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[Development of computer software in ramp slope controller for treadmill ergometer].

We developed computer software to produce a treadmill ramp protocol through which oxygen uptake (VO2) is increased in a linear fashion, thus enabling subjects to walk until the end of exercise. The developed software simulates the increases in speed and grade of the treadmill displayed on a personal computer screen, and produces the ramp protocol by arbitrarily determining the variables of the following formula: 1) Increments of VO2 = a1t+a2 (ml/min/kg) [t = exercise time (min)] 2) Predicted VO2 by speed (S) and grade (G) = a3S2 + a4G2 + a5SG + a6S + a7G + a8 (ml/min/kg) [S = speed (km/hr); G = grade (%)] 3) Speed suitable for desired exercise time (S or S2) = a9t2 + a10t + a11 (km/hr) 4) Grade suitable for desired exercise time (G or G2) = a12t2 + a13t + a14 (%) In this study, the increment of VO2 was determined by considering the subject's exercise capacity (VO2 = 4t + 7 ml/min/kg), using the Ito's formula (VO2 = 0.067S2 + 0.289SG + 7.73 ml/min/kg). The formula of grade was determined following the formula arbitrarily (G2 = 25t + 5%). The formula of speed for exercise time was calculated automatically. The new ramp protocol, which was applied to 10 healthy subjects (mean age: 24.8 +/- 4.8 years old), disclosed a similar linear relationship between the predicted VO2 and the measured VO2.

Adult

FDA regulation of biomedical software.

A major problem faced by biomedical software developers and users is the complexity of the regulatory regimes confronting them. Of particular concern is whether, and to what extent, they are regulated by the Food and Drug Administration (FDA) and the consequences of such regulation. Producers, distributors, and users of biomedical software often are unaware that FDA regulates many of these products as medical devices. Developers, vendors, distributors, or users of such software are subject to significant civil and criminal liability for noncompliance. This article explains the current regulatory requirements imposed on computer software developers and users by FDA, biomedical and some proactive strategies for avoiding adverse enforcement.

Documentation

Ada software for cytometry.

Ada is a new general-purpose language that embodies the concepts of software engineering. Although it was initially developed for military purposes, it is suitable for developing software for cytometry and other health-related applications. A pilot study has demonstrated the feasibility of employing Ada for cytometry applications. Three packages were created. The first subtracts a control three-dimensional population from multiple individual experimental populations and presents the results in spread sheet form. A second package has the capability of finding aggregates of cells. The results of this package are visualized employing a commercially available program for three-dimensional presentation of the data that permits rotation in real time. A third package consists primarily of interface drivers for two commercially available personal computer boards, an ADC and a stepper motor controller. The major problems with the coding were due to incomplete implementation of the language. This pilot study, together with others, indicates that it would be both cost effective and beneficial to implement cytometry and other medical devices in Ada.

Cytophotometry

Development of a computerized database for the study of anaesthesia care.

To record, tabulate and report problems associated with anaesthesia, we have developed an information collection system and computer software to follow all patients attended by an anaesthetist at a teaching hospital in Canada. For the last 15 mo, data for 17,000 patients have been collected and the system is ongoing. Data collection is from three sources: carbonless copies of the handwritten Operating Room (OR) and Post Anaesthetic Care Unit (PACU) records, other hospital databases, and postoperative visits. Adverse events (observations which differ from specific physiological variables, or require an intervention and do not normally occur during the routine conduct of anaesthesia), are defined directly on each OR and PACU record. These events are recorded when they occur by the attending anaesthetist or the PACU nurse. All data are verified by a research nurse and an anaesthetist. Computer software, developed from DBase IV, is used to track 95 individual items on preoperative status and anaesthetic technique and another possible 1,450 selections for drugs, physicians, airways, surgical procedures and events for each patient. Data are analyzed with SAS software and reports generated to link the casemix and process with outcome. Comparison of data entered into the computer programme to a retrospective chart review revealed discrepancies of less than 0.5%. Collection, verification and computer entry takes five minutes per patient and the on-going cost is estimated at $4 per patient record. Analysis of the information collected in this database has been useful for research of adverse outcome following anaesthesia, resident expertise profiles, and the administrative management of an anaesthesia department.

Anesthesia Department, Hospital

[Program for the computerized control of a regional system of cadaveric kidneys exchange developed for the São Paulo Interior Transplante].

Authors present a computer software developed to control the regional cadaver kidney exchange program in the state of São Paulo (Interior Transplante), and capable of two distinct routines: 1) management of the data bank concerning the enrolled recipients, and 2) selection of patients that are HLA compatible with a given donor, and final selection of kidney recipients based on the following 4 criteria in addition to HLA compatibility: time in waiting list, panel, age, and logistic factors. The software has been in use for one year and has proved to be extremely useful when compared to the previously used method which involved a standard card file.

Brazil

Treatment planning for gamma knife radiosurgery with multiple isocenters.

Many arteriovenous malformations and tumors suitable for radiosurgical treatment have non-spherical or irregular shapes. Forty-eight percent of the first 156 patients treated with the gamma unit at the University of Pittsburgh required treatment with two or more isocenters to optimize dose distributions. Dose distributions for combining gamma knife treatments to two or more isocenters were systematically investigated. High speed computerized dosimetry was performed using specially developed software and dose distributions were confirmed with film densitometry. We have developed guidelines for treatment to two or more isocenters which help reduce treatment planning time, and facilitate selection of treatment doses and optimum dose distributions. These guidelines include maintaining an account of the distances between all isocenters, using a catalogue of sample two-isocenter isodose plans, comparing dose volume histograms, and calculating complication probabilities using the integrated logistic formula.

Cobalt Radioisotopes

VA's Integrated Imaging System on three platforms.

The DHCP Integrated Imaging System provides users with integrated patient data including text, image and graphics data. This system has been transferred from its original two screen DOS-based MUMPS platform to an X window workstation and a Microsoft Windows-based workstation. There are differences between these various platforms that impact on software design and on software development strategy. Data structures and conventions were used to isolate hardware, operating system, imaging software, and user-interface differences between platforms in the implementation of functionality for text and image display and interaction. The use of an object-oriented approach greatly increased system portability.

Computer Graphics

[Semi-automated quantification of MRI high signals observed in multiple sclerosis].

MR T2 Weighted sequences on the brain demonstrate disseminated "high signal zones" (HSZ) in patients with Multiple Sclerosis; these morphological alterations are corresponding to the plaques. From the very beginnings of MR in 1981, everybody recognizes the main importance of this fact. MR appears as the most sensible exploration in patients with M.S. But the signal alteration is not specific; the clinical considerations and the evolution are requested. The aim of this work is to give a reference tool for evolutive evaluation of the disease. A work station with a specially developed software are presented. The HSZ thresholding is partially automatic. The edition of a cerebral mapping is developed. These results are discussed.

Humans

The present and future medicolegal importance of record keeping in anesthesia and intensive care: the case for automation.

The anesthesia record is often crucial to successful defense in a meritless claim, because the adversarial role of the plaintiff's medical expert witness requires an attack on the record. Likewise the record may be pivotal in determining whether a defense should even be mounted as an alternative to an early settlement, because the failure of meaningful, supportive, or exculpatory documentation raises serious questions about the quality of care rendered. Advancing technology has made possible revolutionary changes in real-time monitoring and data recording. Concepts favoring the development and adoption of automated record systems for anesthesia are outlined through historic medicolegal perspectives on record keeping in general and computerization of the monitoring and recording methods in specific as a means of providing the best medicolegal evidence in defense of the anesthesiologist's performance. The analogy is often made between the successful development and acceptance of the flight data recorder and cockpit voice recorder combination in aviation and ongoing software development for automated recordkeeping and the quest for its use and professional acceptance in both anesthesia and intensive care settings.

Anesthesiology

Economic analysis of immunization programmes.

Two economic analyses of immunization programmes, one from Denmark and one from Kenya, are described with emphasis on practical problems in relation to the collection of data. The Danish study was performed by a study group with participation of experts within health economics and epidemiology and a specifically designed computer programme was developed. The Kenyan study was performed by the management unit of the Kenyan immunization programme using standard computer software developed by WHO (EPICost) and without external assistance. Both studies yielded results of significant relevance for the dialogue with the administration and politicians.

Child

POLLUX: a program for simulated cloning, mutagenesis and database searching of DNA constructs.

Computer support for research in biotechnology has developed rapidly and has provided several tools to aid the researcher. This report describes the capabilities of new computer software developed in this laboratory to aid in the documentation and planning of experiments in molecular biology. The program, POLLUX, provides a graphical medium for the entry, edit and manipulation of DNA constructs and a textual format for display and edit of construct descriptive data. Program operation and procedures are designed to mimic the actual laboratory experiments with respect to capability and the order in which they are performed. Flexible control over the content of the computer-generated displays and program facilities is provided by a mouse-driven menu interface. Programmed facilities for mutagenesis, simulated cloning and searching of the database from networked workstations are described.

Base Sequence

NUMEDICS: a system for on-line data processing in nuclear medicine.

A multiterminal system --NUMEDICS--has been developed to study the problems of on-line acquisition, processing, and display of scintigraphic data. The hardware-software configuration of NUMEDICS permits simultaneous and independent operation of terminals in the Division of Nuclear Medicine, the Physics Research Laboratory, and the Cyclotron Laboratory of the Massachusetts General Hospital. This paper describes the hardware and software developments in NUMEDICS which have been proven to be of value in clinical and research applications. These features are illustrated by applications to the evaluation of left ventricular performance, three-dimensional imaging, and functional imaging of rCBF.

Nuclear Medicine

Topographical brain electrical activity mapping on an IBM-compatible personal computer.

A new system for computing brain electrical activity maps on a standard IBM-compatible computer has been developed. The EEG is recorded using a CED1401 intelligent laboratory interface and stored in the computer; colour coded maps are generated using software developed in Turbo PASCAL and displayed on the EGA graphics screen. An acceptable computation time of 1.2 s for a 64 x 64 map displayed as a 128 x 128 pixel image has been achieved by incorporating assembly language routines and a maths coprocessor. The system may be readily upgraded as improved hardware becomes available and further software can be added. In addition to triggering auditory, visual and somatosensory stimulators, it provides the potential for the generation of complex stimuli for cognitive experiments by means of mass RAM and digital-to-analogue converters.

Brain Mapping

Interactive video: an analysis of its value to nurse education.

This paper attempts to explain the emerging technology of interactive video and examine its possible place in nursing education. A brief description of the media is given with an exploration of the educational theory and justification underlying its use. A range of approaches to the evaluation of the technology itself and software available are given, which examine advantages and disadvantages for individual learners and for an organisation considering investment in this area. The possible role of interactive video in nurse education is discussed and a recommendation given that nurse educators need to keep up-to-date with developments in this type of educational technology and develop software suitable for the needs of nurses, rather than having to use packages developed for other purposes which have limited application for nursing.

Computer-Assisted Instruction

Quality controlling interpretive reporting systems in clinical medicine--a changing responsibility.

This paper presents some observations on a number of topics which affect the quality of computer software and includes: current trends in software design, current levels of responsibilities for the various parties involved in bringing automation to clinical medicine, why software development is so difficult to quality control, and certain characteristics of system development which contribute most to the construction of inaccurate models.

Humans

A cardiac potential mapping system.

The technical aspects of a multiple-purpose cardiac mapping system are presented. The authors begin with a brief history of hardware and software development and then concentrate on the major problems in acquiring high-quality recordings from the torso surface or from the epicardial surface and on the processing of the signals for display of color maps or other analysis. To achieve the desired adaptability to a variety of cardiac applications and experiments, they incorporated three parallel microprocessors that can record the signals from 240 electrodes and simultaneously provide display and analysis of the incoming cardiac data. While the parallel processors and modular software offer computational and flexibility advantages, the user interacts with an ordinary AT-compatible computer. This discussion is not a survey of the systems used in the many research laboratories or specific cardiac applications but is focused on experience in developing the specific hardware for such a multi-purpose instrument, and less specifically on the software that makes the system easy to use and adaptable to a variety of experimental and clinical situations.

Action Potentials

Magnetic resonance imaging simulator: a teaching tool for radiology.

The increasing use of magnetic resonance imaging (MRI) as a clinical modality has put an enormous burden on medical institutions to cost effectively teach MRI scanning techniques to technologists and physicians. Since MRI scanner time is a scarce resource, it would be ideal if the teaching could be effectively performed off-line. In order to meet this goal, the radiology Department at the University of Pennsylvania has designed and developed a Magnetic Resonance Imaging Simulator. The simulator in its current implementation mimics the General Electric Signa (General Electric Magnetic Resonance Imaging System, Milwaukee, WI) scanner's user interface for image acquisition. The design is general enough to be applied to other MRI scanners. One unique feature of the simulator is its incorporation of an image-synthesis module that permits the user to derive images for any arbitrary combination of pulsing parameters for spin-echo, gradient-echo, and inversion recovery pulse sequences. These images are computed in 5 seconds. The development platform chosen is a standard Apple Macintosh II (Apple Computer, Inc, Cupertino, CA) computer with no specialized hardware peripherals. The user interface is implemented in HyperCard (Apple Computer Inc, Cupertino, CA). All other software development including synthesis and display functions are implemented under the Macintosh Programmer's Workshop 'C' environment. The scan parameters, demographics, and images are tracked using an Oracle (Oracle Corp, Redwood Shores, CA) data base. Images are currently stored on magnetic disk but could be stored on optical media with minimal effort.

Computer Simulation

Image-guided stereotactic surgery: a 10-year evolutionary experience.

The recent revolution in medical imaging has demanded concurrent development of sophisticated and compatible stereotactic guiding devices in order to diagnose or treat mass lesions on the brain and disorders of cerebral physiology. Between July 1, 1979, and July 1, 1989, 1,006 patients underwent image-guided stereotactic surgery at the University of Pittsburgh. During this 10-year interval the first dedicated computed tomography stereotactic operating room and the first North American radiosurgical suite containing a 201 60Co source gamma knife were constructed. Early in our experience, 60.5% of the patients underwent diagnostic (biopsy) stereotactic surgery whereas, by 1988, 77.8% of the patients underwent therapeutic stereotactic surgery. At our institution, stereotactic surgery was performed last year in 257 patients, representing 19.9% of all neurosurgical operations. During the past 10 years, stereotactic surgery has developed an integral and definitive role in contemporary mainstream neurosurgery. Across the world stereotactic technology is now widely available. In the future increasing emphasis will be placed on therapy, image integration, computer software development, and new instrumentation designed to meet the evolving needs of neurological surgeons who demand safe, precise, and effective tools to explore the brain.

Biopsy