Home About us Contact
|
Home About us Contact | ||
|
|
||
Review Panel (review + panel)
Selected AbstractsCaptan: Transition from ,B2' to ,not likely'.JOURNAL OF APPLIED TOXICOLOGY, Issue 5 2007How pesticide registrants affected the EPA Cancer Classification Update Abstract On 24 November 2004 EPA changed the cancer classification of captan from a ,probable human carcinogen' (Category B2) to ,not likely' when used according to label directions. The new cancer classification considers captan to be a potential carcinogen at prolonged high doses that cause cytotoxicity and regenerative cell hyperplasia. These high doses of captan are many orders of magnitude above those likely to be consumed in the diet, or encountered by individuals in occupational or residential settings. This revised cancer classification reflects EPA's implementation of their new cancer guidelines. The procedures involved in the reclassification effort were agreed upon with EPA and involved an Independent Transparent Review as it related to four components that formed the basis of the original 1986 B2 classification: mouse tumors; rat tumors; mutagenicity; and structural similarity to other carcinogens. A Peer Review Panel organized and administered by Toxicology Excellence for Risk Assessment (TERA) met on 2,3 September 2003. The Panel concluded that captan acted through a non-mutagenic threshold mode of action that required prolonged irritation of the duodenal villi as the initial key event. EPA's Cancer Assessment Review Committee (CARC) met on 9 June 2004 and endorsed the Peer Review findings. EPA intended to have the FIFRA Scientific Advisory Panel (SAP) consider the basis for this reclassification but found the science was robust and judged that a SAP review was not warranted. Using the revised classification, the margin of exposure is approximately 1,200,000, supporting the ,not likely' characterization. Copyright © 2007 John Wiley & Sons, Ltd. [source] Peer Review Panel, 1984,2004.JOURNAL OF SCHOOL HEALTH, Issue 10 2004Journal of School Health No abstract is available for this article. [source] Forming a national multicentre collaboration to conduct clinical trials: Increasing high-quality research in the drug and alcohol fieldDRUG AND ALCOHOL REVIEW, Issue 5 2010ROB SANSON-FISHER Abstract Issues. There is a shortage of high-quality intervention-based evidence in the drug and alcohol misuse field. That is, evidence based on replicated effects using rigorous methodology, to establish a causal knowledge base around ethical, cost-effective methods relevant to clinical practice. The knowledge base in this field is limited participant recruitment challenges; difficulty generalising results from single-centre studies; lack of research culture; issues in managing research teams; incentives for descriptive research; and limited expertise in research design and working in multidisciplinary teams. Approach. An Australian national multicentre collaboration is proposed to overcome these barriers, and reduce the burden of drug and alcohol misuse by increasing the number of high-quality clinical trials in this field. It would involve: selecting a representative sample of centres nation-wide with expertise in specific drug and alcohol issues; creating an expert multidisciplinary team to facilitate clinical trials; simultaneous recruitment and implementation of clinical trials across centres; establishing a virtual infrastructure; forming an independent data-integrity and methodology review panel; and attracting and allocating funding for clinical trials. Implications. The ability to allocate funding, the involvement of multidisciplinary experts in drug and alcohol research, and the establishment of infrastructure and procedures are likely to result in the national multicentre group's capacity to prescribe the type of research conducted under its auspices. Conclusion. The proposed initiative is likely to increase the volume of high-quality clinical trials in the Australian drug and alcohol field, a key step towards reducing the burden of drug and alcohol misuse.[Sanson-Fisher R, Brand M, Shakeshaft A, Haber P, Day C, Conigrave K, Mattick R, Lintzeris N, Teesson M. Forming a national multicentre collaboration to conduct clinical trials: Increasing high-quality research in the drug and alcohol field. Drug Alcohol Rev 2010;29;469,474] [source] Nursing and midwifery management of hypoglycaemia in healthy term neonatesINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 7 2005Vivien Hewitt BSc(Hons) GradDipLib Executive summary Objectives The primary objective of this review was to determine the best available evidence for maintenance of euglycaemia, in healthy term neonates, and the management of asymptomatic hypoglycaemia in otherwise healthy term neonates. Inclusion criteria Types of studies The review included any relevant published or unpublished studies undertaken between 1995 and 2004. Studies that focus on the diagnostic accuracy of point-of-care devices for blood glucose screening and/or monitoring in the neonate were initially included as a subgroup of this review. However, the technical nature and complexity of the statistical information published in diagnostic studies retrieved during the literature search stage, as well as the considerable volume of published research in this area, suggested that it would be more feasible to analyse diagnostic studies in a separate systematic review. Types of participants The review focused on studies that included healthy term (37- to 42-week gestation) appropriate size for gestational age neonates in the first 72 h after birth. Exclusions ,,preterm or small for gestational age newborns; ,,term neonates with a diagnosed medical or surgical condition, congenital or otherwise; ,,babies of diabetic mothers; ,,neonates with symptomatic hypoglycaemia; ,,large for gestational age neonates (as significant proportion are of diabetic mothers). Types of intervention All interventions that fell within the scope of practice of a midwife/nurse were included: ,,type (breast or breast milk substitutes), amount and/or timing of feeds, for example, initiation of feeding, and frequency; ,,regulation of body temperature; ,,monitoring (including screening) of neonates, including blood or plasma glucose levels and signs and symptoms of hypoglycaemia. Interventions that required initiation by a medical practitioner were excluded from the review. Types of outcome measures Outcomes that were of interest included: ,,occurrence of hypoglycaemia; ,,re-establishment and maintenance of blood or plasma glucose levels at or above set threshold (as defined by the particular study); ,,successful breast-feeding; ,,developmental outcomes. Types of research designs The review initially focused on randomised controlled trials reported from 1995 to 2004. Insufficient randomised controlled trials were identified and the review was expanded to include additional cohort and cross-sectional studies for possible inclusion in a narrative summary. Search strategy The major electronic databases, including MEDLINE/PubMed, CINAHL, EMBASE, LILACS, Cochrane Library, etc., were searched using accepted search techniques to identify relevant published and unpublished studies undertaken between 1995 and 2004. Efforts were made to locate any relevant unpublished materials, such as conference papers, research reports and dissertations. Printed journals were hand-searched and reference lists checked for potentially useful research. The year 1995 was selected as the starting point in order to identify any research that had not been included in the World Health Organisation review, which covered literature published up to 1996. The search was not limited to English language studies. Assessment of quality Three primary reviewers conducted the review assisted by a review panel. The review panel was comprised of nine nurses with expertise in neonatal care drawn from senior staff in several metropolitan neonatal units and education programs. Authorship of journal articles was not concealed from the reviewers. Methodological quality of each study that met the inclusion criteria was assessed by two reviewers, using a quality assessment checklist developed for the review. Disagreements between reviewers were resolved through discussion or with the assistance of a third reviewer. Data extraction and analysis Two reviewers used a data extraction form to independently extract data relating to the study design, setting and participants; study focus and intervention(s); and measurements and outcomes. As only one relevant randomised controlled trial was found, a meta-analysis could not be conducted nor tables constructed to illustrate comparisons between studies. Instead, the findings were summarised by a narrative identifying any relevant findings that emerged from the data. Results Seven studies met the inclusion criteria for the objective of this systematic review. The review provided information on the effectiveness of three categories of intervention , type of feeds, timing of feeds and thermoregulation on two of the outcome measures identified in the review protocol , prevention of hypoglycaemia, and re-establishment and maintenance of blood or plasma glucose levels above the set threshold (as determined by the particular study). There was no evidence available on which to base conclusions for effectiveness of monitoring or developmental outcomes, and insufficient evidence for breast-feeding success. Given that only a narrative review was possible, the findings of this review should be interpreted with caution. The findings suggest that the incidence of hypoglycaemia in healthy, breast-fed term infants of appropriate size for gestational age is uncommon and routine screening of these infants is not indicated. The method and timing of early feeding has little or no influence on the neonatal blood glucose measurement at 1 h in normal term babies. In healthy, breast-fed term infants the initiation and timing of feeds in the first 6 h of life has no significant influence on plasma glucose levels. The colostrum of primiparous mothers provides sufficient nutrition for the infant in the first 24 h after birth, and supplemental feeds or extra water is unnecessary. Skin-to-skin contact appears to provide an optimal environment for fetal to neonatal adaptation after birth and can help to maintain body temperature and adequate blood glucose levels in healthy term newborn infants, as well as providing an ideal opportunity to establish early bonding behaviours. Implications for practice The seven studies analysed in this review confirm the World Health Organisation's first three recommendations for prevention and management of asymptomatic hypoglycaemia, namely: 1Early and exclusive breast-feeding is safe to meet the nutritional needs of healthy term newborns worldwide. 2Healthy term newborns that are breast-fed on demand need not have their blood glucose routinely checked and need no supplementary foods or fluids. 3Healthy term newborns do not develop ,symptomatic' hypoglycaemia as a result of simple underfeeding. If an infant develops signs suggesting hypoglycaemia, look for an underlying condition. Detection and treatment of the cause are as important as correction of the blood glucose level. If there are any concerns that the newborn infant might be hypoglycaemic it should be given another feed. Given the importance of thermoregulation, skin-to-skin contact should be promoted and ,kangaroo care' encouraged in the first 24 h after birth. While it is important to main the infant's body temperature care should be taken to ensure that the child does not become overheated. [source] ML08 CONDUCTING A REVIEW , THE IMPORTANCE OF PROCESSANZ JOURNAL OF SURGERY, Issue 2007A. F. Merry Reviews of practice tend to arise out of conflict between the person reviewed and the organisation requesting the review, usually after a failure of the two parties to resolve their differences at a lower level. It follows that legal challenges are likely, and this has been borne out by experience. Such challenges will generally be based on alleged failures in process. Furthermore, being reviewed is exceptionally stressful for any doctor and creates serious risks to his or her health and reputation. It is essential that these risks are minimized and that all parties emerge from the review believing that the process has been impartial, professional, confidential and fair. The key is to engage a senior lawyer with appropriate experience and expressly charge him or her (in writing) with the responsibility for process. This lawyer must be independent (the reviewing organisation's own lawyers are not appropriate for this position), directly accountable to the chair of the review panel, and have unrestricted time for this task. He or she should be present at all meetings between the panel and the reviewed doctor and should revise all documents produced by the panel. The panel chair should assign the primary responsibility for reviewing the professional competence of the doctor to other panel members and should focus instead on ,chairing', on process, and on the wider (or ,big picture') issues which surround the review. Previous experience in reviews is essential for this role. [source] Does NAFTA (North American Free Trade Agreement) Chapter 19 make a difference?CONTEMPORARY ECONOMIC POLICY, Issue 2 2000Dispute settlement, the incentive structure of U.S./Canada unfair trade petitions NAFTA Chapter 19 sets up bilateral review panels to replace the domestic judicial appeals process of resolving disputes among NAFTA members over the enforcement of unfair trade laws. In principle, such panels can change the incentive structure of filing unfair trade law petitions by reducing the likelihood of an affirmative finding of injurious unfair trade. Using data from U.S. and Canadian unfair trade petition filings, empirical tests show support for this hypothesis. However, a more comprehensive settlement of conflicts will require progressive legal integration, including an extension of national treatment measures to alleged "unfair trade" that is not currently envisaged under the NAFTA. [source] | ||||||||||