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PubMed2001

Searching fee and non-fee toxicology information resources: an overview of selected databases.

Toxicology profiles organize information by broad subjects, the first of which affirms identity of the agent studied. Studies here show two non-fee databases (ChemFinder and ChemIDplus) verify the identity of compounds with high efficiency (63% and 73% respectively) with the fee-based Chemical Abstracts Registry file serving well to fill data gaps (100%). Continued searching proceeds using knowledge of structure, scope and content to select databases. Valuable sources for information are factual databases that collect data and facts in special subject areas organized in formats available for analysis or use. Some sources representative of factual files are RTECS, CCRIS, HSDB, GENE-TOX and IRIS. Numerous factual databases offer a wealth of reliable information; however, exhaustive searches probe information published in journal articles and/or technical reports with records residing in bibliographic databases such as BIOSIS, EMBASE, MEDLINE, TOXLINE and Web of Science. Listed with descriptions are numerous factual and bibliographic databases supplied by 11 producers. Given the multitude of options and resources, it is often necessary to seek service desk assistance. Questions were posed by telephone and e-mail to service desks at DIALOG, ISI, MEDLARS, Micromedex and STN International. Results of the survey are reported.

Bibliographies as Topic↗
PubMed1999

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↗
PubMedDate not supplied

The importance of large, high quality clinical databases in nephrology.

While clinical trials constitute an undisputed standard, they are not perfect because they are focused on a well defined segment of patients with a given disease. Generalizability is a problem with these studies because the experimental setting often differs substantially from everyday clinical practice. Clinical files are traditionally the main source of information for clinical medicine. The quality of recorded information in clinical files is often unsatisfactory. Yet clinical files are data-rich and ought to be considered as a valuable resource, particularly when clinical information is stored in electronic format. Clinicians have already started to construct very large, high quality clinical databases. Outcome research based on high quality data retrieved from well organized and exhaustive clinical files is bound to become increasingly important. Standardization is fundamental for these projects to be successful. The task may be daunting but worth while; due to complexity and cost the randomised clinical trial is unlikely to remain the only source of information on which to base clinical decisions about treatments.

Clinical Trials as Topic↗
PubMed2003

Demographic and migraine characteristics of adolescents with migraine: Glaxo Wellcome clinical trials' database.

OBJECTIVE: To describe the demographics and migraine characteristics of patients in the Glaxo Wellcome adolescent clinical trials' database. METHODS: Data from 8 sumatriptan (tablet and nasal spray) and naratriptan (tablet) trials (6 placebo controlled and 2 open label) were reviewed. Adolescents aged 12 to 17 years who had participated in migraine clinical trials and used at least 1 dose of study medication were summarized using descriptive statistics. Patient demographic (gender, age, race, height, and weight) and migraine (diagnosis, pain location and intensity, time and day of migraine onset and treatment, and associated symptoms) characteristics were examined. RESULTS: One thousand nine hundred thirty-two adolescents with migraine were identified; mean age was 14.1 years (standard deviation, 1.64; range, 11 to 18) and 54% of patients were female. More males were represented in the 12- to 14-year-old group (646 [73%] of 885) than in the 15- to 17-year-old group (234 [26%] of 885). Most patients reported migraine without aura (67%, 1121 of 1672), unilateral migraine pain (58%, 458 of 787), and pulsating pain (74%, 582 of 790). Migraine was aggravated by physical activity in most of the adolescents (88%, 526 of 598). Most migraine attacks (73%, 1363 of 1858) began between 6 am and 6 pm, and proportionately more attacks occurred Monday through Wednesday. Pretreatment vomiting was experienced by 5% (97 of 1830) of patients, nausea by 53% (983 of 1849), and photophobia or phonophobia (or both) by 88% (1628 of 1858) of patients. The incidence of associated symptoms was directly related to pretreatment headache severity. CONCLUSIONS: In this large clinical trials' database, adolescents had migraine without aura characterized by unilateral and pulsating pain and aggravated by activity. The incidence of associated symptoms was directly related to pretreatment pain intensity. More migraines occurred Monday through Wednesday during typical school hours. These data may facilitate clinicians' efforts to tailor migraine therapy to the needs of this patient population.

Adolescent↗
PubMed1997

[Meta-analysis].

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Clinical Trials as Topic↗
PubMed1994

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↗
PubMed1993

Meta-analysis.

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Bias↗
PubMed1996

[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↗
PubMed2002

Oral medicine and oral pathology--the impact of electronic information.

This paper discusses recent advances in electronic information, with particular reference to Oral Medicine and Oral Pathology. Email has become the norm for professional communication; Medline is freely accessible; content alerts can be established to alert the subscriber to new publications; evidence-based practice is emerging with the development of the Cochrane library and numerous other databases are also available for a variety of purposes. Conferences are moving to use electronic information as the medium for dissemination of proceedings. Bulletin boards provide a forum for interchange of ideas and opinions in both Oral Medicine and Oral Pathology and electronic data transfer can be used in various applications in telemedicine, telepathology and teleradiology. Without doubt these mechanisms will be further developed and refined in the present century.

Congresses as Topic↗
PubMedDate not supplied

The AIDS Clinical Trials Information Service (ACTIS): a decade of providing clinical trials information.

The AIDS Clinical Trials Information Service (ACTIS) is a central resource for information about federally and privately funded HIV/AIDS clinical trials. Sponsored by four components of the U.S. Department of Health and Human Services, ACTIS has been a key part of U.S. HIV/AIDS information and education services since 1989. ACTIS offers a toll-free telephone service, through which trained information specialists can provide callers with information about AIDS clinical trials in English or Spanish, and a website that provides access to clinical trials databases and a variety of educational resources. Future priorities include the development of new resources to target diverse and underserved populations. In addition, research needs to be conducted on the use of telephone services vs. Web-based information exchange to ensure the broadest possible dissemination of up-to-date information on HIV infection and clinical trials.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Evaluating the evidence of effectiveness for preventive interventions: using a registry system to influence policy through science.

In order to deal with the serious problems of drug use, delinquency, and mental health problems in this country, policy makers, communities, practitioners, and advocates need to identify prevention programs that have empirical support and at the same time meet their own community needs regarding acceptability, cost, and training, and supervision. An "evidence-based" approach to prevention, one that identifies the scientific knowledge about what prevention programs work, for whom, and under what circumstances, should play a critical part in this process. The premise of this evidence-based approach is that the wide adoption of prevention programs that have been found to be successful in rigorous evaluations, will lead to successful population-based prevention strategies. A web-based registry, or database that describes the available scientific information on individual preventive trials, would be of high potential use to policy makers engaged in prevention planning for their communities. This presentation describes a model registry based on descriptions of 167 preventive trials aimed at children aged 0-6. Empirical findings are presented regarding two critical components of the registry, the measurement of the quality of the trial and the strength of evidence for a beneficial effect produced by each intervention. Implications for the use of such a registry are also discussed.

Adolescent↗
PubMed1998

The effectiveness of acupuncture in treating acute dental pain: a systematic review.

OBJECTIVE: Acupuncture is frequently advocated as an effective treatment of dental pain. The question whether or not it is effective for this indication remains controversial. The aim of this systematic review therefore was to assess the effectiveness of acupuncture in dental pain. DATA SOURCES: Four electronic databases were searched: Medline, Embase, CISCOM, and the Cochrane Library. Only controlled trials were included in this review. DATA EXTRACTION: Information was extracted from included studies and entered on standard forms independently by both authors. Methodological quality was assessed using the Jadad score. MAIN RESULTS: 16 such studies were located. The majority of these trials imply that acupuncture is effective in dental analgesia. However, important questions remain unanswered. CONCLUSION: It is concluded that acupuncture can alleviate dental pain and that future investigations should define the optimal acupuncture technique and its relative efficacy compared with conventional methods of analgesia.

Acupuncture Analgesia↗
PubMedDate not supplied

Use of methylene blue in sepsis: a systematic review.

A systematic review of the literature was conducted to determine if the administration of methylene blue in humans improves hemodynamic status and/or outcome in patients with septic shock. Studies were identified from MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials database. The review included human studies of patients with septic shock treated with methylene blue in which hemodynamic variables or mortality rates were reported. An electronic form was used to extract items including study design, population characteristics, intervention details, and outcomes. No meta-analysis was performed. Methylene blue administration in patients with septic shock increases mean arterial pressure and systemic vascular resistance while decreasing vasopressor requirements. Increased pulmonary vascular resistance has been reported with bolus administration but might be avoided by continuous infusion. No other ill effects were reported. Effects on mortality have not been adequately evaluated in the literature.

Blood Pressure↗
PubMedDate not supplied

Differential diagnosis and treatment strategies for biologic complications and failing oral implants: a review of the literature.

The aim of this article was to review the literature on differential diagnosis and treatment of biologic complications and failing implants. All types of publications, with the exception of abstracts, published in English up to December 1998, were included. A multi-layered search strategy was used. Controlled clinical trials (CCTs) were searched in the Cochrane Oral Health Group's Specialized Register of Trials. This database contains all CCTs identified in MEDLINE and EMBASE. PubMed was searched using various key words and the "related articles" feature. All identified publications were obtained and none were excluded. Infection, impaired healing, and overload are considered the major etiologic factors for the loss of oral implants. Only a few clinical and animal investigations were found that tested the validity of the proposed therapeutic approaches. The treatment of failing implants is still based mainly on empirical considerations, often derived from periodontal research, from data extrapolated from in vitro findings, or from anecdotal case reports performed on a trial-and-error basis.

Animals↗