ABSTRACT
Background. Salivary glands ultrasonography (SGUS) is an emerging tool to evaluate damages in primary sjogren patients (pSS). Up to date, SGUS has demonstrated its metric properties as an outcome measure for diagnosing pSS. As New therapeutics protocols are in developing it seems mandatory to use validated SGUS scoring systems. Objectives. The goal of our study was to evaluate international SGUS reliability exercise before beginning an international SGUS study to evaluate Modification Abnormalities of Salivary glands in pSS According to disease duration (MASAI study). Methods. Fourteen sonographers with different levels of SGUS participated in the exercise, evaluating 60 grey scale static images (30 parotid and 30 submandibular glands). Before the exercise, training was done by videoconferencing showing the different pathological SGUS findings and explaining the new OMERACT scoring system. We evaluated homogeneity (yes/no), location of hypoechogenity (0 to 3), hyperechoic band (0-3), comprehensive OMERACT scoring system (0-3), binary comprehensive OMERACT (0-1 versus 2-3) and diagnosis appreciation (No/yes). Intra-reader and interreader reliability were estimated by computing Cohen's kappa coefficients using SPSS 25.0 (SPSS Inc., Chicago, IL), and was interpreted as follows: slight, 0-0.20;fair, 0.21-0.40;moderate, 0.41-0.60;substantial, 0.61-0.80;and almost perfect, 0.81-1. The most experienced sonographer (P4) was considered as the gold standard. Results. Intra-reader reliability of the most experienced was perfect and substantial for the OMERACT scoring system. Intra-reader reliability of the other sonographers was fair to almost perfect for homogeneity and diagnosis whereas the reliability was fair to substantial for other items. Inter-reader reliability between the two most experienced sonographers (P4 and P12) was almost perfect for homogeneity, substantial for diagnosis and moderate for OMERACT scoring system. Changing OMERACT scoring system in binary items, the reliability of the most experienced sonographer was good 0.65 (9 images with homogeneity and low OMERACT, 42 had heterogeneity and high OMERACT, 9 had no homogeneity but low OMERACT and none had homogeneity with high OMERACT), clearly lower that of homogeneity. Compared to the most experienced sonographer, reliabilities of other sonographers were moderate to almost perfect for both homogeneity and diagnosis but only fair to moderate for OMERACT (Table I, II). Conclusions. According to the updated literature, we confirmed that homogeneity is the most reliable item, very close to diagnosis appreciation. Structural damages evaluations by the OMERACT scoring systems gave lower kappa values but remain still useful for diagnosing and particularly following parenchymal modifications. (Table Presented).
ABSTRACT
Objectives. To investigate the safety and efficacy of SARS-Cov-2 vaccination in a large international cohort of patients with primary Sjogren syndrome due to scarcity of data in this population. Methods. By the first week of May 2021, all Big Data Sjogren Consortium centers had been contacted and asked for Registry patients to be included in the study if they had received at least one dose of any SARS-CoV-2 vaccine. The in-charge physician asked patients about local and systemic reactogenicity, using a pre-defined electronic questionnaire to collect epidemiologic data, COVID 19 vaccination data, and COVID 19 vaccination side effects. Adverse events were defined as those reported by the patient at the site of injection within 7 days from vaccination (reactogenicity) as local adverse events, systemic symptoms as systemic side effects, and postvaccination AEs of special interest related to SS as SS flares. Results. The vaccination data of 1237 patients (1170 women, with a mean age at diagnosis of primary SjS of 50.5 13.2) were received. A total of 835 patients (67 percent) reported any adverse event, including local (53 percent) and systemic (50 percent) AEs. Subjective symptoms (63%) were the most common local AEs, followed by objective signs at the injection site (16%) and general symptoms were the most commonly reported systemic AEs (46 percent), followed by musculoskeletal (25 percent), gastrointestinal (9 percent), cardiopulmonary (3 percent), and neurological (2 percent). People under 60 years old had a higher risk of developing AE after vaccination (OR 2.48, CI 95 1.89-3.27 percent), as did those with low systemic SS activity (OR 1.62, CI 95 1.22-2.15) and those who received mRNA vaccines, according to a multivariate analysis (OR 1.57, CI 95 percent 1.12- 2.18). The risk of developing systemic AEs was also higher in women (OR 2.85, CI 95 percent 1.60-5.2346), White people (OR 1.73, CI 95 1.14-2.65), and those who received a deficient vaccination regimen (OR 1.78, CI 95 1.12-2.88 percent). In addition to 141 (11%) patients who reported a significant worsening/exacerbation of their pre-vaccination sicca symptoms as a result of post-vaccination SS flares, 15 (1.2%) patients (13 women, mean age at vaccination 41.9 years) reported active involvement in the glandular (n=8), articular (n=7), cutaneous (n=6), pulmonary (n=2), and peripheral nervous system (n=1) domains as post-vaccination systemic flare. All side effects and flares subsided within 1-3 weeks, with no lasting effects or deaths. In terms of vaccination efficacy, breakthrough SARS-CoV-2 infection was confirmed after vaccination in three (0.24 percent) patients, all of whom recovered completely, and positive anti-SARS-Cov-2 antibodies were detected in approximately 95 percent of vaccinated SjS patients, according to data available. Conclusions. SARS-CoV-2 vaccination in patients with primary SjS, like other vaccines with adequate response and no safety signals, raised no concerns about the vaccine's efficacy or safety.
ABSTRACT
BACKGROUND: The corona crisis not only affects professional activities but also teaching and learning at universities. Buzzwords, such as elearning and digitalization suggest the possibility of innovative teaching approaches that are readily available to solve the problems of teaching in the current COVID-19 pandemic. The current conversion to digital teaching is not primarily driven by didactic rationale or institutional strategy but by external circumstances. OBJECTIVE: The aim of the study was to determine the teaching situation at national university ENT clinics and academic teaching hospitals at the start of the virtual corona summer semester in 2020. MATERIAL AND METHODS: A specifically self-designed questionnaire regarding the local situation and conditions as well as nationwide scenarios was sent to all 39 national university ENT clinics and 20 ENT departments at academic teaching hospitals. RESULTS: A total of 31 university hospitals and 10 academic teaching hospitals took part in the survey. There were obvious discrepancies between available resources and effectively available digital teaching and learning contents. Further criticism was expressed regarding the communication with the medical faculty, the digital infrastructure and particularly the frequent lack of collaboration with central support facilities, such as media, didactics and datacenters. CONCLUSION: There are positive examples of successful transformation of classroom teaching to an exclusively virtual summer semester 2020 within the university ENT clinics; however, critical ratings of assistant professors and medical directors regarding the current teaching situation predominated. A time-critical strategic advancement is urgently needed.