Standardized metadata collection to reinforce collaboration in Collaborative Research Centers

We present our approach for research (meta)data exchange and interconnection of scientists in medium-scale academic projects such as medical collaborative research centers (CRCs). Our webbased tool, fredato, connects established services, which we configure to a custom-tailored software bundle to match the needs of researchers. To improve collaboration, we implemented a metadata acquisition component and search function to complement the existing data management and sharing. More specifically, we enhance three points: 1. Relevant projects need to be findable to re-use data or results, avoid redundant work and improve communication among crc members. 2. The scientists also process sensitive human data for which a privacy-protected, secure exchange is critical. 3. A self-explanatory user interface is required for increased user acceptance. The main feature we present is the handling of metadata in our web application without overwhelming users through extensive and generic forms. We use flexible JSON schemas to precisely target scientists' needs of documentation and enrich them with only ontology components relevant to their use cases. The schemas are stored distributedly as datasets themselves, and automatically converted to modern web forms. Besides custom, domain-specific forms we use this editor for the addition of common metadata schemas (e.g. DataCite). We use the continuous integration capabilities of a connected Gitlab to run data-driven scripts. This includes indexing of all metadata, which makes them searchable in a structured way. Users are provided with contact information for matches and can ask to share data and results. Because project owners decide with whom to share and because datasets and metadata are bundled together, the complete dataset is always accessible (e.g. for publication at a third party repository) and full control retained by data owners. By adding this component to our tool, we provide simple, secure and searchable means for improving collaboration in the context of CRCs

Needs assessment towards research data management at the Medical Faculty of the University of Freiburg – Data of the BE-KONFORM study

In order to investigate employees’ needs of the Medical Faculty of the University of Freiburg regarding research data management, the BE-KONFORM study was performed in a two-step approach. First, guideline-based qualitative video interviews with four researchers were performed to identify key constructs of relevance. Second, a standardized online survey was conducted from 1st to 15th of November 2020 based on e-mail invitation by the dean and a faculty newsletter. The questionnaire was provided bilingual (English and German) using a backward-forward translation method, no reminders and incentives were used to increase the response rate. The online survey was programmed in REDCap and was accessible via online link. The target population were members of the Medical Faculty (listed in the newsletter mailing list) regardless of the type of working contract signed. The final dataset contains 236 complete cases (90% German and 10% English). The study includes a randomised module asking for data publication (group A) or not (group B). 113 cases were randomized into group A and 99% of them consented to the publication of the collected research data in anonymized form (n=112). The dataset comprised questions about work-related characteristics (professional status, working experience, scientific field of work), data management-related items (definition of research data management, type of data used, type of storage used for saving data, use of electronic laboratory notebooks), experience and attitudes towards data publication in data repositories, as well as needs and preferences regarding research data management support. The produced data offers the possibility to connect with other data collected in this field in other contexts (faculties or universities)

Psychometric properties of the German version of the Leicester Cough Questionnaire in sarcoidosis

<div><p>Background</p><p>Cough is one of the most common symptoms in general and pulmonary medicine with profound negative impact on health-related quality of life (HRQL). The Leicester Cough Questionnaire (LCQ) is a validated HRQL questionnaire, yet a validated German version of the LCQ is not available and it has never been tested in a cohort with sarcoidosis.</p><p>Objectives</p><p>To translate the LCQ into German and determine its psychometric properties.</p><p>Methods</p><p>The LCQ was translated in a forward-backward approach. Structured interviews in sarcoidosis patients were performed. Subsequently, sarcoidosis patients were asked to answer the German LCQ and comparative questionnaires. Distribution properties, item difficulty, concurrent validity, Rasch model fit and internal consistency of the German LCQ were determined.</p><p>Results</p><p>200 patients with sarcoidosis were included. We provide evidence for reliability, unidimensionality and internal consistency. However, only a moderate correlation with general and respiratory-specific HRQL questionnaires, no Rasch model fit could be shown. Skewed responses caused by floor effects were detected.</p><p>Conclusion</p><p>We demonstrate that the German LCQ is valid and reliable and its psychometric properties fulfil the standards required for its use in clinical settings as well as in interventional trials.</p></div

Evaluation of an Interactive Web-Based Health Program for Weight Loss&mdash;A Randomized Controlled Trial

Personal behavior patterns, such as unhealthy diet and lack of physical activity, lead to the development of overweight and obesity. These are associated with other comorbidities, reduced quality of life, premature frailty and increased mortality. Personalized web-based interventions are promising in inducing behavioral change leading to effective reductions in body weight at relatively low costs. However, the long-term effects have not been thoroughly investigated. This work evaluates the effectiveness of web-based interactive weight loss coaching and compares it to a non-interactive web-based health program. Therefore, a randomized controlled trial (RCT) was implemented, measuring primary and secondary outcomes at four time points (program start; end of the 12-week-program; 6 months after program end, 12 months after program end). The net sample covered 1499 subjects in the intervention group and 1492 in the control group. On average, the IG was 43 years old (&plusmn;13.6), 80.1% male, and had 86.4 kg body weight (&plusmn;16.1) at baseline. The CG was 42.7 years old (&plusmn;13.9), 79.5% male and had a mean body weight of 86.1 (&plusmn;15.7). Multilevel analyses with fixed effects were carried out both from the perspective of an intention-to-treat (ITT) and a complete cases approach (CCA). In sum, our adjusted models suggest a weight loss of 0.4 kg per time point. At the end of the program, significant differences in weight loss in % to baseline (delta M = 1.8 in the CCA) were observed in favor of the intervention group. From a long-term perspective, no superiority of the intervention group in comparison to the control group could be found. More intensive use of the program was not statistically associated with higher weight loss

Effects of a Web-Based Weight Loss Program on the Healthy Eating Index-NVS in Adults with Overweight or Obesity and the Association with Dietary, Anthropometric and Cardiometabolic Variables: A Randomized Controlled Clinical Trial

This randomized, controlled clinical trial examined the impact of a web-based weight loss intervention on diet quality. Furthermore, it was investigated whether corresponding changes in diet quality were associated with changes in measures of cardiovascular risk profile. Individuals with a body mass index (BMI) of 27.5 to 34.9 kg/m2 and an age of 18 to 65 y were assigned to either an interactive and fully automated web-based weight loss program focusing on dietary energy density (intervention) or a non-interactive web-based weight loss program (control). Examinations were performed at baseline (t0), after the 12-week web-based intervention (t1), and after an additional 6 (t2) and 12 months (t3). Based on a dietary record, the Healthy Eating Index-NVS (HEI-NVS) was calculated and analyzed using a robust linear mixed model. In addition, bootstrapped correlations were performed independently of study group to examine associations between change in HEI-NVS and change in dietary, anthropometric, and cardiometabolic variables. A total of n = 153 participants with a mean BMI of 30.71 kg/m2 (SD 2.13) and an average age of 48.92 y (SD 11.17) were included in the study. HEI-NVS improved significantly in the intervention group from baseline (t0) to t2 (p = 0.003) and to t3 (p = 0.037), whereby the course was significantly different up to t2 (p = 0.013) and not significantly different up to t3 (p = 0.054) compared to the control group. Independent of study group, there was a significant negative association between change in HEI-NVS and dietary energy density. A higher total score in HEI-NVS did not correlate with improvements in cardiovascular risk profile. The interactive and fully automated web-based weight loss program improved diet quality. Independent of study group, changes in HEI-NVS correlated with changes in energy density, but there was no association between improvements in HEI-NVS and improvements in cardiovascular risk profile

Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials

Web-based lifestyle interventions have attracted considerable research interest. Available evidence on such interventions suggests health-promoting effects, but further research is needed. Therefore, this study aims to investigate short-, medium-, and long-term health effects of a web-based health program (&ldquo;TK-HealthCoach&rdquo;, TK-HC) offered by a national statutory health insurance fund (Techniker Krankenkasse, TK). The study comprises two randomized controlled clinical trials to evaluate the health goals &ldquo;Increasing Fitness&rdquo; (Fclin) and &ldquo;Losing and Maintaining Weight&rdquo; (Wclin). A total of n = 186 physically inactive (Fclin) and n = 150 overweight or obese (Wclin) adults will be randomly assigned to a 12-week interactive (TK-HC) or non-interactive web-based health program using permuted block randomization with a 1:1 allocation ratio. Primary outcomes include cardiorespiratory fitness (Fclin) and body weight (Wclin). Secondary outcomes comprise musculoskeletal fitness (Fclin), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (Fclin, Wclin). All outcomes will be measured before and after the 12-week intervention and after a 6- and 12-month follow-up. Additionally, usage behavior data on the health programs will be assessed. Linear mixed models (LMMs) will be used for statistical analysis. Findings of this study will expand the available evidence on web-based lifestyle interventions