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It is important to choose appropriate topics for audit in order to produce satisfactory results and maintain interest and enthusiasm. A trail of incomplete audit cycles is unhelpful and demoralizing. The audit should be carefully designed and a vital stage is choosing appropriate standards upon which to measure current performance. An agreed policy provides a practical standard against which to audit the use of antibiotics.
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C1 esterase inhibitor (C1-INH) deficiency is a rare disorder that lacks consensus for diagnosis therapy and management. Recognizing that Canada is behind the European approach to this disorder, we have formed the Canadian Hereditary Angioedema Society (CHAES)/Société d'angioédème héréditaire du Canada (SAHC) to foster knowledge of this disorder in Canada and to advance care of patients with this disorder in Canada. We here present a review of treatment of this disorder in Canada including prevention of angioedema events and use of replacement therapy and present an algorithm for diagnosis therapy and management of C1-INH deficiency in Canada for discussion at our International Conference on Hereditary Angioedema to be held in Toronto, Canada, October 24th to 26th, 2003.
This paper discusses regulatory requirements essential during the non-clinical development of cancer vaccines. DNA vaccines and vaccines containing monoclonal antibodies are specifically addressed. ICH, CHMP, FDA, and WHO guidance documents in addition to scientific literature are reviewed and the regulatory framework, including respective EMEA and the FDA divisions responsible for review and assessment of cancer vaccines, is described. Selection criteria for an appropriate animal model for efficacy and/or toxicity studies are discussed.
Emergency contraception is a therapy for women who have had unprotected sexual intercourse, including sexual assault. It also has been called the "morning-after pill," interception, and postcoital contraception. Methods of emergency contraception include use of combination or progestin-only oral contraceptives, danazol, synthetic estrogens and conjugated estrogens, antiprogestins, and the insertion of an intrauterine device. One particular combination oral-contraceptive regimen is the Yuzpe method This document addresses only combination and progestin-only oral contraceptives because they are the most frequently used methods. This document will present evidence regarding the safety, efficacy, risks, and benefits of the use of oral contraceptives for emergency contraception. For widespread use of this therapy, physician familiarity with the method public awareness of the method's availability, prompt availability of these methods (because of their time-sensitive nature), and access to a physician who is available to prescribe the method must be increased.
Nurses have an instrumental role to play in tobacco reduction, which is one strategy used to address tobacco use; a primary source of preventable morbidity and mortality globally. The following review addresses activities by two groups of nurses: nursing governance bodies and nurse scientists, whom together provide vision and knowledge to support and shape nursing practice. While nursing governance bodies and scientists have contributed a great deal to tobacco reduction, there are also gaps. Areas that require strengthening are: support for tobacco dependent nurses, basic nursing education concerning tobacco dependency treatment, and integration of tobacco dependence treatment into nursing practice.
Although the ultimate goal of any chemoprevention study is to extend life by preventing cancer, it is also important that in doing so, the quality of life is not reduced. Hence, quality of life (QOL) endpoints are secondary only in importance to survival as an endpoint for prostate chemoprevention trials. One can conceptualize QOL endpoints as just another surrogate endpoint biomarker. QOL can be administered and collected in a valid and reliable fashion from cancer patients as demonstrated by numerous clinical trials. To date more than 25 prostate cancer QOL tools have been developed with over 700 different items. However, patients may be asymptomatic, leaving the sensitivity and specificity of the QOL instrumentation in question. Judicious use of a global QOL measure supplemented by protocol-specific or disease-specific instruments is an efficient approach for prostate chemoprevention trials. Clinical significance and missing data considerations need to be elucidated a priori in definitive terms so that results are directly interpretable from the data obtained. The effect of chemopreventive agents on QOL needs to be sufficiently modest to be practical to justify administration in a healthy population. As such, great care needs to be given to a priori determination of the QOL constructs that are most likely to change.
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The L5178Y tk+/- mouse lymphoma assay (MLA) has been in use for more than 15 years as a tool for evaluating the mutagenic potential of various agents. As with other genetic toxicology test systems, one criterion for a positive response has been the requirement of at least a 2-fold increase in mutant frequency (MF) as compared to the respective MF of the solvent controls. More recently, an actual specific increase in MF has been proposed as a criterion for determining a positive response in the MLA; however, this may not be appropriate for laboratories with a low, yet stable, background MF. The twofold rule criterion was evaluated in our laboratory with 66 compounds. The mutagenic status of these compounds was previously determined in other test systems and at one or more laboratories, including Lilly Research Laboratories. The results of this evaluation demonstrate that the twofold rule is an effective method for identifying mutagenic agents in the MLA at LRL where a lower, yet acceptable, background mutation frequency is the norm. A small number of compounds (6) yielded results discordant with the literature; however, these compounds have been previously found to be either difficult to detect in genotoxic assays or to show specific sensitivity in the MLA.
The purpose of this document is to provide recommendations for the selection of the optimal target population for lung cancer screening trials with Spiral Computer Tomography based on an analysis of risk factors and high-risk populations. Our recommendations are to include current or ex-smokers (<5 years) with a smoking history of at least 30 years and an average consumption of at least 20 cigarettes a day. When these selection criteria are applied there is no need for a lower age cut-off. Elderly people can be included as long as their life expectancy is more than 10 years. Participants should be fit enough to undergo thoracic surgery. They may have a history of previous cancer, provided that the cancer has been curatively treated at least 5 years ago without evidence of relapse, except for breast cancer, melanoma and hypernephroma. People with an inability to lie flat, who are unable to hold their breath for 20 s, with a body weight above 140 kg, a chest CT scan within 1 year before enrolment or a previous pneumonectomy should not be invited. The inadequacy of the unit 'Pack-Years' (PY) to estimate the individual lung cancer risk is recognised, and future initiatives to develop an appropriate lung cancer risk model are encouraged.
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Apart from providing a potential framework for a universally acceptable protocol for the pathological diagnosis of Alzheimer's disease, the Working Party has dispelled one of the major myths of so-called normal aging, namely that minor degrees of Alzheimer-type change (i.e., plaques and tangles) are not the product of growing older alone but should always be regarded as pathological, as they probably represent the tissue substrate of incipient Alzheimer's disease. Establishment of the pathological criteria for such preclinical disease will be of equal importance as that associated with clinical change.
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Toxicokinetic (TK) study is generally required for toxicological evaluation and safety assessment, particularly in the pivotal toxicological studies which are requested on the basis of drug registration. The estimation points of TK data are: (1) determination of TK profile in toxicity study, (2) selection of dose, dosing form, alternative dosing route, (3) help for the evaluation of toxicity (non-effect/toxic dose, toxicological mechanism), (4) comparative evaluation between animal and human cases, (5) recommendation of the starting dose in the first human clinical trial. On the other hand, as a very recent trend, TK data are practically used for the purpose of drug discovery such as lead-optimization and candidate-selection. This paper presents practical examples of TK data in terms of their usefulness, and discusses how to evaluate the toxicity of a drug with the aid of a variety of TK studies.
A resolution, introduced by the American College of Preventive Medicine at the 1996 American Medical Association (AMA) Annual Meeting, asked the AMA to recommend to physicians the use of the United States Preventive Services Task Force's Guide to Clinical Preventive Services, Second Edition. In response to that resolution, the AMA's Council on Scientific Affairs has reviewed and evaluated this publication. The recommendations of the Council on Scientific Affairs on the use of the Guide to Clinical Preventive Services, Second Edition, by clinicians and medical educators are included in this report. These recommendations were adopted as AMA Policy at the AMA Annual Meeting in June 1997.