ABSTRACT
Introduction: With cancelled student placements due to the COVID-19 pandemic, there is a shift towards non-patient-facing methods to deliver medical education. The aim was to design, deliver and evaluate an ENT course for undergraduate medical students. Method: A three-part simulation course on common and emergency ENT conditions was delivered by ENT trainees to undergraduate medical students (n=50). It involved theoretical and hands-on experience with otoscopy on head models;nasoendoscopy and epistaxis management with upper airway head models and nasal packing kits;and management of compromised airways using critical airway models, airway adjuncts, intubation and cricothyroidotomy kits. Delegates were given pre- and post-course questionnaires, with another at six-weeks to test knowledge retention. Results were statistically analysed using paired and independent sample t-tests. Results: A statistically significant improvement in post-test knowledge of 55% (p<0.01) was observed. Delegates also demonstrated a sustained improvement of 51% (p<0.01) six-weeks later compared to baseline knowledge. 76% and 80% reported improved confidence managing epistaxis and performing intubation respectively;46% reported increased interest in pursuing ENT as a potential career. Conclusions: This study demonstrated statistically significant and sustained improvements in knowledge about common and emergency ENT concepts. ENT simulation therefore represents an efficacious mechanism for teaching key ENT concepts and improving confidence in undergraduate medical students, whilst improving interest in pursuing ENT as a career. Additionally, simulation is an invaluable educational adjunct that may foster more realistic, impactful, and safer educational experiences for medical students whilst exposure to patients is minimised due to the current pandemic.
ABSTRACT
Background : Adeno-associated virus (AAV)-mediated gene therapy is being investigated as a treatment for people with hemophilia A (PwHA). Commonly studied AAV serotypes include AAV5, AAV6, and AAV8. Pre-existing immunity against these AAVs restricts patient eligibility yet, published data on AAV seroprevalence and seroconversion rate in PwHA are limited. Aims : To describe design and recruitment methods used for the SAVVY study. This study is designed to characterize AAV antibody prevalence and titers, evaluate changes in antibody titer over time, and examine factors that may influence antibody positivity, titer, and seroconversion. Study design and recruitment methods seek to minimize the need for in-person study interactions during the COVID-19 pandemic. Methods : SAVVY is a patient-centered, decentralized, prospective, observational study involving blood draws at 2 time points. The target sample size of 1,000 PwHA represents approximately 5% of PwHA in the US. SAVVY employs a user-friendly mobile application, provides remote recruitment through e-consent, and uses a network of 1,800+ laboratories throughout the US for biospecimen sample collection. This approach minimizes patient travel, reduces potential exposure to COVID-19, and removes burden from HTC staff to perform study assessments. Recruitment has leveraged various forms of virtual outreach to physicians, HTC staff, and patient advocacy groups;direct-to-patients are being used to create awareness of the study and its scientific aims. See Table 1. Results : First patient enrollment occurred within four months of final protocol;41 patients were enrolled within 2 weeks of activation. At the time of abstract submission, 105 patients had consented to participate. Conclusions : The COVID-19 pandemic disrupted the progress of clinical studies necessary for the advancement of treatments. Adaptability to existing conditions is critical. Careful study design and multi-modal engagement with the hemophilia community can facilitate the conduct of studies, minimize risks associated with COVID-19, and may enhance patient experience and clinical trial recruitment.