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PubMed1997

European regulations relevant to the marketing and use of fish vaccines.

In the Member States of the European Union (EU), vaccines cannot be marketed unless a marketing authorisation has been granted for the product by the relevant competent authority, and there are similar requirements in other European countries, such as Norway. The legal basis of this control in EU Member States is through the national implementation of the various directives and regulations, principally Council Directive 81/851/EEC as amended and Council Regulation (EEC) 2309/93. This Regulation also provides the framework for the decentralised system for authorisation of products in more than one member state and for the centralised procedure for authorisation in all of the countries of the EU. Council Directive 81/852/EEC as amended and EU guidance notes set out requirements for the quality, safety and efficacy of the vaccines. Only products which conform with the requirements can now be given an authorisation for marketing in a Member State, and all existing vaccines must be shown to conform by April 1998. Requirements for vaccines are also included in the monographs of the European Pharmacopoeia, which set legally binding standards for products on the market in Europe. Monographs for various types of fish vaccines are now being elaborated. In addition to control through marketing authorisations, a number of European countries have a system for official control of each batch which is to be released for sale. Distribution and supply of the products are also subject to controls. The system used varies from country to country but, for example, in some countries vaccines can only be supplied on receipt of a prescription from a veterinary surgeon. Thus, the marketing and use of fish vaccines are subject to a series of regulations which must be addressed by any company wishing to supply such products in Europe.

Animals↗

PubMed2005

Nucleotide-dependent formation of catalytically competent dimers from engineered monomeric ribonucleotide reductase protein R1.

Each catalytic turnover by aerobic ribonucleotide reductase requires the assembly of the two proteins, R1 (alpha(2)) and R2 (beta(2)), to produce deoxyribonucleotides for DNA synthesis. The R2 protein forms a tight dimer, whereas the strength of the R1 dimer differs between organisms, being monomeric in mouse R1 and dimeric in Escherichia coli. We have used the known E. coli R1 structure as a framework for design of eight different mutations that affect the helices and proximal loops that comprise the dimer interaction area. Mutations in loop residues did not affect dimerization, whereas mutations in the helices had very drastic effects on the interaction resulting in monomeric proteins with very low or no activity. The monomeric N238A protein formed an interesting exception, because it unexpectedly was able to reduce ribonucleotides with a comparatively high capacity. Gel filtration studies revealed that N238A was able to dimerize when bound by both substrate and effector, a result in accordance with the monomeric R1 protein from mouse. The effects of the N238A mutation, fit well with the notion that E. coli protein R1 has a comparatively small dimer interaction surface in relation to its size, and the results illustrate the stabilization effects of substrates and effectors in the dimerization process. The identification of key residues in the dimerization process and the fact that there is little sequence identity between the interaction areas of the mammalian and the prokaryotic enzymes may be of importance in drug design, similar to the strategy used in treatment of HSV infection.

Amino Acid Sequence↗

PubMed2004

Counseling Latina mothers of preschool children about weight issues: suggestions for a new framework.

OBJECTIVE: To assess Latina mothers' health beliefs and attitudes regarding early childhood weight issues and to use the information to update current nutrition education methods. DESIGN: Data were collected in eight focus group sessions using a semistructured questionnaire. SUBJECTS/SETTING: Forty-three Latina mothers (and grandmothers) with children aged 2 to 5 years were recruited at five different Special Supplemental Nutrition Program for Women, Infants, and Children sites in California. ANALYSIS: Transcripts of focus groups were imported into QSR NUD*IST software, facilitating in-depth iterative analysis of emergent themes. RESULTS: Fifteen emergent themes were identified and organized into four functional domains relevant to nutrition education: health beliefs surrounding weight, impact and cause of overweight, life values and concerns, and strategies for making changes in children's eating and activity patterns. Information from this qualitative study demonstrates that the traditional nutrition counseling paradigm may not be effective with Latina mothers. In addition, cultural beliefs can be barriers to successful prevention and treatment of overweight. To ensure that culturally competent services are provided, educators must be prepared to adjust education approaches according to the cultural background of the clients. Key among the issues was mothers' difficulty acknowledging overweight among their children and their perception that health and weight were poorly associated. Certain cultural values were identified as barriers to adopting healthful behaviors. Mothers were able to identify specific ways in which nutrition education could be improved. APPLICATIONS/CONCLUSIONS: Our findings suggest that nutrition education efforts targeting Latina mothers of young children can be reframed to better address the belief system and cultural framework of the population, like identifying positive eating behaviors rather than focusing on a child's weight.

Adolescent↗

PubMed2004

Assessment of young children's social-emotional development and psychopathology: recent advances and recommendations for practice.

In this paper we have tried to document some of the recent advances in the conceptualization and assessment of early-emerging social-emotional and behavior problems, competencies, and psychopathology. Considerable evidence documents that young children evidence significant psychopathology (cf., Del Carmen & Carter, in press; Emde, 1999; Zeanah, 2001; Zeanah et al., 1997). Given the range of new assessment measures that have become available over the past 10 years, the field of young child mental health is poised for dramatic gains in knowledge. It is critical to conduct large-scale, longitudinal, epidemiological studies to inform our understanding of the course of psychopathological conditions within the context of a normative developmental framework. Multi-method, multi-informant assessment approaches are more essential in early childhood due to young children's inability to provide self-reports and the embedded nature of children's development in their caregiving contexts. Screening large representative samples affords the opportunity to ascertain unbiased clinically informative sub-samples for methodologically intensive sub-studies. These sub-studies can address the child's cognitive and linguistic developmental capacities as well as utilize observational methods to examine the relational context. This approach provides an opportunity to merge dimensional and diagnostic assessments and will yield critical information for disentangling continuities and discontinuities in normative and atypical development. The assessment methodology currently exists to routinely screen very young children for social-emotional and behavior problems as well as delays in the acquisition of competencies in pediatric settings as well as in early intervention programs. Yet, despite the likely long-term benefits and cost-saving potential of early identification and intervention services, short-term cost and knowledge barriers currently limit widespread implementation. Discussions with pediatricians suggest that one of the greatest barriers to screening is the limited availability of mental health referral sources. Indeed, very few children who are rated by parents as having elevated social-emotional and behavior problems are receiving any behavioral health services (Horwitz et al., in press). Unmet mental health needs exist among non-referred children in the community as well as among children receiving early intervention services for developmental concerns. Documenting the mental health needs of young children may promote training of professionals who have the competence to treat young children and their families. Moreover, the availability of social-emotional and behavior problem assessment tools should increase studies that focus on the clinical efficacy and effectiveness of prevention and early intervention programs designed to promote positive mental health. Finally, although significant progress is occurring in the arena of young child diagnosis, a strong case can be made for intervening when young children are exhibiting elevations in problem behaviors or delays in the acquisition of competence. This is particularly true when children are also experiencing exposure to multiple contextual risk factors. It is therefore important to advocate for changes to systems that require child diagnosis as a gateway to intervention. As we learn more about the precursors or prodromal manifestations of clinical psychopathology we will be able to examine the efficacy of earlier targeted preventive intervention approaches.

Affect↗

PubMed1997

Coping and adjustment during childhood and adolescence.

This paper reviews research published within the last 10 years on child and adolescent strategies for coping with commonly occurring stressors in nonclinical populations and the relationship of these strategies to adjustment. Current conceptual and classification schemes for children's coping strategies are analyzed and compared. Studies of child coping are reviewed in three clusters: (a) descriptive and taxonomic studies, (b) age-group comparisons, and (c) evaluations of coping-adjustment relationships. Developmental commonalities and changes are identified across studies and conceptual models. Conceptual models compatible with problem-focused/ emotion-focused and approach/avoidance frameworks have proven to be useful for descriptive purposes. However, it is of concern that categories in the current classification systems do not distinguish coping strategies that promote adjustment from ones that limit adjustment. Future directions for addressing this issue and developmental considerations are suggested, including an alternative model pertaining to coping competence.

Adaptation, Psychological↗

PubMed2002

Healthcare system disaster preparedness, part 1: readiness planning.

Recent world events have raised the scope and intensity of disaster planning and readiness activities, including assessment, planning, implementation, and evaluation. In all efforts, the chief nurse executive is critical to the clinical operations and implementation of changes across a system, whether that system is a single hospital or a multiple site integrated healthcare system. In this article (part 1 of a 2-part series), the authors discuss the use of the nursing process as a framework to prepare for an all-hazards threat to disaster and mass casualty possibilities. They share one region's attempt to better integrate communication efforts across all care providers, including public health, county fire and rescue, state agencies, and hospital and service providers. Part 2 (October 2002) will discuss the role competencies of the nurse executive in disaster preparation.

Communication↗

PubMed1999

Structural determinants in domain II of human glutathione transferase M2-2 govern the characteristic activities with aminochrome, 2-cyano-1,3-dimethyl-1-nitrosoguanidine, and 1,2-dichloro-4-nitrobenzene.

Two human Mu class glutathione transferases, hGST M1-1 and hGST M2-2, with high sequence identity (84%) exhibit a 100-fold difference in activities with the substrates aminochrome, 2-cyano-1,3-dimethyl-1-nitrosoguanidine (cyanoDMNG), and 1,2-dichloro-4-nitrobenzene (DCNB), hGST M2-2 being more efficient. A sequence alignment with the rat Mu class GST M3-3, an enzyme also showing high activities with aminochrome and DCNB, demonstrated an identical structural cluster of residues 164-168 in the alpha6-helices of rGST M3-3 and hGST M2-2, a motif unique among known sequences of human, rat, and mouse Mu class GSTs. A putative electrostatic network Arg107-Asp161-Arg165-Glu164(-Gln167) was identified based on the published three-dimensional structure of hGST M2-2. Corresponding variant residues of hGSTM1-1 (Leu165, Asp164, and Arg167) as well as the active site residue Ser209 were targeted for point mutations, introducing hGST M2-2 residues to the framework of hGST M1-1, to improve the activities with substrates characteristic of hGST M2-2. In addition, chimeric enzymes composed of hGST M1-1 and hGST M2-2 sequences were analyzed. The activity with 1-chloro-2,4-dinitrobenzene (CDNB) was retained in all mutant enzymes, proving that they were catalytically competent, but none of the point mutations improved the activities with hGST M2-2 characteristic substrates. The chimeric enzymes showed that the structural determinants of these activities reside in domain II and that residue Arg165 in hGST M2-2 appears to be important for the reactions with cyanoDMNG and DCNB. A mutant, which contained all the hGST M2-2 residues of the putative electrostatic network, was still lacking one order of magnitude of the activities with the characteristic substrates of wild-type hGST M2-2. It was concluded that a limited set of point mutations is not sufficient, but that indirect secondary structural affects also contribute to the hGST M2-2 characteristic activities with aminochrome, cyanoDMNG, and DCNB.

Amino Acid Sequence↗

PubMed2004

Simulation and clinical practice: strengthening the relationship.

INTRODUCTION: This discussion paper argues for a creative synthesis between simulation and clinical practice, where an iterative process of continual interaction ensures that skills are learned and reinforced within the context of everyday professional life. BACKGROUND: Evidence is mounting that long-established approaches to surgical training are no longer acceptable in the current ethical and professional climate. This paper considers alternatives to the traditional approach of 'learning by doing' in a clinical context, focusing on recent developments in the technology of simulation and virtual reality. Clinical expertise is a complex phenomenon and no single theory can account for its acquisition. After a brief contextualising overview, Vygotsky's 'zone of proximal development' is proposed as a conceptual framework for task-based surgical learning that takes place within skills laboratories. The discussion is located within a wider context of educational theory, drawing on current thinking about situated learning and apprenticeship. The notion of 'legitimate peripheral participation' in a complex professional environment places technical skill alongside a range of other competencies that are necessary to safe practice. CONCLUSIONS: Simulation offers a safe environment within which learners can repeatedly practise a range of clinical skills without endangering patients. Comprehensive simulated environments allow a move away from isolated tasks to more complex clinical situations, recreating many of the challenges of real life. Such simulations, however, can operate in isolation from their clinical context, ignoring the learning needs of individuals within a real health care environment. To realise its full potential as a learning aid, simulation must be used alongside clinical practice and linked closely with it.

Clinical Competence↗

PubMed1999

Establishing LA VIDA: a community-based partnership to prevent intimate violence against Latina women.

LA VIDA--the Southwest Detroit Partnership to Prevent Intimate Violence Against Latina Women--evolved in response to community concern about the problem of intimate partner violence (IPV) and the lack of culturally competent preventive and support services for Latino women and men in southwest Detroit. Since 1997, diverse organizations have mobilized as a community-academic partnership to ensure the availability, accessibility, and utilization of IPV services. This article describes and analyzes the evolution of LA VIDA within a community-based participatory research framework using a case study approach that draws on multiple data sources including group and individual interviews and field notes. The challenges and lessons learned in addressing a complex multifaceted problem such as IPV in an ethnic minority community are highlighted in an examination of the process of mobilizing diverse organizations, conducting community diagnosis and needs assessment activities, establishing goals and objectives within a social ecological framework, and integrating evaluation during the development phase.

Community Health Centers↗

PubMed2006

[Bedside learning, characteristics and challenges of education in work situations of the hemodialysis nurse].

This clinical exploratory research relates to the situation of the professional graduate male nurse who, within the framework of the continuous training profits from a formation of a few weeks at all formalized in a center of hemodialysis. The analysis of the directing semi talks carried out near dialysed patients, formative male nurses and learning male nurses, could highlight the characteristics of the actors of this situation of on-the-job training, the general aspects of this formation, the object and stakes of the training as well as the facilitating and blocking factors. The taking into account of these elements allowed certain recommendations as regards training scheme and to define the role of the framework of health in the setting in of this program. It also made it possible to question the relational training through this situation of formation which mixes three othernesses: learning and its tutor, but also the dialysed patient touched in his flesh by the object of training and shown that the relational competence developed in the care enriches relational competences in andragogy and conversely.

Adult↗

PubMed2005

Communication strategies and interpersonal skills of instructors of esophageal speech: an observation study.

OBJECTIVE: In this article, the way that the Instructor of Esophageal Speech (IES) works is considered from an interactive-analytic perspective. METHODS: The observation project data were gathered during 6 months in 2004 at the training sessions of the Ginreikai-Asian Federation of Laryngectomees' Association using the Six Category Intervention Analysis framework (6CIA) by a trained communication specialist as an active-observer. RESULTS: Mean scores of each of the six categories and a series of percentage distributions were extracted from the usage-frequency data and interpreted together with the results of Chi-square analysis of usage-frequency units. We found the IES used more frequently authoritative categories and used less facilitative categories. Our results of the data analysis show that the 30 IES used more authoritative interventions and used more frequently the prescription and information giving than the confrontation or cathartic interventions. CONCLUSION: The results of the present study show that the 6CIA framework has its potential and value as an analytic tool to explore the IES' actual behavior in a specific therapy related context. PRACTICE IMPLICATIONS: We argue for the utility of the 6CIA as an analytic framework to investigate the interpersonal behavior of the IES in the Japanese cultural setting.

Aged↗

PubMed1994

Occupational settings facilitating wisdom-related knowledge: the sample case of clinical psychologists.

Wisdom can be defined as expert knowledge in the fundamental pragmatics of life. Examined here is whether clinical practice may facilitate access to and acquisition of such knowledge. Spontaneous think-aloud responses to 2 wisdom-related dilemmas from young (M = 32 years) and older (M = 70 years) clinicians were compared with responses obtained from other professionals. Raters judged clinicians' responses as higher on 5 criteria of wisdom: factual knowledge, procedural knowledge, life-span contextualism, value relativism, and management of uncertainty. Contrary to most studies of cognitive aging, young and older adults did not differ. Rather, each age-cohort group received highest ratings when responding to a life dilemma matched to their own life phase. Discussed is the application of a wisdom framework to assessing therapeutic treatment goals and therapist interventions as well as global changes in client's beliefs during therapy.

Adult↗

PubMed2003

Developing clinical supervision for complementary therapy educators.

To facilitate reflective practice with students of complementary therapy clinical tutors themselves require an understanding and experience of reflective practice. The aim of this study was to implement and evaluate a clinical supervision framework for clinical tutors teaching on the complementary therapy undergraduate program. Clinical supervision was conducted in small groups with a skilled clinical supervisor, and focused on issues arising in the teaching clinic. The evaluation consisted of questionnaires, interviews and focus groups with participants (clinical tutors and clinical supervision facilitators). There is strong evidence that clinical supervision groups offered a supportive learning framework for the clinical tutors, and that this was likely to impact on work with students and patients in a positive way.

Adult↗

PubMed1997

Measuring general practice-based primary care: generic outcomes. Welsh Primary Care Outcomes Group.

Increasing attention is being paid to the measurement of outcomes in primary care. However, many of the methods proposed are measures based on readily collectable data or standardized population measures of health status. These may interest population scientists but are unlikely to satisfy most primary-care clinicians. The reason for this dissonance is that the population measures do not reflect the complex and personal nature of primary care. Quality measures are needed that have validity to clinicians and patients. An alternative classification is proposed which is based more formally on the functions of primary care. This would appear to provide a framework which is more likely to be valued by those who provide primary care. The need for further research and testing of some outcome measures is identified.

Clinical Competence↗

PubMed2004

The organizational and performance effects of nurse practitioner roles.

BACKGROUND: Most studies evaluating the roles of Nurse Practitioners have compared the care delivered by individual Nurse Practitioners with that provided by other professionals. These studies should be complemented by research focusing on a higher unit of analysis, namely the organization of the care process for a specific patient group. The most important reason is that Nurse Practitioners are increasingly involved in direct, multiprofessional care in complex health care organizations and networks. In these work settings, their roles may, in both positive and negative ways, lead to changes in the organization of the entire care delivery system. AIM: The aim of this paper is to stimulate awareness and evaluation of these organizational changes and their potential impact on the effectiveness of the care process. APPROACH: A conceptual model based on patterned systems contingency theory is proposed. With the help of this model, attention is drawn to issues at the level of the organization and the effectiveness of the care processes that merit attention when Nurse Practitioner positions are being introduced. These issues are derived from case studies in Dutch hospitals. RESULTS: According to the model, a Nurse Practitioner position will change the work structure of the care process involved. Therefore, the effectiveness of a Nurse Practitioner position will be dependent on the changes realized in the work structure. The resulting structure should fit the task characteristics of the care services demanded by the specific patient group. On the basis of this model and the examples presented, questions for further study are formulated. CONCLUSIONS: Nurse Practitioner roles can only enhance the effectiveness of care processes when embedded in a work structure that is internally consistent and adjusted to the task environment and available skill-mix. A structural contingency framework may be helpful in identifying relevant organizational issues. To determine the effects of Nurse Practitioner roles, cross-sectional as well as longitudinal studies are needed.

Clinical Competence↗

PubMed2004

Mentoring: a human becoming perspective.

There have been reports of an absence or a lack of support for one another within the discipline of nursing. By establishing patterns of engagement, seasoned veterans connect with their novice colleagues to promote standards of excellence and scholarship. In order to provide the multidimensional benefits of a mentorship opportunity, a clear theoretical vision of mentoring is required. The theoretical perspective of human becoming provides a framework for mentors to establish gentle urgings with their mentees and thus provide for the growing of nurses as well as the discipline of nursing.

Attitude of Health Personnel↗

PubMedDate not supplied

Developmental supervision for nurses.

Developmental supervision is gaining increasing recognition in nursing as a form of clinical supervision that will promote professional growth and ultimately lead to improved patient care. Benner's (1984) model of career development is used as a framework in which to examine appropriate forms of supervision for each developmental stage. Directive, collaborative and non-directive supervision are applied to each of these developmental levels.

Career Mobility↗

PubMed2001

The origins of informed consent: the International Scientific Commission on Medical War Crimes, and the Nuremburg code.

The Nuremberg Code has generally been seen as arising from the Nuremberg Medical Trial. This paper examines developments prior to the Trial, involving the physiologist Andrew Conway Ivy and an inter-Allied Scientific Commission on Medical War Crimes. The paper traces the formulation of the concept of a medical war crime by the physiologist John West Thompson, as part of the background to Ivy's code on human experiments of 1 August 1946. It evaluates subsequent responses by the American Medical Association, and by other war crimes experts, notably Leo Alexander, who developed Ivy's conceptual framework. Ivy's interaction with the judges at Nuremberg alerted them to the importance of formulating ethical guidelines for clinical research.

Ethics, Medical↗