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Cybersecurity in Health Care
(2020)
Ethical questions have always been crucial in health care; the rapid dissemination of ICT makes some of those questions even more pressing and also raises new ones. One of these new questions is cybersecurity in relation to ethics in health care. In order to more closely examine this issue, this chapter introduces Beauchamp and Childress’ four principles of biomedical ethics as well as additional ethical values and technical aims of relevance for health care. Based on this, two case studies—implantable medical devices and electronic Health Card—are presented, which illustrate potential conflicts between ethical values and technical aims as well as between ethical values themselves. It becomes apparent that these conflicts cannot be eliminated in general but must be reconsidered on a case-by-case basis. An ethical debate on cybersecurity regarding the design and implementation of new (digital) technologies in health care is essential.
This article highlights methodological and ethical challenges in research with adults of older and oldest age, by presenting field experiences of the current research project “Motion Monitoring of Geriatric Trauma Patients - Explorative Study on the Rehabilitation Process after Hip Fracture Using Sensor-based Data”. Depiction of the survey situation, with regard to the subjects in particular, can serve as practical examples for designing future research projects.
The group of older adults is a rather large and growing group for which research is required, especially concerning their heterogeneity, their individual autonomy and quality of life. It is assumed, that research designs of studies on the target group must be specifically adjusted, in particular when considering the attribution of vulnerability of the group members. At the same time, it is not clear yet what exact specifics of the subjects and target group must be considered in research designs, as surprisingly little is known about the target group as subjects and corresponding theories have been insufficiently tested.
The exploratory long-term design of the research project presented in the second section of this chapter has a positive evaluation of an ethics committee. Still ethical challenges occurred in the field situation, that are illustrated in the third section of this chapter, by providing information on the patients, their role as research subjects, how they were recruited, how an informed consensus was reached, and in some cases how participation was rejected or abandoned. After a summary, the end of the paper is marked by recommendations on how to design future research projects.
Cumulatively it must always be expected that interaction between researchers and research subjects of this target group can become very intensive, what requires to follow clearly defined procedures and at the same time to be prepared to act flexibly.
Bioresorbable materials are under investigation due to their promising properties for applications as implant material. This study is about the degradation and bioactivity behaviour of magnesium foils, which allegorize dental membranes. The degradation behaviour including pitting corrosion during immersion tests can be precisely observed using micro-computed tomography. Using the bioactivity test according to Kokubo, it is shown that magnesium has strong Ca-phosphate layer formation correlated with high degradation. Therefore, magnesium foils appear to hold a great potential for bone implant application.
Background: This preparatory study accelerates an implementation of individualized monitoring and feedback of physical motion using conventional motion trackers in the rehabilitation process of geriatric trauma patients. Regaining mobility is accompanied with improved quality of life in persons of very advanced age recovering from fragility fractures.
Objectives: Quantitative survey of regaining physical mobility provides recommendations for action on how to use motion trackers effectively in a clinical geriatric setting.
Methods: Method mix of quantitative and qualitative interdisciplinary and mutual complementary research approaches (sociology, health research, philosophy/ethics, medical informatics, nursing science, gerontology and physical therapy). While validating motion tracker use in geriatric traumatology preliminary data are used to develop a target group oriented motion feedback. In addition measurement accuracy of a questionnaire about quality of life of multimorbid geriatric patients (FLQM) is tested.
Conclusion: Implementing a new technology in a complex clinical setting needs to be based on a strong theoretical background but will not succeed without careful field testing.
With examples concerning the development and dissemination of computer technology in the Soviet Union, the U.S., and other Western countries it shall be demonstrated that computer development on the one hand
and social change as well as changes in policy making and administration on the other hand are mingled with each other without a clear direction of causation being discernible.It also shall be shown that perceived social and political threats imposed by early computer technology sometimes actually helped to stop or at least slow down social change.
One conclusion that can be drawn from the case studies described for RRI is that the conscious steering of innovations fails because of diffuse and uncoordinated resistance from very different stakeholders. The case studies also suggest that the effectiveness of RRI might be rather limited.
Mg and Mg alloys are becoming more and more of interest for several applications. In the case of biomaterial applications, a special interest exists due to the fact that a predictable degradation should be given. Various investigations were made to characterize and predict the corrosion behavior in vitro and in vivo. Mostly, the simple oxidation of Mg to Mg2+ ions connected with adequate hydrogen development is assumed, and the negative difference effect (NDE) is attributed to various mechanisms and electrochemical results. The aim of this paper is to compare the different views on the corrosion pathway of Mg or Mg alloys and to present a neglected pathway based on thermodynamic data as a guideline for possible reactions combined with experimental observations of a delay of visible hydrogen evolution during cyclic voltammetry. Various reaction pathways are considered and discussed to explain these results, like the stability of the Mg+ intermediate state, the stability of MgH2 and the role of hydrogen overpotential. Finally, the impact of MgH2 formation is shown as an appropriate base for the prediction of the degradation behavior and calculation of the corrosion rate of Mg and Mg alloys.
Background
Breast reconstruction is an important coping tool for patients undergoing a mastectomy. There are numerous surgical techniques in breast reconstruction surgery (BRS). Regardless of the technique used, creating a symmetric outcome is crucial for patients and plastic surgeons. Three-dimensional surface imaging enables surgeons and patients to assess the outcome’s symmetry in BRS. To discriminate between autologous and alloplastic techniques, we analyzed both techniques using objective optical computerized symmetry analysis. Software was developed that enables clinicians to assess optical breast symmetry using three-dimensional surface imaging.
Methods
Twenty-seven patients who had undergone autologous (n = 12) or alloplastic (n = 15) BRS received three-dimensional surface imaging. Anthropomorphic data were collected digitally using semiautomatic measurements and automatic measurements. Automatic measurements were taken using the newly developed software. To quantify symmetry, a Symmetry Index is proposed.
Results
Statistical analysis revealed that there is no dif- ference in the outcome symmetry between the two groups (t test for independent samples; p = 0.48, two-tailed).
Conclusion
This study’s findings provide a foundation for qualitative symmetry assessment in BRS using automatized digital anthropometry. In the present trial, no difference in the outcomes’ optical symmetry was detected between autologous and alloplastic approaches.
We have developed a novel, computer-assisted operation method for minimal-invasive total hip replacement (THR) following the concept of “femur first/combined anteversion,” which incorporates various aspects of performing a functional optimization of the prosthetic stem and cup position (CAS FF). The purpose of this study is to assess whether the hip joint reaction forces and patient’s gait parameters are being improved by CAS FF in relation to conventional THR (CON). We enrolled 60 patients (28 CAS FF/32 CON) and invited them for gait analysis at three time points (preoperatively, postop six months, and postop 12 months). Data retrieved from gait analysis was processed using patient-specific musculoskeletal models. The target parameters were hip reaction force magnitude (hrf), symmetries, and orientation with respect to the cup. Hrf in the CAS FF group were closer to a young healthy normal. Phase-shift symmetry showed an increase in the CAS FF group. Hrf orientation in the CAS FF group was closer to optimum, though no edge or rim-loading occurred in the CON group as well. The CAS FF group showed an improved hrf orientation in an early stage and a trend to an improved long-term outcome.
In-stent restenosis remains a major problem of arteriosclerosis treatment by stenting. Expansion-optimized stents could reduce this problem. With numerical simulations, stent designs/ expansion behaviours can be effectively analyzed. For reasons of efficiency, simplified models of balloon-expandable stents are often used, but their accuracy must be challenged due to insufficient experimental validation. In this work, a realistic stent life-cycle simulation has been performed including balloon folding, stent crimping and free expansion of the balloon-stent-system. The successful simulation and validation of two stent designs with homogenous and heterogeneous stent stiffness and an asymmetrically positioned stent on the balloon catheter confirm the universal applicability of the simulation approach. Dogboning ratio, as well as the final dimensions of the folded balloon, the crimped and expanded stent, correspond well to the experimental dimensions with only slight deviations. In contrast to the detailed stent life-cycle simulation, a displacement-controlled simulation can not predict the transient stent expansion, but is suitable to reproduce the final expanded stent shape and the associated stress states. The detailed stent life-cycle simulation is thus essential for stent expansion analysis/optimization, whereas for reasons of computational efficiency, the displacement-controlled approach can be considered in the context of pure stress analysis.
Finite element (FE)–based studies of preoperative processes such as folding,pleating, and stent crimping with a comparison with experimental inflation tests are not yet available. Therefore, a novel workflow is presented in which residual stresses of balloon folding and pleating, as well as stent crimping, and the geometries of all contact partners were ultimately implemented in an FE code to simulate stent expansion by using an implicit solver. The numerical results demonstrate that the incorporation of residual stresses and strains experienced during the production step significantly increased the accuracy of the subsequent simulations, especially of the stent expansion model. During the preoperative processes, stresses inside the membrane and the stent material also reached a rather high level. Hence, there can be no presumption that balloon catheters or stents are undamaged before the actual surgery. The implementation of the realistic geometry, in particular the balloon tapers, and the blades of the process devices improved the simulation of the expansion mech-anisms, such as dogboning, concave bending, or overexpansion of stent cells. This study shows that implicit solvers are able to precisely simulate the mentioned preoperative processes and the stent expansion procedure without a preceding manipulation of the simulation time or physical mass.
Document recommendation systems for locating relevant literature have mostly relied on methods developed a decade ago. This is largely due to the lack of a large offline gold-standard benchmark of relevant documents that cover a variety of research fields such that newly developed literature search techniques can be compared, improved and translated into practice. To overcome this bottleneck, we have established the RElevant LIterature SearcH consortium consisting of more than 1500 scientists from 84 countries, who have collectively annotated the relevance of over 180 000 PubMed-listed articles with regard to their respective seed (input) article/s. The majority of annotations were contributed by highly experienced, original authors of the seed articles. The collected data cover 76% of all unique PubMed Medical Subject Headings descriptors. No systematic biases were observed across different experience levels, research fields or time spent on annotations. More importantly, annotations of the same document pairs contributed by different scientists were highly concordant. We further show that the three representative baseline methods used to generate recommended articles for evaluation (Okapi Best Matching 25, Term Frequency–Inverse Document Frequency and PubMed Related Articles) had similar overall performances. Additionally, we found that these methods each tend to produce distinct collections of recommended articles, suggesting that a hybrid method may be required to completely capture all relevant articles. The established database server located at https://relishdb.ict.griffith.edu.au is freely available for the downloading of annotation data and the blind testing of new methods. We expect that this benchmark will be useful for stimulating the development of new powerful techniques for title and title/abstract-based search engines for relevant articles in biomedical research.
Based on previous work by our group with manual annotation of visible Barrett oesophagus (BE) cancer images, a real-time deep learning artificial intelligence (AI) system was developed. While an expert endoscopist conducts the endoscopic assessment of BE, our AI system captures random images from the real-time camera livestream and provides a global prediction (classification), as well as a dense prediction (segmentation) differentiating accurately between normal BE and early oesophageal adenocarcinoma (EAC). The AI system showed an accuracy of 89.9% on 14 cases with neoplastic BE.
The growing number of publications on the application of artificial intelligence (AI) in medicine underlines the enormous importance and potential of this emerging field of research.
In gastrointestinal endoscopy, AI has been applied to all segments of the gastrointestinal tract most importantly in the detection and characterization of colorectal polyps. However, AI research has been published also in the stomach and esophagus for both neoplastic and non-neoplastic disorders.
The various technical as well as medical aspects of AI, however, remain confusing especially for non-expert physicians.
This physician-engineer co-authored review explains the basic technical aspects of AI and provides a comprehensive overview of recent publications on AI in gastrointestinal endoscopy. Finally, a basic insight is offered into understanding publications on AI in gastrointestinal endoscopy.
Background: For surgical fixation of bone fractures of the human hand, so-called Kirschner-wires (K-wires) are drilled through bone fragments. Due to the minimally invasive drilling procedures without a view of risk structures like vessels and nerves, a thorough training of young surgeons is necessary. For the development of a virtual reality (VR) based training system, a three-dimensional (3D) printed phantom hand is required. To ensure an intuitive operation, this phantom hand has to be realistic in both, its position relative to the driller as well as in its haptic features. The softest 3D printing material available on the market, however, is too hard to imitate human soft tissue. Therefore, a support-material (SUP) filled metamaterial is used to soften the raw material. Realistic haptic features are important to palpate protrusions of the bone to determine the drilling starting point and angle. An optical real-time tracking is used to transfer position and rotation to the training system.
Methods: A metamaterial already developed in previous work is further improved by use of a new unit cell. Thus, the amount of SUP within the volume can be increased and the tissue is softened further. In addition, the human anatomy is transferred to the entire hand model. A subcutaneous fat layer and penetration of air through pores into the volume simulate shiftability of skin layers. For optical tracking, a rotationally symmetrical marker attached to the phantom hand with corresponding reference marker is developed. In order to ensure trouble-free position transmission, various types of marker point applications are tested.
Results: Several cuboid and forearm sample prints lead to a final 30 centimeter long hand model. The whole haptic phantom could be printed faultless within about 17 hours. The metamaterial consisting of the new unit cell results in an increased SUP share of 4.32%. Validated by an expert surgeon study, this allows in combination with a displacement of the uppermost skin layer a good palpability of the bones. Tracking of the hand marker in dodecahedron design works trouble-free in conjunction with a reference marker attached to the worktop of the training system.
Conclusions: In this work, an optically tracked and haptically correct phantom hand was developed using dual-material 3D printing, which can be easily integrated into a surgical training system.
A key requirement in both native knee joints and total knee arthroplasty is a stable capsular ligament complex. However, knee stability is highly individual and ranges from clinically loose to tight. So far, hardly any in vivo data on the intrinsic mechanical of the knee are available. This study investigated if stiffness of the native ligament complex may be determined in vivo using a standard knee balancer. Measurements were obtained with a commercially available knee balancer, which was initially calibrated in vitro. 5 patients underwent reconstruction of the force-displacement curves of the ligament complex. Stiffness of the medial and lateral compartments were calculated to measure the stability of the capsular ligament complex. All force-displacement curves consisted of a non-linear section at the beginning and of a linear section from about 80 N onwards. The medial compartment showed values of 28.4 ± 1.2 N/mm for minimum stiffness and of 39.9 ± 1.1 N/mm for maximum stiffness; the respective values for the lateral compartment were 19.9 ± 0.9 N/mm and 46.6 ± 0.8 N/mm. A commercially available knee balancer may be calibrated for measuring stiffness of knee ligament complex in vivo, which may contribute to a better understanding of the intrinsic mechanical behaviour of knee joints.
Background
There is a wide range of mechanical properties of spinal ligaments documented in literature. Due to the fact that ligaments contribute in stabilizing the spine by limiting excessive intersegmental motion, those properties are of particular interest for the implementation in musculoskeletal models. The aim of this study was to investigate the effect of varying ligament stiffness on the kinematic behaviour of the lumbar spine.
Methods
A musculoskeletal model with a detailed lumbar spine was modified according to fluoroscopic recordings and corresponding data files of three different subjects. For flexion, inverse dynamics analysis with a variation of the ligament stiffness matrix were conducted. The influence of several degrees of ligament stiffness on the lumbar spine model were investigated by tracking ligament forces, disc forces and resulting moments generated by the ligaments. Additionally, the kinematics of the motion segments were evaluated.
Results
An increase of ligament stiffness resulted in an increase of ligament and disc forces, whereas the relative change of disc force increased at a higher rate at the L4/L5 level (19 %) than at the L3/L4 (10 %) level in a fully flexed posture. The same behaviour applied to measured moments with 67 % and 45 %. As a consequence, the motion deflected to the lower levels of the lumbar spine and the lower discs had to resist an increase in loading.
Conclusions
Higher values of ligament stiffness over all lumbar levels could lead to a shift of the loading and the motion between segments to the lower lumbar levels. This could lead to an increased risk for the lower lumbar parts.
Background
Iliac crest bone harvesting is a frequently performed surgical procedure widely used to treat bone defects. The objective of this study is to assess the biomechanical quantities related to risk for pelvic fracture after harvesting an autologous bone graft at the anterior iliac crest.
Methods
Finite element models with a simulated harvest site (sized 15 × 20 mm, 15 × 35 mm, 30 × 20 mm and 30 × 35 mm) in the iliac wing are created. The relevant loading case is when the ipsilateral leg is lifted off the ground. Musculoskeletal analysis is utilized to compute the muscle and joint forces involved in this motion. These forces are used as boundary conditions for the finite element analyses. Bone tissue stress is analyzed.
Results
Critical stress peaks are located between the anterior superior iliac spine (ASIS) and the anterior edge of the harvest site. Irrespective of the graft size, the iliac wing does not show any significant stress peaks with the harvest site being 20 to 25 mm posterior to the ASIS. The harvest area itself inhibits the distribution of the forces applied on the ASIS to extend to the posterior iliac wing. This leads to a lack of stress posterior to the harvest site. A balanced stress distribution with no stress peaks appears when the bone graft is taken below the iliac crest.
Conclusion
A harvest site located at least 20 to 25 mm posterior to the ASIS should be preferred to minimize the risk of iliac fatigue fracture.
Companies use special designed flow shops, in order to satisfy specific demands. Products need to be transported (from one station to the next station) by a crane and the way of working of this crane excludes the intermediate storage (of a work piece). In addition, the way of working restricts the set of feasible schedules even more than the no-buffer restriction discussed in the literature in the case of limited storage. Since this scheduling problem is integrated in the usual hierarchical planning, the tardiness is minimised. A linear optimisation model is presented to provide a formal description of this NP-hard problem. It is also used to explain the performance of priority rule based heuristic solutions on small test problems. In detail, priority rules as well as a priority rule based branch and bound procedure are analysed; priority rules are regarded, because a priority rule is still the standard procedure for on-line scheduling in industrial practise. Out of successful priority rules in the literature the best one is identified by an extensive simulative investigation. An improved look-ahead is realised by a restricted search over all possible schedules.
Folgender Beitrag untersucht die Notwendigkeit einer Berücksichtigung von Mitarbeiterauslastungen und davon abhängiger Bearbeitungszeiten in der Hauptproduktionsprogrammplanung. Zudem wird aufgezeigt, dass dieses Themengebiet aktuell eine Forschungslücke darstellt. Aus diesem Grund wird ein selbst entwickeltes lineares Optimierungsmodell für die Hauptproduktionsprogrammplanung vorgestellt, welches soziale Kriterien und eine geeignete Fallstudie enthält. Die Ergebnisse verdeutlichen, dass erhebliche Abweichungen durch eine Ignoranz von Mitarbeiterauslastungen und davon abhängiger Bearbeitungszeiten entstehen. Deshalb ist eine Integration zu empfehlen. Allerdings wird auch deutlich, dass weitere Forschungen notwendig sind, speziell für die Bestimmung geeigneter Erschöpfungsfunktionen, so wie beispielsweise Funktionen für Lerneffekte existieren.
In diesem Beitrag wird anhand einer Fallstudie die Bedeutung der Hauptproduktionsprogrammplanung (HPPLAN) für die hierarchische Produktionsplanung herausgearbeitet werden. Dazu wird versucht das Ergebnis der aggregierten Gesamtplanung (AGGRPLAN) durch Veränderung einzelner Paramater so zu verbessern, dass es dem Ergebnis der HPPLAN entspricht. Im Rahmen der Untersuchungen konnten dabei Verbesserungen für einzelne Planungssituationen erzielt werden, eine generelle Lösung konnte jedoch nicht gefunden werden. Insbesondere der Einsatz eines geeigneten Kapazitätsreduktionsfaktors in Verbindung mit der Berücksichtigung der Durchlaufzeit führt zu einer Verbesserung der Lösung. Bei der Planung von mehr als einem Produkt ist allerdings schwierig einen geeigneten Kapazitätsreduktionsfaktor zu finden, da dieser abhängig von der Nachfrage ist.
Companies often use specially-designed production systems and change them from time to time. They produce small batches in order to satisfy specific demands with the least tardiness. This imposes high demands on high-performance scheduling algorithms which can be rapidly adapted to changes in the production system. As a solution, this paper proposes a generic approach: solutions were obtained using a widely-used commercially-available tool for solving linear optimization models, which is available in an Enterprise Resource Planning System (in the SAP system for example) or can be connected to it. In a real-world application of a flow shop with special restrictions this approach is successfully used on a standard personal computer. Thus, the main implication is that optimal scheduling with a commercially-available tool, incorporated in an Enterprise Resource Planning System, may be the best approach.
In this paper, the risks of a Smart Factory are to be examined and structured in order to be able to evaluate the status of the Smart Factory. This thesis thus serves as an overview of the technical components of a Smart Factory and the associated risks. The study takes a holistic view of the smart factory. The results show that the greatest need for action lies in the technological field. Thus, the topics of standardization, information security, availability of IT infrastructure, availability of fast internet and complex systems were prioritized. The organizational and financial risks, which also play an important role in a Smart Factory transformation, are addressed.
Backround
Scaphoidectomy and midcarpal fusion can be performed using traditional fixation methods like K-wires, staples, screws or different dorsal (non)locking arthrodesis systems. The aim of this study is to test the Aptus four corner locking plate and to compare the clinical findings to the data revealed by CT scans and semi-automated segmentation.
Methods:
This is a retrospective review of eleven patients suffering from scapholunate advanced collapse (SLAC) or scaphoid non-union advanced collapse (SNAC) wrist, who received a four corner fusion between August 2011 and July 2014. The clinical evaluation consisted of measuring the range of motion (ROM), strength and pain on a visual analogue scale (VAS). Additionally, the Disabilities of the Arm, Shoulder and Hand (QuickDASH) and the Mayo Wrist Score were assessed. A computerized tomography (CT) of the wrist was obtained six weeks postoperatively. After semi-automated segmentation of the CT scans, the models were post processed and surveyed.
Results
During the six-month follow-up mean range of motion (ROM) of the operated wrist was 60°, consisting of 30° extension and 30° flexion. While pain levels decreased significantly, 54% of grip strength and 89% of pinch strength were preserved compared to the contralateral healthy wrist. Union could be detected in all CT scans of the wrist. While X-ray pictures obtained postoperatively revealed no pathology, two user related technical complications were found through the 3D analysis, which correlated to the clinical outcome.
Conclusion
Due to semi-automated segmentation and 3D analysis it has been proved that the plate design can keep up to the manufacturers’ promises. Over all, this case series confirmed that the plate can compete with the coexisting techniques concerning clinical outcome, union and complication rate.
Background: Currently, it is common practice to use three-dimensional (3D) printers not only for rapid prototyping in the industry, but also in the medical area to create medical applications for training inexperienced surgeons. In a clinical training simulator for minimally invasive bone drilling to fix hand fractures with Kirschner-wires (K-wires), a 3D-printed hand phantom must not only be geometrically but also haptically correct. Due to a limited view during an operation, surgeons need to perfectly localize underlying risk structures only by feeling of specific bony protrusions of the human hand.
Methods: The goal of this experiment is to imitate human soft tissue with its haptic and elasticity for a realistic hand phantom fabrication, using only a dual-material 3D printer and support-material-filled metamaterial between skin and bone. We present our workflow to generate lattice structures between hard bone and soft skin with iterative cube edge (CE) or cube face (CF) unit cells. Cuboid and finger shaped sample prints with and without inner hard bone in different lattice thickness are constructed and 3D printed.
Results: The most elastic available rubber-like material is too firm to imitate soft tissue. By reducing the amount of rubber in the inner volume through support material (SUP), objects become significantly softer. Without metamaterial, after disintegration, the SUP can be shifted through the volume and thus the body loses its original shape. Although the CE design increases the elasticity, it cannot restore the fabric form. In contrast to CE, the CF design increases not only the elasticity but also guarantees a local limitation of the SUP. Therefore, the body retains its shape and internal bones remain in its intended place. Various unit cell sizes, lattice thickening and skin thickness regulate the rubber material and SUP ratio. Test prints with higher SUP and lower rubber material percentage appear softer and vice versa. This was confirmed by an expert surgeon evaluation. Subjects adjudged pure rubber-like material as too firm and samples only filled with SUP or lattice structure in CE design as not suitable for imitating tissue. 3D-printed finger samples in CF design were rated as realistic compared to the haptic of human tissue with a good palpable bone structure.
Conclusions: We developed a new dual-material 3D print technique to imitate soft tissue of the human hand with its haptic properties. Blowy SUP is trapped within a lattice structure to soften rubber-like 3D print material, which makes it possible to reproduce a realistic replica of human hand soft tissue.