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PubMedDate not supplied

[Neonatal neurology decision-making starting from systematic reviews of Cochrane Collaboration].

INTRODUCTION: Cochrane Collaboration (CC) provides growing and readily accessible resource to help that decision-making care is based on detailed, critical, and current reviews of the best available evidence. There are many clinical questions for which there is no good evidence on which to base clinical practice. AIM: To analyse the bibliometric characteristics of the systematic reviews (SR) about neonatal neurology published in Neonatal CC. MATERIALS AND METHODS: Bibliometric analysis of The Cochrane Database Systematic Reviews in Neonatal CC, Issue 1, 2004 (n = 169 SR). The dependent variable registered in each SR was subject area of study (mainly neurology subject area) and the rest of variables were considered independent: authors (number and country), dates (late review and update), characteristics of included clinical trials (number and type), characteristics of the newborns included (number and gestational age), reviewer's conclusions and potential conflicts of interest. RESULTS: Neurology was the third most important subject area in Neonatal CC (13 SR), after the subject area of respiratory (73 SR) and gastroenterology-nutrition (26 RS). We identified three selective clusters of secondary investigation in neonatal neurology SR: intraventricular haemorrhage (4 SR), perinatal asphyxia (4 SR) and opiate withdrawal syndrome (2 SR). The number of clinical trials (median 4), patients (median 193), update (46%), sufficient conclusion (54%) and potential conflicts of interest (8 %) in each SR is similar to the rest of SR in Neonatal CC; the only difference we found is less preterm infants (15%) in this SR. All the SR are about interventions for the treatment or prevention of diseases, and we don't found any review about diagnostic tests. CONCLUSIONS: At the moment, the neonatal neurology SR published in Neonatal CC are infrequent and almost half of them the reviewer's conclusions are insufficient for inferring probable effects in clinical practice. Many therapies in neonatal neurology persist without supportive evidence, and some common therapies may actually be harmful, and these are the conclusions found in SR about intraventricular haemorrhage. We detected no SR about important neuropediatric themes in neonatal period: hypoxic-ischemic encephalopathy, periventricular leukomalacia, neonatal seizures, hypotonia, etc.

Bibliometrics↗

PubMed2003

A Web-based compendium of clinical questions and medical evidence to educate internal medicine residents.

The authors designed an electronic database of clinical questions (CQs) and medical evidence and implemented it in 2001-02 at Duke University Medical Center and the Veterans Administration Medical Center in Durham, North Carolina. This Web-based data collection system is called the Critical Appraisal Resource (CAR) and is still in operation. This report is of ten months of the system's operation. During their medicine ward rotations, residents entered CQs into the CAR; they also entered Medline reference links and validated article summaries. Residents' utilization of the CAR database, Medline, and other electronic resources was prospectively measured. In addition, residents were prospectively surveyed regarding the impact of each question and associated reference on medical decision making for individual patients. Over ten months, residents entered 625 patient-based CQs into the CAR and were able to obtain useful information from the medical literature on 82% of the CQs they searched. The two most prevalent CQ types were therapy and diagnosis questions (53% and 22%). Sixty percent of the therapy articles considered useful were reports of randomized controlled trials. Residents obtained 77% of their useful data from Medline. They reported that obtaining useful data altered patient management 47% of the time. Residents used the CAR as a resource, searching the database for information 1,035 times over the study period. In summary, the use of an evidence-based critical appraisal resource led residents to engage the medical literature on behalf of their patients and influenced approximately half of their patient-care decisions. Residents benefited from questions previously searched by other residents, allowing them to address a wider spectrum of CQs during ward rotations.

Clinical Trials as Topic↗

PubMed2003

TrialDB: A web-based Clinical Study Data Management System.

Clinical Study Data Management Systems (CSDMSs) are a class of software that support centralized management of data generated during the conduct of clinical studies. Commercial CSDMSs include Oracle Clinical, ClinTrial and MetaTrial. Such systems, which are typically deployed at an institutional or organizational level, must accommodate diverse types of data from different clinical domains that is generated by different groups of clinical investigators. Large-scale CSDMSs typically employ a high-end database engine that is usually accessed over an intranet or the Internet using Web-based technologies. CSDMSs in institution-wide use for a variety of clinical domains are best served by entity-attribute-value (EAV) modeling for the clinical data: all the commercial CSDMSs that we are aware of use EAV design. However, de novo development of EAV databases for data management is a challenging task. A large body of generic metadata-driven code must be developed before a basic EAV application can be written. Clearly, the availability of pre-existing software with the requisite functionality would be very valuable. We will discuss the benefits of such software being in open-source form.

Clinical Trials as Topic↗

PubMed2000

A process for ensuring optimal cardiovascular intervention and identifying candidates for glycoprotein IIb/IIIa receptor inhibitor therapy.

Data from trials with glycoprotein (GP) IIb/IIIa receptor inhibitors have led to a new standard of care for patients with unstable angina or non-wave myocardial infarction (MI) who are undergoing percutaneous coronary intervention. Additional data are necessary to compare patient responses to various GP IIb/IIIa agents in a nontrial setting with results from clinical trials. Seton Medical Center has designed a database to accommodate this task. Data from >20,000 patients have been collected since 1979 and the interventional experience from the years 1997 through 1999 has been analyzed for patients who were candidates for receiving these agents. The data are being used to evaluate the outcomes of therapy and to devise models that can stratify patients according to risk, thereby ensuring optimal cardiovascular intervention and choice of the most cost-effective GP IIb/IIIa inhibitor agent.

Abciximab↗

PubMed1989

A microcomputer-based clinical trial database incorporated with an 'audit trail' for correction process.

Multicenter clinical trials usually involve several hundred research variables with tens of thousands of records and require mainframe computers for processing. Because of recent advances in hardware and software, it has become possible to support data management and statistical analysis for a complex research project totally on a microcomputer. The Veterans Administration Cooperative Studies Program Coordinating Center (CSPCC) in Hines, IL, U.S.A. has successfully implemented three studies employing the SIR/PC Database Management System (DBMS) on an IBM PC AT. The CSPCC DBMS was designed with a method of verifying data and of updating the database, that leaves a more detailed 'audit trial' of the original data and subsequent modifications than provided by the SIR audit trail facility. Data validation can be done at any time throughout the study to facilitate error identification as early as possible in the data handling process. DBMS operation and maintenance are automated by a system of menus. The utility programs are prestored in a procedure file to optimize performance. The simple design speeds implementation and also reduces the cost of development.

Clinical Trials as Topic↗

PubMed1991

ABLEDATA: a database of products for the disabled.

ABLEDATA (ABLE), a database funded by the National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education and produced by the Adaptive Equipment Center of Newington Children's Hospital, Newington, Connecticut, provides information on more than 17,000 rehabilitation products from over 2,000 manufacturers in the U.S. and Canada. ABLE, which is available through BRS Search Service, BRS Colleague, and BRS After Dark, is a useful resource for rehabilitation professionals and others who wish to locate appropriate assistive devices for all categories of disabled persons.

Canada↗

PubMed1993

The safety of sumatriptan in asthmatic migraineurs.

A recent report has questioned the safety of sumatriptan in asthmatic migraineurs. To investigate this, we have reviewed the sumatriptan clinical trial safety database of over 75 completed trials. Within the clinical trial database, 375 asthmatic patients were identified who treated 1214 migraine attacks with sumatriptan. The incidence and nature of adverse events in the asthmatic patient subgroup who received sumatriptan was similar to that in the complete clinical trial population. Six reports of asthma were recorded as adverse events, but only one case was classified by the investigator as related to treatment. There is no clinical or pharmacological evidence to suggest that the safety profile of sumatriptan is altered in asthmatic patients compared to other migraine sufferers.

Asthma↗

PubMed2004

Construction, training and clinical validation of an interpretation system for genotypic HIV-1 drug resistance based on fuzzy rules revised by virological outcomes.

OBJECTIVES: To evaluate whether fuzzy operators can be usefully applied to the interpretation of genotypic HIV-1 drug resistance by experts, and to improve the prediction of salvage therapy outcome by adapting interpretation rules of genotypic resistance on the basis of their association with virological response data. METHODS: We used a clinical dataset of 231 patients failing highly active antiretroviral therapy (HAART) and starting salvage therapy with baseline resistance genotyping and virological outcomes after 3 and 6 months. A set of rules predicting genotypic resistance was initially derived from an expert (ADL). Rules were implemented using a fuzzy logic approach and the virological outcomes dataset used for the training phase. The resulting algorithm was validated using a separate set of 184 selected patients by correlating the resulting predicted activity with observed virological response at 3 months. For comparison, the expert systems from the drug resistance group of the Agence Nationale de Recherches sur le SIDA (ANRS-AC11) and the algorithm from the Stanford's HIV drug resistance database (Stanford HIVdb) were evaluated on the same set. RESULTS: The starting algorithm had a correlation with virological outcomes of R2=0.06 (P=0.0001). After the training phase the correlation with virological outcomes increased to R2=0.19 (P<0.000001). In the validation set of patients, the activity of the salvage regimen predicted by the fuzzy algorithm was the only variable independently predictive of the 3-month viral load change even after adjusting by the activity predicted by the two expert systems and baseline viral load (for each 10% salvage regimen's activity increase, mean HIV RNA change from baseline: -0.27 log10 copies/ml; 95% CI -0.39, -0.15). CONCLUSION: Using fuzzy operators in a virological outcomes training database to implement a rules-based algorithm for genotypic resistance interpretation, significant improvements of outcomes prediction were obtained. The resulting algorithm showed an independent predictive capability of virological outcomes over that of two rules-based interpretation algorithms made by experts. Although the system was trained and validated on a limited number of cases, the approach deserves further evaluation.

Adolescent↗

PubMed2002

Management of data from clinical trials using the ArchiMed system.

Clinical trials constitute a key source of medical research and are therefore conducted on a regular basis at university hospitals. The professional execution of trials requires, among other things, a repertoire of tools that support efficient data management. Tasks that are essential for efficient data management in clinical trials include the following: the design of the trial database, the design of electronic case report forms, recruiting patients, collection of data, and statistical analysis. The present article reports the manner in which these tasks are supported by the ArchiMed system at the University of Vienna and Graz Medical Schools. ArchiMed is customized for clinical end users, allowing them to autonomously manage their clinical trials without having to consult computer experts. An evaluation of the ArchiMed system in 12 trials recently conducted at the University of Vienna Medical School shows that the individual system functions can be usefully applied for data management in clinical trials.

Austria↗

PubMed1996

A model for storage and retrieval of theoretical medical knowledge.

A database model for structure and access of theoretical medical knowledge is presented. The basic principle is the organization of knowledge in three dimensions: Each topic--first dimension--is explained with media--second dimension--in different versions of varying details--third dimension--suitable for different users. Every topic is one database entry. Topics are interconnected with heading and sub-topics (tree structure) and to logically related topics (cross references). Access follows the 3D-concept with initial access by topic, by media, or user specific, and with intra-unit access to related topics, media, and user specific versions. The model is discussed and possible implementations are described.

Computer-Assisted Instruction↗

PubMed2007

A relational database for management of flow cytometry and ELISpot clinical trial data.

BACKGROUND: Although relational databases are widely used in bioinformatics with deposited and finalized data, they have not received widespread usage among immunologists for managing raw laboratory data such as that generated by ELISpot or flow cytometry assays. Almost no published guidance exists for immunologists to design appropriate and useful data management systems. METHODS: We describe the design and implementation of a Microsoft Access relational database used in a clinical trial in which the primary immunogenicity measures were ELISpot and intracellular cytokine staining. RESULTS: Our data management system enabled us to perform sophisticated queries and to interpret our data as quantitatively as possible. It could easily be used without modification by other researchers using automated plate reading of ELISpot plates or four color flow cytometry. CONCLUSION: We illustrate in detail the use of a flexible data management system for two of the most widely used immunological techniques. Minor modifications for more colors or other outputs can easily be implemented. Based on this example, other modifications could be easily envisaged for any other quantitative output.

Biological Specimen Banks↗

PubMed2006

Patterns of care among adolescents with malignancy in Ohio.

Adolescents with malignancy represent a unique population in oncology that traditionally has received care at a variety of institutions. Recent data have shown that clinical trial involvement and patient outcomes in this age group may be influenced by the type of hospital at which they are treated. This article examines factors influencing the location of treatment of patients aged 15 to 19 years from selected areas in Ohio. Patients 15 to 19 years of age with malignancy from the selected 45 counties between 1996 and 1999 were identified from the Ohio Cancer Incidence and Surveillance System database. Factors analyzed included specific diagnosis, age, race, and treating institution. A total of 169 patients were identified, with 46.7% treated at pediatric institutions, 24.8% at adult academic centers, and 28.5% at community hospitals. Diagnosis influenced treatment location: leukemias, central nervous system tumors, and sarcomas were treated more often at pediatric hospitals, whereas melanoma was more often treated at adult academic centers. Patient age and distance from an academic center were also found to affect the location of treatment. Specific diagnosis, age, and geographic location influence the site of treatment of adolescent patients. Efforts to improve survival and increase enrollment in clinical trials must take these factors into account.

Academic Medical Centers↗

PubMedDate not supplied

Past and current trends in soy supplementation: a bibliographic study.

The aim was to determine in what areas the therapeutic application of soy predominates in clinical trials and to assess the emerging fields of its use by means of an analysis of bibliographic resources. A search was performed in the MEDLINE database up to 31 december 2004, limited to the Title/Abstract field, and Clinical Trials as the type of publication. The abstracts from the publications selected (n=86) were reviewed and different variables were assessed. A total of 3280 subjects were included: 15% men and 59% women (71% postmenopausal). The studies were performed basically in healthy individuals (71%). Twenty five percent of the studies investigated plasma levels of different metabolites and 21% determined hormone or lipid profiles. After the year 2000 a new population focus was detected, with the publication of two studies in elite gymnasts and judoists, with positive results. The present observations indicate that soy supplementation in the competitive sports elite may be an emerging application.

Adult↗

PubMed2002

A global livestock production and health atlas (GLiPHA) for interactive presentation, integration and analysis of livestock data.

An interactive electronic atlas has been developed with the purpose of providing a scaleable overview of spatial and temporal variation in animal production and health-related information for decision and policy makers in national and international institutions. The information contained in the atlas is currently managed and presented using the Key Indicators Mapping System (KIMS), and will also be integrated using the Key Indicators Database System (KIDS). Both systems were developed by the World Agricultural Information Centre of the FAO (FAO-WAICENT), the former as a stand-alone application and the latter for access via the Internet. Components of the atlas include vector maps, livestock disease and production databases, rules for country-level disease risk classification and 'disease cards' containing basic background information on diseases included in the atlas. The disease data is currently based primarily on Office International des Epizooties (OIE) disease reports, and the livestock production data on the FAO-WAICENT database. The atlas is highly interactive and allows visual presentation of information using maps, tables and charts. It also contains links to relevant resource information on the Internet. Diseases covered in the animal health layer include most OIE List A diseases and a subset of OIE List B diseases. Extensive analyses have been conducted to develop a set of qualitative and semi-quantitative criteria that allow improved disease status classifications based on 5-years cumulative OIE disease reports, and official disease control declarations. Classification rules were determined depending on the epidemiological features of each disease and considering spatial heterogeneity of disease presence in local regions.

Animal Diseases↗

PubMed2005

Aspergillosis in the CLEAR outcomes trial: working toward a real-world clinical perspective.

Aspergillosis is a potentially lethal infection of immunocompromised patients. Until 10 years ago, antifungal therapy was largely limited to amphotericin B deoxycholate. Perceived poor response rates and inherent toxicities with amphotericin B deoxycholate were a major stimulus for the development of newer antifungals, including lipid-formulated amphotericin B, broad spectrum azoles, and echinocandins. Response rates to antifungals are highly dependent on the underlying diagnosis and degree of immune suppression of the patient. Patients at highest risk of death from aspergillosis also have very high mortality rates from other causes as well. Outcomes reported in historical literature reviews fail to distinguish between overall mortality and death attributable to aspergillosis. While this distinction can often be difficult to assess clinically, the net effect is to underestimate the therapeutic success rates of antifungals. The CLEAR (Collaborative Exchange of Antifungal Research) project started as a post approval survey to monitor clinical use of amphotericin B lipid complex (ABLC). The scope of the CLEAR project included collection of clinical data to assess outcomes in patients with invasive fungal infections treated with ABLC. Clinical data from more than 3500 patients were entered into the CLEAR database. Outcomes were assessed for 509 patients with documented aspergillosis and complete data records. Overall response rate was 63% (cured/improved/stable) with site-specific response rates of 61%, 59%, and 32% for lung, sinus, and central nervous system infections, respectively. Solid organ transplant recipients had higher response rates than patients with hematological malignancies. Bone marrow transplant recipients had the lowest response rates. Clinical response rates with ABLC reported in the CLEAR trial are higher than response rates reported for amphotericin B deoxycholate in other trials. Since it is unlikely we will see any new comparative Phase III trials for aspergillosis, CLEAR-type outcome studies will prove useful for the foreseeable future to guide clinical management of aspergillosis.

Amphotericin B↗

PubMed1998

Bridging studies.

The duplication of usually large-scale efficacy trials to generalise the clinical database of a new vaccine to other populations can be avoided by bridging studies. Immunogenicity data can easily be used to extrapolate efficacy results when the immune response correlates with vaccine induced immunity. In the absence of such a correlate of protection, the bridging process will be more controversial. Previous experiences should be valuable in identifying the factors, either ethnic or vaccine-related that may have an influence on vaccine efficacy. The probability that such a factor is associated with a clinically significant difference in efficacy is critical to the decision to conduct a bridging study. Bridging studies are designed to demonstrate equivalent immunogenicity i.e. exclude a clinically significant difference in the immune response between the population in whom efficacy was shown and the population to whom those efficacy results are extrapolated.

Clinical Trials as Topic↗

PubMed1997

Analyzing the research record of an institution's list of faculty publications.

Few health sciences libraries maintain databases and produce bibliographies of the publications of their institution's faculty. By offering such services, libraries can provide faculty members with a qualitative analysis of where and how their research is cited and its impact in the fields of biomedicine and related health sciences. Journal Citation Reports (JCR), produced by the Institute for Scientific Information, is a powerful tool that provides information on citations appearing in the largest, most frequently used, most cited, and highest-impact journals. This paper discusses the role libraries play in providing information about faculty publications, reviews how JCR is used by libraries, discusses how the Ehrman Medical Library of the New York University Medical Center uses JCR, and makes recommendations for the use of JCR to strengthen the librarian's role in providing information to faculty about the value of their research.

Bibliographies as Topic↗

PubMed2005

Efficacy and effectiveness of physical therapy in enhancing postural control in children with cerebral palsy.

The purpose of this article was to conduct a systematic review of studies that examined the efficacy and effectiveness of postural control intervention strategies for children with CP. Only physical therapy interventions were included, e.g. adaptive seating devices, ankle foot orthoses, neurodevelopmental treatment. A multifaceted search strategy was employed to identify all potential studies published between 1990 and 2004. The search strategy included electronic databases, reference list scanning, author and citation tracking of relevant studies, and hand searching of pediatric physical therapy journals and conference proceedings. Twelve studies (1991-2004), comprising ten group design studies and two single subject studies, met our inclusion criteria. A variety of age ranges and severity of children with cerebral palsy (n=132) participated in the studies. The study quality scores ranged from 2 to 7 (total possible range of 0 to 7) with a median score of 5.5 and a mode of 6. As was true in an earlier systematic review on adaptive seating, most of the 12 'experimental' studies published since 1990 that were aimed at evaluating the effectiveness of postural control strategies provided lower levels of evidence, i.e. Sackett Levels III to V. Additional studies with stronger designs are needed to establish that postural control interventions for children with CP are effective.

Adult↗