-19, found that in more severe forms, the administration of methylprednisolone significantly reduced the risk of death by 62%. The literature to date does not fully support the routine use of corticosteroids in COVID-19, but some findings suggest that methylprednisolone could lower mortality rate in more severe forms of the condition.