(1) Background: Although DR screening is effective, one of its most significant problems is a lack of attendance. The aim of the present study was to demonstrate the effectiveness of our algorithm in predicting the development of any type of DR and referable DR. (2) Methods: A retrospective study with an 11-year follow-up of a population of 120,389 T2DM patients was undertaken. (3) Results: Applying the results of the algorithm showed an AUC of 0.93 (95% CI, 0.92-0.94) for any DR and 0.90 (95% CI, 0.89-0.91) for referable DR. Therefore, we achieved a promising level of agreement when applying our algorithm. (4) Conclusions: The algorithm is useful for predicting which patients may develop referable forms of DR and also any type of DR. This would allow a personalized screening plan to be drawn up for each patient.

INTRODUCTION: During the COVID-19 pandemic, EMA set-up a large-scale cohort event monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug reactions (ADRs) of different COVID-19 vaccines across the participating countries. This study aims to give an up to date and in-depth analysis of the frequency of patient-reported ADRs after the 1st, 2nd, and booster vaccination, to identify potential predictors in developing ADRs and to describe time-to-onset (TTO) and time-to-recovery (TTR) of ADRs. METHODS: A CEM study was rolled out in a period ranging from February 2021 to February 2023 across multiple European countries; The Netherlands, Belgium, France, the United Kingdom, Italy, Portugal, Romania, Slovakia and Spain. Analysis consisted of a descriptive analyses of frequencies of COVID-19 vaccine-related ADRs for 1st, 2nd and booster vaccination, analysis of potential predictors in developing ADRs with a generalized linear mixed-effects model, analysis of TTO and TTR of ADRs and a sensitivity analysis for loss to follow-up (L2FU). RESULTS: A total of 29,837 participants completed at least the baseline and the first follow-up questionnaire for 1st and 2nd vaccination and 7,250 participants for the booster. The percentage of participants who reported at least one ADR is 74.32% (95%CI 73.82-74.81). Solicited ADRs, including injection site reactions, are very common across vaccination moments. Potential predictors for these reactions are the brand of vaccine used, the patient’s age, sex and prior SARS-CoV-2 infection. The percentage of serious ADRs in the study is low for 1st and 2nd vaccination (0.24%, 95%CI 0.19–0.31) and booster (0.26%, 95%CI 0.15, 0.41). The TTO was 14 h (median) for dose 1 and slightly longer for dose 2 and booster dose. TTR is generally also within a few days. The effect of L2FU on estimations of frequency is limited. CONCLUSION: Despite some limitations due to study design and study-roll out, CEM studies can allow prompt and almost real-time observations of the safety of medications directly from a patient-centered perspective, which can play a crucial role for regulatory bodies during an emergency setting such as the COVID-19 pandemic.

Background: The study of thoracic injuries and biomechanics during CPR requires detailed studies that are very scarce. The role of the heart in CPR biomechanics has not been determined. This study aimed to determine the risk factors importance for serious ribcage damage due to CPR. Methods: Data were collected from a prospective registry of out-of-hospital cardiac arrest between April 2014 and April 2017. This study included consecutive out-of-hospital CPR attempts undergoing an autopsy study focused on CPR injuries. Cardiac mass ratio was defined as the ratio of real to expected heart mass. Pearson’s correlation coefficient was used to select clinically relevant variables and subsequently classification tree models were built. The Gini index was used to determine the importance of the associated serious ribcage damage factors. The LUCAS (R) chest compressions device forces and the cardiac mass were analyzed by linear regression. Results: Two hundred CPR attempts were included (133 manual CPR and 67 mechanical CPR). The mean age of the sample was 60.4 +/- 13.5, and 56 (28%) were women. In all, 65.0% of the patients presented serious ribcage damage. From the classification tree build with the clinically relevant variables, age (0.44), cardiac mass ratio (0.26), CPR time (0.22), and mechanical CPR (0.07), in that order, were the most influential factors on serious ribcage damage. The chest compression forces were greater in subjects with higher cardiac mass. Conclusions: The heart plays a key role in CPR biomechanics being cardiac mass ratio the second most important risk factor for CPR injuries.

In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021-February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee’s characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection.

BACKGROUND: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Future estimations suggest an increase in global burden of AF greater than 60% by 2050. Numerous studies provide growing evidence that AF is not only associated with stroke but also with cognitive impairment and dementia. AIM: The main goal is to assess the impact of the combined use of cardiac rhythm monitoring devices, echocardiography, biomarkers and neuroimaging on the early diagnosis of AF, silent strokes and cognitive decline, in subjects at high risk of AF. METHODS AND ANALYSIS: Two-year follow-up of a cohort of individuals aged 65-85 years at high risk for AF, with no prior diagnosis of either stroke or dementia. The study involves baseline echocardiography, biomarkers, and neuroimaging, yearly cardiac monitoring, and semiannual clinical assessments. Different parameters from these tests will be analysed as independent variables. Throughout the study period, primary outcomes: new diagnoses of AF, stroke and cognitive impairment, along with any clinical and therapeutic changes, will be registered. A first descriptive and bivariate statistical analysis, appropriate to the types of variables, will be done. The information obtained from the data analysis will encompass adjusted risk estimates along with 95% confidence intervals. Event risk predictions will rely on multivariate Cox proportional hazards regression models. The predictive value of the model will be evaluated through the utilisation of receiver operating characteristic curves for area under the curve calculation. Additionally, time-to-event analysis will be performed using Kaplan-Meier curves. ETHICS AND DISSEMINATION: This study protocol has been reviewed and approved by the Independent Ethics Committee of the Foundation University Institute for Primary Health Care Research-IDIAP Jordi Gol (expedient file 22/090-P). The authors plan to disseminate the study results to the general public through various scientific events. Publication in open-access journals and presentations at scientific congresses, seminars and meetings is also foreseen. TRIAL REGISTRATION NUMBER: NCT05772806.