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Evidence-based pharmacotherapy: review of basic concepts and applications in clinical practice.

OBJECTIVE: To introduce concepts that may assist pharmacists in the use and application of scientific evidence in clinical practice. These concepts are followed by examples of clinical trials as well as case scenarios that guide the reader through solving clinical problems using the tools discussed in the article. BACKGROUND: The introduction of evidence-based practice in the 1990s has had a positive impact on the practices of medicine and pharmacy. Part of this impact has been in the area of drug therapy. Although much literature has been published on the principles of evidence-based practice in the past few years, most of this material was intended for practicing physicians. We are not aware of any articles on the use of the evidence-based principles intended for clinical pharmacists. We are also aware that discussing all of these principles is an enormous task and thus beyond the scope of this article. Therefore, we focused this discussion on a brief summary of different study designs, factors affecting the strength of scientific evidence, and interpretation of the data. An approach in the use of these concepts is discussed through the use of case scenarios. RECOMMENDATIONS: Clinical pharmacists must use concepts in evidence-based practice when making pharmacotherapeutic decisions.

Clinical Trials as Topic↗

Ethical analysis of the concept of disability.

The concept of disability from an ethical viewpoint was examined. Whether disability results from the way society is built and the way ideas and judgments considering disability are established in a communal interaction was discussed (i.e., is disability socially created and constructed?). Although views on disability emphasizing its social nature are basically sound, they are also insufficient because they fail to consider the normative dimension attached to the concept of disability. The core of the concept of disability is ethical, which is why a moral philosophical examination of the concept is needed. Three possible ethical theories of disability (universal, objective, subjectivist, and communitarian) are briefly presented and discussed and a preliminary outline of a basis for a sound ethical model of disability presented.

Child↗

The Confucian relational concept of the person and its modern predicament.

The Confucian relational concept of the person has been proposed as an epistemically more cogent and ethically more attractive alternative to that of liberal individualism. Two arguments are raised against this proposal without defending liberal individualism. Ethically, Confucianism is vitiated by certain unattractive features that cannot be removed without reducing the Confucian relational concept of the person to an abstract and not very helpful notion of human relatedness. Epistemically, Confucianism commits the essentialist fallacy of treating its own concept of human relations as reflecting the nature of things. In view of these limitations, the Confucian relational concept of the person does not provide a viable framework for dealing with social issues including bioethics.

Bioethics↗

Knowledge of oral cancer risk factors and diagnostic concepts among North Carolina dentists. Implications for diagnosis and referral.

BACKGROUND: Dentists play a critical role in the early detection of oral and pharyngeal cancer (OPC). The authors administered a survey that assessed the level of knowledge among dentists regarding risk factors and diagnostic concepts. METHODS: In 2002, the authors mailed a 38-item, pretested survey to a random sample of 1,115 licensed dentists practicing in North Carolina. Three-level (low, medium, high) composite index scores for knowledge of risk factors and diagnostic concepts were created using previously developed scales. The authors formulated multivariable models for risk factor and diagnostic knowledge indexes. RESULTS: Of the 584 respondents, only 181 (31 percent) had consistent medium-to-high levels of knowledge on both highly correlated indexes. Dentists who had higher risk factor and diagnostic knowledge scores were significantly (P < .05) more likely to have heard of one or more diagnostic aids (odds ratio [OR], 2.7), to have graduated from dental school within the previous 20 years (OR, 1.8) and to have performed biopsies or referred five or more patients with suspicious lesions per year (OR, 1.7 and 1.5, respectively) than were less-knowledgeable respondents. CONCLUSIONS: More education is needed in dental schools, postgraduate programs and continuing education programs to enhance dental professionals' knowledge of OPC risk factors and diagnostic concepts. Such programs should include information about adjunctive diagnostic aids. PRACTICE IMPLICATIONS: Greater knowledge of risk factors and diagnostic concepts may result in more frequent patient referrals, biopsy procedures or both, thus aiding in the early diagnosis and treatment of patients with OPC.

Analysis of Variance↗

A new concept for quality control of clinical laboratory investigations in the light of clinical requirements and based on reference method values.

Quality control is an essential element in clinical laboratory investigations. In the basic programs for quality control used in recent years accuracy control has been carried out through a comparison with method-dependent assigned values. With this system the "accuracy" of results from different laboratories is relative, and comparability is assured only when the laboratories use the same analytical method. Considering the steadily increasing variety of methods and equipment, a meaningful exchange of information in patient care, teaching and research is becoming more and more difficult; but clinical requirements make such an exchange essential. In this paper a new concept for quality control is presented for discussion. In the basic program incorporating the new concept the method-dependent assigned values are replaced by reference method values, which are method-independent. In addition to accuracy control, an ongoing monitoring procedure using a Shewhart control chart is also carried out. The maximum allowable day-to-day imprecision and the maximum allowable deviation from the reference method value are fixed on the basis of clinical requirements. This means that the ratio of biological variation to analytical between-day imprecision should be greater than or equal to 2. If the biological variation is unknown, then the reference interval is used in its place; the quotient, reference interval/analytical between-day imprecision, should then be greater than or equal to 8. The decision limits for the interlaboratory surveys should be fixed in an analogous manner independent of the analytical method. After the introduction of quality control based on the new concept the results from different laboratories would be comparable to the extent dictated by clinical requirements. The main principles underlying the new concept and the effects of using the new approach are presented for discussion, and the reader is invited to submit comments in writing.

Blood Glucose↗

The evolution of the reference value concept.

This manuscript reviews the introduction of the concept of reference values, the corresponding philosophy, and subsequent recommendations reflecting the different subtopics of the field. The generally unrecognised phenomenon that laboratory results of the population tended to be lognormal instead of Gaussian attracted the attention of the author, who became sceptical of the concept of normal values because of its ambiguity. Together with N.-E. Saris a new concept of reference values was launched at a congress in 1969. Briefly, clinical measurements should be interpreted against values from proper control subjects. Subsequently international, regional and national societies established expert panels which produced recommendations covering the general principles and terminology of reference values, the concept of health, standardised specimen collection and preanalytical factors, statistical treatment of collected values, stratification of data, relating observed (patient) values to reference values, etc. The importance of using correct terminology, taking into consideration the aim of ordering the laboratory test and some neglected procedures (e.g., survival values) are emphasised. New developments such as reference changes are mentioned. The field has evolved largely as the result of constructive international teamwork.

Chemistry, Clinical↗

Effects of increased thyroxine dosage pre-conception on thyroid function during early pregnancy.

OBJECTIVE: To compare the effects of pregnancy on the serum free thyroxine (FT4) levels in two cohorts of primary hypothyroid women treated with different levothyroxine (L-T4) doses before gestation. DESIGN AND METHOD: Twenty-five women with compensated hypothyroidism of different aetiology (thyroidectomized and Hashimoto's thyroiditis) were enrolled in this prospective study. The women were receiving substitutive doses of L-T4 and were anticipating pregnancy. They were assigned to two groups: 14 patients (group I) were switched to partially suppressive treatment while 11 patients (group II) continued the same therapeutic regimen. RESULTS: Pre-conceptional thyroid function evaluation demonstrated significantly higher FT4 and lower TSH in group I (P<0.001, for both hormones) and comparable free 3,5,3'-triiodothyronine (FT3) levels. The first post-conception thyroid function evaluation occurred at a median time of 6 (5-8) and 7 (5-9) weeks of gestation, for groups I and II respectively (P<0.05); all women in group I showed adequate serum FT4 levels while three patients in group II showed low-normal FT4 levels and one case was below normal levels. Statistical analysis demonstrated significantly higher frequencies (0% vs 36.4%; P<0.05) of low-normal FT4 levels in patients receiving substitutive doses of L-T4. None of the Hashimoto's-affected patients showed low or low-normal serum FT4 levels regardless of their therapeutic regimen. CONCLUSION: Our results suggest that in hypothyroid women anticipating pregnancy (with serum TSH in the lower quartile of normal range), the pre-conception adjustment of L-T4 doses may result in adequate maternal thyroid function up to the first post-conception evaluation. The procedure seems safe and inexpensive; it may be a worthwhile treatment, at least in thyroidectomized women, in view of the well-known potential effects of even marginal maternal thyroid hypofunction on the subsequent IQ of the progeny.

Adult↗

[Concept analysis of presenteeism and its possible applications in Japanese occupational health].

The purposes of this systematic review were to define the concept of presenteeism in accordance with Rodgers' concept analysis methods and to examine the possibility of applying the concept to Japanese occupational health. Using presenteeism as a search term, articles were selected from the MEDLINE, PsycINFO and Japana Centra Revuo Medicina databases. The definitions, antecedents, and consequences of presenteeism were extracted from the selected articles and were examined in order to determine how presenteeism was used in the literature. A total of forty-four articles published from 1955 to 2005 were selected for analysis. Based on the extracted definitions, four attributes of presenteeism were identified, and presenteeism was defined as "a self-rated measurable loss of work performance due to health problems in the workplace." Antecedents of presenteeism were classified into occupational and personal factors. These factors affected the decisions of workers with health problems regarding whether or not to go to work. Consequences of presenteeism were the aggravation of quality of life and health status, increases in health-related costs, adverse effects on colleagues, increases in occupational accidents, and deterioration of the quality of products and services. Therefore, the reduction of presenteeism is considered to be an important challenge for occupational health professionals. Possible applications of the concept of presenteeism in Japanese occupational health are the following: 1) measurement of presenteeism and examination of its related factors, 2) identification of factors that discourage workers from taking adequate sickness absenteeism, and 3) design of occupational health activity plans and the evaluation of such activities. In order to measure presenteeism in Japan, it is necessary to introduce Euro-American instruments suitable for the purpose of measuring presenteeism and to develop new measures. Occupational health professionals can incorporate assessments of presenteeism in their occupational health activities by considering not only the individual state of presenteeism, but also the state of the entire organization and interaction among workers' health problems, occupational factors, and personal factors. Moreover, if the loss of work performance due to presenteeism is converted to financial loss, it is considered that the necessity and the validity of workplace-based health activities will be clarified.

Absenteeism↗

The lightweight and large porous mesh concept for hernia repair.

In modern hernia surgery, there are two competing mesh concepts which often lead to controversial discussions, on the one hand the heavyweight small porous model and on the other, the lightweight large porous hypothesis. The present review illustrates the rationale of both mesh concepts and compares experimental data with the first clinical data available. In summary, the lightweight large porous mesh philosophy takes into consideration all of the recent data regarding physiology and mechanics of the abdominal wall and inguinal region. Furthermore, the new mesh concept reveals an optimized foreign body reaction based on reduced amounts of mesh material and, in particular, a significantly decreased surface area in contact with the recipient host tissues by the large porous model. Finally, recent data demonstrate that alterations in the extracellular matrix of hernia patients play a crucial role in the development of hernia recurrence. In particular, long-term recurrences months or years after surgery and implantation of mesh can be explained by the extracellular matrix hypothesis. However, if the altered extracellular matrix proves to be the weak area, the decisive question is whether the amount of material as well as mechanical and tensile strength of the surgical mesh are really of significant importance for the development of recurrent hernia. All experimental evidence and first clinical data indicate the superiority of the lightweight large porous mesh concept with regard to a reduced number of long-term complications and particularly, increased comfort and quality of life after hernia repair.

Biocompatible Materials↗

[The concept of transcultural nursing: the analysis of its development in a Master degree dissertation].

This is an analytic-bibliographic study which analyzes the concept of nursing in Leininger's Theory and the conceptual development of Nursing presented in the master's degree dissertation chosen for this study. Barnum's model for the analysis and evaluation of theories (Barnum 1998) was used, in relation to the clarity and consistency of the concept, together with questions about Nursing. The group of statements presented in Leininger's transcultural nursing concept and in the dissertation shows what is the focus of nursing and the intrinsic relation to the process of looking after somebody, which must be developed coherently with culture. It also demonstrates that Nursing has a body of specific professional knowledge which guides the care for the client, valuing one's individuality, subjectivity and way of seeing the world. The study made it possible to validate concepts taken from the Theory of Universality and Cultural Diversity of caring and their use in the research according to the analyzed criteria.

Models, Nursing↗

[Nursing actions in nephrology: a theoretical referral expanded beyond the biologicist health conception].

This article focuses ways of nursing performance in nephrology in the health promotion programs. Therefore, we present a theoretical referral formed by concepts of health promotion, health education and technologies. The conception of health promotion is anchored in the First International Conference documents about the subject, which took place in Ottawa, Canada in 1986. Health education is based on the empowerment paradigm, seen as a social action process that promotes people's participation in controlling their lives and health. The concept of technologies is presented in accordance with Merhy's conception, classifying them as hard technologies, light-hard and light ones. This referral will surely represent a new challenge for nurses in nephrology.

Health Promotion↗

The development of a scale to measure concepts of schizophrenia: experience among Brazilian psychiatrists.

INTRODUCTION: Among psychiatric disorders schizophrenia is often said to be the condition with the most disputed definition. The Bleulerian and Schneiderian approaches have given rise to diagnostic formulations that have varied with time and place. Controversies over the concept of schizophrenia were examined within European/North American settings in the early 1970s but little has since been reported on the views of psychiatrists in developing countries. In Brazil both concepts are referred to in the literature. A scale was developed to measure adherence to Bleulerian and Schneiderian concepts among psychiatrists working in S. Paulo. METHODOLOGY: A self-reported questionnaire comprising seventeen visual analogue-scale statements related to Bleulerian and Schneiderian definitions of Schizophrenia, plus sociodemographic and training characteristics, was distributed to a non-randomised sample of 150 psychiatrists. The two sub-scales were assessed by psychometric methods for internal consistency, sub-scale structure and test-retest reliability. Items selected according to internal consistency were examined by a two-factor model exploratory factor analysis. Intraclass correlation coefficients described the stability of the scale. RESULTS: Replies were received from 117 psychiatrists (mean age 36 (SD 7.9)), 74% of whom were made and 26% female. The Schneiderian scale showed better overall internal consistency than the Bleulerian scale. Intra-class correlation coefficients for test-retest comparisons were between 0.5 and 0.7 for Schneiderian items and 0.2 and 0.7 for Bleulerian items. There was no negative association between Bleulerian and Schneiderian scale scores, suggesting that respondents may hold both concepts. Place of training was significantly associated with the respondent's opinion; disagreement with a Bleulerian standpoint predominated for those trained at the University of S. Paulo. CONCLUSIONS: The less satisfactory reliability for the Bleulerian sub-scale limits confidence in the whole scale but on the other hand this questionnaire contributes to the understanding of the controversy over Bleulerian and Schneiderian models for conceptualisation of schizophrenia, the former requiring more inference and therefore being prone to unreliability.

Adult↗

[Differences between proposals for implementation of the social class concept in epidemiological studies]

This article compares different proposals for the implementation of the concept of social class and analyzes the alternatives used in each proposal, considering previous epidemiological studies on this issue and the potential of such a concept as a central category in studies on social determination in the health/disease process. Seven basic differences were identified, pertaining to the following aspects: class structure; research objective; the social class concept as a reference; the decision as to which individual has his/her occupational activity taken as defining the family's social class; the class status of the unemployed, housewives, and the retired; class status of students; and criteria for distinguishing between the "bourgeoisie", "petty bourgeoisie", "new petty bourgeoisie", and "proletariat" and whether there is a specific flow in certain population groups. Given the observed differences and underlying theoretical models, this study discusses problems related to the fact that the use of a specific concept of social class can have various implementation models.

Journal Article↗

[The concept of space in epidemiology: a historical and epistemological interpretation].

This study provides an interpretation of the concept of space in epidemiology. The authors highlight that the epistemological orientation of the space concept in epidemiology is the theory of disease, emphasizing the importance of the concept of specific etiologic agents and their transmission as the central structure for grasping the relationship between space and the body. Characterization of the space for circulation of etiologic agents was the epistemological base shaping the use of various theoretical developments in geography, allowing for the construction of different explanatory watersheds in the concept of space. The article specifically analyzes the Latin American watershed, reviewing the main authors orienting these studies, like Pavlovsky, Max Sorre, and Samuel Pessoa. The authors highlight Milton Santos' thinking as a fundamental reference in recent research on the social organization of space and disease emergence or prevalence. The authors also approach contemporary changes in the understanding of space as they are reflected in epidemiological studies.

Brazil↗

[A review of concepts in health services access and utilization].

The purposes of this article are to review the concepts of health services access and utilization and to analyze how these concepts interrelate. Access is a complex concept (often used inaccurately) which changes over time and according to the context. Health services utilization is at the core of health systems functioning. Despite some disagreement, according to this review the prevailing perspective is that access is related to characteristics of services supply. Health care services utilization can be applied as a measure of access, but use of services depends on other factors. Individual and contextual factors influence the use of services. The article shows that the concept of access is becoming more comprehensive and is changing its focus from entry into the health system to outcome of care. Access is valued in relation to its impact on health and depends on the effectiveness of care delivered. As an outcome measure, access becomes multidimensional and difficult to operationalize. Finally, the article discusses how health determinants differ from those of health services utilization, which impacts directly on illness, but only indirectly on health.

Health Services↗

[Bipolar disorder: evolution of the concept and current controversies].

The author reviews the evolution of the concept of bipolar disorder as an ongoing process. Its roots can be found in the work of Araeteus of Capadocia, who assumed that melancholia and mania were two forms of the same disease. The modern understanding of bipolar disorder began in France, through the work of Falret (1851) and Baillarger (1854). The pivotal concepts of Emil Kraepelin changed the basis of psychiatric nosology, and Kraepelin's unitary concept of manic-depressive insanity was largely accepted. Kraepelin and Weigandt's ideas on mixed states were the cornerstone of this unitary concept. After Kraepelin, however, the ideas of Kleist and Leonhard, in Germany, as well as the work of Angst, Perris and Winokur, emphasized the distinction between unipolar and bipolar forms of depression. More recently, the emphasis has shifted again to the bipolar spectrum, which, in its mild forms, expanded to the limits of normal temperament. In concluding, the author summarizes the polemic aspects concerning the nosology of bipolar disorder and its boundaries in comparison with those of with schizophrenia, schizoaffective disorders and cycloid psychosis.

Bipolar Disorder↗

Increased concentrations of immunoreactive inhibin during conception cycles in the marmoset monkey: suppression with an LHRH antagonist and cloprostenol.

Peripheral concentrations of immunoreactive (ir) inhibin have been measured during the ovarian cycle and early pregnancy in the marmoset monkey. Blood samples were taken (three per week) during conception (n = 6) and non-conception (n = 5) cycles. Ir-inhibin was measured by radioimmunoassay using an antiserum raised against a synthetic peptide fragment of the alpha subunit of human inhibin. Monomeric bovine alpha subunit and 32 kDa bovine inhibin were used as tracer and standard respectively. In all animals low concentrations of ir-inhibin were recorded during the follicular phase (40-60 micrograms/l) of the cycle. After ovulation, ir-inhibin concentrations increased but the peak concentrations attained differed between conception and non-conception cycles. In non-pregnant animals ir-inhibin concentrations reached a maximum of 242 +/- 16 micrograms/l on days 12/13 after ovulation. In pregnant animals ir-inhibin concentrations were significantly (P less than 0.05) higher (1.8-fold) than in non-pregnant animals on days 8/9 after ovulation, and reached a maximum value of 636 +/- 141 micrograms/l on days 20/21 after ovulation. Administration of an LHRH antagonist during the luteal phase on days 6-8 after ovulation resulted in a significant (P less than 0.05) decrease in progesterone and ir-inhibin concentrations within 4 and 8 h respectively. This was prevented by co-administration with human chorionic gonadotrophin. Administration of cloprostenol to pregnant animals between days 17 and 20 after ovulation halved the initial concentrations of both inhibin and progesterone within 1.5 h.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Psychometrics of the Laffrey Health Conception Scale for adolescents.

The purposes of this methodological study were to factor analyze the Laffrey Health Conception Scale (LHCS) and to assess construct validity of the instrument with early adolescents. The final sample consisted of 230 early adolescents, aged 12 to 14, who responded to instrument packets in classrooms in an urban middle school. Data obtained on the LHCS were subjected to principal components factor analysis with oblique rotation. A two-factor solution was accepted, which is consistent with early adolescents' conceptions of health. Factor I was labeled Wellness and Factor II was labeled Clinical Health. A higher order factor analysis yielded one factor with 26 items, labeled the LHCS for Early Adolescents. The 26-item LHCS had a coefficient alpha of .95. Construct validity was assessed by testing three theoretical propositions, which significantly linked health conception to social support, self-esteem, and positive health practices. The findings indicate that the LHCS is a reliable and valid measure of health conceptions in early adolescents. Results also offer flexibility to researchers interested in testing theory involving the constructs of the definition of health, wellness, and clinical health in early adolescents.

Adolescent↗