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Distribution and communication in software engineering environments. Application to the HELIOS Software Bus.

Modularity, distribution and integration are current trends in Software Engineering. To reach these goals HELIOS, a distributive Software Engineering Environment dedicated to the medical field, has been conceived and a prototype implemented. This environment is made by the collaboration of several, well encapsulated Software Components. This paper presents the architecture retained to allow communication between the different components and focus on the implementation details of the Software Bus, the communication and integration vector of the currently running prototype.

Computer Communication Networks

Software quality regulation under the Safe Medical Devices Act of 1990: hospitals are now the canaries in the software mine.

The 1990 Medical Device Amendments to the Food and Drug Act have caused a significant change in the regulation of medical software. The 1990 Act replaces the prior emphasis on premarket approvals with an emphasis on postmarket surveillance. Hospitals and other institutional users are now required to report to the FDA product defects that cause injuries or death. They are also required to report product defects to the manufacturer. The Act provides for rapid suspensions of device approval, recalls of defective products and civil penalties for violators. The combination of these factors may lead to enhanced FDA supervision of the purchase and use of medical software, and particularly an emphasis on finding unregistered producers. In addition, the new Act will have a direct effect on the regulation of software, because it is much better suited to addressing the problem of software quality than the 1976 Act.

Equipment Safety

United States government regulation of medical device software: a review.

A brief history of the regulation of medical device software within the United States is presented, along with a discussion of the reasoning that the US Food and Drug Administration (FDA) presents for modifying the requirements for software regulation from those previously used for hardware devices. The current regulatory status is discussed for the two categories of medical device software, software used within medical devices and software used to produce or test medical devices. The published FDA documents which determine the current environment for the regulation of software are summarized and discussed. The two types of medical device software are related to the two areas of FDA regulation, good manufacturing practices and permission to sell medical devices. The expected direction of future medical device software regulation, and its relationship to the European Economic Community (EEC) and international markets is discussed.

Equipment and Supplies

Validation of respiratory mechanics software in microprocessor-controlled ventilators.

BACKGROUND AND METHODS: Several microprocessor-controlled ventilators, available for clinical use, contain optional computer software programs capable of performing near-instantaneous determinations of airway resistance and lung compliance. This study was undertaken to determine the validity of the measurements for airway resistance and lung compliance obtained by the software packages on three microprocessor-controlled ventilators. Three ventilator models were studied. An artificial ventilator-patient circuit was constructed using a test lung and an endotracheal tube. Airway pressure and gas flow curves were recorded using conventional means. Static lung compliance and airway resistance were calculated using standard equations, while automated measurements were obtained from the ventilators. The following parameters were then varied to simulate a wide variety of clinical situations: tidal volume, peak inspiratory flow rate, respiratory rate, endotracheal tube, and test lung compliance. RESULTS: Automated measurements were highly correlated with values obtained manually (resistance: Puritan-Bennett 7200a r2 = .94, Bear 5 r2 = .98, Veolar r2 = .96; compliance: 7200a r2 = .93, Bear 5 r2 = .97, Veolar r2 = .97). Calculated limits of agreement between the two methods demonstrate that although not in absolute agreement, the software-determined values for airway resistance and lung compliance differed from the manually derived values in a ventilator-specific, predictable fashion. CONCLUSIONS: The correlation and agreement demonstrated between values of airway resistance and lung compliance measured by the respiratory mechanics software packages and those values derived manually suggest that these software packages may be useful for measuring trends, as well as responding to treatment in the clinical setting. These results apply only to the controlled, mechanical ventilation mode. Further studies are indicated to validate this software in patients capable of generating spontaneous breaths.

Airway Resistance

[The general practitioner and clinical records: a survey of the knowledge of users of a software package].

The FATMA project--subproject 6, Line of Research 2--aims at implementing a new computerized information network for general practitioners using the same kind of software and homogeneously located throughout Italy. Thus, patients' case form data can be collected for public health purposes. After a study of literature in order to check whether other countries had implemented similar projects and what they consisted of, a survey based on a computerized questionnaire was carried out on a group of g.p.s. who had already received a software for the management of their clinical and professional activities from Janssen Informedica. This survey aimed at judging some aspects of users in order to select potential monitors of the information network who would test a new software. The analysis regards both g.p.s' social and professional data and the use of a computer package with reference to the quality and quantity of the clinical data they input. 2,010 questionnaires were filled in all their parts and mailed back to Informedica. It came out that g.p.s. believe more and more they can improve the organization and management of their work by using a software equipped with routines and easy access procedures so that clinical data, diagnostic reports and treatment can be collected, placed on files and updated. Thus, a new software should be developed. While meeting g.p.s' needs, it must overcome the limits of packages now available concerning the possibility of carrying out epidemiological studies. The software can become a tool to collect clinical data of patients, diseases and diagnostic procedures through standard protocols directly from g.p.s records.

Adult

Effect of computer software on time required to prepare parenteral nutrient solutions.

Pharmacist and technician times required for the preparation of parenteral nutrient (PN) solutions were studied before and after the introduction of a software package that is used with an automated compounder. At a 580-bed teaching hospital, work sampling was used to collect data on how time was spent by personnel in the i.v. admixture pharmacy during six-week periods before and after the introduction of software that calculates the quantities of PN solution ingredients on a computer-generated work sheet and prints labels. The second data-collection period began when the software had been in use for four months. In the second study period, there was a significant decrease (28%) in total pharmacist time spent per PN solution; the mean +/- S.D. pharmacist times per PN solution per day for the two study periods were 14.03 +/- 3.24 minutes and 10.12 +/- 1.61 minutes, respectively. There were also significant decreases in pharmacist time spent performing calculations, checking calculations, and typing labels. After introduction of the software, technicians spent significantly less time typing labels and pumping base solutions. Overall, technicians spent significantly less time per PN solution in the second study period (20.15 +/- 3.50 versus 17.82 +/- 1.94 minutes). Use of the software allowed pharmacist staffing in the i.v. admixture pharmacy to be reduced, and the pharmacy resources were reallocated toward the provision of clinical services. The generation of PN labels and calculation worksheets by computer software reduced pharmacist and technician time requirements for PN solution preparation.

Data Collection

A new microcomputer software system evaluation paradigm: the medical perspective.

The new fourth-generation software has enormously eased the burden of computing for users, but they have also created a confusing, difficult problem in software evaluation and selection. Therefore it is argued that a sound and complete evaluation paradigm is a key element in an efficient and effective software system design and use process. While much has been written about software evaluation in general, in the medical field, the guidances and recommendations previously provided are too general to be of practical use. Considering also the other weaknesses of conventional evaluation paradigms we have decided to develop a more adequate one which will have a solid theoretical framework, specific guidances, strict and well-defined taxonomic space, and a fair ranking approach. In the present paper we will therefore introduce our new evaluation paradigm and show its applicability in evaluation and selection of medical software systems according to their usability.

Classification

[Workload in software development work. A consideration based on work-characteristics and analysis on workload factors of each working group].

To clarify workload factors in software developing work, we designed questionnaires composed of questions of work-content based on the interview survey. For the analysis of workload, Cumulative Fatigue Symptom Index (CFSI) and the stress-rating-method by 7-likert-scale were used. With the cooperation of the Japanese Software Engineers' Association (SEA) responses were obtained from 270 out of 1,100 members and from 553 non-member software engineers in 18 companies in Japan. The CFSI score obtained was higher than those of other groups of other industries obtained in our previous studies. The stress-rating showed that "time-pressure," "too much amount of work, and "ambiguity in job specification" were the highest stressors. The work groups were categorized by the results of CFSI profile into 4 types. The results of stress-ratings were significantly different between the 4 type groups. Based on the multiple comparison analysis, the workload factors of each group could be specified. Out of the foregoing 4 types, the work groups which showed the deviation in F1B (depression) in CFSI and the work groups which showed high scores in every category in CFSI were higher in "ambiguity of specification" in stress-ratings. This result indicates that "ambiguity in specification" is a significant stressor in software engineers. This stressor is caused by the complicated communication process between users and engineers and by the shortage of tools or rules in this process. This stressor is considered to be the most typical workload which characterizes the software developing work.

Adult

A general software package for the handling of medical images.

PICS (portable imaging computer software), is a software system designed for handling and processing a variety of types of medical image. It has been designed to satisfy the following criteria: (a) the software should be portable between different items of hardware with minimal alteration; (b) there should be a simple operator interface to enable use by inexperienced users, while avoiding the need for experienced users to be directed through tedious menu trees; (c) the programming environment should enable simple integration of new data handling protocols. To meet these requirements the software was written in FORTRAN using structured subroutine organization. The software has basic image handling and processing facilities and contains a comprehensive set of nuclear medicine clinical protocols. Other facilities include alignment of images from different modalities with display of superimposed images and ability to handle, analyse and display three-dimensional data sets. Data transfer programs have been written to capture data from gamma camera, CT, MRI, ultrasound and radiographs by converting the images to a common data format. The system provides a hospital with a central digital image handling resource, enabling investigation of the value of digital image processing in potential clinical applications.

Diagnostic Imaging

MCHS: an application software for family welfare programmes.

At the level of first contact, a primary health care centre, information management is an unwieldy task, therefore health information systems are reported to be inadequate and weak. Microcomputers could improve information management at this level, but there is little success due to a lack of specialized application software. In this paper we describe software developed after a multi-centre systems analysis study, on an essential data set, to support the delivery of the public health programmes for family welfare, i.e. maternal health care, family planning and immunization programmes. The modular approach was taken to develop a common application software for information management use at multiple sites. The software is tested in a laboratory mode by retrospective data entry from sites in Sweden and in India. All the information could be entered and site-specific reports that were generated are compared. The software provided a common data collection format, an essential platform for outcomes research.

Adolescent

[Stereotactic aspiration using coordinate software for hypertensive intracerebral hematomas].

Stereotactic aspiration for intracerebral hematoma has become widely used due to improvements in computed tomography (CT). CT-guided stereotactic aspiration for hypertensive intracranial hematomas was performed in 46 cases. Stereotactic aspiration with coordinate software was carried out among 16 cases. We compared the clinical results of conventional stereotactic aspiration with results of the new method using coordinate software. Using coordinate software, we can examine the route for the target point, as well as the target point of the hematoma before surgery. Therefore we can avoid obstacles such as ventricles and internal capsules. Further, we can aspirate hematoma by using only this one procedure. Mean hematoma aspiration percentage has risen from 44.9 to 87.2% by using coordinate software. Rate of drainage tube insertion after operation has decreased from 90 to 50%. The period of placement of the drainage tube and the frequency of infection due to the drainage tube has become lower, too. Therefore we can say that the outcome of treatment of hypertensive intracranial hematomas is improved by using coordinate software.

Cerebral Hemorrhage

Portable image-manipulation software: what is the extra development cost?

A hospital-wide picture archiving and communication system (PACS) project is currently under development at the University Hospital of Geneva. The visualization and manipulation of images provided by different imaging modalities constitutes one of the most challenging component of a PACS. It was necessary to provide this visualization software on a number of types of workstations because of the varying requirements imposed by the range of clinical uses it must serve. The user interface must be the same, independent of the underlying workstation. In addition to a standard set of image-manipulation and processing tools, there is a need for more specific clinical tools that can be easily adapted to specific medical requirements. To achieve this goal, it was elected to develop a modular and portable software called OSIRIS. This software is available on two different operating systems (the UNIX standard X-11/OSF-Motif based workstations and the Macintosh family) and can be easily ported to other systems. The extra effort required to design such software in a modular and portable way was worthwhile because it resulted in a platform that can be easily expanded and adapted to a variety of specific clinical applications. Its portability allows users to benefit from the rapidly evolving workstation technology and to adapt the performance to suit their needs.

Costs and Cost Analysis

[Electronic data processing in the hospital: current status, options, "branch packets", customer-specific software and users' needs].

Data management in hospitals used to be the data management of the hospital-management in the last 15 years, not however the data management the doctors performed. The acceptance for electronic means slowly rising more software is used in the clinics today but still by the doctors privately. Software specialists have registered the growing market available for their products. That is why the danger to accept even unusuable software rises every day, as unexperienced software-beginners as doctors mostly are often relied on offers without being told about their dignity and usefulness.

Electronic Data Processing

Approaching the millennium: perinatal problems and software solutions.

Strategic planning for rational development of perinatal computing capabilities for the year 2000 should be driven by anticipated trends in (1) the health care business, (2) computer technology and (3) medicine, as well as (4) the needs of perinatal practitioners. In the USA, health care is the fastest growing segment of the economy. This will produce increasing attention from hardware and software developers, and vendors, and will lead to a proliferation of computing platforms, operating systems and specific medical application software. Desktop computers, already capable of 20 million instructions per second (MIPS) with massive storage capacities, will continue to evolve and fall in price. Increasingly, perinatologists will develop software packages to facilitate patient care in their own environments. All of these trends will lead to severe fragmentation in medical computing. Simultaneously, however, the need for integrated institutional computer-based data access for quality assurance and fiscal and operations management will increase. Perinatal care will be more regionalized, complex and rigorous with new clinical trial- and effectiveness research-based interventions, as well as molecular diagnosis and therapy. To practice appropriately, clinicians will need to be familiar with computer capabilities. Having been exposed to computer-aided instruction (CAI) at the undergraduate and postgraduate levels, they will except on-line access to detailed and accurate patient information with linkage to laboratory, radiology and other medical databases, as well as to reference databases, such as Medlines and the Oxford Database of Perinatal Trials. Artificial intelligence (AI) software may support perinatal decision making; computerized professional and facility billing will be available.

Forecasting

Software and hardware integration of a microprogrammable state machine for NMR imaging.

We have integrated a commercially available microprogrammable state machine (Tecmag PULSkit) for use as a magnetic resonance pulse programmer. Providing the capability for active research environment imaging protocols, it features timing resolution of 100 nsec, ten 16-bit loop counters, and individually addressable look-up tables. This integration involved hardware and software integration with a VAX 11/750 at several levels. Hardware: Each of the three gradient channels employs three digital-to-analog converters (DACs). An 8-bit, 4-quadrant, multiplying DAC generates the gradient waveform shape. A 12-bit DAC generates the multiplying DAC scaling voltage, controlling gradient amplitude and sign. A third 12-bit DAC produces a gradient offset (shim) voltage. An eddy current compensation network is present for each gradient channel. Software: The software design philosophy was to create a flexible interface (interactive window environment), while not constraining complex manipulation of the hardware (direct use of the pulse-sequence compiler primitives and microprogramming). The software levels include (a) pulse-sequence microprogramming, (b) pulse-sequence compiler, (c) interactive parameter specification, and (d) canned pulse-sequence microcode library.

Computer Systems

Software suite for image archiving and retrieval.

The efficient operation of a clinical picture archiving and communication system (PACS) requires a fully functional image archive. The archive should not only be able to store and retrieve images reliably but should also work in concert with software that optimizes the flow of image-related information throughout the PACS. The authors devised a software suite that serves to improve the flow and content of information and the integrity of the data. The software was developed by translating the functions performed by a conventional film library. Types of transactions possible with this system include scheduling, canceling, rescheduling, and prestaging examinations; changing demographic information; merging patient information; and generating reports. The authors believe such a software suite is essential for a clinically useful PACS.

Data Display

A comparison of software for analysis of rare and common short tandem repeat (STR) variation using human genome sequences from clinical and population-based samples.

Short tandem repeat (STR) variation is an often overlooked source of variation between genomes. STRs comprise about 3% of the human genome and are highly polymorphic. Some cause Mendelian disease, and others affect gene expression. Their contribution to common disease is not well-understood, but recent software tools designed to genotype STRs using short read sequencing data will help address this. Here, we compare software that genotypes common STRs and rarer STR expansions genome-wide, with the aim of applying them to population-scale genomes. By using the Genome-In-A-Bottle (GIAB) consortium and 1000 Genomes Project short-read sequencing data, we compare performance in terms of sequence length, depth, computing resources needed, genotyping accuracy and number of STRs genotyped. To ensure broad applicability of our findings, we also measure genotyping performance against a set of genomes from clinical samples with known STR expansions, and a set of STRs commonly used for forensic identification. We find that HipSTR, ExpansionHunter and GangSTR perform well in genotyping common STRs, including the CODIS 13 core STRs used for forensic analysis. GangSTR and ExpansionHunter outperform HipSTR for genotyping call rate and memory usage. ExpansionHunter denovo (EHdn), STRling and GangSTR outperformed STRetch for detecting expanded STRs, and EHdn and STRling used considerably less processor time compared to GangSTR. Analysis on shared genomic sequence data provided by the GIAB consortium allows future performance comparisons of new software approaches on a common set of data, facilitating comparisons and allowing researchers to choose the best software that fulfils their needs.

Humans

[Mental health in software engineers. I. Frequency of mental complaints, physical complaints and psychiatric disorders].

This study examined the physical complaints, mental complaints and psychiatric disorders in software engineers. Subjects were 101 male software engineers. They were evaluated by a semistructured interview. Psychiatric diagnosis was based on DSM-III (Diagnostic and Statistical Manual of Mental Disorders, third edition). The results are summarized as follows: 1) Physical complaints were observed in 68% of the subjects with 25% of the subjects complaining of physical ill-health. This study showed that 12% of the subjects had hypertension, 12%, gastritis or gastro-duodenal ulcer, 14%, allergic disease, and 19% miscellaneous diseases. 2) Of the subjects 62% had mental complaints and 31% mental ill-health. Depressive symptom was the most frequent mental complaint with 32% of the subjects diagnosed as DSM-III. The common diagnoses were adjustment disorders (19%), major affective disorders (6%), psychological factors affecting physical condition (5%) and dysthymic disorder (3%). Only one subject sought professional help from a psychiatrist for relief of mental complaints. The data suggest the severity of mental ill health in software engineers, but methodological limitations preclude a firm conclusion at this time. Further studies should be made on the mental health state in software engineers.

Adult