#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research.

INTRODUCTION: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries. MATERIALS AND METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability. RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented. CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.

The knowledge and attitudes of pharmacists related to the use of dietary supplements: An observational study in northeastern Italy.

Inappropriate use of dietary supplements can be potentially harmful to patients, especially given the uncontrolled information on the Internet and social media. The role that pharmacists play in advising citizens and purchasing these products can help improve their safer use, but the knowledge, attitudes, and practices of these professionals on this topic are still largely unknown. Pharmacists in the Italian Region of Friuli-Venezia Giulia (FVG) were surveyed from September 2020 to February 2021 using a 54-item online questionnaire. The questions were related to knowledge, attitudes, and practice. Data on gender, age, work experience, degree, and function in pharmacy were also collected. 232 questionnaires were completed, predominantly by women (71 %). The majority of respondents had a degree in Pharmacy (77 %) and were employed in a pharmacy (66 %) where they had worked for at least 10 years (61 %). Pharmacists' knowledge was rated as low, with one-third of participants above the median; knowledge was higher among more experienced pharmacists. Larger knowledge gaps were noted regarding the potential carcinogenicity of multivitamin misuse and the undesirable presence of unlabeled ingredients in dietary supplements. Employees were more likely than owners to report purchasing dietary supplements at the direct request of patients (p < 0.05). The low level of pharmacists' knowledge about the use of dietary supplements is unsatisfactory, with concerning impact on patient safety. Young professionals in particular would benefit from continuous education to better advise patients. Nevertheless, the European regulatory framework for the manufacture, sale and post-marketing surveillance of dietary supplements needs to be strengthened.

Age-Related Changes in Clinical Presentation of Covid-19: the EPICOVID19 Web-Based Survey.

BACKGROUND: The influence of aging and multimorbidity on Covid-19 clinical presentation is still unclear. OBJECTIVES: We investigated whether the association between symptoms (or cluster of symptoms) and positive SARS-CoV-2 nasopharyngeal swab (NPS) was different according to patients' age and presence of multimorbidity. METHODS: The study included 6680 participants in the EPICOVID19 web-based survey, who reported information about symptoms from February to June 2020 and who underwent at least one NPS. Symptom clusters were identified through hierarchical cluster analysis. The associations between symptoms (and clusters of symptoms) and positive NPS were investigated through multivariable binary logistic regression in the sample stratified by age (<65 vs ≥65 years) and number of chronic diseases (0 vs 1 vs ≥2). RESULTS: The direct association between taste/smell disorders and positive NPS was weaker in older and multimorbid patients than in their younger and healthier counterparts. Having reported no symptoms reduced the chance of positive NPS by 86% in younger (95%CI: 0.11-0.18), and by 46% in older participants (95%CI: 0.37-0.79). Of the four symptom clusters identified (asymptomatic, generic, flu-like, and combined generic and flu-like symptoms), those associated with a higher probability of SARS-CoV-2 infection were the flu-like for older people, and the combined generic and flu-like for the younger ones. CONCLUSIONS: Older age and pre-existing chronic diseases may influence the clinical presentation of Covid-19. Symptoms at disease onset tend to aggregate differently by age. New diagnostic algorithms considering age and chronic conditions may ease Covid-19 diagnosis and optimize health resources allocation. TRIAL REGISTRATION: NCT04471701 (ClinicalTrials.gov).