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The increasing importance of computer-stored databases for clinical research prompted a historical review of their evolution over the past three decades. The special problems associated with the computer processing of clinical research data were reviewed, and the various types of clinical research registers and databases were described.
The need to systematically and comprehensively manage data to support nursing services asserts itself in all areas and contexts where nursing services are delivered to patients and families. While most applications have targeted inpatient nursing services, several systems to sustain ambulatory nursing care have been proposed as well. In this paper, we outline the purpose and general structure of a custom-designed computerized database management system to support the clinical, administrative, and research operations of a geriatric nursing outreach program in rural Virginia.
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A need for centralized access to biomedical databanks was identified at the Medical University of South Carolina. The library has taken a leadership role in administering selection, acquisition, storage, and dissemination of access to these databases. A discussion of established policies and procedures is included. The appendix describes the biomedical databanks and search software selected.
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Researchers and public health officials involved in surveying and forecasting the course of the HIV epidemic require complete and unfiltered information from many sources. Governments should respond by establishing national HIV databases.
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Epidemiological and health system research projects are often delayed due to the difficulties to build validated data basis in personal computers. This papers presents a new computer interactive program for handling numeric data from a given questionnaire to a structured archive. The questionnaire includes the basic variables of the dwelling and of the members of the household. A list of sociodemographic and health variables are selected, although other variables can be easily added, according to special needs. All the intermediate steps regularly needed to construct a data base are included in the package: capture, verification, validation and record linkage. The package is equipped with the basic procedures needed to produce tabulations and basic statistical analysis.
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Modern science is preoccupied with basic mechanisms at the level of the gene, molecule, atom and fundamental particle. This preoccupation has affected attitudes to medical science. Paradoxically, politicians and Departments of Health are largely concerned with clinical epiphenomena--outcomes, interventions, effectiveness, efficiency--that are often disregarded by medical scientists and viewed without favour by granting bodies. In the surgical sciences, there is renewed interest in clinical research. The small computer and the readily available database with its compatible statistical package have added a new dimension to clinical research. Database design and analysis are as much a part of the surgical investigator's skills as are laboratory techniques. There are simple rules that govern database design. The database should be simple and flexible, but provide an adequate patient profile. Entry should be standardized by precise inclusion criteria and precise definitions. Data input should be numerical whenever possible. The database program should convert simply to a comprehensive statistical program. The clinical database is useful for both observational and investigational studies. Case series, case control studies and cohort studies can all be developed from well maintained databases. In the Department of Surgery at Westmead Hospital, databases have been maintained for 10 years. The hepatobiliary and pancreatic group of databases have led to 34 publications. The liver tumour database has produced 12 studies and nearly 20 papers. The process of development of one study is outlined in detail. The chance observation of an excess incidence of gallstones in patients having regular ultrasound examinations after major abdominal surgery has been confirmed in a case control study.(ABSTRACT TRUNCATED AT 250 WORDS)
The use of computerized databases for nursing research and quality assurance is discussed. The advantages and disadvantages of using these databases are identified. Examples of both bibliographic and actual databases are provided. Two examples illustrate the difficulties of using computerized databases.
OBJECTIVE: To describe the current status of funding for general practice research in Australia. DESIGN: A descriptive survey analysing funding arrangements of research projects included in a national research database, established by the Royal Australian College of General Practitioners. SETTING AND PARTICIPANTS: Research projects involving, or directly related to, general practice that had commenced in Australia since 1 January, 1989. Responses were specifically sought from all universities, the Family Medicine Programme and the Royal Australian College of General Practitioners. MAIN OUTCOME MEASURES: Extent and source(s) of funding received or requested, or both; relationship of funding received to the following: qualification and affiliations of the principal investigator; submission of the research project towards a higher degree; subject area(s) covered by the research; study design method used; and duration of project. RESULTS: A total of 237 projects from 130 principal investigators were included in the analysis. Of these, 149 (63%) had been submitted for funding and 98 (66%) had been successful. The amount of funding ranged between $300 and $855,600. The most common source of funding was the General Practice Evaluation Programme. Research contributing towards a higher degree was associated with successfully receiving funding. Other variables, including the study design and study area, were not significantly associated with an increased success of funding. CONCLUSIONS: The total amount of funds spent on general practice research is still small, relative to the size of the workforce. However, over half of general practice research undertaken in Australia is not submitted for funding. Of the research that is submitted, the success rate of receiving funds is high.
Clinical databases are growing rapidly. The clinical database is heavily used for medical research in many settings. This paper discusses design features for medical databases that facilitate their use for research. The database management system should allow complex data structures, have a syntax-facilitating collection of longitudinal data, interface with major statistical software packages, allow an extensive data dictionary, conveniently merge files, facilitate archival documentation, have an associated data entry system that allows complex logical checking, and have coordinated mainframe and microcomputer software.
Prospective research into factors affecting health care costs for individual patients requires a hybrid information management system with some features usually associated with a medical billing package and other features common to research databases. Furthermore, data collection for such a project must often be done in the field where a portable computer is most convenient. A software program is described which has been developed to address these disparate needs. It allows classification by study protocol assignment and provides multiple summary formats for the assessment of costs. For example, charges can be stratified by specialty, by category of service (pharmacy, room, surgery, respiratory therapy, etc.), by magnitude of expense ('big' vs 'little' ticket items) and so forth. The system design described may prove useful to other investigators studying variation in health care costs.
The massive volume of hemodynamic data routinely available within the Cardiovascular Intensive Care Unit (CVICU) can adversely affect the quality, relevance and timing of hemodynamic management decisions on patients after cardiac surgery. Yet, at the same time, the lack of appropriate treatment-outcome data and access to prior CV case histories deprives the clinician of any opportunity to improve personal decision-making skill and assess the effectiveness of various treatment methods. This paper presents a formalized decision-support model for CVICU that incorporates expert and quantitative knowledge, as well as prior outcome and case experience to augment the clinician's decision-making capability. This includes the proposed use of optimal hemodynamic patterns derived from outcome analysis as therapy goals, expert rules and trend analysis to interpret incoming data, standardized protocols based on predefined hemodynamic patterns from clinical cases, and access to the database for similar case comparison. Most importantly, the model suggests an integrated approach where the clinical database is not only a documentation source for the patient, but can also serve as an outcome research database where clinical experience can be formalized and combined with expert knowledge to influence future therapy decisions. At present, a prototype is being developed at the CVICU of the University of Alberta Hospitals on a Unix platform using ART-IM, C and Ingres. Once implemented, the prototype will be evaluated on a small group of CV patients for its effectiveness and acceptability to clinicians.
A computerized system for the management of a clinical research database has been developed with several attractive features. This relational database management system allows for screen-driven data entry, data checking, system security, and report generation in a timely manner. In addition, the system is cost-effective in a number of ways: (1) development time is considerably reduced due to the inherent programming features of the software, (2) once developed the system can be maintained by nontechnical personnel thereby reducing personnel costs, (3) the system can be developed and maintained on a microcomputer system, and (4) the commercial software used in our system is periodically updated thereby assuring the user of state-of-the-art technology. Beyond the initial expenditures for hardware and software, no additional system costs are incurred. While this system, currently adopted by the Yale Comprehensive Cancer Center, represents an effective approach to handling the data-management needs of a large, single-institution cancer research center, the design and programming methodology can be readily adapted to other research settings.
It has been accepted generally that the cancer registry has more of a 'back room' than a 'front line' role in cancer control, its particular responsibilities lying in description of cancer patterns, care, and outcome, in monitoring these variables in relation to control activities, and in providing a research database--often, for others to utilize. While readily justifiable, this prevailing concept of the cancer registry's role may not be sustainable in times of economic restraint. A survey of members of the International Association of Cancer Registries showed that most registries fit the accepted mold. Some, however, extend beyond it, particularly in the direct conduct of epidemiologic research and in the implementation of control programs, particularly screening. Sixteen percent appeared only to be collecting incidence statistics and may be at risk of economic rationalization. It would be consonant with their basic role and skills, and promote more rational cancer control, if cancer registries were to take on an expanded role, including direct participation in epidemiologic research, evaluation of interventions against cancer at the population level, situation analysis and cancer control planning, and implementation of aspects of cancer control--particularly coordination of screening--and monitoring the performance of cancer control programs. This expanded role could become the responsibility of specialized cancer control units of which cancer registration would be the central function.