BACKGROUND. The COVID-19 vaccines currently in use require 2 doses to achieve optimal protection. Currently, there is no indication as to whether individuals who have been exposed to SARS-CoV-2 should be vaccinated, or whether they should receive 1 or 2 vaccine doses. METHODS. We tested the antibody response developed after administration of the Pfizer/BioNTech vaccine in 124 health care professionals, of whom 57 had a previous history of SARS-CoV-2 exposure with or without symptoms. RESULTS. Postvaccine antibodies in SARS-CoV-2–exposed individuals increased exponentially within 5 to 18 days after the first dose compared to naive subjects (P < 0.0001). In a multivariate linear regression (LR) model we showed that the antibody response depended on the IgG prevaccine titer and on the exposure to SARS-CoV-2. In symptomatic SARS-CoV-2–exposed individuals, IgG reached a plateau after the second dose, and those who voluntarily refrained from receiving the second dose (n = 7) retained their antibody response. Gastrointestinal symptoms, muscle pain, and fever markedly positively correlated with increased IgG responses. By contrast, all asymptomatic/paucisymptomatic and unexposed individuals showed an important increase after the second dose. CONCLUSION. One vaccine dose is sufficient in symptomatic SARS-CoV-2–exposed subjects to reach a high titer of antibodies, suggesting no need for a second dose, particularly in light of current vaccine shortage. TRIAL REGISTRATION. ClinicalTrials.gov NCT04387929. FUNDING. Dolce & Gabbana and the Italian Ministry of Health (Ricerca corrente).
Aims: Whether pulmonary artery (PA) dimension and coronary artery calcium (CAC) score, as assessed by chest computed tomography (CT), are associated with myocardial injury in patients with coronavirus disease 2019 (COVID-19) is not known. The aim of this study was to explore the risk factors for myocardial injury and death and to investigate whether myocardial injury has an independent association with all-cause mortality in patients with COVID-19. Methods and Results: This is a single-centre cohort study including consecutive patients with laboratory-confirmed COVID-19 undergoing chest CT on admission. Myocardial injury was defined as high-sensitivity troponin I >20 ng/L on admission. A total of 332 patients with a median follow-up of 12 days were included. There were 68 (20.5%) deaths; 123 (37%) patients had myocardial injury. PA diameter was higher in patients with myocardial injury compared with patients without myocardial injury [29.0 (25th–75th percentile, 27–32) mm vs. 27.7 (25–30) mm, P < 0.001). PA diameter was independently associated with an increased risk of myocardial injury [adjusted odds ratio 1.10, 95% confidence interval (CI) 1.02–1.19, P = 0.01] and death [adjusted hazard ratio (HR) 1.09, 95% CI 1.02–1.17, P = 0.01]. Compared with patients without myocardial injury, patients with myocardial injury had a lower prevalence of a CAC score of zero (25% vs. 55%, P < 0.001); however, the CAC score did not emerge as a predictor of myocardial injury by multivariable logistic regression. Myocardial injury was independently associated with an increased risk of death by multivariable Cox regression (adjusted HR 2.25, 95% CI 1.27–3.96, P = 0.005). Older age, lower estimated glomerular filtration rate, and lower PaO2/FiO2 ratio on admission were other independent predictors for both myocardial injury and death. Conclusions: An increased PA diameter, as assessed by chest CT, is an independent risk factor for myocardial injury and mortality in patients with COVID-19. Myocardial injury is independently associated with an approximately two-fold increased risk of death.
The systematic evaluation of the quality of medical records is crucial. Nevertheless, even if the improvement of medical records quality represents a priority for every health organization, it might be difficult to realize. This is the first study to assess the efficacy of internal audit as a tool to improve the quality of medical records in hospital setting. The program was carried out in a third level teaching hospital. Trained ad hoc evaluation teams carried out two retrospective assessments of quality of medical records using a random sampling strategy. The quality assessment was performed using a 48-items evaluation grid divided into 9 domains: General; Patient Medical History and Physical Examination; Daily Clinical Progress Notes; Daily Nursing Progress Notes; Drug Therapy Chart; Pain Chart; Discharge Summary; Surgery Register; Informed Consent. After the first evaluation of 1.460 medical records, an audit departmental program was set up. The second evaluation was carried out after the internal auditing for 1.402 medical records. Compared to the first analysis, a significant quality amelioration in all the sections of the medical chart was shown with the second analysis, with an increase of all the scores above 50%. The differences found for each section of medical records between the first and second analysis are all significant (p<0.01). Internal audits are not just measurement activities but a necessary activity to support the organization in achieving its objectives and assessing the quality of clinical care and maintaining high quality professional performance
The purpose of this study was to evaluate the efficacy and safety of the Moderna-1273 mRNA vaccine for SARS-CoV-2 in patients with immune-mediated diseases under different treatments. Anti-trimeric spike protein antibodies were tested in 287 patients with rheumatic or autoimmune diseases (10% receiving mycophenolate mofetil, 15% low-dose glucocorticoids, 21% methotrexate, and 58% biologic/targeted synthetic drugs) at baseline and in 219 (76%) 4 weeks after the second Moderna-1273 mRNA vaccine dose. Family members or caretakers were enrolled as the controls. The neutralizing serum activity against SARS-CoV-2-G614, alpha, and beta variants in vitro and the cytotoxic T cell response to SARS-CoV-2 peptides were determined in a subgroup of patients and controls. Anti-SARS-CoV-2 antibody development, i.e., seroconversion, was observed in 69% of the mycophenolate-treated patients compared to 100% of both the patients taking other treatments and the controls (p < 0.0001). A dose-dependent impairment of the humoral response was observed in the mycophenolate-treated patients. A daily dose of >1 g at vaccination was a significant risk factor for non-seroconversion (ROC AUC 0.89, 95% CI 0.80–98, p < 0.0001). Moreover, in the seroconverted patients, a daily dose of >1 g of mycophenolate was associated with significantly lower anti-SARS-CoV-2 antibody titers, showing slightly reduced neutralizing serum activity but a comparable cytotoxic response compared to other immunosuppressants. In non-seroconverted patients treated with mycophenolate at a daily dose of >1 g, the cytotoxic activity elicited by viral peptides was also impaired. Mycophenolate treatment affects the Moderna-1273 mRNA vaccine immunogenicity in a dose-dependent manner, independent of rheumatological disease.
Background: The possible benefits of using semantic language models in the early diagnosis of major ischemic stroke (MIS) based on artificial intelligence (AI) are still underestimated. The present study strives to assay the feasibility of the word2vec word embedding-based model in decreasing the risk of false negatives during the triage of patients with suspected MIS in the emergency department (ED). Methods: The main ICD-9 codes related to MIS were used for the 7-year retrospective data collection of patients managed at the ED with a suspected diagnosis of stroke. The data underwent “tokenization” and “lemmatization”. The word2vec word-embedding algorithm was used for text data vectorization. Results: Out of 648 MIS, the word2vec algorithm successfully identified 83.9% of them, with an area under the curve of 93.1%. Conclusions: Natural language processing (NLP)-based models in triage have the potential to improve the early detection of MIS and to actively support the clinical staff.