ABSTRACT
Introduction: Following The mass rollout of COVID-19 vaccination, regional lymphadenopathy presents as a diagnostic dilemma for clinicians. The aim of this study explores The incidence and management of unilateral axillary lymphadenopathy following vaccination at a symptomatic tertiary breast unit. Method(s): This is a retrospective review of a prospectively maintained database of all patients who underwent axillary imaging for symptomatic or incidental axillary lymphadenopathy detected On imaging following COVID-19 vaccination between January 2021-December 2021. Radiological and histological information were obtained from The hospital s NIMIS radiology and PIPE histology system. Additional patient and clinical information was obtained from patient's clinical notes. Result(s): A total of 253 patients underwent axillary ultrasounds during The twelve-month interval. Of these 24 (9.4%) of patients underwent investigation for axillary lymphadenopathy related to recent COVID vaccination. Of these, 21 patients had image consistent reactive nodes while The remaining 3 patients had normal radiological investigation. Only 6 patients underwent ultrasound guided biopsy of these nodes which confirmed reactive notes. Conclusion(s): Patient and clinician educationisrequiredtoraiseawareness in COVID-19 related axillary lymphadenopathy. Standardization in The management including The timing of breast screening and radiological investigation in relation to COVID vaccination is required, in order to minimize over investigation in this patient cohort. Take-home message: COVID-19 vaccine related axillary lymphadenopathy is being seen in tertiary symptomatic breast clinic. Patient and clinician education is necessary to raise awareness of this and contribute to a standardised approach of investigation and management of this phenomenon.
ABSTRACT
Delandistrogene moxeparvovec (SRP-9001) is an investigational gene transfer therapy developed for targeted skeletal and cardiac muscle expression of micro-dystrophin. In ongoing delandistrogene moxeparvovec Studies 101 and 102, remote functional assessment was initiated during the COVID-19 pandemic, in accordance with US Food and drug administration guidance. To evaluate the reliability of remote assessment of functional measures versus in-person testing, we assessed the reproducibility of remote North Star Ambulatory Assessment (NSAA), 10-metre Walk/Run (10MWR), and Time to Rise scores against in-person scores using pre-specified statistical analyses—including intraclass correlation coefficient (ICC), Pearson, Spearman, and Bland-Altman analyses. Preliminary results from eight patients with Duchenne muscular dystrophy (DMD), who completed an in-clinic assessment within 2 weeks of a remote assessment in Part 1 of Study 102, found strong correlations between remote and in-person NSAA scores (ICC=0.97 [95% confidence interval 0.87–0.99];Pearson=0.98 [95% CI 0.88–1.00];Spearman=0.93 [95% CI 0.66–0.99]). Analysis of all eight patients from Part 1 of Study 102 showed no statistical or clinical differences in NSAA scores attained remotely versus in person. Results from additional patients in Studies 101 and 102 (Parts 1 and 2), including correlations between remote and in-person scores on the 10MWR and time to rise, will also be presented. These findings suggest that remote functional assessment of patients with DMD is not statistically different from in-person assessment and has comparable clinical meaningfulness, validating its use in clinical trials of delandistrogene moxeparvovec. Given the burden that treatment and monitoring place on patients with DMD and their caregivers, remote assessment may be beneficial in future research, clinical trials, and clinical settings. [ FROM AUTHOR] Copyright of Neuromuscular Disorders is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)