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This project aims to evaluate existing big data infrastructures for their applicability in the operating room to support medical staff with context-sensitive systems. Requirements for the system design were generated. The project compares different data mining technologies, interfaces, and software system infrastructures with a focus on their usefulness in the peri-operative setting. The lambda architecture was chosen for the proposed system design, which will provide data for both postoperative analysis and real-time support during surgery.
Purpose
For the modeling, execution, and control of complex, non-standardized intraoperative processes, a modeling language is needed that reflects the variability of interventions. As the established Business Process Model and Notation (BPMN) reaches its limits in terms of flexibility, the Case Management Model and Notation (CMMN) was considered as it addresses weakly structured processes.
Methods
To analyze the suitability of the modeling languages, BPMN and CMMN models of a Robot-Assisted Minimally Invasive Esophagectomy and Cochlea Implantation were derived and integrated into a situation recognition workflow. Test cases were used to contrast the differences and compare the advantages and disadvantages of the models concerning modeling, execution, and control. Furthermore, the impact on transferability was investigated.
Results
Compared to BPMN, CMMN allows flexibility for modeling intraoperative processes while remaining understandable. Although more effort and process knowledge are needed for execution and control within a situation recognition system, CMMN enables better transferability of the models and therefore the system. Concluding, CMMN should be chosen as a supplement to BPMN for flexible process parts that can only be covered insufficiently by BPMN, or otherwise as a replacement for the entire process.
Conclusion
CMMN offers the flexibility for variable, weakly structured process parts, and is thus suitable for surgical interventions. A combination of both notations could allow optimal use of their advantages and support the transferability of the situation recognition system.
Automatic segmentation is essential for the brain tumor diagnosis, disease prognosis, and follow-up therapy of patients with gliomas. Still, accurate detection of gliomas and their sub-regions in multimodal MRI is very challenging due to the variety of scanners and imaging protocols. Over the last years, the BraTS Challenge has provided a large number of multi-institutional MRI scans as a benchmark for glioma segmentation algorithms. This paper describes our contribution to the BraTS 2022 Continuous Evaluation challenge. We propose a new ensemble of multiple deep learning frameworks namely, DeepSeg, nnU-Net, and DeepSCAN for automatic glioma boundaries detection in pre-operative MRI. It is worth noting that our ensemble models took first place in the final evaluation on the BraTS testing dataset with Dice scores of 0.9294, 0.8788, and 0.8803, and Hausdorf distance of 5.23, 13.54, and 12.05, for the whole tumor, tumor core, and enhancing tumor, respectively. Furthermore, the proposed ensemble method ranked first in the final ranking on another unseen test dataset, namely Sub-Saharan Africa dataset, achieving mean Dice scores of 0.9737, 0.9593, and 0.9022, and HD95 of 2.66, 1.72, 3.32 for the whole tumor, tumor core, and enhancing tumor, respectively.
The scoring of sleep stages is one of the essential tasks in sleep analysis. Since a manual procedure requires considerable human and financial resources, and incorporates some subjectivity, an automated approach could result in several advantages. There have been many developments in this area, and in order to provide a comprehensive overview, it is essential to review relevant recent works and summarise the characteristics of the approaches, which is the main aim of this article. To achieve it, we examined articles published between 2018 and 2022 that dealt with the automated scoring of sleep stages. In the final selection for in-depth analysis, 125 articles were included after reviewing a total of 515 publications. The results revealed that automatic scoring demonstrates good quality (with Cohen's kappa up to over 0.80 and accuracy up to over 90%) in analysing EEG/EEG + EOG + EMG signals. At the same time, it should be noted that there has been no breakthrough in the quality of results using these signals in recent years. Systems involving other signals that could potentially be acquired more conveniently for the user (e.g. respiratory, cardiac or movement signals) remain more challenging in the implementation with a high level of reliability but have considerable innovation capability. In general, automatic sleep stage scoring has excellent potential to assist medical professionals while providing an objective assessment.
Mobile monitoring of outpatients during cancer therapy becomes possible through technological advancements. This study leveraged a new remote patient monitoring app for in-between systemic therapy sessions. Patients’ evaluation showed that the handling is feasible. Clinical implementation must consider an adaptive development cycle for reliable operations.
Sleep is extremely important for physical and mental health. Although polysomnography is an established approach in sleep analysis, it is quite intrusive and expensive. Consequently, developing a non-invasive and non-intrusive home sleep monitoring system with minimal influence on patients, that can reliably and accurately measure cardiorespiratory parameters, is of great interest. The aim of this study is to validate a non-invasive and unobtrusive cardiorespiratory parameter monitoring system based on an accelerometer sensor. This system includes a special holder to install the system under the bed mattress. The additional aim is to determine the optimum relative system position (in relation to the subject) at which the most accurate and precise values of measured parameters could be achieved. The data were collected from 23 subjects (13 males and 10 females). The obtained ballistocardiogram signal was sequentially processed using a sixth-order Butterworth bandpass filter and a moving average filter. As a result, an average error (compared to reference values) of 2.24 beats per minute for heart rate and 1.52 breaths per minute for respiratory rate was achieved, regardless of the subject’s sleep position. For males and females, the errors were 2.28 bpm and 2.19 bpm for heart rate and 1.41 rpm and 1.30 rpm for respiratory rate. We determined that placing the sensor and system at chest level is the preferred configuration for cardiorespiratory measurement. Further studies of the system’s performance in larger groups of subjects are required, despite the promising results of the current tests in healthy subjects.
In order to ensure sufficient recovery of the human body and brain, healthy sleep is indispensable. For this purpose, appropriate therapy should be initiated at an early stage in the case of sleep disorders. For some sleep disorders (e.g., insomnia), a sleep diary is essential for diagnosis and therapy monitoring. However, subjective measurement with a sleep diary has several disadvantages, requiring regular action from the user and leading to decreased comfort and potential data loss. To automate sleep monitoring and increase user comfort, one could consider replacing a sleep diary with an automatic measurement, such as a smartwatch, which would not disturb sleep. To obtain accurate results on the evaluation of the possibility of such a replacement, a field study was conducted with a total of 166 overnight recordings, followed by an analysis of the results. In this evaluation, objective sleep measurement with a Samsung Galaxy Watch 4 was compared to a subjective approach with a sleep diary, which is a standard method in sleep medicine. The focus was on comparing four relevant sleep characteristics: falling asleep time, waking up time, total sleep time (TST), and sleep efficiency (SE). After evaluating the results, it was concluded that a smartwatch could replace subjective measurement to determine falling asleep and waking up time, considering some level of inaccuracy. In the case of SE, substitution was also proved to be possible. However, some individual recordings showed a higher discrepancy in results between the two approaches. For its part, the evaluation of the TST measurement currently does not allow us to recommend substituting the measurement method for this sleep parameter. The appropriateness of replacing sleep diary measurement with a smartwatch depends on the acceptable levels of discrepancy. We propose four levels of similarity of results, defining ranges of absolute differences between objective and subjective measurements. By considering the values in the provided table and knowing the required accuracy, it is possible to determine the suitability of substitution in each individual case. The introduction of a “similarity level” parameter increases the adaptability and reusability of study findings in individual practical cases.
Background: Polysomnography (PSG) is the gold standard for detecting obstructive sleep apnea (OSA). However, this technique has many disadvantages when using it outside the hospital or for daily use. Portable monitors (PMs) aim to streamline the OSA detection process through deep learning (DL).
Materials and methods: We studied how to detect OSA events and calculate the apnea-hypopnea index (AHI) by using deep learning models that aim to be implemented on PMs. Several deep learning models are presented after being trained on polysomnography data from the National Sleep Research Resource (NSRR) repository. The best hyperparameters for the DL architecture are presented. In addition, emphasis is focused on model explainability techniques, concretely on Gradient-weighted Class Activation Mapping (Grad-CAM).
Results: The results for the best DL model are presented and analyzed. The interpretability of the DL model is also analyzed by studying the regions of the signals that are most relevant for the model to make the decision. The model that yields the best result is a one-dimensional convolutional neural network (1D-CNN) with 84.3% accuracy.
Conclusion: The use of PMs using machine learning techniques for detecting OSA events still has a long way to go. However, our method for developing explainable DL models demonstrates that PMs appear to be a promising alternative to PSG in the future for the detection of obstructive apnea events and the automatic calculation of AHI.
Motivation
In order to enable context-aware behavior of surgical assistance systems, the acquisition of various information about the current intraoperative situation is crucial. To achieve this, the complex task of situation recognition can be delegated to a specialized system. Consequently, a standardized interface is required for the seamless transfer of the recognized contextual information to the assistance systems, enabling them to adapt accordingly.
Methods
Our group analyzed four medical interface standards to determine their suitability for exchanging intraoperative contextual information. The assessment was based on a harmonized data and service model derived from the requirements of expected context-aware use cases. The Digital Imaging and Communications in Medicine (DICOM) and IEEE 11073 for Service-oriented Device Connectivity (SDC) were identified as the most appropriate standards.
Results
We specified how DICOM Unified Procedure Steps (UPS), can be used to effectively communicate contextual information. We proposed the inclusion of attributes to formalize different granularity levels of the surgical workflow.
Conclusions
DICOM UPS SOP classes can be used for the exchange of intraoperative contextual information between a situation recognition system and surgical assistance systems. This can pave the way for vendor-independent context awareness in the OR, leading to targeted assistance of the surgical team and an improvement of the surgical workflow.
Due to the wide variety of benign and malignant salivary gland tumors, classification and malignant behavior determination based on histomorphological criteria can be difficult and sometimes impossible. Spectroscopical procedures can acquire molecular biological information without destroying the tissue within the measurement processes. Since several tissue preparation procedures exist, our study investigated the impact of these preparations on the chemical composition of healthy and tumorous salivary gland tissue by Fourier-transform infrared (FTIR) microspectroscopy. Sequential tissue cross-sections were prepared from native, formalin-fixed and formalin-fixed paraffin-embedded (FFPE) tissue and analyzed. The FFPE cross-sections were dewaxed and remeasured. By using principal component analysis (PCA) combined with a discriminant analysis (DA), robust models for the distinction of sample preparations were built individually for each parotid tissue type. As a result, the PCA-DA model evaluation showed a high similarity between native and formalin-fixed tissues based on their chemical composition. Thus, formalin-fixed tissues are highly representative of the native samples and facilitate a transfer from scientific laboratory analysis into the clinical routine due to their robust nature. Furthermore, the dewaxing of the cross-sections entails the loss of molecular information. Our study successfully demonstrated how FTIR microspectroscopy can be used as a powerful tool within existing clinical workflows.
Purpose
Artificial intelligence (AI), in particular deep learning (DL), has achieved remarkable results for medical image analysis in several applications. Yet the lack of human-like explanations of such systems is considered the principal restriction before utilizing these methods in clinical practice (Yang, Ye, & Xia, 2022).
Methods
Explainable Artificial Intelligence (XAI) provides a human-explainable and interpretable description of the “black-box” nature of DL (Gulum, Trombley, & Kantardzic, 2021). An effective XAI diagnosis generator, namely NeuroXAI (refer to Fig. 1), has been developed to extract 3D explanations from convolutional neural networks (CNN) models of brain gliomas (Zeineldin et al., 2022). By providing visual justification maps, NeuroXAI can help make DL models transparent and thus increase the trust of medical experts.
Results
NeuroXAI has been applied to two applications of the most widely investigated problems in brain imaging analysis, i.e. image classification and segmentation using magnetic resonance imaging (MRI). Visual attention maps of multiple XAI methods have been generated and compared for both applications, which could help to provide transparency about the performance of DL systems.
Conclusion
NeuroXAI helps to understand the prediction process of 3D CNN networks for brain glioma using human-understandable explanations. Results revealed that the investigated DL models behave in a logical human-like manner and can improve the analytical process of the MRI images systematically. Due to its open architecture, ease of implementation, and scalability to new XAI methods, NeuroXAI could be utilized to assist medical professionals in the detection and diagnosis of brain tumors. NeuroXAI code is publicly accessible at https://github.com/razeineldin/NeuroXAI
Perforations of the tympanic membrane (TM) can occur as a result of injury or inflammation of the middle ear. These perforations can lead to conductive hearing loss (HL), where in some cases the magnitude of HL exceeds that attributable to the observed TM perforation alone. We aim with this study to better understand the effects of location and size of TM perforations on the sound transmitting properties of the middle ear.
The middle ear transfer function (METF) of six human temporal bones (TB; freshly frozen specimen of body donors) were compared before and after perforation of the TM at different locations (anterior or posterior lower quadrant) and of different sizes (1mm, ¼ of the TM, ½ of the TM, and full ablation). The
METF were correlated with a Finite Element (FE) model of the middle ear, in which similar alterations were simulated.
The measured and simulated FE model METFs exhibited frequency and perforation size dependent amplitude losses at all locations and severities. In direct comparison, posterior TM perforations affected the transmission properties to a larger degree than perforations of the anterior quadrant. This could possibly be caused by an asymmetry of the TM, where the malleus-incus complex rotates and results in larger deflections in the posterior TM half than in the anterior TM half. The FE model of the TM with a sealed cavity suggest that small perforations result in a decrease of TM rigidity and thus to an increase in oscillation amplitude of the TM, mostly above 1 kHz.
The location and size of TM perforations influence the METF in a reproducible way. Correlating our data with the FE model could help to better understand the pathologic mechanisms of middle-ear diseases. If small TM perforations with uncharacteristically significant HL are observed in daily clinical practice, additional middle ear pathologies should be considered. Further investigations on the loss of TM pretension due to perforations may be informative.
In order to evaluate the performance of different stapes prosthesis types, a coupled finite element (FE) model of human ear was developed. First, the middle-ear FE model was developed and validated using the middle-ear transfer function measurements available in literature including pathological cases. Then, the inner-ear FE model was developed and validated using tonotopy, impedance, and level of cochlea amplification curves from literature. Both models are based on pre-existing research with some improvements and were combined into one coupled FE model. The stapes in the coupled FE ear model was replaced with a model of a stapes prosthesis to create a reconstructed ear model that can be used to estimate how different types of protheses perform relative to each other as well as to the natural ear. This will help in designing of new innovative types of stapes prostheses or any other type of middle-ear prostheses as well as to improve the ones that are already available on the market.
Simulation models of the middle ear have rarely been used for diagnostic purposes due to their limited predictive ability with respect to pathologies. One big challenge is the large uncertainty and ambiguity in the choice of material parameters of the model.
Typically, the model parameters are determined by fitting simulation results to validation measurements. In a previous study, it was shown that fitting the model parameters of a finite-element model using the middle-ear transfer function and various other measurable output variables from normal ears alone is not sufficient to obtain a good predictive ability of the model on pathological middle-ear conditions. However, the inclusion of validation measurements on one pathological case resulted in a very good predictive ability also for other pathological cases. Although the found parameter set was plausible in all aspects, it was not yet possible to draw conclusions about the uniqueness and the accuracy or the uncertainty of the parameter set.
To answer these questions, statistical solution approaches are used in this study. Using the Monte Carlo method, a large number of plausible model data sets are generated that correctly represent the normal and pathological middle-ear characteristics in terms of various output variables like e.g., impedance, reflectance, umbo, and stapes transfer function. Subsequent principal component analyses (PCA) allow to draw conclusions about correlations, quantitative limits and statistical density of parameter values.
Furthermore, applying inverse PCA yields numerous plausible parameterizations of the middle-ear model, which can be used for data augmentation and training of a neural network which is capable of distinguishing between a normal middle ear and pathologies like otosclerosis, malleus fixation, and disarticulation based on objectively measured quantities like impedance, reflectance, and umbo velocity.
Rational behavior is a standard assumption in science. Indeed, rationality is required for environmental action towards net-zero emissions or public health interventions during the SARS-CoV-2 pandemic. Yet, little is known about the elements of rationality. This paper explores a dualism of rationality comprised of optimality and consistency. By designing a new guessing game, we experimentally uncover and disentangle two building blocks of human rationality: the notions of optimality and consistency. We find evidence that rationality is largely associated to optimality and weakly to consistency. Remarkably, under uncertainty, rationality gradually shifts to a heuristic notion. Our findings provide insights to better understand human decision making.
The hearing contact lens® (HCL) is a new type of hearing aid devices. One of its main components is a piezo-electric actuator. In order to evaluate and maximize the HCL’s performance, a model of the HCL coupled to the middle ear was developed using finite element approach. The model was validated step by step starting with the HCL only. To validate the HCL model, vibrational measurements on the HCL were performed using a Laser-Doppler-Vibrometer (LDV). Then, a silicone cap was placed onto the HCL to provide an interface between the HCL and the tympanic membrane of the middle-ear model and additional LDV measurements on temporal bones were performed to validate the coupled model. The coupled model was used to evaluate the equivalent sound pressure of the HCL. Moreover, a deeper insight was gained into the contact between the HCL and tympanic membrane and its effects on the HCL performance. The model can be used to investigate the sensitivity of geometrical and material parameters with respect to performance measures of the HCL and evaluate the feedback behavior.
Purpose
Supporting the surgeon during surgery is one of the main goals of intelligent ORs. The OR-Pad project aims to optimize the information flow within the perioperative area. A shared information space should enable appropriate preparation and provision of relevant information at any time before, during, and after surgery.
Methods
Based on previous work on an interaction concept and system architecture for the sterile OR-Pad system, we designed a user interface for mobile and intraoperative (stationary) use, focusing on the most important functionalities like clear information provision to reduce information overload. The concepts were transferred into a high-fidelity prototype for demonstration purposes. The prototype was evaluated from different perspectives, including a usability study.
Results
The prototype’s central element is a timeline displaying all available case information chronologically, like radiological images, labor findings, or notes. This information space can be adapted for individual purposes (e.g., highlighting a tumor, filtering for own material). With the mobile and intraoperative mode of the system, relevant information can be added, preselected, viewed, and extended during the perioperative process. Overall, the evaluation showed good results and confirmed the vision of the information system.
Conclusion
The high-fidelity prototype of the information system OR-Pad focuses on supporting the surgeon via a timeline making all available case information accessible before, during, and after surgery. The information space can be personalized to enable targeted support. Further development is reasonable to optimize the approach and address missing or insufficient aspects, like the holding arm and sterility concept or new desired features.
Background
Personalized medicine requires the integration and analysis of vast amounts of patient data to realize individualized care. With Surgomics, we aim to facilitate personalized therapy recommendations in surgery by integration of intraoperative surgical data and their analysis with machine learning methods to leverage the potential of this data in analogy to Radiomics and Genomics.
Methods
We defined Surgomics as the entirety of surgomic features that are process characteristics of a surgical procedure automatically derived from multimodal intraoperative data to quantify processes in the operating room. In a multidisciplinary team we discussed potential data sources like endoscopic videos, vital sign monitoring, medical devices and instruments and respective surgomic features. Subsequently, an online questionnaire was sent to experts from surgery and (computer) science at multiple centers for rating the features’ clinical relevance and technical feasibility.
Results
In total, 52 surgomic features were identified and assigned to eight feature categories. Based on the expert survey (n = 66 participants) the feature category with the highest clinical relevance as rated by surgeons was “surgical skill and quality of performance” for morbidity and mortality (9.0 ± 1.3 on a numerical rating scale from 1 to 10) as well as for long-term (oncological) outcome (8.2 ± 1.8). The feature category with the highest feasibility to be automatically extracted as rated by (computer) scientists was “Instrument” (8.5 ± 1.7). Among the surgomic features ranked as most relevant in their respective category were “intraoperative adverse events”, “action performed with instruments”, “vital sign monitoring”, and “difficulty of surgery”.
Conclusion
Surgomics is a promising concept for the analysis of intraoperative data. Surgomics may be used together with preoperative features from clinical data and Radiomics to predict postoperative morbidity, mortality and long-term outcome, as well as to provide tailored feedback for surgeons.
Personalized remote healthcare monitoring is in continuous development due to the technology improvements of sensors and wearable electronic systems. A state of the art of research works on wearable sensors for healthcare applications is presented in this work. Furthermore, a state of the art of wearable devices, chest and wrist band and smartwatches available on the market for health and sport monitoring is presented in this paper. Many activity trackers are commercially available. The prices are continuously reducing and the performances are improving, but commercial devices do not provide raw data and are therefore not useful for research purposes.
Gamification is one of the recognized methods of motivating people in various life processes, and it has spread to many spheres of life, including healthcare. This article proposes a system design for long-term care patients using the method mentioned. The proposed system aims to increase patient engagement in the treatment and rehabilitation process via gamification. Literature research on available and earlier proposed systems was conducted to develop a suited system design. The primary target group includes bedridden patients and a sedentary lifestyle (predominantly lying in bed). One of the main criteria for selecting a suitable option was its contactless realization for the mentioned target groups in long-term care cases. As a result, we developed the system design for hardware and software that could prevent bedsores and other health problems from occurring because of low activity. The proposed design can be tested in hospitals, nursing homes, and rehabilitation centers.
In recent decades, it can be observed that a steady increase in the volume of tourism is a stable trend. To offer travel opportunities to all groups, it is also necessary to prepare offers for people in need of long-term care or people with disabilities. One of the ways to improve accessibility could be digital technologies, which could help in planning as well as in carrying out trips. In the work presented, a study of barriers was first conducted, which led to selecting technologies for a test setup after analysis. The main focus was on a mobile app with travel information and 360° tours. The evaluation results showed that both technologies could increase accessibility, but some essential aspects (such as usability, completeness, relevance, etc.) need to be considered when implementing them.
The digital twin concept has been widely known for asset monitoring in the industry for a long time. A clear example is the automotive industry. Recently, there has also been significant interest in the application of digital twins in healthcare, especially in genomics in what is known as precision medicine. This work focuses on another medical speciality where digital twins can be applied, sleep medicine. However, there is still great controversy about the fundamentals that constitute digital twins, such as what this concept is based on and how it can be included in healthcare effectively and sustainably. This article reviews digital twins and their role so far in what is known as personalized medicine. In addition, a series of steps will be exposed for a possible implementation of a digital twin for a patient suffering from sleep disorders. For this, artificial intelligence techniques, clinical data management, and possible solutions for explaining the results derived from artificial intelligence models will be addressed.
In many cases continuous monitoring of vital signals is required and low intrusiveness is an important requirement. Incorporating monitoring systems in the hospital or home bed could have benefits for patients and caregivers. The objective of this work is the definition of a measurement protocol and the creation of a data set of measurements using commercial and low-cost prototypes devices to estimate heart rate and breathing rate. The experimental data will be used to compare results achieved by the devices and to develop algorithms for feature extraction of vital signals.
There have been substantial research efforts for algorithms to improve continuous and automated assessment of various health-related questions in recent years. This paper addresses the deployment gap between those improving algorithms and their usability in care and mobile health applications. In practice, most algorithms require significant and founded technical knowledge to be deployed at home or support healthcare professionals. Therefore, the digital participation of persons in need of health care professionals lacks a usable interface to use the current technological advances. In this paper, we propose applying algorithms taken from research as web-based microservices following the common approach of a RESTful service to bridge the gap and make algorithms accessible to caregivers and patients without technical knowledge and extended hardware capabilities. We address implementation details, interpretation and realization of guidelines, and privacy concerns using our self-implemented example. Also, we address further usability guidelines and our approach to those.
Glioblastomas are the most aggressive fast-growing primary brain cancer which originate in the glial cells of the brain. Accurate identification of the malignant brain tumor and its sub-regions is still one of the most challenging problems in medical image segmentation. The Brain Tumor Segmentation Challenge (BraTS) has been a popular benchmark for automatic brain glioblastomas segmentation algorithms since its initiation. In this year, BraTS 2021 challenge provides the largest multi-parametric (mpMRI) dataset of 2,000 pre-operative patients. In this paper, we propose a new aggregation of two deep learning frameworksnamely, DeepSeg and nnU-Net for automatic glioblastoma recognition in pre-operative mpMRI. Our ensemble method obtains Dice similarity scores of 92.00, 87.33, and 84.10 and Hausdorff Distances of 3.81, 8.91, and 16.02 for the enhancing tumor, tumor core, and whole tumor regions, respectively, on the BraTS 2021 validation set, ranking us among the top ten teams. These experimental findings provide evidence that it can be readily applied clinically and thereby aiding in the brain cancer prognosis, therapy planning, and therapy response monitoring. A docker image for reproducing our segmentation results is available online at (https://hub.docker.com/r/razeineldin/deepseg21).
The imaging and force-distance curve modes of atomic force microscopy (AFM) are explored to compare the morphological and mechanical signatures of platelets from patients diagnosed with classical neurodegenerative diseases (NDDs) and healthy individuals. Our data demonstrate the potential of AFM to distinguish between the three NDDs-Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD), and normal healthy platelets. The common features of platelets in the three pathologies are reduced membrane surface roughness, area and height, and enhanced nanomechanics in comparison with healthy cells. These changes might be related to general phenomena associated with reorganization in the platelet membrane morphology and cytoskeleton, a key factor for all platelets’ functions. Importantly, the platelets’ signatures are modified to a different extent in the three pathologies, most significant in ALS, less pronounced in PD and the least in AD platelets, which shows the specificity associated with each pathology. Moreover, different degree of activation, distinct pseudopodia and nanocluster formation characterize ALS, PD and AD platelets. The strongest alterations in the biophysical properties correlate with the highest activation of ALS platelets, which reflect the most significant changes in their nanoarchitecture. The specific platelet signatures that mark each of the studied pathologies can be added as novel biomarkers to the currently used diagnostic tools.
Purpose
Context awareness in the operating room (OR) is important to realize targeted assistance to support actors during surgery. A situation recognition system (SRS) is used to interpret intraoperative events and derive an intraoperative situation from these. To achieve a modular system architecture, it is desirable to de-couple the SRS from other system components. This leads to the need of an interface between such an SRS and context-aware systems (CAS). This work aims to provide an open standardized interface to enable loose coupling of the SRS with varying CAS to allow vendor-independent device orchestrations.
Methods
A requirements analysis investigated limiting factors that currently prevent the integration of CAS in today's ORs. These elicited requirements enabled the selection of a suitable base architecture. We examined how to specify this architecture with the constraints of an interoperability standard. The resulting middleware was integrated into a prototypic SRS and our system for intraoperative support, the OR-Pad, as exemplary CAS for evaluating whether our solution can enable context-aware assistance during simulated orthopedical interventions.
Results
The emerging Service-oriented Device Connectivity (SDC) standard series was selected to specify and implement a middleware for providing the interpreted contextual information while the SRS and CAS are loosely coupled. The results were verified within a proof of concept study using the OR-Pad demonstration scenario. The fulfillment of the CAS’ requirements to act context-aware, conformity to the SDC standard series, and the effort for integrating the middleware in individual systems were evaluated. The semantically unambiguous encoding of contextual information depends on the further standardization process of the SDC nomenclature. The discussion of the validity of these results proved the applicability and transferability of the middleware.
Conclusion
The specified and implemented SDC-based middleware shows the feasibility of loose coupling an SRS with unknown CAS to realize context-aware assistance in the OR.
Purpose
Artificial intelligence (AI), in particular deep neural networks, has achieved remarkable results for medical image analysis in several applications. Yet the lack of explainability of deep neural models is considered the principal restriction before applying these methods in clinical practice.
Methods
In this study, we propose a NeuroXAI framework for explainable AI of deep learning networks to increase the trust of medical experts. NeuroXAI implements seven state-of-the-art explanation methods providing visualization maps to help make deep learning models transparent.
Results
NeuroXAI has been applied to two applications of the most widely investigated problems in brain imaging analysis, i.e., image classification and segmentation using magnetic resonance (MR) modality. Visual attention maps of multiple XAI methods have been generated and compared for both applications. Another experiment demonstrated that NeuroXAI can provide information flow visualization on internal layers of a segmentation CNN.
Conclusion
Due to its open architecture, ease of implementation, and scalability to new XAI methods, NeuroXAI could be utilized to assist radiologists and medical professionals in the detection and diagnosis of brain tumors in the clinical routine of cancer patients. The code of NeuroXAI is publicly accessible at https://github.com/razeineldin/NeuroXAI.
Background
Although teledermatology has been proven internationally to be an effective and safe addition to the care of patients in primary care, there are few pilot projects implementing teledermatology in routine outpatient care in Germany. The aim of this cluster randomized controlled trial was to evaluate whether referrals to dermatologists are reduced by implementing a store-and-forward teleconsultation system in general practitioner practices.
Methods
Eight counties were cluster randomized to the intervention and control conditions. During the 1-year intervention period between July 2018 and June 2019, 46 general practitioner practices in the 4 intervention counties implemented a store-and-forward teledermatology system with Patient Data Management System interoperability. It allowed practice teams to initiate teleconsultations for patients with dermatologic complaints. In the four control counties, treatment as usual was performed. As primary outcome, number of referrals was calculated from routine health care data. Poisson regression was used to compare referral rates between the intervention practices and 342 control practices.
Results
The primary analysis revealed no significant difference in referral rates (relative risk = 1.02; 95% confidence interval = 0.911–1.141; p = .74). Secondary analyses accounting for sociodemographic and practice characteristics but omitting county pairing resulted in significant differences of referral rates between intervention practices and control practices. Matched county pair, general practitioner age, patient age, and patient sex distribution in the practices were significantly related to referral rates.
Conclusions
While a store-and-forward teleconsultation system was successfully implemented in the German primary health care setting, the intervention's effect was superimposed by regional factors. Such regional factors should be considered in future teledermatology research.
Physicians in interventional radiology are exposed to high physical stress. To avoid negative long-term effects resulting from unergonomic working conditions, we demonstrated the feasibility of a system that gives feedback about unergonomic
situations arising during the intervention based on the Azure Kinect camera. The overall feasibility of the approach could be shown.
Recognition of sleep and wake states is one of the relevant parts of sleep analysis. Performing this measurement in a contactless way increases comfort for the users. We present an approach evaluating only movement and respiratory signals to achieve recognition, which can be measured non-obtrusively. The algorithm is based on multinomial logistic regression and analyses features extracted out of mentioned above signals. These features were identified and developed after performing fundamental research on characteristics of vital signals during sleep. The achieved accuracy of 87% with the Cohen’s kappa of 0.40 demonstrates the appropriateness of a chosen method and encourages continuing research on this topic.
Motivation: Aim of this project is the automatic classification of total hip endoprosthesis (THEP) components in 2D Xray images. Revision surgeries of total hip arthroplasty (THA) are common procedures in orthopedics and trauma surgery. Currently, around 400.000 procedures per year are performed in the United States (US) alone. To achieve the best possible result, preoperative planning is crucial. Especially if parts of the current THEP system are to be retained.
Methods: First, a ground truth based on 76 X-ray images was created: We used an image processing pipeline consisting of a segmentation step performed by a convolutional neural network and a classification step performed by a support vector machine (SVM). In total, 11 classes (5 pans and 6 shafts) shall be classified.
Results: The ground truth generated was of good quality even though the initial segmentation was performed by technicians. The best segmentation results were achieved using a U-net architecture. For classification, SVM architectures performed much better than additional neural networks.
Conclusions: The overall image processing pipeline performed well, but the ground truth needs to be extended to include a broader variability of implant types and more examples per training class.
One of the key challenges for automatic assistance is the support of actors in the operating room depending on the status of the procedure. Therefore, context information collected in the operating room is used to gain knowledge about the current situation. In literature, solutions already exist for specific use cases, but it is doubtful to what extent these approaches can be transferred to other conditions. We conducted a comprehensive literature research on existing situation recognition systems for the intraoperative area, covering 274 articles and 95 cross-references published between 2010 and 2019. We contrasted and compared 58 identified approaches based on defined aspects such as used sensor data or application area. In addition, we discussed applicability and transferability. Most of the papers focus on video data for recognizing situations within laparoscopic and cataract surgeries. Not all of the approaches can be used online for real-time recognition. Using different methods, good results with recognition accuracies above 90% could be achieved. Overall, transferability is less addressed. The applicability of approaches to other circumstances seems to be possible to a limited extent. Future research should place a stronger focus on adaptability. The literature review shows differences within existing approaches for situation recognition and outlines research trends. Applicability and transferability to other conditions are less addressed in current work.
The scoring of sleep stages is an essential part of sleep studies. The main objective of this research is to provide an algorithm for the automatic classification of sleep stages using signals that may be obtained in a non-obtrusive way. After reviewing the relevant research, the authors selected a multinomial logistic regression as the basis for their approach. Several parameters were derived from movement and breathing signals, and their combinations were investigated to develop an accurate and stable algorithm. The algorithm was implemented to produce successful results: the accuracy of the recognition of Wake/NREM/REM stages is equal to 73%, with Cohen's kappa of 0.44 for the analyzed 19324 sleep epochs of 30 seconds each. This approach has the advantage of using the only movement and breathing signals, which can be recorded with less effort than heart or brainwave signals, and requiring only four derived parameters for the calculations. Therefore, the new system is a significant improvement for non-obtrusive sleep stage identification compared to existing approaches.
Context-aware systems to support actors in the operating room depending on the status of the intervention require knowledge about the current situation in the intra-operative area. In literature, solutions to achieve situation awareness already exist for specific use cases, but applicability and transferability to other conditions are less addressed. It is assumed that a unified solution that can be adapted to different processes and sensors would allow for greater flexibility, applicability, and thus transferability to different applications. To enable a flexible and intervention-independent system, this work proposes a concept for an adaptable situation recognition system. The system consists of four layers with several modular components for different functionalities. The feasibility is demonstrated via prototypical implementation and functional evaluation of a first basic framework prototype. Further development goal is the stepwise extension of the prototype.
In the era of precision medicine, digital technologies and artificial intelligence, drug discovery and development face unprecedented opportunities for product and business model innovation, fundamentally changing the traditional approach of how drugs are discovered, developed and marketed. Critical to this transformation is the adoption of new technologies in the drug development process, catalyzing the transition from serendipity-driven to data-driven medicine. This paradigm shift comes with a need for both translation and precision, leading to a modern Translational Precision Medicine approach to drug discovery and development. Key components of Translational Precision Medicine are multi-omics profiling, digital biomarkers, model-based data integration, artificial intelligence, biomarker-guided trial designs and patient-centric companion diagnostics. In this review, we summarize and critically discuss the potential and challenges of Translational Precision Medicine from a cross-industry perspective.
Background/Aim: The aim of this study was the conception, production, material analysis and cytocompatibility analysis of a new collagen foam for medical applications. Materials and Methods: After the innovative production of various collagen sponges from bovine sources, the foams were analyzed ex vivo in terms of their structure (including pore size) and in vitro in terms of cytocompatibility according to EN ISO 10993-5/-12. In vitro, the collagen foams were compared with the established soft and hard tissue materials cerabone and Jason membrane (both botiss biomaterials GmbH, Zossen, Germany). Results: Collagen foams with different compositions were successfully produced from bovine sources. Ex vivo, the foams showed a stable and long-lasting primary structure quality with a bubble area of 1,000 to 2,000 μm2. In vitro, all foams showed sufficient cytocompatibility. Conclusion: Collagen sponges represent a promising material for hard and soft tissue regeneration. Future studies could focus on integrating and investigating different additives in the foams.
This paper presents a generic method to enhance performance and incorporate temporal information for cardiorespiratory-based sleep stage classification with a limited feature set and limited data. The classification algorithm relies on random forests and a feature set extracted from long-time home monitoring for sleep analysis. Employing temporal feature stacking, the system could be significantly improved in terms of Cohen’s κ and accuracy. The detection performance could be improved for three classes of sleep stages (Wake, REM, Non-REM sleep), four classes (Wake, Non-REM-Light sleep, Non-REM Deep sleep, REM sleep), and five classes (Wake, N1, N2, N3/4, REM sleep) from a κ of 0.44 to 0.58, 0.33 to 0.51, and 0.28 to 0.44 respectively by stacking features before and after the epoch to be classified. Further analysis was done for the optimal length and combination method for this stacking approach. Overall, three methods and a variable duration between 30 s and 30 min have been analyzed. Overnight recordings of 36 healthy subjects from the Interdisciplinary Center for Sleep Medicine at Charité-Universitätsmedizin Berlin and Leave-One-Out-Cross-Validation on a patient-level have been used to validate the method.
Programmable nano-bio interfaces driven by tuneable vertically configured nanostructures have recently emerged as a powerful tool for cellular manipulations and interrogations. Such interfaces have strong potential for ground-breaking advances, particularly in cellular nanobiotechnology and mechanobiology. However, the opaque nature of many nanostructured surfaces makes non-destructive, live-cell characterization of cellular behavior on vertically aligned nanostructures challenging to observe. Here, a new nanofabrication route is proposed that enables harvesting of vertically aligned silicon (Si) nanowires and their subsequent transfer onto an optically transparent substrate, with high efficiency and without artefacts. We demonstrate the potential of this route for efficient live-cell phase contrast imaging and subsequent characterization of cells growing on vertically aligned Si nanowires. This approach provides the first opportunity to understand dynamic cellular responses to a cell-nanowire interface, and thus has the potential to inform the design of future nanoscale cellular manipulation technologies.
Health monitoring in a home environment can have broader use since it may provide continuous control of health parameters with relatively minor intrusiveness into regular life. This work aims to verify if it is possible to replace the typical in some sleep medicine areas subjective questioning by an objective measurement using electronic devices. For this purpose, a study was conducted with ten subjects, in which objective and subjective measurement of relevant sleep parameters took place. The results of both measurement methods were evaluated and analyzed. The results showed that while for some measures, such as Total Time in Bed, there is a high agreement between objective and subjective measurements, for others, such as sleep quality, there are significant differences. For this reason, currently, a combination of both measurement methods may be beneficial and provide the most detailed results, while a partial replacement can already reduce the number of questions at the subjective measurement by measurement through electronic devices.
Purpose
Injury or inflammation of the middle ear often results in the persistent tympanic membrane (TM) perforations, leading to conductive hearing loss (HL). However, in some cases the magnitude of HL exceeds that attributable by the TM perforation alone. The aim of the study is to better understand the effects of location and size of TM perforations on the sound transmission properties of the middle ear.
Methods
The middle ear transfer functions (METF) of six human temporal bones (TB) were compared before and after perforating the TM at different locations (anterior or posterior lower quadrant) and to different degrees (1 mm, ¼ of the TM, ½ of the TM, and full ablation). The sound-induced velocity of the stapes footplate was measured using single-point laser-Doppler-vibrometry (LDV). The METF were correlated with a Finite Element (FE) model of the middle ear, in which similar alterations were simulated.
Results
The measured and calculated METF showed frequency and perforation size dependent losses at all perforation locations. Starting at low frequencies, the loss expanded to higher frequencies with increased perforation size. In direct comparison, posterior TM perforations affected the transmission properties to a larger degree than anterior perforations. The asymmetry of the TM causes the malleus-incus complex to rotate and results in larger deflections in the posterior TM quadrants than in the anterior TM quadrants. Simulations in the FE model with a sealed cavity show that small perforations lead to a decrease in TM rigidity and thus to an increase in oscillation amplitude of the TM mainly above 1 kHz.
Conclusion
Size and location of TM perforations have a characteristic influence on the METF. The correlation of the experimental LDV measurements with an FE model contributes to a better understanding of the pathologic mechanisms of middle-ear diseases. If small perforations with significant HL are observed in daily clinical practice, additional middle ear pathologies should be considered. Further investigations on the loss of TM pretension due to perforations may be informative.
Background: One of the most promising health care development areas is introducing telemedicine services and creating solutions based on blockchain technology. The study of systems combining both these domains indicates the ongoing expansion of digital technologies in this market segment.
Objective: This paper aims to review the feasibility of blockchain technology for telemedicine.
Methods: The authors identified relevant studies via systematic searches of databases including PubMed, Scopus, Web of Science, IEEE Xplore, and Google Scholar. The suitability of each for inclusion in this review was assessed independently. Owing to the lack of publications, available blockchain-based tokens were discovered via conventional web search engines (Google, Yahoo, and Yandex).
Results: Of the 40 discovered projects, only 18 met the selection criteria. The 5 most prevalent features of the available solutions (N=18) were medical data access (14/18, 78%), medical service processing (14/18, 78%), diagnostic support (10/18, 56%), payment transactions (10/18, 56%), and fundraising for telemedical instrument development (5/18, 28%).
Conclusions: These different features (eg, medical data access, medical service processing, epidemiology reporting, diagnostic support, and treatment support) allow us to discuss the possibilities for integration of blockchain technology into telemedicine and health care on different levels. In this area, a wide range of tasks can be identified that could be accomplished based on digital technologies using blockchains.
The main aim of presented in this manuscript research is to compare the results of objective and subjective measurement of sleep quality for older adults (65+) in the home environment. A total amount of 73 nights was evaluated in this study. Placing under the mattress device was used to obtain objective measurement data, and a common question on perceived sleep quality was asked to collect the subjective sleep quality level. The achieved results confirm the correlation between objective and subjective measurement of sleep quality with the average standard deviation equal to 2 of 10 possible quality points.
The present work proposes the use of modern ICT technologies such as smartphones, NFCs, internet, and web technologies, to help patients in carrying out their therapies. The implemented system provides a calendar with a reminder of the assumptions, ensures the drug identification through NFC, allows remote assistance from healthcare staff and family members to check and manage the therapy in real-time. The system also provides centralized information on the patient's therapeutic situation, helpful in choosing new compatible therapies.
We investigated the state of artificial intelligence (AI) in pharmaceutical research and development (R&D) and outline here a risk and reward perspective regarding digital R&D. Given the novelty of the research area, a combined qualitative and quantitative research method was chosen, including the analysis of annual company reports, investor relations information, patent applications, and scientific publications of 21 pharmaceutical companies for the years 2014 to 2019. As a result, we can confirm that the industry is in an ‘early mature’ phase of using AI in R&D. Furthermore, we can demonstrate that, despite the efforts that need to be managed, recent developments in the industry indicate that it is worthwhile to invest to become a ‘digital pharma player’.
It has been widely shown that biomaterial surface topography can modulate host immune response, but a fundamental understanding of how different topographies contribute to pro-inflammatory or anti-inflammatory responses is still lacking. To investigate the impact of surface topography on immune response, we undertook a systematic approach by analyzing immune response to eight grades of medical grade polyurethane of increasing surface roughness in three in vitro models of the human immune system. Polyurethane specimens were produced with defined roughness values by injection molding according to the VDI 3400 industrial standard. Specimens ranged from 0.1 μm to 18 μm in average roughness (Ra), which was confirmed by confocal scanning microscopy. Immunological responses were assessed with THP-1-derived macrophages, human peripheral blood mononuclear cells (PBMCs), and whole blood following culture on polyurethane specimens. As shown by the release of pro-inflammatory and anti-inflammatory cytokines in all three models, a mild immune response to polyurethane was observed, however, this was not associated with the degree of surface roughness. Likewise, the cell morphology (cell spreading, circularity, and elongation) in THP-1-derived macrophages and the expression of CD molecules in the PBMC model on T cells (HLA-DR and CD16), NK cells (HLA-DR), and monocytes (HLA-DR, CD16, CD86, and CD163) showed no influence of surface roughness. In summary, this study shows that modifying surface roughness in the micrometer range on polyurethane has no impact on the pro-inflammatory immune response. Therefore, we propose that such modifications do not affect the immunocompatibility of polyurethane, thereby supporting the notion of polyurethane as a biocompatible material.
The recovery of our body and brain from fatigue directly depends on the quality of sleep, which can be determined from the results of a sleep study. The classification of sleep stages is the first step of this study and includes the measurement of vital data and their further processing. The non-invasive sleep analysis system is based on a hardware sensor network of 24 pressure sensors providing sleep phase detection. The pressure sensors are connected to an energy-efficient microcontroller via a system-wide bus. A significant difference between this system and other approaches is the innovative way in which the sensors are placed under the mattress. This feature facilitates the continuous use of the system without any noticeable influence on the sleeping person. The system was tested by conducting experiments that recorded the sleep of various healthy young people. Results indicate the potential to capture respiratory rate and body movement.
Methods based exclusively on heart rate hardly allow to differentiate between physical activity, stress, relaxation, and rest, that is why an additional sensor like activity/movement sensor added for detection and classification. The response of the heart to physical activity, stress, relaxation, and no activity can be very similar. In this study, we can observe the influence of induced stress and analyze which metrics could be considered for its detection. The changes in the Root Mean Square of the Successive Differences provide us with information about physiological changes. A set of measurements collecting the RR intervals was taken. The intervals are used as a parameter to distinguish four different stages. Parameters like skin conductivity or skin temperature were not used because the main aim is to maintain a minimum number of sensors and devices and thereby to increase the wearability in the future.
The ballistocardiography is a technique that measures the heart rate from the mechanical vibrations of the body due to the heart movement. In this work a novel noninvasive device placed under the mattress of a bed estimates the heart rate using the ballistocardiography. Different algorithms for heart rate estimation have been developed.
Artificial intelligence (AI) technologies, such as machine learning or deep learning, have been predicted to highly impact future organizations and radically change the way how projects are managed. The Project Management Institute (PMI), the network of around 1.1 million certified project managers, ranked AI as one of the top three disruptors of their profession. In an own study on the effect of AI, 37% of the project management processes can be executed by machine learning and other AI technologies. In addition, Gartner recently postulated that 80% of the work of today's project managers may be eliminated by AI in 2030.
This editorial aims to outline today's project and portfolio management in context of pharmaceutical research and development (R&D), followed by an AI-vision and a more tangible mission, and illustrate what the consequences of an AI-enabled project and portfolio management could be for pharmaceutical R&D.