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Annemarie Voss,1 Bianca Kollhorst,2 Katharina Platzbecker,1 Ute Amann,1 Ulrike Haug1,3 1Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen, Germany; 2Department of Biometry and Data Management, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen, Germany; 3Faculty of Human and Health Sciences, University of Bremen, Bremen, GermanyCorrespondence: Ulrike Haug, Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen, Germany, Tel +49 421 218 56862, Email haug@leibniz-bips.dePurpose: Over the last decade, the use of direct oral anticoagulants (DOACs) has strongly increased. We aimed to describe and compare risk profiles including potential changes over time among persons with non-valvular atrial fibrillation initiating treatment with different DOACs or phenprocoumon (vitamin K antagonist) between 2011 and 2019 in Germany.Patients and Methods: Using the German Pharmacoepidemiological Research Database (GePaRD; claims data of ~20% of the German population), we identified persons with a first dispensing of phenprocoumon or a DOAC and a diagnosis of non-valvular atrial fibrillation between August 2011 and December 2019. We described the morbidity of included patients prior to treatment initiation, stratified by year of treatment initiation.Results: Overall, we included 448,028 new users (phenprocoumon: N = 118,117, rivaroxaban: N = 130,997, apixaban: N = 130,300, edoxaban: N = 38,128, dabigatran: N = 30,486). Comparing new DOAC users in 2019, the proportion with prior ischemic stroke was highest for dabigatran (17%) and lowest for rivaroxaban (8%). The proportion with prior major bleeding was also highest for dabigatran (25%) and lowest for edoxaban (20%). New users of apixaban were oldest and, eg, showed the highest prevalence of congestive heart failure. Changes over time were most pronounced for phenprocoumon. For example, among persons initiating phenprocoumon in 2012 vs 2019, the proportion with prior major bleeding increased from 18% to 35%; the proportion with renal disease increased from 20% to 36% and the proportion with liver disease from 18% to 24%.Conclusion: This study demonstrated differences in risk profiles between new users of different oral anticoagulants and substantial changes over time among new phenprocoumon users. These differences have to be considered in head-to-head comparisons of these drugs based on observational data, especially regarding potential unmeasured confounding.Keywords: atrial fibrillation, oral anticoagulants, direct oral anticoagulants, DOACs, risk profiles

Lindsay Amann,1 Elizabeth Kruse,1 Allison J Lazard,2,3 Beth A Reboussin,4 Kimberly G Wagoner,5 E Alfonso Romero-Sandoval1 1Department of Anesthesiology, Pain Mechanisms Laboratory; Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA; 2Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, 27514, USA; 3Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel HIll, NC, 27599, USA; 4Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA; 5Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USACorrespondence: E Alfonso Romero-Sandoval, Pain Mechanisms Laboratory, Anesthesiology, 1 Medical Center Boulevard, Winston-Salem, NC, 27157, USA, Tel +1 336-716-2725, Fax +1 336-713-2616, Email earomero.sandoval@gmail.comIntroduction: Cannabidiol (CBD) products are available nearly nationwide in the US and can coexist with medical or recreational programs. North Carolina (NC) is an example of a state with a program dedicated to integrating hemp cultivation and medicinal CBD exclusively, containing a multitude of retailers selling it as a primary product. The Food and Drug Administration (FDA) mandates that non-FDA approved CBD products cannot be marketed using medical or health-related claims and has sent warning letters to retailers violating these terms. We aim to characterize the online content of the NC CBD market by analyzing retailers’ websites to determine whether hemp/CBD shops comply with FDA regulations in terms of medical claims and analyze the claimed CBD content and price of products offered online.Methods: We randomly selected three CBD retailers from the ten most populated cities of NC. We analyzed their website content: product type, medical claims, other disclaimers, price, and CBD content.Results: We found that edible, oral, inhalable, and topical products are offered in similar proportions. Word analysis of product description revealed that “pain” and “pain relief” were the most common medical claim, followed by inflammation and anxiety. Health claims were mostly related to wellbeing. Other attributes indicate that products are associated with pleasant flavors or sensations (ie, cool, lavender, delicious, honey, menthol), which resembles the strategies used for tobacco advertisement. Most products (61%) claimed to contain less than 1000 mg of CBD. The median price of products ranged from $15– 30 per 300 mg. We found a positive correlation between CBD content and price.Discussion: Our data demonstrate that the NC online CBD market does not comply with FDA regulations, primarily targets patients with pain, inflammation, or anxiety, and offers products with low CBD concentration and high prices. New policies should limit the access and online promotion of non-pharmaceutical grade CBD products.Keywords: cannabidiol, hemp, medical marijuana, dispensary, cannabis market, misleading claims

Optical microresonators are attractive comb sources due to their small form factor and stable broad optical spectra. We report on the first demonstration of microcomb-based digital holography. The large line spacing of microcombs promises an unprecedented combination of precision, fast update rate and ambiguity ranges on the scale of a few mm. Using a pulse-driven lithium niobate microcomb of 100 GHz line spacing and a scanning Michelson interferometer, we generate spectral hypercubes of holograms. Our first experimental results show that the amplitude and phase information of the object can be recovered for more than 100 comb lines.

The computed tomography imaging spectrometer (CTIS) is a relatively unknown snapshot hyperspectral camera. It utilizes computational imaging approaches to gain the hyperspectral image from a spatio-spectral smeared sensor image. We present a strongly miniaturized system with a dimension of only 36 × 40.5 × 52.8 mm and a diagonal field of view of 29°. We achieve this using a Galilean beam expander and a combination of off-the-shelf lenses, a highly aspherical imaging system from a commercial smartphone, and a 13 MP monochrome smartphone image sensor. The reconstructed hyperspectral image has a spatial resolution of 400 × 300 pixel with 39 spectral channels.

BackgroundSpinal cord injury is a complex chronic health condition that requires individuals to actively self-manage. Therefore, an evidence-based, self-management app would be of value to support individuals with spinal cord injury in the prevention of pressure injuries. ObjectiveThe main objectives of this study were to (1) establish a co-design approach for developing a high-fidelity prototype app for the self-management of individuals with spinal cord injury, (2) design the prototype that resulted from this process, and (3) conduct the first usability assessment of the prototype app. MethodsWe adopted a co-design approach to develop an evidence-based app prototype. Starting from a preliminary content model (based on clinical guidelines for the prevention of pressure injuries) and three research-based user personas, we conducted an ideation workshop involving individuals with spinal cord injury and health care professionals. The ideation workshop formed the basis for two consecutive design sprints. The result of this co-design phase was an interactive app prototype. The prototype was evaluated in two rounds of usability testing (N=4 and N=15, respectively) using a combination of qualitative and quantitative methods. ResultsThe co-design process resulted in a high-fidelity prototype with two key components: a self-management component and a communication component. The final prototype included a combination of features to support individuals with spinal cord injury in the prevention of pressure injuries, namely a smart camera, pressure injury diary, expert consultation, reminders, and knowledge repository. Findings of the usability testing showed that most participants navigated the app fluently with little back and forth navigation and were able to successfully complete a set of assigned tasks. These positive results are supported by the average system usability score achieved (78.5/100; range 47.5-95.0) and our qualitative analysis of the semistructured interviews. Despite an overall positive evaluation of the app prototype, we identified areas for improvement (eg, inclusion of a search function). ConclusionsIndividuals with spinal cord injury often need to navigate competing interests and priorities, paired with uncertainty about the accuracy and relevance of clinical recommendations. Understanding what matters to individuals with spinal cord injury can help guide the design of behavioral interventions that are useful and acceptable to these individuals in their daily lives. This study shows that involving individuals with spinal cord injury and health care professionals in co-designing a self-management app can foster knowledge cocreation at the intersection of lived experience, medical expertise, and technical solutions.

BackgroundTechnological solutions, particularly mobile health (mHealth), have been shown to be potentially viable approaches for sustaining individuals’ self-management of chronic health conditions. Theory-based interventions are more successful, as evidence-based information is an essential prerequisite for appropriate self-management. However, several reviews have shown that many existing mobile apps fail to be either theoretically grounded or based on evidence. Although some authors have attempted to address these two issues by focusing on the design and development processes of apps, concrete efforts to systematically select evidence-based content are scant. ObjectiveThe objective of this study was to present a procedure for the participatory identification of evidence-based content to ground the development of a self-management app. MethodsTo illustrate the procedure, we focused on the prevention and management of pressure injuries (PIs) in individuals with spinal cord injury (SCI). The procedure involves the following three steps: (1) identification of existing evidence through review and synthesis of existing recommendations on the prevention and self-management of PIs in SCI; (2) a consensus meeting with experts from the field of SCI and individuals with SCI to select the recommendations that are relevant and applicable to community-dwelling individuals in their daily lives; and (3) consolidation of the results of the study. ResultsIn this case study, at the end of the three-step procedure, the content for an mHealth intervention was selected in the form of 98 recommendations. ConclusionsThis study describes a procedure for the participatory identification and selection of disease-specific evidence and professional best practices to inform self-management interventions. This procedure might be especially useful in cases of complex chronic health conditions, as every recommendation in these cases needs to be evaluated and considered in light of all other self-management requirements. Hence, the agreement of experts and affected individuals is essential to ensure the selection of evidence-based content that is considered to be relevant and applicable.

BackgroundData have become an essential factor in driving health research and are key to the development of personalized and precision medicine. Primary and secondary use of personal data holds significant potential for research; however, it also introduces a new set of challenges around consent processes, privacy, and data sharing. Research institutions have issued ethical guidelines to address challenges and ensure responsible data processing and data sharing. However, ethical guidelines directed at researchers and medical professionals are often complex; require readers who are familiar with specific terminology; and can be hard to understand for people without sufficient background knowledge in legislation, research, and data processing practices. ObjectiveThis study aimed to visually represent an ethics framework to make its content more accessible to its stakeholders. More generally, we wanted to explore the potential of visualizing policy documents to combat and prevent research misconduct by improving the capacity of actors in health research to handle data responsibly. MethodsWe used a mixed methods approach based on knowledge visualization with 3 sequential steps: qualitative content analysis (open and axial coding, among others); visualizing the knowledge structure, which resulted from the previous step; and adding interactive functionality to access information using rapid prototyping. ResultsThrough our iterative methodology, we developed a tool that allows users to explore an ethics framework for data sharing through an interactive visualization. Our results represent an approach that can make policy documents easier to understand and, therefore, more applicable in practice. ConclusionsMeaningful communication and understanding each other remain a challenge in various areas of health care and medicine. We contribute to advancing communication practices through the introduction of knowledge visualization to bioethics to offer a novel way to tackle this relevant issue.

The computed tomography imaging spectrometer (CTIS) is a relatively unknown snapshot hyperspectral camera. It utilizes computational imaging approaches to gain the hyperspectral image from a spatiospectral smeared sensor image. We present a strongly miniaturized system with a dimension of only 36mm x 40.5mm x 52.8mm and a diagonal field of view of 29°. We achieve this using a Galilean beam expander and a combination of off-the-shelf lenses, a highly aspherical imaging system from a commercial smartphone and a 13 MP monochrome smartphone image sensor. The reconstructed hyperspectral image has a spatial resolution of 400 x 300 pixel with 39 spectral channels.