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Building safe computer-controlled systems.

Software safety becomes an issue when life-critical systems are built with computers as important components. In order to make these systems safe, software developers have concentrated on making them ultrareliable. Unfortunately, this will not necessarily make them safe. This paper discusses why reliability enhancement techniques are not adequate to ensure safety and describes what needs to be done to protect life and property in these systems.

Computers↗

Computerised method for acquisition and display of gastrointestinal motility data.

A computerised system is developed for the acquisition and display of gastrointestinal motility data which utilises a purpose developed software program called 'PC-motil', running on an IBM compatible microcomputer. 'PC-motil' displays data during collection, writes data to disk file and compresses all data at the end of a study on to a single monitor screen for convenient overview. Any area of interest, in single or multiple channels, may be selected and expanded for detailed examination. This system is tested by the recording of gastric and jejunal motility patterns of 11 healthy volunteers in fasting and fed states. All antral and jejunal migrating motor complexes (MMCs) in fasting studies, as well as all fed motility patterns were recognisable in both 'compressed' and 'expanded' form. The reproduction of motility patterns by the computer based system was indistinguishable from that of a conventional analogue chart recorder. This computerised system provides a convenient and cost-effective means of acquisition, storage and display of motility data in digital form.

Adult↗

[Possibilities of an open magnetic resonance scanner integration in therapy simulation and three-dimensional radiotherapy planning].

PURPOSE: A system for digital integration of an open MR scanner (0.23 T, Figure 1) in therapy simulation and 3D radiation treatment planning is described. METHOD: MR images were acquired using the body coil and various positioning and immobilization aids. A gradient echo sequence (TR/TE 320 ms/24 ms) was used to create axial and coronal data sets. Image distortions were measured and corrected using phantom measurements (Figure 2) and specially developed software. RESULTS: Maximal and mean distortions of the MR images could be reduced from 19 mm to 8.2 mm and from 2.7 mm to 0.7 mm, respectively (Figure 3 to 5, Table 1). Coronal MR images were recalculated in fan beam projection for use at the therapy simulator. Tumor and organ contours were transferred from the MR image to the digitally acquired and corrected simulator image using a landmark matching algorithm (Figure 6 and 7). For 3D treatment planning, image fusion of axial MR images with standard CT planning images was performed using a landmark matching algorithm, as well (Figure 8). Representative cases are shown to demonstrate potential applications of the system. CONCLUSION: The described system enables the integration of the imaging information from an open MR system in therapy simulation and 3D treatment planning. The low-field MR scanner is an attractive adjunct for the radio-oncologist because of the open design and the low costs.

Algorithms↗

[First annual report of practitioners of interventional cardiology in private practice in Germany. Results of procedures of left heart catheterization and coronary interventions in the year 1996].

The German Society for Cardiac Angiography and Interventions in Private Practice has started a registry of cardiac procedures since 1996 in order to establish a standard for performance. Although quality management for the cath lab makes sense and is also legally required, there is no generally recommended infrastructure for quality assurance existing in Germany at this time. Therefore, the German Society of Cardiologists in Private Practice (BNK) initiated a project in 1994 to develop a computer program for paperless documentation of diagnostic cardiac catheterizations and coronary interventions (PTCA) using a minimal data set. In 1996, 8 private associated groups participated in this project. The (anonymous) analysis of 10,316 diagnostic cardiac catheterizations and 2597 PTCA yielded the following results: In 95% of the patients, diagnostic cardiac catheterization was performed using the femoral and in 5% the brachial/radial approach. The mean volume of administered contrast medium was 164 +/- 138 ml/patient. The mean LV-EF was greater than 50% in 58.4% of the patients and between 30% and 50% in 10.1%. Coronary artery disease was diagnosed in 69.6% of the patients and valvular/congenital heart disease in 8.5%. In 18.4% of the patients undergoing diagnostic cardiac catheterizations no significant heart disease was identified. Mortality in the cath lab as well as the rate of cerebral insults was 0.05%. In 22.9% and 19% of the patients PTCA and cardiac surgery respectively was recommended. In patients undergoing PTCA, stable angina was present in 74.4% and unstable angina in 13.1%. Of the total number of PTCA procedures, 5.8% were performed in the setting of acute myocardial infarction. The PTCA lesion success rate was 96%, the mean diameter stenosis was 81% pre and 6% post-intervention. The mortality rate at 1 month post-PTCA was 0.4%, and myocardial infarction 1.0%. An acute occlusion occurred in 1.3% of the PTCA patients; 0.6% had to be transferred for emergency bypass surgery. None of the cath labs had on-site surgery. In comparison to other registries, our data show some similarities but also some different trends. Thus, our newly developed software proved to be reliable, fast and easy to use. Participating centers receive immediate feedback regarding their position within the whole group.

Angiocardiography↗

Functional improvement of the mandibular neuromuscular guidance by orthodontic-surgical treatment.

The primary aim of the study was to reveal whether adult patients with skeletal mandibular retrognathism combined with a dental Class II relationship without craniomandibular pain show a characteristic pattern of free mandibular movements compared to patients with a Class I skeletal and dental morphology. The secondary aim was to investigate whether these characteristic structures are subject to change following combined orthodontic-surgical treatment. Free mandibular movements were measured with an ultrasound device and analyzed with computer software developed by the authors. In all patients examined, 2 maxillarily and mandibularly fixed axes were found. These axes have no direct relation to the temporomandibular joints, are positioned above and anterior to the joints and maintain a constant distance. This gear system is referred to as a neuromuscularly determined dimeric link chain. The position of the mandible is defined by the rotational angle mu and the inclination angle alpha around the axes of the dimeric link chain. This dimeric link chain of free movements of patients with Class I skeletal and dental relationship functions according to the principle of least action: The angular velocities around the 2 axes show a constant ratio within the different segments of motion, and in the mu-alpha diagrams the segments of mandibular movements are represented by straight lines, the shortest paths between 2 positions. Individual cases and statistical data show that the structure of mandibular movements of patients with skeletal mandibular retrognathism combines with a dental Class II relationship without craniomadibular pain differs significantly from that of patients with Class I alignment. Mandibular retrognathism and a Class II relationship are accompanied by marked coordination disturbances in the rotary movements around the maxillary and mandibular neuromuscular axes. Following orthodontic-surgical treatment to restore ideal alignment of the occlusal, articular, and skeletal structures, the patients showed a similar pattern in the structure of mandibular movements to that of patients with Class I sketal and dental relationships. Thus, combined orthodontic-surgical treatment leads to measurable functional hamonization not only of the skeletal and dental structures but also of the neuromuscular guidance system.

Adult↗

[Navigated reposition of transverse acetabulum fractures. A precision analysis].

Up to now navigated reduction control based on computed tomography (CT) image data could not be used commercially. With newly developed software, a transverse fracture of the acetabulum was reduced with navigation control in a laboratory test. The results were compared to visual and tactile control in a foam pelvis and specimen. Measurements were done with another magnet-based navigation system. The residual dislocation was measured with translation (mm) and rotation (degrees). Compared with visually controlled reduction, navigated reduction led to a residual dislocation of 0.7 mm and 0.9 degrees. Navigated reduction based on CT image data is also accurate for reduction of joint fractures under laboratory conditions. Further improvements of the software are planned for later in vivo use.

Acetabulum↗

[Development and validation of the Visual Analogue Scale (VAS) Spine Score].

The aim of the study was the development and validation of a new subjective rating scale for assessment of outcome in patients with thoracolumbar fractures and fracture dislocations. The VAS spine score consists of 19 score items, using 100-mm visual analogue scales. The items are answered by the patients independently of rater assessment. To measure the analogue scales and calculate the score, a computer-aided system was evolved consisting of self-developed software and digitizer board. The overall score is the mean of all items answered with values between 0 and 100. The individual score loss is calculated as the difference between the preinjury score and at follow-up with values between 0 and 100. The VAS spine score was tested for reliability with a group of 136 healthy volunteers. We performed a test-retest study with an interval of 24 h. For statistical analysis of the validity, we prospectively followed a group of 53 patients with the new outcome score. We chose patients with injuries of the thoracolumbar spine, all having been operatively treated by combined posterior-anterior stabilization and fusion between 1994 and 1996. In the reference group, the average test score was 91.95 (58-100) and 92.10 (58-100) at retest. The mean individual difference between test and retest scored 1.037 (0-8). A high reliability was proved by a strong correlation with a coefficient of 0.976 (p < 0.001). A high internal consistency of the VAS spine score was shown by a Cronbach-alpha of 0.9117. The mean score for the preinjury status of the patients was comparable to the reference group, amounting to 89.60 (21-100). The mean score at the time of implant removal was significantly (p < 0.001) decreased to 58.25 (13-97). Until the time of follow-up a significant (p < 0.001) increase was noted, and the group scored 66.08 (15-100) at follow-up. This was a significant (p < 0.001) difference compared with the preinjury status. The individual score loss averaged 24.1 (0-80). In the patient group we also noted a Cronbach-alpha > 0.95, indicating a high internal consistency. With the VAS spine score the authors have inaugurated a new tool for outcome measurement in the treatment of patients with thoracolumbar injuries. The study has proved the score to be both reliable and valid. The application of the score is helpful in analyzing the subjective outcome, and the results can be correlated with objective measures. The score is a useful tool for comparative clinical studies, addressing the outcome after different methods of treatment.

Adult↗

Diagnosis-related frequency of compulsory measures in 10 German psychiatric hospitals and correlates with hospital characteristics.

OBJECTIVE: To investigate the incidence of coercive measures in standard psychiatric care in different psychiatric hospitals. METHODS: We developed a common documentation of mechanical restraint, seclusion, and medication by coercion, and introduced it in 10 participating hospitals. We developed software able to process the data and to calculate four key indicators for routine clinical use. RESULTS: 9.5% of 36,690 cases treated in 2004 were exposed to coercive measures with the highest percentage among patients with organic psychiatric disorders (ICD-10 F0) (28.0%). Coercive measures were applied a mean 5.4 times per case and lasted a mean 9.7 h each. The incidence and duration of coercive measures varied highly between different diagnostic groups and different hospitals. Use of detailed guidelines for seclusion and restraint was associated with a lower incidence of coercive measures. DISCUSSION: Data interpretation should consider numerous confounding factors such as case mix and hospital characteristics. Suggestions on how to cope with ethical and technical problems in the processing of large multi-site data sets in routine clinical use are made.

Coercion↗

[Single-image roentgen analysis for the measurement of hip endoprosthesis migration].

A method to determine migration of hip endoprostheses is described. Migration is measured by means of standard AP radiographs and therefore can also be evaluated in retrospective studies. Measurement is conducted in X-ray studies displayed on a computer screen. Enhancement of bony structures by application of filters is available. The developed software can be used with common commercially available computers and X-ray scanners, and does not require special hardware. Several methods to determine accuracy are described. The accuracy of the described method is about 1 mm (95% confidence limit), which compares favourably with other methods, but is less accurate than roentgen stereophotogrammetry. For other methods, accuracy was not determined adequately. Two years after implantation, revision within the first 10 years of follow-up can be predicted with a sensitivity and specificity of more than 80%.

Acetabulum↗

[Custom-made knee endoprosthetics using subtraction data of 3-dimensional CT scans. A new approach].

A new method is presented which allows the construction and implantation of highly precise custom-made endoprostheses for knee joints. The procedure is based on a computer-aided subtraction process of three-dimensional CT data. Using the differences of the CT scans, the endprosthetic components are modelled by means of a newly developed software package. The implants are manufactured by CNC machines and stereolithography. The method enables the surgeon to reduce bone resections and ensures an exact profile of the bone-implant interface. Incorrect positioning will be avoided and the implantation process can be performed more easily while the size of the operative approach will be minimized. Better postoperative kinematics and reduction of shearing effects will lead to better results in the long run. The procedure offers a series of new possibilities to optimize monocondylar and bicondylar knee joint endoprostheses.

Arthroplasty, Replacement, Knee↗

Disposable microfluidic ELISA for the rapid determination of folic acid content in food products.

A micro-analytical system for rapid and quantitative analysis by inhibition immunoassay is presented and applied to the detection of folic acid. Eight polymer microchannels of 65-nL volume each and containing microelectrodes are embedded in a cartridge so that they can be operated simultaneously. All fluidic steps as well as the amperometric detection in the channels are operated by an instrument and software developed in-house. The fluidic steps of the immunoassay occur through hydrodynamic loading of the different solutions through the channels. The speed and duration of the flow and incubation parameters can thus be adapted to the biological and testing requirements. The effectiveness of the system was demonstrated by analysing folic acid concentrations in real infant formula samples within 5 min. In an effort to get a fully monitored assay, each fluidic step is monitored thanks to continuous amperometric detection of oxygen in the microchannel.

Alkaline Phosphatase↗

Trabecular microstructure and surface changes in the greater tuberosity in rotator cuff tears.

OBJECTIVE: When planning surgery in patients with rotator cuff tear, strength of bone at the tendon insertion and trabecular bone structure in the greater tuberosity are usually taken into consideration. We investigated radiographic changes in bone structure of the greater tuberosity in rotator cuff tears. DESIGN: Twenty-two human cadaveric shoulders from subjects ranging from 55 to 75 years of age were obtained. The integrity of the rotator cuff was examined by sonography to determine if it is intact without any tear, or torn partially or completely. The humeral head was sectioned in 3 mm thick coronal slab sections and microradiographed. After digitization of the microradiographs and imaging processing with in-house semi-automated image processing software tools developed using software interfaces on a Sun workstation, the trabecular histomorphometrical structural parameters and connectivity in the greater tuberosity were quantified. The degenerative changes on the surface of the greater tuberosity were interpreted blindly by 2 independent readers. RESULTS: Among the 22 shoulder specimens, the rotator cuff was found intact in 10 shoulders, partially in 7 and fully torn in 5. Statistically significant loss in apparent trabecular bone volume fraction, number of trabecular nodes, and number of trabecular branches, and a statistically significant increase in apparent trabecular separation and number of trabecular free ends were found in the greater tuberosity of the shoulders with tears. The loss was greater in association with full tear than in partial tear. Thickening of the cortical margin of the enthesis, irregularity of its surface, and calcification beyond the tidemark were observed in 2 (20%) shoulders with intact rotator cuff, in 6 (86%) shoulders with partial tear, and in 5 (100%) shoulders with full tear. CONCLUSIONS: Rotator cuff tears are associated with degenerative changes on the bone surface and with disuse osteopenia of the greater tuberosity. Aging, degenerative enthesopathy of the supraspinatus tendon, and rotator cuff tears appear closely related.

Aged↗

Use of technetium-99m sestamibi ECG-gated single-photon emission tomography for the evaluation of left ventricular function following coronary artery bypass graft: comparison with three-dimensional magnetic resonance imaging.

In patients who had undergone cardiac surgery (coronary artery bypass graft) and whose hearts showed abnormal movement during the cardiac cycle, we studied the accuracy of functional assessment using ECG-gated single-photon emission tomography (SPET) and the automated software developed by Germano et al. by comparing the findings with magnetic resonance (MR) images acquired three-dimensionally. Sixteen patients who had undergone cardiac surgery underwent 99mTc-sestamibi gated SPET (MIBI-g-SPET) and MRI on the same day. Left ventricular end-diastolic and end-systolic volumes (EDV, ESV) and ejection fraction (LVEF) were measured using MIBI-g-SPET and the aforementioned algorithm. Regional wall thickening was assessed using a four-point scale on MIBI-g-SPET and cine MRI. There was a good correlation between MIBI-g-SPET and MRI in respect of EDV (r=0.89), ESV (r=0.93) and LVEF (r=0.89). A high degree of agreement was found between the wall thickening scores obtained by MIBI-g-SPET and MRI in total segments (kappa=0.62) and in septal segments (kappa=0.67). It is concluded that ECG-gated perfusion SPET can provide regional and global functional information, including absolute volumes, in patients following cardiac surgery.

Aged↗

Performance of Web-based image distribution: server-oriented measurements.

The aim of this study was to assess the performance of Web-based image distribution when multiple personal computers (PCs) are downloading images simultaneously for different server hardware configurations. Using specially developed software, the time-to-display (TTD) of different image types was measured with up to 16 concurrent PCs for various combinations of processor, random access memory (RAM), network connection and image compression. The TTD increased linearly with the number of concurrent PCs but remained under 5 s in most of the cases, even with 16 concurrent PCs. Only with a 10-Mbit/s network connection or with lossy compression were TTDs above 5 s obtained. Two processors instead of one led to a slight and constant improvement of the TTD. Reducing the amount of RAM increased the TTD mainly for computed radiography (CR) images. There was no difference between a 200- and 100-Mbit/s network, but 10 Mbit/s proved significantly worse. When increasing the number of clients lossless compression performed substantially better than lossy. A standard off-the-shelf server provides an appropriate download performance even with 16 concurrent clients. Processor speed and RAM amount are of minor importance, but it is highly recommended to use a 100-Mbit/s network connection and to avoid the application of on-demand lossy compression in a local area network.

Internet↗

Two-dimensional and three-dimensional oxygen mapping by 3He-MRI validation in a lung phantom.

The aim of this study was to validate oxygen-sensitive 3He-MRI in noninvasive determination of the regional, two- and three-dimensional distribution of oxygen partial pressure. In a gas-filled elastic silicon ventilation bag used as a lung phantom, oxygen sensitive two- and three-dimensional 3He-MRI measurements were performed at different oxygen concentrations which had been equilibrated in a range of normal and pathologic values. The oxygen partial pressure distribution was determined from 3He-MRI using newly developed software allowing for mapping of oxygen partial pressure. The reference bulk oxygen partial pressure inside the phantom was measured by conventional respiratory gas analysis. In two-dimensional measurements, image-based and gas-analysis results correlated with r=0.98; in three-dimensional measurements the between-methods correlation coefficient was r=0.89. The signal-to-noise ratio of three-dimensional measurements was about half of that of two-dimensional measurements and became critical (below 3) in some data sets. Oxygen-sensitive 3He-MRI allows for noninvasive determination of the two- and three-dimensional distribution of oxygen partial pressure in gas-filled airspaces.

Helium↗

[Analysis of the dynamics of the ciliary muscle during accommodation].

BACKGROUND: The magnitude of anterioaxial shift of the human ciliary muscle during accommodation and its ceasing of ciliary function with advanced age are still unknown. PATIENTS AND METHODS: A total 105 patients (aged 10-91 years) were examined by high-resolution ultrasound biomicroscopy during disaccommodation and voluntary accommodation. Accommodative changes in the total area of the ciliary muscle and in the outer contour were quantified with a specially developed software program for automatic contour determination. RESULTS: A significant anterior shift independent of age was observed in the total area of the ciliary muscle and defined points on the outer contour of the muscle in the range of 56-121 microns, while the inward displacement was less obvious. A decrease in the magnitude of configurational changes during accommodation was observed with age. CONCLUSION: The new software program could be useful in further investigations of the accommodative process and evaluation of the potential causes of presbyopia.

Accommodation, Ocular↗

Preliminary evidence for neuronal damage in cortical grey matter and normal appearing white matter in short duration relapsing-remitting multiple sclerosis: a quantitative MR spectroscopic imaging study.

Neuronal damage and loss is likely to underlie irreversible disability in multiple sclerosis (MS). The time of onset, location and extent of neuronal damage in early disease are all uncertain. To explore this issue 16 patients with short duration, mild relapsing-remitting disease (mean disease duration 1.8 years, median EDSS 1) were studied using short echo time proton magnetic resonance spectroscopic imaging (1H-MRSI) to quantify the concentration of the neuronal marker N-acetyl-aspartate (NAA). The data were compared with those from 12 age-matched controls. 1H-MRSI was obtained from a 1.5-cm-thick slice just above the lateral ventricles. The Linear Combination (LC) Model combined with locally developed software allowed automated measurement of absolute metabolite concentrations from lesions, normal-appearing white matter (NAWM) and cortical grey matter (CGM). MS CGM exhibited significantly lower NAA (P = 0.01) and myo-inositol (P = 0.04) than control CGM. MS NAWM exhibited a lower concentration of NAA (P = 0.01) and increased myo-inositol (P = 0.03) than control white matter. More marked reductions in NAA and increases in myo-inositol were seen in lesions. The reduced NAA in MS CGM and NAWM suggest that mild but widespread neuronal dysfunction or loss occurs early in the course of relapsing-remitting MS. This preliminary finding should be confirmed in a larger cohort, and follow-up studies are also needed to determine the prognostic and pathophysiological significance of these early changes.

Adult↗

Dynamics of PAF-induced conjunctivitis reveals differential expression of PAF receptor by macrophages and eosinophils in the rat.

The action of platelet-activating factor (PAF) toward the PAF receptor (PAF-R) plays an important role in inflammation. We employed immunohistochemistry and quantitative confocal immunofluorescence microscopy to examine the dynamic changes of PAF-R expression in the conjunctiva in response to PAF-induced conjunctivitis in Brown Norway rats within the first 2 h after topical administration of PAF. Instillation of PAF caused an alteration in pattern of recruitment of macrophages and eosinophils into the conjunctiva, as was visualized by immunohistochemical staining for the antigens ED 1 and ED 2 (markers of macrophages) and MBP (a marker of eosinophils). An increase in the number of PAF-R positive cells was alos detected. Quantitative colocalization analysis revealed ther strongest rise in the degree of PAF-R expression by macrophages within the first 6 h, whereas their infiltration increased throughout the period of observation. However, eosinophils showed a high degree of PAF-R expression during all 24 h of the experiment, although they infiltrated strongly only within the first 2 h. Thus, for the first time, the use of quantitative colocalization analysis software developed by us has reveal intrinsic details of the interaction of PAF anf PAF-R in conjunctivitis, findings not otherwise obtainable by using qualitative approaches alone. Our results provide a theoretical basis for a definition of the proper time-frame in which to prevent and control the infiltration of macrophages and eosinophils into the conjunctiva.

Administration, Topical↗