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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 253 records · Page 14Linked to original sources
PubMed2006

Types of clinical studies. Systematic reviews.

Systematic reviews are analytic instruments that summarize the best available scientific evidence in order to provide evidence-based answers to clinically relevant questions. Meta-analyses are systematic reviews with a quantitative analysis of results. The process of conducting a systematic review is a rigorous and standardized procedure that includes: 1) formulating a clinically relevant question; 2) explicit selection of studies (primary or secondary) to be included in the review; 3) critical appraisal of the relevant evidence; 4) summarizing the evidence; and 5) statistical analysis of the results. In this paper we describe the steps involved in conducting a systematic review of scientific evidence, the methodology, and problems.

Clinical Trials as Topic↗
PubMed2006

Managing clinical data for worldwide acceptance.

Manufacturers conducting clinical studies to support medical device safety and performance claims need to ensure that clinical study data are appropriately managed. Not doing so can risk the success of the project related to the clinical study. This article discusses a guideline that can assist in this effort.

Clinical Trials as Topic↗
PubMedDate not supplied

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↗
PubMed2006

Returning genetic research results to individuals: points-to-consider.

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non-validated or hypothesis-generating). There is, however, a trend for research participants to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico-legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer 'Points-to-Consider' regarding returning results in the context of drug development trials based on their knowledge and experience. Theses considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit-to-risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies.

Access to Information↗
PubMed1990

[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↗
PubMed2006

Rationale and uses of a public HIV drug-resistance database.

Knowledge regarding the drug resistance of human immunodeficiency virus (HIV) is critical for surveillance of drug resistance, development of antiretroviral drugs, and management of infections with drug-resistant viruses. Such knowledge is derived from studies that correlate genetic variation in the targets of therapy with the antiretroviral treatments received by persons from whom the variant was obtained (genotype-treatment), with drug-susceptibility data on genetic variants (genotype-phenotype), and with virological and clinical response to a new treatment regimen (genotype-outcome). An HIV drug-resistance database is required to represent, store, and analyze the diverse forms of data underlying our knowledge of drug resistance and to make these data available to the broad community of researchers studying drug resistance in HIV and clinicians using HIV drug-resistance tests. Such genotype-treatment, genotype-phenotype, and genotype-outcome correlations are contained in the Stanford HIV RT and Protease Sequence Database and have specific usefulness.

Anti-HIV Agents↗
PubMed2004

Predicting the response to sumatriptan: the Sumatriptan Naratriptan Aggregate Patient Database.

OBJECTIVE: The efficacy and tolerability profiles of sumatriptan and other 5HT(1B/1D) agonists (triptans) have been well established. However, the determinants for optimal response to sumatriptan are unknown. The Sumatriptan Naratriptan Aggregate Patient (SNAP) database contains data from 128 clinical trials including 28,407 migraine sufferers treating over 130,000 attacks. The authors analyzed these data to identify factors predicting response (headache relief and pain-free response) to sumatriptan. METHODS: The authors assessed 24 possible univariate predictors of headache response in 3,706 patients (18 years and older) receiving sumatriptan tablets 100 mg or placebo in a double-blind study using recursive partitioning and logistic regression techniques. RESULTS: The authors found seven predictors of headache relief 2 hours postdose. Moderate pain at baseline was the strongest predictor (adjusted p = 3.32 x 10(-35)), followed by absence of a disability requiring bedrest (adjusted p = 3.11 x 10(-18)). Other predictors included absence at baseline of vomiting, pulsating pain, nausea, or photophobia/phonophobia, and onset of headache during daytime hours. Logistic regression confirmed that treatment with sumatriptan was the strongest predictor of headache relief, with significant baseline covariates being pain severity, level of disability, and presence or absence of vomiting. A similar pattern of results was reported for predictors of pain-free response 2 hours after taking sumatriptan. CONCLUSIONS: Pretreatment pain severity is the most important predicting factor for response to sumatriptan in migraine attacks: the lower baseline severity, the better.

Adolescent↗