Pragmatic MDR: a metadata repository with bottom-up standardization of medical metadata through reuse.

BACKGROUND: The variety of medical documentation often leads to incompatible data elements that impede data integration between institutions. A common approach to standardize and distribute metadata definitions are ISO/IEC 11179 norm-compliant metadata repositories with top-down standardization. To the best of our knowledge, however, it is not yet common practice to reuse the content of publicly accessible metadata repositories for creation of case report forms or routine documentation. We suggest an alternative concept called pragmatic metadata repository, which enables a community-driven bottom-up approach for agreeing on data collection models. A pragmatic metadata repository collects real-world documentation and considers frequent metadata definitions as high quality with potential for reuse. METHODS: We implemented a pragmatic metadata repository proof of concept application and filled it with medical forms from the Portal of Medical Data Models. We applied this prototype in two use cases to demonstrate its capabilities for reusing metadata: first, integration into a study editor for the suggestion of data elements and, second, metadata synchronization between two institutions. Moreover, we evaluated the emergence of bottom-up standards in the prototype and two medical data managers assessed their quality for 24 medical concepts. RESULTS: The resulting prototype contained 466,569 unique metadata definitions. Integration into the study editor led to a reuse of 1836 items and item groups. During the metadata synchronization, semantic codes of 4608 data elements were transferred. Our evaluation revealed that for less complex medical concepts weak bottom-up standards could be established. However, more diverse disease-related concepts showed no convergence of data elements due to an enormous heterogeneity of metadata. The survey showed fair agreement (Kalpha = 0.50, 95% CI 0.43-0.56) for good item quality of bottom-up standards. CONCLUSIONS: We demonstrated the feasibility of the pragmatic metadata repository concept for medical documentation. Applications of the prototype in two use cases suggest that it facilitates the reuse of data elements. Our evaluation showed that bottom-up standardization based on a large collection of real-world metadata can yield useful results. The proposed concept shall not replace existing top-down approaches, rather it complements them by showing what is commonly used in the community to guide other researchers.

Medical Emergency Datasets Can Improve the Comprehensiveness of Handover Information: A Simulation Study.

Background: Access to patients' medical histories can be of vital importance to ensure proper treatment in an emergency. Germany is planning to introduce a medical emergency dataset (MED), accessible through an electronic health card, and comprising important patient information, such as diagnoses, medications, and allergies. Introduction: This article evaluates the effect of MEDs on the comprehensiveness of a physician's documentation and handover process to the emergency department of a hospital. Materials and Methods: In 2 randomized, crossover simulation studies, 72 emergency physicians participated in 2 emergency scenarios, either with or without access to an MED. Subsequently, they had to document the key information (pre-existing conditions, medications, and allergies) and hand it over to a fictional hospital. The influence of the MED on the documentation of key information was analyzed using the two-sided Prescott's exact test. Sensitivity analyses adjusting for scenario were conducted. Results: The results show that in scenarios with an MED, documentation of key information in the handover process was more complete. In the first trial, 2 of 3 key items (pre-existing conditions/information and allergies) presented a statistically noticeable difference in scenarios with the MED. The second trial confirmed these results for all key items. Discussion: The findings indicate that the use of MEDs in emergency care could be beneficial since documentation and handover in scenarios with an MED were superior to current real-world practices. Conclusions: Access to more complete patient information through an MED could help to improve the patient's treatment.

Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial.

INTRODUCTION: Development of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany. METHODS AND ANALYSIS: 80 000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2 years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design. ETHICS AND DISSEMINATION: This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer-reviewed journals. TRIAL REGISTRATION: NCT03377036; Pre-results.

Short-term effects of high soy supplementation on sex hormones, bone markers, and lipid parameters in young female adults.

BACKGROUND: High intake of soy products has been suggested to prevent breast cancer, osteoporosis, and cardiovascular diseases. AIM OF THE STUDY: To investigate the effects of isoflavone-containing soy on circulating sex hormones, biomarkers of bone turnover, and lipoprotein profiles. METHODS: Fourteen young women received in a randomized crossover design 5 soy cookies (52 mg isoflavones) or 5 soy-free cookies (no isoflavones) per day for one menstrual cycle starting one week before menstruation. Serum and urine analyses were performed on day 3 after onset of menstruation (t(1)), 3 days before ovulation (t(2)), 3 days after ovulation (t(3)), during the midluteal phase (t(4)), and again 3 days after onset of the next menstruation (t(5)). RESULTS: With the exception of higher progesterone levels at t(2), soy supplementation did not affect the physiologic fluctuations in circulating sex hormones. The ratio of C-telopeptide (a bone resorption marker) to osteocalcin (a bone formation marker) was slightly higher at t(4) during the soy period compared to t(4) during the control period (P < 0.05), indicating an uncoupling of bone resorption and formation processes. Serum levels of total cholesterol, LDL cholesterol, and HDL cholesterol were not influenced by soy intake. CONCLUSIONS: High short-term isoflavone-containing soy intake slightly affects physiologic fluctuations in bone turnover, but has no significant effects on most circulating sex hormones and on lipoprotein parameters in young healthy women.