[Central hemodynamics in healthy pregnant women according to the data of integral rheography of the body].
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A major responsibility of any Quality Assurance Unit (QUA) is to ensure data integrity. Errors made during data entry can lead to many problems in the study review process and decrease the quality, accuracy, and overall efficiency of data management. One technique that can reduce the number of data entry errors in computer data sets is the use of a dual entry data system. Currently available software allows creation of customized data entry screens that either closely resemble or duplicate the data collection forms used during studies. Two data entry operators enter data into two independent data sets. The use of an on-screen display that resembles the data collection form reduces the potential for keypunch errors. The two data sets can then be electronically compared. The comparison reports differences between the two data sets. When differences exist, the correct values can be determined by reference to the original data sheets and the two data files can then be corrected. Theoretically, the only key punch errors that will exist after making these corrections are when the two independent entry operators make the same exact data entry error. Typically, the time required for two people to enter data is minimal compared to the time required to manually identify and correct data entry discrepancies. With error-free data entry, we have found that electronic data quality, accuracy, and audit efficiency are improved at every subsequent step of data management, analysis, quality assurance auditing, and report generation.
Safety evaluation of pharmaceuticals consists of two processes; firstly, to grade the adverse effects of a test material on individuals based on scientific evidence, and, secondly, to judge whether the adverse effects occurring under the dose condition of the material capable of exhibiting its efficacy in patients remains within the acceptable safe range. Accordingly, the basic criteria for safety evaluation of pharmaceuticals can be, simply, said to know how high the dose-response curve of adverse effects lies above that of efficacy. On the other hand, the judgement concerning how much difference is necessary between both dose-response curves with regard to the safety would require a careful consideration on a case by case basis taking into account various information on the risk/benefit balance of the drug such as 1) medical usefulness and social needs of the drug and 2) the presumed severity of adverse effects in man.
Aggression research does not lack data--it lacks a model for integrating data. One of the problems confronting aggression researchers is the extensive body of multidisciplinary data that is difficult to synthesize to generate new directions in research. This paper proposes one solution that starts by asking "what is the minimal number of categories of concepts and measurements which are necessary to describe a person?". The answer is four categories of concepts: biological; cognitive; behavioral; environmental (physical and social). One way of many for integrating these four categories of concepts is a proposed discipline neutral heuristic model that is used herein to compare two different research approaches to the study of impulsive aggression. This comparison identifies clearly the differences in the two approaches with regard to different emphases among the four categories of constructs for each program. Using the model an example of common ground between the two approaches is sought as a basis for extending aggression research. The main conclusion of one of the research programs was that central nervous arousal is related to impulsive aggression. This program demonstrated that phenytoin will reduce impulsive aggressive acts and has an effect on CNS arousal. The other research program on impulsive aggression has been at the forefront in demonstrating the well established inverse relationship between serotonin levels and aggression. The comparison resulted in the suggestion that both serotonin and phenytoin may relate to a common neurochemical substrate which interacts in part to control CNS arousal, especially at the cortical level. The proposed heuristic model made obvious the need to use synthesizing concepts (e.g. information processing or language) which can interrelate multidisciplinary concepts and data from different research programs within the four categories of constructs when comparing interdisciplinary research.
The fragmentation of the electronic patient record among hospital information systems (HIS), radiology information systems (RIS), and picture archiving and communication systems (PACS) makes the viewing of the complete medical patient record inconvenient. The purpose of this report is to describe the system architecture, development tools, and implementation issues related to providing transparent access to HIS, RIS, and PACS information. A client-mediator-server architecture was implemented to facilitate the gathering and visualization of electronic medical records from these independent heterogeneous information systems. The architecture features intelligent data access agents, run-time determination of data access strategies, and an active patient cache. The development and management of the agents were facilitated by data integration CASE (computer-assisted software engineering) tools. HIS, RIS, and PACS data access and translation agents were successfully developed. All pathology, radiology, medical, laboratory, admissions, and radiology reports for a patient are available for review from a single integrated workstation interface. A data caching system provides fast access to active patient data. New network architectures are evolving that support the integration of heterogeneous software subsystems. Commercial tools are available to assist in the integration procedure.
The GenBank(R) sequence database (http://www.ncbi.nlm.nih.gov/) incorporates DNA sequences from all available public sources, primarily through the direct submission of sequence data from individual laboratories and from large-scale sequencing projects. Most submitters use the BankIt (WWW) or Sequin programs to send their sequence data. Data exchange with the EMBL Data Library and the DNA Data Bank of Japan helps ensure comprehensive worldwide coverage. GenBank data is accessible through NCBI's integrated retrieval system, Entrez , which integrates data from the major DNA and protein sequence databases along with taxonomy, genome and protein structure information. MEDLINE(R) abstracts from published articles describing the sequences are also included as an additional source of biological annotation. Sequence similarity searching is offered through the BLAST series of database search programs. In addition to FTP, e-mail and server/client versions of Entrez and BLAST, NCBI offers a wide range of World Wide Web retrieval and analysis services of interest to biologists.
The GenBank (Registered Trademark symbol) sequence database incorporates DNA sequences from all available public sources, primarily through the direct submission of sequence data from individual laboratories and from large-scale sequencing projects. Most submitters use the BankIt (Web) or Sequin programs to format and send sequence data. Data exchange with the EMBL Data Library and the DNA Data Bank of Japan helps ensure comprehensive worldwide coverage. GenBank data is accessible through NCBI's integrated retrieval system, Entrez, which integrates data from the major DNA and protein sequence databases along with taxonomy, genome and protein structure information. MEDLINE (Registered Trademark symbol) s from published articles describing the sequences are included as an additional source of biological annotation through the PubMed search system. Sequence similarity searching is offered through the BLAST series of database search programs. In addition to FTP, Email, and server/client versions of Entrez and BLAST, NCBI offers a wide range of World Wide Web retrieval and analysis services based on GenBank data. The GenBank database and related resources are freely accessible via the URL: http://www.ncbi.nlm.nih.gov
The GenBank((R))sequence database incorporates publicly available DNA sequences of >55 000 different organisms, primarily through direct submission of sequence data from individual laboratories and large-scale sequencing projects. Most submissions are made using the BankIt (Web) or Sequin programs and accession numbers are assigned by GenBank staff upon receipt. Data exchange with the EMBL Data Library and the DNA Data Bank of Japan helps ensure comprehensive worldwide coverage. GenBank data is accessible through NCBI's integrated retrieval system, Entrez, which integrates data from the major DNA and protein sequence databases along with taxonomy, genome, mapping and protein structure information, plus the biomedical literature via PubMed. Sequence similarity searching is provided by the BLAST family of programs. Complete bimonthly releases and daily updates of the GenBank database are available by FTP. NCBI also offers a wide range of WWW retrieval and analysis services based on GenBank data. The GenBank database and related resources are freely accessible via the NCBI home page at http://www.ncbi.nlm.nih.gov
OBJECTIVE: The purposes of this article are to describe the overall protocol for the Identification of Neonatal Hearing Impairment (INHI) project and to describe the management of the data collected as part of this project. A well-defined protocol and database management techniques were needed to ensure that data were 1) collected accurately and in the same way across sites; 2) maintained in a database that could be used to provide feedback to individual sites regarding enrollment and the extent to which the protocol was complete on individual subjects; and 3) available to answer project questions. This article describes techniques that were used to meet these needs. DESIGN: This study was a prospective, randomized study that was designed to evaluate auditory brain stem responses, transient evoked otoacoustic emissions, and distortion product otoacoustic emissions as hearing-screening tools, and to relate neonatal test findings to hearing status, defined by visual reinforcement audiometry at 8 to 12 mo of age. Measures of middle-ear function also were obtained at some sites as part of the neonatal test battery. In addition, other clinical and demographic data were gathered to determine the extent to which factors, other than auditory status, influenced test behavior. Three groups were evaluated: neonatal intensive care unit (NICU) infants (those who spent 3 or more days in a NICU), well babies with risk factors for hearing loss, and well babies without risk factors. Six centers participated in the trial. The testers for the project included audiologists, technicians, audiology graduate students, and medical research staff. The same computerized neonatal test program was applied at each center. This program generated the neonatal test database automatically. Clinical and demographic data were collected by means of concise data collection forms and were entered into a database at each site. After the neonatal test, subjects from the NICU and at-risk well babies were evaluated with visual reinforcement audiometry starting at 8 to 12 mo of age. All data were electronically transmitted to the core site where they were merged into one overall database. This database was exercised to provide feedback and to identify discrepancies throughout the course of the study. In its final form, it served as the database on which all analyses were performed. RESULTS AND CONCLUSION: The protocol was a departure from typical hearing screening procedures in terms of 1) its regimented application of three screening measures; 2) the detailed information that was obtained regarding subject clinical and demographic factors; and 3) its application of the same procedures across six centers having diverse geographic location and subject demographics. A learning curve for successfully executing the study protocols was observed. Throughout the study, monthly reports were generated to monitor subject enrollment, check for data completeness, and to perform data integrity checks. In combination with monthly data reports and checks that occurred throughout the progression of the study, miscellaneous data audits were performed to check accuracy of neonatal testing programs and to cross-check information entered in the clinical and demographic database. The data management techniques used in this project helped to ensure the quality of the data collection process and also allowed for detailed analyses once data were collected. This was particularly important because it enabled us to evaluate not only the performance of individual measures as screening tools, but also permitted an evaluation of the influence of other variables on screening test results.
This article outlines an alternative procedure to household surveys for obtaining individual observation-level data. The procedure, called statistical matching, integrates data on an individual observation from one source with data on a different observation identified as the "best matching" or "most similar" record from a second source. The best match is determined by objective statistical criteria. Also reported is a significant application of the procedure between the Survey of Income and Education and the 1976 National Health Interview Survey. The success of merging these two large, nationally representative data files shows statistical matching as a viable method of creating databases for health services research.
The medical information, financial, and logistic aspects of a comprehensive computer-based Appointment, Registration, Information System, and Evaluation (ARISE) are analyzed for the management of a family planning program serving 30,000 patients annually. An overview of the existing computer system network is presented with descriptions of the interactive master patient index, the batch appointment process, the management statistics package, and Department of Health, Education, and Welfare (HEW) reporting. Emphasis is placed on the financial management control system which includes 1) procedures for third-party submission of claims for payment, in particular Titles IVA, XX, and XIX (Social Security Act), together with discussion of related administrative requirements; 2) technics of auditing data integrity including systematic sampling of collected data; and 3) the process of billing and receipts collection. Methodology and implementation aspects of ARISE may have wide applicability to other family planning and similarly structured clinical programs.
Although the concept of distributed systems for the storage of patient data is more and more commonly accepted, for some considerable time yet most patient data will be stored in centralized rather than departmental systems. An important advantage of storage in a central system is hospital-wide access to much of the patient data. Disadvantages are however that these data cannot be reviewed through one user interface, and that the structure of the data does not lend itself to exploitation for other purposes. We describe the implementation of an Andrology Research Information System in which these data are integrated in a well-structured database facilitating multiple views on the patient data through a graphical user interface, and clinical research, quality control and summary reports. The data can be analyzed directly using the Hermes workstation. In this way the strengths of the centralized system are combined with those of the dedicated ARIS system.
A medical information relational database system (MIRDS) which is resident on a relational database machine and is accessed via microcomputers has been created for a pediatric pulmonary division of a research hospital. The power and flexibility of MIRDS has permitted the integration of clinical tasks, research interests, and laboratory functions. Procedures have been devised to assure data integrity, allow flexibility in data retrievals, produce standardized report formats, and permit data access for users with a wide range of query expertise. There are few impediments to the integration of additional clinical, research, and laboratory functions as the system evolves.
The state of the art for computer-based generation and documentation of ultrasonography reports is described. Arguments for standard nomenclature and structured data collection are given. Remarks concerning system integration, data privacy, and image archiving follow.
This report describes several image archival problems facing the authors' department and the results of their attempt to define the requirements for an enterprise digital image archive. The problems identified include the costs of supporting multiple distinct archives, the increased complexity of supporting multiple archive interfaces, the differences in data handling policies and resulting variations in data integrity, and variability in support for nonimage data. The authors also describe the data collected including image volumes and trends and imaging device trends. Finally, the resulting specification for an enterprise digital image archive, including storage and retrieval performance and interface requirements are presented.
The Ministry of Health and Environmental Control of Berlin is developing a Health Information System (HIS) on the basis of a multi-satellite network system, comprising a central, regional, local and functional unit level. The main part of this paper describes the conceptual structure of the Common Data Base (CDB) of HIS with special regard to the patient-oriented medical information originating from the various institutions of the health care system. This structure comprises the following five levels: 1. PATIENT 2. PROBLEM 3. CASE 4. EVENT 5. ACT Each of the levels represents a node in the structure model. A node is an entity with a set of "local properties" being specified for each level, referring to selected data on inferior levels. The structures of these five levels are described in detail. In the last part, so-called "data-manipulation procedures" are treated. These are descriptions covering any data manipulation and represent the basis of data integrity through system controlled transaction with the data base.
Progress in surgery and anesthesia has contributed to lowering operative risk and expanding the indications for operations in higher age groups. The goal of treatment in the elderly is to achieve the best possible degree of reducing discomfort and increasing personal independence. Methods. A brochure with a clinical study on 1,021 patients chosen at random shows the frequency of complications arising during the peri- and post-operative course in patients around 60 years of age and older. Operative areas were general and emergency surgery, vascular surgery, neurosurgery, and urology. Operations were carried out in regional or general anesthesia. Patients were divided into groups below and above age 60. Evaluation of the data was carried out according to an integrated data processing concept. This program enables quantitative and qualitative data to be combined at will, taking into consideration that evaluating criteria can be varied considerably. Results. The results demonstrate that patients over 60 have significantly more complications than patients under 60. Analysis of the influence of the factors associated with surgical risk reveals that factors related to the operation such as type, length, and extent do not increase the risk as much as the numerous accompanying illnesses in both age groups. As far more elderly patients are affected by multimorbidity, the conclusion may be drawn that the increased risk observed is not due mainly to age, but rather to the patient's condition prior to surgery. The results indicate clearly that an exact analysis of the initial condition as well as avoiding failure or malfunction of certain organs must have priority in both age groups.
The value of a common pool of veterinary data, using clinical records from general practices, welfare organisations, research bodies and veterinary schools is described. Developments in computer technology are outlined and the computer's application to integrated data collection, storage, querying and dissemination is indicated. Proposals for a computerised integrated veterinary clinical data base, using a standard coded case record, are presented.