A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol.

BACKGROUND: Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries". METHODS: RECUR builds on the technical infrastructure of Germany's Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. DISCUSSION: The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry's technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. TRIAL REGISTRATION: This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11th 2022.

[RECUR - Establishment of An Automated Digital Registry for Patients with Recurrent Stones in the Upper Urinary Tract]. / RECUR ­ Aufbau eines automatisierten digitalen Registers für Patient*innen mit rezidivierenden Steinen des oberen Harntraktes.

Kidney stones, like cardiovascular diseases and diabetes mellitus, affect a large number of people. Patients suffer from acute pain, repeated hospitalizations and associated secondary diseases, such as arterial hypertension and renal insufficiency. This results in considerable costs for the society and its health care system. The recurrence rate is as high as 50%. The registry for RECurrent URolithiasis (RECUR) aims to fill existing evidence gaps. The prospective and longitudinal RECUR registry is funded by the German Ministry of Education and Science (BMBF). It is based on the digital infrastructure of the German Medical Informatics Initiative (MII). RECUR aims to include patients that have suffered from more than one stone occurrence and treated at any one of the ten participating university hospitals of the MIRACUM consortium. The intention is to obtain new information on risk factors and to evaluate different diagnosis and treatment algorithms. Along with the data form the patient's Electronic Health Records (EHR), the RECUR project will also collect Patient Reported Outcomes data from patients with recurrent kidney stones. These data will be collected at participating sites using digital questionnaires via a smartphone app. These data will be merged with medical data from the hospital information systems and saved in the MII research data repositories. The RECUR registry has a model character due to its fully federated, digital approach. This allows the recruitment of many patients, the collection of a wide range of data and their processing with low administrative and personnel costs.

How to compete with Google and Co.: big data and artificial intelligence in stones.

PURPOSE OF REVIEW: To elucidate the keywords big data and artificial intelligence and corresponding literature in the field of urolithiasis. RECENT FINDINGS: Numbers of publications on big data and artificial intelligence in the field of urolithiasis are rising, but still low. Most publications describe the development, testing, and validation of automated computational analyses of clinical data sets and/or images in a preclinical setting. SUMMARY: In the field of digital health services, there is a discrepancy between the enormous commitment of large private companies and investments of public funds. This situation means a still small number of medical publications on this topic in the urolithiasis field. Nevertheless, as doctors and scientists, we should try to provide our patients with secure and worthwhile digital services.

FAIRification of health-related data using semantic web technologies in the Swiss Personalized Health Network.

The Swiss Personalized Health Network (SPHN) is a government-funded initiative developing federated infrastructures for a responsible and efficient secondary use of health data for research purposes in compliance with the FAIR principles (Findable, Accessible, Interoperable and Reusable). We built a common standard infrastructure with a fit-for-purpose strategy to bring together health-related data and ease the work of both data providers to supply data in a standard manner and researchers by enhancing the quality of the collected data. As a result, the SPHN Resource Description Framework (RDF) schema was implemented together with a data ecosystem that encompasses data integration, validation tools, analysis helpers, training and documentation for representing health metadata and data in a consistent manner and reaching nationwide data interoperability goals. Data providers can now efficiently deliver several types of health data in a standardised and interoperable way while a high degree of flexibility is granted for the various demands of individual research projects. Researchers in Switzerland have access to FAIR health data for further use in RDF triplestores.

International Comparisons of Harmonized Laboratory Value Trajectories to Predict Severe COVID-19: Leveraging the 4CE Collaborative Across 342 Hospitals and 6 Countries: A Retrospective Cohort Study.

Objectives: To perform an international comparison of the trajectory of laboratory values among hospitalized patients with COVID-19 who develop severe disease and identify optimal timing of laboratory value collection to predict severity across hospitals and regions. Design: Retrospective cohort study. Setting: The Consortium for Clinical Characterization of COVID-19 by EHR (4CE), an international multi-site data-sharing collaborative of 342 hospitals in the US and in Europe. Participants: Patients hospitalized with COVID-19, admitted before or after PCR-confirmed result for SARS-CoV-2. Primary and secondary outcome measures: Patients were categorized as "ever-severe" or "never-severe" using the validated 4CE severity criteria. Eighteen laboratory tests associated with poor COVID-19-related outcomes were evaluated for predictive accuracy by area under the curve (AUC), compared between the severity categories. Subgroup analysis was performed to validate a subset of laboratory values as predictive of severity against a published algorithm. A subset of laboratory values (CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin) was compared between North American and European sites for severity prediction. Results: Of 36,447 patients with COVID-19, 19,953 (43.7%) were categorized as ever-severe. Most patients (78.7%) were 50 years of age or older and male (60.5%). Longitudinal trajectories of CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin showed association with disease severity. Significant differences of laboratory values at admission were found between the two groups. With the exception of D-dimer, predictive discrimination of laboratory values did not improve after admission. Sub-group analysis using age, D-dimer, CRP, and lymphocyte count as predictive of severity at admission showed similar discrimination to a published algorithm (AUC=0.88 and 0.91, respectively). Both models deteriorated in predictive accuracy as the disease progressed. On average, no difference in severity prediction was found between North American and European sites. Conclusions: Laboratory test values at admission can be used to predict severity in patients with COVID-19. Prediction models show consistency across international sites highlighting the potential generalizability of these models.

Regional Differences in Thrombectomy Rates : Secondary use of Billing Codes in the MIRACUM (Medical Informatics for Research and Care in University Medicine) Consortium.

BACKGROUND AND PURPOSE: Mechanical thrombectomy, in addition to intravenous (i.v.) thrombolysis is recommended for treatment of acute stroke in patients with large vessel occlusions (LVO) in the anterior circulation up to 6 h after symptom onset. We compared thrombectomy rates of eight university hospitals of the MIRACUM consortium to analyze the implementation of this guideline in clinical routine. METHODS: Anonymized billing data in a standardized format were loaded into a local i2b2 data warehouse by applying already existing extract, transform and load (ETL) routines. A locally executed uniform SQL (structured query language) query delivered aggregated site data for all inpatients with a discharge diagnosis of ischemic stroke (ICD-10 I63) containing counts for type of acute treatment, type of admission and age groups, which were centrally analyzed with R. RESULTS: From 2014 to 2016, the thrombectomy rate almost doubled from a mean of 4.7% to 9.6%, although significant differences between centers exist (range in 2016: 5.8-17%). The number of drip-and-ship procedures increased in 3 out of 8 centers. There was no evidence for a decrease in thrombectomy rates during weekends/holiday or among patients older than 80 years, but this age group is more likely to receive i.v. recombinant tissue plasminogen activator (rtPA). CONCLUSION: The observed increase of thrombectomy rates and drip-and-ship procedures without a significant difference between weekdays and weekends or patients of different ages is substantiating a rapid implementation of stroke guidelines within the analyzed neurovascular centers. The prototype of the MIRACUM Data Integration Center already contributes to health services research in Germany.

Evaluation of healthy EEG responses for spelling through listener-assisted scanning.

We investigated whether listener-assisted scanning, an alternative communication method for persons with severe motor and visual impairments but preserved cognitive skills, could be used for spelling with EEG. To that end spoken letters were presented sequentially, and the participants made selections by performing motor execution/imagery or a cognitive task. The motor task was a brisk dorsiflexion of both feet, and the cognitive task was related to working memory and perception of human voice. The motor imagery task yielded the most promising results with respect to letter selection accuracy, albeit with a large variation in individual performance. The cognitive task yielded significant ( p = 0.05) albeit moderate results. Closer inspection of grand average ERPs for the cognitive task revealed task-related modulation of a late negative component, which is novel in the auditory BCI literature. Guidelines for further development are presented.

Improved concept and first results of an auditory single-switch BCI for the future use in disorders of consciousness patients.

A promising approach to establish basic communication for disorders of consciousness (DOC) patients, is the application of Brain-Computer Interface (BCI) systems, especially the use of single-switch BCIs (ssBCIs). Recently we proposed the concept of a novel auditory ssBCI paradigm and presented first classification results. In this study we report on the evaluation of four different modifications of the original paradigm with the intention to increase the suitability. Therefore we investigated different sound types and the inclusion of additional spatial information. Finally, the classification investigation with the most encouraging modifications shows an enhancement compared to our original paradigm, within healthy subjects, implicating better results for the future use in DOC patients.

Detection of mental imagery and attempted movements in patients with disorders of consciousness using EEG.

Further development of an EEG based communication device for patients with disorders of consciousness (DoC) could benefit from addressing the following gaps in knowledge-first, an evaluation of different types of motor imagery; second, an evaluation of passive feet movement as a mean of an initial classifier setup; and third, rapid delivery of biased feedback. To that end we investigated whether complex and/or familiar mental imagery, passive, and attempted feet movement can be reliably detected in patients with DoC using EEG recordings, aiming to provide them with a means of communication. Six patients in a minimally conscious state (MCS) took part in this study. The patients were verbally instructed to perform different mental imagery tasks (sport, navigation), as well as attempted feet movements, to induce distinctive event-related (de)synchronization (ERD/S) patterns in the EEG. Offline classification accuracies above chance level were reached in all three tasks (i.e., attempted feet, sport, and navigation), with motor tasks yielding significant (p < 0.05) results more often than navigation (sport: 10 out of 18 sessions; attempted feet: 7 out of 14 sessions; navigation: 4 out of 12 sessions). The passive feet movements, evaluated in one patient, yielded mixed results: whereas time-frequency analysis revealed task-related EEG changes over neurophysiological plausible cortical areas, the classification results were not significant enough (p < 0.05) to setup an initial classifier for the detection of attempted movements. Concluding, the results presented in this study are consistent with the current state of the art in similar studies, to which we contributed by comparing different types of mental tasks, notably complex motor imagery and attempted feet movements, within patients. Furthermore, we explored new venues, such as an evaluation of passive feet movement as a mean of an initial classifier setup, and rapid delivery of biased feedback.

A single-switch BCI based on passive and imagined movements: toward restoring communication in minimally conscious patients.

We investigate whether an electroencephalography technique could be used for yes/no communication with auditory scanning. To be usable by the target group, i.e., minimally conscious individuals, such a brain-computer interface (BCI) has to be very simple and robust. This leads to the concept of a single-switch BCI (ssBCI). With an ssBCI it is possible to reliably detect one certain, individually trained, brain pattern of the individual, and use it to control all kinds of applications using yes/no responses. A total of 10 healthy volunteers (20-27 years) participated in an initial cue-based session with a motor imagery (MI) task after brisk passive feet/hand movement. Four of them reached MI classification accuracies above 70% and, thus, fulfilled the inclusion criterion for participation in the 2nd session. In the 2nd session, MI was used to communicate yes/no answers to a series of questions in an auditory scanning mode. Two of the three participants of the 2nd session were able to reliably communicate their intent with 90% or above correct and 0% false responses. This work showed, for the 1st time, the use of a ssBCI based on passive and imagined movements for communication in auditory scanning mode.

Combined motor imagery and SSVEP based BCI control of a 2 DoF artificial upper limb.

A Brain-Computer Interface (BCI) is a device that transforms brain signals, which are intentionally modulated by a user, into control commands. BCIs based on motor imagery (MI) and steady-state visual evoked potentials (SSVEP) can partially restore motor control in spinal cord injured patients. To determine whether these BCIs can be combined for grasp and elbow function control independently, we investigated a control method where the beta rebound after brisk feet MI is used to control the grasp function, and a two-class SSVEP-BCI the elbow function of a 2 degrees-of-freedom artificial upper limb. Subjective preferences for the BCI control were assessed with a questionnaire. The results of the initial evaluation of the system suggests that this is feasible.

Optimized stimulus presentation patterns for an event-related potential EEG-based brain-computer interface.

P300 brain-computer interface (BCI) systems typically use a row/column (RC) approach. This article presents a P300 BCI based on a 12 x 7 matrix and new paradigmatic approaches to flashing characters designed to decrease the number of flashes needed to identify a target character. Using an RC presentation, a 12 x 7 matrix requires 19 flashes to present all items twice (12 columns and seven rows) per trial. A 12 x 7 matrix contains 84 elements (characters). To identify a target character in 12 x 7 matrix using the RC pattern, 19 flashes (sub-trials) are necessary. In each flash, the selected characters (one column or one row in the RC pattern) are flashing. We present four new paradigms and compare the performance to the RC paradigm. These paradigms present quasi-random groups of characters using 9, 12, 14 and 16 flashes per trial to identify a target character. The 12-, 14- and 16-flash patterns were optimized so that the same character never flashed twice in succession. We assessed the practical bit rate and classification accuracy of the 9-, 12-, 14-, 16- and RC (19-flash) pattern conditions in an online experiment and with offline simulations. The results indicate that 16-flash pattern is better than other patterns and performance of an online P300 BCI can be significantly improved by selecting the best presentation paradigm for each subject.

An adaptive P300-based control system.

An adaptive P300 brain-computer interface (BCI) using a 12 × 7 matrix explored new paradigms to improve bit rate and accuracy. During online use, the system adaptively selects the number of flashes to average. Five different flash patterns were tested. The 19-flash paradigm represents the typical row/column presentation (i.e. 12 columns and 7 rows). The 9- and 14-flash A and B paradigms present all items of the 12 × 7 matrix three times using either 9 or 14 flashes (instead of 19), decreasing the amount of time to present stimuli. Compared to 9-flash A, 9-flash B decreased the likelihood that neighboring items would flash when the target was not flashing, thereby reducing the interference from items adjacent to targets. 14-flash A also reduced the adjacent item interference and 14-flash B additionally eliminated successive (double) flashes of the same item. Results showed that the accuracy and bit rate of the adaptive system were higher than those of the non-adaptive system. In addition, 9- and 14-flash B produced significantly higher performance than their respective A conditions. The results also show the trend that the 14-flash B paradigm was better than the 19-flash pattern for naive users.

Asynchronous steady-state visual evoked potential based BCI control of a 2-DoF artificial upper limb.

A brain-computer interface (BCI) provides a direct connection between the human brain and a computer. One type of BCI can be realized using steady-state visual evoked potentials (SSVEPs), resulting from repetitive stimulation. The aim of this study was the realization of an asynchronous SSVEP-BCI, based on canonical correlation analysis, suitable for the control of a 2-degrees of freedom (DoF) hand and elbow neuroprosthesis. To determine whether this BCI is suitable for the control of 2-DoF neuroprosthetic devices, online experiments with a virtual and a robotic limb feedback were conducted with eight healthy subjects and one tetraplegic patient. All participants were able to control the artificial limbs with the BCI. In the online experiments, the positive predictive value (PPV) varied between 69% and 83% and the false negative rate (FNR) varied between 1% and 17%. The spinal cord injured patient achieved PPV and FNR values within one standard deviation of the mean for all healthy subjects.

A new P300 stimulus presentation pattern for EEG-based spelling systems.

A P300 spelling system is one of the most popular EEG-based spelling systems. This system is normally presented as a matrix and allows its users to select one of many options by focused attention. It is possible to use large matrices as a large menu (computer keyboard, etc.), but then more time is required for each selection, because all rows and columns of the matrix must flash once per trial to locate the target character in the row/column (RC) speller method. In this paper, a new flash pattern design based on mathematical combinations is suggested. This new method decreases the number of flashes required in each trial. A typical example of a 6x6 matrix is considered. Only 9 flashes per trial for the 6x6 matrix are required in this new method, which is 3 flashes less than the RC speller method (12 flashes per trial). In this paper, practical bit rate was used. Results from offline analysis have shown that the 9-flash pattern yielded significantly higher practical bit rate than the 12-flash pattern (RC pattern).