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"Virtual" clinical trials: case control experiments utilizing a health services research workstation.

We created an interface to a growing repository of clinical and administrative information to facilitate the design and execution of case-control experiments. The system enables knowledgeable users to generate and test hypotheses regarding associations among diseases and outcomes. The intuitive interface allows the user to specify criteria for selecting cases and defining putative risks. The repository contains comprehensive administrative and selected clinical information on all ambulatory and emergency department visits as well as hospital admissions since 1994. We tested the workstation's ability to determine relationships between outpatient diagnoses including hypertension, osteoarthritis and hypercholesterolemia with the occurrence of admissions for stroke and myocardial infarction and achieved results consistent with published studies. Successful implementation of this Health Services Research Workstation will allow "virtual" clinical trials to validate the results of formal clinical trials on a local population and may provide meaningful analyses of data when formal clinical trials are not feasible.

Case-Control Studies

Automatic query mapping among genomic databases: a pilot exploration.

As databases in the human genome project proliferate, it is important for users of one genomic database to identify similar or inconsistent data in other autonomously developed genomic databases. To do so, the user needs to issue the same query across multiple databases. We describe an approach that allows a query issued against one database to be automatically mapped to an equivalent query against another structurally different database. Our approach features two components: 1) a database designed to capture knowledge (metadata) that describes the correspondences among individual database components and 2) a module that utilizes the metadata to perform query mappings. As a demonstration, we apply our query mapping approach to two chromosome map databases (DB/12 and GDB).

Algorithms

Information and research needs of acute-care clinical nurses.

The majority of nurses surveyed used the library on a regular but limited basis to obtain information needed in caring for or making decisions about their patients. A minority indicated that the libraries in their own institutions totally met their information needs. In fact, only 4% depended on the library to stay abreast of new information and developments in the field. Many of the nurses had their own journal subscriptions, which could account in part for the limited use of libraries and the popularity of the professional journal as the key information source. This finding correlates with the research of Binger and Huntsman, who found that 95% of staff development educators relied on professional journal literature to keep up with current information in the field, and only 45% regularly monitored indexing-and-abstracting services. The present study also revealed that nurses seek information from colleagues more than from any other source, supporting the findings of Corcoran-Perry and Graves. Further research is necessary to clarify why nurses use libraries on a limited basis. It appears, as Bunyan and Lutz contend, that a more aggressive approach to marketing the library to nurses is needed. Further research should include an assessment of how the library can meet the information needs of nurses for both research and patient care. Options to be considered include offering library orientation sessions for new staff nurses, providing current-awareness services by circulating photocopied table-of-contents pages, sending out reviews of new monographs, inviting nurses to submit search requests on a topic, scheduling seminars and workshops that teach CD-ROM and online search strategies, and providing information about electronic databases covering topics related to nursing. Information on databases may be particularly important in light of the present study's finding that databases available in CD-ROM format are consulted very little. Nursing education programs should be expanded to include curricula bibliographic sessions where the librarian, in cooperation with the teaching faculty, visits the classroom to explain all pertinent information sources or invites the class to the library for hands-on demonstration and practice. Nurses who gain working knowledge of the tools that open the doors to retrieval of research findings and who have information about new innovations in medicine and medical technology have superior chances for success in their chosen profession.

Adult

Decision support for clinical trial eligibility determination in breast cancer.

We have developed a system for clinical trial eligibility determination where patients or primary care providers can enter clinical information about a patient and obtain a ranked list of clinical trials for which the patient is likely to be eligible. We used clinical trial eligibility information from the National Cancer Institute's Physician Data Query (PDQ) database. We translated each free-text eligibility criterion into a machine executable statement using a derivation of the Arden Syntax. Clinical trial protocols were then structured as collections of these eligibility criteria using XML. The application compares the entered patient information against each of the eligibility criteria and returns a numerical score. Results are displayed in order of likelihood of match. We have tested our system using all phase II and III clinical trials for treatment of metastatic breast cancer found in the PDQ database. Preliminary results are encouraging.

Algorithms

Optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature Database (LILACS).

OBJECTIVE: To define and disseminate the optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature (LILACS). This strategy was elaborated based on the optimal search strategy for MEDLINE recommended by Cochrane Collaboration for the identification of clinical trials in electronic databases. DESIGN: Technical information. SETTING: Clinical Trials and Meta-Analysis Unit, Federal University of São Paulo, in conjunction with the Brazilian Cochrane Center, São Paulo, Brazil. (http://www.epm.br/cochrane). DATA: LILACS/CD-ROM (Latin American and Caribbean Health Science Information Database), 27th edition, January 1997, edited by BIREME (Latin American and Caribbean Health Science Information Center). LILACS Indexes 670 journals in the region, with abstracts in English, Portuguese or Spanish; only 41 overlap in the MEDLINE-EMBASE. Of the 168,902 citations since 1982, 104,016 are in human trials, and 38,261 citations are potentiality clinical trials. Search strategy was elaborated combining headings with text word in three languages, adapting the interface of the LILACS. We will be working by locating clinical trials in LILACS for Cochrane Controlled Trials Database. This effort is being coordinated by the Brazilian Cochrane Center.

Caribbean Region

[Structured abstracting of scientific medical publications].

Abstracts play an important role in medical literature as the carriers of synthetic information. Their significance grows as computerized data bases are in use in which whole information should comprise no more than 250 words. Critical appraisal the abstracts' standard resulted in a proposal for data presentation divided into significant parts (structured abstracts). The abstract of an original clinical trial should contain description of the objective, design, setting, patients, intervention, main outcome measures, results and conclusions. The abstract of the review article should provide information about the purpose, data identification, study selection, data extraction, results of data synthesis and conclusions. This form obliges the authors to precise, logical formulation draws out the essential aspects of the work, facilitates literature review, and critical appraisal.

Abstracting and Indexing

Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

Clinical Trials as Topic

A database system for integrated clinical trial management, control, statistical analysis and ICH-compliant reporting.

Clinical trial management and quality assurance is a complex activity that, when manually executed, is prone to errors and delays, and organizations involved in the conduct of clinical drug trials must rely on database systems to ensure adequate data integrity and timely reporting. We report the design and implementation of an integrated computer system for the management and control of multiple phase II to IV clinical drug trials, and for automated generation of monitoring and statistical analysis reports that are fully compliant with international guidelines. This Windows-based system incorporates a number of third-party software tools and applications, and its major components are COATI (Control, Assessment and Tracking of Therapeutic Investigations), a client-server database application; DART (Data Analysis and Reporting Tool) for automated data abstraction and reporting; and PANDA (Data Analysis Package) for automated statistical analysis. The system is in production for two years and was used in 15 clinical trials in a diversity of medical conditions and study designs.

Clinical Trials as Topic

[Meta-analysis].

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Clinical Trials as Topic

Interactions between stroke data banks and clinical trials.

The number of clinical trials to evaluate new therapies for stroke treatment and prevention is growing rapidly. Although stroke data banks cannot answer treatment efficacy questions, they can have powerful interactions with the design and conduct of clinical trials. Through data banks one can generate hypotheses regarding treatment, estimate the frequency of outcome events, calculate sample size, determine stratification factors that may or may not be needed in a clinical trial, establish inclusion and exclusion criteria and decide on the elements to include in the data collection forms. Using a data bank one can estimate the number of patients that may be screened, eligible, refused, and enrolled in a clinical trial with given inclusion and exclusion criteria. Data banks are helpful for surveillance of all eligible subjects and calculating the proportion of the total cases who were randomized. With the more widespread analyses of stroke data banks we can design focused clinical trials and reach some definitive conclusions regarding the future treatment of stroke.

Bias

Meta-analysis.

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Bias

[Statistics in the clinical research on drugs. A study of original articles emanating from Spanish centers].

BACKGROUND: The aim of this study was to evaluate statistical analysis reported in clinical investigation articles of Spanish drugs. METHODS: Original articles provided by Spanish centers and indexed in EMBASE in 1975, 1980, 1985 and 1990 were studied. The type of statistics used, their description and different aspects of results presentation are reported. RESULTS: Two hundred eighty-eight articles were studied of which 73.3% used inferential statistics with 57.3% presenting an adequate description of the same. The most frequently used statistical tests were bivariant techniques, mainly the Student's t test (33.7%) and chi square test (28.8%). The complexity of the statistical tests increased progressively in the years reviewed being greater in the articles published in foreign journals. The results were presented adequately and in a comprehensive form in 40% of the cases. Confidence intervals were used in 22.2% in the presentation of the results. In 49.1% of the articles statistical significance favored the group receiving the therapy studied. Of the 46.6% which did not present differences only 9.3% the statistical power was calculated. CONCLUSIONS: Although an improvement was observed in the years evaluated, the articles on clinical drug investigation carried out in Spanish centers still present insufficient information on statistical methodology, particularly in those published in Spanish journals.

Clinical Trials as Topic