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Biomedical subjects

R Bradshaw

Publications and source records attributed to R Bradshaw.

11 recordsLinked to original sources

Women subjects in NIH-funded clinical research literature: lack of progress in both representation and analysis by sex.

The National Institutes of Health (NIH) issued guidelines in 1990 requiring the inclusion of women and minorities in all NIH-sponsored clinical research and revised these guidelines in 1994 to require analysis of clinical trial outcomes by sex of the subjects. To ascertain whether these guidelines are yet reflected in the scientific literature, we performed a survey of research articles published in major medical journals. All original research articles in the New England Journal of Medicine, the Journal of the American Medical Association, the Journal of the National Cancer Institute, and Circulation from the years 1993, 1995, 1997, and 1998 were examined. Articles were assessed for use of human subjects, source of funding, type of study (clinical trial or not), sex-relatedness of the disease or condition, inclusion of women as study subjects, and analysis of outcomes by sex of the subjects. Among NIH-funded, non-sex-specific studies, approximately one fifth of the studies published each year failed to include women as research subjects. This number did not improve significantly over the 5-year period analyzed. Only one quarter to one third of the studies that included women analyzed data by sex of the subjects, with no significant change over the time period studied. Although most clinical trials included women as study subjects, in only a small percentage of the trials were results analyzed by sex of the subjects, with no significant improvement over time. These data clearly show the need for increased awareness and monitoring of recruitment and retention of women in clinical research and for analysis of data by sex of the subjects to be carried out consistently.

Clinical Trials as Topic↗

Gene targeting is locus dependent in the filamentous fungus Aspergillus nidulans.

The effect of altering the conditions of transformation on the efficiency of gene targeting in filamentous fungi was studied using Aspergillus nidulans as a model organism. The niaD and amdS genes of A. nidulans, which are both involved in nitrogen source utilisation, were selected as target loci. Homologous recombination of transforming DNA at these loci resulted in niaD and amdS mutants with an impaired ability to utilise nitrate or acetamide as the sole nitrogen source, respectively. Vectors were constructed that contained the Neurospora crassa pyr4 gene as a selectable marker and an internal segment of the amdS (0.6-1.27 kb) or niaD (0.9-2.15 kb) genes. The parameters investigated for their effect on gene targeting included (a) length of homologous DNA in the disruption cassette, (b) conformation of the transforming vector (circular or linear), (c) transcriptional status (on/off) of the targeted gene, (d) concentration of DNA in the transformation mix and (e) temperature of incubation of the transformation reaction and of protoplast regeneration on selective media. Parameters shown to have an effect on the targeting frequency at the niaD locus were tested at the amdS locus. The level of gene targeting when circular DNA was used was found to correlate with the size of the homologous segment at both loci. Similarly the level of targeting was shown to increase when vectors were linearised within the region of homology. The level of targeting was unaltered at the niaD locus when transcription was induced at different stages in the transformation procedure. Likewise, targeting was unaffected by altering the amount of DNA in the reaction mix over the concentration range tested. The regeneration temperature did have an effect on targeting, with enhanced targeting observed at 25 degrees compared with 37 degrees C. However, the most dramatic effect was the difference between targeting efficiency at different genetic loci, with targeting of niaD being at least five fold more efficient than amdS under all conditions tested.

Amidohydrolases↗

Telling rights from wrong.

Is it right to medicate patients without their knowledge and consent? Or to tell an adult woman what she can eat? The UKCC is producing new guidance specifically to help mental health and learning disabilities nurses with the daily dilemmas of clinical practice.

Adult↗

Standardization of clinical decision making for the conduct of credible clinical research in complicated medical environments.

The likelihood that past experience will produce correct guides to current practice depends on the signal-to-noise ratio for the clinical problem of interest. If the signal-to-noise ratio is high, the decision will be sound and patient benefit likely to occur. If the signal-to-noise ratio is low, as is commonly the case with difficult clinical decisions, then personal experience and the best intentions will not assure sound clinical decisions. When the probability of benefit cannot be quantified, clinicians in complex settings are in danger of being misled by data and experience. Quantifiable probabilities established by group experiment or observation will be necessary for clinical decisions that can be expected to confer benefit on the patient. Explicit methods are necessary for interventions that can be replicated in experiments or in practice. Computerized protocols force the articulation of explicit clinical care methods and standardize clinical decision making. We have developed explicit, rule-based protocols, implemented them in our hospital, exported them to other hospitals, and successfully achieved a rigorous experimental environment in the clinical ICU. Exportation of such explicit methods may narrow the gap between efficacy (university hospital) and effectiveness (community hospital) research results.

Clinical Trials as Topic↗

Medical informatics academia and industry: a symbiotic relationship that may assure survival of both through health care reform.

There are often clear lines drawn identifying the demilitarized zone between medical informatics academics and industry. Academics were "pure" intellectuals sequestered in ivory towers that effectively shielded them from the realities of the world. Industry has historically focused on creating effective products that produce financial return to the corporation. Both the paradigms of academia and industry are quickly becoming dinosaurs in the era of health care reform where both medical informatics academia and industry are under increasing pressure to develop and prove that medical informatics has a positive impact on health care both in terms of the quality of care as well as cost. Unfortunately, neither academia or industry alone are going to be able to successfully complete this task. The purpose of this paper is to describe such a collaborative effort that has produced a computerized decision support system for the management of mechanical ventilation in patients with the Adult Respiratory Distress Syndrome (ARDS) that is now installed and supported on three different commercial CIS platforms. This collaborative effort has allowed us to successfully mount a large multi-center clinical trial designed to determine efficacy.

Clinical Protocols↗

Reducing alcohol consumption through television advertising.

Regular drinkers from the general public whose drinking behavior was known to be unaffected by a previous antidrug advertising campaign were involved in a field experiment to assess the impact of a television commercial based on controlled-drinking principles. In a 2 x 2 factorial arrangement of exposure to the advertising campaign (advertisement, no advertisement) and exposure to a letter announcing the campaign (letter, no letter), 96 subjects from two cities in tropical North Queensland provided baseline and posttreatment details of alcohol consumption and alcohol-related attitudes. Baseline measures were taken approximately 12 months prior to the start of the campaign, and posttesting occurred 3 weeks after the campaign. Results were consistent with the proposition that the advertisement reduced intake provided that subjects also received the standard letter alerting them to the start of the campaign.

Adolescent↗