Exploring residents and supervisors' workplace learning needs during postgraduate medical education.

Objectives: To identify the main enablers and challenges for workplace learning during postgraduate medical education among residents and their supervisors involved in training hospital specialists across different medical specialties and clinical teaching departments. Methods: A qualitative explorative study using semi-structured focus group interviews was employed. A purposeful sampling method was utilized to invite participants who were involved in postgraduate medical education for hospital specialist medicine at two universities. Hospital physicians in training, also called residents (n=876) and supervisors (n=66), were invited by email to participate. Three focus groups were organized: two with residents and one with supervisors. Due to the COVID-19 pandemic rules prohibiting real group meetings, these focus groups were online and asynchronous. The data was analyzed following an inductive thematic analysis. Results: The following overarching themes were identified: 1) the dual learning path, which balances working in the hospital and formal courses, 2) feedback, where quality, quantity, and frequency are discussed, and 3) learning support, including residents' self-directed learning, supervisors' guidance, and ePortfolio support. Conclusions: Different enablers and challenges for postgraduate medical education were identified. These results can guide all stakeholders involved with workplace learning to develop a better understanding of how workplace learning can be optimized to improve the postgraduate medical education experience. Future studies could focus on confirming the results of this study in a broader, perhaps international setting and exploring strategies for aligning residencies to improve quality.

Reply to Davison, G. Comment on "Huijghebaert et al. Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union. Int. J. Environ. Res. Public Health 2021, 18, 5066".

We have read the comment from Davison with great interest [...].

Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union.

BACKGROUND: nasal or oral sprays are often marketed as medical devices (MDs) in the European Union to prevent common cold (CC), with ColdZyme®/Viruprotect® (trypsin/glycerol) mouth spray claiming to prevent colds and the COVID-19 virus from infecting host cells and to shorten/reduce CC symptoms as an example. We analyzed the published (pre)-clinical evidence. METHODS: preclinical: comparison of in vitro tests with validated host cell models to determine viral infectivity. Clinical: efficacy, proportion of users protected against virus (compared with non-users) and safety associated with trypsin/glycerol. RESULTS: preclinical data showed that exogenous trypsin enhances SARS-CoV-2 infectivity and syncytia formation in host models, while culture passages in trypsin presence induce spike protein mutants. The manufacturer claims >98% SARS-CoV-2 deactivation, although clinically irrelevant as based on a tryptic viral digest, inserting trypsin inactivation before host cells exposure. Efficacy and safety were not adequately addressed in clinical studies or leaflets (no COVID-19 data). Protection was obtained among 9-39% of users, comparable to or lower than placebo-treated or non-users. Several potential safety risks (tissue digestion, bronchoconstriction) were identified. CONCLUSIONS: the current European MD regulations may result in insufficient exploration of (pre)clinical proof of action. Exogenous trypsin exposure even raises concerns (higher SARS-CoV-2 infectivity, mutations), whereas its clinical protective performance against respiratory viruses as published remains poor and substandard.