The caregiver (or nurse) as risk manager: the law and logistics of obtaining valid consents.
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The results from studies on potential treatment effects of acupuncture are often limited due to serious difficulties in methodology. Randomized controlled trials on acupuncture should test a widely accepted treatment strategy of verum and sham acupuncture. However, in clinical practice various patterns of acupuncture techniques are employed, and up to now no generally accepted guidelines on how to perform a reliable verum or sham treatment have been established. Another limitation is that in most studies the study populations are too small to obtain reliable data and to detect subtle differences between the unspecific needling of sham acupuncture and specific needling of verum acupuncture with sufficient statistical power. Moreover, only a multicenter trial in an outpatient setting would guarantee a naturalistic environment in which acupuncture is used in clinical practice. In the present report we discuss such methodological aspects in detail and summarize some practical considerations for planning an acupuncture trial that fulfills evidence-based medical criteria. The largest German study on the treatment effects of acupuncture in patients with chronic shoulder pain (recruited patients n = 452), might serve as an example for such a well-designed study. Before we could conduct our study, clear definitions and protocols for the verum and sham acupuncture treatments as well as adequate endpoints had to be developed. For this we used a combination of a comprehensive study of the literature and structured interviews with experienced physicians followed by an expert panel. A total of 41 physicians had to be trained to achieve a homogeneously high quality of acupuncture treatment. The latter represents a prerequisite for reproducibility, constituting a critical component of rigorous efficacy trials in scientific acupuncture research.
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Antidotal compounds are principally classified into three groups. The most important compounds are available in all hospitals and pharmacies. They guarantee the basic supply of antidotes in all part of Switzerland. More specific antidotes are constantly available in 24 regional centres, some of which being further specialized in certain areas (e.g. Cantonal Pharmacy of Zurich: anti-venoms and radionucleotide-antidotes). Ongoing routine collaboration between the Swiss Toxicological Information Centre (STIC) and the Swiss Association of Hospital Pharmacists (GSASA) is important for continuous and competent information about the availability of newly developed antidotal drugs in Switzerland.
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Variations of fluorouracil (5-FU) therapy have formed the backbone of chemotherapy for advanced colorectal cancer for many years. With the advent of newer agents that often work best with or even require chemotherapy to optimize their activity, the issue of the optimal schedule and regimen of administration of 5-FU has taken on a renewed importance. The combination of irinotecan with 5-FU/leucovorin has consistently improved survival and response rates in comparison to 5-FU/leucovorin alone. However, the combination also increases the toxicity of the treatment, thus resulting in continuing attempts to improve on the toxicity profile of the combination, while retaining or improving upon the therapeutic outcomes. This article reviews the various combinations of irinotecan with 5-FU/leucovorin.
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A version of a logical combinatorial intellectual system (DMS system) has been developed to predict the toxicity and hazards of chemical substances. The system is based on the combined description of the substances, which includes both structural and numerical descriptors, particularly those characterizing the reactivity of compounds or their metabolites. The selection of numerical descriptors is based on the classification of processes of the interaction of the substance with the body in accordance with the key stage of the mechanism responsible for its toxic action. The new version of the DSM system takes into account the fact that the toxicity and hazard of chemicals are frequently determined by their bioactivation. Examples of how to apply the system to the prediction of carcinogenicity are given.
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