Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Acceptance Process”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 829 records · Page 46Linked to original sources
PubMed2005

The need for a formal invalidation process for animal and non-animal tests.

A plethora of regulations require that many chemicals and chemical products are tested for efficacy and/or toxicity. When permitted to operate effectively and without bias, the ECVAM/ICCVAM/OECD validation process can be used to independently establish that new animal and non-animal test procedures are sufficiently relevant and reliable for their stated purposes and should be considered for regulatory use. However, the validation process is under threat because of vested interests of various kinds, and it is clear that many currently-accepted animal tests and candidate animal and non-animal tests do not, and could never, meet the agreed criteria for necessity, test development, prevalidation, validation and acceptance. We therefore need an invalidation process to parallel and protect the validation process, so that such methods could be independently reviewed and declared irrelevant and/or unreliable for their claimed purposes. An additional advantage of such a process would be that valuable resources would no longer be wasted in attempts to secure the acceptance of inherently inadequate tests.

Animal Use Alternatives↗
PubMed2006

Behavior of pesticides in water-sediment systems.

Many experimental reports on the fate of pesticides in either laboratory or outdoor water-sediment systems have been obtained from both research and regulatory aspects that show some trends in distribution and degradation for each chemical class of pesticides. Adsorption, diffusion, hydrolysis, and biodegradation processes are important in controlling the behavior of pesticides in these water-sediment systems. Through these investigations, the contribution of suspended particles and dissolved organic matter has become more accepted in relation to these processes. Not only the physicochemical properties and degradability of a pesticide but also the characteristics of the many phases composing a water-sediment system determine the actual pesticide behavior, and therefore we should appropriately design an experimental system by considering the real situation of the natural aqueous environment to be examined. Many factors controlling experimental results in a laboratory system such as water-sediment ratio, depth of water and sediment phases, and mixing of water column have been clarified; however, there are still many issues to be examined. For example, a pesticide is always used as a formulation, but its effects on pesticide behavior in a water-sediment system have not been extensively examined. When its behavior in a natural aquatic system is considered, the effect and importance of photolysis are necessary to examine as an individual degradation process, but photolysis has been only briefly discussed in outdoor microcosm and mesocosm studies. Many studies discuss the distribution and degradation pathways of a pesticide, but its transport between water and sediment phases has scarcely been investigated because of its complexity, especially for a pesticide that is moderately or easily degraded in a water-sediment system. This form of investigation would be very useful when metabolites or degradates having more toxicological impact on aquatic species and sediment dwellers are found. From this point of view, the behavior of a pesticide and its metabolite(s) in an interstitial sediment porewater should become another critical point to be examined in the future. Other issues to be investigated further are the relevant processes in the neighborhood of interfaces. In an air-water interface, the effect of a surface microlayer has been examined mainly through microcosm and mesocosm studies, but the contribution of interfaces to either volatilization or photodegradation should be examined in more detail to precisely estimate dissipation profiles of a pesticide in the real aquatic environment. Furthermore, the enrichment of a pesticide in this interface should be investigated in relation to an emergence of chironomids. Recently, many kinetic approaches have been attempted to more effectively use experimental data in prediction of the fate of a pesticide by the aid of a simulation model. Most existing rate data usually represent apparent dissipation rates but not degradation rates, and therefore separation of the degradation rate from dissipation by considering adsorption-desorption and transport processes would be of immense value.

Ecosystem↗
PubMed2000

European association of tissue banks standards for cryopreserved cardiovascular tissue banking.

The Cardiovascular Tissue Banking Standards are designed as an addition to the General Standards of the European Association of Tissue Banks to provide a minimum acceptable level for the donation, processing, storage, testing, labelling and distribution of cardiac tissue throughout Europe. The aim is that all heart valve banks in Europe should work to these Standards so that heart valves can be exchanged between countries without having to check the individual protocols of the donor processing facility. The writing of the Standards has been performed by the Heart Valve Council of EATB with input from cardiac surgeons. It is proposed that once the Standards are accepted they will form the document on which EATB may accredit tissue banks in the future and may form the basis on which National Legislation for Tissue Banking is based.

Journal Article↗
PubMed1998

Use of soybean oil and ammonium sulfate additions to optimize secondary metabolite production.

A valine-overproducing mutant (MA7040, Streptomyces hygroscopicus) was found to produce 1.5 to 2.0 g/L of the immunoregulant, L-683,590, at the 0.6 m3 fermentation scale in a simple batch process using soybean oil and ammonium sulfate-based GYG5 medium. Levels of both lower (L-683,795) and higher (HH1 and HH2) undesirable homolog levels were controlled adequately. This batch process was utilized to produce broth economically at the 19 m3 fermentation scale. Material of acceptable purity was obtained without the multiple pure crystallizations previously required for an earlier culture, MA6678, requiring valine supplementation for impurity control. Investigations at the 0.6 m3 fermentation scale were conducted, varying agitation, pH, initial soybean oil/ammonium sulfate charges, and initial aeration rate to further improve growth and productivity. Mid-cycle ammonia levels and lipase activity appeared to have an important role. Using mid-cycle soybean oil additions, a titer of 2.3 g/L of L-683,590 was obtained, while titers reached 2.7 g/L using mid-cycle soybean oil and ammonium sulfate additions. Both higher and lower homolog levels remained acceptable during this fed-batch process. Optimal timing of mid-cycle oil and ammonium sulfate additions was considered a critical factor to further titer improvements.

Ammonium Sulfate↗
PubMed2006

Appraisal, assessment and career development for doctors in training: the Mersey Deanery personal development portfolio.

OBJECTIVES: To develop a robust valid and exportable appraisal and assessment process for doctors in training which is portfolio based and works at all hospitals within the deanery. It is called the personal development portfolio. DESIGN: For every senior house officer, there was a recorded meeting with his or her supervisor, at the beginning, midterm and at the end of the post. An outside assessor witnessed the exit assessment meeting. SETTING: The Wirral Hospital, a District General Hospital with 72 senior house officers in 10 different specialties was used as a pilot site to develop the process. Then the process was exported and implemented at the other 12 trusts of the deanery. MAIN OUTCOME MEASURES: Records were kept of the induction, midterm and exit assessment meetings. A record was kept of the number of senior house officers succeeding and failing at their exit assessments. Also, the number promoted to the specialist registrar grade was recorded. RESULTS: The process was performed every 6 months on 11 occasions between 2000 and 2005. It involved 72 senior house officers in 10 different specialties. On each occasion, participation usually exceeded 70%: 623 were appraised and assessed and 609 of them (97.8%) had satisfactory exit assessments. For 14 doctors (2.2%), the process identified a cause for concern, which was usually accepted by the doctor and sometimes allowed remedial action to be taken. Twenty-six (4.2%) were promoted to the specialist registrar grade in this period. The process also identified the strengths and weaknesses of the senior house officer posts in the 10 different specialties that had such posts, and was used to encourage good medical teaching practice in them. Over 4 years, we exported the process to all the other 12 Trusts in the Mersey Deanery. Once established, the process was easy to use for both trainees and trainers, although it was time consuming. CONCLUSIONS: It was possible to develop and implement a portfolio based appraisal and assessment process, which was accepted by senior house officers and their trainers in all specialties at all hospitals within the deanery. Now that the senior house officer grade has been superseded by the Foundation and the training grade years, the principles of the personal development portfolio are being used to appraise and assess doctors in these grades too.

Career Mobility↗
PubMed2003

Mutual acceptance of data: harmonised test methods and quality assurance of data--the process explained.

An essential aspect of the OECD is that it should not be considered a supranational organisation, but rather a center for discussion where governments express their points of view, share their experiences and search for common ground. This implies that decisions are made by consensus instead of majority. Once the Council, which is the highest authority of the OECD, adopts a formal Decision, such a decision is binding on all Member countries. The OECD Guidelines for the Testing of Chemicals, which are considered the leading international standard for safety testing, form an integrated part of such a binding Council Decision. An even more important part of that same Council Decision is that on Mutual Acceptance of Data, where it states that: 'Data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice (GLP) shall be accepted in other Member countries for purposes of assessment and other use relating to the protection of man and the environment.' In the various steps of the process of Test Guideline development, the National Co-ordinators of the Test Guideline Programme play an important role. The initiative to start the development of a particular guideline can be taken by the OECD Secretariat, by one or more Member countries or, most importantly, by the scientific community itself. Proposals, received by the Secretariat are discussed at the yearly Meeting of the National Co-ordinators. During these meetings, priorities for future activities are set and the approach that should be followed in dealing with the selected activities is discussed. Quite often, so-called Detailed Review Papers (DRP's) form the basis of a new or updated Guideline. These DRP's, which are either prepared by a Member country or by a consultant appointed by the Secretariat, describe the current 'state of the art' in scientific progress and technical possibilities of a well-defined area of research. After completion, either an expert meeting or a commenting round will be organised. All Member countries will have sufficient possibilities to express their views. When the DRP is acceptable to the experts of all Member countries, the next step is to actually develop a Test Guideline. Similar to the procedure followed for the DRP, the Test Guideline proposal will be circulated for comment to all Member countries and should reach the desks of relevant experts, nominated by their National Co-ordinator. Frequently, in addition to the commenting rounds, Test Guideline proposals are discussed in special expert meetings. Once the experts reach consensus on a particular Test Guideline, the proposal is put forward to the Meeting of the National Co-ordinators for approval. Since each guideline will form an integrated part of the earlier mentioned Council Decision, each new guideline also needs formal adoption by the Council before it becomes effective.

Animals↗
PubMed2005

IL-1-regulated responses in astrocytes: relevance to injury and recovery.

In the central nervous system (CNS), the cellular processes of astrocytes make intimate contact with essentially all areas of the brain. They have also been shown to be functionally coupled to neurons, oligodendrocytes, and other astrocytes via both contact-dependent and non-contact-dependent pathways. These observations have led to the suggestion that a major function of astrocytes in the CNS is to maintain the homeostatic environment, thus promoting the proper functioning of the neuronal network. Inflammation in the CNS disrupts this process either transiently or permanently and, as such, is thought to be tightly regulated by both astrocytes and microglia. The remarkable role that single cytokines, such as TNF and IL-1, may play in this process has now been well accepted, but the extent of the reprogramming of the transcriptional machinery initiated by these factors remains to be fully appreciated. With the advent of microarray technology, a more comprehensive analysis of this process is now available. In this report we review data obtained with this technology to provide an overview of the extent of changes induced in astrocytes by the cytokine IL-1.

Animals↗
PubMed2001

Social behaviour and illness information interact to influence the peer acceptance of children with chronic illness.

OBJECTIVES: Social behaviour was investigated as a contributor to the peer acceptance of children with chronic illness. We predicted that children with illness would receive less acceptance than children without illness, and that prosocial behaviour would improve acceptance, while aggressive behaviour would hamper it. Based upon attribution and cognitive bias theories, we also predicted that prosocial behaviour would be more beneficial and aggressive behaviour less damaging to the acceptance of children with illness compared to healthy children. DESIGN: A 3 (social behaviour: prosocial, aggressive, no information) x 2 (physical status: chronically ill, healthy) within-subjects analogue design was used. METHODS: Preadolescents (N = 149) indicated social acceptance of hypothetical children portrayed in vignettes as either chronically ill or healthy with prosocial, aggressive, or no social behaviour. A 13-item social intentions scale gauged acceptance. RESULTS: The hypotheses were supported. Although children described as ill received lower acceptance ratings than healthy children, prosocial/ill children were more accepted than aggressive/ill children. Social behaviour interacted with physical status to affect acceptance. CONCLUSIONS: Social behaviour influences the peer acceptance of hypothetical children with chronic illness. Prosocial behaviour enhances acceptance of children described with illness, while aggressive behaviour hampers it. Additionally, prosocial behaviour is more beneficial, and aggressive behaviour is less damaging for children described as ill versus healthy. The potential processes by which peers judge acceptance of children with illness are discussed.

Journal Article↗
PubMed2006

[Concept analysis of DNR (do-not-resuscitate)].

PURPOSE: The purpose of this study was to analyze and clarify the ambiguous concept of DNR, and to distinguish between DNR and euthanasia. METHOD: This study used the process of Walker & Avant's concept analysis. RESULT: The definable attributes of DNR were care for comfort, no further treatment and no CPR. The antecedents of DNR were the autonomy of patients and families feelings about death, the uselessness of treatment and the right to die with dignity. The process of the DNR decision should be documented and the antecedents of DNR also can be a basis for objective standards of DNR decision-making. The result of DNR was the acceptance of death by patients and families. CONCLUSION: DNR is decided and documented by the antecedents of DNR, and the result is a natural acceptance of death, the last process of human life. Hospice care should be activated and nurses must be patient's advocates and families' supporters in the process.

Attitude to Death↗
PubMed1995

Evaluation of marking materials for cutaneous surgical margins.

Microscopic evaluation of the margins of excised cutaneous neoplasms is of paramount importance for determining that neoplastic tissue does not extend to the excision borders. Dyes or pigments that indelibly mark the tissue should be more reliable than sectioning techniques or suture markers for identifying the surgical margins before and after tissue processing. We evaluated 5 pigments to select a material that could be rapidly applied by surgeons, and readily identified on histologic section by the pathologists. Twenty normal canine skin specimens were assigned to each of 5 groups. Each group was treated with artists' pigments in acetone, India ink in acetone, alcian blue, typists' correction fluid, or a commercially available marking kit. Ten specimens within each group were marked before formalin fixation, and 10 were marked after fixation. Application properties, fixation and processing properties, and microscopic characteristics were evaluated for each material. Application properties were acceptable for all marking materials on unfixed specimens, and for alcian blue, India ink in acetone, and correction fluid on fixed specimens. Fixation and processing properties were acceptable for all materials except correction fluid. All marking materials survived fixation and processing, and colors were readily visualized under the microscope. Microscopic characteristics were acceptable for alcian blue, India ink in acetone, and the commercial kit. Overall, alcian blue was the best marking material, with India ink in acetone and the commercial kit also acceptable. Correction fluid and artist' pigments in acetone were not acceptable because pigment fragmentation and incomplete tissue coverage hindered microscopic evaluation of resection margins.

Alcian Blue↗
PubMed2001

The quality of care in Barrett's esophagus: endoscopist and pathologist practices.

BACKGROUND: The diagnosis of Barrett's esophagus (BE) has important psychological and economic implications. Although accepted standards for endoscopic biopsy methods and pathological interpretation for BE exist, adherence to these standards as a measure of the quality of care in BE has not been evaluated. Our aim was to assess the quality of care in BE by evaluating the process of care and adherence to accepted standards of practice. METHODS: Explicit process-of-care criteria were developed using a systematic literature review and expert opinion in four domains of care: the quality of biopsy methods, the adequacy in identifying endoscopic landmarks, endoscopist-pathologist communication, and pathological interpretation and reporting. We reviewed all endoscopy and pathology reports of BE patients at two institutions from 1994-1997. An academic medical center (N = 237) with staff endoscopists and an academically affiliated community hospital (N = 100) with private-practice endoscopists were analyzed. RESULTS: Physicians showed the highest adherence to accepted standards of care in the "adequacy of identifying landmarks" and "endoscopist-pathologist communication" domains, with a > or =70% adherence rate in most criteria. Conversely, physicians demonstrated the poorest adherence with the "quality of biopsy methods" and "pathologist interpretation and reporting" domains, with adherence rates frequently <60%. Significantly, biopsies were taken in the presence of visible esophagitis 35% of the time. Performance on several of the quality indicators varied significantly by the practice setting. CONCLUSIONS: We have identified several opportunities for quality improvement efforts. In every domain, there is room for improvement, particularly in the quality of biopsy methods. As initiatives to screen the large population of gastroesophageal reflux disease patients for BE may be imminent, the time is now to define the critical process-of-care measures to minimize the risk of overdiagnosis and inadequate endoscopic surveillance.

Barrett Esophagus↗
PubMed1982

Chemotaxis in Bacillus subtilis: effects of attractants on the level of methylation of methyl-accepting chemotaxis proteins and the role of demethylation in the adaptation process.

By performing in vivo methylation experiments and using highly resolving NaDodSO4-polyacrylamide gels, we have examined the effects of amino acid attractants on the methylation profile of Bacillus subtilis MCPs. Both increases and decreases have been found to occur in the level of methylation of these proteins. By using competition experiments and Conway diffusion cells, we have found that the demethylation event is correlated with the adaptation process. Gas chromatographic analysis indicates that methanol is evolved upon demethylation of these proteins. As more attractant receptors are titrated, corresponding increases in methanol evolution result. During this period of increased rate of methanol production, bacteria swim smoothly.

Amino Acids↗
PubMed2003

Fear appeals motivate acceptance of action recommendations: evidence for a positive bias in the processing of persuasive messages.

Three experiments are reported that tested the hypothesis that the use of fear appeals in health persuasion may lead to positively biased systematic processing of a subsequent action recommendation aimed at reducing the health threat and, consequently, to more persuasion, regardless of the quality of the arguments in the recommendation. The levels of participants' vulnerability to as well as the severity of a health risk were varied independently, followed by a manipulation of the quality of the arguments in the subsequent action recommendation. The dependent variables included measures of persuasion (attitude, intention, and action), negative affect, and cognitive responses. The results show that participants who felt vulnerable to the health threat were more persuaded, experienced more negative emotions, and had more favorable cognitive responses. Both negative emotions concerning one's vulnerability and positive thoughts concerning the recommendation mediated the effects of vulnerability on persuasion.

Affect↗
PubMed2003

Trans-unsaturated fatty acids and acrylamide in food as potential atherosclerosis progression factors. Based on own studies.

Atherosclerosis is a chronic pathological process and it is generelly accepted that lipids, coagulation and inflammatory factors play an important role in its development. Environmental factors such as bed diet and cigarette smoking strongly stimulate initation and progression of atherosclerotic changes in the artery wall. It has been recognized that deeply processed food may be a source of various factors potentiating processes related to atherosclerosis development among which inflammatory processes are of great importance. The aim of our studies was to find out if the trans-unsaturated fatty acids as well as acrylamide present in foods have the potential to provoke pro-inflammatory states in the body and enhance atherosclerosis risk. The results of our in vitro studies have shown that trans fatty acids cause a significant increase in secretion of reactive oxygen species, interleukin-6, tumor necrosis factor a and metalloproteinase-9, and enhance apoptosis. It indicates that in vivo trans-fatty acids may distroy the endothelium integrity and cause plaque rupture. Our in vivo studies in the group of healthy volunteers have shown that the consumption of potato chips rich in acrylamide cause the significant increase in plasma C-reactive protein and homocysteine concentrations. Enhanced CRP and HCY levels are accepted markers of enhanced atherosclerosis risk.

Acrylamide↗
PubMed2002

The influence of response competition on cerebral asymmetries for processing hierarchical stimuli revealed by ERP recordings.

It is widely accepted that the left and right hemispheres differ with respect to the processing of global and local aspects of visual stimuli. Recently, behavioural experiments have shown that this processing asymmetry strongly depends on the response competition between the global and local levels of a stimulus. Here we report electrophysiological data that underline this observation. Hemispheric differences for global/local processing were mainly observed for response-incompatible stimuli and were most prominent between 320 and 400 ms after stimulus onset. These results underpin the idea that hemispheric differences are more likely to show up when a more elaborated stimulus representation is needed for triggering the response, that is, when a response conflict has to be resolved.

Adult↗