Appropriate use of restricted antimicrobial agents in hospitals: the importance of empirical therapy and assisted re-evaluation.
(1/15)
We evaluated the appropriateness of use of restricted antimicrobial agents in the context of a newly implemented order form and delivery system for restricted antimicrobial agents, using sequential prospective audits of prescriptions. Four antimicrobial agents were selected: glycopeptides (61 prescriptions), ciprofloxacin (42), piperacillin-tazobactam (42) and imipenem- cilastatin (47). The justification and adequacy of the antibiotic or combination used, reassessment of therapy and duration of treatment were appraised with reference to the clinical situation and hospital's guidelines. Of the 192 prescriptions, 30 (16%) were empirical therapy, 95 (49%) empirical and secondarily documented and 67 (35%) initially documented therapy. Overall, 73% of prescriptions conformed to guidelines, but the adequacy varied from 93% for vancomycin to only 38% for ciprofloxacin. Of 83/157 initially inadequate prescriptions, 42 (51%) were switched according to guidelines, but only 14% of ciprofloxacin prescriptions were adapted later. An intervention audit with counselling on ciprofloxacin usage increased this rate to 75%. Although implementation of the guidelines resulted in a marked reduction in overall antimicrobial costs, inappropriate antibiotic usage may persist for some drugs despite restricted access. These results emphasize the need for combined interventions using education and expert counselling, targeted to classes of antibiotic for which inappropriate usage is most common. (+info)
Empirically supported treatments in pediatric psychology: regimen adherence.
(2/15)
OBJECTIVE: To review empirical studies of psychological interventions for nonadherence to medical regimens for three chronic illnesses: asthma, juvenile rheumatoid arthritis (JRA), and type 1 diabetes. METHODS: The Chambless criteria for "promising," "probably efficacious," or "well-established" were applied to 8 intervention studies on asthma, 4 on JRA, and 11 on type 1 diabetes. RESULTS: For asthma, organizational strategies appear probably efficacious in promoting adherence, whereas educational and behavioral strategies appear promising. For JRA, behavioral strategies appear probably efficacious in improving adherence. For type 1 diabetes, multicomponent packages and operant learning procedures appear probably efficacious, whereas cognitive-behavioral strategies appear promising. No interventions were identified as "well-established." CONCLUSIONS: Future studies will need to develop adequate definitions of adherence, accurate methods of assessing adherence, and appropriate designs to evaluate multicomponent treatment programs to advance interventions to the "well-established" category. (+info)
Cefepime versus cefotaxime for empirical treatment of bacterial pneumonia in HIV-infected patients: an open, randomized trial.
(3/15)
An open, randomized, multicentre clinical trial was conducted to compare the efficacy and safety of cefepime 2 g iv bd (2 g tds daily in cases of Pseudomonas aeruginosa pneumonia) with cefotaxime 2 g iv tds, in the empirical treatment of bacterial pneumonia in HIV-infected patients. The primary end-point was effectiveness after 3-5 days of treatment, taking success to be when the study drug was continued during this period of time. Clinical and bacteriological responses at end of treatment (EOT) were also evaluated. Analyses of the intention-to-treat population (n = 160) and the as-per-protocol groups (n = 150) were carried out. Treatment groups were comparable with regard to sex, age, HIV status and degree of severity of pneumonia. The primary end-point for cefepime was considered successful for the intention-to-treat and as-per-protocol groups in 85.7% and 93.5% of cases, respectively, and for cefotaxime, in 77.6% and 80.8% of cases, respectively (P = 0.22 and P = 0.02). In the as-per-protocol group, cefotaxime treatment was independently related to failure at the primary end-point. A satisfactory clinical response in the intention-to-treat population was observed in 83.3% of cefepime and 82.9% of cefotaxime patients. Bacteriological cure was obtained in 100% of evaluable cefepime and 93.4% of evaluable cefotaxime patients at EOT. Safety of the study drugs was comparable in both treatment groups. Cefepime 2 g iv bd was at least as effective and as well tolerated as cefotaxime 2 g iv tds in the treatment of bacterial pneumonia in HIV-infected patients. (+info)
Decisional capacity of patients with schizophrenia to consent to research: taking stock.
(4/15)
With the growth in recent years of studies of decisional capacity for research among people with schizophrenia, this is an opportune time to ask three questions: What have we learned from these studies? What remains to be learned? And what normative issues still need to be resolved? Among the things learned are that patients with schizophrenia, as a group, have lower scores on measures of decisional capacity than normals, but higher performance than patients with dementia. However, performance is highly variable within the group, correlates most strongly with neuropsychological impairment, and seems susceptible in many patients to successful remediation. The issues that remain in need of exploration include the development of a brief screening instrument for decisional capacity that can be used routinely, and the identification of those patients most likely to benefit from more intensive informational procedures. Finally, among the normative issues still in need of resolution are the degree of capacity needed to consent to research participation, how to deal with fluctuating capacity during research projects, and the legitimate extent of surrogate consent for participation of incompetent patients in research. (+info)
The relevance of empirical research in bioethics.
(5/15)
Empirical research related to ethical issues in clinical research has grown dramatically in recent years. However, little attention has been devoted to the ethical relevance of the findings from this research. In order to examine the value and limitations of ethics-related empirical research, we discuss 3 case studies involving research with stored biological samples, placebo-controlled trials, and the idea of the therapeutic misconception. (+info)
Emerging empirical evidence on the ethics of schizophrenia research.
(6/15)
Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics. (+info)
Meta-consent in research on decisional capacity: a "Catch-22"?
(7/15)
Empirical studies of ethical issues, which have increased in number and scope in recent years, may themselves raise both practical and ethical issues. One example of such an issue is the question of who may be legitimately enrolled in studies of decision-making capacity; must all participants in studies of consent capacity have capacity to consent? This question may pose a "Catch-22": For example, if some of the participants in a study of consent capacity are deemed by a particular standard to be incapable of consent. In weighing the risks and benefits of studies of consent capacity, how should reviewers consider the context of actual versus hypothetical trials for which the participant's consent is being sought? Here, we explore these "meta-consent" issues by describing the dimensions of the issue and potential solutions, centering around the concept of "active assent" (requiring expressed understanding of the purpose of the study and its voluntary nature, as well as expression of a choice to participate). (+info)
Mental disorder ethics: theory and empirical investigation.
(8/15)
Mental disorders and their care present unusual problems within biomedical ethics. The disorders themselves invite an ethical critique, as does society's attitude to them; researching the diagnosis and treatment of mental disorders also presents special ethical issues. The current high profile of mental disorder ethics, emphasised by recent political and legal developments, makes this a field of research that is not only important but also highly topical. For these reasons, the Wellcome Trust's biomedical ethics programme convened a meeting, "Investigating Ethics and Mental Disorders", in order to review some current research, and to stimulate topics and methods of future research in the field. The meeting was attended by policy makers, regulators, research funders, and researchers, including social scientists, psychiatrists, psychologists, lawyers, philosophers, criminologists, and others. As well as aiming to inspire a stronger research endeavour, the meeting also sought to stimulate an improved understanding of the methods and interactions that can contribute to "empirical ethics" generally. This paper reports on the meeting by describing contributions from individual speakers and discussion sections of the meeting. At the end we describe and discuss the conclusions of the meeting. As a result, the text is referenced less than would normally be expected in a review. Also, in summarising contributions from named presenters at the meeting it is possible that we have created inaccuracies; however, the definitive version of each paper, as provided directly by the presenter, is available at http://www.wellcome.ac.uk/doc.WTX025116.html. (+info)