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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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PubMed1995

[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↗
PubMed1998

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↗
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↗
PubMed1997

[Meta-analysis].

Explore the source record for details and available documents.

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.

Explore the source record for details and available documents.

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↗
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

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↗
PubMedDate not supplied

[Evaluation of the degree of compliance of Spanish scientific biomedical journals with international standards of presentation of periodicals].

BACKGROUND: Because standardization is important to ensure the successful transfer of scientific information, compliance with international standards for the presentation of periodicals in 205 Spanish biomedical journals, with the aim of improving their quality as instruments of information transfer, is evaluated. METHODS: Journals were identified by consulting five printed bibliographies and four electronic databases. A total of 136 parameters of evaluation for the presentation of periodicals derived from ISO (International Standardization Organization) standards (86%) and recommendations published by UNESCO, the International Committee of Medical Journal Editors, The Council of Biology Editors, and EJ Huth (14%) were evaluated. Three features (inclusion, presentation and location) were recorded for most data item, and the total number of items studied was 342. RESULTS: The rate of compliance with standards in Spanish biomedical journals was 33.5% +/- 8.5 (DE). Compliance was highest for items related with the identification of the journal in the text pages and the issue contents list. The lowest rates of compliance were found for items related the volume and the abstract sheet. The worst standardized journals were those published by private firms and public administration organizations. As a group, journals published annually were the best standardized. CONCLUSIONS: The low rate of compliance with standards did not reflect inadequate compliance with all items, but was rather the result of complete noncompliance with particular standards, especially those relating to the abstract sheet, volume front cover, volume contents list and volume index. To improve compliance a change in the policies governing the availability of standards, the preparation of guides and manuals for scientific periodical publishing, and the development of training programs aimed at authors, editors, publishers, librarians and information scientists, is suggested.

Bibliographies as Topic↗
PubMed1997

Safety of oral terbinafine: results of a postmarketing surveillance study in 25,884 patients.

OBJECTIVE: To broaden the safety database for oral terbinafine by determining the incidence of adverse events, particularly rare risks, that accompany its uncontrolled use in actual clinical practice. DESIGN: Four open, prospective, uncontrolled, postmarketing surveillance studies were conducted in unselected patients in 4 countries. No exclusion criteria were applied. The only treatment instructions participating physicians received were the manufacturer's product information. Physicians monitored patients for adverse events at baseline, during treatment, and at the end of treatment. Serious events were identified according to study protocol, which was consistent for all 4 studies, allowing data to be pooled and analyzed collectively. SETTING: Patients were recruited from dermatology, general, and family practices in the United Kingdom, the Netherlands, Germany, and Austria. PATIENTS: Of the 25884 patients who entered the study, 38.6% had concomitant diseases, 42.8% were taking other medications, and 22.7% were older than 60 years. The predominant indication for terbinafine treatment was onychomycosis (72.2%). INTERVENTIONS: Data on treatment duration was available for 25091 patients. Median duration of treatment was 12 weeks (mean, 13.2 weeks). Treatment extended beyond 6 weeks in 76.0% of patients and for at least 12 weeks in 59.3%. MAIN OUTCOME MEASURES: The incidence of adverse events as reported by physicians, with their opinions regarding relationship to terbinafine therapy. RESULTS: The incidence of adverse events was 10.5%; the majority involved the gastrointestinal system (4.9%) or skin (2.3%). These tended to be mild, transient, and reversible. Terbinafine was considered a possible or probable cause of 11 (0.04%) serious adverse events. No drug interactions were reported, even in patients taking oral antidiabetic agents, astemizole, terfenadine, or cimetidine hydrochloride. CONCLUSIONS: The positive safety profile established during controlled clinical trials of oral terbinafine extends to its uncontrolled use in clinical practice. No previously unrecognized risks were identified.

Adolescent↗
PubMedDate not supplied

Finding, reading and documenting literature.

Before embarking on an evaluation project it is important to be familiar with the relevant literature. Critical reading of the literature is essential in helping the investigator refine the questions and design of his or her study. The retrieval and use of available literature for use in a study proposal is outlined here.

Bibliographies as Topic↗
PubMed1999

The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force.

Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of MS (e.g. , cognitive function), and they have psychometric limitations as well. Based on analyses of pooled data from natural history studies and from placebo groups in clinical trials, the National MS Society's Clinical Outcomes Assessment Task Force recently proposed a new multidimensional clinical outcome measure, the MS Functional Composite (MSFC). The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg function/ambulation, arm/hand function, and cognitive function. Scores on component measures are converted to standard scores (z-scores), which are averaged to form a single MSFC score. Preliminary analyses confirm that: (1) the three clinical dimensions of the MSFC are relatively independent; (2) the MSFC is sensitive to clinical changes over 1- and 2-year intervals; and (3) the MSFC has acceptable criterion validity (i.e., predicts both concurrent and subsequent EDSS change). The advantages and potential limitations of incorporating quantitative functional outcome measures such as the MSFC into collaborative databases are discussed.

Clinical Trials as Topic↗