FAIRness through automation: development of an automated medical data integration infrastructure for FAIR health data in a maximum care university hospital.

BACKGROUND: Secondary use of routine medical data is key to large-scale clinical and health services research. In a maximum care hospital, the volume of data generated exceeds the limits of big data on a daily basis. This so-called "real world data" are essential to complement knowledge and results from clinical trials. Furthermore, big data may help in establishing precision medicine. However, manual data extraction and annotation workflows to transfer routine data into research data would be complex and inefficient. Generally, best practices for managing research data focus on data output rather than the entire data journey from primary sources to analysis. To eventually make routinely collected data usable and available for research, many hurdles have to be overcome. In this work, we present the implementation of an automated framework for timely processing of clinical care data including free texts and genetic data (non-structured data) and centralized storage as Findable, Accessible, Interoperable, Reusable (FAIR) research data in a maximum care university hospital. METHODS: We identify data processing workflows necessary to operate a medical research data service unit in a maximum care hospital. We decompose structurally equal tasks into elementary sub-processes and propose a framework for general data processing. We base our processes on open-source software-components and, where necessary, custom-built generic tools. RESULTS: We demonstrate the application of our proposed framework in practice by describing its use in our Medical Data Integration Center (MeDIC). Our microservices-based and fully open-source data processing automation framework incorporates a complete recording of data management and manipulation activities. The prototype implementation also includes a metadata schema for data provenance and a process validation concept. All requirements of a MeDIC are orchestrated within the proposed framework: Data input from many heterogeneous sources, pseudonymization and harmonization, integration in a data warehouse and finally possibilities for extraction or aggregation of data for research purposes according to data protection requirements. CONCLUSION: Though the framework is not a panacea for bringing routine-based research data into compliance with FAIR principles, it provides a much-needed possibility to process data in a fully automated, traceable, and reproducible manner.

Use of Infrared Thermography in Medical Diagnosis, Screening, and Disease Monitoring: A Scoping Review.

Thermography provides non-invasive, radiation-free diagnostic imaging. Despite the extensive literature on medical thermography, a comprehensive overview of current applications is lacking. Hence, the aim of this scoping review is to identify the medical applications of passive infrared thermography and to catalogue the technical and environmental modalities. The diagnostic performance of thermography and the existence of specific reference data are evaluated, and research gaps and future tasks identified. The entire review process followed the Joanna Briggs Institute (JBI) approach and the results are reported according to PRISMA-ScR guidelines. The scoping review protocol is registered at the Open Science Framework (OSF). PubMed, CENTRAL, Embase, Web of Science, OpenGrey, OSF, and PROSPERO were searched using pretested search strategies based on the Population, Concept, Context (PCC) approach. According to the eligibility criteria, references were screened by two researchers independently. Seventy-two research articles were identified describing screening, diagnostic, or monitoring studies investigating the potential of thermography in a total of 17,314 participants within 38 different health conditions across 13 therapeutic areas. The use of several camera models from various manufacturers is described. These and other facts and figures are compiled and presented in a detailed, descriptive tabular and visual format. Thermography offers promising diagnostic capabilities, alone or in addition to conventional methods.

[Mapping as an Iterative Visualization Process: Insights into Regional Care Structures in the SARS-CoV-2 Pandemic]. / Mapping als iterativer Visualisierungsprozess ­ Einblicke in regionale Versorgungsstrukturen in der SARS-CoV-2 Pandemie.

OBJECTIVE: Little is known about the cooperation of different health care providers during the pandemic. The aim of this study was to develop a graphically mediated, deeper understanding of the processes involved, using a novel expert-supported visualization method, by taking a definite region in Baden-Württemberg as an example. METHODS: The development of an overall picture ("mapping") of the pandemic situation in the Ulm/Alb-Donau district was based on the "Knowledge Visualization" method in several phases. First, semi-structured interviews were conducted with local players in the district of Ulm and the Alb-Donau. The visualized individual perspectives were then presented in a joint video conference. This was followed by a moderated discussion, with the aim to agree on common strategies for care in the pandemic. This process was documented with the help of a visulization expert ("Visionom") in the form of a professionally prepared overall picture ("mapping"). RESULTS: All players showed great motivation and appreciated getting to know the perspectives of other regional players. The iterative visualization was strongly activating and stimulated reflection processes. Personal responsibilities proved to be not always clear, communication problems were revealed. A wish to continue the initiated process was expressed. CONCLUSION: Iterative visualizations can initiate implications at the level of action, metastructures and authorities. We recommend this method also for other questions related to local or regional structures.

[Teacher-Based Health Promotion in Primary School Children in Baden-Württemberg: Effects on Endurance Performance and Incidence of Abdominal Obesity]. / Lehrerbasierte Gesundheitsförderung bei Grundschulkindern in Baden-Württemberg: Effekte auf Ausdauerleistungsfähigkeit und Inzidenz abdominaler Adipositas.

BACKGROUND: Health promotion has to start early. Many prevention programmes lack proof of effectiveness. A programme that promotes an active and healthy lifestyle for primary school children in Baden-Württemberg is "Join the Healthy Boat". AIM: The effect of this one-year school-based intervention on endurance performance and incidence of paediatric abdominal obesity was investigated in a large cluster randomised study. METHODS: Data of 1739 children (7.1±0.6 years) were available at baseline and follow-up. Background variables were assessed via parent questionnaires. Endurance performance (6-minute run) and anthropometric data were collected on-site. Children with waist-to-height-ratio (WHtR) ≥ 0.5 were classified as being abdominally obese. The difference in endurance capacity and the incidence of abdominal obesity between baseline and follow-up were calculated and analysed in simple and hierarchical regression models taking into account the school effect. RESULTS: Adjusted for gender and grade level, the difference in completed meters in the intervention group after one year was significantly greater (70.5±128.6 vs. 59.2±106.6 m, n=1708). However, after taking into account data clustering of schools, the significance was lost. Odds for the development of abdominal obesity in the intervention group were more than halved after adjustment for gender, grade, baseline WHtR and no-breakfasts (odds ratio=0.48, 95% CI [0.25; 0.94], n=1535). CONCLUSION: Children should learn to make healthy choices from an early age. With the prevention of abdominal obesity as an indicator, this intervention is characterised as an effective health promotion.

Cardio-metabolic and socio-environmental correlates of waist-to-height ratio in German primary schoolchildren: a cross-sectional exploration.

BACKGROUND: Controversial messages of childhood obesity emerge: Levelling off in terms of body mass index (BMI) is foiled by increases in abdominal obesity. Waist-to-height ratio (WHtR) may be used as a screening tool for abdominal obesity in children. The aim of this study was to investigate clinical and socio-environmental correlates of abdominal obesity in primary schoolchildren. METHODS: Cross-sectional data from 753 children participating in baseline assessments of the outcome evaluation of a school-based prevention program were analysed. Abdominal obesity was defined as WHtR ≥0.5. According to German age and sex-specific BMI-percentiles, overweight (>90th percentile) and obesity (>97th percentile) were determined. Anthropometric and sonographic measurements, blood pressure and blood samples were taken by clinical staff in a standardized manner. Socio-environmental and lifestyle data were assessed via parental questionnaires. Differences between abdominally obese children and others, and correlations of WHtR with clinical data were tested. Socio-environmental correlates of abdominal obesity were explored in a logistic regression analysis. RESULTS: At the time of the examination children were 7.57 ± 0.42 years old. Abdominal obesity was observed in 132 (17.5%) children. According to BMI-percentiles, 22.9% of these children were obese, 38.2% overweight, and 38.2% normal weight. Affected children more often used screen media and less often participated in club sports. Abdominal obesity was associated with higher blood pressure, lower HDL- and higher LDL-cholesterol. WHtR significantly correlated with intra-abdominal fat thickness (IAF). The logistic regression model revealed migration background (odds ratio (OR) 2.12, 95% confidence interval (CI) [1.41, 3.19]), smoking during pregnancy (OR 2.30, 95% CI [1.37, 3.86]), parental obesity (OR 1.95, 95% CI [1.22, 3.10]) and higher educational level (OR 0.64, 95% CI [0.42, 0.98]) to be significantly associated with abdominal obesity in children. CONCLUSION: WHtR correlates strongly with IAF. Abdominal obesity in primary schoolchildren is associated with cardio-metabolic risk factors and also occurs in otherwise normal weight children. Against the background of rising numbers of abdominal obesity in children, targeted preventive measures are long overdue. The focus of such measures should be used on children with migration background and involve parents, especially those who are obese and those with lower educational levels.

Skipping breakfast, overconsumption of soft drinks and screen media: longitudinal analysis of the combined influence on weight development in primary schoolchildren.

BACKGROUND: Regular breakfast and well-balanced soft drink, and screen media consumption are associated with a lower risk of overweight and obesity in schoolchildren. The aim of this research is the combined examination of these three parameters as influencing factors for longitudinal weight development in schoolchildren in order to adapt targeted preventive measures. METHODS: In the course of the Baden-Württemberg Study, Germany, data from direct measurements (baseline (2010) and follow-up (2011)) at schools was available for 1733 primary schoolchildren aged 7.08 ± 0.6 years (50.8% boys). Anthropometric measurements of the children were taken according to ISAK-standards (International Standard for Anthropometric Assessment) by trained staff. Health and lifestyle characteristics of the children and their parents were assessed in questionnaires. A linear mixed effects regression analysis was conducted to examine influences on changes in waist-to-height-ratio (WHtR), weight, and body mass index (BMI) measures. A generalised linear mixed effects regression analysis was performed to identify the relationship between breakfast, soft drink and screen media consumption with the prevalence of overweight, obesity and abdominal obesity at follow-up. RESULTS: According to the regression analyses, skipping breakfast led to increased changes in WHtR, weight and BMI measures. Skipping breakfast and the overconsumption of screen media at baseline led to higher odds of abdominal obesity and overweight at follow-up. No significant association between soft drink consumption and weight development was found. CONCLUSION: Targeted prevention for healthy weight status and development in primary schoolchildren should aim towards promoting balanced breakfast habits and a reduction in screen media consumption. Future research on soft drink consumption is needed. Health promoting interventions should synergistically involve children, parents, and schools. TRIAL REGISTRATION: The Baden-Württemberg Study is registered at the German Clinical Trials Register (DRKS) under the DRKS-ID: DRKS00000494 .

Skipping breakfast is detrimental for primary school children: cross-sectional analysis of determinants for targeted prevention.

BACKGROUND: Skipping breakfast was found to be associated with abdominal obesity in primary school children. The aim of this research was to examine factors associated with skipping breakfast in primary school children in order to develop targeted preventive measures. METHODS: Baseline data assessment (2010) of a cluster-randomized controlled trial for the evaluation of a school-based health promotion program in primary school children in the state of Baden-Württemberg, Germany. Anthropometric measures of 1,943 primary school children aged 7.1 ± 0.6 years (51.2% boys) were conducted according to ISAK-standards (International Standard for Anthropometric Assessment) by trained staff. Further information on the health and living conditions of the children and their parents were assessed in parental questionnaires. Generalized linear mixed regression analysis was calculated to define correlates for skipping breakfast in terms of odds ratios (OR) and 95% confidence intervals (CI). RESULTS: According to the final regression models, significant correlates of skipping breakfast can be divided into modifiable behavioral components (high consumption of soft drinks (OR 2.49, 95% CI 1.81; 3.43), screen media (OR 2.48, 95% CI 1.77; 3.46) and high levels of physical activity (OR 0.64, 95% CI 0.44; 0.93)) on the one hand, and more or less static socio-economic factors (migration background (OR 2.81, 95% CI 2.02; 3.91), single parenting (OR 2.13, 95% CI 1.34; 3.40), and high family education level (OR 0.42, 95% CI 0.28; 0.64)) on the other hand, and finally individual factors (female gender (OR 1.43, 95% CI 1.03; 1.99) and having a percentage of body fat at or above the 95th percentile (OR 1.47, 95% CI 1.00; 2.17)). CONCLUSION: Targeted prevention should aim at health-related behaviors accompanying the habit of skipping breakfast. Focusing on vulnerable groups, characterized by not so easily modifiable socio-economic as well as individual factors, may improve results. Interventions should synergistically promote children's health and involve their parents in order to be successful. To reach all children and to avoid skipping breakfast, schools should offer regular breakfast at the start of a school day. Policy makers should support healthy eating habits at all times.

Effects of statewide health promotion in primary schools on children's sick days, visits to a physician and parental absence from work: a cluster-randomized trial.

BACKGROUND: Based on the World Health Organization's global school health initiative we investigate intervention effects of statewide health promotion in schools on the numbers of children's sick days and visits to a physician, and parental days off work due to child illness. METHODS: Cluster-randomized trial with 1-year follow-up in primary schools in the state of Baden-Württemberg, Germany. Anthropometric measurements of first and second grade school children were taken by trained staff. Parents filled in questionnaires for information about socio-demographics, health-related variables, numbers of children's sick days, visits to a physician, and days parents had to stay off work to care for a sick child. Longitudinal differences in the outcome variables were calculated between baseline and follow-up. Intraclass correlation coefficients were determined to quantify a possible clustering of data in schools. Accordingly, linear models and linear mixed models were applied to identify relationships and ascertain significances. RESULTS: Data from 1943 children (1st grade n = 1024, 6.6 ± 0.4 years old; 2nd grade n = 919, 7.6 ± 0.4 years old) were available at baseline. Unadjusted differences regarding both grades were found between mean longitudinal changes in intervention and control group in children's sick days (-3.2 ± 7.1 vs. -2.3 ± 5.6, p = 0.013), and maternal days off work (-0.9 ± 2.4 vs. -0.5 ± 2.8, p = 0.019). The intervention effect on sick days was adjusted in a linear regression for baseline values, gender and migration background and confirmed for first grade children (B = -0.83, p = 0.003). The intervention effect on maternal days off work lost its significance after adjusting for baseline values. No significant differences were detected in the numbers of children's visits to a physician and paternal days off work. CONCLUSIONS: School-based health promotion slightly reduces sick days in first grade children. Subsequently, parents may not need to stay off work themselves. Small individual effects add up to larger benefits in a statewide implementation of health promotion. Additionally, health promotion may also positively contribute to school success. TRIAL REGISTRATION: The study was registered on the German Clinical Trials Register (DRKS), Freiburg University, Germany, under the DRKS-ID: DRKS00000494 . Registered: 25 August 2010.

Why do mothers encourage their children to control their weight? A cross-sectional study of possible contributing factors.

BACKGROUND: Mothers encouraging their children to control their weight is problematic as it is associated with children's body dissatisfaction and weight concerns as well as further weight gain. The aim of this study was to identify factors in children and mothers associated with mothers encouraging their children to control their weight and possible gender differences therein. METHODS: Cross-sectional questionnaire data was available from 1658 mothers of primary school children (mean age 7.1 ±0.6 years, 50.4% boys) participating in the Baden-Württemberg Study. Children's body weight and height were measured in a standardised manner. Logistic regressions were computed separately for boys and girls, adjusted odds ratios (OR) and 95% confidence intervals (CI) from the final model are reported. RESULTS: 29% of children were encouraged by their mothers, girls (32.4%) significantly more often than boys (25.6%). Child BMI (girls OR 1.77, CI 1.57 to 1.99; boys OR 1.88, CI 1.66 to 2.13), and child migration background (girls OR 2.14, CI 1.45 to 3.16; boys OR 1.60, CI 1.07 to 2.37) were significantly associated with encouragement by mothers. For girls, maternal body dissatisfaction (OR 1.59, CI 1.10 to 2.30) and maternal perception of a low influence on health (OR 0.51, CI 0.29 to 0.89) were also significantly associated with maternal encouragement. For boys, this was true of mothers self-efficacy to influence their children's physical activity (OR 0.58, CI 0.40 to 0.85). CONCLUSION: Different factors are associated with mothers encouraging boys and girls to control their weight. Identifying correlates and underlying processes of maternal encouragement can inform preventive measures targeting weight and eating related problems in children.

FAIR+R: Making Clinical Data Reliable Through Qualitative Metadata.

Metadata are often the first access to data repositories for researchers within secondary use. Through automatic metadata generation and metadata harvesting the amount of data about data has been growing ever since. In order to make data not only FAIR but also reliable, the aspect of metadata quality has to be considered. But as earlier assessments of metadata of different repositories showed, metadata quality still lacks behind its capability. Providing an extensive literature review the authors conclude nine measures to assess metadata in relation to clinical care repositories, such as Medical Data Integration Centers (MeDICs). Proceeding from these measures the authors propose an addition of the FAIR Guiding Principles by adding a fifth block for Reliability including three principles, that resulted from the measures presented. The results form the basis for the future work of an assessment of metadata, that is stored in a MeDIC.

Correlates of weight gain in German children attending elementary school.

OBJECTIVE: To examine the association of physical fitness, sports participation, physical activity and sedentary behavior as well as dietary patterns and family background with weight gain in non-overweight elementary school children, independent of absolute body weight. METHODS: Height, weight, and physical fitness were assessed in 1249 (51% male) children in south-west Germany during the fall of 2010 and 2011 (age at baseline: 7.0±0.6years). Based on changes in body mass index percentiles children were classified into a weight loss, constant weight, or weight gain group. Health behavior and family background were assessed via parent questionnaire. Group differences were examined via analysis of variance and multinomial logistic regression. RESULTS: Weight gain was associated with low physical activity, lack of active transport, and lack of regular breakfast at follow-up. Children in the weight gain category also displayed lower fitness during baseline and follow-up, but differences were more pronounced during follow-up. TV time, migration background or parental education was not associated with weight gain. CONCLUSION: Ensuring adequate physical activity and high fitness is an important aspect in the prevention of excessive weight gain during childhood. In addition to sports participation active transport should be emphasized in future weight management programs in children.

Is central obesity associated with poorer health and health-related quality of life in primary school children? Cross-sectional results from the Baden-Württemberg Study.

BACKGROUND: Childhood obesity and its consequences are a growing threat to national economies and health services. The aim of this study was to determine associations between waist-to-height ratio (WHtR) as a measure of central obesity, and health-related quality of life (HRQoL) and absenteeism of primary school children in the state of Baden-Württemberg, Germany. METHODS: Cross-sectional data from 1888 first and second grade children (7.1±0.6 years) participating in the baseline measurements of the Baden-Württemberg Study were analyzed. Parents completed questionnaires including a rating of their children's HRQoL using KINDLR and EQ5D-Y VAS. Days of absence because of illness, and number of visits to a physician during the last year of school/kindergarten were asked, as well as the number of days parents took off work to care for their sick child. Anthropometric measurements were taken by trained staff. The Mann-Whitney-U test was used for statistical analysis of differences between WHtR groups. Logistic regression models were used to identify factors associated with sick days. RESULTS: A total of 158 (8.4%) children were centrally obese (WHtR ≥0.5). These children had significantly more sick days (9.05 vs. 6.84, p < 0.001) and visits to a physician (3.58 vs. 2.91, p < 0.05), but not days of parental absence than other children. According to regression analysis, sick days were also associated with age, migration status, physical activity pattern, maternal health awareness and family education level. Parent-rated HRQoL was significantly lower in centrally obese children for the EQ5D-Y VAS (88.1 vs. 91.6, p < 0.001), and the KINDLR subscales 'school' (79.9 vs. 82.5, p < 0.05) and 'friends' (75.4 vs. 78.3, p < 0.05), but not for the total score. CONCLUSIONS: Cross-sectional results show higher rates of absence, more visits to a physician and lower HRQoL in children with central obesity. Each missed day at school implies a hazard to academic achievement and each additional visit to a physician is related to higher health care costs. Thus, the negative impact of central obesity is already measurable in primary school children, which emphasizes the urgent need for early delivery of health promotion and targeted prevention.

Proposal of a Method for Transferring High-Quality Scientific Literature Data to Virtual Patient Cases Using Categorical Data Generated by Bernoulli-Distributed Random Values: Development and Prototypical Implementation.

BACKGROUND: Teaching medicine is a complex task because medical teachers are also involved in clinical practice and research and the availability of cases with rare diseases is very restricted. Automatic creation of virtual patient cases would be a great benefit, saving time and providing a wider choice of virtual patient cases for student training. OBJECTIVE: This study explored whether the medical literature provides usable quantifiable information on rare diseases. The study implemented a computerized method that simulates basic clinical patient cases utilizing probabilities of symptom occurrence for a disease. METHODS: Medical literature was searched for suitable rare diseases and the required information on the respective probabilities of specific symptoms. We developed a statistical script that delivers basic virtual patient cases with random symptom complexes generated by Bernoulli experiments, according to probabilities reported in the literature. The number of runs and thus the number of patient cases generated are arbitrary. RESULTS: We illustrated the function of our generator with the exemplary diagnosis "brain abscess" with the related symptoms "headache, mental status change, focal neurologic deficit, fever, seizure, nausea and vomiting, nuchal rigidity, and papilledema" and the respective probabilities from the literature. With a growing number of repetitions of the Bernoulli experiment, the relative frequencies of occurrence increasingly converged with the probabilities from the literature. For example, the relative frequency for headache after 10.000 repetitions was 0.7267 and, after rounding, equaled the mean value of the probability range of 0.73 reported in the literature. The same applied to the other symptoms. CONCLUSIONS: The medical literature provides specific information on characteristics of rare diseases that can be transferred to probabilities. The results of our computerized method suggest that automated creation of virtual patient cases based on these probabilities is possible. With additional information provided in the literature, an extension of the generator can be implemented in further research.

Evaluation of a health promotion program in children: Study protocol and design of the cluster-randomized Baden-Württemberg primary school study [DRKS-ID: DRKS00000494].

BACKGROUND: Increasing prevalences of overweight and obesity in children are known problems in industrialized countries. Early prevention is important as overweight and obesity persist over time and are related with health problems later in adulthood. "Komm mit in das gesunde Boot - Grundschule" is a school-based program to promote a healthier lifestyle. Main goals of the intervention are to increase physical activity, decrease the consumption of sugar-sweetened beverages, and to decrease time spent sedentary by promoting active choices for healthy lifestyle. The program to date is distributed by 34 project delivery consultants in the state of Baden-Württemberg and is currently implemented in 427 primary schools. The efficacy of this large scale intervention is examined via the Baden-Württemberg Study. METHODS/DESIGN: The Baden-Württemberg Study is a prospective, stratified, cluster-randomized, and longitudinal study with two groups (intervention group and control group). Measurements were taken at the beginning of the academic years 2010/2011 and 2011/2012. Efficacy of the intervention is being assessed using three main outcomes: changes in waist circumference, skinfold thickness and 6 minutes run. Stratified cluster-randomization (according to class grade level) was performed for primary schools; pupils, teachers/principals, and parents were investigated. An approximately balanced number of classes in intervention group and control group could be reached by stratified randomization and was maintained at follow-up. DISCUSSION: At present, "Komm mit in das Gesunde Boot - Grundschule" is the largest school-based health promotion program in Germany. Comparative objective main outcomes are used for the evaluation of efficacy. Simulations showed sufficient power with the existing sample size. Therefore, the results will show whether the promotion of a healthier lifestyle in primary school children is possible using a relatively low effort within a school-based program involving children, teachers and parents. The research team anticipates that not only efficacy will be proven in this study but also expects many other positive effects of the program. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494.

Intermittent Use of Anti-Hormonal Agents for the Endocrine Therapy of Sex-Hormone-Dependent Breast and Prostate Cancer: A Protocol for a Systematic Review.

Therapies with the continuous administration of anti-hormonal agents in sex-hormone-dependent malignancies such as prostate and breast carcinomas often lead to the development of resistant tumor cells. A systematic evaluation of the use and effects of the intermittent application of endocrine therapy could provide information on the state of knowledge in this research area. PubMed, Cochrane Library, Embase, and Web of Science will be systematically searched using pretested search strategies. Randomized and non-randomized controlled trials, pragmatic trials, case-control, and comparative cohort studies will be eligible. Primary outcomes will be progression-free survival, disease-free survival, and overall survival. The literature retrieved will be selected based on predefined inclusion and exclusion criteria. Relevant data will be extracted from included references into a pre-designed table. The risk of bias will be assessed, and the report of the results will follow PRISMA recommendations and include any deviations from this protocol. The increasing prevalence of breast and prostate cancer and limitations of current therapeutic approaches require a closer look at alternatives. Additionally, to explore new therapeutic agents, modalities of administration should be rigorously reviewed to determine the best regimens for patients. This proposed systematic review aims to summarize and evaluate the current knowledge regarding intermittent endocrine cancer therapy to provide a basis for further research.

Harvesting metadata in clinical care: a crosswalk between FHIR, OMOP, CDISC and openEHR metadata.

Metadata describe information about data source, type of creation, structure, status and semantics and are prerequisite for preservation and reuse of medical data. To overcome the hurdle of disparate data sources and repositories with heterogeneous data formats a metadata crosswalk was initiated, based on existing standards. FAIR Principles were included, as well as data format specifications. The metadata crosswalk is the foundation of data provision between a Medical Data Integration Center (MeDIC) and researchers, providing a selection of metadata information for research design and requests. Based on the crosswalk, metadata items were prioritized and categorized to demonstrate that not one single predefined standard meets all requirements of a MeDIC and only a maximum data set of metadata is suitable for use. The development of a convergence format including the maximum data set is the anticipated solution for an automated transformation of metadata in a MeDIC.

Use of infrared thermography in medical diagnostics: a scoping review protocol.

INTRODUCTION: Thermography offers a non-invasive radiation-free methodology for diagnostic imaging and temperature measurement, but the extent of the current application is unclear, as is the level of evidence for each use case. Moreover, population-based thermographic reference values for diagnostic purposes are nearly unknown. The aim of this scoping review is to identify patient populations and diseases in which thermography is applied, cataloguing of technical and environmental modalities, investigation of the existence of specific reference data and finally exploration of gaps and future tasks. METHODS AND ANALYSIS: PubMed, Cochrane Database of Systematic Reviews and CENTRAL, Embase, Web of Science and OpenGrey are to be searched using pretested suitable search strategies, with no language restriction, but abstracts should be available in English or German and articles should not have been published before 2000. This limited time frame is due to the rapid technological progress, which makes it necessary to exclude reports based on outdated technology. The literature found will be selected on the basis of previously defined inclusion and exclusion criteria. Subsequently, relevant data will be extracted from the included references into a predesigned table. The selection and extraction process will be conducted by two researchers independently. The report of the results will be according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. The entire review process will follow the Joanna Briggs Institute approach. The scoping review protocol is registered at the Open Science Framework. ETHICS AND DISSEMINATION: Ethical approval is not required for this work, but ethical medicine also obliges us to carefully consider diagnostic alternatives and compare them with current standards. The dissemination of the results will take place in a variety of ways. First and foremost through publication in an open access journal, but also through conference proceedings. In addition, this scoping review will serve to open up new research foci with regard to thermography.

The Weight Problem: Overview of the Most Common Concepts for Body Mass and Fat Distribution and Critical Consideration of Their Usefulness for Risk Assessment and Practice.

The prevalence of obesity already reached epidemic proportions many years ago and more people may die from this pandemic than from COVID-19. However, the figures depend on which measure of fat mass is used. The determination of the associated health risk also depends on the applied measure. Therefore, we will examine the most common measures for their significance, their contribution to risk assessment and their applicability. The following categories are reported: indices of increased accumulation of body fat; weight indices and mortality; weight indices and risk of disease; normal weight obesity and normal weight abdominal obesity; metabolically healthy obesity; the obesity paradox. It appears that BMI is still the most common measure for determining weight categories, followed by measures of abdominal fat distribution. Newer measures, unlike BMI, take fat distribution into account but often lack validated cut-off values or have limited applicability. Given the high prevalence of obesity and the associated risk of disease and mortality, it is important for a targeted approach to identify risk groups and determine individual risk. Therefore, in addition to BMI, a measure of fat distribution should always be used to ensure that less obvious but risky manifestations such as normal weight obesity are identified.

Early or Delayed Onset of Food Intake in Time-Restricted Eating: Associations with Markers of Obesity in a Secondary Analysis of Two Pilot Studies.

Time-restricted eating (TRE) has rapidly gained interest in the public and the scientific community. One presumed mechanism of action is the adaptation of the eating-fasting rhythm to the evolutionary circadian rhythm of the metabolism. Study results regarding the suggestion that earlier beginning of food intake leads to better outcomes are heterogeneous. We conducted a secondary analysis of pooled data from two pilot studies on TRE to examine an association between the timing of onset of food intake with obesity-related outcomes. Participants (n = 99, 83 females aged 49.9 ± 10.8 years) were asked to restrict their daily eating to 8-9 h for three months. Tertiles of the onset of food intake were assessed for changes in anthropometry, blood lipid levels, and health-related quality of life. We detected no significant differences in outcomes between early (before 9:47), medium (9:47-10:50), and late onset (after 10:50) of food intake. However, the duration of the eating period was longest in the group with the earliest (8.6 ± 1.0 h) and shortest in the group with the latest onset (7.5 ± 0.8 h). Subsequently, fasting duration was longest in the last group (16.5 h). This may have compromised the results. More research is needed in this area to address this question.

Applicability of time-restricted eating for the prevention of lifestyle-dependent diseases in a working population: results of a pilot study in a pre-post design.

Background: The ongoing epidemic of lifestyle-dependent diseases in industrialized countries threatens to overtax the health and social systems of these nations. New approaches beyond the usual therapeutic and preventive measures which have been applied so far must be tested. A paradigm shift with regard to nutrition and associated illness is overdue. Time-restricted eating (TRE) offers a low-threshold and easy-to-implement lifestyle change which may have what it takes for broad, population-wide applicability and a widely diversified range of possible effects. In this pilot study, we examine the feasibility and adherence of TRE in healthy adult employees. Methods: Pre-post design study with healthy volunteers from the staff of Ulm University and Ulm University Hospital. Participants were asked to reduce their daily eating time to 8-9 hours for three months. Surrounding the eating time, they were allowed drinks other than water for 12 hours, and water for the rest of the day. Anthropometric measurements were taken by trained staff, and blood samples were taken at baseline and follow-up. Pre- and post-data on lifestyle, health and health-related quality of life (HRQoL, recorded with the Visual Analog Scale (VAS) of the EuroQol 5-Dimension (EQ-5D)), and attitudes towards TRE were collected in questionnaires. During the course of the study, timing of the first and the last meal, as well as sleep duration and quality, were assessed in diaries. Primary outcome was the percentage of days with achievement of the fasting goal out of the total number of days recorded per participant. Results: Sixty-three participants (aged 47.8±10.5 years, 86% female) were recruited and started the intervention immediately after the baseline assessment. Two persons dropped out while all others finished the study. Ratings of compatibility of TRE with professional activities were good in 78% of participants, neither good nor difficult in 3%, and 18% reported to have encountered some difficulties. On average, the fasting target was reached on 72.2±18.9% of the recorded days. After three months of TRE, participants showed moderate reductions in weight (-1.3±2.3 kg, p≤0.001) and waist circumference (-1.7±3.2 cm, p≤0.001). HRQoL increased significantly by 5.8±12.4 (p=0.008) points between baseline and follow-up. Conclusion: TRE is feasible and well accepted, even in regularly employed persons, and may improve HRQoL. TRE may help to reduce obesity and abdominal obesity in adult working people, thereby preventing lifestyle-dependent diseases; however, volunteers need more guidance to increase effects.