Making the Dictionary of Epidemiology.
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This paper presents the attitudes and experiences of one group of practicing internists, the IMCARE Practice Guidelines Network, with clinical practice guidelines. From its beginning the Network has enjoyed close ties to both the Agency for Health Care Policy and Research (AHCPR) and the Institute of Medicine (IOM) with their guideline mandates. The Network is a self-selected group of 471 internists and their subspecialty colleagues, dispersed throughout the U.S. Network member evaluations of draft clinical practice guidelines present a compelling case for the need for clarity of language and a more condensed guideline structure. As Network members' critique indicates, once published, guidelines have become communication tools.
At the 2nd Medicago meeting (a satellite of the 1999 IS-MPMI meeting in Amsterdam), investigators perceived a need for standardization of genetic nomenclature in Medicago truncatula, due to the rapid growth of research on this species in the past few years. Establishment of such standards grew out of discussions begun at this meeting and continued electronically throughout the M. truncatula community. The proposed standards presented here are the consensus results of those discussions. In addition to standards for gene nomenclature, a method for community governance and a website for cataloging gene names and submitting new ones are presented. The purpose of implementing these guidelines is to help maintain consistency in the literature, to avoid redundancy, to contribute to the accuracy of databases, and, in general, to aid the international collaborations that have made M. truncatula a model system for legume biology.
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Due to the scarcity of clinical trials (CTs) directly comparing newer antidepressants, clinicians and reviewers often compare drugs on the basis of active drug and placebo-subtracted adverse event rates (AERs) published in references such as the Physician's Desk Reference in the United States, the Compendium of Pharmaceutical Specialities in Canada, and product monographs. This study examined the suitability of the above data and methods for comparing AERs of nine newer antidepressants: bupropion, citalopram, fluoxetine, fluvoxamine, moclobemide, nefazodone, paroxetine, sertraline, and venlafaxine. First, the authors examined data precision and comparability across drugs by analyzing placebo-arm AERs and their 95% confidence limits for each drug and by testing the homogeneity of placebo-arm AERs across drugs. The rationale was that placebo AER heterogeneity is likely a reflection of heterogeneity of nonpharmacologic factors among CTs. For all 16 adverse events examined, placebo AERs were found to be significantly heterogenous, suggesting significant nonpharmacologic heterogeneity across drugs. Second, using placebo AER heterogeneity as a measure of nonpharmacologic heterogeneity, the authors estimated the degree to which active drug and placebo-subtracted AERs were related to nonpharmacologic heterogeneity by estimating the degree of association between active drug and placebo AERs and between placebo-subtracted and placebo AERs. Also, 95% confidence limits for placebo-subtracted AERs were calculated. It was found that most active drug AERs and some placebo-subtracted AERs were significantly correlated with placebo AERs, suggesting a relationship with nonpharmacologic heterogeneity. Placebo-subtracted AERs were less strongly related than were active drug AERs. Finally, the authors discuss factors that may be associated with the observed heterogeneity and offer suggestions that may improve the methodology and reporting of CTs.
The authors investigated various aspects of the international use of and experience with DSM-III through a consultation by mail sponsored by the World Psychiatric Association. The respondents were 175 expert diagnosticians nominated as such by the national psychiatric associations of 52 countries spanning all continents. The United States diagnostic system was used by 72% of the participants, only slightly less than the internationally official International Classification of Diseases, Injuries, and Causes of Death, ninth revision (ICD-9) (77%). Furthermore, DSM-III was perceived to be considerably more useful than the current international classification manual. The leading difficulties encountered with DSM-III involved problematic boundaries or definitions of diagnostic categories and the lack of suitable categories in some cases. The most frequent recommendations offered for the advancement of diagnostic systems included the improvement of patient evaluation procedures, the greater use and refinement of multiaxial diagnosis, and the empirical validation of diagnostic systems.
This report outlines the activities undertaken by the Inter-PORT Dissemination work group during its first 2 years of operation. The work group's initial purpose was to assist the individual PORTs in developing their plans for both disseminating research findings and evaluating the effectiveness of these strategies. However, it became quickly apparent that in a discipline little more than a decade old, a commonly understood vocabulary had yet to be adopted. Even the term "dissemination" held different meaning for different constituencies. Consequently, the work group has tried to encourage the development of both a definitional framework and a set of common data elements of importance to all dissemination programs. The work group has analogously attempted to agree on minimum standards of methodologic rigor as a starting point for coordination of evaluations across PORTs. To help determine the potential for further coordination, a matrix of each individual PORT's target audiences, intervention strategies, and evaluation designs has been constructed. Much remains to be learned before we can know with any certainty how best to translate research findings into useful behavior change and improved patient outcomes. Our goal is that the efforts of the work group will serve to catalyze this process.
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Nomenclature, far from being a dry dusty subject, is today more relevant than ever before. Researchers into genomics are discovering again the need for systems of nomenclature-names are what we use to communicate about organisms, and by extension the rest of their biology. Here, we briefly outline the history of the published international codes of nomenclature, tracing them from the time of Linnaeus in the eighteenth century to the present day. We then outline some of what we feel are the major challenges that face the codes in the twenty-first century; focusing primarily on publication, priority, typification and the role of science in the naming of organisms. We conclude that the codes are essential for taxonomists in the pursuance of their science, and that the democratic nature of decision-making in the regulation of the rules of nomenclature, though sometimes perceived as a potential weakness, is in fact one of its great strengths.
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Additives for use in animal nutrition are regulated under Regulation (EC) No. 1831/2003. The scope of this paper addresses the specific microbiological issues relevant to a microbial feed additive, containing a Bacillus spp. and uses as an example a product with the trade name, Calsporin. Bacillus subtilis C-3102 is the active ingredient in Calsporin and is added to animal feed to favourably affect animal production and performance (growth and feed efficiency), by modulating the gastrointestinal flora. It is not the purpose of this review to present the raw data for Calsporin but rather to use Calsporin as an example of the type of data required by the European regulatory authorities. At the time of preparation of this manuscript Calsporin has yet to be reviewed by the authorities. The regulatory system under the auspices of the EFSA FEEDAP Panel is clearly attempting to move in line with development of scientific opinion and is to be applauded for such efforts. Bacteria do need to be regulated, and the regulations clearly provide adequate and appropriate protection to human health and to environmental considerations.
AIM: To define protocol-based care to make this way of delivering health care amenable to theoretical and empirical studies. BACKGROUND: Although protocol-based care is associated with the evidence-based practice and standardization movements, it is an ill-defined and understood concept. METHOD: A multiphase concept analysis, inspired by an evolutionary view was used to clarify 'what is protocol-based care'. The inductive, five-phase process drew upon content analysis of policy documents and the literature, plus interviews with a purposive sample of 35 opinion leaders. RESULTS: The term was used interchangeably with protocols, pathways and guidelines in policy and guidance documents. A search of seven databases produced only 57 references to protocol-based care. The concept analysis revealed a continuum of scope and specificity and also distinguished specialist and generic applications of protocol-based care. CONCLUSIONS: Managers need to take cognizance of the significance and complexity of protocol-based care when introducing this way of working.