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At least 73 records · Page 4Linked to original sources

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↗

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↗

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↗

AIDS information from the National Library of Medicine.

As part of a U.S government effort to combat AIDS, the National Library of Medicine (NLM) is expanding its information services in this area. In response to the Health Omnibus Program Extension Act of 1988, NLM has expanded its AIDS Bibliography, enhanced its DIRLINE file with AIDS-related organizations, and developed three new online MEDLARS (Medical Literature Retrieval and Analysis System) databases: AIDSLINE, AIDSTRIALS, and AIDSDRUGS. NLM's AIDS-related programs and services are discussed.

Acquired Immunodeficiency Syndrome↗

The Internet for the medical and scientific community.

With the explosion of data coming out from the international scientific community, researchers can now locate and manipulate data of interest quickly and easily on the Internet. The scope of this review is to focus on some of the recent developments of the Internet that are specially relevant to health scientists. The review also provides the medical and scientific community with a selection of sites to visit on the Internet, dealing with clinical and laboratory aspects of science.

Bibliographies as Topic↗

On the need for evidence-based medicine.

Doctors always seek to base their decisions on the best available evidence. Often this evidence represents extrapolations of pathophysiological principles and logic rather than established facts based on data derived from patients. The advent and proliferation of randomized controlled trials have led to a rapid increase in the quantity and quality of clinically valid evidence concerning clinical history taking and physical examination, issues of diagnosis, prognosis, therapy and other important health care issues. As a result it is becoming possible to make explicit much of the implicit non-verbal reasoning of expert clinicians, making their clinical reasoning more comprehensible and accessible to trainees. The ability to track down, critically appraise and incorporate evidence into clinical practice has been named 'evidence-based medicine'. As the quantity of valid evidence increases so does the requirement for each of us to develop the skills necessary to assimilate, evaluate and make best use of that evidence for patients. Often we fail to identify or address our daily needs for clinically important knowledge, leading to a progressive decline in our clinical competency. When we do seek knowledge traditional sources of information such as journals and text-books are often either too disorganized or out of date and we often resort to asking colleagues. The need to maintain and expand clinically important knowledge has been partially addressed by increasing demands for continuing medical education but how might this be best achieved? Recent evaluations suggest that three evidence-based medicine strategies help fulfill these goals. They include; learning evidence-based medicine, seeking and applying evidence-based medical summaries generated by others, and accepting evidence-based protocols developed by others.

Community-Institutional Relations↗

[Center monitoring and management of data bases].

In this article the authors show the correct method to gather together clinical data. First they explain how to compile clinical files (five cards) and how to maintain the centres and monitor them. The initial quality of the data is increased by the creating of a structure with "regional" and "central" monitors. Thirdly the authors explain data management: how to code and enter data, how to check its correctness and lastly data base authorization.

Acetylcarnitine↗