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Sample records for methodological issues clinical

  1. METHODOLOGICAL ISSUES OF CLINICAL TRIALS IN THE PEDIATRIC POPULATION

    Directory of Open Access Journals (Sweden)

    S.V. Topolyanskaya

    2010-01-01

    Full Text Available Conducting clinical trials on children population is a challenge both for organizers and pediatricians involved in trials. Difficulties in recruiting patients, a significant heterogenecity of the population, specific side reactions, difficulties in identifying the objective final points warrant the specific nature of designing clinical trials in pediatrics. The article illustrates key issues and methodology aspects: planning, design, control groups, patient recruitment. It stresses the need to carefully consider specific characteristics of a child’s system and multi-disciplinary approach involving a pediatrician at the early stages of planning, preliminary consultations with parent organizations, children and regulators.Key words: clinical trials, methodology, planning, design, patient recruitment, children. (Pediatric Pharmacology. – 2010; 7(5:6-10

  2. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  3. Attentional bias modification based on visual probe task: methodological issues, results and clinical relevance

    Directory of Open Access Journals (Sweden)

    Fernanda Machado Lopes

    2015-12-01

    Full Text Available Introduction: Attentional bias, the tendency that a person has to drive or maintain attention to a specific class of stimuli, may play an important role in the etiology and persistence of mental disorders. Attentional bias modification has been studied as a form of additional treatment related to automatic processing. Objectives: This systematic literature review compared and discussed methods, evidence of success and potential clinical applications of studies about attentional bias modification (ABM using a visual probe task. Methods: The Web of Knowledge, PubMed and PsycInfo were searched using the keywords attentional bias modification, attentional bias manipulation and attentional bias training. We selected empirical studies about ABM training using a visual probe task written in English and published between 2002 and 2014. Results: Fifty-seven studies met inclusion criteria. Most (78% succeeded in training attention in the predicted direction, and in 71% results were generalized to other measures correlated with the symptoms. Conclusions: ABM has potential clinical utility, but to standardize methods and maximize applicability, future studies should include clinical samples and be based on findings of studies about its effectiveness.

  4. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  5. Methodological Issues and Practices in Qualitative Research.

    Science.gov (United States)

    Bradley, Jana

    1993-01-01

    Discusses methodological issues concerning qualitative research and describes research practices that qualitative researchers use to address these methodological issues. Topics discussed include the researcher as interpreter, the emergent nature of qualitative research, understanding the experience of others, trustworthiness in qualitative…

  6. The Attachment and Clinical Issues Questionnaire: a new methodology for science and practice in criminology and forensics.

    Science.gov (United States)

    Lindberg, Marc A; Fugett, April; Lounder, Lindsay

    2014-10-01

    Most modern theories suggest that interpersonal relationships are of central importance in the development of criminal behavior. We tested the parent attachment scales of a new research and clinical measure, the Attachment and Clinical Issues Questionnaire (ACIQ). It is a 29-scale battery assessing attachments to mother, father, partner, and peers, which also includes several related clinical scales. Sixty-one (18-20 years of age) male offenders from a maximum security detention center and 131 contrasts completed the ACIQ. ANOVA demonstrated that mother and father attachments displayed different patterns. The attachment scales also predicted the numbers of crimes within the population of juvenile offenders. Thus, the parent attachment scales of the ACIQ showed promise as an instrument to test dynamic systems approaches to developmental models of criminal behavior. © The Author(s) 2013.

  7. Methodological Issues in Questionnaire Design.

    Science.gov (United States)

    Song, Youngshin; Son, Youn Jung; Oh, Doonam

    2015-06-01

    The process of designing a questionnaire is complicated. Many questionnaires on nursing phenomena have been developed and used by nursing researchers. The purpose of this paper was to discuss questionnaire design and factors that should be considered when using existing scales. Methodological issues were discussed, such as factors in the design of questions, steps in developing questionnaires, wording and formatting methods for items, and administrations methods. How to use existing scales, how to facilitate cultural adaptation, and how to prevent socially desirable responding were discussed. Moreover, the triangulation method in questionnaire development was introduced. Steps were recommended for designing questions such as appropriately operationalizing key concepts for the target population, clearly formatting response options, generating items and confirming final items through face or content validity, sufficiently piloting the questionnaire using item analysis, demonstrating reliability and validity, finalizing the scale, and training the administrator. Psychometric properties and cultural equivalence should be evaluated prior to administration when using an existing questionnaire and performing cultural adaptation. In the context of well-defined nursing phenomena, logical and systematic methods will contribute to the development of simple and precise questionnaires.

  8. Muscle dysmorphia: methodological issues, implications for research.

    Science.gov (United States)

    Suffolk, Mark T; Dovey, Terence M; Goodwin, Huw; Meyer, Caroline

    2013-01-01

    Muscle dysmorphia is a male-dominated, body image-related psychological condition. Despite continued investigation, contention surrounds the nosological status of this disorder. The aim of this article was to review the literature on muscle dysmorphia to provide a qualitative account of methodological issues that may inhibit our understanding. Key areas relating to non-standardized participant groups, measuring instruments, and terminology were identified as potentially inhibiting symptom coherence and diagnostic reliability. New measuring instruments validated with clinical samples and carefully described participant groups, standardized terminology, and a greater emphasis on prospective longitudinal research with specific sub groups of the weight training community would be of interest to the field.

  9. Exhaled nitric oxide measurements in the first 2 years of life: methodological issues, clinical and epidemiological applications

    Directory of Open Access Journals (Sweden)

    de Benedictis Fernando M

    2009-07-01

    Full Text Available Abstract Fractional exhaled nitric oxide (FeNO is a useful tool to diagnose and monitor eosinophilic bronchial inflammation in asthmatic children and adults. In children younger than 2 years of age FeNO has been successfully measured both with the tidal breathing and with the single breath techniques. However, there are a number of methodological issues that need to be addressed in order to increase the reproducibility of the FeNO measurements within and between infants. Indeed, a standardized method to measure FeNO in the first 2 years of life would be extremely useful in order to meaningfully interpret FeNO values in this age group. Several factors related to the measurement conditions have been found to influence FeNO, such as expiratory flow, ambient NO and nasal contamination. Furthermore, the exposure to pre- and postnatal risk factors for respiratory morbidity has been shown to influence FeNO values. Therefore, these factors should always be assessed and their association with FeNO values in the specific study population should be evaluated and, eventually, controlled for. There is evidence consistently suggesting that FeNO is increased in infants with family history of atopy/atopic diseases and in infants with recurrent wheezing. These findings could support the hypothesis that eosinophilic bronchial inflammation is present at an early stage in those infants at increased risk of developing persistent respiratory symptoms and asthma. Furthermore, it has been shown that FeNO measurements could represent a useful tool to assess bronchial inflammation in other airways diseases, such as primary ciliary dyskinesia, bronchopulmonary dysplasia and cystic fibrosis. Further studies are needed in order to improve the reproducibility of the measurements, and large prospective studies are warranted in order to evaluate whether FeNO values measured in the first years of life can predict the future development of asthma or other respiratory diseases.

  10. Research methodological issues in evaluating herbal interventions

    Directory of Open Access Journals (Sweden)

    Dipika Bansal

    2010-02-01

    Full Text Available Dipika Bansal, Debasish Hota, Amitava ChakrabartiPostgraduate Institute of Medical Education and Research, Chandigarh, IndiaAbstract: Randomized controlled trials provide the best evidence, and is seen as the gold standard for allopathic research. Herbal therapies are not an integral part of conventional care although they are still used by patients in their health care management. These medicines need to be subjected to rigorous research to establish their effectiveness and safety. Clearly defined treatments are required and should be recorded in a manner that enables other suitably trained researchers to reproduce them reliably. Quality control of herbal products is also a prerequisite of credible clinical trials. Methodological strategies for investigating the herbal interventions and the issues regarding appropriate patient selection, randomization and blinding, placebo effects and choice of comparator, occupational standardization and the selection of appropriate study endpoints to prove efficacy are being discussed. This paper will review research options and propose some suggestions for future research design.Keywords: CAM research, herbal therapies, methodology, clinical trial

  11. Methodological issues of postoperative cognitive dysfunction research

    DEFF Research Database (Denmark)

    Funder, Kamilia S; Steinmetz, Jacob; Rasmussen, Lars S

    2010-01-01

    to reveal postoperative cognitive decline, and questionnaires are not useful for this purpose. There is a profound lack of consensus regarding the research methodology for detection of cognitive deterioration, especially the diagnostic criteria. Issues, such as baseline performance, learning effects...

  12. A systematic review of methodology applied during preclinical anesthetic neurotoxicity studies: important issues and lessons relevant to the design of future clinical research.

    Science.gov (United States)

    Disma, Nicola; Mondardini, Maria C; Terrando, Niccolò; Absalom, Anthony R; Bilotta, Federico

    2016-01-01

    Preclinical evidence suggests that anesthetic agents harm the developing brain thereby causing long-term neurocognitive impairments. It is not clear if these findings apply to humans, and retrospective epidemiological studies thus far have failed to show definitive evidence that anesthetic agents are harmful to the developing human brain. The aim of this systematic review was to summarize the preclinical studies published over the past decade, with a focus on methodological issues, to facilitate the comparison between different preclinical studies and inform better design of future trials. The literature search identified 941 articles related to the topic of neurotoxicity. As the primary aim of this systematic review was to compare methodologies applied in animal studies to inform future trials, we excluded a priori all articles focused on putative mechanism of neurotoxicity and the neuroprotective agents. Forty-seven preclinical studies were finally included in this review. Methods used in these studies were highly heterogeneous-animals were exposed to anesthetic agents at different developmental stages, in various doses and in various combinations with other drugs, and overall showed diverse toxicity profiles. Physiological monitoring and maintenance of physiological homeostasis was variable and the use of cognitive tests was generally limited to assessment of specific brain areas, with restricted translational relevance to humans. Comparison between studies is thus complicated by this heterogeneous methodology and the relevance of the combined body of literature to humans remains uncertain. Future preclinical studies should use better standardized methodologies to facilitate transferability of findings from preclinical into clinical science. © 2015 John Wiley & Sons Ltd.

  13. Methodological issues in lipid bilayer simulations

    NARCIS (Netherlands)

    Anezo, C; de Vries, AH; Holtje, HD; Tieleman, DP; Marrink, SJ

    2003-01-01

    Methodological issues in molecular dynamics (MD) simulations, such as the treatment of long-range electrostatic interactions or the type of pressure coupling, have important consequences for the equilibrium properties observed. We report a series of long (up to 150 ns) MD simulations of

  14. Methodological issues involved in conducting qualitative research ...

    African Journals Online (AJOL)

    The purpose of this article is to describe the methodological issues involved in conducting qualitative research to explore and describe nurses' experience of being directly involved with termination of pregnancies and developing guidelines for support for these nurses. The article points out the sensitivity and responsibility ...

  15. Methodological issues of postoperative cognitive dysfunction research

    DEFF Research Database (Denmark)

    Funder, Kamilia S; Steinmetz, Jacob; Rasmussen, Lars S

    2010-01-01

    Postoperative cognitive dysfunction (POCD) is a subtle impairment of memory, concentration, and speed of information processing. It is a frequent complication following surgery and can have a debilitating effect on patients' recovery and future prognosis. Neuropsychological testing is needed...... to reveal postoperative cognitive decline, and questionnaires are not useful for this purpose. There is a profound lack of consensus regarding the research methodology for detection of cognitive deterioration, especially the diagnostic criteria. Issues, such as baseline performance, learning effects...

  16. Least-cost Paths - Some Methodological Issues

    Directory of Open Access Journals (Sweden)

    Irmela Herzog

    2014-06-01

    Full Text Available This article deals with methodological issues connected with least-cost path (LCP calculations in archaeology. The number of LCP studies in archaeology has increased rapidly during the last couple of years, but not all of the approaches applied are based on an appropriate model and implementation. Many archaeologists rely on standard GIS software with default settings for calculating LCPs and are not aware of possible alternatives and the pitfalls that are described in this article. After briefly introducing the aims and applications of LCP methods in archaeology, LCP algorithms are discussed. The outcome of the LCP calculations depends not only on the algorithm but also on the cost model, which often includes several cost components. The discussion of the cost components has a focus on slope, because nearly all archaeological LCP studies take this cost component into account and because several methodological issues are connected with slope-based cost models. Other possible cost components are: the load of the walker, vegetation cover, wetlands or other soil properties, travelling and transport on water, water as barrier and as attractor, aspect, altitude, and social or cultural cost components. Eventually, advantages and disadvantages of different ways of combining cost components are presented. Based on the methodological issues I conclude that both validation checks and variations of the model are necessary to analyse the reliability of archaeological LCP results.

  17. Economic evaluation in stratified medicine: methodological issues and challenges

    Directory of Open Access Journals (Sweden)

    Hans-Joerg eFugel

    2016-05-01

    Full Text Available Background: Stratified Medicine (SM is becoming a practical reality with the targeting of medicines by using a biomarker or genetic-based diagnostic to identify the eligible patient sub-population. Like any healthcare intervention, SM interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. Methodological standards and guidelines exist for economic evaluations in clinical pharmacology and are an important component for health technology assessments (HTAs in many countries. However, these guidelines have initially been developed for traditional pharmaceuticals and not for complex interventions with multiple components. This raises the issue as to whether these guidelines are adequate to SM interventions or whether new specific guidance and methodology is needed to avoid inconsistencies and contradictory findings when assessing economic value in SM.Objective: This article describes specific methodological challenges when conducting health economic (HE evaluations for SM interventions and outlines potential modifications necessary to existing evaluation guidelines /principles that would promote consistent economic evaluations for SM.Results/Conclusions: Specific methodological aspects for SM comprise considerations on the choice of comparator, measuring effectiveness and outcomes, appropriate modelling structure and the scope of sensitivity analyses. Although current HE methodology can be applied for SM, greater complexity requires further methodology development and modifications in the guidelines.

  18. Methodological issues of genetic association studies.

    Science.gov (United States)

    Simundic, Ana-Maria

    2010-12-01

    Genetic association studies explore the association between genetic polymorphisms and a certain trait, disease or predisposition to disease. It has long been acknowledged that many genetic association studies fail to replicate their initial positive findings. This raises concern about the methodological quality of these reports. Case-control genetic association studies often suffer from various methodological flaws in study design and data analysis, and are often reported poorly. Flawed methodology and poor reporting leads to distorted results and incorrect conclusions. Many journals have adopted guidelines for reporting genetic association studies. In this review, some major methodological determinants of genetic association studies will be discussed.

  19. Privacy and CHI : methodologies for studying privacy issues

    NARCIS (Netherlands)

    Patil, S.; Romero, N.A.; Karat, J.

    2006-01-01

    This workshop aims to reflect on methodologies to empirically study privacy issues related to advanced technology. The goal is to address methodological concerns by drawing upon both theoretical perspectives as well as practical experiences.

  20. Big data and virtual communities: methodological issues

    OpenAIRE

    Martínez Torres, María del Rocío; Toral, S. L.; Fornara, Nicoletta

    2014-01-01

    Virtual communities represent today en emergent phenomenon through which users get together to create ideas, to obtain help from one another, or just to casually engage in discussions. Their increasing popularity as well as their utility as a source of business value and marketing strategies justify the necessity of defi ning some specifi c methodologies for analyzing them. The aim of this paper is providing new insights into virtual communities from a methodological viewpoint, hi...

  1. Methodological Issues on Climate Change Mitigation Studies

    DEFF Research Database (Denmark)

    Sørensen, Lene; Borges, Pedro Castro; Vidal, Rene Victor Valqui

    1999-01-01

    This paper uses national greenhouse gas emission abatement costing studies as a case to discuss influential factors that determine their outcome and achievement. Costing studies are seen as part of an interconnected whole social process where actors (decision makers, clients, facilitators, expert...... such methodologies to case studies is seen as one way of improving the chances of understanding and handling environmental problems...

  2. Evolution of courseware development methodology : recent issues

    NARCIS (Netherlands)

    Moonen, J.C.M.M.; Schoenmaker, Jan

    1992-01-01

    To improve the quality of courseware products and the efficiency of the courseware development process, a methodology based upon "courseware engineering", being a combination of instructional systems development and software engineering, has emerged over the last 10¿15 years. Recently, software

  3. International Comparisons: Issues of Methodology and Practice

    Directory of Open Access Journals (Sweden)

    Serova Irina A.

    2017-12-01

    Full Text Available The article discusses the methodology and organization of statistical observation of the level of countries’ economic development. The theoretical basis of international comparisons is singled out and on its basis the comparative evaluation of inconsistency of theoretical positions and the reasons of differences of GDP growth is carried out. Based on the complexity of the formation of homogeneous data sets in order to obtain correct comparison results, a general scheme for the relationship between the theoretical base of international comparisons and PPP constraints is defined. The possibility of obtaining a single measurement of the indicators of national economies based on the existing sampling errors, measurement uncertainties and classification errors is considered. The emphasis is placed on combining the work using the ICP and CPI with the aim of achieving comparability of data in the territorial and temporal cross-section. Using the basic characteristics of sustainable economic growth, long-term prospects for changing the ranking positions of countries with different levels of income are determined. It is shown that the clarity and unambiguity of the theoretical provisions is the defining condition for the further process of data collection and formation of correct analytical conclusions.

  4. Ethical and methodological issues in research with Sami experiencing disability.

    Science.gov (United States)

    Melbøe, Line; Hansen, Ketil Lenert; Johnsen, Bjørn-Eirik; Fedreheim, Gunn Elin; Dinesen, Tone; Minde, Gunn-Tove; Rustad, Marit

    2016-01-01

    A study of disability among the indigenous Sami people in Norway presented a number of ethical and methodological challenges rarely addressed in the literature. The main study was designed to examine and understand the everyday life, transitions between life stages and democratic participation of Norwegian Sami people experiencing disability. Hence, the purpose of this article is to increase the understanding of possible ethical and methodological issues in research within this field. The article describes and discusses ethical and methodological issues that arose when conducting our study and identifies some strategies for addressing issues like these. The ethical and methodological issues addressed in the article are based on a qualitative study among indigenous Norwegian Sami people experiencing disability. The data in this study were collected through 31 semi-structured in-depth interviews with altogether 24 Sami people experiencing disability and 13 next of kin of Sami people experiencing disability (8 mothers, 2 fathers, 2 sister and 1 guardian). The researchers identified 4 main areas of ethical and methodological issues. We present these issues chronologically as they emerged in the research process: 1) concept of knowledge when designing the study, 2) gaining access, 3) data collection and 4) analysis and accountability. The knowledge generated from this study has the potential to benefit future health research, specifically of Norwegian Sami people experiencing disability, as well as health research concerning indigenous people in general, providing scientific-based insight into important ethical and methodological issues in research with indigenous people experiencing disability.

  5. Students' Involvement in Faculty Research: Ethical and Methodological Issues

    Directory of Open Access Journals (Sweden)

    Linda M. Ferguson

    2004-12-01

    Full Text Available Faculty who engage students as participants in their qualitative research often encounter methodological and ethical problems. Ethical issues arise from the fiduciary relationship between faculty and their students, and violations of that relationship occur when the educator has a dual role as researcher with those students. Methodological issues arise from research designs to address these ethical issues. This conflict is particularly evident in faculty research on pedagogy in their own disciplines, for which students are necessary as participants but are captive in the relationship. In this article, the authors explore the issues of double agency when faculty involve students as participants in their research.

  6. Methodological and Clinical Issues in Studies of the Performance of Emotionally Disturbed Children and Adolescents on Abbreviated Forms of the WISC-R: A Review.

    Science.gov (United States)

    Zimet, Sara G.; Adler, Shoshana Shapiro

    1990-01-01

    Reviews research from 1974 to 1988 that suggests there is promise in valid and reliable use of a short form of the Wechsler Intelligence Scale for Children as a means of obtaining clinically relevant information and as an emergency screening device with children with serious emotional disorders. Discusses situations in which children should…

  7. Methodological Issues in HIV-Related Social Research in Nigeria

    African Journals Online (AJOL)

    AJRH Managing Editor

    Methodological Issues in HIV/AIDS Social Research in Nigeria ... convaincue au commencement de l'étude qu'une étude sur l'interaction entre le VIH/sida et les questions sensibles comme les ..... One of the vexed issues was the requirement.

  8. A six-month crossover chemoprevention clinical trial of tea in smokers and non-smokers: methodological issues in a feasibility study

    Science.gov (United States)

    2012-01-01

    Background Chemoprevention crossover trials of tea can be more efficient than parallel designs but the attrition and compliance rates with such trials are unknown. Methods Attrition (dropouts) and compliance with treatment were assessed in a 25-week randomized, placebo controlled, crossover, feasibility clinical trial of four tea treatments to investigate the effect of tea on oral cancer biomarkers. Each treatment lasted 4 weeks with 2 weeks of washout in between. Participants were 32 smokers and 33 non-smokers without any evidence of premalignant oral lesions. The interventions consisted of packets of green tea, black tea, caffeinated water, or placebo. Participants were assigned to each treatment for four weeks, and were instructed to drink five packets per day while on the treatment. Dropout from the trial and compliance (consumption of ≥ 85% of the prescribed treatment packets) are the main outcome measures reported. Results There was a high rate of dropout (51%) from the study, and the rates were significantly higher among smokers (64%) than non-smokers (36%). Among participants who completed the study the rate of compliance was 72%. The highest rates of dropouts occurred between the first and second treatment visits in both smokers (38% dropout) and non-smokers (18% dropout). Throughout the study smokers were more likely to dropout than non-smokers. Black tea treatment was associated with the highest rates of dropout among smokers (37%), but was associated with the lowest rate of dropout among non-smokers (4%). Conclusions In a study conducted to test the feasibility of a four-treatment crossover tea trial, a high rate of dropout among smokers and non-smokers was observed. Multi-arm crossover tea trials might pose a higher burden on participants and research is needed to improve adherence and treatment compliance in such trials. Trial registration number ISRCTN70410203 PMID:22800470

  9. Issues in the global applications of methodology in forensic anthropology.

    Science.gov (United States)

    Ubelaker, Douglas H

    2008-05-01

    The project and research reported in this collection of articles follows a long-term historical pattern in forensic anthropology in which new case work and applications reveal methodological issues that need to be addressed. Forensic anthropological analysis in the area of the former Yugoslavia led to questions raised regarding the applicability of methods developed from samples in other regions. The subsequently organized project reveals that such differences exist and new methodology and data are presented to facilitate applications in the Balkan area. The effort illustrates how case applications and court testimony can stimulate research advances. The articles also serve as a model for the improvement of methodology available for global applications.

  10. Making the Invisible Visible: A Methodological and a Substantive Issue

    Science.gov (United States)

    Dagley, Valerie

    2004-01-01

    This article discusses the issue of "making the invisible visible" from a methodological and a substantive viewpoint. The ideas emerged from a doctoral research study into individual target setting with middle ability students in an English secondary school. The students involved had been identified by assessments as "average"…

  11. Personality Assessment of Global Talent: Conceptual and Methodological Issues

    Science.gov (United States)

    van de Vijver, Fons J. R.

    2008-01-01

    The recruitment of managers who will operate in a culturally heterogeneous context (as expatriate managers, managers in a global company, or managers of a multicultural workforce) is increasingly important in an age of globalization. This article describes conceptual and methodological issues in the assessment of such managers, notably in the…

  12. Some methodological issues in neuroradiological research in psychiatry

    International Nuclear Information System (INIS)

    Becker, T.; Retz, W.; Hofmann, E.; Becker, G.; Teichmann, E.; Gsell, W.

    1995-01-01

    An outline is given of some of the methodological issues discussed in neuroradiological research on psychiatric illnesses. The strengths and shortcomings of magnetic resonance imaging (MRI) in depicting and quantifying brain structures are described. Temporal lobe anatomy and pathology are easily accessible to MRI, whereas limits on anatomical delineation hamper approaches to frontal lobe study. White matter hyperintense lesions are sensitively depicted by MRI, but specificity is limited. The distinction of vascular and primary degenerative dementia is considerably improved by CT and MRI analysis. Computed tomography (CT) and MRI have enhanced the understanding of treatable organic psychiatric disorders, e.g., normal pressure hydrocephalus. Subcortical and white matter pathology has been replicated in CT and MRI studies of late onset psychiatric disorders, clinical overlap with cerebrovascular disease or neuro degeneration may be of import. Trans cranial sonography findings of brainstem structural change specific to unipolar depression may contribute to the understanding of affective psychoses. Magnetic resonance spectroscopy and functional MRI are likely to stimulate psychiatric research in the future. (author)

  13. Contemporary Research on Parenting: Conceptual, Methodological, and Translational Issues

    OpenAIRE

    Power, Thomas G.; Sleddens, Ester F. C.; Berge, Jerica; Connell, Lauren; Govig, Bert; Hennessy, Erin; Liggett, Leanne; Mallan, Kimberley; Santa Maria, Diane; Odoms-Young, Angela; St. George, Sara M.

    2013-01-01

    Researchers over the last decade have documented the association between general parenting style and numerous factors related to childhood obesity (e.g., children's eating behaviors, physical activity, and weight status). Many recent childhood obesity prevention programs are family focused and designed to modify parenting behaviors thought to contribute to childhood obesity risk. This article presents a brief consideration of conceptual, methodological, and translational issues that can infor...

  14. Nuclear methodology development for clinical analysis

    International Nuclear Information System (INIS)

    Oliveira, Laura Cristina de

    2003-01-01

    In the present work the viability of using the neutron activation analysis to perform urine and blood clinical analysis was checked. The aim of this study is to investigate the biological behavior of animals that has been fed with chow doped by natural uranium for a long period. Aiming at time and cost reduction, the absolute method was applied to determine element concentration on biological samples. The quantitative results of urine sediment using NAA were compared with the conventional clinical analysis and the results were compatible. This methodology was also used on bone and body organs such as liver and muscles to help the interpretation of possible anomalies. (author)

  15. Methodological choice and the study of sensitive issues

    Directory of Open Access Journals (Sweden)

    Nora Ahlberg

    1999-01-01

    Full Text Available There has been relatively little concern with methodological issues within the study of religion. In this article the author considers the need for a continuing clarification of how diverse methodological approaches relate to the study of religion in general, and what is more, of certain aspects of the role of the researcher in particular. A main difference between the methodological approaches as referred to in this article — and illustrated by reference to minority studies -is in the closeness of the researcher to his field. One could perhaps state that while the researcher draws nearer to his field in soft approaches the theories remain further away from the empirical data (i.e. in that one creates greater vistas while the opposite is true for those that work with hard data designs, that meta-theories are almost excluded (as pure speculation due to the strict demands for operationalization, as the (effect of the researcher is to a greater extend likewise excluded from the picture. Though in both cases the choices made must naturally be made explicit as must the researcher relate to a qualified discussion between experts who have some kind of relationship to the kind of empirical material or theoretical thinking that is at issue in the particular project.

  16. Action research methodology in clinical pharmacy

    DEFF Research Database (Denmark)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh

    2016-01-01

    Introduction The focus in clinical pharmacy practice is and has for the last 30-35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process...... by establishing partnerships with staff. On the background of the authors' widespread action research (AR)-based experiences, recommendations and comments for how to conduct an AR-study is described, and one of their AR-based studies illustrate the methodology and the research methods used. Methodology AR...... is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented...

  17. Regional issue identification and assessment: study methodology. First annual report

    Energy Technology Data Exchange (ETDEWEB)

    1980-01-01

    The overall assessment methodologies and models utilized for the first project under the Regional Issue Identification and Assessment (RIIA) program are described. Detailed descriptions are given of the methodologies used by lead laboratories for the quantification of the impacts of an energy scenario on one or more media (e.g., air, water, land, human and ecology), and by all laboratories to assess the regional impacts on all media. The research and assessments reflected in this document were performed by the following national laboratories: Argonne National Laboratory; Brookhaven National Laboratory; Lawrence Berkeley Laboratory; Los Alamos Scientific Laboratory; Oak Ridge National Laboratory; and Pacific Northwest Laboratory. This report contains five chapters. Chapter 1 briefly describes the overall study methodology and introduces the technical participants. Chapter 2 is a summary of the energy policy scenario selected for the RIIA I study and Chapter 3 describes how this scenario was translated into a county-level siting pattern of energy development. The fourth chapter is a detailed description of the individual methodologies used to quantify the environmental and socioeconomic impacts of the scenario while Chapter 5 describes how these impacts were translated into comprehensive regional assessments for each Federal Region.

  18. Methodological issues in studies of air pollution and reproductive health.

    Science.gov (United States)

    Woodruff, Tracey J; Parker, Jennifer D; Darrow, Lyndsey A; Slama, Rémy; Bell, Michelle L; Choi, Hyunok; Glinianaia, Svetlana; Hoggatt, Katherine J; Karr, Catherine J; Lobdell, Danelle T; Wilhelm, Michelle

    2009-04-01

    In the past decade there have been an increasing number of scientific studies describing possible effects of air pollution on perinatal health. These papers have mostly focused on commonly monitored air pollutants, primarily ozone (O(3)), particulate matter (PM), sulfur dioxide (SO(2)), carbon monoxide (CO), and nitrogen dioxide (NO(2)), and various indices of perinatal health, including fetal growth, pregnancy duration, and infant mortality. While most published studies have found some marker of air pollution related to some types of perinatal outcomes, variability exists in the nature of the pollutants and outcomes associated. Synthesis of the findings has been difficult for various reasons, including differences in study design and analysis. A workshop was held in September 2007 to discuss methodological differences in the published studies as a basis for understanding differences in study findings and to identify priorities for future research, including novel approaches for existing data. Four broad topic areas were considered: confounding and effect modification, spatial and temporal exposure variations, vulnerable windows of exposure, and multiple pollutants. Here we present a synopsis of the methodological issues and challenges in each area and make recommendations for future study. Two key recommendations include: (1) parallel analyses of existing data sets using a standardized methodological approach to disentangle true differences in associations from methodological differences among studies; and (2) identification of animal studies to inform important mechanistic research gaps. This work is of critical public health importance because of widespread exposure and because perinatal outcomes are important markers of future child and adult health.

  19. Echolalia: issues and clinical applications.

    Science.gov (United States)

    Schuler, A L

    1979-11-01

    Echolalic behaviors have been reported within the context of various pathologies but have remained poorly defined. Consequently, it is not easy to determine whether and to what extent normal repetition can be separated from pathological echoing. Hence, it is unclear whether the occurrence of echolalic behavior may be useful for differential diagnostic purposes. Also, much room is left for controversies about the clinical management of echolalic behavior. This article reviews the various conditions associated with echolalia and the role of repetitions in normal language behavior. Suggestions are made in terms of the various dimensions along which echolalic behavior should be assessed, as well as of the desirability of particular intervention techniques.

  20. Methodological issues and research recommendations for prognosis after mild traumatic brain injury

    DEFF Research Database (Denmark)

    Kristman, Vicki L; Borg, Jörgen; Godbolt, Alison K

    2014-01-01

    methodological concerns and knowledge gaps in the literature. Here we report and make recommendations on how to avoid methodological flaws found in prognostic studies of MTBI. Additionally, we discuss issues of MTBI definition and identify topic areas in need of further research to advance the understanding......, Prevention, Management and Rehabilitation Task Force on the prognosis of MTBI. Of 299 relevant studies, 101 were accepted as scientifically admissible. The methodological quality of the research literature on MTBI prognosis has not improved since the 2002 Task Force report. There are still many...... of prognosis after MTBI. Priority research areas include but are not limited to the use of confirmatory designs, studies of measurement validity, focus on the elderly, attention to litigation/compensation issues, the development of validated clinical prediction rules, the use of MTBI populations other than...

  1. Clinical governance and operations management methodologies.

    Science.gov (United States)

    Davies, C; Walley, P

    2000-01-01

    The clinical governance mechanism, introduced since 1998 in the UK National Health Service (NHS), aims to deliver high quality care with efficient, effective and cost-effective patient services. Scally and Donaldson recognised that new approaches are needed, and operations management techniques comprise potentially powerful methodologies in understanding the process of care, which can be applied both within and across professional boundaries. This paper summarises four studies in hospital Trusts which took approaches to improving process that were different from and less structured than business process re-engineering (BPR). The problems were then amenable to change at a relatively low cost and short timescale, producing significant improvement to patient care. This less structured approach to operations management avoided incurring overhead costs of large scale and costly change such as new information technology (IT) systems. The most successful changes were brought about by formal tools to control quantity, content and timing of changes.

  2. PET/MRI. Methodology and clinical applications

    Energy Technology Data Exchange (ETDEWEB)

    Carrio, Ignasi [Autonomous Univ. of Barcelona, Hospital Sant Pau (Spain). Dept. Medicina Nuclear; Ros, Pablo (ed.) [Univ. Hospitals Case, Medical Center, Cleveland, OH (United States). Dept. of Radiology

    2014-04-01

    Provides detailed information on the methodology and equipment of MRI-PET. Covers a wide range of clinical applications in oncology, cardiology, and neurology. Written by an international group of experts in MRI and PET. PET/MRI is an exciting novel diagnostic imaging modality that combines the precise anatomic and physiologic information provided by magnetic resonance imaging (MRI) with the molecular data obtained with positron emission tomography (PET). PET/MRI offers the promise of a simplified work flow, reduced radiation, whole-body imaging with superior soft tissue contrast, and time of flight physiologic information. It has been described as the pathway to molecular imaging in medicine. In compiling this textbook, the editors have brought together a truly international group of experts in MRI and PET. The book is divided into two parts. The first part covers methodology and equipment and comprises chapters on basic molecular medicine, development of specific contrast agents, MR attenuation and validation, quantitative MRI and PET motion correction, and technical implications for both MRI and PET. The second part of the book focuses on clinical applications in oncology, cardiology, and neurology. Imaging of major neoplasms, including lymphomas and tumors of the breast, prostate, and head and neck, is covered in individual chapters. Further chapters address functional and metabolic cardiovascular examinations and major central nervous system applications such as brain tumors and dementias. Risks, safety aspects, and healthcare costs and impacts are also discussed. This book will be of interest to all radiologists and nuclear medicine physicians who wish to learn more about the latest developments in this important emerging imaging modality and its applications.

  3. Methodological issues related to studies of lead mobilization during menopause

    Directory of Open Access Journals (Sweden)

    Berkowitz Gertrud S.

    1999-01-01

    Full Text Available While there has been a substantial decline in lead exposure in the United States during the past two decades, mobilization of existing lead stored in bone potentially represents an important endogenous source of exposure for menopausal women. It has been hypothesized that lead may be mobilized from skeletal stores during conditions of high bone turnover, such as during menopause. However, such mobilization has not been documented in prospective studies. This discussion is focussed on some of the methodological difficulties to be anticipated in longitudinal studies of lead mobilization specific to menopause and the issues that need to be taken into account when evaluating the results of such studies. To evaluate whether lead mobilization occurs during menopause, a prospective repeated measures design is needed using X-ray fluorescence analysis of lead in bone and serial measurements of blood lead. Potential confounders and effect modifiers also need to be taken into account in the statistical analysis.

  4. Contemporary research on parenting: conceptual, methodological, and translational issues.

    Science.gov (United States)

    Power, Thomas G; Sleddens, Ester F C; Berge, Jerica; Connell, Lauren; Govig, Bert; Hennessy, Erin; Liggett, Leanne; Mallan, Kimberley; Santa Maria, Diane; Odoms-Young, Angela; St George, Sara M

    2013-08-01

    Researchers over the last decade have documented the association between general parenting style and numerous factors related to childhood obesity (e.g., children's eating behaviors, physical activity, and weight status). Many recent childhood obesity prevention programs are family focused and designed to modify parenting behaviors thought to contribute to childhood obesity risk. This article presents a brief consideration of conceptual, methodological, and translational issues that can inform future research on the role of parenting in childhood obesity. They include: (1) General versus domain specific parenting styles and practices; (2) the role of ethnicity and culture; (3) assessing bidirectional influences; (4) broadening assessments beyond the immediate family; (5) novel approaches to parenting measurement; and (6) designing effective interventions. Numerous directions for future research are offered.

  5. Contemporary Research on Parenting: Conceptual, Methodological, and Translational Issues

    Science.gov (United States)

    Sleddens, Ester F. C.; Berge, Jerica; Connell, Lauren; Govig, Bert; Hennessy, Erin; Liggett, Leanne; Mallan, Kimberley; Santa Maria, Diane; Odoms-Young, Angela; St. George, Sara M.

    2013-01-01

    Abstract Researchers over the last decade have documented the association between general parenting style and numerous factors related to childhood obesity (e.g., children's eating behaviors, physical activity, and weight status). Many recent childhood obesity prevention programs are family focused and designed to modify parenting behaviors thought to contribute to childhood obesity risk. This article presents a brief consideration of conceptual, methodological, and translational issues that can inform future research on the role of parenting in childhood obesity. They include: (1) General versus domain specific parenting styles and practices; (2) the role of ethnicity and culture; (3) assessing bidirectional influences; (4) broadening assessments beyond the immediate family; (5) novel approaches to parenting measurement; and (6) designing effective interventions. Numerous directions for future research are offered. PMID:23944927

  6. School resources and student achievment: worldwide findings and methodological issues

    Directory of Open Access Journals (Sweden)

    Paulo A. Meyer. M. Nascimento

    2008-03-01

    Full Text Available The issues raised in the Education Production Function literature since the US 1966 Coleman Report have fuelled high controversy on the role of school resources in relation to student performance. In several literature reviews and some self estimates, Erik Hanushek (1986, 1997, 2006 systematically affirms that these two factors are not associated one to another – neither in the US nor abroad. In recent cross-country analyses, Ludger Woessmann (2003; 2005a; 2005b links international differences in attainment to institutional differences across educational systems – not to resourcing levels. In the opposite direction, Stephen Heyneman and William Loxley (1982, 1983 tried to demonstrate in the 1980’s that, at least for low income countries, school factors seemed to outweigh family characteristics on the determination of students’ outcomes – although other authors show evidence that such a phenomenon may have existed only during a limited period of the 20th Century. In the 1990s, meta-analyses raised the argument that school resources were sufficiently significant to be regarded as pedagogically important. The turn of the Century witnessed a new movement: the recognition that endogenous determination of resource allocation is a substantial methodological issue. Therefore, efforts have been made to incorporate the decision-making processes that involve families, schools and policy-makers in economic models. This implies changes in research designs that may affect the direction of future policy advices patronised by international development and educational organisations.

  7. Methodological issues in human studies of endocrine disrupting chemicals.

    Science.gov (United States)

    Lee, Duk-Hee; Jacobs, David R

    2015-12-01

    Possible harm from endocrine disrupting chemicals (EDCs) in humans is speculated based on two types of evidence; 1) increasing trends of suspected diseases in ecological studies of populations and 2) findings from traditional epidemiological studies of individuals. However, ecological findings are not regarded as direct human evidence of the relation between EDCs and disease, while the evidence among epidemiological studies of individuals is often inconsistent. Thus, a criticism is that linking EDCs and health in human is naively presumed without solid evidence. However, human studies of EDCs are methodologically complex and understanding methodological issues will help to interpret findings from existing human studies and to properly design optimal human studies. The key issues are low reliability of exposure assessment of EDCs with short half-lives, EDC mixtures, possibility of non-monotonic dose-response relationships, non-existence of an unexposed group, difficulties in measuring exposure during critical periods, and interactions with established risk factors. Furthermore, EDC mixtures may affect human health through other mechanisms than traditional endocrine disruption, for example glutathione depletion or mitochondrial dysfunction. Given this complexity, the most plausible scenario in humans is that exposure to EDC mixtures leads to increasing risk of related diseases at the ecological level, but inconsistent associations would be expected in traditional epidemiological studies. Although epidemiologists have long relied on Bradford Hill's criteria to objectively evaluate whether associations observed in epidemiology can be interpreted as causal, there are challenges to use these criteria for EDCs, particularly concerning consistency across studies and the findings of linear dose-response relationships. At the individual level, compared to EDCs with short half-lives, epidemiological studies of EDCs with long half-lives among populations with a relatively low

  8. Multilingual Children Who Stutter: Clinical Issues

    Science.gov (United States)

    Shenker, Rosalee C.

    2011-01-01

    Stuttering occurs across all languages and cultures. However, the impact of speaking more than one language on assessment and treatment of young children who stutter is not well documented. This paper discusses some of the challenges related to clinical issues pertaining to this population including (a) identifying stuttering in an unfamiliar…

  9. Theoretical Issues in Clinical Social Group Work.

    Science.gov (United States)

    Randall, Elizabeth; Wodarski, John S.

    1989-01-01

    Reviews relevant issues in clinical social group practice including group versus individual treatment, group work advantages, approach rationale, group conditions for change, worker role in group, group composition, group practice technique and method, time as group work dimension, pretherapy training, group therapy precautions, and group work…

  10. Methodological Issues in Online Qualitative Consumer Behavior Research

    Directory of Open Access Journals (Sweden)

    Žaneta Paunksnienė

    2014-03-01

    Full Text Available The aim of this paper is to reveal and discuss the methodological issues related to online qualitative consumer behavior research. A number of methodological issues are examined, related with the online qualitative research on consumer in-store emotional experience implemented by the authors. It is concluded that the Internet is becoming an increasingly attractive environment for consumer behavior research. A large part of scholars use the Internet as a medium for data collection and analysis. At the same time, researchers study the Internet as a source of information about consumer preferences, their virtual communities, prevailing relationships, traditions and attitudes. The Internet is analyzed as a phenomenon in itself, too. In this article, the Internet is analyzed as a tool for communicating with research participants, and collecting, storing and analyzing data. In general, qualitative inquiry is characterized by contextual and naturalistic approach to the study of objects and processes. Therefore, decision to carry out qualitative study in virtual environment must take additional strategic and tactical solutions. Most often, researchers need to decide about the mode of communication that solves time management, spontaneity and security problems. It is also relevant to sampling and its contents. Different solutions from quantitative studies are required in ensuring the ethics and quality of the study. During the analysis of the qualitative data collected through the Internet, mostly in a form of computer communication language (text, specific characteristics, such as backspacing and correction during the communication that impact spontaneity rate, the absence of non-verbal language, etc., are necessary to be taken into accountIt is concluded that all the above-mentioned issues must be addressed individually to the research topic, object, aim, research problem and the specifics of the respondents. When deciding about the method of

  11. Clinical track faculty: merits and issues.

    Science.gov (United States)

    Lee, Won-Hee; Kim, Cho Ja; Roh, Young Sook; Shin, Hyunsook; Kim, Mi Ja

    2007-01-01

    Clinical track faculty (CTF) has been in operation for more than two decades in the United States, and 12 of the top 20 schools of nursing with the highest National Institutes of Health funding in the United States have CTF in place. Yet, only limited articles have been published regarding the merits and issues related to its operation. This article examines the advantages/merits of establishing CTF in schools of nursing, discusses the qualification criteria and types of appointment for CTF, and analyzes issues related to operating CTF in Korea. A questionnaire survey and two workshops were conducted involving faculty from a college of nursing and clinical nurse managers from university-affiliated medical centers and community agencies. Most of the respondents indicated that establishing CTF was advantageous. Merits included the following: increasing reality-based clinical education and training; decreasing the reality shock of students; increasing student satisfaction; and linking education, practice, and research more effectively. Major issues were as follows: getting the approval of medical centers/universities; developing an agreement on CTF operation between the college of nursing and clinical agencies; clarifying types and criteria of appointment and promotion; and developing a statement on role and compensation policies. Most issues are similar to what U.S. schools of nursing have faced, except for the first one. In conclusion, establishing CTF in Korea appears to be highly desirable. Merits outweigh issues/concerns, and Korean nursing schools may look for an opportune time for obtaining the approval of medical centers/universities. Nursing schools in other countries that face a similar challenge of providing clinical teaching with high research performance may consider instituting CTF.

  12. Medical databases in studies of drug teratogenicity: methodological issues

    Directory of Open Access Journals (Sweden)

    Vera Ehrenstein

    2010-03-01

    Full Text Available Vera Ehrenstein1, Henrik T Sørensen1, Leiv S Bakketeig1,2, Lars Pedersen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Norwegian Institute of Public Health, Oslo, NorwayAbstract: More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.Keywords: databases, birth defects, epidemiologic methods, pharmacoepidemiology

  13. Work load issues in clinical nursing education.

    Science.gov (United States)

    Schuster, P; Fitzgerald, D C; McCarthy, P A; McDougal, D

    1997-01-01

    This survey of 22 baccalaureate (BSN) programs was undertaken to describe and analyze work load issues in BSN nursing education. Academic careers of nursing faculty may be at risk because clinical work load policies generally place less value on clinical teaching than on classroom teaching. Research question addressed teaching credit hours received for each clinical contact hour, remaining weekly hours available for clinical faculty to accomplish service and research activities, and student-to-faculty ratios in clinical settings. Seventy per cent of the programs surveyed allocated less than 1 teaching credit hour to 1 clinical contact hour. Nursing faculty who taught clinical courses with 5:1 to .25:1 work load credit for face-to-face contact hour ratios needed to work between 8 and 24 hours more in face-to-face teaching compared with colleagues teaching lecture courses, thus leaving less time for scholarship and service activities. Fifty per cent of the programs reported 10 or more students in some of the clinical courses. Faculty reported concerns about quality of learning experiences and supervisory difficulties as student numbers in clinical courses exceeded 8 students/faculty member.

  14. Personality and chronic fatigue syndrome: methodological and conceptual issues.

    Science.gov (United States)

    van Geelen, Stefan M; Sinnema, Gerben; Hermans, Hubert J M; Kuis, Wietse

    2007-12-01

    Among clinical psychologists, consulting physicians, scientific researchers and society in general an image has emerged of patients with chronic fatigue syndrome (CFS) as perfectionist, conscientious, hardworking, somewhat neurotic and introverted individuals with high personal standards, a great desire to be socially accepted and with a history of continuously pushing themselves past their limits. The aim of this article is to (a) give a concise review of the main recent studies on personality and CFS, (b) address the major methodological problems in the study of personality in CFS and (c) discuss some of the conceptual assumptions that seem to limit the research on personality and CFS. The results of the reviewed studies range from no evidence of major differences between the personalities of patients with CFS and controls, to evidence of severe psychopathology and personality disorder in patients with CFS. Although personality seems to play a role in CFS, it is difficult to draw general conclusions on the relation between personality and CFS. It is argued that this is partially due to the diversity and heterogeneity in study methods, patient populations, control groups and CFS case definitions. Personality should be regarded as an important factor to be studied in CFS. However, additional studies are needed, not focusing exclusively on personality disorder, or personality considered on a general trait level. In recent developments in personality research, the continually evolving life narrative that makes sense of, and gives direction to, an individual's life is also regarded as an important aspect of personality. New insights into personality and CFS might be gained by systematically studying the self-narratives of patients with the syndrome.

  15. Cannabis cultivation: Methodological issues for obtaining medical-grade product.

    Science.gov (United States)

    Chandra, Suman; Lata, Hemant; ElSohly, Mahmoud A; Walker, Larry A; Potter, David

    2017-05-01

    As studies continue to reveal favorable findings for the use of cannabidiol in the management of childhood epilepsy syndromes and other disorders, best practices for the large-scale production of Cannabis are needed for timely product development and research purposes. The processes of two institutions with extensive experience in producing large-scale cannabidiol chemotype Cannabis crops-GW Pharmaceuticals and the University of Mississippi-are described, including breeding, indoor and outdoor growing, harvesting, and extraction methods. Such practices have yielded desirable outcomes in Cannabis breeding and production: GW Pharmaceuticals has a collection of chemotypes dominant in any one of eight cannabinoids, two of which-cannabidiol and cannabidivarin-are supporting epilepsy clinical trial research, whereas in addition to a germplasm bank of high-THC, high-CBD, and intermediate type cannabis varieties, the team at University of Mississippi has established an in vitro propagation protocol for cannabis with no detectable variations in morphologic, physiologic, biochemical, and genetic profiles as compared to the mother plants. Improvements in phytocannabinoid yields and growing efficiency are expected as research continues at these institutions. This article is part of a Special Issue entitled "Cannabinoids and Epilepsy". Copyright © 2016. Published by Elsevier Inc.

  16. Investigating precipitation changes of anthropic origin: data and methodological issues

    Science.gov (United States)

    de Lima, Isabel; Lovejoy, Shaun

    2017-04-01

    There is much concern about the social, environmental and economic impacts of climate change that could result directly from changes in temperature and precipitation. For temperature, the situation is better understood; but despite the many studies that have been already dedicated to precipitation, change in this process - that could be associated to the transition to the Anthropocene - has not yet been convincingly proven. A large fraction of those studies have been exploring temporal (linear) trends in local precipitation, sometimes using records over only a few decades; other fewer studies have been dedicated to investigating global precipitation change. Overall, precipitation change of anthropic origin has showed to be difficult to establish with high statistical significance and, moreover, different data and products have displayed important discrepancies; this is valid even for global precipitation. We argue that the inadequate resolution and length of the data commonly used, as well as methodological issues, are among the main factors limiting the ability to identify the signature of change in precipitation. We propose several ways in which one can hope to improve the situation - or at least - clarify the difficulties. From the point of view of statistical analysis, the problem is one of detecting a low frequency anthropogenic signal in the presence of "noise" - the natural variability (the latter includes both internal dynamics and responses to volcanic, solar or other natural forcings). A consequence is that as one moves to longer and longer time scales, fluctuations are increasingly averaged and at some point, the anthropogenic signal will stand out above the natural variability noise. This approach can be systematized using scaling fluctuation analysis to characterizing different precipitation scaling regimes: weather, macroweather, climate - from higher to lower frequencies; in the anthropocene, the macroweather regime covers the range of time scales

  17. Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations

    Science.gov (United States)

    Hammerschlag, Richard; Mills, Paul; Cohen, Lorenzo; Krieger, Richard; Vieten, Cassandra; Lutgendorf, Susan

    2015-01-01

    Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a client's biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider. PMID:26665043

  18. [Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

    Science.gov (United States)

    Xing, D; Wang, B; Lin, J H

    2017-06-01

    At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

  19. Deciding the way. Comparing energy risks: methodologies and issues

    International Nuclear Information System (INIS)

    Matsuki, Yoshio; Lee, R.

    1999-01-01

    The following major issues in comparative assessment of energy systems are discussed: target users; decision making process; subject policy-making; setting boundaries; aggregated health indicators; monetary valuation; long-term health effects; global warming; methods to reflect uncertainties. Suggestions for study approaches of the mentioned issues are proposed

  20. Methodological Issues in Survey Research: A Historical Review

    NARCIS (Netherlands)

    de Heer, W.; de Leeuw, E.D.; van der Zouwen, J.

    1999-01-01

    In this paper, we present a historical overview of social surveys and describe the historical development of scientific survey methodology and survey statistics. The origins of survey research can be traced back to the early 19th century and the first scientiflc survey was conducted in England in

  1. The meaning of dwelling features : Conceptual and methodological issues

    NARCIS (Netherlands)

    Coolen, H.C.C.H.

    2008-01-01

    This study is about the meaning of dwelling features. It relates the research areas of housing preferences and the meaning of a dwelling with each other and with aspects of the means-end approach as applied in marketing research. It results in a conceptual and methodological framework for studying

  2. How to emerge from the conservatism in clinical research methodology?

    Science.gov (United States)

    Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

    2017-09-01

    Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.

  3. Online data collection from video game players: methodological issues.

    Science.gov (United States)

    Wood, Richard T A; Griffiths, Mark D; Eatough, Virginia

    2004-10-01

    The paper outlines the advantages and disadvantages of using the Internet to collect data concerning both online and offline gamers. Drawing from experience of a number of studies carried out online by the authors and by reviewing the available literature, the authors discuss the main issues concerning data collected from video game players. The paper examines a number of areas, including recruiting and utilizing participants, validity, suitable methods of data collection (i.e., questionnaire studies, online tests, participant observation, online interviews), and ethical issues. It is concluded that online research methods can be a useful way of examining the psychosocial aspects of video game playing.

  4. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  5. Methodology Series Module 4: Clinical Trials.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  6. Fundamentals of clinical methodology: 2. Etiology.

    Science.gov (United States)

    Sadegh-Zadeh, K

    1998-03-01

    The concept of etiology is analyzed and the possibilities and limitations of deterministic, probabilistic, and fuzzy etiology are explored. Different kinds of formal structures for the relation of causation are introduced which enable us to explicate the notion of cause on qualitative, comparative, and quantitative levels. The conceptual framework developed is an approach to a theory of causality that may be useful in etiologic research, in building nosological systems, and in differential diagnosis, therapeutic decision-making, and controlled clinical trials. The bearings of the theory are exemplified by examining the current Chlamydia pneumoniae hypothesis on the incidence of myocardial infarction.

  7. Statistical Issues in TBI Clinical Studies

    Directory of Open Access Journals (Sweden)

    Paul eRapp

    2013-11-01

    Full Text Available The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made:1. A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure.2. Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy.3. A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. 4. Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment.5. A procedure for discriminating between treatment responders and nonresponders requires, minimally, a two phase investigation. This procedure must include a

  8. Frequent methodological errors in clinical research.

    Science.gov (United States)

    Silva Aycaguer, L C

    2018-03-07

    Several errors that are frequently present in clinical research are listed, discussed and illustrated. A distinction is made between what can be considered an "error" arising from ignorance or neglect, from what stems from a lack of integrity of researchers, although it is recognized and documented that it is not easy to establish when we are in a case and when in another. The work does not intend to make an exhaustive inventory of such problems, but focuses on those that, while frequent, are usually less evident or less marked in the various lists that have been published with this type of problems. It has been a decision to develop in detail the examples that illustrate the problems identified, instead of making a list of errors accompanied by an epidermal description of their characteristics. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

  9. Clinical issues of mucus accumulation in COPD

    Directory of Open Access Journals (Sweden)

    Osadnik CR

    2014-03-01

    Full Text Available Christian R Osadnik,1,2 Christine F McDonald,2,3 Anne E Holland2,4,51Department of Physiotherapy, Monash University, 2Institute for Breathing and Sleep, Austin Health, 3Department of Respiratory and Sleep Medicine, Austin Health, 4Department of Physiotherapy, La Trobe University, 5Department of Physiotherapy, Alfred Health, Melbourne, VIC, AustraliaWe wish to thank Ramos et al for presenting a succinct and up-to-date synthesis of the evidence relating to the important issue of mucus hypersecretion in COPD.1 The authors highlight the association of mucus hypersecretion with poor outcomes, including increased risk of exacerbations, hospitalization and mortality. These associations have led to interest in the potential benefits of mucus clearance techniques in COPD. As Ramos et al1 point out, although the physiological rationale for airway clearance techniques (ACTs in COPD is strong, clinical efficacy has historically been difficult to establish, perhaps due to the variety of techniques and outcomes that have been employed in small studies. We have recently synthesized this body of evidence in a Cochrane systematic review of ACTs for individuals with COPD. The review demonstrated ACTs are safe and meta-analysis showed they confer small beneficial effects on a limited range of important clinical outcomes, such as the need for and duration of ventilatory assistance during an acute exacerbation of COPD (AECOPD.2View original paper by Ramos and colleagues.

  10. Non-Hodgkin's lymphomas: clinical governance issues.

    Science.gov (United States)

    Fields, P A; Goldstone, A H

    2002-09-01

    Every patient in every part of the world has the right to expect the best possible quality of care from health care providers. Non-Hodgkin's lymphomas (NHL) are an extremely heterogeneous group of conditions which require important decisions to be taken at many points along the treatment pathway. To get this right every time requires that high-quality standards are instituted and adhered to, so that the best possible outcome is achieved. In the past this has not always been the case because of the failure of clinicians sometimes to adhere to an optimal management plan. In 1995, the UK government commissioned an inquiry into the running of cancer services in the United Kingdom, which culminated in a series of recommendations to improve them. Subsequently, these recommendations were implemented as objectives of the NHS Cancer Plan which is the framework by which the UK government wishes to improve cancer services. Concurrently another general concept has emerged which is designed to ensure that the highest quality standards may be achieved for all patients across the whole National Health Service (NHS). This concept, termed 'clinical governance', brings together a corporate responsibility of all health care workers to deliver high quality standards, in the hope that this will translate into better long-term survival of patients with malignant disease. This chapter focuses on the issues surrounding clinical governance and how the principles of this concept relate to non-Hodgkin's lymphomas.

  11. Medicine and the humanities--theoretical and methodological issues.

    Science.gov (United States)

    Puustinen, Raimo; Leiman, M; Viljanen, A M

    2003-12-01

    Engel's biopsychosocial model, Cassell's promotion of the concept "person" in medical thinking and Pellegrino's and Thomasma's philosophy of medicine are attempts to widen current biomedical theory of disease and to approach medicine as a form of human activity in pursuit of healing. To develop this approach further we would like to propose activity theory as a possible means for understanding the nature of medical practice. By "activity theory" we refer to developments which have evolved from Vygotsky's research on socially mediated mental functions and processes. Analysing medicine as activity enforces the joint consideration of target and subject: who is doing what to whom. This requires the use of historical, linguistic, anthropological, and semiotic tools. Therefore, if we analyse medicine as an activity, humanities are both theoretically and methodologically "inbound" (or internal) to the analysis itself. On the other hand, literature studies or anthropological writings provide material for analysing the various forms of medical practices.

  12. Life Cycle Assessment of electricity generation: overview and methodological issues

    DEFF Research Database (Denmark)

    Turconi, Roberto; Boldrin, Alessio; Astrup, Thomas Fruergaard

    study focuses on the comparability between different technologies, identifying and quantifying the possible mistakes that can occur when comparing two technologies whose environmental assessments have been performed with conflicting assumptions. Nine different power generation technologies were examined......: hard coal, lignite, natural gas, oil, nuclear, biomass, hydroelectric, solar photovoltaic and wind. More than 150 published studies were selected and analyzed to investigate whether "typical" GHG, NOx and SO2 emission factors for each technology could be identified. For a better overview of the sources...... of emissions, those were divided among three life cycle phases: fuel provision, operation of the plant and infrastructure. It was possible to estimate typical emission factors for all technologies except for biomass, where methodological and technical aspects result in very variable outcomes. Within...

  13. Practical Issues of Conducting a Q Methodology Study: Lessons Learned From a Cross-cultural Study.

    Science.gov (United States)

    Stone, Teresa Elizabeth; Maguire, Jane; Kang, Sook Jung; Cha, Chiyoung

    This article advances nursing research by presenting the methodological challenges experienced in conducting a multination Q-methodology study. This article critically analyzes the relevance of the methodology for cross-cultural and nursing research and the challenges that led to specific responses by the investigators. The use of focus groups with key stakeholders supplemented the Q-analysis results. The authors discuss practical issues and shared innovative approaches and provide best-practice suggestions on the use of this flexible methodology. Q methodology has the versatility to explore complexities of contemporary nursing practice and cross-cultural health research.

  14. Emerging issues and methodological advances in fisheries reproductive biology

    DEFF Research Database (Denmark)

    Lowerre-Barbieri, Susan K.; Brown-Peterson, Nancy J.; Murua, Hilario

    2011-01-01

    Although incorporating detailed reproductive data into all stock assessments is not a practical goal, the need to understand how reproductive biology affects population productivity is being increasingly recognized.More research focused on reproductive biology—coupled with a shift towards...... a resilience perspective in fisheries science—is resulting in challenges to many long-held assumptions; the emergence of important new issues; and identification of the need to improve data and methods used in reproductive studies. Typically, data for reproductive studies are based on an assessment of gonadal...... while introducing improved and new histological techniques. In this introduction, we address the following needs: (1) to employ standardization, thereby improving our ability to conduct comparative studies; (2) to better understand patterns of gonadal development and spawning events over time; and (3...

  15. Identification of new treatments for epilepsy: issues in preclinical methodology

    Science.gov (United States)

    Galanopoulou, Aristea S.; Buckmaster, Paul S.; Staley, Kevin J.; Moshé, Solomon L.; Perucca, Emilio; Engel, Jerome; Löscher, Wolfgang; Noebels, Jeffrey L.; Pitkänen, Asla; Stables, James; White, Steve H.; O’Brien, Terence J.; Simonato, Michele

    2013-01-01

    Summary Preclinical research has facilitated the discovery of valuable drugs for the symptomatic treatment of epilepsy. Yet, despite these therapies, seizures are not adequately controlled in a third of all affected individuals, and comorbidities still impose a major burden on quality of life. The introduction of multiple new therapies into clinical use over the past two decades has done little to change this. There is an urgent demand to address the unmet clinical needs for: (a) new symptomatic anti-seizure treatments for drug-resistant seizures with improved efficacy/tolerability profiles, (b) disease modifying treatments that prevent or ameliorate the epileptogenic state, and (c) treatments for the common comorbidities that contribute to disability in people with epilepsy. New therapies also need to address the special needs of certain subpopulations, i.e. age- or gender-specific treatments. Preclinical development in these treatment areas is complex due to heterogeneity in presentation and etiology, and may need to be formulated with a specific seizure, epilepsy syndrome or comorbidity in mind. The aim of this report is to provide a framework that will help define future guidelines that improve and standardize the design, reporting, and validation of data across preclinical anti-epilepsy therapy development studies targeting drug-resistant seizures, epileptogenesis and comorbidities. PMID:22292566

  16. Identification of new epilepsy treatments: issues in preclinical methodology.

    Science.gov (United States)

    Galanopoulou, Aristea S; Buckmaster, Paul S; Staley, Kevin J; Moshé, Solomon L; Perucca, Emilio; Engel, Jerome; Löscher, Wolfgang; Noebels, Jeffrey L; Pitkänen, Asla; Stables, James; White, H Steve; O'Brien, Terence J; Simonato, Michele

    2012-03-01

    Preclinical research has facilitated the discovery of valuable drugs for the symptomatic treatment of epilepsy. Yet, despite these therapies, seizures are not adequately controlled in a third of all affected individuals, and comorbidities still impose a major burden on quality of life. The introduction of multiple new therapies into clinical use over the past two decades has done little to change this. There is an urgent demand to address the unmet clinical needs for: (1) new symptomatic antiseizure treatments for drug-resistant seizures with improved efficacy/tolerability profiles, (2) disease-modifying treatments that prevent or ameliorate the process of epileptogenesis, and (3) treatments for the common comorbidities that contribute to disability in people with epilepsy. New therapies also need to address the special needs of certain subpopulations, that is, age- or gender-specific treatments. Preclinical development in these treatment areas is complex due to heterogeneity in presentation and etiology, and may need to be formulated with a specific seizure, epilepsy syndrome, or comorbidity in mind. The aim of this report is to provide a framework that will help define future guidelines that improve and standardize the design, reporting, and validation of data across preclinical antiepilepsy therapy development studies targeting drug-resistant seizures, epileptogenesis, and comorbidities. Wiley Periodicals, Inc. © 2012 International League Against Epilepsy.

  17. Transsexualism: Clinical Features and Legal Issues

    Directory of Open Access Journals (Sweden)

    Necla Keskin

    2015-12-01

    Full Text Available Although the epidemiological data is generally obtained from the patients that applied for gender reassignment surgery, it is known that transsexualism is not seen as rarely as it was estimated in the past and should be evaluated in detail because of its psychological and social consequences. Etiology remains to be unclear and biological and psychosocial factors are thought to be responsible for its development. Gender identity stabilizes approximately in 3-4 ages and it is impossible to change it after these ages. For this reason the aim of treatment approaches is to improve the conformity of individuals to their identity and life, but not to change the gender identity. The World Professional Association for Transgender Health [WPATH] published a guideline including standards of care [SOC] and SOC provide clinical guidance in follow-up and treatment of transsexual individuals. There is a detailed code in civil law about gender reassignment but when this code implemented strictly, the use of it is very limited and it is clear that a new arrangement is needed in this issue.

  18. Deaf murderers: clinical and forensic issues.

    Science.gov (United States)

    Vernon, M; Steinberg, A G; Montoya, L A

    1999-01-01

    Data are reported on 28 deaf individuals who were convicted, pled guilty, or have been charged and awaiting trial for murder. The unique forensic issues raised by these cases are discussed, and their clinical picture presented. A significant percentage of these deaf murderers and defendants had such severely limited communication skills in both English and American Sign Language that they lacked the linguistic ability to understand the charges against them and/or to participate in their own defense. As such, they were incompetent to stand trial, due not to mental illness or mental retardation, but to linguistic deficits. This form of incompetence poses a dilemma to the courts that remains unresolved. This same linguistic disability makes it impossible for some deaf suspects to be administered Miranda Warnings in a way comprehensible to them. This paper identifies the reasons for the communication problems many deaf persons face in court and offers remedial steps to help assure fair trials and police interrogations for deaf defendants. The roles and responsibilities of psychiatric and psychological experts in these cases are discussed. Data are provided on the etiology of the 28 individuals' hearing losses, psychiatric/psychological histories, IQs, communication characteristics, educational levels, and victim characteristics. Copyright 1999 John Wiley & Sons, Ltd.

  19. Modeling postpartum depression in rats: theoretic and methodological issues

    Science.gov (United States)

    Ming, LI; Shinn-Yi, CHOU

    2016-01-01

    The postpartum period is when a host of changes occur at molecular, cellular, physiological and behavioral levels to prepare female humans for the challenge of maternity. Alteration or prevention of these normal adaptions is thought to contribute to disruptions of emotion regulation, motivation and cognitive abilities that underlie postpartum mental disorders, such as postpartum depression. Despite the high incidence of this disorder, and the detrimental consequences for both mother and child, its etiology and related neurobiological mechanisms remain poorly understood, partially due to the lack of appropriate animal models. In recent decades, there have been a number of attempts to model postpartum depression disorder in rats. In the present review, we first describe clinical symptoms of postpartum depression and discuss known risk factors, including both genetic and environmental factors. Thereafter, we discuss various rat models that have been developed to capture various aspects of this disorder and knowledge gained from such attempts. In doing so, we focus on the theories behind each attempt and the methods used to achieve their goals. Finally, we point out several understudied areas in this field and make suggestions for future directions. PMID:27469254

  20. Modeling postpartum depression in rats: theoretic and methodological issues

    Directory of Open Access Journals (Sweden)

    Ming LI

    2018-06-01

    Full Text Available The postpartum period is when a host of changes occur at molecular, cellular, physiological and behavioral levels to prepare female humans for the challenge of maternity. Alteration or prevention of these normal adaptions is thought to contribute to disruptions of emotion regulation, motivation and cognitive abilities that underlie postpartum mental disorders, such as postpartum depression. Despite the high incidence of this disorder, and the detrimental consequences for both mother and child, its etiology and related neurobiological mechanisms remain poorly understood, partially due to the lack of appropriate animal models. In recent decades, there have been a number of attempts to model postpartum depression disorder in rats. In the present review, we first describe clinical symptoms of postpartum depression and discuss known risk factors, including both genetic and environmental factors. Thereafter, we discuss various rat models that have been developed to capture various aspects of this disorder and knowledge gained from such attempts. In doing so, we focus on the theories behind each attempt and the methods used to achieve their goals. Finally, we point out several understudied areas in this field and make suggestions for future directions.

  1. Cutting edge issues in allergy and clinical immunology.

    Science.gov (United States)

    Matthias, Torsten; Shoenfeld, Yehuda

    2007-02-01

    Approximately every 5 yr, Clinical Reviews in Allergy and Immunology deviates from its usual practice of publishing volumes devoted to one theme to including papers that cover a range of subjects. This issue is one such exception and arose following a symposium at the International Institute for Research in Autoimmune Diseases named AESKU.KIPP Institute at their Wendelsheim facility. The AESKU.KIPP Institute was a particularly venue because it was initially established by a German diagnostic company and a Swiss benefactor, Karl- Heinz Kipp. The goal of the Institute was to develop a unique atmosphere to encourage original research in the field of autoimmunity and clinical immunology. The thought was to create an institute where young scientists from throughout the world could come for short periods of time to learn newer methodologies in both clinical immunology and also molecular biology. This theme contains several of the papers presented at the opening of the Institute and are incorporated herein because they focus on several unique aspects of clinical immunology, often referred to as the mosaic of autoimmunity.

  2. Methodology for Multileaf Collimator Quality Assurance in clinical conditions

    International Nuclear Information System (INIS)

    Diaz M, R. M.; Rodriguez Z, M.; Juarez D, A.; Romero R, R.

    2013-01-01

    Multileaf Collimators (MLCs) have become an important technological advance as part of clinical linear accelerators (linacs) for radiotherapy. Treatment planning and delivery were substantially modified after these devices. However, it was needed to develop Quality Assurance (QA) methodologies related to the performance of these developments. The most common methods for QA of MLC are made in basic conditions that hardly cover all possible difficulties in clinical practice. Diaz et. el. developed a methodology based upon volumetric detectors bidimensional arrays that can be extended to more demanding situations. In this work, the Auril methodology of Diaz et. al. was implemented to the irradiation with the linac gantry in horizontal position. A mathematical procedure was developed to ease the dosimetric centering of the device with the Auril centering tool. System calibration was made as in the typical Auril methodology. Patterns with leaf misplacements in known positions were irradiated. the method allowed the detection of leafs' misplacements with a minimum number of false positives. We concluded that Auril methodology can be applied in clinical conditions. (Author)

  3. Animal Models of Virus-Induced Neurobehavioral Sequelae: Recent Advances, Methodological Issues, and Future Prospects

    Directory of Open Access Journals (Sweden)

    Marco Bortolato

    2010-01-01

    Full Text Available Converging lines of clinical and epidemiological evidence suggest that viral infections in early developmental stages may be a causal factor in neuropsychiatric disorders such as schizophrenia, bipolar disorder, and autism-spectrum disorders. This etiological link, however, remains controversial in view of the lack of consistent and reproducible associations between viruses and mental illness. Animal models of virus-induced neurobehavioral disturbances afford powerful tools to test etiological hypotheses and explore pathophysiological mechanisms. Prenatal or neonatal inoculations of neurotropic agents (such as herpes-, influenza-, and retroviruses in rodents result in a broad spectrum of long-term alterations reminiscent of psychiatric abnormalities. Nevertheless, the complexity of these sequelae often poses methodological and interpretational challenges and thwarts their characterization. The recent conceptual advancements in psychiatric nosology and behavioral science may help determine new heuristic criteria to enhance the translational value of these models. A particularly critical issue is the identification of intermediate phenotypes, defined as quantifiable factors representing single neurochemical, neuropsychological, or neuroanatomical aspects of a diagnostic category. In this paper, we examine how the employment of these novel concepts may lead to new methodological refinements in the study of virus-induced neurobehavioral sequelae through animal models.

  4. Diabetes and end of life: ethical and methodological issues in gathering evidence to guide care.

    Science.gov (United States)

    Dunning, Trisha; Duggan, Nicole; Savage, Sally; Martin, Peter

    2013-03-01

    Providing palliative care for people with diabetes at the end of life is part of the chronic disease care trajectory, but end of life care is complex and the presence of diabetes further complicates management. The aim of the paper is to discuss the ethical and methodological issues encountered when undertaking research to develop guidelines for managing diabetes at the end of life and the strategies used to address the issues. The issues emerged as we developed guidelines for managing diabetes at the end of life, which included conducting individual interviews with 14 people with diabetes requiring palliative care and 10 family members. A reflexive researcher journal was maintained throughout the guideline development process. The interview transcripts and researcher's journal were analysed to determine key methodological, ethical and researcher-related issues. Key themes were vulnerability of the sampling population, methodological issues included recruiting participants and ensuring rigor, ethical issues concerned benefit and risk, justice, autonomy, privacy, professional boundaries and informed consent. Researcher-related issues were identified such as managing participant distress and their own emotional distress. People were willing to discuss end of life diabetes management preferences. Undertaking research with people at the end of life is complex because of their vulnerability and the ethical issues involved. However, the ethical principles of autonomy and justice apply and people should be given the relevant information and opportunity to decide whether to participate or not. © 2012 The Authors. Scandinavian Journal of Caring Sciences © 2012 Nordic College of Caring Science.

  5. Methodologic ramifications of paying attention to sex and gender differences in clinical research.

    Science.gov (United States)

    Prins, Martin H; Smits, Kim M; Smits, Luc J

    2007-01-01

    Methodologic standards for studies on sex and gender differences should be developed to improve reporting of studies and facilitate their inclusion in systematic reviews. The essence of these studies lies within the concept of effect modification. This article reviews important methodologic issues in the design and reporting of pharmacogenetic studies. Differences in effect based on sex or gender should preferably be expressed in absolute terms (risk differences) to facilitate clinical decisions on treatment. Information on the distribution of potential effect modifiers or prognostic factors should be available to prevent a biased comparison of differences in effect between genotypes. Other considerations included the possibility of selective nonavailability of biomaterial and the choice of a statistical model to study effect modification. To ensure high study quality, additional methodologic issues should be taken into account when designing and reporting studies on sex and gender differences.

  6. [Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

    Science.gov (United States)

    Ruiz, Martial; Thibult, François

    2014-06-01

    The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

  7. Innovation and Integrity in Intervention Research: Conceptual Issues, Methodology, and Knowledge Translation.

    Science.gov (United States)

    Malti, Tina; Beelmann, Andreas; Noam, Gil G; Sommer, Simon

    2018-04-01

    In this article, we introduce the special issue entitled Innovation and Integrity in Intervention Science. Its focus is on essential problems and prospects for intervention research examining two related topics, i.e., methodological issues and research integrity, and challenges in the transfer of research knowledge into practice and policy. The main aims are to identify how to advance methodology in order to improve research quality, examine scientific integrity in the field of intervention science, and discuss future steps to enhance the transfer of knowledge about evidence-based intervention principles into sustained practice, routine activities, and policy decisions. Themes of the special issue are twofold. The first includes questions about research methodology in intervention science, both in terms of research design and methods, as well as data analyses and the reporting of findings. Second, the issue tackles questions surrounding the types of knowledge translation frameworks that might be beneficial to mobilize the transfer of research-based knowledge into practice and public policies. The issue argues that innovations in methodology and thoughtful approaches to knowledge translation can enable transparency, quality, and sustainability of intervention research.

  8. Behavioral issues in operations management new trends in design, management, and methodologies

    CERN Document Server

    2013-01-01

    Behavioral Operations Management  has been identified in the last years as one of the most promising emerging fields in Operations Management. Behavioral Issues in Operations Management  explains and examines up-to-date research in this field, which works to analyze the impact of human behavior on the management of complex operating systems.   A collection of studies from leading scholars presents different methodologies and approaches, supported by real data and case studies. Issues such as building trust and strong cooperative relationships with suppliers, enhancing motivation and designing proper incentives for stimulating more effective decision maker behaviours are considered. The main decision-making processes affected by behavioral issues are also analyzed with a focus on new product development, logistics, and supply chain integration.   The broad coverage of methodologies and practical implications makes Behavioral Issues in Operations Management an ideal reference for both researchers developing...

  9. Research Issues in Clinical Data Warehousing

    DEFF Research Database (Denmark)

    Pedersen, Torben Bach; Jensen, Christian Søndergaard

    1998-01-01

    to data warehousing technologies, over those posed by conventional data warehouse applications. This article presents a number of exciting new research challenges posed by clinical applications, to be met by the database research community. These include the need for complex-data modeling features...

  10. Current educational issues in the clinical neurosciences.

    Science.gov (United States)

    Desbiens, R; Elleker, M G; Goldsand, G; Hugenholtz, H; Puddester, D; Toyota, B; Findlay, J M

    2001-11-01

    Canadian training in the clinical neurosciences, neurology and neurosurgery, faces significant challenges. New balances are being set by residents, their associations and the Royal College of Physicians and Surgeons of Canada between clinical service, education and personal time. The nature of hospital-provided medical service has changed significantly over the past decade, impacting importantly on resident training. Finally, future manpower needs are of concern, especially in the field of neurosurgery, where it appears that soon more specialists will be trained than can be absorbed into the Canadian health care system. A special symposium on current challenges in clinical neuroscience training was held at the Canadian Congress of Neurological Sciences in June 2000. Representatives from the Canadian Association of Interns and Residents, the Royal College of Physicians and Surgeons of Canada and English and French neurology and neurosurgery training programs made presentations, which are summarized in this report. Residency training has become less service-oriented, and this trend will continue. In order to manage the increasingly sophisticated hospital services of neurology and neurosurgery, resident-alternatives in the form of physician "moonlighters" or more permanent hospital-based clinicians or "hospitalists" will be necessary in order to operate major neuroclinical units. Health authorities and hospitals will need to recognize and assume this responsibility. As clinical experience diminishes during residency training, inevitably so will the concept of the fully competent "generalist" at the end of specialty training. Additional subspecialty training is being increasingly sought by graduates, particularly in neurosurgery. Training in neurology and neurosurgery, as in all medical specialties, has changed significantly in recent years and continues to change. Programs and hospitals need to adapt to these changes in order to ensure the production of fully

  11. Application of a methodology to determine priorities for nuclear power plant safety issues

    International Nuclear Information System (INIS)

    Daling, P.M.

    1988-01-01

    The Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) is sponsoring a research program to determine priorities of nuclear power plant safety issues. A methodology has been developed at the Pacific Northwest Laboratory (PNL) to provide technical assistance in the development of risk and cost estimates for implementing resolutions to the safety issues. The information development methods are intended to provide the NRC with a consistent level of information for use in ranking the issues. The NRC uses this information, along with judgmental factors, to rank the issues for further consideration by the NRC staff. The primary purpose of the priority rankings are to assist in the allocation of resources to issues that have high potential for reducing public risk as well as to remove issues from further consideration that have little safety significance

  12. Team Dynamics. Essays in the Sociology and Social Psychology of Sport Including Methodological and Epistemological Issues.

    Science.gov (United States)

    Lenk, Hans

    This document contains nine essays on the sociology and social psychology of team dynamics, including methodological and epistemological issues involved in such study. Essay titles are: (1) Conflict and Achievement in Top Athletic Teams--Sociometric Structures of Racing Eight Oar Crews; (2) Top Performance Despite Internal Conflict--An Antithesis…

  13. Evaluation of Adult Literacy Education in the United States: A Review of Methodological Issues

    Science.gov (United States)

    Shi, Yan; Tsang, Mun C.

    2008-01-01

    This is a critical review of methodological issues in the evaluation of adult literacy education programs in the United States. It addresses the key research questions: What are the appropriate methods for evaluating these programs under given circumstances. It identifies 15 evaluation studies that are representative of a range of adult literacy…

  14. A Content and Methodological Review of Articles Concerning Multiracial Issues in Six Major Counseling Journals

    Science.gov (United States)

    Edwards, Lisa M.; Pedrotti, Jennifer Teramoto

    2008-01-01

    This study describes a comprehensive content and methodological review of articles about multiracial issues in 6 journals related to counseling up to the year 2006. The authors summarize findings about the 18 articles that emerged from this review of the "Journal of Counseling Psychology," "Journal of Counseling & Development," "The Counseling…

  15. Combining nutrition and exercise to optimize survival and recovery from critical illness: Conceptual and methodological issues.

    Science.gov (United States)

    Heyland, Daren K; Stapleton, Renee D; Mourtzakis, Marina; Hough, Catherine L; Morris, Peter; Deutz, Nicolaas E; Colantuoni, Elizabeth; Day, Andrew; Prado, Carla M; Needham, Dale M

    2016-10-01

    Survivors of critical illness commonly experience neuromuscular abnormalities, including muscle weakness known as ICU-acquired weakness (ICU-AW). ICU-AW is associated with delayed weaning from mechanical ventilation, extended ICU and hospital stays, more healthcare-related hospital costs, a higher risk of death, and impaired physical functioning and quality of life in the months after ICU admission. These observations speak to the importance of developing new strategies to aid in the physical recovery of acute respiratory failure patients. We posit that to maintain optimal muscle mass, strength and physical function, the combination of nutrition and exercise may have the greatest impact on physical recovery of survivors of critical illness. Randomized trials testing this and related hypotheses are needed. We discussed key methodological issues and proposed a common evaluation framework to stimulate work in this area and standardize our approach to outcome assessments across future studies. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  16. Contemporary issues in clinical trials for medulloblastoma

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1996-01-01

    Medulloblastoma is the seminal pediatric brain tumor providing opportunities for clinical investigation to define improved treatment strategies for both disease control and ultimate functional integrity. Recent studies addressing neuraxis radiation dose provide a 'standard' for conventional therapy while establishing 5-year disease control rates for 'favorable' or 'low risk' presentations approximating 60% following surgery and irradiation. A highly visible recent report of combined post-operative irradiation and chemotherapy incorporating a platinum- and alkylator-based regimen indicates 5-year disease control approaching 90% in localized medulloblastoma. Despite unfavorable outcome with reduced-dose neuraxis irradiation in earlier trials, further data from recent studies suggest the addition of post-operative chemotherapy to similarly reduced-dose neuraxis irradiation (23.4 Gy) in 'favorable' presentations may result in progression-free survival rates at least equivalent to those achieved with full-dose neuraxis irradiation (36 Gy) absent chemotherapy. The panel will (1) provide updated information regarding the major clinical trials that form the basis for current and planned protocols and (2) debate the therapeutic modifications appropriate for contemporary clinical investigations. Critical in planning future studies in the analysis of risk factors that may identify 'favorable' patients versus 'high risk' patients. Risk-related studies appropriately address maintaining or improving current disease control rates in the context of diminishing late treatment sequelae for 'favorable' presentations. For those identified as 'high risk' (e.g., patients with disease beyond the primary site), studies are in development that increase the intensity of chemotherapy and explore modifications of radiation delivery. Study designs that permit assessment of innovations in surgical, radiotherapeutic, and chemotherapeutic approaches will be presented and debated by the panelists

  17. HRS Clinical Document Development Methodology Manual and Policies: Executive summary.

    Science.gov (United States)

    Indik, Julia H; Patton, Kristen K; Beardsall, Marianne; Chen-Scarabelli, Carol A; Cohen, Mitchell I; Dickfeld, Timm-Michael L; Haines, David E; Helm, Robert H; Krishnan, Kousik; Nielsen, Jens Cosedis; Rickard, John; Sapp, John L; Chung, Mina

    2017-10-01

    The Heart Rhythm Society (HRS) has been developing clinical practice documents in collaboration and partnership with other professional medical societies since 1996. The HRS formed a Scientific and Clinical Documents Committee (SCDC) with the sole purpose of managing the development of these documents from conception through publication. The SCDC oversees the process for developing clinical practice documents, with input and approval from the HRS Executive Committee and the Board of Trustees. As of May 2017, the HRS has produced more than 80 publications with other professional organizations. This process manual is produced to publicly and transparently declare the standards by which the HRS develops clinical practice documents, which include clinical practice guidelines, expert consensus statements, scientific statements, clinical competency statements, task force policy statements, and proceedings statements. The foundation for this process is informed by the Institute of Medicine's standards for developing trustworthy clinical practice guidelines; the new criteria from the National Guidelines Clearinghouse, effective June 2014; SCDC member discussions; and a review of guideline policies and methodologies used by other professional organizations. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  18. Optimizing value utilizing Toyota Kata methodology in a multidisciplinary clinic.

    Science.gov (United States)

    Merguerian, Paul A; Grady, Richard; Waldhausen, John; Libby, Arlene; Murphy, Whitney; Melzer, Lilah; Avansino, Jeffrey

    2015-08-01

    Value in healthcare is measured in terms of patient outcomes achieved per dollar expended. Outcomes and cost must be measured at the patient level to optimize value. Multidisciplinary clinics have been shown to be effective in providing coordinated and comprehensive care with improved outcomes, yet tend to have higher cost than typical clinics. We sought to lower individual patient cost and optimize value in a pediatric multidisciplinary reconstructive pelvic medicine (RPM) clinic. The RPM clinic is a multidisciplinary clinic that takes care of patients with anomalies of the pelvic organs. The specialties involved include Urology, General Surgery, Gynecology, and Gastroenterology/Motility. From May 2012 to November 2014 we performed time-driven activity-based costing (TDABC) analysis by measuring provider time for each step in the patient flow. Using observed time and the estimated hourly cost of each of the providers we calculated the final cost at the individual patient level, targeting clinic preparation. We utilized Toyota Kata methodology to enhance operational efficiency in an effort to optimize value. Variables measured included cost, time to perform a task, number of patients seen in clinic, percent value-added time (VAT) to patients (face to face time) and family experience scores (FES). At the beginning of the study period, clinic costs were $619 per patient. We reduced conference time from 6 min/patient to 1 min per patient, physician preparation time from 8 min to 6 min and increased Medical Assistant (MA) preparation time from 9.5 min to 20 min, achieving a cost reduction of 41% to $366 per patient. Continued improvements further reduced the MA preparation time to 14 min and the MD preparation time to 5 min with a further cost reduction to $194 (69%) (Figure). During this study period, we increased the number of appointments per clinic. We demonstrated sustained improvement in FES with regards to the families overall experience with their providers

  19. Perceived age as a biomarker of ageing: a clinical methodology

    DEFF Research Database (Denmark)

    Gunn, David A; Murray, Peter G; Tomlin, Cyrena C

    2008-01-01

    In a previous field-based study, how old one looks for one's age (perceived age) was found to be predictive of mortality in elderly individuals. In conjunction, perceived age is of relevance and interest to the layperson. Here, a clinical methodology for generating perceived age as a biomarker...... of facial ageing is detailed. The methodology utilises facial photographs of subjects to present images to large numbers of age assessors who are primarily nationals of the country of study origin. In five observational studies in five different countries involving 874 female subjects it was found...... that subject age and assessor gender, nationality, age and ageing expertise had little effect on the perceived age data generated. However, increasing the numbers of age assessors up to 50 substantially increased the reproducibility of the mean perceived age for an image and a minimum of 10 assessors were...

  20. Metapsychological and clinical issues in psychosomatics research.

    Science.gov (United States)

    Press, Jacques

    2016-02-01

    The author starts by treating the general epistemological problems inherent to research and emphasizes that all investigation takes place between two poles: a creative pole and one that is defensive in relation to the unknown and formlessness. In the psychosomatic field, an additional difficulty resides in the western dualistic vision of the relationship between psyche and soma which influences our way of thinking about the body as well as about otherness. The author continues by exploring Pierre Marty's psychosomatic model. Its psychosomatic monism is revolutionary but incomplete and creates a distance with the other, the somatizing patient, resulting in a medically oriented nosology symptomatic of the impossibility to think about some of the most important aspects of counter-transference. With the help of clinical material, the author considers these unthought aspects and some of their theoretical implications, particularly the way of understanding the negative often so prevalent with these patients. Based on these reflections as well as Freud's on beyond the pleasure principle and Winnicott's theorization on the fear of breakdown, the author suggests some directions for research. Somatic illness might occur when the attempts at filling the cracks created by a breakdown are unsuccessful. Copyright © 2015 Institute of Psychoanalysis.

  1. Review on the NEI Methodology of Debris Transport Analysis in Sump Blockage Issue for APR1400

    International Nuclear Information System (INIS)

    Kim, Jong Uk; Lee, Jeong Ik; Hong, Soon Joon; Lee, Byung Chul; Bang, Young Seok

    2007-01-01

    Since USNRC (United State Nuclear Regulatory Committee) initially addressed post-accident sump performance under Unresolved Safety Issue USI A-43, sump blockage issue has gone through GSI-191, Regulation Guide 1.82, Rev. 3 (RG. 1.82 Rev.3), and generic Letter 2004-02 for PWRs (Pressurized Water Reactors). As a response of these USNRC's activities, NEI 04-07 was issued in order to evaluate the post-accident performance of a plant's recirculation sump. The baseline methodology of NEI 04-07 is composed of break selection, debris generation, latent debris, debris transport, and head loss. In analytical refinement of NEI 04-07, computational fluid dynamic (CFD) is suggested for the evaluation of debris transport in emergency core cooling (ECC) recirculation mode as guided by RG. 1.82 Rev.3. In Korea nuclear industry also keeps step with international activities of this safety issue, with Kori 1 plant as a pioneering edge. Korean nuclear industry has been also pursuing development of an advanced PWR of APR1400, which incorporates several improved safety features. One of the key features, considering sump blockage issue, is the adoption of IRWST (In-containment Refueling Water Storage Tank). This device, as the acronym implies, changes the emergency core cooling water injection pattern. This fact makes us to review the applicability of NEI 04-07's methodology. In this paper we discuss the applicability of NEI 04- 07's methodology, and more over, new methodology is proposed. And finally the preliminary debris transport is analyzed

  2. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    Full Text Available Sayeeda Rahman1, Md Anwarul Azim Majumder1, Sami F Shaban2, Nuzhat Rahman3, Moslehuddin Ahmed4, Khalid Bin Abdulrahman5, Urban JA D’Souza61Department of Clinical Sciences, School of Life Sciences, University of Bradford, West Yorkshire, Bradford, UK; 2Department of Medical Education, Faculty of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates; 3Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA; 4Department of Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh; 5Department of Family Medicine and Medical Education, College of Medicine, Al-Imam University, Riyadh, Saudi Arabia; 6Department of Post Graduate Studies, School of Medicine, University Malaysia Sabah, Kota Kinabalu, Sabah, MalaysiaAbstract: The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system- or organization-related as well as research- and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and

  3. Methodological Issues and Practical Strategies in Research on Child Maltreatment Victims' Abilities and Experiences as Witnesses

    Science.gov (United States)

    Chae, Yoojin; Goodman, Gail S.; Bederian-Gardner, Daniel; Lindsay, Adam

    2011-01-01

    Scientific studies of child maltreatment victims' memory abilities and court experiences have important legal, psychological, and clinical implications. However, state-of-the-art research on child witnesses is often hindered by methodological challenges. In this paper, we address specific problems investigators may encounter when attempting such…

  4. An Evaluation Methodology Development and Application Process for Severe Accident Safety Issue Resolution

    Directory of Open Access Journals (Sweden)

    Robert P. Martin

    2012-01-01

    Full Text Available A general evaluation methodology development and application process (EMDAP paradigm is described for the resolution of severe accident safety issues. For the broader objective of complete and comprehensive design validation, severe accident safety issues are resolved by demonstrating comprehensive severe-accident-related engineering through applicable testing programs, process studies demonstrating certain deterministic elements, probabilistic risk assessment, and severe accident management guidelines. The basic framework described in this paper extends the top-down, bottom-up strategy described in the U.S Nuclear Regulatory Commission Regulatory Guide 1.203 to severe accident evaluations addressing U.S. NRC expectation for plant design certification applications.

  5. Research on Evaluation Methodology for High Temperature Components and Technical Issues

    International Nuclear Information System (INIS)

    Kim, Y.J.; Han, S.B.

    2007-03-01

    The research on evaluation methodology for high temperature components and technical issues includes the comparison of evaluation technology of Very High Temperature Reactors(VHTRs) with that of present commercial reactors, the review of Hot Gas Duct(HGD) insulation designs, the analysis of the codes related to VHTR component construction and the analysis of technical issues on application of present codes to HGD construction. Codes to assure the integrity of the VHTR components are not fully prepared yet in any country. To understand the evaluation technology of the VHTR-related codes, key requirements of ASME B and PV Code Section III, Subsection NB and NH were compared. Six kinds of HGD designs were reviewed and compared. A reference which analyzed seven kinds of present component codes were reviewed and the limitations of them were summarized. Especially it was found that the selection of materials is limited, material property data are not enough, and design analysis methodology is not fully specified

  6. Integrating rock mechanics issues with repository design through design process principles and methodology

    International Nuclear Information System (INIS)

    Bieniawski, Z.T.

    1996-01-01

    A good designer needs not only knowledge for designing (technical know-how that is used to generate alternative design solutions) but also must have knowledge about designing (appropriate principles and systematic methodology to follow). Concepts such as open-quotes design for manufactureclose quotes or open-quotes concurrent engineeringclose quotes are widely used in the industry. In the field of rock engineering, only limited attention has been paid to the design process because design of structures in rock masses presents unique challenges to the designers as a result of the uncertainties inherent in characterization of geologic media. However, a stage has now been reached where we are be able to sufficiently characterize rock masses for engineering purposes and identify the rock mechanics issues involved but are still lacking engineering design principles and methodology to maximize our design performance. This paper discusses the principles and methodology of the engineering design process directed to integrating site characterization activities with design, construction and performance of an underground repository. Using the latest information from the Yucca Mountain Project on geology, rock mechanics and starter tunnel design, the current lack of integration is pointed out and it is shown how rock mechanics issues can be effectively interwoven with repository design through a systematic design process methodology leading to improved repository performance. In essence, the design process is seen as the use of design principles within an integrating design methodology, leading to innovative problem solving. In particular, a new concept of open-quotes Design for Constructibility and Performanceclose quotes is introduced. This is discussed with respect to ten rock mechanics issues identified for repository design and performance

  7. APPLICATION OF LOT QUALITY ASSURANCE SAMPLING FOR ASSESSING DISEASE CONTROL PROGRAMMES - EXAMINATION OF SOME METHODOLOGICAL ISSUES

    OpenAIRE

    T. R. RAMESH RAO

    2011-01-01

    Lot Quality Assurance Sampling (LQAS), a statistical tool in industrial setup, has been in use since 1980 for monitoring and evaluation of programs on disease control / immunization status among children / health workers performance in health system. While conducting LQAS in the field, there are occasions, even after due care of design, there are practical and methodological issues to be addressed before it is recommended for implementation and intervention. LQAS is applied under the assumpti...

  8. Methodological and theoretical issues in the comparative analysis of gender relations in Western Europe

    OpenAIRE

    S Walby

    1994-01-01

    The aim in this paper is to contribute to the development of a research agenda for the comparative analysis of gender relations in Western Europe. Its focus is the clarification of the methodological and theoretical issues involved. Several different indices of gender inequality are assessed. It is argued that it is important to distinguish between the form and degree of patriarchy, rather than assuming that these are closely associated. Data from the EC and Scandinavia are used to illustrate...

  9. Evaluation of speech errors in Putonghua speakers with cleft palate: a critical review of methodology issues.

    Science.gov (United States)

    Jiang, Chenghui; Whitehill, Tara L

    2014-04-01

    Speech errors associated with cleft palate are well established for English and several other Indo-European languages. Few articles describing the speech of Putonghua (standard Mandarin Chinese) speakers with cleft palate have been published in English language journals. Although methodological guidelines have been published for the perceptual speech evaluation of individuals with cleft palate, there has been no critical review of methodological issues in studies of Putonghua speakers with cleft palate. A literature search was conducted to identify relevant studies published over the past 30 years in Chinese language journals. Only studies incorporating perceptual analysis of speech were included. Thirty-seven articles which met inclusion criteria were analyzed and coded on a number of methodological variables. Reliability was established by having all variables recoded for all studies. This critical review identified many methodological issues. These design flaws make it difficult to draw reliable conclusions about characteristic speech errors in this group of speakers. Specific recommendations are made to improve the reliability and validity of future studies, as well to facilitate cross-center comparisons.

  10. Argumentation in elementary science education: addressing methodological issues and conceptual understanding

    Science.gov (United States)

    Kaya, Ebru

    2017-11-01

    In this review essay I respond to issues raised in Mijung Kim and Wolff-Michael Roth's paper titled "Dialogical argumentation in elementary science classrooms", which presents a study dealing with dialogical argumentation in early elementary school classrooms. Since there is very limited research on lower primary school students' argumentation in school science, their paper makes a contribution to research on children's argumentation skills. In this response, I focus on two main issues to extend the discussion in Kim and Roth's paper: (a) methodological issues including conducting a quantitative study on children's argumentation levels and focusing on children's written argumentation in addition to their dialogical argumentation, and (b) investigating children's conceptual understanding along with their argumentation levels. Kim and Roth emphasize the difficulty in determining the level of children's argumentation through the Toulmin's Argument Pattern and lack of high level arguments by children due to their difficulties in writing texts. Regarding these methodological issues, I suggest designing quantitative research on coding children's argument levels because such research could potentially provide important findings on children's argumentation. Furthermore, I discuss alternative written products including posters, figures, or pictures generated by children in order to trace children's arguments, and finally articulating argumentation and conceptual understanding of children.

  11. [Nursing methodology applicated in patients with pressure ulcers. Clinical report].

    Science.gov (United States)

    Galvez Romero, Carmen

    2014-05-01

    The application of functional patterns lets us to make a systematic and premeditated nursing assessment, with which we obtain a lot of relevant patient data in an organized way, making easier to analize them. In our case, we use Marjory Gordon's functional health patterns and NANDA (North American Nursing Diagnosis Association), NOC (Nursing Outcomes Classification), NIC (Nursing Intervention Classification) taxonomy. The overall objective of this paper is to present the experience of implementation and development of nursing methodology in the care of patients with pressure ulcers. In this article it's reported a case of a 52-year-old female who presented necrosis of phalanxes in upper and lower limbs and suffered amputations of them after being hospitalized in an Intensive Care Unit. She was discharged with pressure ulcers on both heels. GENERAL ASSESSMENT: It was implemented the nursing theory known as "Gordon's functional health patterns" and the affected patterns were identified. The Second Pattern (Nutritional-Metabolic) was considered as reference, since this was the pattern which altered the rest. EVOLUTION OF THE PATIENT: The patient had a favourable evolution, improving all the altered patterns. The infections symptoms disappeared and the pressure ulcers of both heels healed completely. The application of nursing methodology to care patients with pressure ulcers using clinical practice guidelines, standardized procedures and rating scales of assessment improves the evaluation of results and the performance of nurses.

  12. Predicting Causes of Data Quality Issues in a Clinical Data Research Network.

    Science.gov (United States)

    Khare, Ritu; Ruth, Byron J; Miller, Matthew; Tucker, Joshua; Utidjian, Levon H; Razzaghi, Hanieh; Patibandla, Nandan; Burrows, Evanette K; Bailey, L Charles

    2018-01-01

    Clinical data research networks (CDRNs) invest substantially in identifying and investigating data quality problems. While identification is largely automated, the investigation and resolution are carried out manually at individual institutions. In the PEDSnet CDRN, we found that only approximately 35% of the identified data quality issues are resolvable as they are caused by errors in the extract-transform-load (ETL) code. Nonetheless, with no prior knowledge of issue causes, partner institutions end up spending significant time investigating issues that represent either inherent data characteristics or false alarms. This work investigates whether the causes (ETL, Characteristic, or False alarm) can be predicted before spending time investigating issues. We trained a classifier on the metadata from 10,281 real-world data quality issues, and achieved a cause prediction F1-measure of up to 90%. While initially tested on PEDSnet, the proposed methodology is applicable to other CDRNs facing similar bottlenecks in handling data quality results.

  13. Problems and Issues in Using Computer- Based Support Tools to Enhance 'Soft' Systems Methodologies

    Directory of Open Access Journals (Sweden)

    Mark Stansfield

    2001-11-01

    Full Text Available This paper explores the issue of whether computer-based support tools can enhance the use of 'soft' systems methodologies as applied to real-world problem situations. Although work has been carried out by a number of researchers in applying computer-based technology to concepts and methodologies relating to 'soft' systems thinking such as Soft Systems Methodology (SSM, such attempts appear to be still in their infancy and have not been applied widely to real-world problem situations. This paper will highlight some of the problems that may be encountered in attempting to develop computer-based support tools for 'soft' systems methodologies. Particular attention will be paid to an attempt by the author to develop a computer-based support tool for a particular 'soft' systems method of inquiry known as the Appreciative Inquiry Method that is based upon Vickers' notion of 'appreciation' (Vickers, 196S and Checkland's SSM (Checkland, 1981. The final part of the paper will explore some of the lessons learnt from developing and applying the computer-based support tool to a real world problem situation, as well as considering the feasibility of developing computer-based support tools for 'soft' systems methodologies. This paper will put forward the point that a mixture of manual and computer-based tools should be employed to allow a methodology to be used in an unconstrained manner, but the benefits provided by computer-based technology should be utilised in supporting and enhancing the more mundane and structured tasks.

  14. Opportunity to discuss ethical issues during clinical learning experience.

    Science.gov (United States)

    Palese, Alvisa; Gonella, Silvia; Destrebecq, Anne; Mansutti, Irene; Terzoni, Stefano; Morsanutto, Michela; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Canzan, Federica; Ponte, Adriana Dal; De Biasio, Laura; Fascì, Adriana; Grosso, Silvia; Mantovan, Franco; Marognolli, Oliva; Nicotera, Raffaela; Randon, Giulia; Tollini, Morena; Saiani, Luisa; Grassetti, Luca; Dimonte, Valerio

    2018-01-01

    Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. Research aims: This study was aimed at exploring nursing students' perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. An Italian national cross-sectional study design was performed in 2015-2016. Participants were invited to answer a questionnaire composed of four sections regarding: (1) socio-demographic data, (2) previous clinical learning experiences, (3) current clinical learning experience quality and outcomes, and (4) the opportunity to discuss ethical issues with nurses in the last clinical learning experience (from 0 - 'never' to 3 - 'very much'). Participants and research context: Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Overall, 4707 (49%) perceived to have discussed ethical issues 'much' or 'very much'; among the remaining, 3683 (38.3%) and 1217 (12.7%) students reported the perception of having discussed, respectively, 'enough' or 'never' ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels (i.e. increased learning opportunities, self-directed learning, safety and nursing care quality, quality of the tutorial strategies, competences learned and supervision by a clinical nurse). In contrast, being male was associated with a perception of less opportunity to discuss ethical issues

  15. Methodological proposal for the jotted issue of the first epoch of the Hero magazine.

    Directory of Open Access Journals (Sweden)

    Maité García Díaz

    2013-07-01

    Full Text Available During the neocolonial republic emerges in Sancti Spiritus a very significative magazine of artistic, literary and scientific sketch: Hero, founded by Jacinto Gomer Fernández-Morera and Anastacio Fernández-Morera del Castillo, it first appeared on December 20th 1907. This issue constitutes a vivid reflect of the commercial, literary, cultural, scientific and historic panorama and above all, of the life of the middle and high class in Sancti Spiritus at the beginning of the XX century. The need to divulge the advantage the texts of Hero constitute for the high school and university students, also to humanistic profile graduates and others, such as investigators, evidenced the need to carry out an investigation that pursued such purposes. That’s why the methodological proposal for the jotted issue of the first epoch of the Hero magazine (1907-1908 takes place, composed by 38 publications, departing from the fundamental theorizations about the jotted issue of the presentation of the methodological proposal on behalf of updating these publication texts for its potential readers.

  16. Methodological issues in radiation dose-volume outcome analyses: Summary of a joint AAPM/NIH workshop

    International Nuclear Information System (INIS)

    Deasy, Joseph O.; Niemierko, Andrzej; Herbert, Donald; Yan, Di; Jackson, Andrew; Ten Haken, Randall K.; Langer, Mark; Sapareto, Steve

    2002-01-01

    This report represents a summary of presentations at a joint workshop of the National Institutes of Health and the American Association of Physicists in Medicine (AAPM). Current methodological issues in dose-volume modeling are addressed here from several different perspectives. Areas of emphasis include (a) basic modeling issues including the equivalent uniform dose framework and the bootstrap method, (b) issues in the valid use of statistics, including the need for meta-analysis, (c) issues in dealing with organ deformation and its effects on treatment response, (d) evidence for volume effects for rectal complications, (e) the use of volume effect data in liver and lung as a basis for dose escalation studies, and (f) implications of uncertainties in volume effect knowledge on optimized treatment planning. Taken together, these approaches to studying volume effects describe many implications for the development and use of this information in radiation oncology practice. Areas of significant interest for further research include the meta-analysis of clinical data; interinstitutional pooled data analyses of volume effects; analyses of the uncertainties in outcome prediction models, minimal parameter number outcome models for ranking treatment plans (e.g., equivalent uniform dose); incorporation of the effect of motion in the outcome prediction; dose-escalation/isorisk protocols based on outcome models; the use of functional imaging to study radio-response; and the need for further small animal tumor control probability/normal tissue complication probability studies

  17. Postclosure risks at the proposed Yucca Mountain repository: A review of methodological and technical issues

    International Nuclear Information System (INIS)

    Emel, J.; Kasperson, R.E.; Goble, R.; Renn, O.

    1988-06-01

    Accordingly, the first section of the report provides an overview and critique of the risk analysis methodology proposed by the US Department of Energy (DOE 1988) in the Draft Site Characterization Plan (SCP) and related documents. The second section addresses specific technical problems associated with the site. Each section considers the significance or implications of the issues for the successful long-term isolation of radioactive wastes from the biosphere. We conclude with overall observations on the adequacy of current understandings and approaches in the waste disposal program and implications for the State of Nevada

  18. Methodological issues of assessing the effects of social inequality in Russia’s regions

    Directory of Open Access Journals (Sweden)

    Ol’ga Anatol’evna Kozlova

    2014-11-01

    Full Text Available The article deals with the issue concerning the assessment of the impact of social inequality on the socio-demographic characteristics of society. The authors evaluate the impact of the social inequality growth in the Russian Federation subjects on the basis of the analysis of the decile ratio dynamics. They propose a methodological approach to determine the degree of dependence of crime rate on the growth of social inequality. The authors compare the influence of the decile ratio and purchasing power on mortality rate in the regions of Russia

  19. Methodological issues in the study of risk perception and human behavior

    International Nuclear Information System (INIS)

    Rathbun, P.F.

    1983-01-01

    The purpose of this paper is to provide a broad perspective on the use of the methods and techniques of the behavioral and social sciences as they pertain to the work of the Nuclear Regulatory Commission, particularly in issues of risk perception. Four major topics or themes are discussed: (1) a brief overview of the classic theories of risk perception; (2) current contractor work in the area of risk perception and cognitive psychology; (3) other uses of the social and behavioral sciences in the Agency; and (4) methodological considerations in using the techniques

  20. Unique topics and issues in rheumatology and clinical immunology.

    Science.gov (United States)

    Selmi, Carlo

    2014-08-01

    Clinicians are facing unexpected issues in everyday practice, and these may become counterintuitive or challenging. Illustrative examples are provided by the hypersensitivity to universally used immunosuppressants such as corticosteroids or antibiotics such as beta-lactam. Secondly, additional issues are represented by the discovery of new pathogenetic mechanisms involved in rheumatoid and psoriatic arthritis or other chronic inflammatory diseases, genomic susceptibility to enigmatic diseases such as giant cell arteritis, or the shared role of specific mediators such as semaphorins. Third, the therapeutic armamentarium has dramatically changed over the past decade following the introduction of biotechnological drugs, and new mechanisms are being proposed to reduce adverse events or increase the drug effectiveness, particularly on cardiovascular comorbidities. Finally, rare diseases continue to represent difficult cases, as for Cogan's syndrome, with limited literature available for clinical recommendations. For these reason, the present issue of Clinical Reviews in Allergy and Immunology is timely and dedicated to these and other unique topics in clinical immunology and allergy. The aim of this issue is thus to help clinicians involved in internal medicine as well as allergists and clinical immunologists while discussing new pathways that will prove important in the near future.

  1. Expert Opinions on Nutrition Issues in Clinical Dentistry.

    Science.gov (United States)

    Palmer, Carole A.; And Others

    1990-01-01

    A survey of 79 experts in dental nutrition sought consensus on the appropriate scope of nutrition in clinical dentistry. Results support the need for greater attention to nutrition issues in dental schools and better models for nutrition interventions in dental practice. (Author/MSE)

  2. Informed Consent: Ethical Issues and Future Challenges in Clinical Education.

    Science.gov (United States)

    Angaran, David M.

    1989-01-01

    A look at pharmaceutical care needs in the future is the basis for discussion of the educational needs of clinical pharmacists. Issues discussed include the appropriate degree (bachelor's vs. doctoral), costs of instruction, faculty/student ratios, the pharmacy practice faculty as role models, and computer-assisted instruction. (MSE)

  3. Diagnostic issues, clinical characteristics, and outcomes for patients with fungemia

    DEFF Research Database (Denmark)

    Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

    2011-01-01

    This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

  4. Diagnostic Issues, Clinical Characteristics, and Outcomes for Patients with Fungemia

    DEFF Research Database (Denmark)

    Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

    2011-01-01

    This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

  5. Capital structure in LNG infrastructures and gas pipelines projects: Empirical evidences and methodological issues

    International Nuclear Information System (INIS)

    Pierru, Axel; Roussanaly, Simon; Sabathier, Jérôme

    2013-01-01

    This paper provides new empirical insights on the capital structure of project-financed LNG infrastructures and gas pipeline projects, by using data relating to projects whose financial close occurred between June 2004 and March 2011. Most results are consistent with the basic view of risk-averse funds suppliers. Especially, the projects located in risky countries and larger projects tend to exhibit lower debt ratios and less-concentrated equity ownerships. In addition, regasification projects appear to have a more diluted equity ownership. Methodological issues raised by the financing of these projects are also examined from a capital-budgeting perspective. In particular, the equity residual method, usually used by industrial practitioners to value these projects, should be adjusted. - Highlights: • This paper provides new empirical insights on the capital structure of project-financed LNG and gas pipeline infrastructures. • Most of our results are consistent with the basic view of risk-averse funds suppliers. • Projects located in risky countries exhibit lower debt ratios and less-concentrated equity ownerships. • Larger projects and regasification projects also have less concentrated equity ownerships. • From a capital-budgeting viewpoint, we examine methodological issues raised by the financing of these projects

  6. How methodological issues affect the energy indicator results for different electricity generation technologies

    International Nuclear Information System (INIS)

    Modahl, Ingunn Saur; Raadal, Hanne Lerche; Gagnon, Luc; Bakken, Tor Haakon

    2013-01-01

    The aim of this paper is to improve the basis for the comparison of energy products. The paper will discuss important methodological issues with regard to various energy indicators and it will, by means of a few selected energy indicators, show examples of results for hydropower, wind power and electricity from biomass, gas and coal. Lastly it will suggest methods to achieve results which are more consistent when comparing electricity production technologies. In general, methodological issues can affect the results of life cycle assessments. In this paper, the authors have focused on the effect of system boundaries for energy indicators and found that the internal ranking of cases within one electricity generation technology is dependent on the indicator used. These variations do not, however, alter the general ranking of the major technologies studied. The authors suggest that future assessments should focus on a smaller set of indicators: the Cumulative Energy Demand (CED), which is the most “universal” indicator, Energy Payback Ratio (EPR) for assessment of upstream activities, and a suggested “Cumulative Fossil Energy Demand” (CFED) for resource depletion assessments. There is also a need for stricter standardisation and increased transparency in the assessment of energy products. - Highlights: • There is a need for stricter standardisation of energy performance assessments. • System boundaries for renewable sources should be harmonised. • One should focus on a smaller set of indicators. CED should be included

  7. Issues in Learning About and Teaching Qualitative Research Methods and Methodology in the Social Sciences

    Directory of Open Access Journals (Sweden)

    Franz Breuer

    2007-01-01

    Full Text Available For many qualitative researchers in the social sciences, learning about and teaching qualitative research methods and methodology raises a number of questions. This topic was the focus of a symposium held during the Second Berlin Summer School for Qualitative Research Methods in July 2006. In this contribution, some of the issues discussed during the symposium are taken up and extended, and some basic dimensions underlying these issues are summarized. How qualitative research methods and methodology are taught is closely linked to the ways in which qualitative researchers in the social sciences conceptualize themselves and their discipline. In the following, we distinguish between a paradigmatic and a pragmatic view. From a pragmatic point of view, qualitative research methods are considered research strategies or techniques and can be taught in the sense of recipes with specific steps to be carried out. According to a paradigmatic point of view (strongly inspired by constructivism, qualitative research methods and methodology are conceptualized as a craft to be practiced together by a "master" and an "apprentice." Moreover, the teaching of qualitative research methods also depends heavily on the institutional standing of qualitative compared to quantitative research method. Based on these considerations, five basic dimensions of learning about and teaching qualitative research methods are suggested: ways of teaching (ranging from the presentation of textbook knowledge to cognitive apprenticeship and instructors' experience with these; institutional contexts, including their development and the teaching of qualitative research methods in other than university contexts; the "fit" between personality and method, including relevant personal skills and talents; and, as a special type of instructional context that increasingly has gained importance, distance learning and its implications for learning about and teaching qualitative research methods

  8. Methodological Note: Neurofeedback: A Comprehensive Review on System Design, Methodology and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Hengameh Marzbani

    2016-04-01

    Full Text Available Neurofeedback is a kind of biofeedback, which teaches self-control of brain functions to subjects by measuring brain waves and providing a feedback signal. Neurofeedback usually provides the audio and or video feedback. Positive or negative feedback is produced for desirable or undesirable brain activities, respectively. In this review, we provided clinical and technical information about the following issues: (1 Various neurofeedback treatment protocols i.e. alpha, beta, alpha/theta, delta, gamma, and theta; (2 Different EEG electrode placements i.e. standard recording channels in the frontal, temporal, central, and occipital lobes; (3 Electrode montages (unipolar, bipolar; (4 Types of neurofeedback i.e. frequency, power, slow cortical potential, functional magnetic resonance imaging, and so on; (5 Clinical applications of neurofeedback i.e. treatment of attention deficit hyperactivity disorder, anxiety, depression, epilepsy, insomnia, drug addiction, schizophrenia, learning disabilities, dyslexia and dyscalculia, autistic spectrum disorders and so on as well as other applications such as pain management, and the improvement of musical and athletic performance; and (6 Neurofeedback softwares. To date, many studies have been conducted on the neurofeedback therapy and its effectiveness on the treatment ofmany diseases. Neurofeedback, like other treatments, has its own pros and cons. Although it  is a non-invasive procedure, its validity has been questioned in terms of conclusive scientific evidence. For example, it is expensive, time-consuming and its benefits are not long-lasting. Also, it might take months to show the desired improvements. Nevertheless, neurofeedback is known as a complementary and alternative treatment of many brain dysfunctions. However, current research does not support conclusive results about its efficacy.

  9. A methodology for evaluation of a markup-based specification of clinical guidelines.

    Science.gov (United States)

    Shalom, Erez; Shahar, Yuval; Taieb-Maimon, Meirav; Lunenfeld, Eitan

    2008-11-06

    We introduce a three-phase, nine-step methodology for specification of clinical guidelines (GLs) by expert physicians, clinical editors, and knowledge engineers, and for quantitative evaluation of the specification's quality. We applied this methodology to a particular framework for incremental GL structuring (mark-up) and to GLs in three clinical domains with encouraging results.

  10. Cultural Adaptations: Conceptual, Ethical, Contextual, and Methodological Issues for Working with Ethnocultural and Majority-World Populations.

    Science.gov (United States)

    Bernal, Guillermo; Adames, Cristina

    2017-08-01

    Mayor advancements have been achieved in research on the cultural adaptation of prevention and treatment interventions that are conducted with diverse ethnocultural groups. This commentary addresses conceptual, ethical, contextual, and methodological issues related to cultural adaptations. The articles in this special issue represent a major contribution to the study of cultural adaptations in prevention science. We frame our analysis of fidelity to core intervention components using a conceptual approach that examines (a) the propositional model (theory of change), (b) the procedural model (theory of action, methods), and (c) the philosophical assumptions that undergird these models. Regarding ethics, we caution against imposing the norms, values, and world views of the Western dominant society onto vulnerable populations such as ethnocultural groups. Given that the assumption of universality in behavioral science has been questioned, and as randomized clinical trials (RCTs) seldom examine the ecological validity of evidence-based interventions and treatments (EBI/T), imposing such interventions onto ethnocultural groups is problematic since these interventions contain values, norms, beliefs, and worldviews that may be contrary to those held by many ethnocultural groups. Regarding methods, several innovative designs are discussed that serve as alternatives to the RCT and represent an important contribution to prevention science. Also, we discuss guidelines for conducting cultural adaptations. Finally, the articles in this special issue make a major contribution to the growing field of cultural adaptation of preventive interventions with ethnocultural groups and majority-world populations.

  11. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues.

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    Ethan Budd Russo

    2016-09-01

    Full Text Available This overview covers a wide range of cannabis topics, initially examining issue in dispensaries and self-administration, plus regulatory requirement for production of cannabis-based medicines, particularly the Food and Drug Administration Botanical Guidance. The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety and public health issues remain.

  12. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

    Science.gov (United States)

    Russo, Ethan B.

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

  13. Soft System Methodology as a Tool to Understand Issues of Governmental Affordable Housing Programme of India: A Case Study Approach

    Science.gov (United States)

    Ghosh, Sukanya; Roy, Souvanic; Sanyal, Manas Kumar

    2016-09-01

    With the help of a case study, the article has explored current practices of implementation of governmental affordable housing programme for urban poor in a slum of India. This work shows that the issues associated with the problems of governmental affordable housing programme has to be addressed to with a suitable methodology as complexities are not only dealing with quantitative data but qualitative data also. The Hard System Methodologies (HSM), which is conventionally applied to address the issues, deals with real and known problems which can be directly solved. Since most of the issues of affordable housing programme as found in the case study are subjective and complex in nature, Soft System Methodology (SSM) has been tried for better representation from subjective points of views. The article explored drawing of Rich Picture as an SSM approach for better understanding and analysing complex issues and constraints of affordable housing programme so that further exploration of the issues is possible.

  14. A Quantitative and Systematic Methodology to Investigate Energy Consumption Issues in Multimodal Intercity Transportation Systems

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    Lili Du

    2015-09-01

    Full Text Available Energy issues in transportation systems have garnered increasing attention recently. This study proposes a systematic methodology for policy-makers to minimize energy consumption in multimodal intercity transportation systems considering suppliers’ operational constraints and travelers’ mobility requirements. A bi-level optimization model is developed for this purpose and considers the air, rail, private auto, and transit modes. The upper-level model is a mixed integer nonlinear program aiming to minimize energy consumption subject to transportation suppliers’ operational constraints and traffic demand distribution to paths resulting from the lower-level model. The lower-level model is a linear program seeking to maximize the trip utilities of travelers. The interactions between the multimodal transportation suppliers and intercity traffic demand are considered under the goal of minimizing system energy consumption. The proposed bi-level mixed integer model is relaxed and transformed into a mathematical program with complementarity constraints, and solved using a customized branch-and-bound algorithm. Numerical experiments, conducted using multimodal travel options between Lafayette, Indiana and Washington, D.C. reiterate that shifting traffic demand from private cars to the transit and rail modes significantly reduce energy consumption. Moreover, the proposed methodology provides tools to quantitatively analyze system energy consumption and traffic demand distribution among transportation modes under specific policy instruments. The results illustrate the need to systematically incorporate the interactions among traveler preferences, network structure, and supplier operational schemes to provide policy-makers insights for developing traffic demand shift mechanisms to minimize system energy consumption. Hence, the proposed methodology provide policy-makers the capability to analyze energy consumption in the transportation sector by a

  15. Overview on hydrogen risk research and development activities: Methodology and open issues

    Energy Technology Data Exchange (ETDEWEB)

    Bentaib, Ahmed; Meynet, Nicolas; Bleyer, Alexande [Institut de Radioprotection et de Surete Nucleaire (IRSN), Severe Accident Department, Fontenay-aux-Roses (France)

    2015-02-15

    During the course of a severe accident in a light water nuclear reactor, large amounts of hydrogen can be generated and released into the containment during reactor core degradation. Additional burnable gases [hydrogen (H2) and carbon monoxide (CO)] may be released into the containment in the corium/concrete interaction. This could subsequently raise a combustion hazard. As the Fukushima accidents revealed, hydrogen combustion can cause high pressure spikes that could challenge the reactor buildings and lead to failure of the surrounding buildings. To prevent the gas explosion hazard, most mitigation strategies adopted by European countries are based on the implementation of passive autocatalytic recombiners (PARs). Studies of representative accident sequences indicate that, despite the installation of PARs, it is difficult to prevent at all times and locations, the formation of a combustible mixture that potentially leads to local flame acceleration. Complementary research and development (R and D) projects were recently launched to understand better the phenomena associated with the combustion hazard and to address the issues highlighted after the Fukushima Daiichi events such as explosion hazard in the venting system and the potential flammable mixture migration into spaces beyond the primary containment. The expected results will be used to improve the modeling tools and methodology for hydrogen risk assessment and severe accident management guidelines. The present paper aims to present the methodology adopted by Institut de Radioprotection et de Su.

  16. Establishment of Requirements and Methodology for the Development and Implementation of GreyMatters, a Memory Clinic Information System.

    Science.gov (United States)

    Tapuria, Archana; Evans, Matt; Curcin, Vasa; Austin, Tony; Lea, Nathan; Kalra, Dipak

    2017-01-01

    The aim of the paper is to establish the requirements and methodology for the development process of GreyMatters, a memory clinic system, outlining the conceptual, practical, technical and ethical challenges, and the experiences of capturing clinical and research oriented data along with the implementation of the system. The methodology for development of the information system involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. The standard Institute of Electrical and Electronics Engineers (IEEE) recommended approach for the specifications of software requirements was adopted. An electronic health record (EHR) standard, EN13606 was used, and clinical modelling was done through archetypes and the project complied with data protection and privacy legislation. The requirements for GreyMatters were established. Though the initial development was complex, the requirements, methodology and standards adopted made the construction, deployment, adoption and population of a memory clinic and research database feasible. The electronic patient data including the assessment scales provides a rich source of objective data for audits and research and to establish study feasibility and identify potential participants for the clinical trials. The establishment of requirements and methodology, addressing issues of data security and confidentiality, future data compatibility and interoperability and medico-legal aspects such as access controls and audit trails, led to a robust and useful system. The evaluation supports that the system is an acceptable tool for clinical, administrative, and research use and forms a useful part of the wider information architecture.

  17. Patterns in clinical students' self-regulated learning behavior: a Q-methodology study.

    Science.gov (United States)

    Berkhout, Joris J; Teunissen, Pim W; Helmich, Esther; van Exel, Job; van der Vleuten, Cees P M; Jaarsma, Debbie A D C

    2017-03-01

    Students feel insufficiently supported in clinical environments to engage in active learning and achieve a high level of self-regulation. As a result clinical learning is highly demanding for students. Because of large differences between students, supervisors may not know how to support them in their learning process. We explored patterns in undergraduate students' self-regulated learning behavior in the clinical environment, to improve tailored supervision, using Q-methodology. Q-methodology uses features of both qualitative and quantitative methods for the systematic investigation of subjective issues by having participants sort statements along a continuum to represent their opinion. We enrolled 74 students between December 2014 and April 2015 and had them characterize their learning behavior by sorting 52 statements about self-regulated learning behavior and explaining their response. The statements used for the sorting were extracted from a previous study. The data was analyzed using by-person factor analysis to identify clusters of individuals with similar sorts of the statements. The resulting factors and qualitative data were used to interpret and describe the patterns that emerged. Five resulting patterns were identified in students' self-regulated learning behavior in the clinical environment, which we labelled: Engaged, Critically opportunistic, Uncertain, Restrained and Effortful. The five patterns varied mostly regarding goals, metacognition, communication, effort, and dependence on external regulation for learning. These discrete patterns in students' self-regulated learning behavior in the clinical environment are part of a complex interaction between student and learning context. The results suggest that developing self-regulated learning behavior might best be supported regarding individual students' needs.

  18. CLINICAL-EPIDEMIOLOGICAL ISSUES OF ACQUIRED CHILD METHEMOGLOBINEMIA

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    Letiția-Doina DUCEAC

    2016-03-01

    Full Text Available Nowadays, intoxication with nitrates continues to represent an important aspect in child pathology. Methemoglobinemia symptoms appear when the human body is exposed to high amounts of toxic compounds.The aim of this work was to evaluate the main clinical, biological and development issues of affected patients hospitalized in a specialized clinic. Acquired methemoglobinemia cases of the ”blue child syndrome” type are more frequent than in born ones. The factors considered for the study were the environment from which patients came, a thorough clinical inspection, data on age, nutrition, methemoglobinemia values, other treatments followed, associated diseases and evolution prognosis. The conclusion of the investigation was that a low living standard, a poor health education, the climate, the presence of ground fertilizers and the type of nourishment determined a significant increase of methemoglobinemia patients.

  19. High-level methodologies for grammar engineering, introduction to the special issue

    Directory of Open Access Journals (Sweden)

    Denys Duchier

    2015-06-01

    Full Text Available Grammar Engineering is the task of designing and implementing linguistically motivated electronic descriptions of natural language (so-called grammars. These grammars are expressed within well-defined theoretical frameworks, and offer a fine-grained description of natural language. While grammars were first used to describe syntax, that is to say, the relations between constituents in a sentence, they often go beyond syntax and include semantic information. Grammar engineering provides precise descriptions which can be used for natural language understanding and generation, making these valuable resources for various natural language applications, including textual entailment, dialogue systems, or machine translation. The first attempts at designing large-scale resource grammars were costly because of the complexity of the task (Erbach et al. 1990 and of the number of persons that were needed (see e.g. Doran et al. 1997. Advances in the field have led to the development of environments for semi-automatic grammar engineering, borrowing ideas from compilation (grammar engineering is compared with software development and machine learning. This special issue reports on new trends in the field, where grammar engineering benefits from elaborate high-level methodologies and techniques, dealing with various issues (both theoretical and practical.

  20. Applications of mixed-methods methodology in clinical pharmacy research.

    Science.gov (United States)

    Hadi, Muhammad Abdul; Closs, S José

    2016-06-01

    Introduction Mixed-methods methodology, as the name suggests refers to mixing of elements of both qualitative and quantitative methodologies in a single study. In the past decade, mixed-methods methodology has gained popularity among healthcare researchers as it promises to bring together the strengths of both qualitative and quantitative approaches. Methodology A number of mixed-methods designs are available in the literature and the four most commonly used designs in healthcare research are: the convergent parallel design, the embedded design, the exploratory design, and the explanatory design. Each has its own unique advantages, challenges and procedures and selection of a particular design should be guided by the research question. Guidance on designing, conducting and reporting mixed-methods research is available in the literature, so it is advisable to adhere to this to ensure methodological rigour. When to use it is best suited when the research questions require: triangulating findings from different methodologies to explain a single phenomenon; clarifying the results of one method using another method; informing the design of one method based on the findings of another method, development of a scale/questionnaire and answering different research questions within a single study. Two case studies have been presented to illustrate possible applications of mixed-methods methodology. Limitations Possessing the necessary knowledge and skills to undertake qualitative and quantitative data collection, analysis, interpretation and integration remains the biggest challenge for researchers conducting mixed-methods studies. Sequential study designs are often time consuming, being in two (or more) phases whereas concurrent study designs may require more than one data collector to collect both qualitative and quantitative data at the same time.

  1. Methodological and ethical issues in research using social media: a metamethod of Human Papillomavirus vaccine studies.

    Science.gov (United States)

    Gustafson, Diana L; Woodworth, Claire F

    2014-12-02

    Online content is a primary source of healthcare information for internet-using adults and a rich resource for health researchers. This paper explores the methodological and ethical issues of engaging in health research using social media. A metamethod was performed on systematically selected studies that used social media as a data source for exploring public awareness and beliefs about Human Papillomaviruses (HPV) and HPV vaccination. Seven electronic databases were searched using a variety of search terms identified for each of three concepts: social media, HPV vaccine, and research method. Abstracts were assessed for eligibility of inclusion; six studies met the eligibility criteria and were subjected to content analysis. A 10-item coding scheme was developed to assess the clarity, congruence and transparency of research design, epistemological and methodological underpinnings and ethical considerations. The designs of the six selected studies were sound, although most studies could have been more transparent about how they built in rigor to ensure the trustworthiness and credibility of findings. Statistical analysis that intended to measure trends and patterns did so without the benefit of randomized sampling and other design elements for ensuring generalizability or reproducibility of findings beyond the specified virtual community. Most researchers did not sufficiently engage virtual users in the research process or consider the risk of privacy incursion. Most studies did not seek ethical approval from an institutional research board or permission from host websites or web service providers. The metamethod exposed missed opportunities for using the dialogical character of social media as well as a lack of attention to the unique ethical issues inherent in operating in a virtual community where social boundaries and issues of public and private are ambiguous. This suggests the need for more self-conscious and ethical research practices when using social media

  2. Prediction of work metabolism from heart rate measurements in forest work: some practical methodological issues.

    Science.gov (United States)

    Dubé, Philippe-Antoine; Imbeau, Daniel; Dubeau, Denise; Auger, Isabelle; Leone, Mario

    2015-01-01

    Individual heart rate (HR) to workload relationships were determined using 93 submaximal step-tests administered to 26 healthy participants attending physical activities in a university training centre (laboratory study) and 41 experienced forest workers (field study). Predicted maximum aerobic capacity (MAC) was compared to measured MAC from a maximal treadmill test (laboratory study) to test the effect of two age-predicted maximum HR Equations (220-age and 207-0.7 × age) and two clothing insulation levels (0.4 and 0.91 clo) during the step-test. Work metabolism (WM) estimated from forest work HR was compared against concurrent work V̇O2 measurements while taking into account the HR thermal component. Results show that MAC and WM can be accurately predicted from work HR measurements and simple regression models developed in this study (1% group mean prediction bias and up to 25% expected prediction bias for a single individual). Clothing insulation had no impact on predicted MAC nor age-predicted maximum HR equations. Practitioner summary: This study sheds light on four practical methodological issues faced by practitioners regarding the use of HR methodology to assess WM in actual work environments. More specifically, the effect of wearing work clothes and the use of two different maximum HR prediction equations on the ability of a submaximal step-test to assess MAC are examined, as well as the accuracy of using an individual's step-test HR to workload relationship to predict WM from HR data collected during actual work in the presence of thermal stress.

  3. Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

    Science.gov (United States)

    Garrocho-Rangel, Arturo; Cerda-Cristerna, Bernardino; Pozos-Guillen, Amaury

    Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

  4. Clinical application of pharmacogenetics: focusing on practical issues.

    Science.gov (United States)

    Chang, Matthew T; McCarthy, Jeanette J; Shin, Jaekyu

    2015-01-01

    Recent large-scale genetic-based studies have transformed the field of pharmacogenetics to identify, characterize and leverage genetic information to inform patient care. Genetic testing can be used to alter drug selection, optimize drug dosing and prevent unnecessary adverse events. As precision medicine becomes the mainstay in the clinic, it becomes critical for clinicians to utilize pharmacogenetics to guide patient care. One primary challenge is identifying patients where genetic tests that can potentially impact patient care. To address this challenge, our review highlights many practical issues clinicians may encounter: identifying candidate patients and clinical laboratories for pharmacogenetic testing, selecting highly curated resources to help asses test validity, reimbursing costs of pharmacogenetic tests, and interpreting of pharmacogenetic test results.

  5. Application of the API/NPRA SVA methodology to transportation security issues.

    Science.gov (United States)

    Moore, David A

    2006-03-17

    Security vulnerability analysis (SVA) is becoming more prevalent as the issue of chemical process security is of greater concern. The American Petroleum Institute (API) and the National Petrochemical and Refiner's Association (NPRA) have developed a guideline for conducting SVAs of petroleum and petrochemical facilities in May 2003. In 2004, the same organizations enhanced the guidelines by adding the ability to evaluate transportation security risks (pipeline, truck, and rail). The importance of including transportation and value chain security in addition to fixed facility security in a SVA is that these issues may be critically important to understanding the total risk of the operation. Most of the SVAs done using the API/NPRA SVA and other SVA methods were centered on the fixed facility and the operations within the plant fence. Transportation interfaces alone are normally studied as a part of the facility SVA, and the entire transportation route impacts and value chain disruption are not commonly considered. Particularly from a national, regional, or local infrastructure analysis standpoint, understanding the interdependencies is critical to the risk assessment. Transportation risks may include weaponization of the asset by direct attack en route, sabotage, or a Trojan Horse style attack into a facility. The risks differ in the level of access control and the degree of public exposures, as well as the dynamic nature of the assets. The public exposures along the transportation route need to be carefully considered. Risks may be mitigated by one of many strategies including internment, staging, prioritization, conscription, or prohibition, as well as by administrative security measures and technology for monitoring and isolating the assets. This paper illustrates how these risks can be analyzed by the API/NPRA SVA methodology. Examples are given of a pipeline operation, and other examples are found in the guidelines.

  6. Was Feyerabend a Popperian? Methodological issues in the History of the Philosophy of Science.

    Science.gov (United States)

    Collodel, Matteo

    2016-06-01

    For more than three decades, there has been significant debate about the relation between Feyerabend and Popper. The discussion has been nurtured and complicated by the rift that opened up between the two and by the later Feyerabend's controversial portrayal of his earlier self. The first part of the paper provides an overview of the accounts of the relation that have been proposed over the years, disentangles the problems they deal with, and analyses the evidence supporting their conclusions as well as the methodological approaches used to process that evidence. Rather than advancing a further speculative account of the relation based on Feyerabend's philosophical work or autobiographical recollections, the second part of the paper strives to clarify the problems at issue by making use of a wider range of evidence. It outlines a historical reconstruction of the social context within which Feyerabend's intellectual trajectory developed, putting a special emphasis on the interplay between the perceived intellectual identity of Feyerabend, Feyerabend's own intellectual self-concept, and the peculiar features of the evolving Popperian research group. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Methodological issues in cardiovascular epidemiology: the risk of determining absolute risk through statistical models

    Directory of Open Access Journals (Sweden)

    Demosthenes B Panagiotakos

    2006-09-01

    Full Text Available Demosthenes B Panagiotakos, Vassilis StavrinosOffice of Biostatistics, Epidemiology, Department of Dietetics, Nutrition, Harokopio University, Athens, GreeceAbstract: During the past years there has been increasing interest in the development of cardiovascular disease functions that predict future events at individual level. However, this effort has not been so far very successful, since several investigators have reported large differences in the estimation of the absolute risk among different populations. For example, it seems that predictive models that have been derived from US or north European populations  overestimate the incidence of cardiovascular events in south European and Japanese populations. A potential explanation could be attributed to several factors such as geographical, cultural, social, behavioral, as well as genetic variations between the investigated populations in addition to various methodological, statistical, issues relating to the estimation of these predictive models. Based on current literature it can be concluded that, while risk prediction of future cardiovascular events is a useful tool and might be valuable in controlling the burden of the disease in a population, further work is required to improve the accuracy of the present predictive models.Keywords: cardiovascular disease, risk, models

  8. Partial least squares path modeling basic concepts, methodological issues and applications

    CERN Document Server

    Noonan, Richard

    2017-01-01

    This edited book presents the recent developments in partial least squares-path modeling (PLS-PM) and provides a comprehensive overview of the current state of the most advanced research related to PLS-PM. The first section of this book emphasizes the basic concepts and extensions of the PLS-PM method. The second section discusses the methodological issues that are the focus of the recent development of the PLS-PM method. The third part discusses the real world application of the PLS-PM method in various disciplines. The contributions from expert authors in the field of PLS focus on topics such as the factor-based PLS-PM, the perfect match between a model and a mode, quantile composite-based path modeling (QC-PM), ordinal consistent partial least squares (OrdPLSc), non-symmetrical composite-based path modeling (NSCPM), modern view for mediation analysis in PLS-PM, a multi-method approach for identifying and treating unobserved heterogeneity, multigroup analysis (PLS-MGA), the assessment of the common method b...

  9. Cobenefits of replacing car trips with alternative transportation: a review of evidence and methodological issues.

    Science.gov (United States)

    Xia, Ting; Zhang, Ying; Crabb, Shona; Shah, Pushan

    2013-01-01

    It has been reported that motor vehicle emissions contribute nearly a quarter of world energy-related greenhouse gases and cause nonnegligible air pollution primarily in urban areas. Reducing car use and increasing ecofriendly alternative transport, such as public and active transport, are efficient approaches to mitigate harmful environmental impacts caused by a large amount of vehicle use. Besides the environmental benefits of promoting alternative transport, it can also induce other health and economic benefits. At present, a number of studies have been conducted to evaluate cobenefits from greenhouse gas mitigation policies. However, relatively few have focused specifically on the transport sector. A comprehensive understanding of the multiple benefits of alternative transport could assist with policy making in the areas of transport, health, and environment. However, there is no straightforward method which could estimate cobenefits effect at one time. In this paper, the links between vehicle emissions and air quality, as well as the health and economic benefits from alternative transport use, are considered, and methodological issues relating to the modelling of these cobenefits are discussed.

  10. Cobenefits of Replacing Car Trips with Alternative Transportation: A Review of Evidence and Methodological Issues

    Directory of Open Access Journals (Sweden)

    Ting Xia

    2013-01-01

    Full Text Available It has been reported that motor vehicle emissions contribute nearly a quarter of world energy-related greenhouse gases and cause nonnegligible air pollution primarily in urban areas. Reducing car use and increasing ecofriendly alternative transport, such as public and active transport, are efficient approaches to mitigate harmful environmental impacts caused by a large amount of vehicle use. Besides the environmental benefits of promoting alternative transport, it can also induce other health and economic benefits. At present, a number of studies have been conducted to evaluate cobenefits from greenhouse gas mitigation policies. However, relatively few have focused specifically on the transport sector. A comprehensive understanding of the multiple benefits of alternative transport could assist with policy making in the areas of transport, health, and environment. However, there is no straightforward method which could estimate cobenefits effect at one time. In this paper, the links between vehicle emissions and air quality, as well as the health and economic benefits from alternative transport use, are considered, and methodological issues relating to the modelling of these cobenefits are discussed.

  11. Implementation of a documentation model comprising nursing terminologies--theoretical and methodological issues.

    Science.gov (United States)

    von Krogh, Gunn; Nåden, Dagfinn

    2008-04-01

    To describe and discuss theoretical and methodological issues of implementation of a nursing services documentation model comprising NANDA nursing diagnoses, Nursing Intervention Classification and Nursing Outcome Classification terminologies. The model is developed for electronic patient record and was implemented in a psychiatric hospital on an organizational level and on five test wards in 2001-2005. The theory of Rogers guided the process of innovation, whereas the implementation procedure of McCloskey and Bulecheck combined with adult learning principals guided the test site implementation. The test wards managed in different degrees to adopt the model. Two wards succeeded fully, including a ward with high percentage of staff with interdisciplinary background. Better planning regarding the impact of the organization's innovative aptitude, the innovation strategies and the use of differentiated methods regarding the clinician's individual premises for learning nursing terminologies might have enhanced the adoption to the model. To better understand the nature of barriers and the importance of careful planning regarding the implementation of electronic patient record elements in nursing care services, focusing on nursing terminologies. Further to indicate how a theory and specific procedure can be used to guide the process of implementation throughout the different levels of management.

  12. Regional cerebral blood flow (rCBF) in psychiatry: Methodological issues

    International Nuclear Information System (INIS)

    Prohovnik, I.

    1984-01-01

    Traditionally, measurements of regional cerebral blood flow (rCBF) have been confined to neurology and nuclear medicine. Only one laboratory had concentrated on using this technique in psychiatric studies. Recently, however, rCBF has been increasingly used in psychiatry, and it seems appropriate at this time to examine the value and limitations of this method. The present article reviews selected methodological issues that may complicate the performance and interpretation of rCBF studies, with the aim of providing some means to evaluate published work and to plan further psychiatric research. In this paper, the term rCBF refers only to the two-dimensional, noninvasive methods that rely on inhalation or intravenous injection of xenon-133. The growing interest of rCBF to psychiatry stems mostly from the fact that this technique can indirectly map cerebral metabolism and, by interface, neural activity or information processing. Regional metabolism and blood flow are closely coupled to the human brain in the absence of gross pathology, and since psychiatric patients rarely present acute neurological abnormalities that might disrupt this coupling, one may infer regional metabolism from flow

  13. Methodological and conceptual issues regarding occupational psychosocial coronary heart disease epidemiology.

    Science.gov (United States)

    Burr, Hermann; Formazin, Maren; Pohrt, Anne

    2016-05-01

    Overview Psychosocial occupational epidemiology has mainly focused on the demand-control and, to a much lesser extent, the effort-reward-imbalance (ERI) models. These models and the strong focus on them raise some conceptual and methodological issues we will address in the following letter. The conceptual issues include the empirical confirmation of the assumptions of these models, the extent to which the focus on the demand-control and ERI models is warranted, and whether the sub-dimensions of the scales in these models have common health effects. We argue that there is a lack of empirical approval of (i) the assumptions behind both models and (ii) the focus on these models. The methodological issues include how exposure to job strain is categorized, how ERI previously has been measured, and the validity of self-reports of job strain. We argue that (i) a population independent definition of job strain is lacking, (ii) the older measurements of ERI mix exposure and effect, and (iii) we know little regarding the validity of the measurement of the psychosocial working environment. Finally, we suggest that analyses of monitoring data with a broader focus on the psychosocial working environment can be used to shed light to some of the issues raised above. Introduction In the last three decades (1, 2), psychosocial occupational epidemiology related to coronary heart disease (CHD) has mainly focused on the job-strain model, also referred to as the demand-control model (3, 4). In this model, two aspects of work are deemed relevant: demands and control. Negative consequences to health are to be expected when high demands are simultaneously present with low control. This combination has been termed job strain (3, 4). Recently, there has also been increased interest in the ERI model (5, 6) which considers the level of effort relative to rewards at work: an imbalance is present when the efforts outweigh the rewards (5, 6). In longitudinal studies of CHD, there has been only a

  14. Comprehensive Psychopathological Assessment Based on the Association for Methodology and Documentation in Psychiatry (AMDP) System: Development, Methodological Foundation, Application in Clinical Routine, and Research

    Science.gov (United States)

    Stieglitz, Rolf-Dieter; Haug, Achim; Fähndrich, Erdmann; Rösler, Michael; Trabert, Wolfgang

    2017-01-01

    The documentation of psychopathology is core to the clinical practice of the psychiatrist and clinical psychologist. However, both in initial as well as further training and specialization in their fields, this particular aspect of their work receives scanty attention only. Yet, for the past 50 years, the Association for Methodology and Documentation in Psychiatry (AMDP) System has been in existence and available as a tool to serve precisely the purpose of offering a systematic introduction to the terminology and documentation of psychopathology. The motivation for its development was based on the need for an assessment procedure for the reliable documentation of the effectiveness of newly developed psychopharmacological substances. Subsequently, the AMDP-System began to be applied in the context of investigations into a number of methodological issues in psychiatry (e.g., the frequency and specificity of particular symptoms, the comparison of rating scales). The System then became increasingly important also in clinical practice and, today, represents the most used instrument for the documentation of psychopathology in the German-speaking countries of Europe. This paper intends to offer an overview of the AMDP-System, its origins, design, and functionality. After an initial account of the history and development of the AMDP-System, the discussion will in turn focus on the System’s underlying methodological principles, the transfer of clinical skills and competencies in its practical application, and its use in research and clinical practice. Finally, potential future areas of development in relation to the AMDP-System are explored. PMID:28439242

  15. Strategic environmental noise mapping: methodological issues concerning the implementation of the EU Environmental Noise Directive and their policy implications.

    LENUS (Irish Health Repository)

    Murphy, E

    2010-04-01

    This paper explores methodological issues and policy implications concerning the implementation of the EU Environmental Noise Directive (END) across Member States. Methodologically, the paper focuses on two key thematic issues relevant to the Directive: (1) calculation methods and (2) mapping methods. For (1), the paper focuses, in particular, on how differing calculation methods influence noise prediction results as well as the value of the EU noise indicator L(den) and its associated implications for comparability of noise data across EU states. With regard to (2), emphasis is placed on identifying the issues affecting strategic noise mapping, estimating population exposure, noise action planning and dissemination of noise mapping results to the general public. The implication of these issues for future environmental noise policy is also examined.

  16. Strategic environmental noise mapping: methodological issues concerning the implementation of the EU Environmental Noise Directive and their policy implications.

    Science.gov (United States)

    Murphy, E; King, E A

    2010-04-01

    This paper explores methodological issues and policy implications concerning the implementation of the EU Environmental Noise Directive (END) across Member States. Methodologically, the paper focuses on two key thematic issues relevant to the Directive: (1) calculation methods and (2) mapping methods. For (1), the paper focuses, in particular, on how differing calculation methods influence noise prediction results as well as the value of the EU noise indicator L(den) and its associated implications for comparability of noise data across EU states. With regard to (2), emphasis is placed on identifying the issues affecting strategic noise mapping, estimating population exposure, noise action planning and dissemination of noise mapping results to the general public. The implication of these issues for future environmental noise policy is also examined. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

  17. Breast cancer and depression: issues in clinical care

    Directory of Open Access Journals (Sweden)

    Thingbaijam B. Singh

    2012-11-01

    Full Text Available Many of breast-cancer patients experience distress and most of them experience depression which may lead to amplification of physical symptoms, increased functional impairment, and poor treatment adherence. We did a review on available literature from PubMed about prevalence, distress magnitudes, coping styles, and treatment methods of major depression in women with breast cancer from 1978 to 2010. Diagnosis and treatment of depressive episodes in women with breast cancer is challenging because of overlapping symptoms and co-morbid conditions. Major depression is often under-recognized and undertreated among breast cancer patients. This review highlighted the issues on identifying and managing depression in breast cancer patients in clinical settings. (Med J Indones. 2012;21:240-6Keywords: Breast cancer, coping, depression, distress

  18. Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology.

    Science.gov (United States)

    Kim, Jae Sun

    2017-12-01

    This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the "Humidifier Disinfectant" case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process. © 2017 The Korean Academy of Medical Sciences.

  19. Conceptual and methodological issues in studying alcohol’s harm to others

    Directory of Open Access Journals (Sweden)

    Room Robin

    2016-12-01

    Full Text Available While there is a longer history of concern about alcohol’s harm to others, researchers’ interest has intensified in the last few years. The background of variation in concern over time in different societies is outlined. Three main traditions of research have emerged: population survey studies of such harm from the perspective of the ‘other’; analysis of register or case-record data which includes information on the involvement of another’s drinking in the case; and qualitative studies of interactions and experiences involved in particular harms from others’ drinking. In the course of the new spate of studies, many conceptual and methodological issues have arisen, some of which are considered in the paper. The diverse types of harms which have been studied are discussed. The social and personal nature of many of the harms means they do not fit easily into a disability or costing model, raising questions about how they might best be counted and aggregated. Harm from others’ drinking is inherently interactional, and subject to varying definitions of what counts as harm. The attribution to drinking, in the usual situation of conditional causation, is also subject to variation, with moral politics potentially coming into play. For measurement and comparison, account needs to be taken of cultural and individual variations in perceptions and thresholds of what counts as a harm, and attribution to alcohol. The view from the windows of a population survey and of a response agency case register are often starkly different, and research is needed, as an input and spur to policy initiatives, on what influences this difference and whether and how the views might be reconciled.

  20. An Improved Methodology to Overcome Key Issues in Human Fecal Metagenomic DNA Extraction

    Directory of Open Access Journals (Sweden)

    Jitendra Kumar

    2016-12-01

    Full Text Available Microbes are ubiquitously distributed in nature, and recent culture-independent studies have highlighted the significance of gut microbiota in human health and disease. Fecal DNA is the primary source for the majority of human gut microbiome studies. However, further improvement is needed to obtain fecal metagenomic DNA with sufficient amount and good quality but low host genomic DNA contamination. In the current study, we demonstrate a quick, robust, unbiased, and cost-effective method for the isolation of high molecular weight (>23 kb metagenomic DNA (260/280 ratio >1.8 with a good yield (55.8 ± 3.8 ng/mg of feces. We also confirm that there is very low human genomic DNA contamination (eubacterial: human genomic DNA marker genes = 227.9:1 in the human feces. The newly-developed method robustly performs for fresh as well as stored fecal samples as demonstrated by 16S rRNA gene sequencing using 454 FLX+. Moreover, 16S rRNA gene analysis indicated that compared to other DNA extraction methods tested, the fecal metagenomic DNA isolated with current methodology retains species richness and does not show microbial diversity biases, which is further confirmed by qPCR with a known quantity of spike-in genomes. Overall, our data highlight a protocol with a balance between quality, amount, user-friendliness, and cost effectiveness for its suitability toward usage for culture-independent analysis of the human gut microbiome, which provides a robust solution to overcome key issues associated with fecal metagenomic DNA isolation in human gut microbiome studies.

  1. MHealth resources for asthma and pregnancy care: methodological issues and social media recruitment. A discussion paper.

    Science.gov (United States)

    Williamson, Graham R; O'Connor, Anita; Chamberlain, Chervonne; Halpin, David

    2018-06-26

    A discussion of methodological issues and social media recruitment to a feasibility study to investigate mHealth resources for asthma and pregnancy care. pregnant women with asthma are reported to be poorly supported according to international research. We sought to establish if a mHealth intervention might be feasible and acceptable to them. a Phase I or modelling study. A project team designed an intervention to address UK national guidelines for the management of asthma during pregnancy, using other resources already accessible on the web. This was made available on a project website optimized for mobile phone usage. Links were Tweeted and advertised on Facebook, asking participants to access the project website, which included links to the resources and before- and after-use questionnaires to establish baseline symptom data and participant views of the resources. Despite 55,700 Twitter impressions in a 76 day period over winter 2016-2017, this recruitment strategy garnered 402 engagements but only seven respondents for questionnaire 1 and zero respondents for questionnaire 2. We could not recruit to this study despite believing that social media recruitment would be effective, and we recommend that social media recruitment be used cautiously. Apparently, we did not sufficiently address theoretical aspects of communications theory and were not clear enough about our key messages. Publication bias may exist regarding the non-publication of other failed telemedicine studies using social media; this goes largely unreported in some systematic reviews and may influence researchers' decision-making regarding social media recruitment. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  2. Tooth wear and erosion: methodological issues in epidemiological and public health research and the future research agenda.

    Science.gov (United States)

    Ganss, C; Young, A; Lussi, A

    2011-09-01

    This paper addresses methodological issues in the field of tooth wear and erosion research including the epidemiological indices, and identifies future work that is needed to improve knowledge about tooth wear and erosion. The paper is result of the work done at the meetings of the Special Interest Group "Tooth Surface Loss and Erosion" at the 2008, 2009 and 2010 conferences of the European Association for Dental Public Health, and the Workshop "Current Erosion indices- flawed or valid" which took place in Basel in 2007. Although there is consensus about the definition and the diagnostic criteria of various forms of tooth wear, gaps in research strategies have been identified. A basic problem is that fundamental concepts of wear and erosion as an oral health problem, have not yet been sufficiently defined. To a certain extent, tooth wear is a physiological condition, and there is no consensus as to whether it can be regarded as a disease. Furthermore, the multitude of indices and flaws in existing indices, make published data difficult to interpret. Topics for the research agenda are: the initiation of a consensus process towards an internationally accepted index, and the initiation of data collection on the prevalence of various forms of wear on a population-based level. There should be an emphasis on promoting communication between basic and clinical sciences, and the area of Public Health Dentistry. Furthermore, the question of whether tooth wear is a public health problem remains open for debate.

  3. ARIA Mexico 2014 Adaptation of the Clinical Practice Guide ARIA 2010 for Mexico. Methodology ADAPTE

    Directory of Open Access Journals (Sweden)

    Désirée Larenas-Linnemann

    2014-11-01

    Full Text Available Background: The global prevalence of allergic rhinitis is high. International Study of Asthma and Allergies in Childhood (ISAAC Phase III reports a total estimated prevalence of 4.6% in Mexico. There is evidence based on allergic rhinitis Clinical Practice Guidelines (CPG, but its promotion, acceptance and application is not optimal or adequate in Mexico. Objective: To generate a guideline for the treatment of allergic rhinitis and its impact on asthma by adaptating the 2010 ARIA Guideline to Mexican reality, through a transculturation process applying the ADAPTE methodology. Material and method: Using the ADAPTE Methodology, the original 2010 ARIA CPG recommendations were evaluated by the guideline development group (GDG into which multiple medical specialities managing patients with allergic rhinitis were incoorporated. The GDG valorated the quality of 2010 ARIA, checked and translated key clinical questions. Moreover, the GDG adjusted recommendations, patient preferences and included comments in the context of the Mexican reality (safety, costs and cultural issues. To accomplish this, we ran Delphi panels with as many rounds as necessary to reach agreement. One extra question, not included in the original 2010 ARIA, on the use of Nasal Lavages for AR was created sustained by a systematic literature review. Results: A total of 45 questions from the original 2010 ARIA were included and divided into six groups covering prevention, medical treatment, immunotherapy and alternative medicine to treat patients with allergic rhinitis with or without asthma. Most of the questions reached agreement in one or two rounds; one question required three rounds. Conclusions: An easy-to-use, adaptated, up-to-date and applicable allergic rhinitis guideline for Mexico is now available.

  4. [ARIA Mexico 2014. Adaptation of the Clinical Practice Guide ARIA 2010 for Mexico. Methodology ADAPTE].

    Science.gov (United States)

    Larenas-Linnemann, Désirée; Mayorga-Butrón, José Luis; Sánchez-González, Andrés; Ramírez-García, Arturo; Medina-Ávalos, Miguel; Figueroa-Morales, Marco Antonio; Montaño-Velázquez, B Beatriz; Montes-Narváez, Gabriel; Romero-Tapia, Sergio; Stone-Aguilar, Héctor; Xochihua-Díaz, Luis; Salas-Hernández, Jorge; Hernán-Ruiz, Héctor; Betancourt-Suárez, Miguel A; Cano-Salas, María Carmen; Curiel-Aceves, Lorenzo; Dibildox-Martínez, Javier; Fernández-Vega, Margarita; García-Bolaños, Carlos; Iduñate-Palacios, Fernando; Jiménez-Chobillon, M Alejandro; López-Lizárraga, Doris N; Matta-Campos, Juan José; Olvera-Salinas, Jorge; Rivera-Gómez, María Antonia; Virgen-Ortega, César; Sienra-Monge, Juan José; Del Río-Navarro, Blanca; Arias-Cruz, Alfredo; Sacre-Hazouri, Antonio; Aguilar-Aranda, Ambrocio; Vásquez Del Mercado-Cordero, Rodrigo; Barnica, Raúl Humberto; Velasco-Hidalgo, Liliana; Solís-Galicia, Cecilia

    2014-01-01

    The global prevalence of allergic rhinitis is high. International Study of Asthma and Allergies in Childhood (ISAAC) Phase III reports a total estimated prevalence of 4.6% in Mexico. There is evidence based on allergic rhinitis Clinical Practice Guidelines (CPG), but its promotion, acceptance and application is not optimal or adequate in Mexico. To generate a guideline for the treatment of allergic rhinitis and its impact on asthma by adaptating the 2010 ARIA Guideline to Mexican reality, through a transculturation process applying the ADAPTE methodology. Using the ADAPTE Methodology, the original 2010 ARIA CPG recommendations were evaluated by the guideline development group (GDG) into which multiple medical specialities managing patients with allergic rhinitis were incoorporated. The GDG valorated the quality of 2010 ARIA, checked and translated key clinical questions. Moreover, the GDG adjusted recommendations, patient preferences and included comments in the context of the Mexican reality (safety, costs and cultural issues). To accomplish this, we ran Delphi panels with as many rounds as necessary to reach agreement. One extra question, not included in the original 2010 ARIA, on the use of Nasal Lavages for AR was created sustained by a systematic literature review. A total of 45 questions from the original 2010 ARIA were included and divided into six groups covering prevention, medical treatment, immunotherapy and alternative medicine to treat patients with allergic rhinitis with or without asthma. Most of the questions reached agreement in one or two rounds; one question required three rounds. An easy-to-use, adaptated, up-to-date and applicable allergic rhinitis guideline for Mexico is now available.

  5. Internet Addiction in adolescence: Neurobiological, psychosocial and clinical issues.

    Science.gov (United States)

    Cerniglia, L; Zoratto, F; Cimino, S; Laviola, G; Ammaniti, M; Adriani, W

    2017-05-01

    Despite it has not been formally included in DSM-5 as a disorder, 'Internet addiction (IA)' has become a worldwide issue. It can be broadly defined as a non-chemical, behavioral addiction, which involves human-machine interaction. We pinpoint it as an "instrumental" form of social interaction (i.e. mediated by machines), a notion that appears useful for the sake of possible preclinical modeling. The features of Internet use reveals as addictive when this comes at the expense of genuine real-life sociability, with an overlap towards the hikikomori phenomenon (i.e., extreme retreat to one's own room). Due to the specific neuro-developmental plasticity in adolescence, IA poses risks to youths' mental health, and may likely produce negative consequences in everyday life. The thwarted development of adolescents' identity, self-image and adaptive social relationships is discussed: the IA adolescents often suffer loss of control, feelings of anger, symptoms of distress, social withdrawal, and familial conflicts. Further, more severe clinical conditions are also associated to IA, such as dysthymic, bipolar, affective, social-anxiety disorders, as well as major depression. This paper overviews the literature on IA, from neuro-biological, psycho-social and clinical standpoints, taking into account recent debates on diagnostic criteria, nosographic label and assessment tools. Neuroimaging data and neurochemical regulations are illustrated with links to pathogenetic hypotheses, which are amenable to validation through innovative preclinical modeling. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Bridge to the future: nontraditional clinical settings, concepts and issues.

    Science.gov (United States)

    Faller, H S; Dowell, M A; Jackson, M A

    1995-11-01

    Healthcare restructuring in the wake of healthcare reform places greater emphasis on primary healthcare. Clinical education in acute care settings and existing community health agencies are not compatible with teaching basic concepts, principles and skills fundamental to nursing. Problems of clients in acute care settings are too complex and clients in the community are often too dispersed for necessary faculty support and supervision of beginning nursing students. Nontraditional learning settings offer the baccalaureate student the opportunity to practice fundamental skills of care and address professional skills of negotiation, assertiveness, organization, collaboration and leadership. An overview of faculty designed clinical learning experiences in nontraditional sites such as McDonald's restaurants, inner city churches, YWCA's, the campus community and homes are presented. The legal, ethical and academic issues associated with nontraditional learning settings are discussed in relation to individual empowerment, decision making and evaluation. Implications for the future address the role of the students and faculty as they interact with the community in which they live and practice.

  7. Contentious issues in research on trafficked women working in the sex industry: study design, ethics, and methodology.

    Science.gov (United States)

    Cwikel, Julie; Hoban, Elizabeth

    2005-11-01

    The trafficking of women and children for work in the globalized sex industry is a global social problem. Quality data is needed to provide a basis for legislation, policy, and programs, but first, numerous research design, ethical, and methodological problems must be addressed. Research design issues in studying women trafficked for sex work (WTSW) include how to (a) develop coalitions to fund and support research, (b) maintain a critical stance on prostitution, and therefore WTSW (c) use multiple paradigms and methods to accurately reflect WTSW's reality, (d) present the purpose of the study, and (e) protect respondents' identities. Ethical issues include (a) complications with informed consent procedures, (b) problematic access to WTSW (c) loss of WTSW to follow-up, (d) inability to intervene in illegal acts or human rights violations, and (e) the need to maintain trustworthiness as researchers. Methodological issues include (a) constructing representative samples, (b) managing media interest, and (c) handling incriminating materials about law enforcement and immigration.

  8. Investigating High-tech and Knowledge-Intensive Ventures: Methodological Issues

    DEFF Research Database (Denmark)

    Madsen, Henning; Neergaard, Helle; Christensen, Patrizia V.

    2003-01-01

    The paper presents and discusses the advantages and disadvantages of the methodology applied in a longitudinal project on entrepreneurship, the SNE project.......The paper presents and discusses the advantages and disadvantages of the methodology applied in a longitudinal project on entrepreneurship, the SNE project....

  9. Current psychometric and methodological issues in the measurement of overgeneral autobiographical memory.

    Science.gov (United States)

    Griffith, James W; Sumner, Jennifer A; Raes, Filip; Barnhofer, Thorsten; Debeer, Elise; Hermans, Dirk

    2012-12-01

    Autobiographical memory is a multifaceted construct that is related to psychopathology and other difficulties in functioning. Across many studies, a variety of methods have been used to study autobiographical memory. The relationship between overgeneral autobiographical memory (OGM) and psychopathology has been of particular interest, and many studies of this cognitive phenomenon rely on the Autobiographical Memory Test (AMT) to assess it. In this paper, we examine several methodological approaches to studying autobiographical memory, and focus primarily on methodological and psychometric considerations in OGM research. We pay particular attention to what is known about the reliability, validity, and methodological variations of the AMT. The AMT has adequate psychometric properties, but there is great variability in methodology across studies that use it. Methodological recommendations and suggestions for future studies are presented. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. Methodological issues concerning the application of reliable laser particle sizing in soils

    Science.gov (United States)

    de Mascellis, R.; Impagliazzo, A.; Basile, A.; Minieri, L.; Orefice, N.; Terribile, F.

    2009-04-01

    During the past decade, the evolution of technologies has enabled laser diffraction (LD) to become a much widespread means of particle size distribution (PSD), replacing sedimentation and sieve analysis in many scientific fields mainly due to its advantages of versatility, fast measurement and high reproducibility. Despite such developments of the last decade, the soil scientist community has been quite reluctant to replace the good old sedimentation techniques (ST); possibly because of (i) the large complexity of the soil matrix inducing different types of artefacts (aggregates, deflocculating dynamics, etc.), (ii) the difficulties in relating LD results with results obtained through sedimentation techniques and (iii) the limited size range of most LD equipments. More recently LD granulometry is slowly gaining appreciation in soil science also because of some innovations including an enlarged size dynamic range (0,01-2000 m) and the ability to implement more powerful algorithms (e.g. Mie theory). Furthermore, LD PSD can be successfully used in the application of physically based pedo-transfer functions (i.e., Arya and Paris model) for investigations of soil hydraulic properties, due to the direct determination of PSD in terms of volume percentage rather than in terms of mass percentage, thus eliminating the need to adopt the rough approximation of a single value for soil particle density in the prediction process. Most of the recent LD work performed in soil science deals with the comparison with sedimentation techniques and show the general overestimation of the silt fraction following a general underestimation of the clay fraction; these well known results must be related with the different physical principles behind the two techniques. Despite these efforts, it is indeed surprising that little if any work is devoted to more basic methodological issues related to the high sensitivity of LD to the quantity and the quality of the soil samples. Our work aims to

  11. Current status and future expectation concerning probabilistic risk assessment of NPPs. 1. Features and issues of probabilistic risk assessment methodology

    International Nuclear Information System (INIS)

    Yamashita, Masahiro

    2012-01-01

    Probabilistic risk assessment (PRA) of Nuclear Power Plants (NPPs) could play an important role in assuring safety of NPPs. However PRA had not always effectively used, which was indicated in Japanese government's report on Fukushima Daiichi NPP accident. At the Risk Technical Committee (RTC) of Standards Committee of Atomic Energy Society of Japan, preparation of standards (implementing criteria) focusing on PRA methodology and investigation on basic philosophy for use of PRA had been in progress. Based on activities of RTC, a serial in three articles including this described current status and future expectation concerning probabilistic risk assessment of NPPs. This article introduced features and issues of PRA methodology related to the use of PRA. Features of PRA methodology could be shown as (1) systematic and comprehensive understanding of risk, (2) support of grading approach, (3) identification of effective safety upgrade measures and (4) quantitative understanding of effects of uncertainty. Issues of PRA methodology were (1) extension of PRA application area, (2) upgrade of PRA methodology, (3) quality assurance of PRA, (4) treatment of uncertainty and (5) quantitative evaluation criteria. (T. Tanaka)

  12. Prescription opioid abuse, pain and addiction: clinical issues and implications.

    Science.gov (United States)

    Ling, Walter; Mooney, Larissa; Hillhouse, Maureen

    2011-05-01

    Prescription opioid misuse in the USA has increased over threefold since 1990 to epidemic proportions, with substantial increases in prescription opioid use also reported in other countries, such as Australia and New Zealand. The broad availability of prescription pain medications, coupled with public misconceptions about their safety and addictive potential, have contributed to the recent surge in non-medical use of prescription opioids and corresponding increases in treatment admissions for problems related to opioid misuse. Given competing pressures faced by physicians to both diagnose and treat pain syndromes and identify individuals at risk for addictive disorders, the use of opioids in the treatment of pain poses a significant clinical challenge. This paper reviews the interaction between pain and opioid addiction with a focus on clinical management issues, including risk factors for opioid dependence in patients with chronic pain and the use of assessment tools to identify and monitor at-risk individuals. Treatment options for opioid dependence and pain are reviewed, including the use of the partial µ agonist buprenorphine in the management of concurrent pain and opioid addiction. Physicians should strive to find a reasonable balance between minimising potential adverse effects of opioid medications without diminishing legitimate access to opioids for analgesia. The article discusses the need to identify methods for minimising risks and negative consequences associated with opioid analgesics and poses research directions, including the development of abuse-deterrent opioid formulations, genetic risk factors for opioid dependence and opioid-induced hyperalgesia as a potential target for medication therapy. © 2011 Australasian Professional Society on Alcohol and other Drugs.

  13. External Validity in the Study of Human Development: Theoretical and Methodological Issues

    Science.gov (United States)

    Hultsch, David F.; Hickey, Tom

    1978-01-01

    An examination of the concept of external validity from two theoretical perspectives: a traditional mechanistic approach and a dialectical organismic approach. Examines the theoretical and methodological implications of these perspectives. (BD)

  14. Methodology Series Module 8: Designing Questionnaires and Clinical Record Forms.

    Science.gov (United States)

    Setia, Maninder Singh

    2017-01-01

    As researchers, we often collect data on a clinical record form or a questionnaire. It is an important part of study design. If the questionnaire is not well designed, the data collected will not be useful. In this section of the module, we have discussed some practical aspects of designing a questionnaire. It is useful to make a list of all the variables that will be assessed in the study before preparing the questionnaire. The researcher should review all the existing questionnaires. It may be efficient to use an existing standardized questionnaire or scale. Many of these scales are freely available and may be used with an appropriate reference. However, some may be under copyright protection and permissions may be required to use the same questionnaire. While designing their own questionnaire, researchers may use open- or close-ended questions. It is important to design the responses appropriately as the format of responses will influence the analysis. Sometimes, one can collect the same information in multiple ways - continuous or categorical response. Besides these, the researcher can also use visual analog scales or Likert's scale in the questionnaire. Some practical take-home points are: (1) Use specific language while framing the questions; (2) write detailed instructions in the questionnaire; (3) use mutually exclusive response categories; (4) use skip patterns; (5) avoid double-barreled questions; and (6) anchor the time period if required.

  15. Methodology of clinical measures of healthcare quality delivered to patients with cardiovascular diseases

    Directory of Open Access Journals (Sweden)

    Posnenkova O.M.

    2014-03-01

    Full Text Available The results of implementation the methodology proposed by American Colleague of Cardiology and American Heart Association (ACC/AHA for development of Russian clinical quality measures for patients with arterial hypertension, coronary heart disease and chronic heart failure. Created quality measures cover the key elements of medical care influencing directly on clinical outcomes of treatment.

  16. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  17. Researching the impact of oral health on diet and nutritional status: methodological issues.

    Science.gov (United States)

    Moynihan, Paula; Thomason, Mark; Walls, Angus; Gray-Donald, Katherine; Morais, Jose A; Ghanem, Henry; Wollin, Stephanie; Ellis, Janice; Steele, Jimmy; Lund, James; Feine, Jocelyne

    2009-04-01

    Assessment of the impact of dental function on diet and nutritional status requires robust methodologies and a standardised approach to increase accuracy of results and to facilitate cross study comparisons. The objectives of this paper are: to report the outcomes of a consensus workshop that critically reviewed publications reporting on dietary methodologies in relation to the impact of oral health on nutrition; to highlight future directions for research and; to make recommendations for appropriate use of methodologies for future research. Data relevant to nutrition and dental status published from 1980 to 2005 in English were presented at the consensus workshop for discussion and appraisal. Relevant papers were retrieved through PubMed. Relevant texts were obtained from the library at Newcastle University, UK. A purposive sample of original articles that illustrated the application of a range of nutritional methodologies to the study of oral health impacts was identified. Original flagship texts on nutritional methodologies were reviewed. Numerous studies have shown an association between loss of teeth and inferior diet. Further research is required to elucidate the impact of novel approaches to prosthetic rehabilitation and the impact of contemporaneous dietary and dental intervention on diet, nutritional status, disease progression and quality of life. The recommendation of the consensus workshop was that future studies should adopt a comprehensive approach to the assessment of nutrition that encompasses measurement of diet, body composition, biochemical indices of intake and levels of nutrients, and functional biomarkers of disease.

  18. Methodologic Guide for Evaluating Clinical Performance and Effect of Artificial Intelligence Technology for Medical Diagnosis and Prediction.

    Science.gov (United States)

    Park, Seong Ho; Han, Kyunghwa

    2018-03-01

    The use of artificial intelligence in medicine is currently an issue of great interest, especially with regard to the diagnostic or predictive analysis of medical images. Adoption of an artificial intelligence tool in clinical practice requires careful confirmation of its clinical utility. Herein, the authors explain key methodology points involved in a clinical evaluation of artificial intelligence technology for use in medicine, especially high-dimensional or overparameterized diagnostic or predictive models in which artificial deep neural networks are used, mainly from the standpoints of clinical epidemiology and biostatistics. First, statistical methods for assessing the discrimination and calibration performances of a diagnostic or predictive model are summarized. Next, the effects of disease manifestation spectrum and disease prevalence on the performance results are explained, followed by a discussion of the difference between evaluating the performance with use of internal and external datasets, the importance of using an adequate external dataset obtained from a well-defined clinical cohort to avoid overestimating the clinical performance as a result of overfitting in high-dimensional or overparameterized classification model and spectrum bias, and the essentials for achieving a more robust clinical evaluation. Finally, the authors review the role of clinical trials and observational outcome studies for ultimate clinical verification of diagnostic or predictive artificial intelligence tools through patient outcomes, beyond performance metrics, and how to design such studies. © RSNA, 2018.

  19. Empirical Psycho-Aesthetics and Her Sisters: Substantive and Methodological Issues--Part II

    Science.gov (United States)

    Konecni, Vladimir J.

    2013-01-01

    Empirical psycho-aesthetics is approached in this two-part article from two directions. Part I, which appeared in the Winter 2012 issue of "JAE," addressed definitional and organizational issues, including the field's origins, its relation to "sister" disciplines (experimental philosophy, cognitive neuroscience of art, and neuroaesthetics), and…

  20. [Mental issues of clinical research interviews in an intercultural context].

    Science.gov (United States)

    Kim, M-S; Derivois, D

    2013-10-01

    39-year-old Korean woman living in Paris illustrates this intersubjective dimension. The analysis of the relationship between the researcher and his object of research will argue the projective dimension. In the quoted research, the researcher is facing a situation in which the participant's problems remind him of his own questionings. The work of analysis, with hindsight and in the after fact, on the position of the researcher and his subjective implication, is necessary to avoid the possible risk of subjectivation. The group dimension has several levels: institutional, national, international or even worldwide. Thus, the intercultural aspect is particularly highlighted in an attempt to present the complexity of the process. The idea of the interculturality awareness at several levels was highlighted in particular by taking the institutional transference/counter-transference movement into consideration. The transfer mezo level revealed itself as one of the analyzers of the group dimension, such as the motivation for accepting the participation in our investigation. In other words, it requires understanding both the relationship conducted by each individual with the institution, and that conducted by two subjects met within the institution. In the current world marked by globalization, "the geohistory of the clinical encounter" (Derivois, 2010) becomes an interesting tool to understand the complexity of the encounter issues arising from the clinical consultation. Copyright © 2012 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  1. Effectiveness of Interventions for Prevention of Road Traffic Injuries in Iran and Some Methodological Issues: A Systematic Review

    Science.gov (United States)

    Azami-Aghdash, Saber; Sadeghi-Bazarghani, Homayoun; Heydari, Mahdiyeh; Rezapour, Ramin; Derakhshani, Naser

    2018-01-01

    Objective: To review the effectiveness of Road Traffic Injuries (RTIs) interventions implemented for prevention of RTIs in Iran and to introduce some methodological issues. Methods: Required data in this systematic review study were collected through searching the following key words: "Road Traffic Injuries", "Road Traffic accidents", "Road Traffic crashes", “prevention”, and Iran in PubMed, Cochrane Library electronic databases, Google Scholar, Scopus, MagIran, SID and IranMedex. Some of the relevant journals and web sites searched manually. Reference lists of the selected articles were also checked. Gray literature search and expert contact was also conducted. Results: Out of 569 retrieved articles, finally 8 articles included. Among the included studies the effectiveness of 10 interventions were assessed containing: seat belt, enforcements of laws and legislations, educational program, wearing helmet, Antilock Braking System (ABS), motorcyclists' penalty enforcement, pupil liaisons’ education, provisional driver licensing, Road bumps and traffic improvement's plans. In 7 studies (9 interventions) reduction of RTIs rate were reported. Decreased rate of mortality from RTIs were reported in three studies. Only one study had mentioned financial issue (Anti-lock Brake System intervention). Inadequate data sources, inappropriate selection of statistical index and not mention about the control of Confounding Variables (CV), the most common methodological issues were. Conclusion: The results of most interventional studies conducted in Iran supported the effect of the interventions on reduction of RTIs. However due to some methodological or reporting shortcoming the results of these studies should be interpreted cautiously. PMID:29719838

  2. Effectiveness of Interventions for Prevention of Road Traffic Injuries in Iran and Some Methodological Issues: A Systematic Review.

    Science.gov (United States)

    Azami-Aghdash, Saber; Sadeghi-Bazarghani, Homayoun; Heydari, Mahdiyeh; Rezapour, Ramin; Derakhshani, Naser

    2018-04-01

    To review the effectiveness of Road Traffic Injuries (RTIs) interventions implemented for prevention of RTIs in Iran and to introduce some methodological issues. Required data in this systematic review study were collected through searching the following key words: "Road Traffic Injuries", "Road Traffic accidents", "Road Traffic crashes", "prevention", and Iran in PubMed, Cochrane Library electronic databases, Google Scholar, Scopus, MagIran, SID and IranMedex. Some of the relevant journals and web sites searched manually. Reference lists of the selected articles were also checked. Gray literature search and expert contact was also conducted. Out of 569 retrieved articles, finally 8 articles included. Among the included studies the effectiveness of 10 interventions were assessed containing: seat belt, enforcements of laws and legislations, educational program, wearing helmet, Antilock Braking System (ABS), motorcyclists' penalty enforcement, pupil liaisons' education, provisional driver licensing, Road bumps and traffic improvement's plans. In 7 studies (9 interventions) reduction of RTIs rate were reported. Decreased rate of mortality from RTIs were reported in three studies. Only one study had mentioned financial issue (Anti-lock Brake System intervention). Inadequate data sources, inappropriate selection of statistical index and not mention about the control of Confounding Variables (CV), the most common methodological issues were. The results of most interventional studies conducted in Iran supported the effect of the interventions on reduction of RTIs. However due to some methodological or reporting shortcoming the results of these studies should be interpreted cautiously.

  3. Project-Based Learning and Agile Methodologies in Electronic Courses: Effect of Student Population and Open Issues

    Directory of Open Access Journals (Sweden)

    Marina Zapater

    2013-12-01

    Full Text Available Project-Based Learning (PBL and Agile methodologies have proven to be very interesting instructional strategies in Electronics and Engineering education, because they provide practical learning skills that help students understand the basis of electronics. In this paper we analyze two courses, one belonging to a Master in Electronic Engineering and one to a Bachelor in Telecommunication Engineering that apply Agile-PBL methodologies, and compare the results obtained in both courses with a traditional laboratory course. Our results support previous work stating that Agile-PBL methodologies increase student satisfaction. However, we also highlight some open issues that negatively affect the implementation of these methodologies,such as planning overhead or accidental complexity. Moreover,we show how differences in the student population, mostly related to the time spent on-campus, their commitment to the course or part-time dedication, have an impact on the benefits of Agile-PBL methods. In these cases, Agile-PBL methodologies by themselves are not enough and need to be combined with other techniques to increase student motivation.

  4. Methodological issues in analyzing human communication – the complexities of multimodality

    DEFF Research Database (Denmark)

    Høegh, Tina

    2017-01-01

    This chapter develops a multimodal method for transcribing speech, communication, and performance. The chapter discusses the methodological solutions to the complex translation of speech, language rhythm and gesture in time and space into the two-dimensional format of a piece of paper. The focus...

  5. Conceptual issues of research methodology for the behavioural, life and social sciences

    NARCIS (Netherlands)

    Mellenbergh, G.J.; Adèr, H.J.; Baird, D.; Berger, M.P.F.; Cornell, J.E.; Hagenaars, J.A.P.; Molenaar, P.C.M.

    2003-01-01

    Research methodology (RM) must be clearly separated from substantive fields, such as medicine, psychology, education, sociology and economics, and, on the other side, from the philosophy of science and statistics. RM starts from substantive research problems and uses statistical knowledge, but it

  6. Methodological issues affecting the study of fish parasites. II. Sampling method affects ectoparasite studies

    Czech Academy of Sciences Publication Activity Database

    Kvach, Yuriy; Ondračková, Markéta; Janáč, Michal; Jurajda, Pavel

    2016-01-01

    Roč. 121, č. 1 (2016), s. 59-66 ISSN 0177-5103 R&D Projects: GA ČR GBP505/12/G112 Institutional support: RVO:68081766 Keywords : Parasite community * Fish sampling method * Methodology * Parasitological examination * Rutilus rutilus Subject RIV: EG - Zoology Impact factor: 1.549, year: 2016

  7. Exploring the concept of "caring cultures": A critical examination of the conceptual, methodological and validity issues with the "caring cultures" construct.

    Science.gov (United States)

    Gillin, Nicola; Taylor, Ruth; Walker, Susan

    2017-12-01

    To critically examine the conceptual, methodological and validity issues with the "caring cultures" construct. Post the Francis Report, "caring cultures" and alternative terminology such as "culture/s of care/caring/compassionate care" have gained prominence in the literature, especially within a UK policy context. However, in order to understand the value these "caring cultures" hold in terms of clinical practice, the concept itself first needs to be understood. A discussion and critical examination of the concept of "caring cultures" and associated terminology. Grey literature, database, library and reference list searches were conducted. It is implied that "caring cultures" influence patient care. However, evidence which verifies this assertion is limited. In this article, the concept of "caring cultures" is deconstructed and its validity explored. An alternative to "caring cultures" is proposed in terms of research, whereby the concept of culture is instead explored in detail, on a microsystem level, using appropriate methodology. The concept of "caring cultures", although attractive in terms of its apparent simplicity, is not considered the most useful nor appropriate phrases in terms of advancing research. Instead, research which examines the established concept of "culture" in relation to outcomes such as patient care, doing so with an appropriate methodology, is viewed as a more suitable alternative. Clarifying concepts and terminology relating to "caring cultures" is essential for research to progress and the impact of culture on clinical practice to be better understood. © 2017 John Wiley & Sons Ltd.

  8. Human Machine Interface and Usability Issues: Exploring a Preliminary Mission Management System Evaluation Methodology

    National Research Council Canada - National Science Library

    Kardos, Monique

    2001-01-01

    ...) concept demonstrator test during June 2000. The questionnaire was designed to examine usability and interface issues relating to the design of the systems or tools, and to provide suggestions for future iterations of the system...

  9. Inernational research in health care management: its need in the 21st century, methodological challenges, ethical issues, pitfalls, and practicalities.

    Science.gov (United States)

    Buttigieg, Sandra C; Rathert, Cheryl; D'Aunno, Thomas A; Savage, Grant T

    2015-01-01

    This commentary argues in favor of international research in the 21st century. Advances in technology, science, communication, transport, and infrastructure have transformed the world into a global village. Industries have increasingly adopted globalization strategies. Likewise, the health sector is more internationalized whereby comparisons between diverse health systems, international best practices, international benchmarking, cross-border health care, and cross-cultural issues have become important subjects in the health care literature. The focus has now turned to international, collaborative, cross-national, and cross-cultural research, which is by far more demanding than domestic studies. In this commentary, we explore the methodological challenges, ethical issues, pitfalls, and practicalities within international research and offer possible solutions to address them. The commentary synthesizes contributions from four scholars in the field of health care management, who came together during the annual meeting of the Academy of Management to discuss with members of the Health Care Management Division the challenges of international research. International research is worth pursuing; however, it calls for scholarly attention to key methodological and ethical issues for its success. This commentary addresses salient issues pertaining to international research in one comprehensive account.

  10. Medicine, methodology, and values: trade-offs in clinical science and practice.

    Science.gov (United States)

    Ho, Vincent K Y

    2011-01-01

    The current guidelines of evidence-based medicine (EBM) presuppose that clinical research and clinical practice should advance from rigorous scientific tests as they generate reliable, value-free knowledge. Under this presupposition, hypotheses postulated by doctors and patients in the process of their decision making are preferably tested in randomized clinical trials (RCTs), and in systematic reviews and meta-analyses summarizing outcomes from multiple RCTs. Since testing under this scheme is predominantly focused on the criteria of generality and precision achieved through methodological rigor, at the cost of the criterion of realism, translating test results to clinical practice is often problematic. Choices concerning which methodological criteria should have priority are inevitable, however, as clinical trials, and scientific research in general, cannot meet all relevant criteria at the same time. Since these choices may be informed by considerations external to science, we must acknowledge that science cannot be value-free in a strict sense, and this invites a more prominent role for value-laden considerations in evaluating clinical research. The urgency for this becomes even more apparent when we consider the important yet implicit role of scientific theories in EBM, which may also be subjected to methodological evaluation and for which selectiveness in methodological focus is likewise inevitable.

  11. Methodological issues in implementing a sustainable forest management plan in remote mountain areas - The Karakorum (Pakistan)

    OpenAIRE

    Ferrari, Efrem

    2014-01-01

    Based on a practical case-study, the Central Karakorum National Park - Gilgit-Baltistan - Pakistan, the aim of the thesis is to present a methodological framework for promoting the sustainable forest management in mountain areas characterized by remoteness, difficulties of access and where few data are available. Forest resources of Karakorum Mountains assume an essential role for the livelihoods of local communities, heavily dependent on wood for heating, cooking and construction purposes...

  12. Theoretical and Methodological issues concerning managers' mental models of competitive industry structures

    OpenAIRE

    Daniels, Kevin; Johnson, Gerry; De Chernatony, Leslie

    1992-01-01

    To be presented at the British Academy of Management Conference, Bradford, September 1992. The methodology traditionally employed by strategic groups theorists categorizes companies on the basis of objective economic variables such as industry supply characteristics. Other lines of research have suggested that this economic approach is limited, and that a more cognitive approach is needed. Strategic groups theory proposes one way in which companies may be categorized, but it is not clea...

  13. Methodological issues affecting the study of fish parasites. III. Effect of fish preservation method

    Czech Academy of Sciences Publication Activity Database

    Kvach, Yuriy; Ondračková, Markéta; Janáč, Michal; Jurajda, Pavel

    2018-01-01

    Roč. 127, č. 3 (2018), s. 213-224 ISSN 0177-5103 R&D Projects: GA ČR(CZ) GBP505/12/G112 Institutional support: RVO:68081766 Keywords : flounder Paralichthys-olivaceus * Neoheterobothrium-hirame * community structure * infection levels * Baltic sea * Odontobutidae * ectoparasites * Perciformes * collection * ecology * Parasite community * Preservation methods * Perca fluviatilis * Rhodeus amarus * Methodology * Parasitological examination Subject RIV: GL - Fish ing OBOR OECD: Fish ery Impact factor: 1.549, year: 2016

  14. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

    OpenAIRE

    Russo, Ethan B.

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanica...

  15. Theory and History, Questions and Methodology: Current and Future Issues in Research into ICT in Education

    Science.gov (United States)

    McDougall, Anne; Jones, Anthony

    2006-01-01

    Serious criticisms of research in information and communications technology (ICT) in education have been published recently in both the UK and the USA. This paper addresses several issues raised in these commentaries: a lack of sound theoretical underpinnings to our research, persistent neglect of the history of our sub-discipline, the choice of…

  16. Empirical Psycho-Aesthetics and Her Sisters: Substantive and Methodological Issues--Part I

    Science.gov (United States)

    Konecni, Vladimir J.

    2012-01-01

    Empirical psycho-aesthetics--an interdisciplinary field with a long tradition--is approached in this two-part article from two directions, in each case with several objectives. Part I, in this issue of "JAE", is devoted to the first direction, which is mainly definitional and organizational: the objectives are to present an outline of the field's…

  17. [Conceptual and methodological issues involved in the research field of diagnostic reasoning].

    Science.gov (United States)

    Di Persia, Francisco N

    2016-05-01

    The psychopathological field is crossed by dilemmas that put in question its methodological, conceptual and philosophical filiations. Since the early works of Ey and Jaspers until recent work of Berrios it has been in question the position psychopathology has in the field of medicine in general, and in the field of psychiatry in particular, especially if it should follow the principles of natural science or if it has an autonomous position between them. This debate has led to two opposing positions facing two different models of psychopathology: the biomedical model and the socio-constructionist model. In this work it is proposed to review the scope and difficulties involved in each model following two central axes: diagnostic reasoning and mental illness conceptual problem. Later, as a synthesis of the analysis proposed they are identified central concepts of each model that could allow the development of a hybrid model in psychopathology; in between them the comprehensive framework employed in symptoms recognition and the social component that characterizes it are highlighted. As a conclusion, these concepts are proposed as central aspects for conceptual and methodological clarification of the research field of diagnostic reasoning in psychopathology.

  18. Exploring the Benefits of Respite Services to Family Caregivers: Methodological Issues and Current Findings

    Science.gov (United States)

    Zarit, Steven H.; Liu, Yin; Bangerter, Lauren R.; Rovine, Michael J.

    2017-01-01

    Objectives There is growing emphasis on empirical validation of the efficacy of community-based services for older people and their families, but research on services such as respite care faces methodological challenges that have limited the growth of outcome studies. We identify problems associated with the usual research approaches for studying respite care, with the goal of stimulating use of novel and more appropriate research designs that can lead to improved studies of community-based services. Method Using the concept of research validity, we evaluate the methodological approaches in the current literature on respite services, including adult day services, in-home respite and overnight respite. Results Although randomized control trials (RCTs) are possible in community settings, validity is compromised by practical limitations of randomization and other problems. Quasi-experimental and interrupted time series designs offer comparable validity to RCTs and can be implemented effectively in community settings. Conclusion An emphasis on RCTs by funders and researchers is not supported by scientific evidence. Alternative designs can lead to development of a valid body of research on community services such as respite. PMID:26729467

  19. Methodological issues in the study of intestinal microbiota in irritable bowel syndrome.

    Science.gov (United States)

    Taverniti, Valentina; Guglielmetti, Simone

    2014-07-21

    Irritable bowel syndrome (IBS) is an intestinal functional disorder with the highest prevalence in the industrialized world. The intestinal microbiota (IM) plays a role in the pathogenesis of IBS and is not merely a consequence of this disorder. Previous research efforts have not revealed unequivocal microbiological signatures of IBS, and the experimental results are contradictory. The experimental methodologies adopted to investigate the complex intestinal ecosystem drastically impact the quality and significance of the results. Therefore, to consider the methodological aspects of the research on IM in IBS, we reviewed 29 relevant original research articles identified through a PubMed search using three combinations of keywords: "irritable bowel syndrome + microflora", "irritable bowel syndrome + microbiota" and "irritable bowel syndrome + microbiome". For each study, we reviewed the quality and significance of the scientific evidence obtained with respect to the experimental method adopted. The data obtained from each study were compared with all considered publications to identify potential inconsistencies and explain contradictory results. The analytical revision of the studies referenced in the present review has contributed to the identification of microbial groups whose relative abundance significantly alters IBS, suggesting that these microbial groups could be IM signatures for this syndrome. The identification of microbial biomarkers in the IM can be advantageous for the development of new diagnostic tools and novel therapeutic strategies for the treatment of different subtypes of IBS.

  20. Socio-clinical issues in cerebral palsy in Sagamu, Nigeria

    African Journals Online (AJOL)

    Nigeria, provides specialist paediatric neurological care to at least three states of the ... parental social indices, clinical diagnoses and the frequencies of clinic .... palsy and oral motor dysfunction.16 Special feeding devices may therefore be .... Knowledge, attitude and practice of community health workers in. Nigeria.

  1. Issues and insights of PRA methodology in nuclear and space applications

    International Nuclear Information System (INIS)

    Hsu, F.

    2005-01-01

    This paper presents some important issues and technical insights on the scope, conceptual framework, and essential elements of nuclear power plant Probabilistic Risk Assessments (PRAs) and that of the PRAs in general applications of the aerospace industry, such as the Space Shuttle PRA being conducted by NASA. Discussions are focused on various lessons learned in nuclear power plant PRA applications and their potential applicability to the PRAs in the aerospace and launch vehicle systems. Based on insights gained from PRA projects for nuclear power plants and from the current Space Shuttle PRA effort, the paper explores the commonalities and the differences between the conduct of the different PRAs and the key issues and risk insights derived from extensive modeling practices in both industries of nuclear and space. (author)

  2. Methodological and Practical Issues of Scientific Research on the Retail Market

    Directory of Open Access Journals (Sweden)

    Balasescu, M.

    2014-06-01

    Full Text Available This paper highlights the role and importance of marketing research in a dynamic and complex sector such as retail. The paper approaches the theoretical issues related to the methods and instruments of marketing research appropriate for the retail market. The theory about qualitative and quantitative research methods is supported by relevant examples which lead to a better understanding of the marketing research process and of its effectiveness on retail activities.

  3. Bringing translation out of the shadows: translation as an issue of methodological significance in cross-cultural qualitative research.

    Science.gov (United States)

    Wong, Josephine Pui-Hing; Poon, Maurice Kwong-Lai

    2010-04-01

    Translation is an integral component of cross-cultural research that has remained invisible. It is commonly assumed that translation is an objective and neutral process, in which the translators are "technicians" in producing texts in different languages. Drawing from the field of translation studies and the findings of a translation exercise conducted with three bilingual Cantonese-English translators, the authors highlight some of the methodological issues about translation in cross-cultural qualitative research. They argue that only by making translation visible and through open dialogue can researchers uncover the richness embedded in the research data and facilitate multiple ways of knowing.

  4. Delivering spacecraft control centers with embedded knowledge-based systems: The methodology issue

    Science.gov (United States)

    Ayache, S.; Haziza, M.; Cayrac, D.

    1994-01-01

    Matra Marconi Space (MMS) occupies a leading place in Europe in the domain of satellite and space data processing systems. The maturity of the knowledge-based systems (KBS) technology, the theoretical and practical experience acquired in the development of prototype, pre-operational and operational applications, make it possible today to consider the wide operational deployment of KBS's in space applications. In this perspective, MMS has to prepare the introduction of the new methods and support tools that will form the basis of the development of such systems. This paper introduces elements of the MMS methodology initiatives in the domain and the main rationale that motivated the approach. These initiatives develop along two main axes: knowledge engineering methods and tools, and a hybrid method approach for coexisting knowledge-based and conventional developments.

  5. [The Philosophical Relevance of the Study of Schizophrenia. Methodological and Conceptual Issues].

    Science.gov (United States)

    López-Silva, Pablo

    2014-01-01

    The study of mental illness involves profound methodological and philosophical debates. This article explores the disciplinary complementarity, particularly, between philosophy of mind, phenomenology, and empirical studies in psychiatry and psychopathology in the context of the understanding of schizophrenia. After clarifying the possible role of these disciplines, it is explored the way in which a certain symptom of schizophrenia (thought insertion) challenges the current phenomenological approach to the relationship between consciousness and self-awareness. Finally, it is concluded that philosophy of mind, phenomenology, and empirical studies in psychiatry and psychopathology should, necessarily, regulate their progress jointly in order to reach plausible conclusions about what we call 'schizophrenia'. Crown Copyright © 2014. Publicado por Elsevier España. All rights reserved.

  6. Ethical Issues of Air Force Nurse Practitioners in Clinical Practice

    Science.gov (United States)

    2000-05-01

    cognitive theory of moral development as set forth by Kohlberg . Crisham explained building on the works of Piaget in the early 30’s, Kohlberg (1976...proposed that development of moral reasoning is directly related to cognitive development. Kohlberg utilized the responses from children of different ages...could not be translated to the general population. This criticism of Kohlberg evolved into her study that concluded that there were other issues besides

  7. Therapy in virtual environments--clinical and ethical issues.

    Science.gov (United States)

    Yellowlees, Peter M; Holloway, Kevin M; Parish, Michelle Burke

    2012-09-01

    As virtual reality and computer-assisted therapy strategies are increasingly implemented for the treatment of psychological disorders, ethical standards and guidelines must be considered. This study determined a set of ethical and legal guidelines for treatment of post-traumatic stress disorder (PTSD)/traumatic brain injury (TBI) in a virtual environment incorporating the rights of an individual who is represented by an avatar. A comprehensive literature review was undertaken. An example of a case study of therapy in Second Life (a popular online virtual world developed by Linden Labs) was described. Ethical and legal considerations regarding psychiatric treatment of PTSD/TBI in a virtual environment were examined. The following issues were described and discussed: authentication of providers and patients, informed consent, patient confidentiality, patient well-being, clinician competence (licensing and credentialing), training of providers, insurance for providers, the therapeutic environment, and emergencies. Ethical and legal guidelines relevant to these issues in a virtual environment were proposed. Ethical and legal issues in virtual environments are similar to those that occur in the in-person world. Individuals represented by an avatar have the rights equivalent to the individual and should be treated as such.

  8. What Can Be Learned From a Laboratory Model of Conceptual Change? Descriptive Findings and Methodological Issues

    Science.gov (United States)

    Ohlsson, Stellan; Cosejo, David G.

    2014-07-01

    The problem of how people process novel and unexpected information— deep learning (Ohlsson in Deep learning: how the mind overrides experience. Cambridge University Press, New York, 2011)—is central to several fields of research, including creativity, belief revision, and conceptual change. Researchers have not converged on a single theory for conceptual change, nor has any one theory been decisively falsified. One contributing reason is the difficulty of collecting informative data in this field. We propose that the commonly used methodologies of historical analysis, classroom interventions, and developmental studies, although indispensible, can be supplemented with studies of laboratory models of conceptual change. We introduce re- categorization, an experimental paradigm in which learners transition from one definition of a categorical concept to another, incompatible definition of the same concept, a simple form of conceptual change. We describe a re-categorization experiment, report some descriptive findings pertaining to the effects of category complexity, the temporal unfolding of learning, and the nature of the learner's final knowledge state. We end with a brief discussion of ways in which the re-categorization model can be improved.

  9. Body image in Brazil: recent advances in the state of knowledge and methodological issues

    Science.gov (United States)

    Laus, Maria Fernanda; Kakeshita, Idalina Shiraishi; Costa, Telma Maria Braga; Ferreira, Maria Elisa Caputo; Fortes, Leonardo de Sousa; Almeida, Sebastião Sousa

    2014-01-01

    OBJECTIVE To analyze Brazilian literature on body image and the theoretical and methodological advances that have been made. METHODS A detailed review was undertaken of the Brazilian literature on body image, selecting published articles, dissertations and theses from the SciELO, SCOPUS, LILACS and PubMed databases and the CAPES thesis database. Google Scholar was also used. There was no start date for the search, which used the following search terms: “body image” AND “Brazil” AND “scale(s)”; “body image” AND “Brazil” AND “questionnaire(s)”; “body image” AND “Brazil” AND “instrument(s)”; “body image” limited to Brazil and “body image”. RESULTS The majority of measures available were intended to be used in college students, with half of them evaluating satisfaction/dissatisfaction with the body. Females and adolescents of both sexes were the most studied population. There has been a significant increase in the number of available instruments. Nevertheless, numerous published studies have used non-validated instruments, with much confusion in the use of the appropriate terms (e.g., perception, dissatisfaction, distortion). CONCLUSIONS Much more is needed to understand body image within the Brazilian population, especially in terms of evaluating different age groups and diversifying the components/dimensions assessed. However, interest in this theme is increasing, and important steps have been taken in a short space of time. PMID:24897056

  10. Childhood leukaemia near British nuclear installations: Methodological issues and recent results

    International Nuclear Information System (INIS)

    Bithell, J. F.; Keegan, T. J.; Kroll, M. E.; Murphy, M. F. G.; Vincent, T. J.

    2008-01-01

    In 2008, the German Childhood Cancer Registry published the results of the Kinderkrebs in der Umgebung von Kernkraftwerken (KiKK) study of childhood cancer and leukaemia around German nuclear power stations. The positive findings appeared to conflict with the results of a recent British analysis carried out by the Committee on Medical Aspects of Radiation in the Environment (COMARE), published in 2005. The present paper first describes the COMARE study, which was based on data from the National Registry of Children's Tumours (NRCT); in particular, the methodology used in this study is described. Although the results of the COMARE study were negative for childhood leukaemia, this apparent discrepancy could be accounted for by a number of differences in approach, especially those relating to the distances from the power stations and the ages of the children studied. The present study was designed to match the KiKK study as far as possible. The incidence observed (18 cases within 5 km against 14.58 expected, p = 0.21) was not significantly raised. The risk estimate for proximity in the regression fitted was actually negative, though the confidence intervals involved are so wide that the difference from that reported in the KiKK study is only marginally statistically significant (p = 0.063). (authors)

  11. Psychotherapeutic issues with "kinky" clients: clinical problems, yours and theirs.

    Science.gov (United States)

    Nichols, Margaret

    2006-01-01

    People whose sexual repertoire includes BDSM, fetish, or other "kinky" practices have become increasingly visible, on the Internet, in the real world, and in psychotherapists' offices. Unfortunately, the prevailing psychiatric view of BDSM remains a negative one: These sexual practices are usually considered paraphilias, i.e., de facto evidence of pathology. A different, affirming view of BDSM is taken in this paper. After defining BDSM and reviewing common misconceptions, a variety of issues the practitioner will face are described. These include problems of countertransference, of working with people with newly emerging sexual identities, working with spouses and partners, and discriminating between abuse and sexual "play."

  12. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for th...

  13. Methodological issues and research recommendations for prognosis after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

    Science.gov (United States)

    Kristman, Vicki L; Borg, Jörgen; Godbolt, Alison K; Salmi, L Rachid; Cancelliere, Carol; Carroll, Linda J; Holm, Lena W; Nygren-de Boussard, Catharina; Hartvigsen, Jan; Abara, Uko; Donovan, James; Cassidy, J David

    2014-03-01

    The International Collaboration on Mild Traumatic Brain Injury (MTBI) Prognosis performed a comprehensive search and critical review of the literature from 2001 to 2012 to update the 2002 best-evidence synthesis conducted by the World Health Organization Collaborating Centre for Neurotrauma, Prevention, Management and Rehabilitation Task Force on the prognosis of MTBI. Of 299 relevant studies, 101 were accepted as scientifically admissible. The methodological quality of the research literature on MTBI prognosis has not improved since the 2002 Task Force report. There are still many methodological concerns and knowledge gaps in the literature. Here we report and make recommendations on how to avoid methodological flaws found in prognostic studies of MTBI. Additionally, we discuss issues of MTBI definition and identify topic areas in need of further research to advance the understanding of prognosis after MTBI. Priority research areas include but are not limited to the use of confirmatory designs, studies of measurement validity, focus on the elderly, attention to litigation/compensation issues, the development of validated clinical prediction rules, the use of MTBI populations other than hospital admissions, continued research on the effects of repeated concussions, longer follow-up times with more measurement periods in longitudinal studies, an assessment of the differences between adults and children, and an account for reverse causality and differential recall bias. Well-conducted studies in these areas will aid our understanding of MTBI prognosis and assist clinicians in educating and treating their patients with MTBI. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  14. On the issue of methodology of estimating the regional competitive advantages by types of activity

    Directory of Open Access Journals (Sweden)

    Azat Rashitovich Safiullin

    2015-06-01

    Full Text Available Objective to develop the research methodology of the competitive position of territories by types of economic activities to define the relevant types of economic activities and to diagnose their competitive advantages. Methods a differentiated approach to the analysis of competitiveness based on matrix models of competitive positioning which allows to identify the relevant types of economic activities of the territory. This approach determined the choice of specific research methods dialectics abstraction systematic logical structural comparative and statistical. The application of the above methods helped to ensure the validity of the analysis results theoretical and practical conclusions. Results in the study were used the experience and knowledge gained during an earlier undertaken series of projects relating to the assessment of economy efficiency of Tatarstan Republic in 20052011.Previous reports dealt with the change of the selected industries positions of the Republic the structure and dynamics of the competitive position of these industries compared to the leading Russian regions. A distinctive feature of the research results presented in this article is a comparative analysis of competitive advantages of economic activities of Tatarstan Republic based on the matrix model of competitive positioning. Scientific novelty for the first time the matrix model of diagnostics of competitive advantages of the territory by the type of economic activity was proposed which allows to identify the priority industrial portfolio and provide targeted management actions to enhance its investment attractiveness. Practical value the main provisions and conclusions of the article can be used by legislative and executive authorities of the Russian Federation business community research institutions and organizations to develop strategies and programs of socioeconomic development and territorial planning schemes priority directions of industrial and investment

  15. A Scoping Review of Clinical Practice Improvement Methodology Use in Rehabilitation

    Directory of Open Access Journals (Sweden)

    Marie-Eve Lamontagne

    2016-01-01

    Full Text Available Context The Clinical Practice Improvement (CPI approach is a methodological and quality improvement approach that has emerged and is gaining in popularity. However, there is no systematic description of its use or the determinants of its practice in rehabilitation settings. Method We performed a scoping review of the use of CPI methodology in rehabilitation settings. Results A total of 103 articles were reviewed. We found evidence of 13 initiatives involving CPI with six different populations. A total of 335 citations of determinants were found, with 68.7% related to CPI itself. Little information was found about what type of external and internal environment, individual characteristics and implementation process might facilitate or hinder the use of CPI. Conclusion Given the growing popularity of this methodological approach, CPI initiatives would gain from increasing knowledge of the determinants of its success and incorporating them in future implementation.

  16. Correct titration of non-drugs and some other methodological issues.

    Science.gov (United States)

    Beneke, M; Rasmus, W; Rød, I S; Fritze, J

    1994-01-01

    Doctors' prescription and dosing behaviour was investigated using data from 9 clinical trials in 550 patients treated with psychotropics. 7 trials were conducted under double- and 2 under single-blind conditions. In 3 of these trials, oral and i.m. preparations were used demanding a double-dummy design. All patients were evaluated on a weekly or 2-week basis using psychopathological rating scales (i.e. Hamilton Anxiety Scale, Hamilton Depression Scale, Clinical Global Impressions, Simpson and Angus EPS). It was found that (a) oral-medication titration was 3- to 4-fold more broad-ranging than i.m. medication titration, (b) oral placebo was titrated to the same extent as the oral investigational drugs, and (c) the titration schedule did not follow protocol requirements. Moreover, the average doses in all drug and placebo groups were the same. Concomitant medication like sleep inducers was found to be more closely related to doctors' habits than to actual medical need. Independent of trial and investigational drug, 10-33% of all patients received additional sleep inducers.

  17. A systematic format for resolving ethical issues in clinical periodontics.

    Science.gov (United States)

    Schloss, Alexander J

    2012-01-01

    Ethical dilemmas are becoming increasingly common in dentistry and periodontics. Clinicians, challenged with such dilemmas, may not know how to apply the appropriate moral reasoning needed to resolve these situations especially when any of the five fundamental principles of ethics that form the foundation of the American Dental Association Principles of Ethics and Code of Professional Conduct--patient autonomy, nonmaleficence, beneficence, justice, and veracity--come into conflict with each other. The author describes one clinical case that presented with an ethical dilemma. An analytic framework, used in medicine, is introduced and used to solve the clinical case on whether to proceed with periodontal surgery on a patient who is not aware of his terminal prognosis from metastatic prostate cancer. Upon using the analytic framework, recommendations are made on the ethically appropriate path for the periodontist to follow in providing care for the patient's periodontal problem consistent with the principles of patient autonomy, respect for persons, and veracity.

  18. Sleep Health Issues for Children with FASD: Clinical Considerations

    OpenAIRE

    Jan, James E.; Asante, Kwadwo O.; Conry, Julianne L.; Fast, Diane K.; Bax, Martin C. O.; Ipsiroglu, Osman S.; Bredberg, Elizabeth; Loock, Christine A.; Wasdell, Michael B.

    2010-01-01

    This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD) focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniqu...

  19. Methodological Issues In Forestry Mitigation Projects: A CaseStudy Of Kolar District

    Energy Technology Data Exchange (ETDEWEB)

    Ravindranath, N.H.; Murthy, I.K.; Sudha, P.; Ramprasad, V.; Nagendra, M.D.V.; Sahana, C.A.; Srivathsa, K.G.; Khan, H.

    2007-06-01

    There is a need to assess climate change mitigationopportunities in forest sector in India in the context of methodologicalissues such as additionality, permanence, leakage, measurement andbaseline development in formulating forestry mitigation projects. A casestudy of forestry mitigation project in semi-arid community grazing landsand farmlands in Kolar district of Karnataka, was undertaken with regardto baseline and project scenariodevelopment, estimation of carbon stockchange in the project, leakage estimation and assessment ofcost-effectiveness of mitigation projects. Further, the transaction coststo develop project, and environmental and socio-economic impact ofmitigation project was assessed.The study shows the feasibility ofestablishing baselines and project C-stock changes. Since the area haslow or insignificant biomass, leakage is not an issue. The overallmitigation potential in Kolar for a total area of 14,000 ha under variousmitigation options is 278,380 tC at a rate of 20 tC/ha for the period2005-2035, which is approximately 0.67 tC/ha/yr inclusive of harvestregimes under short rotation and long rotation mitigation options. Thetransaction cost for baseline establishment is less than a rupee/tC andfor project scenario development is about Rs. 1.5-3.75/tC. The projectenhances biodiversity and the socio-economic impact is alsosignificant.

  20. Studies of self-pollution in diesel school buses: methodological issues.

    Science.gov (United States)

    Borak, Jonathan; Sirianni, Greg

    2007-09-01

    Considerable interest has focused on levels of exhaust emissions in the cabins of diesel-powered school buses and their possible adverse health effects. Significantly different policy and engineering issues would be raised if compelling evidence found that inc-cabin contamination was due to self-pollution from bus emissions, rather than ambient pollution, neighboring vehicles, and/or re-entrained road dust. We identified 19 reports from 11 studies that measured diesel exhaust particulate in the cabins of 58 school bus of various type. Studies were evaluated in light of their experimental design, their data quality, and their capacity to quantify self-pollution. Only one study had a true experimental design, comparing the same buses with and without emission controls, while four others used intentional tracers to quantify tail pipe and/or crankcase emissions. Although definitive data are still lacking, these studies suggest that currently available control technologies can nearly eliminate particulate self-pollution inside diesel school buses.

  1. Evaluation of the performance of diagnosis-related groups and similar casemix systems: methodological issues.

    Science.gov (United States)

    Palmer, G; Reid, B

    2001-05-01

    With the increasing recognition and application of casemix for managing and financing healthcare resources, the evaluation of alternative versions of systems such as diagnosis-related groups (DRGs) has been afforded high priority by governments and researchers in many countries. Outside the United States, an important issue has been the perceived need to produce local versions, and to establish whether or not these perform more effectively than the US-based classifications. A discussion of casemix evaluation criteria highlights the large number of measures that may be used, the rationale and assumptions underlying each measure, and the problems in interpreting the results. A review of recent evaluation studies from a number of countries indicates that considerable emphasis has been placed on the predictive validity criterion, as measured by the R2 statistic. However, the interpretation of the findings has been affected greatly by the methods used, especially the treatment and definition of outlier cases. Furthermore, the extent to which other evaluation criteria have been addressed has varied widely. In the absence of minimum evaluation standards, it is not possible to draw clear-cut conclusions about the superiority of one version of a casemix system over another, the need for a local adaptation, or the further development of an existing version. Without the evidence provided by properly designed studies, policy-makers and managers may place undue reliance on subjective judgments and the views of the most influential, but not necessarily best informed, healthcare interest groups.

  2. [CAP quality management system in clinical laboratory and its issue].

    Science.gov (United States)

    Tazawa, Hiromitsu

    2004-03-01

    The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

  3. Methodological issues for the economic evaluation of health interventions: a concise state of the art

    Directory of Open Access Journals (Sweden)

    Gian Luca Di Tanna

    2013-06-01

    Full Text Available This paper presents a preliminary report of the Italian Society of Medical Statistics and Clinical Epidemiology (SISMEC working group called SiPrEMAS (Evidence Synthesis and Decision Modelling in Health collating some topics addressed throughout the first two years of collaboration. It contains a rapid overview of the principal methods used for the economic evaluation of health interventions. Special focus is given to the process of assembling and pooling the available evidence, modeling methods, the analysis of uncertainty (structural and on parameters, cost analysis and cost consequences analysis. This paper intends to stimulate the discussion among different professionals involved in the decision making process at national level, trying to (rebridge the gap between decision makers and researchers.

  4. Summary and recommendations of a National Cancer Institute workshop on issues limiting the clinical use of Monte Carlo dose calculation algorithms for megavoltage external beam radiation therapy

    International Nuclear Information System (INIS)

    Fraass, Benedick A.; Smathers, James; Deye, James

    2003-01-01

    Due to the significant interest in Monte Carlo dose calculations for external beam megavoltage radiation therapy from both the research and commercial communities, a workshop was held in October 2001 to assess the status of this computational method with regard to use for clinical treatment planning. The Radiation Research Program of the National Cancer Institute, in conjunction with the Nuclear Data and Analysis Group at the Oak Ridge National Laboratory, gathered a group of experts in clinical radiation therapy treatment planning and Monte Carlo dose calculations, and examined issues involved in clinical implementation of Monte Carlo dose calculation methods in clinical radiotherapy. The workshop examined the current status of Monte Carlo algorithms, the rationale for using Monte Carlo, algorithmic concerns, clinical issues, and verification methodologies. Based on these discussions, the workshop developed recommendations for future NCI-funded research and development efforts. This paper briefly summarizes the issues presented at the workshop and the recommendations developed by the group

  5. Bone mineral content measurement in small infants by single-photon absorptiometry: current methodologic issues

    International Nuclear Information System (INIS)

    Steichen, J.J.; Asch, P.A.; Tsang, R.C.

    1988-01-01

    Single-photon absorptiometry (SPA), developed in 1963 and adapted for infants by Steichen et al. in 1976, is an important tool to quantitate bone mineralization in infants. Studies of infants in which SPA was used include studies of fetal bone mineralization and postnatal bone mineralization in very low birth weight infants. The SPA technique has also been used as a research tool to investigate longitudinal bone mineralization and to study the effect of nutrition and disease processes such as rickets or osteopenia of prematurity. At present, it has little direct clinical application for diagnosing bone disease in single patients. The bones most often used to measure bone mineral content (BMC) are the radius, the ulna, and, less often, the humerus. The radius appears to be preferred as a suitable bone to measure BMC in infants. It is easily accessible; anatomic reference points are easily palpated and have a constant relationship to the radial mid-shaft site; soft tissue does not affect either palpation of anatomic reference points or BMC quantitation in vivo. The peripheral location of the radius minimizes body radiation exposure. Trabecular and cortical bone can be measured separately. Extensive background studies exist on radial BMC in small infants. Most important, the radius has a relatively long zone of constant BMC. Finally, SPA for BMC in the radius has a high degree of precision and accuracy. 61 references

  6. Preventing medico-legal issues in clinical practice

    Directory of Open Access Journals (Sweden)

    Bevinahalli N Raveesh

    2016-01-01

    Full Text Available The medical profession is considered to be one of the noblest professions in the world. The practice of medicine is capable of rendering noble service to humanity provided due care, sincerity, efficiency, and professional skill is observed by the doctors. However, today, the patient–doctor relationship has almost diminished its fiduciary character and has become more formal and structured. Doctors are no longer regarded as infallible and beyond questioning. Corporatization of health care has made it like any other business, and the medical profession is increasingly being guided by the profit motive rather than that of service. On the other hand, a well-publicized malpractice case can ruin the doctor's career and practice. The law, like medicine, is an inexact science. One cannot predict with certainty an outcome of cases many a time. It depends on the particular facts and circumstances of the case, and also the personal notions of the judge concerned who is hearing the case. The axiom “you learn from your mistakes” is too little honored in healthcare. The best way to handle medico-legal issues is by preventing them, and this article tries to enumerate the preventive measures in safeguarding the doctor against negligence suit.

  7. [Female intimate partner homicide: clinical and criminological issues].

    Science.gov (United States)

    Cechova-Vayleux, E; Leveillee, S; Lhuillier, J-P; Garre, J-B; Senon, J-L; Richard-Devantoy, S

    2013-12-01

    Female intimate partner homicide (FIPH) is a fatal complication of domestic violence. The aim of this study was to describe the socio-demographic, clinical and criminological characteristics of male perpetrators of FIPH and to compare them to the perpetrators of extrafamilial homicide and the perpetrators of intrafamilial homicide other than FIPH. Between 1975 and 2005, 32 FIPH were perpetrated in the region of Angers (France), and these were compared to 26 intrafamilial homicides other than FIPH and to 97 extrafamilial homicides perpetrated in the same period, in the same region. The socio-demographic, clinical and criminological data were collected from psychiatric expert reports and medical files. The mean age of the FIPH perpetrators was 37.8years. They were professionally active, in majority as manual workers. They had a psychiatric record (69%), a previous criminal record (31%), and a history of violence against others (47%). Half of these perpetrators also had experienced a traumatic event before the age of 18. Compared to extrafamilial homicide perpetrators, FIPH perpetrators occupied more frequently a manual job and had prior criminal records less frequently. In the majority of cases of FIPH and intrafamilial homicide, the murder occurred in the evening, at the victim's home, and while the perpetrator was intoxicated. FIPH was mostly premeditated and was accompanied four times less frequently by another criminal behaviour compared to extrafamilial homicide. The FIPH perpetrators had more depressive symptoms and suicidal ideations when committing the crime and remained on the crime scene more often than extrafamilial homicide perpetrators who mostly attempted to flee the crime scene. FIPH perpetrators and extra- and intrafamilial homicide perpetrators were found criminally responsible in half of the cases. The socio-demographic, clinical and criminological characteristics of FIPH perpetrators were not statistically different from those of perpetrators of

  8. Methodological issues in protein and lipidic expressions in brain tissue exposed to Co60 based on DESI/MALDI-MS

    International Nuclear Information System (INIS)

    Soares, Matheus F.; Campos, Tarcísio P.R.; Augusti, Rodinei; Eberlin, Marcos N.; Vendramini, Pedro H.

    2017-01-01

    The present paper attempts to present some issues in the methodology of identifying lipid and protein changes in brain tissue induced by radiation. The goal was to address the analysis of the methodology and to investigate the feasibility of the generation of lipid/protein profiles of irradiated brain tissue, in order to identify radioinduced changes. Lipids and proteins are biomolecules with diverse structures and functionalities that participate in important intracellular processes. Changes in the lipid and the tissue protein profiles may indicate a cellular response to an external stimulus as well as the emergence of neoplasms or neurodegenerative diseases such as Alzheimer's. DESI-MS is a convenient method for identifying lipids and their spatial distribution in tissue beyond analytical quantification. DESI-MS allows the creation of an image of several low lipid m/z classes. MALDI-MS has already been a method used in the study of macromolecules as structural, membrane, hormone, neuromediator and immunological peptides. Through a full-scan matrix scan, with a m/z spectrum between 500-1000 for lipids and with a mass spectrum of 1000-15000 Da for proteins, the molecular profile can be analyzed. Generated pixel shape 2D chemical image. The produced image allows to associate the tissue distribution of the lipids and proteins with their chemical profile identified, allowing the verification of the changes radioinduced. Radiation triggers intense oxidative stress by increasing reactive oxygen species (ROS) and free radicals, causing DNA damage with consequent alterations in proteomics and cellular lipid explaining such changes in the lipid and protein expressions. The cellular morphophysiological changes are responsible for both the clonogenic inhibition and the induction of the apoptotic process. The images's production was directly dependent on the rigorous execution of the methodological procedures. Innumerable interferences could impair the image

  9. Sleep Health Issues for Children with FASD: Clinical Considerations

    Directory of Open Access Journals (Sweden)

    James E. Jan

    2010-01-01

    Full Text Available This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniques used for typical children are less suitable for children with FASD who need individually designed interventions. The types, causes, and adverse effects of sleep disorders, the modification of environment, scheduling and preparation for sleep, and sleep health for their caregivers are discussed. It is our hope that parents and also researchers, who are interested in the sleep disorders of children with FASD, will benefit from this presentation and that this discussion will stimulate much needed evidence-based research.

  10. Sleep Health Issues for Children with FASD: Clinical Considerations.

    Science.gov (United States)

    Jan, James E; Asante, Kwadwo O; Conry, Julianne L; Fast, Diane K; Bax, Martin C O; Ipsiroglu, Osman S; Bredberg, Elizabeth; Loock, Christine A; Wasdell, Michael B

    2010-01-01

    This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD) focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniques used for typical children are less suitable for children with FASD who need individually designed interventions. The types, causes, and adverse effects of sleep disorders, the modification of environment, scheduling and preparation for sleep, and sleep health for their caregivers are discussed. It is our hope that parents and also researchers, who are interested in the sleep disorders of children with FASD, will benefit from this presentation and that this discussion will stimulate much needed evidence-based research.

  11. Methodological issues in systematic reviews of headache trials: adapting historical diagnostic classifications and outcome measures to present-day standards.

    Science.gov (United States)

    McCrory, Douglas C; Gray, Rebecca N; Tfelt-Hansen, Peer; Steiner, Timothy J; Taylor, Frederick R

    2005-05-01

    Recent efforts to make headache diagnostic classification and clinical trial methodology more consistent provide valuable advice to trialists generating new evidence on effectiveness of treatments for headache; however, interpreting older trials that do not conform to new standards remains problematic. Systematic reviewers seeking to utilize historical data can adapt currently recommended diagnostic classification and clinical trial methodological approaches to interpret all available data relative to current standards. In evaluating study populations, systematic reviewers can: (i) use available data to attempt to map study populations to diagnoses in the new International Classification of Headache Disorders; and (ii) stratify analyses based on the extent to which study populations are precisely specified. In evaluating outcome measures, systematic reviewers can: (i) summarize prevention studies using headache frequency, incorporating headache index in a stratified analysis if headache frequency is not available; (ii) summarize acute treatment studies using pain-free response as reported in directly measured headache improvement or headache severity outcomes; and (iii) avoid analysis of recurrence or relapse data not conforming to the sustained pain-free response definition.

  12. Vulnerability or Sensitivity to the Environment? Methodological Issues, Trends, and Recommendations in Gene–Environment Interactions Research in Human Behavior

    Directory of Open Access Journals (Sweden)

    Caroline Leighton

    2017-06-01

    Full Text Available Research on the potential role of gene–environment interactions (GxE in explaining vulnerability to psychopathology in humans has witnessed a shift from a diathesis-stress perspective to differential susceptibility approaches. This paper critically reviews methodological issues and trends in this body of research. Databases were screened for studies of GxE in the prediction of personality traits, behavior, and mental health disorders in humans published between January 2002 and January 2015. In total, 315 papers were included. Results showed that 34 candidate genes have been included in GxE studies. Independent of the type of environment studied (early or recent life events, positive or negative environments, about 67–83% of studies have reported significant GxE interactions, which is consistent with a social susceptibility model. The percentage of positive results does not seem to differ depending on the gene studied, although publication bias might be involved. However, the number of positive findings differs depending on the population studied (i.e., young adults vs. older adults. Methodological considerations limit the ability to draw strong conclusions, particularly as almost 90% (n = 283/315 of published papers are based on samples from North America and Europe, and about 70% of published studies (219/315 are based on samples that were also used in other reports. At the same time, there are clear indications of methodological improvements over time, as is shown by a significant increase in longitudinal and experimental studies as well as in improved minimum genotyping. Recommendations for future research, such as minimum quality assessment of genes and environmental factors, specifying theoretical models guiding the study, and taking into account of cultural, ethnic, and lifetime perspectives, are formulated.

  13. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

  14. Cognition in epilepsy: current clinical issues of interest.

    Science.gov (United States)

    Witt, Juri-Alexander; Helmstaedter, Christoph

    2017-04-01

    This review provides an update and summary of recent neuropsychological findings in epilepsy focusing on three major clinical topics among the many developments in the field. We will critically outline the current state with regard to cognition in new-onset epilepsies, social cognition in epilepsy, and the long-term outcome of epilepsy surgery and the cognitive outcomes of superselective surgical procedures. Current studies indicate that neuropsychological impairments are prevalent already at the onset of epilepsy and even before, social cognition (i.e., emotion recognition and theory of mind) is impaired in different epilepsy populations, the long-term outcome of epilepsy surgery is mostly characterized by a stable or even improved cognitive status, and superselective epilepsy surgeries are associated with a promising neuropsychological outcome. The high prevalence of cognitive deficits around epilepsy onset challenges the assumption that epilepsy is the major cause of cognitive problems and calls for early neuropsychological diagnostics. Social cognition seems to be a relevant domain that is not yet routinely considered in epilepsy. The cognitive long-term outcome of epilepsy surgery is mostly positive. Stereotactic thermocoagulation and gamma knife surgery appear to be cognitively safe procedures.

  15. Traumatic optic neuropathy—Clinical features and management issues

    Science.gov (United States)

    Yu-Wai-Man, Patrick

    2015-01-01

    Traumatic optic neuropathy (TON) is an uncommon cause of visual loss following blunt or penetrating head trauma, but the consequences can be devastating, especially in cases with bilateral optic nerve involvement. Although the majority of patients are young adult males, about 20% of cases occur during childhood. A diagnosis of TON is usually straightforward based on the clinical history and examination findings indicative of an optic neuropathy. However, the assessment can be difficult when the patient's mental status is impaired owing to severe trauma. TON frequently results in profound loss of central vision, and the final visual outcome is largely dictated by the patient's baseline visual acuities. Other poor prognostic factors include loss of consciousness, no improvement in vision after 48 hours, the absence of visual evoked responses, and evidence of optic canal fractures on neuroimaging. The management of TON remains controversial. Some clinicians favor observation alone, whereas others opt to intervene with systemic steroids, surgical decompression of the optic canal, or both. The evidence base for these various treatment options is weak, and the routine use of high-dose steroids or surgery in TON is not without any attendant risks. There is a relatively high rate of spontaneous visual recovery among patients managed conservatively, and the possible adverse effects of intervention therefore need to be even more carefully considered in the balance. PMID:26052483

  16. Methodological issues associated with collecting sensitive information over the telephone - experience from an Australian non-suicidal self-injury (NSSI prevalence study

    Directory of Open Access Journals (Sweden)

    Fullerton Simon

    2011-02-01

    Full Text Available Abstract Background Collecting population data on sensitive issues such as non-suicidal self-injury (NSSI is problematic. Case note audits or hospital/clinic based presentations only record severe cases and do not distinguish between suicidal and non-suicidal intent. Community surveys have largely been limited to school and university students, resulting in little much needed population-based data on NSSI. Collecting these data via a large scale population survey presents challenges to survey methodologists. This paper addresses the methodological issues associated with collecting this type of data via CATI. Methods An Australia-wide population survey was funded by the Australian Government to determine prevalence estimates of NSSI and associations, predictors, relationships to suicide attempts and suicide ideation, and outcomes. Computer assisted telephone interviewing (CATI on a random sample of the Australian population aged 10+ years of age from randomly selected households, was undertaken. Results Overall, from 31,216 eligible households, 12,006 interviews were undertaken (response rate 38.5%. The 4-week prevalence of NSSI was 1.1% (95% ci 0.9-1.3% and lifetime prevalence was 8.1% (95% ci 7.6-8.6. Methodological concerns and challenges in regard to collection of these data included extensive interviewer training and post interview counselling. Ethical considerations, especially with children as young as 10 years of age being asked sensitive questions, were addressed prior to data collection. The solution required a large amount of information to be sent to each selected household prior to the telephone interview which contributed to a lower than expected response rate. Non-coverage error caused by the population of interest being highly mobile, homeless or institutionalised was also a suspected issue in this low prevalence condition. In many circumstances the numbers missing from the sampling frame are small enough to not cause worry

  17. The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

    Science.gov (United States)

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2016-01-01

    When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

  18. The Adequacy of the Q Methodology for Clinical Validation of Nursing Diagnoses Related to Subjective Foci.

    Science.gov (United States)

    Miguel, Susana; Caldeira, Sílvia; Vieira, Margarida

    2018-04-01

    This article describes the adequacy of the Q methodology as a new option for the validation of nursing diagnoses related to subjective foci. Discussion paper about the characteristics of the Q methodology. This method has been used in nursing research particularly related to subjective concepts and includes both a quantitative and qualitative dimension. The Q methodology seems to be an adequate and innovative method for the clinical validation of nursing diagnoses. The validation of nursing diagnoses related to subjective foci using the Q methodology could improve the level of evidence and provide nurses with clinical indicators for clinical reasoning and for the planning of effective interventions. Descrever a adequação da metodologia Q como uma nova opção para a validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos. MÉTODOS: Artigo de discussão sobre as características da metodologia Q. Este método tem sido utilizado na pesquisa em enfermagem relacionada com conceitos subjetivos e inclui em simultâneo uma vertente qualitativa e quantitativa. CONCLUSÕES: A metodologia Q parece ser uma opção metodológica adequada para a validação clínica de diagnósticos de enfermagem. IMPLICAÇÕES PARA A PRÁTICA: A utilização da metodologia Q na validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos pode melhorar o nível e evidência e facilitar o raciocínio clínico dos enfermeiros, ao providenciar indicadores clínicos também necessários ao desenvolvimento de intervenções efetivas. © 2016 NANDA International, Inc.

  19. Measurement of leukocyte rheology in vascular disease: clinical rationale and methodology. International Society of Clinical Hemorheology.

    Science.gov (United States)

    Wautier, J L; Schmid-Schönbein, G W; Nash, G B

    1999-01-01

    The measurement of leukocyte rheology in vascular disease is a recent development with a wide range of new opportunities. The International Society of Clinical Hemorheology has asked an expert panel to propose guidelines for the investigation of leukocyte rheology in clinical situations. This article first discusses the mechanical, adhesive and related functional properties of leukocytes (especially neutrophils) which influence their circulation, and establishes the rationale for clinically-related measurements of parameters which describe them. It is concluded that quantitation of leukocyte adhesion molecules, and of their endothelial receptors may assist understanding of leukocyte behaviour in vascular disease, along with measurements of flow resistance of leukocytes, free radical production, degranulation and gene expression. For instance, vascular cell adhesion molecule (VCAM-1) is abnormally present on endothelial cells in atherosclerosis, diabetes mellitus and inflammatory conditions. Soluble forms of intercellular adhesion molecule (ICAM-1) or VCAM can be found elevated in the blood of patients with rheumatoid arthritis or infections disease. In the second part of the article, possible technical approaches are presented and possible avenues for leukocyte rheological investigations are discussed.

  20. Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

    Directory of Open Access Journals (Sweden)

    Carmel Jacobs

    Full Text Available Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored

  1. Mephedrone (4-methylmethcathinone; 'meow meow'): chemical, pharmacological and clinical issues.

    Science.gov (United States)

    Schifano, Fabrizio; Albanese, Antonio; Fergus, Suzanne; Stair, Jackie L; Deluca, Paolo; Corazza, Ornella; Davey, Zoe; Corkery, John; Siemann, Holger; Scherbaum, Norbert; Farre', Magi'; Torrens, Marta; Demetrovics, Zsolt; Ghodse, A Hamid

    2011-04-01

    Recently, those substances deriving from the active ingredient of the Khat plant, cathinone, have been rising in popularity. Indeed, 4-methylmethcathinone (mephedrone; 'meow meow' and others) has been seen by some as a cheaper alternative to other classified recreational drugs. We aimed here at providing a state-of-the-art review on mephedrone history and prevalence of misuse, chemistry, pharmacology, legal status, product market appearance, clinical/management and related fatalities. Because of the limited evidence, some of the information here presented has been obtained from user reports/drug user-orientated web sites. The most common routes for mephedrone recreational use include insufflation and oral ingestion. It elicits stimulant and empathogenic effects similar to amphetamine, methylamphetamine, cocaine and MDMA. Due to its sympathomimetic actions, mephedrone may be associated with a number of both physical and psychopathological side effects. Recent preliminary analysis of recent UK data carried out in 48 related cases have provided positive results for the presence of mephedrone at postmortem. Within the UK, diffusion of mephedrone may have been associated with an unprecedented combination of a particularly aggressive online marketing policy and a decreasing availability/purity of both ecstasy and cocaine. Mephedrone has been recently classified in both the UK and in a number of other countries as a measure to control its availability. Following this, a few other research psychoactives have recently entered the online market as yet unregulated substances that may substitute for mephedrone. Only international collaborative efforts may be able to tackle the phenomenon of the regular offer of novel psychoactive drugs.

  2. Methodological Reflections on the Contribution of Qualitative Research to the Evaluation of Clinical Ethics Support Services.

    Science.gov (United States)

    Wäscher, Sebastian; Salloch, Sabine; Ritter, Peter; Vollmann, Jochen; Schildmann, Jan

    2017-05-01

    This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services (CESS) for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the (formative) evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. © 2017 John Wiley & Sons Ltd.

  3. Arctic development and historical analysis: the use of historical methodology in addressing current issues in the Arctic.

    Science.gov (United States)

    Douglas, Vasiliki Kravariotis

    2008-06-01

    To demonstrate the applicability of historical methodology to current issues in the Canadian Arctic. This is a literature-based analytical historical study, which draws on material from database searches of MEDLINE, Anthropology Plus, POLARInfo, the Arctic Blue Books and Historical Abstracts. Material was also obtained from physical searches of the University of Alberta Libraries and Library and Archives Canada collections, as well as from field research in the records of the Inuulitsivik Maternities. The historical technique of tracing epistemological change over time, pioneered by Michel Foucault and further developed by Ian Hacking, was applied to the history of Canadian authority in the Arctic. This was linked with epistemological changes occurring throughout Western/Southern culture in this period. The applicability of this historical analysis for current issues in the region was then evaluated. An epistemological shift in Western society has moved authority from traditional human actors in government, medicine and, increasingly, science to statistics, which is seen as both impartial and accurate. Human authorities now routinely appeal to statistical authority to validate policy decisions. This change is as apparent in the Arctic as elsewhere, but it has also opened a space for Inuit practices, rooted in traditional Inuit epistemology, to reassert themselves, provided they can satisfy demands for statistical validity. Historical analysis provides a means to identify the spaces which epistemological change and historical contingency have opened in which social and cultural change can occur.

  4. Methodological issues in developing a community forestry greenhouse gas emissions mitigation project in Mancherial forest division of Andhra Pradesh, India

    International Nuclear Information System (INIS)

    Murthy, I.K.; Hegde, G.T.; Sudha, P.; Ravindranath, N.H.

    2006-01-01

    There are several contentious issues related to forestry mitigation projects. The special report of the IPCC and literature published so far have shown that permanence, leakage, baseline establishment, measurement, monitoring, etc., could be addressed satisfactorily using existing scientific methods and accounting rules. To understand the methodological issues of developing community forestry projects, a case study was conducted in Mancherial forest division of Adilabad district in Andhra Pradesh, India. This paper addresses: the setting of project boundaries, baseline selection, establishment of additionality and the calculation of carbon sequestration as a result of the project, prior to project implementation. The steps involved in development of the project and the different methods used for establishing baseline, estimating leakage and transaction cost of developing a community forestry project are presented. The stock is projected to increase by 1480 x 10 3 t C during 2000-2012 over the baseline scenario under the modeling approach and the cost of establishing a baseline and project formulation for a project extending over 32,956 ha is estimated to be US$ 1.25 ha -1 and US$ 4 t C -1

  5. Lifting the veil: a typological survey of the methodological features of Islamic ethical reasoning on biomedical issues.

    Science.gov (United States)

    Abdur-Rashid, Khalil; Furber, Steven Woodward; Abdul-Basser, Taha

    2013-04-01

    We survey the meta-ethical tools and institutional processes that traditional Islamic ethicists apply when deliberating on bioethical issues. We present a typology of these methodological elements, giving particular attention to the meta-ethical techniques and devices that traditional Islamic ethicists employ in the absence of decisive or univocal authoritative texts or in the absence of established transmitted cases. In describing how traditional Islamic ethicists work, we demonstrate that these experts possess a variety of discursive tools. We find that the ethical responsa-i.e., the products of the application of the tools that we describe-are generally characterized by internal consistency. We also conclude that Islamic ethical reasoning on bioethical issues, while clearly scripture-based, is also characterized by strong consequentialist elements and possesses clear principles-based characteristics. The paper contributes to the study of bioethics by familiarizing non-specialists in Islamic ethics with the role, scope, and applicability of key Islamic ethical concepts, such as "aims" (maqāṣid), "universals" (kulliyyāt), "interest" (maṣlaḥa), "maxims" (qawā`id), "controls" (ḍawābit), "differentiators" (furūq), "preponderization" (tarjīḥ), and "extension" (tafrī`).

  6. Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology

    Science.gov (United States)

    Esposito, Pasquale; Dal Canton, Antonio

    2014-01-01

    Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings. PMID:25374819

  7. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report

    OpenAIRE

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-01-01

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients i...

  8. Ethical and methodological issues in qualitative studies involving people with severe and persistent mental illness such as schizophrenia and other psychotic conditions: a critical review.

    Science.gov (United States)

    Carlsson, Ing-Marie; Blomqvist, Marjut; Jormfeldt, Henrika

    2017-01-01

    Undertaking research studies in the field of mental health is essential in mental health nursing. Qualitative research methodologies enable human experiences to become visible and recognize the importance of lived experiences. This paper argues that involving people with schizophrenia in research is critical to promote their health and well-being. The quality of qualitative research needs scrutinizing according to methodological issues such as trustworthiness and ethical standards that are a fundamental part of qualitative research and nursing curricula. The aim of this study was to critically review recent qualitative studies involving people with severe and persistent mental illness such as schizophrenia and other psychotic conditions, regarding descriptions of ethical and methodological issues in data collection and analysis. A search for relevant papers was conducted in three electronic databases, in December 2016. Fifteen qualitative interview studies were included and reviewed regarding methodological issues related to ethics, and data collection and analysis. The results revealed insufficient descriptions of methodology regarding ethical considerations and issues related to recruitment and sampling in qualitative interview studies with individuals with severe mental illness, putting trustworthiness at risk despite detailed descriptions of data analysis. Knowledge from the perspective of individuals with their own experience of mental illness is essential. Issues regarding sampling and trustworthiness in qualitative studies involving people with severe mental illness are vital to counteract the stigmatization of mental illness.

  9. Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

    Science.gov (United States)

    Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Gamble, Carrol; Denegri, Simon; Muir, Delia; Simon, Natalie A; Thomas, Stephen; Elliot, Jim T; Bulbeck, Helen; Crocker, Joanna C; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry

    2017-12-01

    Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. A modified Delphi process including a two round online survey and a stakeholder consensus meeting. In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  10. Methodological issues in detecting gene-gene interactions in breast cancer susceptibility: a population-based study in Ontario

    Directory of Open Access Journals (Sweden)

    Onay Venus

    2007-08-01

    Full Text Available Abstract Background There is growing evidence that gene-gene interactions are ubiquitous in determining the susceptibility to common human diseases. The investigation of such gene-gene interactions presents new statistical challenges for studies with relatively small sample sizes as the number of potential interactions in the genome can be large. Breast cancer provides a useful paradigm to study genetically complex diseases because commonly occurring single nucleotide polymorphisms (SNPs may additively or synergistically disturb the system-wide communication of the cellular processes leading to cancer development. Methods In this study, we systematically studied SNP-SNP interactions among 19 SNPs from 18 key genes involved in major cancer pathways in a sample of 398 breast cancer cases and 372 controls from Ontario. We discuss the methodological issues associated with the detection of SNP-SNP interactions in this dataset by applying and comparing three commonly used methods: the logistic regression model, classification and regression trees (CART, and the multifactor dimensionality reduction (MDR method. Results Our analyses show evidence for several simple (two-way and complex (multi-way SNP-SNP interactions associated with breast cancer. For example, all three methods identified XPD-[Lys751Gln]*IL10-[G(-1082A] as the most significant two-way interaction. CART and MDR identified the same critical SNPs participating in complex interactions. Our results suggest that the use of multiple statistical approaches (or an integrated approach rather than a single methodology could be the best strategy to elucidate complex gene interactions that have generally very different patterns. Conclusion The strategy used here has the potential to identify complex biological relationships among breast cancer genes and processes. This will lead to the discovery of novel biological information, which will improve breast cancer risk management.

  11. Ethically-based clinical decision-making in physical therapy: process and issues.

    Science.gov (United States)

    Finch, Elspeth; Geddes, E Lynne; Larin, Hélène

    2005-01-01

    The identification and consideration of relevant ethical issues in clinical decision-making, and the education of health care professionals (HCPs) in these skills are key factors in providing quality health care. This qualitative study explores the way in which physical therapists (PTs) integrate ethical issues into clinical practice decisions and identifies ethical themes used by PTs. A purposive sample of eight PTs was asked to describe a recent ethically-based clinical decision. Transcribed interviews were coded and themes identified related to the following categories: 1) the integration of ethical issues in the clinical decision-making process, 2) patient welfare, 3) professional ethos of the PT, and 4) health care economics and business practices. Participants readily described clinical situations involving ethical issues but rarely identified specific conflicting ethical issues in their description. Ethical dilemmas were more frequently resolved when there were fewer emotional sequelae associated with the dilemma, and the PT had a clear understanding of professional ethos, valued patient autonomy, and explored a variety of alternative actions before implementing one. HCP students need to develop a clear professional ethos and an increased understanding of the economic factors that will present ethical issues in practice.

  12. High-resolution proton NMR spectroscopy of cerebrospinal fluid: methodological issues and potential clinical applications

    International Nuclear Information System (INIS)

    Kriat, M.; Nicoli, F.; Vion-Dury, J.; Confort-Gouny, S.; Cozzone, P.J.; Nicoli, F.; Gastaut, J.L.; Dano, P.; Grisoli, F.

    1991-01-01

    High resolution proton nuclear magnetic resonance (NMR) spectroscopy is a new analytical technique which allows to readily identify and quantitate a variety of key metabolites in cerebrospinal fluid (CSF) in relation to normal and pathological brain activity. Proton NMR spectroscopy can be performed on native CSF, with or without addition of exchange reagent (NH 4 Cl). The analysis of native CSF provides qualitative information (identification) of metabolites or xenobiotics present in the fluid. Alternately, CSF can be lyophilized and dissolved in deuterated water. This concentration offers 2 advantages: additional compounds are detected and a precise quantification of all CSF metabolites can be obtained. Both protocols require a very small volume of CFS (1-2 ml). The high informational content available on the NMR spectra of CSF, the ease-of-use of NMR spectroscopy and its cost effectiveness concur to predict that this analytical approach will keep developing to completement the array of existing tests which are already routinely performed on CSF. 6 figs [fr

  13. Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

    Science.gov (United States)

    Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

    2017-07-01

    Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic

  14. Lean six sigma methodologies improve clinical laboratory efficiency and reduce turnaround times.

    Science.gov (United States)

    Inal, Tamer C; Goruroglu Ozturk, Ozlem; Kibar, Filiz; Cetiner, Salih; Matyar, Selcuk; Daglioglu, Gulcin; Yaman, Akgun

    2018-01-01

    Organizing work flow is a major task of laboratory management. Recently, clinical laboratories have started to adopt methodologies such as Lean Six Sigma and some successful implementations have been reported. This study used Lean Six Sigma to simplify the laboratory work process and decrease the turnaround time by eliminating non-value-adding steps. The five-stage Six Sigma system known as define, measure, analyze, improve, and control (DMAIC) is used to identify and solve problems. The laboratory turnaround time for individual tests, total delay time in the sample reception area, and percentage of steps involving risks of medical errors and biological hazards in the overall process are measured. The pre-analytical process in the reception area was improved by eliminating 3 h and 22.5 min of non-value-adding work. Turnaround time also improved for stat samples from 68 to 59 min after applying Lean. Steps prone to medical errors and posing potential biological hazards to receptionists were reduced from 30% to 3%. Successful implementation of Lean Six Sigma significantly improved all of the selected performance metrics. This quality-improvement methodology has the potential to significantly improve clinical laboratories. © 2017 Wiley Periodicals, Inc.

  15. METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

    Directory of Open Access Journals (Sweden)

    V. B. Ivanov

    2017-01-01

    Full Text Available The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.

  16. Practical and conceptual issues of clinical trial registration for Brazilian researchers

    Directory of Open Access Journals (Sweden)

    Carolina Gomes Freitas

    Full Text Available CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014 on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE. Recent Brazilian regulations require that all clinical trials (phases I to IV involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

  17. Characterisation of organisational issues in paediatric clinical ethics consultation: a qualitative study.

    Science.gov (United States)

    Opel, D J; Wilfond, B S; Brownstein, D; Diekema, D S; Pearlman, R A

    2009-08-01

    The traditional approach to resolving ethics concerns may not address underlying organisational issues involved in the evolution of these concerns. This represents a missed opportunity to improve quality of care "upstream". The purpose of this study was to understand better which organisational issues may contribute to ethics concerns. Directed content analysis was used to review ethics consultation notes from an academic children's hospital from 1996 to 2006 (N = 71). The analysis utilised 18 categories of organisational issues derived and modified from published quality improvement protocols. Organisational issues were identified in 68 of the 71 (96%) ethics consult notes across a range of patient settings and reasons for consultation. Thirteen of the 18 categories of organisational issues were identified and there was a median of two organisational issues per consult note. The most frequently identified organisational issues were informal organisational culture (eg, collective practices and approaches to situations with ethical dimensions that are not guided by policy), policies and procedures (eg, staff knows policy and/or procedural guidelines for an ethical concern but do not follow it) and communication (eg, communication about critical information, orders, or hand-offs repeatedly does not occur among services). Organisational issues contribute to ethical concerns that result in clinical ethics consults. Identifying and addressing organisational issues such as informal culture and communication may help decrease the recurrence of future similar ethics concerns.

  18. Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease.

    Science.gov (United States)

    Lo, Bernard; Parham, Lindsay

    2010-01-01

    Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial to yield generalizable knowledge, negative findings and serious adverse events must be reported.

  19. Action research methodology in clinical pharmacy: how to involve and change.

    Science.gov (United States)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh

    2016-06-01

    Introduction The focus in clinical pharmacy practice is and has for the last 30-35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process by establishing partnerships with staff. On the background of the authors' widespread action research (AR)-based experiences, recommendations and comments for how to conduct an AR-study is described, and one of their AR-based studies illustrate the methodology and the research methods used. Methodology AR is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented study? What learning and/or changes took place? What challenges/pitfalls had to be overcome? What were the influence/consequences for the involved parts? When to use If you want to implement new services and want to involve staff and others in the process, an AR methodology is very suitable. The basic advantages of doing AR-based studies are grounded in their participatory and democratic basis and their starting point in problems experienced in practice. Limitations Some of the limitations in AR-studies are that neither of the participants in a project steering group are the only ones to decide. Furthermore, the collective process makes the decision-making procedures relatively complex.

  20. Nursing students' experiences of ethical issues in clinical practice: A New Zealand study.

    Science.gov (United States)

    Sinclair, J; Papps, E; Marshall, B

    2016-03-01

    Nursing students experience ethical problems in clinical practice in a different way from registered nurses. In order to develop ethical reasoning and competence in nursing students, nurse educators must recognise the unique issues students face. This research described the occurrence of ethical issues in clinical practice for 373 undergraduate nursing students who responded to a national questionnaire investigating the frequency of pre-determined ethical issues and the corresponding level of distress. Over two thirds of respondents experienced breaches of a patient's right to confidentiality, privacy, dignity or respect and 87% experienced unsafe working conditions. The most distressing issues were those that compromised patient safety, including unsafe healthcare practices, working conditions and suspected abuse or neglect. Themes that emerged from an open-ended question included lack of support and supervision, bullying and end of life issues. This research found the frequency at which ethical issues are experienced was highest in year three participants. However, the overall distress levels were lower for the majority of issues for those participants in the later part of their degree. Recommendations from this research include developing ethics education around the main concerns that students face in order to enhance students' understanding, resilience and ability to respond appropriately. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Attitudes towards rotating shift work in clinical nurses: a Q-methodology study.

    Science.gov (United States)

    Ha, Eun-Ho

    2015-09-01

    To identify clinical nurses' attitudes towards rotating shift work. Many hospitals worldwide employ rotating shift work patterns to staff their facilities. Attitudes of clinical nurses towards rotating shift work vary. To understand clinical nurses' attitudes towards rotating shift work, Q-methodology, a method for the analysis of subjective viewpoints with the strengths of both qualitative and quantitative methods, was used. Forty-six selected Q-statements from each of the 39 participants were classified into a normal distribution using an 11-point bipolar scale. The collected data were analysed using pc-QUANL program. Three discrete factors emerged as follows: factor I (rotating shift work is frustrating: objectionable perspective), factor II (rotating shift work is satisfactory: constructive perspective) and factor III (rotating shift work is problematic, but necessary: ambivalent perspective). The subjective viewpoints of the three identified factors can be applied in developing various roster designs for nurses engaging in rotating shift work. The findings provide the baseline for nurse leaders in helping nurses adjust and deal with rotating shift work. © 2015 John Wiley & Sons Ltd.

  2. A Diagnostic Model for Dementia in Clinical Practice-Case Methodology Assisting Dementia Diagnosis.

    Science.gov (United States)

    Londos, Elisabet

    2015-04-02

    Dementia diagnosis is important for many different reasons. Firstly, to separate dementia, or major neurocognitive disorder, from MCI (mild cognitive impairment), mild neurocognitive disorder. Secondly, to define the specific underlying brain disorder to aid treatment, prognosis and decisions regarding care needs and assistance. The diagnostic method of dementias is a puzzle of different data pieces to be fitted together in the best possible way to reach a clinical diagnosis. Using a modified case methodology concept, risk factors affecting cognitive reserve and symptoms constituting the basis of the brain damage hypothesis, can be visualized, balanced and reflected against test results as well as structural and biochemical markers. The model's origin is the case method initially described in Harvard business school, here modified to serve dementia diagnostics.

  3. HIV positive refugees/asylum seekers and clinical trials: some ethical issues

    OpenAIRE

    McDonald, Linda

    2014-01-01

    The aim of this thesis was to identify some of the ethical issues of HIV positive asylum seekers and refugees participating in clinical trials in Britain. While all individuals are to some degree vulnerable in clinical trials, I have shown in this thesis that this group is particularly vulnerable in a number of areas. Many will not have English as a first language and while they may be able to understand everyday language, the participant information sheet (PIS) may be difficult to comprehend...

  4. Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach.

    Science.gov (United States)

    Mertz, Marcel; Strech, Daniel

    2014-12-04

    Clinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs. The development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach. The six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs. If DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed

  5. Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

    Science.gov (United States)

    Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E

    2013-01-01

    To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.

  6. Impact of Parental Severe Mental Illness: Ethical and Clinical Issues for Counselors

    Science.gov (United States)

    Spiegelhoff, Sarah F.; Ahia, C. Emmanuel

    2011-01-01

    This article draws attention to the issue of parental severe mental illness and the ethical and clinical implications for counselors who work with this population. Parents with mental illness face a multitude of life challenges including, but not limited to, parenting difficulties, medication and hospitalization, custody and placement of their…

  7. Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

    DEFF Research Database (Denmark)

    Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

    2017-01-01

    Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

  8. Feature Issue Introduction: Bio-Optics in Clinical Applications, Nanotechnology, and Drug Discovery

    OpenAIRE

    Nordstrom, Robert J.; Almutairi, Adah; Hillman, Elizabeth M.C.

    2010-01-01

    The editors introduce the Biomedical Optics Express feature issue, “Bio-Optics in Clinical Applications, Nanotechnology, and Drug Discovery,” which combines three technical areas from the 2010 Optical Society of America (OSA), Biomedical Optics (BIOMED) Topical Meeting held on 11–14 April in Miami, FL and includes contributions from conference attendees.

  9. Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

    Science.gov (United States)

    Woolacott, Nerys; Corbett, Mark; Jones-Diette, Julie; Hodgson, Robert

    2017-10-01

    Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. We examined these methodological challenges through a pragmatic review of the available literature. Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  10. The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics.

    Science.gov (United States)

    Carli, Vladimir; Wasserman, Camilla; Wasserman, Danuta; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Kaess, Michael; Kahn, Jean Pierre; Keeley, Helen; Keresztény, Agnes; Iosue, Miriam; Mars, Ursa; Musa, George; Nemes, Bogdan; Postuvan, Vita; Reiter-Theil, Stella; Saiz, Pilar; Varnik, Peeter; Varnik, Airi; Hoven, Christina W

    2013-05-16

    Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents. To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample. Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5). Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach's alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799). SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis of SEYLE data will shed light on the effectiveness

  11. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

    OpenAIRE

    Douglas H. Marin dos Santos; Álvaro N. Atallah

    2015-01-01

    The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the ...

  12. Methodological issues in assessing changes in costs pre- and post-medication switch: a schizophrenia study example

    Directory of Open Access Journals (Sweden)

    Nyhuis Allen W

    2009-05-01

    Full Text Available Abstract Background Schizophrenia is a severe, chronic, and costly illness that adversely impacts patients' lives and health care payer budgets. Cost comparisons of treatment regimens are, therefore, important to health care payers and researchers. Pre-Post analyses ("mirror-image", where outcomes prior to a medication switch are compared to outcomes post-switch, are commonly used in such research. However, medication changes often occur during a costly crisis event. Patients may relapse, be hospitalized, have a medication change, and then spend a period of time with intense use of costly resources (post-medication switch. While many advantages and disadvantages of Pre-Post methodology have been discussed, issues regarding the attributability of costs incurred around the time of medication switching have not been fully investigated. Methods Medical resource use data, including medications and acute-care services (hospitalizations, partial hospitalizations, emergency department were collected for patients with schizophrenia who switched antipsychotics (n = 105 during a 1-year randomized, naturalistic, antipsychotic cost-effectiveness schizophrenia trial. Within-patient changes in total costs per day were computed during the pre- and post-medication change periods. In addition to the standard Pre-Post analysis comparing costs pre- and post-medication change, we investigated the sensitivity of results to varying assumptions regarding the attributability of acute care service costs occurring just after a medication switch that were likely due to initial medication failure. Results Fifty-six percent of all costs incurred during the first week on the newly initiated antipsychotic were likely due to treatment failure with the previous antipsychotic. Standard analyses suggested an average increase in cost-per-day for each patient of $2.40 after switching medications. However, sensitivity analyses removing costs incurred post-switch that were potentially

  13. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

    Science.gov (United States)

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-09-27

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  14. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues.

    Science.gov (United States)

    Gekas, Jean; Langlois, Sylvie; Ravitsky, Vardit; Audibert, François; van den Berg, David Gradus; Haidar, Hazar; Rousseau, François

    2016-01-01

    Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening) was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women.

  15. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy

    Science.gov (United States)

    Harper, Joyce C; Geraedts, Joep; Borry, Pascal; Cornel, Martina C; Dondorp, Wybo; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather; Soini, Sirpa; Spits, Claudia; Veiga, Anna; Vermeesch, Joris Robert; Viville, Stéphane; de Wert, Guido; Macek, Milan

    2013-01-01

    In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogentest2 Coordination Action Project. The main goal of this meeting was to discuss developments at the interface between clinical genetics and ARTs. As more genetic causes of reproductive failure are now recognised and an increasing number of patients undergo testing of their genome before conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and preimplantation genetic diagnosis (PGD) may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from randomised clinical trials to substantiate that the technique is both effective and efficient. Whole-genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (International Standards Organisation – ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving but still remains very heterogeneous and often contradictory. The lack of legal harmonisation and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe and beyond. The aim of this paper is to complement previous publications and

  16. The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

    Science.gov (United States)

    Brown, Alison; Santilli, Mario; Scott, Belinda

    2015-12-01

    Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  17. [Discussion on solutions to ethical issues of clinical researches in a real world].

    Science.gov (United States)

    Wang, Si-Cheng; Liu, Bao-Yan; Xiong, Ning-Ning; Xie, Qi; Zhang, Run-Shun; Zhou, Xue-Zhong; Qiao, Jie

    2013-04-01

    The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years' practices to enhance the scientificity and ethical level of real-world studies.

  18. The entry-level occupational therapy clinical doctorate: advantages, challenges, and international issues to consider.

    Science.gov (United States)

    Brown, Ted; Crabtree, Jeffrey L; Mu, Keli; Wells, Joe

    2015-04-01

    Internationally, occupational therapy education has gone through several paradigm shifts during the last few decades, moving from certificate to diploma to bachelors to masters and now in some instances to clinical doctorate as the entry-level professional credential to practice. In the United States there is a recommendation under consideration by the American Occupational Therapy Association (AOTA) that by 2025, all occupational therapy university programs will move to the clinical doctorate level. It should be noted, however, that the AOTA Board can only make recommendations and it is the Accreditation Council for Occupational Therapy Education (ACOTE) who has regulatory authority to approve such a change. What are the potential implications for the profession, our clients, and funders of occupational therapy services? What are the primary drivers for the move towards the clinical doctorate being the educational entry point? Is the next step in the evolution of occupational therapy education globally a shift to the entry-level clinical doctorate? This article reviews current literature and discusses issues about the occupational therapy entry-level clinical doctorate. The published evidence available about the occupational therapy entry-level clinical doctorate is summarized and the perceived or frequently cited pros and cons of moving to the clinical doctorate as the singular entry point to occupational therapy practice are considered. The potential impacts of the introduction of the clinical doctorate as the entry-to-practice qualification across the United States on the occupational therapy community internationally will be briefly discussed. If the United States moves toward the entry-level clinical doctorate as the only educational starting point for the profession, will other jurisdictions follow suit? Further discourse and investigation of this issue both inside and outside of the United States is needed so that informed decisions can be made.

  19. Clinical Education, the lessons learned from practical applications - Albanian issues, East Europe and the advanced international practices on Clinical Education

    Directory of Open Access Journals (Sweden)

    Alban Koci

    2015-01-01

    In legal clinics, students perform various tasks just as an attorney would do in the same job position, such as doing legal research, drafting briefs and other legal documents, and interviewing clients. Many jurisdictions even allow students to appear in court on behalf of clients, even in criminal defense. Legal clinics is part of the academic law program in the most of the law faculties all over the world and it has a great impact in the community’s life. Throughout legal clinics students not only get the opportunity to be part of an important experience, but also they can be effective and help the people in need with their work. This paper aims to bring attention to the importance of clinical education in the formation of young lawyers and how one can learn from experience. There will be discussed important issues about legal clinic, the objectives and its mission, how to apply it and the benefits legal clinic brings not only for the academic area but also for the society.

  20. Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

    Science.gov (United States)

    Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

    2017-08-01

    As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

  1. Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

    Science.gov (United States)

    Brunoni, André R; Tadini, Laura; Fregni, Felipe

    2010-03-03

    There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

  2. Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

    Directory of Open Access Journals (Sweden)

    André R Brunoni

    2010-03-01

    Full Text Available There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years.We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine. All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time.Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

  3. Introduction to the special issue: toward implementing physiological measures in clinical child and adolescent assessments.

    Science.gov (United States)

    De Los Reyes, Andres; Aldao, Amelia

    2015-01-01

    The National Institute of Mental Health recently launched the Research Domain Criteria (RDoC). The RDoC is an initiative to improve classification of mental health concerns by promoting research on the brain mechanisms underlying these concerns, with the ultimate goal of developing interventions that target these brain mechanisms. A key focus of RDoC involves opening new lines of research examining patients' responses on biological measures. The RDoC presents unique challenges to mental health professionals who work with children and adolescents. Indeed, mental health professionals rarely integrate biological measures into clinical assessments. Thus, RDoC's ability to improve patient care rests, in part, on the development of strategies for implementing biological measures within mental health assessments. Further, mental health professionals already carry out comprehensive assessments that frequently yield inconsistent findings. These inconsistencies have historically posed challenges to interpreting research findings as well as assessment outcomes in practice settings. In this introductory article, we review key issues that informed the development of a special issue of articles demonstrating methods for implementing low-cost measures of physiological functioning in clinical child and adolescent assessments. We also outline a conceptual framework, informed by theoretical work on using and interpreting multiple informants' clinical reports (De Los Reyes, Thomas, Goodman, & Kundey, 2013 ), to guide hypothesis testing when using physiological measures within clinical child and adolescent assessments. This special issue and the conceptual model described in this article may open up new lines of research testing paradigms for implementing clinically feasible physiological measures in clinical child and adolescent assessments.

  4. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy.

    Science.gov (United States)

    Harper, Joyce; Geraedts, Joep; Borry, Pascal; Cornel, Martina C; Dondorp, Wybo J; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather; Soini, Sirpa; Spits, Claudia; Veiga, Anna; Vermeesch, Joris Robert; Viville, Stéphane; de Wert, Guido; Macek, Milan

    2014-08-01

    How has the interface between genetics and assisted reproduction technology (ART) evolved since 2005? The interface between ART and genetics has become more entwined as we increase our understanding about the genetics of infertility and we are able to perform more comprehensive genetic testing. In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and ART and published an extended background paper, recommendations and two Editorials. An interdisciplinary workshop was held, involving representatives of both professional societies and experts from the European Union Eurogentest2 Coordination Action Project. In March 2012, a group of experts from the European Society of Human Genetics, the European Society of Human Reproduction and Embryology and the EuroGentest2 Coordination Action Project met to discuss developments at the interface between clinical genetics and ART. As more genetic causes of reproductive failure are now recognized and an increasing number of patients undergo testing of their genome prior to conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and PGD may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from RCTs to substantiate that the technique is both effective and efficient. Whole genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving, but still remains very

  5. FCγ Chimeric Receptor-Engineered T Cells: Methodology, Advantages, Limitations, and Clinical Relevance

    Directory of Open Access Journals (Sweden)

    Giuseppe Sconocchia

    2017-04-01

    Full Text Available For many years, disappointing results have been generated by many investigations, which have utilized a variety of immunologic strategies to enhance the ability of a patient’s immune system to recognize and eliminate malignant cells. However, in recent years, immunotherapy has been used successfully for the treatment of hematologic and solid malignancies. The impressive clinical responses observed in many types of cancer have convinced even the most skeptical clinical oncologists that a patient’s immune system can recognize and reject his tumor if appropriate strategies are implemented. The success immunotherapy is due to the development of at least three therapeutic strategies. They include tumor-associated antigen (TAA-specific monoclonal antibodies (mAbs, T cell checkpoint blockade, and TAA-specific chimeric antigen receptors (CARs T cell-based immunotherapy. However, the full realization of the therapeutic potential of these approaches requires the development of strategies to counteract and overcome some limitations. They include off-target toxicity and mechanisms of cancer immune evasion, which obstacle the successful clinical application of mAbs and CAR T cell-based immunotherapies. Thus, we and others have developed the Fc gamma chimeric receptors (Fcγ-CRs-based strategy. Like CARs, Fcγ-CRs are composed of an intracellular tail resulting from the fusion of a co-stimulatory molecule with the T cell receptor ζ chain. In contrast, the extracellular CAR single-chain variable fragment (scFv, which recognizes the targeted TAA, has been replaced with the extracellular portion of the FcγRIIIA (CD16. Fcγ-CR T cells have a few intriguing features. First, given in combination with mAbs, Fcγ-CR T cells mediate anticancer activity in vitro and in vivo by an antibody-mediated cellular cytotoxicity mechanism. Second, CD16-CR T cells can target multiple cancer types provided that TAA-specific mAbs with the appropriate specificity are available

  6. Introduction to the Special Issue on Clinical Neuropsychology of Movement Disorders.

    Science.gov (United States)

    Tröster, Alexander I

    2017-11-01

    The special issue on the clinical neuropsychology of movement disorders provides an overview for the non-subspecialist clinical neuropsychologist and other clinical neuroscientists of the neuropsychological features, assessment and treatment of Parkinson's disease and Lewy body dementias, atypical parkinsonian disorders (corticobasal syndrome, progressive supranuclear palsy, and multiple system atrophy), Huntington's disease, dystonia, and amyotrophic lateral sclerosis. Additionally, articles provide overviews of neuropsychological and ethical issues related to deep brain stimulation and a discussion of non-pharamcologic and non-invasive treatment of cognitive dysfunction in Parkinson's disease. A search of PubMed using neuropsycholog* and parkinson* as search terms indicates that the number of articles dealing with neuropsychology of parkinsonian disorders has more than doubled in each of the past three decades (1990-99:269 entries, 2000-09:575 entries, 2010-17:967 entries). This rapid growth of research makes a special issue on the topic very timely. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  7. OPTIGOV - A new methodology for evaluating Clinical Governance implementation by health providers

    Directory of Open Access Journals (Sweden)

    Nardella Pierangela

    2010-06-01

    Full Text Available Abstract Background The aim of Clinical Governance (CG is to the pursuit of quality in health care through the integration of all the activities impacting on the patient into a single strategy. OPTIGOV (Optimizing Health Care Governance is a methodology for the assessment of the level of implementation of CG within healthcare organizations. The aim of this paper is to explain the process underlying the development of OPTIGOV, and describe its characteristics and steps. Methods OPTIGOV was developed in 2006 by the Institute of Hygiene of the Catholic University of the Sacred Heart and Eurogroup Consulting Alliance. The main steps of the process were: choice of areas for analysis and questionnaire development, based on a review of scientific literature; assignment of scores and weights to individual questions and areas; implementation of a software interfaceable with Microsoft Office. Results OPTIGOV consists of: a a hospital audit with a structured approach; b development of an improvement operational plan. A questionnaire divided into 13 areas of analysis is used. For each area there is a form with a variable number of questions and "closed" answers. A score is assigned to each answer, area of analysis, healthcare department and unit. The single scores can be gathered for the organization as a whole. The software application allows for collation of data, calculation of scores and development of benchmarks to allow comparisons between healthcare organizations. Implementation consists of three stages: the preparation phase includes a kick off meeting, selection of interviewees and development of a survey plan. The registration phase includes hospital audits, reviewing of hospital documentation, data collection and score processing. Lastly, results are processed, inserted into a final report, and discussed in a meeting with the Hospital Board and in a final workshop. Conclusions The OPTIGOV methodology for the evaluation of CG implementation was

  8. Methodological issues affecting the study of fish parasites. I. Duration of live fish storage prior to dissection

    Czech Academy of Sciences Publication Activity Database

    Kvach, Yuriy; Ondračková, Markéta; Janáč, Michal; Jurajda, Pavel

    2016-01-01

    Roč. 119, č. 2 (2016), s. 107-115 ISSN 0177-5103 R&D Projects: GA ČR GBP505/12/G112 Institutional support: RVO:68081766 Keywords : Parasite community * Temporal changes * Carassius gibelio * Fish holding * Methodology * Parasitological examination Subject RIV: EG - Zoology Impact factor: 1.549, year: 2016

  9. ISSUES ON USING PRICE INDICES FOR ESTIMATING GDP AND ITS COMPONENTS AT CONSTANT PRICES ACCORDING TO SNA METHODOLOGY

    Directory of Open Access Journals (Sweden)

    K. Prykhodko

    2014-06-01

    Full Text Available The article examines requirements and methodological approaches to the calculation of price indices (deflators in the national accounts. It gives estimation for the level and dynamics of price indicators. It proposes on improving the calculation of price indices (deflators in the national accounts of Ukraine.

  10. An Examination of the State of Imitation Research in Children with Autism: Issues of Definition and Methodology

    Science.gov (United States)

    Sevlever, Melina; Gillis, Jennifer M.

    2010-01-01

    Several authors have suggested that children with autism are impaired in their ability to imitate others. However, diverse methodologies, contradictory findings, and varying theoretical explanations continue to exist in the literature despite decades of research. A comprehensive account of imitation in children with autism is hampered by the lack…

  11. Methodological Issues in Documentary Ethnography: A Renewed Call for Putting Cameras in the Hands of the People.

    Science.gov (United States)

    Huesca, Robert

    The participatory method of image production holds enormous potential for communication and journalism scholars operating out of a critical/cultural framework. The methodological potentials of mechanical reproduction were evident in the 1930s, when Walter Benjamin contributed three enduring concepts: questioning the art/document dichotomy; placing…

  12. Exploring the Society-Body-School Nexus: Theoretical and Methodology Issues in the Study of Body Pedagogics

    Science.gov (United States)

    Shilling, Chris

    2010-01-01

    In this article I identify how developments in consumer culture, waged-work and health policy have informed our current interest in the body, before suggesting that Durkheim's and Mauss's methodological approach towards the external and internal dimensions of "social facts" provides us with a valuable basis on which we can analyse the…

  13. Predictors of clinical outcome in total hip and knee replacement : a methodological appraisal of implants and patient factors

    NARCIS (Netherlands)

    Keurentjes, Johan Christiaan

    2014-01-01

    In this thesis, we studied both implants and patient and surgeon factors as predictors of clinical outcome after total hip and knee replacement. Additionally, we studied a number of methodological aspects of orthopaedic research, such as competing risks in estimating the probability of revision

  14. Regional Issue Identification and Assessment Program (RIIA). A methodology for analyzing the short-term air quality impacts of new power plants: issue paper 5

    Energy Technology Data Exchange (ETDEWEB)

    Lipfert, F.W.

    1979-07-01

    A simplified methodology is presented, based on Gaussian plume relationships, which could be used to assess regulatory constraints and vegetation damage for new power plants. Data input requirements include: (a) power plant size (MW), (b) fuel type, sulfur content, and level of control, and (c) nearby terrain elevation difference, with respect to stack base, for critical receptors. Based on sample calculations the 24-hour PSD increment is seen to be the most restrictive, using the ASME dispersion coefficients. An 800-MW plant (which is close to the optimum size from cost and reliability considerations according to a recent analysis), could be forced to reduce emissions below the levels assumed in this paper if adverse conditions were encountered. For example, terrain features higher than about 300 m at the critical distance from the plant could be restrictive, as could sufficiently persistent winds that would confine 24-hour plume spreading to <10/sup 0/.

  15. Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

    Science.gov (United States)

    Kalil, Andre C; Sun, Junfeng

    2014-10-01

    To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

  16. The changing training needs of clinical nurse managers: exploring issues for continuing professional development.

    Science.gov (United States)

    Gould, D; Kelly, D; Goldstone, L; Maidwell, A

    2001-04-01

    To identify areas where clinical nurse managers perceived that they would benefit from further training and to make recommendations for planning future programmes to meet their needs. The effectiveness of the clinical nurse manager has traditionally been associated with maintaining standards of care. Continuing professional development (CPD) is essential to ensure this important group feel adequately prepared to perform their role and has been recognized as an important factor in maintaining job satisfaction and reducing wasteful staff turnover. A review of the literature indicated that since the 1980s the CPD needs of clinical nurse managers have tended to be overlooked despite increasing complexity of the tasks expected of them. Thus it appeared that a fresh study to address these needs would be justified and should take into account sources of work-related stress and variables relating to job satisfaction. The study involved clinical nurse managers employed in all four acute hospital National Health Service (NHS) trusts where training needs were served by a major inner city educational consortium. Data collection proceeded in two stages. Initially interviews were undertaken with a random sample of 15 clinical nurse managers to provide in-depth, qualitative data. This information was used to develop a survey questionnaire distributed to the remaining 182 clinical nurse managers in each of the trusts. Data from the interviews indicated that clinical nurse managers appeared to feel clinically competent but generally experienced lack of confidence when dealing with a range of issues, in particular; human resources, managing budgets, deputizing for senior colleagues across the trust ('acting up') and using information technology in everyday practice. Response rate to the survey was good (65%). The results corroborated the interview findings, indicating a need for updating in the same wide range of topics. There were few differences in training needs across all four

  17. Assessment of clinical practice guideline methodology for the treatment of knee osteoarthritis with intra-articular hyaluronic acid.

    Science.gov (United States)

    Altman, Roy D; Schemitsch, Emil; Bedi, Asheesh

    2015-10-01

    Clinical practice guidelines are of increasing importance in the decision making for the treatment of knee osteoarthritis. Inconsistent recommendations regarding the use of intra-articular hyaluronic acid for the treatment of knee osteoarthritis have led to confusion among treating physicians. Literature search to identify clinical practice guidelines that provide recommendations regarding the use of intra-articular hyaluronic acid treatment for knee osteoarthritis was conducted. Included guidelines were appraised using the AGREE II instrument. Guideline development methodologies, how the results were assessed, the recommendation formation, and work group composition were summarized. Overall, 10 clinical practice guidelines were identified that met our inclusion criteria. AGREE II domain scores were variable across the included guidelines. The methodology utilized across the guidelines was heterogeneous regarding the evidence inclusion criteria, analysis of evidence results, formulation of clinical practice recommendations, and work group composition. The recommendations provided by the guidelines for intra-articular hyaluronic acid treatment for knee osteoarthritis are highly inconsistent as a result of the variability in guideline methodology. Overall, 30% of the included guidelines recommended against the use of intra-articular hyaluronic acid in the treatment of knee osteoarthritis, while 30% deemed the treatment an appropriate intervention under certain scenarios. The remaining 40% of the guidelines provided either an uncertain recommendation or no recommendation at all, based on the high variability in reviewed evidence regarding efficacy and trial quality. There is a need for a standard "appropriate methodology" that is agreed upon for osteoarthritis clinical practice guidelines in order to prevent the development of conflicting recommendations for intra-articular hyaluronic acid treatment for knee osteoarthritis, and to assure that treating physicians who

  18. Neurofeedback: A Comprehensive Review on System Design, Methodology and Clinical Applications

    Science.gov (United States)

    Marzbani, Hengameh; Marateb, Hamid Reza; Mansourian, Marjan

    2016-01-01

    Neurofeedback is a kind of biofeedback, which teaches self-control of brain functions to subjects by measuring brain waves and providing a feedback signal. Neurofeedback usually provides the audio and or video feedback. Positive or negative feedback is produced for desirable or undesirable brain activities, respectively. In this review, we provided clinical and technical information about the following issues: (1) Various neurofeedback treatment protocols i.e. alpha, beta, alpha/theta, delta, gamma, and theta; (2) Different EEG electrode placements i.e. standard recording channels in the frontal, temporal, central, and occipital lobes; (3) Electrode montages (unipolar, bipolar); (4) Types of neurofeedback i.e. frequency, power, slow cortical potential, functional magnetic resonance imaging, and so on; (5) Clinical applications of neurofeedback i.e. treatment of attention deficit hyperactivity disorder, anxiety, depression, epilepsy, insomnia, drug addiction, schizophrenia, learning disabilities, dyslexia and dyscalculia, autistic spectrum disorders and so on as well as other applications such as pain management, and the improvement of musical and athletic performance; and (6) Neurofeedback softwares. To date, many studies have been conducted on the neurofeedback therapy and its effectiveness on the treatment of many diseases. Neurofeedback, like other treatments, has its own pros and cons. Although it is a non-invasive procedure, its validity has been questioned in terms of conclusive scientific evidence. For example, it is expensive, time-consuming and its benefits are not long-lasting. Also, it might take months to show the desired improvements. Nevertheless, neurofeedback is known as a complementary and alternative treatment of many brain dysfunctions. However, current research does not support conclusive results about its efficacy. PMID:27303609

  19. Mesh fixation in endoscopic inguinal hernia repair: evaluation of methodology based on a systematic review of randomised clinical trials.

    Science.gov (United States)

    Lederhuber, Hans; Stiede, Franziska; Axer, Stephan; Dahlstrand, Ursula

    2017-11-01

    The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned. PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life. Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions. High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.

  20. Dental Students' Perceived Clinical Competence in Prosthodontics: Comparison of Traditional and Problem-Based Learning Methodologies.

    Science.gov (United States)

    Montero, Javier; Dib, Abraham; Guadilla, Yasmina; Flores, Javier; Santos, Juan Antonio; Aguilar, Rosa Anaya; Gómez-Polo, Cristina

    2018-02-01

    The aim of this study was to compare the perceived competence for treating prosthodontic patients of two samples of fourth-year dental students: those educated using traditional methodologies and those educated using problem-based learning (PBL). Two cohorts of fourth-year dental students at a dental school in Spain were surveyed: the traditional methods cohort (n=46) was comprised of all students in academic years 2012 and 2013, and the PBL cohort (n=57) was comprised of all students in academic years 2014 and 2015. Students in both cohorts reported the number of prosthodontic treatments they carried out per year and their perceived level of competence in performing such treatments. The results showed that the average number of treatments performed was similar for the two cohorts, except the number of metal-based removable partial dentures was significantly higher for students in the traditional (0.8±1.0) than the PBL (0.4±0.6) cohort. The level of perceived competence to treat complete denture patients for the combined cohorts was significantly higher (7.3±1.1) than that for partial acrylic dentures (6.7±1.5) and combined dentures (5.7±1.3). Students' clinical competence in prosthodontics mainly depended on number of treatments performed as the operator as well as the assistant. Students in the traditional methods cohort considered themselves to be significantly more competent at treating patients for removable partial and fixed prostheses (7.8±1.1 and 7.6±1.1, respectively) than did students in the PBL cohort (6.4±1.5 and 6.6±1.5, respectively). Overall, however, the study found that practical experiences were more important than the teaching method used to achieve students' perceived competence.

  1. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Douglas H. Marin dos Santos

    2015-06-01

    Full Text Available The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA, aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov. We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

  2. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study.

    Science.gov (United States)

    Marin Dos Santos, Douglas H; Atallah, Álvaro N

    2015-01-01

    The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

  3. Creating and sharing clinical decision support content with Web 2.0: Issues and examples.

    Science.gov (United States)

    Wright, Adam; Bates, David W; Middleton, Blackford; Hongsermeier, Tonya; Kashyap, Vipul; Thomas, Sean M; Sittig, Dean F

    2009-04-01

    Clinical decision support is a powerful tool for improving healthcare quality and patient safety. However, developing a comprehensive package of decision support interventions is costly and difficult. If used well, Web 2.0 methods may make it easier and less costly to develop decision support. Web 2.0 is characterized by online communities, open sharing, interactivity and collaboration. Although most previous attempts at sharing clinical decision support content have worked outside of the Web 2.0 framework, several initiatives are beginning to use Web 2.0 to share and collaborate on decision support content. We present case studies of three efforts: the Clinfowiki, a world-accessible wiki for developing decision support content; Partners Healthcare eRooms, web-based tools for developing decision support within a single organization; and Epic Systems Corporation's Community Library, a repository for sharing decision support content for customers of a single clinical system vendor. We evaluate the potential of Web 2.0 technologies to enable collaborative development and sharing of clinical decision support systems through the lens of three case studies; analyzing technical, legal and organizational issues for developers, consumers and organizers of clinical decision support content in Web 2.0. We believe the case for Web 2.0 as a tool for collaborating on clinical decision support content appears strong, particularly for collaborative content development within an organization.

  4. Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study

    OpenAIRE

    Vinluan, Jessele; Retegan, Claudia; Chen, Andrew; Beiles, Charles Barry

    2014-01-01

    Objective Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved. Design This study used retrospectively analysed observational data from VASM. Clinical management issues between eight speci...

  5. Examining the Role of Mental Health and Clinical Issues within Talent Development

    Directory of Open Access Journals (Sweden)

    Andy eHill

    2016-01-01

    Full Text Available Although significant research supports the association between physical activity and mental wellbeing, current literature acknowledges that athletes are no less susceptible to mental illness than the general population. Despite welcomed initiatives aimed at improving mental health within elite sport, these programs often fail to target young athletes; an important concern given that the genesis of many mental illnesses are recognized to occur during this critical period. Given the importance of early intervention and effective treatment, and the potentially devastating consequences of clinical issues going undiagnosed, the implications for talent identification and development become obvious. With this in mind, this study sought to examine the range of mental health issues that may impact upon developing athletes and potential consequences for the development process, specific risk and protective factors associated with talent development, along with an examination of current practices concerning the identification of mental health issues in such environments. Qualitative interviews were conducted with purposively sampled clinicians (n = 8 experienced in working with adolescents and/or young athletes. Inductive content analysis was undertaken, identifying four main themes: key behavioral indicators; associated risk factors; associated protective factors; and issues around identification and diagnosis. Key behavioral indicators included behavioral change, along with behaviors associated with eating disorders, anxiety and depression. Risk factors centered on family background, the performance environment, and issues surrounding adolescence. Protective factors were primarily social in nature. Finally, a lack of awareness and understanding of clinical issues, multiple causes of symptoms, non-disclosure and the need for triangulation of assessment were identified. The need for improved identification and intervention strategies was apparent, with

  6. Examining the Role of Mental Health and Clinical Issues within Talent Development.

    Science.gov (United States)

    Hill, Andy; MacNamara, Áine; Collins, Dave; Rodgers, Sheelagh

    2015-01-01

    Although significant research supports the association between physical activity and mental wellbeing, current literature acknowledges that athletes are no less susceptible to mental illness than the general population. Despite welcomed initiatives aimed at improving mental health within elite sport, these programs often fail to target young athletes; an important concern given that the genesis of many mental illnesses are recognized to occur during this critical period. Given the importance of early intervention and effective treatment, and the potentially devastating consequences of clinical issues going undiagnosed, the implications for talent identification and development (TID) become obvious. With this in mind, this study sought to examine the range of mental health issues that may impact upon developing athletes and potential consequences for the development process, specific risk and protective factors associated with talent development, along with an examination of current practices concerning the identification of mental health issues in such environments. Qualitative interviews were conducted with purposively sampled clinicians (n = 8) experienced in working with adolescents and/or young athletes. Inductive content analysis was undertaken, identifying four main themes: key behavioral indicators; associated risk factors; associated protective factors; and issues around identification and diagnosis. Key behavioral indicators included behavioral change, along with behaviors associated with eating disorders, anxiety and depression. Risk factors centered on family background, the performance environment, and issues surrounding adolescence. Protective factors were primarily social in nature. Finally, a lack of awareness and understanding of clinical issues, multiple causes of symptoms, non-disclosure and the need for triangulation of assessment were identified. The need for improved identification and intervention strategies was apparent, with coaches

  7. Examining the Role of Mental Health and Clinical Issues within Talent Development

    Science.gov (United States)

    Hill, Andy; MacNamara, Áine; Collins, Dave; Rodgers, Sheelagh

    2016-01-01

    Although significant research supports the association between physical activity and mental wellbeing, current literature acknowledges that athletes are no less susceptible to mental illness than the general population. Despite welcomed initiatives aimed at improving mental health within elite sport, these programs often fail to target young athletes; an important concern given that the genesis of many mental illnesses are recognized to occur during this critical period. Given the importance of early intervention and effective treatment, and the potentially devastating consequences of clinical issues going undiagnosed, the implications for talent identification and development (TID) become obvious. With this in mind, this study sought to examine the range of mental health issues that may impact upon developing athletes and potential consequences for the development process, specific risk and protective factors associated with talent development, along with an examination of current practices concerning the identification of mental health issues in such environments. Qualitative interviews were conducted with purposively sampled clinicians (n = 8) experienced in working with adolescents and/or young athletes. Inductive content analysis was undertaken, identifying four main themes: key behavioral indicators; associated risk factors; associated protective factors; and issues around identification and diagnosis. Key behavioral indicators included behavioral change, along with behaviors associated with eating disorders, anxiety and depression. Risk factors centered on family background, the performance environment, and issues surrounding adolescence. Protective factors were primarily social in nature. Finally, a lack of awareness and understanding of clinical issues, multiple causes of symptoms, non-disclosure and the need for triangulation of assessment were identified. The need for improved identification and intervention strategies was apparent, with coaches

  8. On Instructional Utility, Statistical Methodology, and the Added Value of ECD: Lessons Learned from the Special Issue

    Science.gov (United States)

    Nelson, Brian; Nugent, Rebecca; Rupp, Andre A.

    2012-01-01

    This special issue of "JEDM" was dedicated to bridging work done in the disciplines of "educational and psychological assessment" and "educational data mining" (EDM) via the assessment design and implementation framework of "evidence-centered design" (ECD). It consisted of a series of five papers: one…

  9. Consistent assignment of nursing staff to residents in nursing homes: a critical review of conceptual and methodological issues.

    Science.gov (United States)

    Roberts, Tonya; Nolet, Kimberly; Bowers, Barbara

    2015-06-01

    Consistent assignment of nursing staff to residents is promoted by a number of national organizations as a strategy for improving nursing home quality and is included in pay for performance schedules in several states. However, research has shown inconsistent effects of consistent assignment on quality outcomes. In order to advance the state of the science of research on consistent assignment and inform current practice and policy, a literature review was conducted to critique conceptual and methodological understandings of consistent assignment. Twenty original research reports of consistent assignment in nursing homes were found through a variety of search strategies. Consistent assignment was conceptualized and operationalized in multiple ways with little overlap from study to study. There was a lack of established methods to measure consistent assignment. Methodological limitations included a lack of control and statistical analyses of group differences in experimental-level studies, small sample sizes, lack of attention to confounds in multicomponent interventions, and outcomes that were not theoretically linked. Future research should focus on developing a conceptual understanding of consistent assignment focused on definition, measurement, and links to outcomes. To inform current policies, testing consistent assignment should include attention to contexts within and levels at which it is most effective. Published by Oxford University Press on behalf of the Gerontological Society of America 2013.

  10. New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials.

    Science.gov (United States)

    Verma, Nishant; Beretvas, S Natasha; Pascual, Belen; Masdeu, Joseph C; Markey, Mia K

    2015-11-12

    As currently used, the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) has low sensitivity for measuring Alzheimer's disease progression in clinical trials. A major reason behind the low sensitivity is its sub-optimal scoring methodology, which can be improved to obtain better sensitivity. Using item response theory, we developed a new scoring methodology (ADAS-CogIRT) for the ADAS-Cog, which addresses several major limitations of the current scoring methodology. The sensitivity of the ADAS-CogIRT methodology was evaluated using clinical trial simulations as well as a negative clinical trial, which had shown an evidence of a treatment effect. The ADAS-Cog was found to measure impairment in three cognitive domains of memory, language, and praxis. The ADAS-CogIRT methodology required significantly fewer patients and shorter trial durations as compared to the current scoring methodology when both were evaluated in simulated clinical trials. When validated on data from a real clinical trial, the ADAS-CogIRT methodology had higher sensitivity than the current scoring methodology in detecting the treatment effect. The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage. This provides a boost to the efficiency of clinical trials requiring fewer patients and shorter durations for investigating disease-modifying treatments.

  11. Quality of methodological reporting of randomized clinical trials of sodium-glucose cotransporter-2 (sglt2 inhibitors

    Directory of Open Access Journals (Sweden)

    Hadeel Alfahmi

    2017-01-01

    Full Text Available Sodium-glucose cotransporter-2 (SGLT2 inhibitors are a new class of medicines approved recently for the treatment of type 2 diabetes. To improve the quality of randomized clinical trial (RCT reports, the Consolidated Standards of Reporting Trials (CONSORT statement for methodological features was created. For achieving our objective in this study, we assessed the quality of methodological reporting of RCTs of SGLT2 inhibitors according to the 2010 CONSORT statement. We reviewed and analyzed the methodology of SGLT2 inhibitors RCTs that were approved by the Food & Drug Administration (FDA. Of the 27 trials, participants, eligibility criteria, and additional analyses were reported in 100% of the trials. In addition, trial design, interventions, and statistical methods were reported in 96.3% of the trials. Outcomes were reported in 93.6% of the trials. Settings were reported in 85.2% of the trials. Blinding and sample size were reported in 66.7 and 59.3% of the trials, respectively. Sequence allocation and the type of randomization were reported in 63 and 74.1% of the trials, respectively. Besides those, a few methodological items were inadequate in the trials. Allocation concealment was inadequate in most of the trials. It was reported only in 11.1% of the trials. The majority of RCTs have high percentage adherence for more than half of the methodological items of the 2010 CONSORT statement.

  12. Methodological issues involved in conducting qualitative research on support for nurses directly involved with women who chose to terminate their pregnancy

    Directory of Open Access Journals (Sweden)

    Antoinette Gmeiner

    2001-11-01

    Full Text Available The purpose of this article is to describe the methodological issues involved in conducting qualitative research to explore and describe nurses’ experience of being directly involved with termination of pregnancies and developing guidelines for support for these nurses. Opsomming Die doel van hierdie artikel is om die metodologiese vraagstukke te beskryf rondom die uitvoer van kwalitatiewe navorsing waar verpleegkundiges se ervaring van hul direkte betrokkenheid by terminasie van swangerskap verken en beskryf is. *Please note: This is a reduced version of the abstract. Please refer to PDF for full text.

  13. Issues in recruiting community-dwelling stroke survivors to clinical trials: the AMBULATE trial.

    Science.gov (United States)

    Lloyd, Gemma; Dean, Catherine M; Ada, Louise

    2010-07-01

    Recruitment to clinical trials is often slow and difficult, with a growing body of research examining this issue. However there is very little work related to stroke. The aim of this study was to examine the success and efficiency of recruitment of community-dwelling stroke survivors over the first two years of a clinical trial aiming to improve community ambulation. Recruitment strategies fell into 2 broad categories: (i) advertisement (such as newspaper advertising and media releases), and (ii) referral (via hospital and community physiotherapists, a stroke liaison officer and other researchers). Records were kept of the number of people who were screened, were eligible and were recruited for each strategy. The recruitment target of 60 in the first two years was not met. 111 stroke survivors were screened and 57 were recruited (i.e., a recruitment rate of 51%). The most successful strategy was referral via hospital-based physiotherapists (47% of recruited participants) and the least successful were media release and local newspaper advertising. The referral strategies were all more efficient than any of the advertisement strategies. In general, recruitment was inefficient and costly in terms of human resources. Given that stroke research is underfunded, it is important to find efficient ways of recruiting stroke survivors to clinical trials. An Australian national database similar to other disease-specific data bases (such as the National Cancer Database) is under development. In the interim, recruiting for several clinical trials at once may increase efficiency.

  14. Forensic nurses' perceptions of labels of mental illness and personality disorder: clinical versus management issues.

    Science.gov (United States)

    Mason, T; Hall, R; Caulfied, M; Melling, K

    2010-03-01

    Anecdotally, forensic psychiatric nurses generally have a more negative perception of people diagnosed with a personality disorder and this negativity is focused more towards managing the behaviours rather than on treatment efficacy and clinical outcomes. This study reports on research carried out across the High, Medium and Low secure psychiatric services in the UK. One thousand two hundred questionnaires were distributed with a response rate of 34.6%. The results indicated a statistically significant difference across High (z = 9.69; P < or = 0.01), Medium (z = 11.06; P < or = 0.01) and Low (z= 9.57; P= 0.01) security with a focus on the management of people with a personality disorder using the Wilcoxon paired samples test. There was also a statistically significant difference in relation to a more clinical/treatment focus for those with a diagnosis of mental illness in Medium (z = 9.69; P < or = 0.01) and Low (z = 9.57; P < or = 0.01) security but not in the High security services. Finally, the results showed significant differences between High, Medium and Low security on each of the four scales of Personality Disorder Clinical-Personality Disorder Management and Mental Illness Clinical-Mental Illness Management. This raises issues of stigma, prejudice and discrimination and suggests a refocus on skills development, acquisition and application for those with a label of personality disorder.

  15. History, applications, methodological issues and perspectives for the use of environmental DNA (eDNA) in marine and freshwater environments.

    Science.gov (United States)

    Díaz-Ferguson, Edgardo E; Moyer, Gregory R

    2014-12-01

    Genetic material (short DNA fragments) left behind by species in nonliving components of the environment (e.g. soil, sediment, or water) is defined as environmental DNA (eDNA). This DNA has been previously described as particulate DNA and has been used to detect and describe microbial communities in marine sediments since the mid-1980's and phytoplankton communities in the water column since the early-1990's. More recently, eDNA has been used to monitor invasive or endangered vertebrate and invertebrate species. While there is a steady increase in the applicability of eDNA as a monitoring tool, a variety of eDNA applications are emerging in fields such as forensics, population and community ecology, and taxonomy. This review provides scientist with an understanding of the methods underlying eDNA detection as well as applications, key methodological considerations, and emerging areas of interest for its use in ecology and conservation of freshwater and marine environments.

  16. Everyday ethics issues in the outpatient clinical practice of pediatric residents.

    Science.gov (United States)

    Moon, Margaret; Taylor, Holly A; McDonald, Erin L; Hughes, Mark T; Carrese, Joseph A

    2009-09-01

    To describe the ethics issues that pediatric residents encounter during routine care in an outpatient teaching clinic. Qualitative study including in-depth interviews with pediatric residents and direct observation of interactions between preceptors and residents in a pediatric teaching clinic. The Johns Hopkins Harriet Lane Pediatric Primary Care Clinic, March 20 through April 11, 2006. A convenience sample including all pediatric faculty preceptors supervising at the clinic during the 19 half-day sessions that occurred during the observation period (N = 15) and the pediatric residents seeing patients during these clinic sessions (N = 50). Main Outcome Measure Field notes of preceptor-resident discussions about patient care were made and transcribed for qualitative analysis. Qualitative analysis of the ethics content of cases presented by residents in this pediatric teaching clinic identified 5 themes for categorizing ethics challenges: (1) promoting the child's best interests in complex and resource-poor home and social settings; (2) managing the therapeutic alliance with parents and caregivers; (3) protecting patient privacy and confidentiality; (4) balancing the dual roles of learner and health care provider; and (5) using professional authority appropriately. Qualitative analysis of the ethics content of directly observed preceptor-resident case discussions yielded a set of themes describing the ethics challenges facing pediatric residents. The themes are somewhat different from the lists of residents' ethics experiences developed using recall or survey methods and may be very different from the ideas usually included in hospital-based ethics discussions. This may have implications for improving ethics education during residency training.

  17. Methodological characteristics of academic clinical drug trials--a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005

    DEFF Research Database (Denmark)

    Berendt, Louise; Håkansson, Cecilia; Bach, Karin F

    2010-01-01

    The aim of this study was to investigate the temporal trends in characteristics of academic clinical drug trials. We here report characteristics on trial methodology.......The aim of this study was to investigate the temporal trends in characteristics of academic clinical drug trials. We here report characteristics on trial methodology....

  18. Methodology for Speech Assessment in the Scandcleft Project-An International Randomized Clinical Trial on Palatal Surgery

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth

    2009-01-01

    Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains......-sum and the overall rating of VPC was 78%. Conclusions: Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed...

  19. [The root of the deep and fast ongoing evolution of both structure and methodology of clinical research].

    Science.gov (United States)

    Tavazzi, Luigi

    2016-03-01

    The growing scientific knowledge and technology development are leading to radical changes in biological and medical research. The prevalent lines of development deal with a pragmatic evolution of controlled clinical trials, a massive diffusion of observational research, which is progressively incorporated in clinical practice, new models and designs of clinical research, the systematic use of information technology to build up vast networks of medical centers producing huge amounts of shared data to be managed through the big data methodology, personalized as well as precision medicine, a reshaped physician-patient relationship based on a co-working principle. All this is leading to profound changes in public health governance, a renewal of clinical epidemiology and prevention, a modified structure of several specific sectors of medical care, hopefully guided by scientific evidences. A few aspects of such an evolving picture are discussed in this article.

  20. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues

    Directory of Open Access Journals (Sweden)

    Gekas J

    2016-02-01

    Full Text Available Jean Gekas,1,2 Sylvie Langlois,3 Vardit Ravitsky,4 François Audibert,5 David Gradus van den Berg,6 Hazar Haidar,4 François Rousseau2,7 1Prenatal Diagnosis Unit, Department of Medical Genetics and Pediatrics, Faculty of Medicine, Université Laval, Québec City, QC, Canada; 2Department of Medical Biology, CHU de Québec, Québec City, QC, Canada; 3Department of Medical Genetics, University of British Columbia, Vancouver, BC, Canada; 4Bioethics Program, Department of Social and Preventive Medicine, School of Public Health, University of Montreal, Montreal, QC, Canada; 5Department of Obstetrics and Gynecology, Hospital Sainte-Justine, Montreal, QC, Canada; 6Department of Social and Preventive Medicine, Faculty of Medicine, Université Laval, Québec City, QC, Canada; 7Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Université Laval, Québec City, QC, Canada Abstract: Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women. Keywords: prenatal diagnosis, Down syndrome, non-invasive prenatal testing, cell-free fetal DNA, informed consent, reproductive autonomy

  1. The neuropsychology of cannabis and other substance use in schizophrenia: review of the literature and critical evaluation of methodological issues.

    Science.gov (United States)

    Coulston, Carissa M; Perdices, Michael; Tennant, Christopher C

    2007-11-01

    Research on the neuropsychology of substance use in schizophrenia has been steadily growing over the past decade. However, significant gaps remain in the knowledge of individual substances and their relationship to cognition in the schizophrenia spectrum disorders. Approximately 65 studies to date have directly examined this relationship. Of these, approximately 20 have focused on nicotine, 15 on alcohol, 10 on cocaine, three on stimulants/hallucinogens, one on benzodiazepines, 10 on polydrug abuse, and seven on cannabis. Research on cannabis is especially lacking, given that worldwide it is the most commonly used illicit drug in schizophrenia, is used at higher rates in schizophrenia than in the general population, and makes its own unique contribution to the onset and prognosis of schizophrenia. In the present paper an overview of the neuropsychology literature on substance use in schizophrenia is presented, with special emphasis on cannabis. This incorporates a discussion of the methodological limitations inherent in these studies, and range of potential confounding variables that were not considered or controlled, providing directions for future research into the cognitive correlates of cannabis and other substance use in schizophrenia.

  2. Methodology and Psychological Knowledge Issues in the Procedural Differentiation Sphere and the Evidence Doctrine: Problems of Theory and Legislation

    Directory of Open Access Journals (Sweden)

    Sergey S. Tsyganenko

    2016-09-01

    Full Text Available The paper is devoted to actual problems of the theory and legislation of the modern criminal trial based on provisions of differentiation of a procedural form. Its basic provisions belong also to questions of evidentiary activity. Characteristics of knowledge on criminal case will claim the psychological knowledge and categories included in the mechanism of legal regulation of criminal procedure activity. Key role is allocated for the principle of freedom of an assessment of proofs. In this case the assessment of proofs is carried out on internal belief. Historically it is connected with institute of jury trial and competitiveness. Both the principle of freedom of assessment of proofs, and many other provisions of the procedural theory and the legislation need interpretation and an explanation with use of modern psychological knowledge. At the same time in modern Russian criminal procedure as well as in foreign types of criminal trial the reduced summary or special procedural jurisdictions are actively applied. It means formation of the differentiated model of criminal legal proceedings at which there is a summary process. Simplification of an order of proof on a criminal case through a wide range of exceptions is characteristic of them that constitutes a theoretical and practical problem. At their decision it is necessary to use a modern arsenal of methodology and the theory, including new achievements in the field of psychological knowledge.

  3. Methodological issues about techniques for the spiking of standard OECD soil with nanoparticles: evidence of different behaviours

    International Nuclear Information System (INIS)

    Miglietta, Maria Lucia; Rametta, Gabriella; Manzo, Sonia; Salluzzo, Antonio; Rimauro, Juri; Francia, Girolamo Di

    2015-01-01

    The aim of this study is to investigate at what extent the results of standard nanoparticle (NP) toxicity testing methodologies are affected by the different exposure procedures on soil organisms. In this view, differences in physicochemical properties of ZnO NPs (<100 nm), ZnO bulk (<200 nm) and ionic Zinc (ZnCl 2 ) and their ecotoxicological potential toward Lepidium sativum were investigated with respect to three different spiking methods. Results show that the spiking procedures give homogeneous distribution of the testing nanomaterial in soil but the physicochemical and ecotoxicological properties of the testing species differ according to the spiking procedure. Dry spiking produced the highest ZnO solubility whereas spiking through dispersions of ZnO in water and in aqueous soil extracts produced the lowest. At the same time, the ecotoxic effects showed different trends with regard to the spiking route. The need for a definition of agreed methods concerning the NP spiking procedures is, therefore, urgent

  4. Towards a common disability assessment framework: theoretical and methodological issues for providing public services and benefits using ICF.

    Science.gov (United States)

    Francescutti, Carlo; Frattura, Lucilla; Troiano, Raffaella; Gongolo, Francesco; Martinuzzi, Andrea; Sala, Marina; Meucci, Paolo; Raggi, Alberto; Russo, Emanuela; Buffoni, Mara; Gorini, Giovanna; Conclave, Mario; Petrangeli, Agostino; Solipaca, Alessandro; Leonardi, Matilde

    2009-01-01

    To report on the preliminary results of an Italian project on the implementation of an ICF-based protocol for providing public services and benefits for persons with disabilities. The UN Convention on the Rights of persons with disabilities (UNC) was mapped to the ICF, and core elements were implemented in an ICF-based evaluation protocol. A person-environment interaction classification (PEIC) tree was also developed for defining evaluation outputs. The PEIC and the ICF-based protocol are the guideline and the data interpretation source, respectively, for providing public services and benefits. They enable to assign persons to different services, from surveillance and monitoring to facilitator provision or sustain over time, to barrier removal or to the reorganisation of environmental factors provision. A detailed description of the target intervention is made available through the implementation of a protocol, which points out the effect of personal support and other environmental factors. The detailed description of functioning and disability provided by our methodology can help policy makers and administrators in decision making, on the basis of a description of real needs, and in targeting person-tailored interventions.

  5. Methodological issues about techniques for the spiking of standard OECD soil with nanoparticles: evidence of different behaviours

    Energy Technology Data Exchange (ETDEWEB)

    Miglietta, Maria Lucia, E-mail: mara.miglietta@enea.it; Rametta, Gabriella; Manzo, Sonia; Salluzzo, Antonio; Rimauro, Juri; Francia, Girolamo Di [ENEA, Portici Technical Unit, C.R. Portici (Italy)

    2015-07-15

    The aim of this study is to investigate at what extent the results of standard nanoparticle (NP) toxicity testing methodologies are affected by the different exposure procedures on soil organisms. In this view, differences in physicochemical properties of ZnO NPs (<100 nm), ZnO bulk (<200 nm) and ionic Zinc (ZnCl{sub 2}) and their ecotoxicological potential toward Lepidium sativum were investigated with respect to three different spiking methods. Results show that the spiking procedures give homogeneous distribution of the testing nanomaterial in soil but the physicochemical and ecotoxicological properties of the testing species differ according to the spiking procedure. Dry spiking produced the highest ZnO solubility whereas spiking through dispersions of ZnO in water and in aqueous soil extracts produced the lowest. At the same time, the ecotoxic effects showed different trends with regard to the spiking route. The need for a definition of agreed methods concerning the NP spiking procedures is, therefore, urgent.

  6. [Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data].

    Science.gov (United States)

    de Lecuona, Itziar

    2018-05-31

    The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals.

    Science.gov (United States)

    Sippel, Daniel; Marckmann, Georg; Ndzie Atangana, Etienne; Strech, Daniel

    2015-01-01

    Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: "confidentiality and information", "interpersonal, relational and behavioral issues", "psychological strain of individuals", and "scarce resources"; B) meso level: "structural issues of medical institutions", "issues with private clinics", "challenges connected to the family", and "issues of education, training and competence"; and C) macro level: "influence of society, culture, religion and superstition", "applicability of western medicine", "structural issues on the political level", and "legal issues". Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into perspective. As many participants reported a lack of awareness of ethical issues amongst other health

  8. [Security Management in Clinical Laboratory Departments and Facilities: Current Status and Issues].

    Science.gov (United States)

    Ishida, Haku; Nakamura, Junji; Yoshida, Hiroshi; Koike, Masaru; Inoue, Yuji

    2014-11-01

    We conducted a questionnaire survey regarding the current activities for protecting patients' privacy and the security of information systems (IS) related to the clinical laboratory departments of university hospitals, certified training facilities for clinical laboratories, and general hospitals in Yamaguchi Prefecture. The response rate was 47% from 215 medical institutions, including three commercial clinical laboratory centers. The results showed that there were some differences in management activities among facilities with respect to continuing education, the documentation or regulation of operational management for paper records, electronic information, remaining samples, genetic testing, and laboratory information for secondary use. They were suggested to be caused by differences in functions between university and general hospitals, differences in the scale of hospitals, or whether or not hospitals have received accreditation or ISO 15189. Regarding the IS, although the majority of facilities had sufficiently employed the access control to IS, there was some room for improvement in the management of special cases such as VIPs and patients with HIV infection. Furthermore, there were issues regarding the login method for computers shared by multiple staff, the showing of the names of personnel in charge of reports, and the risks associated with direct connections to systems and the Internet and the use of portable media such as USB memory sticks. These results indicated that further efforts are necessary for each facility to continue self-assessment and make improvements.

  9. Faith-to-faith at the bedside: theological and ethical issues in ecumenical clinical chaplaincy.

    Science.gov (United States)

    Mellon, Brad F

    2003-04-01

    Chaplains who serve in a clinical context often minister to patients representing a wide variety of faiths. In order to offer the best pastoral care possible, the chaplain should first possess a set of personal theological convictions as a foundation for ministry. Second, he or she needs to be sensitive to the beliefs and practices of the patients. Third, it is vital to develop a relationship of acceptance and trust not only with patients under their care, but also with family members and caregivers as well. At times, situations will arise that are purely religious or theological. In a clinical setting, however, the questions and problems that arise more often are both theological and ethical. It is beneficial for the chaplain to be involved in an ethics committee, where the specifics of each case can be discussed, and staff can offer counsel to patients and their families. This study examines issues that chaplains face at the bedside, such as terminal care, life-prolonging treatments, dementia, persistent vegetative state, and euthanasia-assisted suicide. We will discover that those who are involved in clinical pastoral ministry will be called upon to be a comforter, mediator, educator, ethicist, and counselor.

  10. Redevelopment of the Arctic Area of Russia as an Objective of Systems Research and Special-Purpose Program Management Methodological Issues

    Directory of Open Access Journals (Sweden)

    Vladimir Nikolayevich Leksin

    2015-12-01

    Full Text Available The paper substantiates the methodological foundations of implementation of the rules and regulations of the development of the Arctic region of Russia, which relies on the hypothesis interpreting such development as the biggest integrated megaproject in the history of Russia. The substantiation involves both the project-oriented approach to identify the subject-matter of the research and the systems approach to assess the key opportunities of providing the integrative structure of the megaproject in the conditions of drastic differences between the areal components of the Arctic region, and to study the internal and external factors’ impact on the character, drivers and pace of the region redevelopment. The set of consistent methodological positions concerning their policy implementation by responsible governmental agencies in the foreseeable future of the Arctic is developed. The most important position involves the identification of the objective of the public administration of the Arctic region development as a systemically organized entity of multiple coordinated actions of the federal, regional and municipal authorities, corporations and civil society institutions integrated by the unique policy target and economic, social and infrastructure links. Implementation of the public administration requires the principles of systems approach, the reasonable trade-off between centralization, decentralization and continuity of governance focused exclusively on the Arctic issues. At the same time, the integration of the projects of the region’s areal components development to insure the common targets of the Arctic’s megaproject accompanied by the reconsideration of the earlier developed programs turns into a genuinely new methodological issue. In the article, recommendations to provide such integration are introduced.

  11. La Familia: methodological issues in the assessment of perinatal social support for Mexicanas living in the United States.

    Science.gov (United States)

    Clark, L

    2001-11-01

    Do Mexicanas receive social support from a close network of family and friends during the perinatal period? To answer this question, a longitudinal ethnographic study followed 28 urban Mexican-origin women living in the US from their last trimester of pregnancy through their first month post-partum. A total of 93 interviews with Mexicanas focused on health and social support. All of the women lived in a large western city in the US but varied in their acculturation and income levels. Analyses identified four social support themes from women's experience (the emic analysis) and four social support typologies from the researcher (etic) analyses. The kinds of support women described as emanating from their support networks were inductively identified as Helping with Daily Hassles, Showing Love and Understanding, Being There for Me, and My Family Failing Me. Approximately half of the women reported densely supportive networks. The other women were disconnected from their support networks, or dealt with antagonism or instability in their networks. Women's perceptions of social support differed from the judgements made by the researcher about received support. Specifically, women perceived more network members in the supportive category than did the researcher by a factor of 1.4, and fewer network members in the disconnected category by a factor of 0.7. From an emic perspective, women listed only half as many antagonistic network members compared to the etic analysis (a factor of 0.50). These emic/etic discrepancies complicate clinical assessment of social support, but suggest that data on social support should be collected as part of the clinical processes of perinatal risking. To enhance assessment of social support, a clinically relevant guide is proposed for use by practitioners caring for Mexicanas in the perinatal period.

  12. Clinical issues in the treatment of anxiety and depression in older adults with Parkinson's disease.

    Science.gov (United States)

    Pachana, Nancy A; Egan, Sarah J; Laidlaw, Ken; Dissanayaka, Nadeeka; Byrne, Gerard J; Brockman, Simone; Marsh, Rodney; Starkstein, Sergio

    2013-12-01

    A significant proportion of persons affected by Parkinson's disease (PD) are over age 65 years. Mental health issues are often less a focus of treatment in this population than physical manifestations of the illness. Anxiety or depression alone, as well as comorbid depression and anxiety, are underrecognized in patients with PD and are associated with deleterious effects on physical and interpersonal functioning, negatively impacting quality of life and well-being. We offer a brief overview of salient clinical points with respect to assessment and treatment approaches to enhance efficacy of the treatment of mental health symptoms in older adults with PD. Cognitive behavior therapy involves the patient learning to overcome behavioral avoidance associated with anxiety and challenge unhelpful negative cognitions. It is suggested that cognitive behavior therapy is an effective approach to treatment of anxiety and depression in PD and should be offered as a treatment to patients. © 2013 Movement Disorder Society.

  13. Ethical issues in recruitment of "healthy volunteers": study of a clinical research organisation in Hyderabad.

    Science.gov (United States)

    Krishna, Shilpa; Prasad, N Purendra

    2014-01-01

    This paper raises some of the ethical issues involved in the recruitment of healthy volunteers (HVs) by clinical research organizations (CROs) for bioavailability and bioequivalent (BA/BE) studies. It also explores the underlying reasons for the participation of the HVs and their interaction with the CROs. The findings are based on the data collected from 50 HVs participating in a BA/BE study conducted by a CRO in Hyderabad and from the key officials involved in it. The findings indicate the existence of various complex networks, throw some light on the role of middlemen ("Anna") and the negotiation process, and give us an insight into the social norms and values that compelled the HVs to participate in the study. The paper offers a critical analysis of a few ethical concerns.

  14. Managing ethical issues in patient care and the need for clinical ethics support.

    Science.gov (United States)

    Doran, Evan; Fleming, Jennifer; Jordens, Christopher; Stewart, Cameron L; Letts, Julie; Kerridge, Ian H

    2015-02-01

    To investigate the range, frequency and management of ethical issues encountered by clinicians working in hospitals in New South Wales (NSW), Australia. A cross-sectional survey was conducted of a convenience sample of 104 medical, nursing and allied health professionals in two NSW hospitals. Some respondents did not provide data for some questions, therefore the denominator is less than 105 for some items. Sixty-two (62/104; 60%) respondents reported occasionally to often having ethical concerns. Forty-six (46/105; 44%) reported often to occasionally having legal concerns. The three most common responses to concerns were: talking to colleagues (96/105; 91%); raising the issue in a group forum (68/105; 65%); and consulting a relevant guideline (64/105; 61%). Most respondents were highly (65/99; 66%) or moderately (33/99; 33%) satisfied with the ethical environment of the hospital. Twenty-two (22/98; 22%) were highly satisfied with the ethical environment of their department and 74 (74/98; 76%) were moderately satisfied. Most (72/105; 69%) respondents indicated that additional support in dealing with ethical issues would be helpful. Clinicians reported frequently experiencing ethical and legal uncertainty and concern. They usually managed this by talking with colleagues. Although this approach was considered adequate, and the ethics of their hospital was reported to be satisfactory, most respondents indicated that additional assistance with ethical and legal concerns would be helpful. Clinical ethics support should be a priority of public hospitals in NSW and elsewhere in Australia.

  15. Behavioral and pharmacological treatment methods for pregnant smokers: issues for clinical practice.

    Science.gov (United States)

    Windsor, R; Oncken, C; Henningfield, J; Hartmann, K; Edwards, N

    2000-01-01

    Active and passive exposure to tobacco smoke are the most serious and preventable causes of poor maternal, fetal, and infant outcomes in the United States. Unfortunately, the majority of pregnant smokers do not quit smoking before or during pregnancy or after childbirth. We describe a standardized behavioral counseling model and discuss issues to consider in recommending the use of pharmacotherapy during pregnancy. Although the Food and Drug Administration no longer classifies nicotine replacement therapy (NRT) as contraindicated during pregnancy, precautions should be carefully considered for use in this population. This paper provides a synopsis of the risks of exposure to tobacco smoke during pregnancy and the postpartum; estimates the population at risk and the potential for increased cessation if effective health education methods during pregnancy were routinely provided; presents a meta-analysis of "best practice" patient education methods for pregnant smokers; and estimates the number of pregnant heavy smokers who might be eligible for NRT. We suggest five issues for the physician to consider before recommending NRT medications to pregnant patients who are heavy smokers. The judicious use of NRT medications may significantly reduce harm to the infants of heavy smokers. More evidence derived from large population-based research, however, is needed to provide guidance to the physician about NRT eligibility, dose, scheduling, and effectiveness in clinical practice.

  16. Methodological issues of optimization the sanitary-educational assistance for children with asthma during the health care reform of Ukraine

    Directory of Open Access Journals (Sweden)

    S. N. Nedelskaya

    2013-08-01

    Full Text Available Entry. Asthma remains the medical, social, economic issue of the day of modern society and industry of health protection. Research works on questions asthma are sanctified to mainly the improvement of diagnostics and treatment of asthma and a sanitary-educational help is underestimated. In the modern terms of structural alteration of network of establishments of health care in Ukraine a sanitary-educational help must be an effective complex in strategy of therapy of patients with asthma. Research aim. To ground importance, modern forms and methods of sanitary -educational help in providing of control above asthma on the stage of structural reorganization of establishments of health care in Ukraine. Materials and research methods. Scientifically-methodical literature was analyzed on general questions of organization and realization of sanitary-educational work in asthma. Long-term of own experience of realization of this work is generalized in the conditions of stationary treatment of patients with asthma. Research results. Sanitary-educational work in a form of education in the program "Asthma school". General practitioner, as a key figure of establishments of primary medical and sanitary help, must own the psychological methods including medical-psychology programs of before- and after graduation medical education. Conclusions. In providing of effective control above bronchial asthma in children a sanitary-educational help must be logical continuation and addition of curative help. Application of the educational programs and volume of work of doctors at their implementation must be legislatively lighted up in "Protocols of diagnostics and treatment of bronchial asthma for children".

  17. Clinical decision support systems in hospital care using ubiquitous devices: Current issues and challenges.

    Science.gov (United States)

    Baig, Mirza Mansoor; GholamHosseini, Hamid; Moqeem, Aasia A; Mirza, Farhaan; Lindén, Maria

    2017-11-01

    Supporting clinicians in decision making using advanced technologies has been an active research area in biomedical engineering during the past years. Among a wide range of ubiquitous systems, smartphone applications have been increasingly developed in healthcare settings to help clinicians as well as patients. Today, many smartphone applications, from basic data analysis to advanced patient monitoring, are available to clinicians and patients. Such applications are now increasingly integrating into healthcare for clinical decision support, and therefore, concerns around accuracy, stability, and dependency of these applications are rising. In addition, lack of attention to the clinicians' acceptability, as well as the low impact on the medical professionals' decision making, are posing more serious issues on the acceptability of smartphone applications. This article reviews smartphone-based decision support applications, focusing on hospital care settings and their overall impact of these applications on the wider clinical workflow. Additionally, key challenges and barriers of the current ubiquitous device-based healthcare applications are identified. Finally, this article addresses current challenges, future directions, and the adoption of mobile healthcare applications.

  18. Quantification and Management of Manifest Occlusal Caries Lesions in Adults: A Methodological and a Clinical Study

    DEFF Research Database (Denmark)

    Bakhshandeh, Azam

    2010-01-01

    teeth with primary occlusal lesions. Randomization was performed in cases of more than one lesion in the same patient, so that the final material consisted of 60 resin sealed and 12 restored lesions. After 2-3 years, there was a drop-out of 15%; 2 patients did not show up for the control and 9...... extension of the lesions from baseline and the last control radiograph, there was scored caries progression beneath 5 (10%) of 49 sealants, caries regression beneath 1 (2%) sealant and unchanged lesion depth beneath 43 (88%) sealants and all restorations (p = 0.64). The methodological study included 110...

  19. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

    DEFF Research Database (Denmark)

    Dellson, P; Nilbert, M; Bendahl, P-O

    2011-01-01

    for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about......Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used...... the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials....

  20. Methodological issues in protein and lipidic expressions in brain tissue exposed to Co{sup 60} based on DESI/MALDI-MS

    Energy Technology Data Exchange (ETDEWEB)

    Soares, Matheus F.; Campos, Tarcísio P.R.; Augusti, Rodinei, E-mail: matheus.soares@gmail.com, E-mail: tprcampos@pq.cnpq.br, E-mail: augusti.rodinei@gmail.com, E-mail: augusti@ufmg.br [Universidade Federal de Minas Gerais (UFMG), Belo Horizonte (Brazil); Eberlin, Marcos N.; Vendramini, Pedro H., E-mail: eberlin@iqm.unicamp.br, E-mail: ph_vendramini@yahoo.com.br [Universidade de Campinas (UNICAMP), SP (Brazil). Thompson Mass Spectroscopy Laboratory

    2017-07-01

    The present paper attempts to present some issues in the methodology of identifying lipid and protein changes in brain tissue induced by radiation. The goal was to address the analysis of the methodology and to investigate the feasibility of the generation of lipid/protein profiles of irradiated brain tissue, in order to identify radioinduced changes. Lipids and proteins are biomolecules with diverse structures and functionalities that participate in important intracellular processes. Changes in the lipid and the tissue protein profiles may indicate a cellular response to an external stimulus as well as the emergence of neoplasms or neurodegenerative diseases such as Alzheimer's. DESI-MS is a convenient method for identifying lipids and their spatial distribution in tissue beyond analytical quantification. DESI-MS allows the creation of an image of several low lipid m/z classes. MALDI-MS has already been a method used in the study of macromolecules as structural, membrane, hormone, neuromediator and immunological peptides. Through a full-scan matrix scan, with a m/z spectrum between 500-1000 for lipids and with a mass spectrum of 1000-15000 Da for proteins, the molecular profile can be analyzed. Generated pixel shape 2D chemical image. The produced image allows to associate the tissue distribution of the lipids and proteins with their chemical profile identified, allowing the verification of the changes radioinduced. Radiation triggers intense oxidative stress by increasing reactive oxygen species (ROS) and free radicals, causing DNA damage with consequent alterations in proteomics and cellular lipid explaining such changes in the lipid and protein expressions. The cellular morphophysiological changes are responsible for both the clonogenic inhibition and the induction of the apoptotic process. The images's production was directly dependent on the rigorous execution of the methodological procedures. Innumerable interferences could impair the image

  1. Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations.

    Science.gov (United States)

    Sarris, Jerome; Lake, James; Hoenders, Rogier

    2011-10-01

    Bipolar disorder (BD) is a debilitating syndrome that is often undiagnosed and undertreated. Population surveys show that persons with BD often self-medicate with complementary and alternative medicine (CAM) or integrative therapies in spite of limited research evidence supporting their use. To date, no review has focused specifically on nonconventional treatments of BD. The study objectives were to present a review of nonconventional (complementary and integrative) interventions examined in clinical trials on BD, and to offer provisional guidelines for the judicious integrative use of CAM in the management of BD. PubMed, CINAHL,(®) Web of Science, and Cochrane Library databases were searched for human clinical trials in English during mid-2010 using Bipolar Disorder and CAM therapy and CAM medicine search terms. Effect sizes (Cohen's d) were also calculated where data were available. Several positive high-quality studies on nutrients in combination with conventional mood stabilizers and antipsychotic medications in BD depression were identified, while branched-chain amino acids and magnesium were effective (small studies) in attenuating mania in BD. In the treatment of bipolar depression, evidence was mixed regarding omega-3, while isolated studies provide provisional support for a multinutrient formula, n-acetylcysteine, and l-tryptophan. In one study, acupuncture was found to have favorable but nonsignificant effects on mania and depression outcomes. Current evidence supports the integrative treatment of BD using combinations of mood stabilizers and select nutrients. Other CAM or integrative modalities used to treat BD have not been adequately explored to date; however, some early findings are promising. Select CAM and integrative interventions add to established conventional treatment of BD and may be considered when formulating a treatment plan. It is hoped that the safety issues and clinical considerations addressed in this article may encourage the practice

  2. Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals

    Science.gov (United States)

    Sippel, Daniel; Marckmann, Georg; Ndzie Atangana, Etienne; Strech, Daniel

    2015-01-01

    Introduction Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. Materials and Methods In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Results Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: “confidentiality and information”, “interpersonal, relational and behavioral issues”, “psychological strain of individuals”, and “scarce resources”; B) meso level: “structural issues of medical institutions”, “issues with private clinics”, “challenges connected to the family”, and “issues of education, training and competence”; and C) macro level: “influence of society, culture, religion and superstition”, “applicability of western medicine”, “structural issues on the political level”, and “legal issues”. Discussion Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into

  3. Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

    Science.gov (United States)

    Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

    2013-01-01

    Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

  4. Sensory action potentials of the maxillary nerve: a methodologic study with clinical implications

    DEFF Research Database (Denmark)

    Thygesen, Torben; Baad-Hansen, Lene; Svensson, Peter

    2009-01-01

    PURPOSE: Recently, recording of sensory nerve action potentials (SNAPs) of the inferior alveolar nerve (IAN) was described and is used as a diagnostic test of traumatic neuropathic trigeminal disorders. The technique is limited to IAN damage; therefore, we adapted the technique to the maxillary...... nerve, which is also frequently injured by either trauma or orthognathic surgery. PATIENTS AND METHODS: Fourteen healthy volunteers participated in this methodologic study in which the infraorbital nerve (ION) was stimulated with 2 needle electrodes. The SNAPs were recorded from the maxillary nerve...... difference. Repeated tests within a session test demonstrated no significant differences in the latency data (ANOVA: P= .225) or amplitude data (ANOVA: P= .44). Stimulus-response curves indicated that the SNAPs saturated at 5.1+/-4.4 mA stimulus intensity. In 1 subject, stimulation of the mental nerve...

  5. Consanguineous marriages in the genetic counseling centers of Isfahan and the ethical issues of clinical consultations.

    Science.gov (United States)

    Nouri, Narges; Nouri, Nayereh; Tirgar, Samane; Soleimani, Elham; Yazdani, Vida; Zahedi, Farzaneh; Larijani, Bagher

    2017-01-01

    Consanguineous marriage, which is common in many regions in the world, has absorbed much attention as a causative factor in raising the incidence of genetic diseases. The adverse effects may be attributed to the expression of the genes received from common ancestors and mortality and morbidity of the offspring. Iran has a high rate of consanguineous marriages. In recent years genetic counseling has come to be considered in health care services. This cross-sectional study was conducted in order to determine the prevalence and types of consanguineous marriages in the genetic clinics in Isfahan. We aimed to define the different types of marriages, specific categories of genetic disorders associated with consanguineous marriages, and mode of inheritance in the family tree. We also narratively reviewed the ethical aspects of the issue. The data were collected using a simple questionnaire. A total number of 1535 couples from urban and rural areas formed the study population. The marriages were classified according to the degree of the relationship between couples, including: double cousin, first cousin, first cousin once removed, second cousin and beyond second cousin. The SPSS software version 16 was used for data analysis. Data obtained through genetic counseling offered during a 5-year period revealed that 74.3% had consanguineous relationships, 62.3% were first cousins, 1% were double cousins and 7.8% were second cousins. In addition, 76% of the couples had at least one genetic disease in their family tree. Related ethical issues were also considered in this study, including autonomy and informed decision making, benefit and harm assessment, confidentiality, ethics in research, justice in access to counseling services, financial problems ethics, and the intellectual property of scientific success.

  6. Alpha-fetoprotein: methodology and clinical experiences with a new radioimmunoassay

    International Nuclear Information System (INIS)

    Lamerz, R.; Rjosk, H.; Schmalhorst, U.; Fateh-Moghadam, A.; Muenchen Univ.

    1976-01-01

    The clinical-diagnostical value of alpha-fetoproteins (AFP) compared with the use of common less sensitive methods was tested. The results obtained clearly showed that in the clinical-internal-surgical sphere the main importance of radioimmunological AFP-determinations lies in the improved supervision of the development of hepatomas in patients suffering from hepatic cirrhosis. In the pre-operative differential diagnosis of testicle tumors, these determinations help to optimize the therapeutic measures and are also useful for the case control of hepatoma and teratoma patients. (GSE) [de

  7. Outbreak!: Teaching Clinical and Diagnostic Microbiology Methodologies with an Interactive Online Game

    Science.gov (United States)

    Clark, Sherri; Smith, Geoffrey Battle

    2004-01-01

    Outbreak! is an online, interactive educational game that helps students and teachers learn and evaluate clinical microbiology skills. When the game was used in introductory microbiology laboratories, qualitative evaluation by students showed very positive responses and increased learning. Outbreak! allows students to design diagnostic tests and…

  8. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  9. Development and Application of a Clinical Microsystem Simulation Methodology for Human Factors-Based Research of Alarm Fatigue.

    Science.gov (United States)

    Kobayashi, Leo; Gosbee, John W; Merck, Derek L

    2017-07-01

    (1) To develop a clinical microsystem simulation methodology for alarm fatigue research with a human factors engineering (HFE) assessment framework and (2) to explore its application to the comparative examination of different approaches to patient monitoring and provider notification. Problems with the design, implementation, and real-world use of patient monitoring systems result in alarm fatigue. A multidisciplinary team is developing an open-source tool kit to promote bedside informatics research and mitigate alarm fatigue. Simulation, HFE, and computer science experts created a novel simulation methodology to study alarm fatigue. Featuring multiple interconnected simulated patient scenarios with scripted timeline, "distractor" patient care tasks, and triggered true and false alarms, the methodology incorporated objective metrics to assess provider and system performance. Developed materials were implemented during institutional review board-approved study sessions that assessed and compared an experimental multiparametric alerting system with a standard monitor telemetry system for subject response, use characteristics, and end-user feedback. A four-patient simulation setup featuring objective metrics for participant task-related performance and response to alarms was developed along with accompanying structured HFE assessment (questionnaire and interview) for monitor systems use testing. Two pilot and four study sessions with individual nurse subjects elicited true alarm and false alarm responses (including diversion from assigned tasks) as well as nonresponses to true alarms. In-simulation observation and subject questionnaires were used to test the experimental system's approach to suppressing false alarms and alerting providers. A novel investigative methodology applied simulation and HFE techniques to replicate and study alarm fatigue in controlled settings for systems assessment and experimental research purposes.

  10. Methodological issues in the use of individual brain measures to index trait liabilities: The example of noise-probe P3.

    Science.gov (United States)

    Perkins, Emily R; Yancey, James R; Drislane, Laura E; Venables, Noah C; Balsis, Steve; Patrick, Christopher J

    2017-01-01

    Recent research initiatives have called for an increased use of biological concepts and measures in defining and studying mental health problems, but important measurement-related challenges confront efforts in this direction. This article highlights some of these challenges with reference to an intriguing measure of neural reactivity: the probe P3 response, a mid-latency brain potential evoked by an intense, unexpected acoustic-probe stimulus. Using data for a large adult sample (N=418), we report evidence that amplitude of probe P3 response to unwarned noise bursts occurring in a picture-viewing task exhibits robust, independent associations with two distinct trait constructs: weak inhibitory control (or disinhibition; DIS) and threat sensitivity (THT). Additionally, we report a selective association for THT with attentional suppression of probe P3 response during viewing of aversive pictures compared to neutral. These results point to separable elements of variance underlying the probe P3 response, including one element reflecting DIS-related variations in cognitive-elaborative processing, and others reflecting THT-related variations in aversive foreground engagement and abrupt defensive reorientation. Key measurement issues are considered in relation to these specific findings, and methodological and statistical approaches for addressing these issues are discussed in relation to advancement of a quantitatively sound, biologically informed science of psychopathology. Copyright © 2016 Elsevier B.V. All rights reserved.

  11. Clinical review: Balancing the therapeutic, safety, and economic issues underlying effective antipseudomonal carbapenem use

    Science.gov (United States)

    Slama, Thomas G

    2008-01-01

    Antipseudomonal carbapenems have played a useful role in our antimicrobial armamentarium for 20 years. However, a review of their use during that period creates concern that their clinical effectiveness is critically dependent on attainment of an appropriate dosing range. Unfortunately, adequate carbapenem dosing is missed for many reasons, including benefit/risk misconceptions, a narrow therapeutic window for imipenem and meropenem (due to an increased rate of seizures at higher doses), increasingly resistant pathogens requiring higher doses than are typically given, and cost containment issues that may limit their use. To improve the use of carbapenems, several initiatives should be considered: increase awareness about appropriate treatment with carbapenems across hospital departments; determine optimal dosing regimens for settings where multidrug resistant organisms are more likely encountered; use of, or combination with, an alternative antimicrobial agent having more favorable pharmacokinetic, pharmacodynamic, or adverse event profile; and administer a newer carbapenem with lower propensity for resistance development (for example, reduced expression of efflux pumps or greater stability against carbapenemases). PMID:18983709

  12. Integrity, standards, and QC-related issues with big data in pre-clinical drug discovery.

    Science.gov (United States)

    Brothers, John F; Ung, Matthew; Escalante-Chong, Renan; Ross, Jermaine; Zhang, Jenny; Cha, Yoonjeong; Lysaght, Andrew; Funt, Jason; Kusko, Rebecca

    2018-06-01

    The tremendous expansion of data analytics and public and private big datasets presents an important opportunity for pre-clinical drug discovery and development. In the field of life sciences, the growth of genetic, genomic, transcriptomic and proteomic data is partly driven by a rapid decline in experimental costs as biotechnology improves throughput, scalability, and speed. Yet far too many researchers tend to underestimate the challenges and consequences involving data integrity and quality standards. Given the effect of data integrity on scientific interpretation, these issues have significant implications during preclinical drug development. We describe standardized approaches for maximizing the utility of publicly available or privately generated biological data and address some of the common pitfalls. We also discuss the increasing interest to integrate and interpret cross-platform data. Principles outlined here should serve as a useful broad guide for existing analytical practices and pipelines and as a tool for developing additional insights into therapeutics using big data. Copyright © 2018 Elsevier Inc. All rights reserved.

  13. Clinical, social and ethical issues associated with non-invasive prenatal testing for aneuploidy.

    Science.gov (United States)

    Griffin, Blanche; Edwards, Samantha; Chitty, Lyn S; Lewis, Celine

    2018-03-01

    Non-invasive prenatal testing (NIPT), based on analysis of cell-free foetal DNA, is rapidly becoming a preferred method to screen for chromosomal aneuploidy with the technology now available in over 90 countries. This review provides an up-to-date discussion of the key clinical, social and ethical implications associated with this revolutionary technology. Stakeholders are positive about a test that is highly accurate, safe, can be perfomed early in pregnancy, identifies affected pregnancies that might otherwise have been missed and reduces the need for invasive testing. Nevertheless, professional societies currently recommend it as an advanced screening test due to the low false positive rate (FPR). Despite the practical and psychological benefits, a number of concerns have been raised which warrant attention. These include the potential for routinisation of testing and subsequent impact on informed decision-making, an "easy" blood test inadvertently contributing to women feeling pressured to take the test, fears NIPT will lead to less tolerance and support for those living with Down syndrome and the heightened expectation of having "perfect babies". These issues can be addressed to some extent through clinician education, patient information and establishing national and international consensus in the development of comprehensive and regularly updated guidelines. As the number of conditions we are able to test for non-invasively expands it will be increasingly important to ensure pre-test counselling can be delivered effectively supported by knowledgeable healthcare professionals.

  14. Early indicators and risk factors for ethical issues in clinical practice.

    Science.gov (United States)

    Pavlish, Carol; Brown-Saltzman, Katherine; Hersh, Mary; Shirk, Marilyn; Nudelman, Olga

    2011-03-01

    Nurses in all clinical settings encounter ethical issues that frequently lead to moral distress. This critical incident study explored nurses' descriptions of ethically difficult situations to identify risk factors and early indicators of ethical conflicts. Employing the critical incident technique, researchers developed a questionnaire that collected information on ethically difficult situations, their risk factors and early indicators, nurse actions, and situational outcomes. Two nurse researchers independently analyzed and categorized data using a constant comparison technique. Most of the ethically difficult situations pertained to end-of-life care for children and adults. Conflicts in interpersonal relationships were prevalent. Nurses were especially moved by patient and family suffering and concerned about patient vulnerability, harm-benefit ratio, and patient autonomy. Researchers discovered risk factor categories for patients, families, healthcare providers, and health systems. Additionally, researchers found subcategories in six major categories of early indicators: signs of conflict, patient suffering, nurse distress, ethics violation, unrealistic expectations, and poor communication. Nurses are keenly aware of pertinent risk factors and early indicators of unfolding ethical conflicts. Many nurses reported feeling powerless in the face of ethical conflict. Research that develops interventions to strengthen nurses' voices in ethically difficult situation is warranted. Nurses are in a key position to identify patient situations with a high risk for ethical conflict. Initiating early ethics consultation and interventions can alter the course of pending conflicts and diminish the potential for patient and family suffering and nurses' moral distress. © 2011 Sigma Theta Tau International.

  15. Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

    Science.gov (United States)

    Loh, Winnie Y; Butow, Phyllis N; Brown, Richard F; Boyle, Frances

    2002-12-01

    Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. The issues raised by these data managers have important implications for the successful conduct of

  16. Issues Of Managerial Accounting Methodology

    OpenAIRE

    Barulina E.V; Barulina M.S

    2012-01-01

    This article deals with management accounting, its role and objectives during financial planning process. Research of on American, German and Russian scientists are also considered. Author formulates his own definitions of aims of management accounting, highlighters that object of financial accounting have to include economic costs, economic revenue and economic added value, economic interest. More  over Author defines methods of managment accounting.

  17. Transcranial direct current stimulation (tDCS in behavioral and food addiction: A systematic review of efficacy, technical and methodological issues

    Directory of Open Access Journals (Sweden)

    Anne eSauvaget

    2015-10-01

    Full Text Available Objectives.Behavioral addictions (BA are complex disorders for which pharmacological and psychotherapeutic treatments have shown their limits. Non-invasive brain stimulation, among which transcranial direct current stimulation (tDCS, has opened up new perspectives in addiction treatment. The purpose of this work is to conduct a critical and systematic review of tDCS efficacy, and of technical and methodological considerations in the field of BA.Methods.A bibliographic search has been conducted on the Medline and ScienceDirect databases until December 2014, based on the following selection criteria: clinical studies on tDCS and BA (namely eating disorders, compulsive buying, Internet addiction, pathological gambling, sexual addiction, sports addiction, video games addiction. Study selection, data analysis and reporting were conducted according to the PRISMA guidelines.Results.Out of 402 potential articles, seven studies were selected. So far focusing essentially on abnormal eating, these studies suggest that tDCS (right prefrontal anode / left prefrontal cathode reduces food craving induced by visual stimuli.ConclusionsDespite methodological and technical differences between studies, the results are promising. So far, only few studies of tDCS in BA have been conducted. New research is recommended on the use of tDCS in BA, other than eating disorders.

  18. Development and interval testing of a naturalistic driving methodology to evaluate driving behavior in clinical research.

    Science.gov (United States)

    Babulal, Ganesh M; Addison, Aaron; Ghoshal, Nupur; Stout, Sarah H; Vernon, Elizabeth K; Sellan, Mark; Roe, Catherine M

    2016-01-01

    Background : The number of older adults in the United States will double by 2056. Additionally, the number of licensed drivers will increase along with extended driving-life expectancy. Motor vehicle crashes are a leading cause of injury and death in older adults. Alzheimer's disease (AD) also negatively impacts driving ability and increases crash risk. Conventional methods to evaluate driving ability are limited in predicting decline among older adults. Innovations in GPS hardware and software can monitor driving behavior in the actual environments people drive in. Commercial off-the-shelf (COTS) devices are affordable, easy to install and capture large volumes of data in real-time. However, adapting these methodologies for research can be challenging. This study sought to adapt a COTS device and determine an interval that produced accurate data on the actual route driven for use in future studies involving older adults with and without AD.  Methods : Three subjects drove a single course in different vehicles at different intervals (30, 60 and 120 seconds), at different times of day, morning (9:00-11:59AM), afternoon (2:00-5:00PM) and night (7:00-10pm). The nine datasets were examined to determine the optimal collection interval. Results : Compared to the 120-second and 60-second intervals, the 30-second interval was optimal in capturing the actual route driven along with the lowest number of incorrect paths and affordability weighing considerations for data storage and curation. Discussion : Use of COTS devices offers minimal installation efforts, unobtrusive monitoring and discreet data extraction.  However, these devices require strict protocols and controlled testing for adoption into research paradigms.  After reliability and validity testing, these devices may provide valuable insight into daily driving behaviors and intraindividual change over time for populations of older adults with and without AD.  Data can be aggregated over time to look at changes

  19. Methodology of developing a smartphone application for crisis research and its clinical application.

    Science.gov (United States)

    Zhang, Melvyn W B; Ho, Cyrus S H; Fang, Pan; Lu, Yanxia; Ho, Roger C M

    2014-01-01

    Recent advancement in Internet based technologies have resulted in the growth of a sub-specialized field, termed as "Infodemiology" and "Infoveillance". Infoveillence refers to the collation of infodemiology measures for the purpose of surveillance and trending. Previous research has only demonstrated the research potential of Web 2.0 medium in collation of data in crisis situation. The objectives for the current study are to demonstrate the methodology of implementation of a smartphone-based application for dissemination and collation of information during a crisis situation. The Haze Smartphone application was developed using an online application builder and using HTML5 as the core programming language. A five-phase developmental method including a) formulation of user requirements, b) system design, c) system development, d) system evaluation and finally e) system application and implementation were adopted. The smartphone application was deployed during a one-week period via a self-sponsored Facebook post and via direct dissemination of the web-links by emails. A total of 298 respondents took part in the survey within the application. Most of them were between the ages of 20- to 29-years old and had a university education. More individuals preferred the option of accessing and providing feedback to a survey on physical and psychological wellbeing via direct access to a Web-based questionnaire. In addition, the participants reported a mean number of 4.03 physical symptoms (SD 2.6). The total Impact of Event Scale-Revised (IES-R) score was 18.47 (SD 11.69), which indicated that the study population did experience psychological stress but not posttraumatic stress disorder. The perceived dangerous Pollutant Standards Index (PSI) level and the number of physical symptoms were associated with higher IES-R Score (Psmartphone application could potentially be used to acquire research data in a crisis situation. However, it is crucial for future research to further

  20. Methodological approaches and magnitude of the clinical unmet need associated with amotivation in mood disorders.

    Science.gov (United States)

    Calabrese, Joseph R; Fava, Maurizio; Garibaldi, George; Grunze, Heinz; Krystal, Andrew D; Laughren, Thomas; Macfadden, Wayne; Marin, Robert; Nierenberg, Andrew A; Tohen, Mauricio

    2014-10-01

    There is growing research interest in studying motivational deficits in different neuropsychiatric disorders because these symptoms appear to be more common than originally reported and negatively impact long-term functional outcomes. However, there is considerable ambiguity in the terminology used to describe motivational deficits in the scientific literature. For the purposes of this manuscript, the term "amotivation" will be utilised in the context of mood disorders, since this is considered a more inclusive/appropriate term for this patient population. Other challenges impacting the study of amotivation in mood disorders, include: appropriate patient population selection; managing or controlling for potential confounding factors; the lack of gold-standard diagnostic criteria and assessment scales; and determination of the most appropriate study duration. This paper summarises the search for a consensus by a group of experts in the optimal approach to studying amotivation in mood disorders. The consensus of this group is that amotivation in mood disorders is a legitimate therapeutic target, given the magnitude of the associated unmet needs, and that proof-of-concept studies should be conducted in order to facilitate subsequent larger investigations. The focus of this manuscript is to consider the study of amotivation, as a residual symptom of major depressive disorder (MDD) or bipolar depression (BD), following adequate treatment with a typical antidepressant or mood stabiliser/antipsychotic, respectively. There is a paucity of data studying amotivation in mood disorders. This manuscript provides general guidance on the most appropriate study design(s) and methodology to assess potential therapeutic options for the management of residual amotivation in mood disorders. Copyright © 2014 Elsevier B.V. All rights reserved.

  1. Elderly Patients with Dementia-Related Symptoms of Severe Agitation and Aggression: Consensus Statement on Treatment Options, Clinical Trials Methodology, and Policy

    Science.gov (United States)

    Salzman, C; Jeste, D; Meyer, RE; Cohen-Mansfield, J; Cummings, J; Grossberg, G; Jarvik, L; Kraemer, H; Lebowitz, B; Maslow, K; Pollock, B; Raskind, M; Schultz, S; Wang, P; Zito, JM; Zubenko, GS

    2009-01-01

    Atypical antipsychotic drugs have been used off-label in clinical practice for treatment of serious dementia-associated agitation and aggression. Following reports of cerebrovascular adverse events associated with the use of atypical antipsychotic in elderly patients with dementia, the FDA issued black box warnings for several atypical antipsychotics, titled “Cerebrovascular Adverse Events, including Stroke, in Elderly Patients with Dementia.” Subsequently, the FDA initiated a meta-analysis of safety data from 17 registration trials across six antipsychotic drugs (five atypical antipsychotics and haloperidol). In 2005, the Agency issued a black box warning regarding increased risk of mortality associated with the use of atypical antipsychotic drugs in this patient population. Geriatric mental health experts participating in a 2006 consensus conference reviewed evidence on the safety and efficacy of antipsychotics, as well as nonpharmacologic approaches, in treating dementia-related symptoms of agitation and aggression. They concluded that, while problems in clinical trials design may have been one of the contributors to the failure to find a signal of drug efficacy, the findings related to drug safety should be taken seriously by clinicians in assessing the potential risks and benefits of treatment in a frail population, and in advising families about treatment. Information provided to patients and family members should be documented in the patient’s chart. Drugs should be used only when non-pharmacologic approaches have failed to adequately control behavioral disruption. Participants also agreed that that there is a need for an FDA-approved medication for the treatment of severe, persistent or recurrent dementia-related symptoms of agitation and aggression (even in the absence of psychosis), that are unresponsive to nonpharmacologic intervention. The authors have outlined methodological enhancements to better evaluate treatment approaches in future

  2. Difference in blood pressure measurements between arms: methodological and clinical implications.

    Science.gov (United States)

    Clark, Christopher E

    2015-01-01

    Differences in blood pressure measurements between arms are commonly encountered in clinical practice. If such differences are not excluded they can delay the diagnosis of hypertension and can lead to poorer control of blood pressure levels. Differences in blood pressure measurements between arms are associated cross sectionally with other signs of vascular disease such as peripheral arterial disease or cerebrovascular disease. Differences are also associated prospectively with increased cardiovascular mortality and morbidity and all cause mortality. Numbers of publications on inter-arm difference are rising year on year, indicating a growing interest in the phenomenon. The prevalence of an inter-arm difference varies widely between reports, and is correlated with the underlying cardiovascular risk of the population studied. Prevalence is also sensitive to the method of measurement used. This review discusses the prevalence of an inter-arm difference in different populations and addresses current best practice for the detection and the measurement of a difference. The evidence for clinical and for vascular associations of an inter-arm difference is presented in considering the emerging role of an inter-arm blood pressure difference as a novel risk factor for increased cardiovascular morbidity and mortality. Competing aetiological explanations for an inter-arm difference are explored, and gaps in our current understanding of this sign, along with areas in need of further research, are considered.

  3. Methodology Series Module 9: Designing Questionnaires and Clinical Record Forms - Part II.

    Science.gov (United States)

    Setia, Maninder Singh

    2017-01-01

    This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources.

  4. Methodology Series Module 9: Designing Questionnaires and Clinical Record Forms – Part II

    Science.gov (United States)

    Setia, Maninder Singh

    2017-01-01

    This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources. PMID:28584367

  5. Echo planar perfusion imaging with high spatial and temporal resolution: methodology and clinical aspects

    International Nuclear Information System (INIS)

    Bitzer, M.; Klose, U.; Naegele, T.; Friese, S.; Kuntz, R.; Voigt, K.; Fetter, M.; Opitz, H.

    1999-01-01

    The purpose of the present study was to analyse specific advantages of calculated parameter images and their limitations using an optimized echo-planar imaging (EPI) technique with high spatial and temporal resolution. Dynamic susceptibility contrast magnetic resonance imaging (DSC-MRI) was performed in 12 patients with cerebrovascular disease and in 13 patients with brain tumours. For MR imaging of cerebral perfusion an EPI sequence was developed which provides a temporal resolution of 0.68 s for three slices with a 128 x 128 image matrix. To evaluate DSC-MRI, the following parameter images were calculated pixelwise: (1) Maximum signal reduction (MSR); (2) maximum signal difference (ΔSR); (3) time-to-peak (T p ); and (4) integral of signal-intensity-time curve until T p (S Int ). The MSR maps were superior in the detection of acute infarctions and ΔSR maps in the delineation of vasogenic brain oedema. The time-to-peak (T p ) maps seemed to be highly sensitive in the detection of poststenotic malperfused brain areas (sensitivity 90 %). Hyperperfused areas of brain tumours were detectable down to a diameter of 1 cm with high sensitivity (> 90 %). Distinct clinical and neuroradiological conditions revealed different suitabilities for the parameter images. The time-to-peak (T p ) maps may be an important advantage in the detection of poststenotic ''areas at risk'', due to an improved temporal resolution using an EPI technique. With regard to spatial resolution, a matrix size of 128 x 128 is sufficient for all clinical conditions. According to our results, a further increase in matrix size would not improve the spatial resolution in DSC-MRI, since the degree of the vascularization of lesions and the susceptibility effect itself seem to be the limiting factors. (orig.)

  6. Obtaining Self-Report Data from Cognitively Impaired Elders: Methodological Issues and Clinical Implications for Nursing Home Pain Assessment

    Science.gov (United States)

    Fisher, Susan E.; Burgio, Louis D.; Thorn, Beverly E.; Hardin, J. Michael

    2006-01-01

    Purpose: We developed and evaluated an explicit procedure for obtaining self-report pain data from nursing home residents across a broad range of cognitive status, and we evaluated the consistency, stability, and concurrent validity of resident responses. Design and Methods: Using a modification of the Geriatric Pain Measure (GPM-M2), we…

  7. Methodological issues for designing and conducting a multicenter, international clinical trial in Acute Stroke: Experience from ARTSS-2 trial.

    Science.gov (United States)

    Rahbar, Mohammad H; Dickerson, Aisha S; Cai, Chunyan; Pedroza, Claudia; Hessabi, Manouchehr; Shen, Loren; Pandurengan, Renganayaki; Jacobs, Amber Nicole M; Indupuru, Hari; Sline, Melvin R; Delgado, Rigoberto I; Macdonald, Claire; Ford, Gary A; Grotta, James C; Barreto, Andrew D

    2015-09-01

    We describe innovations in the study design and the efficient data coordination of a randomized multicenter trial of Argatroban in Combination with Recombinant Tissue Plasminogen Activator for Acute Stroke (ARTSS-2). ARTSS-2 is a 3-arm, multisite/multiregional randomized controlled trials (RCTs) of two doses of Argatroban injection (low, high) in combination with recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients and rt-PA alone. We developed a covariate adaptive randomization program that balanced the study arms with respect to study site as well as hemorrhage after thrombolysis (HAT) score and presence of distal internal carotid artery occlusion (DICAO). We used simulation studies to validate performance of the randomization program before making any adaptations during the trial. For the first 90 patients enrolled in ARTSS-2, we evaluated performance of our randomization program using chi-square tests of homogeneity or extended Fisher's exact test. We also designed a four-step partly Bayesian safety stopping rule for low and high dose Argatroban arms. Homogeneity of the study arms was confirmed with respect to distribution of study site (UK sites vs. US sites, P=0.98), HAT score (0-2 vs. 3-5, P=1.0), and DICAO (N/A vs. No vs. Yes, P=0.97). Our stopping thresholds for safety of low and high dose Argatroban were not crossed. Despite challenges, data quality was assured. We recommend adaptive designs for randomization and Bayesian safety stopping rules for multisite Phase I/II RCTs for maintaining additional flexibility. Efficient data coordination could lead to improved data quality. Copyright © 2015. Published by Elsevier Inc.

  8. Exhaled nitric oxide measurements in the first 2 years of life: Methodological issues, clinical and epidemiological applications

    NARCIS (Netherlands)

    C. Gabriele (Carmelo); F.M. de Benedictis (Fernando Maria); J.C. de Jongste (Johan)

    2009-01-01

    textabstractFractional exhaled nitric oxide (FeNO) is a useful tool to diagnose and monitor eosinophilic bronchial inflammation in asthmatic children and adults. In children younger than 2 years of age FeNO has been successfully measured both with the tidal breathing and with the single breath

  9. Gaining access to the life-world of women suffering from stroke - methodological issues in clinical phenomenological studies

    DEFF Research Database (Denmark)

    Kvigne, Kari; Gjengedal, Eva; Kirkevold, Marit

    2002-01-01

    - the informant's openness in describing his/her life-world, and the sensitivity of the researcher as regards seeing and hearing what is conveyed in the situation. Both forms of openness can be influenced positively or negatively by many factors, including the physical and mental health of the informants......Aim. First to give a brief introduction to some dimensions of phenomenology as philosophy, and then to discuss some problems related to empirical research. The objectives of the discussion are: (1) to show what is involved in investigating changes in the life-world caused by illness and (2) to show...

  10. Attention-deficit/hyperactivity disorder and phonological working memory: Methodological variability affects clinical and experimental performance metrics.

    Science.gov (United States)

    Tarle, Stephanie J; Alderson, R Matt; Patros, Connor H G; Lea, Sarah E; Hudec, Kristen L; Arrington, Elaine F

    2017-05-01

    Despite promising findings in extant research that suggest impaired working memory (WM) serves as a central neurocognitive deficit or candidate endophenotype of attention-deficit/hyperactivity disorder (ADHD), findings from translational research have been relatively underwhelming. This study aimed to explicate previous equivocal findings by systematically examining the effect of methodological variability on WM performance estimates across experimental and clinical WM measures. Age-matched boys (ages 8-12 years) with (n = 20) and without (n = 20) ADHD completed 1 experimental (phonological) and 2 clinical (digit span, letter-number sequencing) WM measures. The use of partial scoring procedures, administration of greater trial numbers, and high central executive demands yielded moderate-to-large between-groups effect sizes. Moreover, the combination of these best-case procedures, compared to worst-case procedures (i.e., absolute scoring, administration of few trials, use of discontinue rules, and low central executive demands), resulted in a 12.5% increase in correct group classification. Collectively, these findings explain inconsistent ADHD-related WM deficits in previous reports, and highlight the need for revised clinical measures that utilize best-case procedures. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  11. [Emotional consequences of sterilization. Clinical comments on the methodology of psychological studies].

    Science.gov (United States)

    Petersen, P

    1983-04-01

    72 detailed psychiatric and psychological retrospective and prospective investigations (from 1928-1975) on the emotional consequences of male and female sterilization were reviewed and the international literature is summarized. Favorable conditions for sterilization are clear and decisive motivation, freedom of decision making, throrough understanding of the decision of the sexual partner, a harmonious relationship with that partner, a stable and sensitive personality, and thorough preoperative individual counseling. Integration of the procedure may take from 1-4 years and occurs in both partners. This is a dynamic process which brings with it a crisis during which the disturbance may be integrated. Consequently, surgical contraception is a challenge to the relationship of the partners. Investigations to date point to coveted motivation. Personal ambition of the investigator, justification for the operation, political motives in favor of widespread surgical sterilization, and pragmatic clinical motives are often found. Rarely is the motive in the investigation the mere search for scientific truth. Frequently, perfectionistic objectivisim and positivism are found and the subjectivity of the investigator and client is eliminated. In future investigations, the transparency in the relationship of the investigator and client and anthropological concepts should be considered. Part of the investigation must consider transcultural comparisons in the significance of liberty, love, and loyality in reproduction and family planning. (author's)

  12. Methodology optimization and diversification for the investigation of virulence potential in Haemophilus influenzae clinical strains.

    Science.gov (United States)

    Giucă, Mihaela Cristina; Străuţ, Monica; Surdeanu, Maria; Nica, Maria; Ungureanu, Vasilica; Mihăescu, Grigore

    2011-01-01

    Ten Haemophilus influenzae strains were isolated from patients aged between 1.6 - 24 years, with various diagnoses (acute meningitis, acute upper respiratory infection, otitis media and acute sinusitis). Identification was based on phenotypic and molecular characteristics; antibiotic susceptibility testing was performed by diffusion method according to CLSI standards 2011 for seven antibiotics. The results of molecular testing showed that all the studied strains produced an amplicon of 1000 bp with ompP2 primers indicating that all strains were H. influenzae. For six strains, the PCR amplicon obtained with bexA specific primers, proving that the strains were capsulated. The results of phenotypic testing showed that four strains were ampicillin nonsusceptible and (beta-lactamase-positive. The virulence potential of H. influenzae clinical strains was investigated by phenotypic methods, including the assessment of the soluble virulence factors on specific media containing the biochemical substratum for the investigated enzymatic factor, as well as the adherence and invasion capacity to HeLa cells monolayer using Cravioto modified method. The studied strains exhibited mainly a diffuse adherence pattern and different adherence indexes. Interestingly, two strains isolated from the same pacient (blood and CSF) showed a different degree of invasiveness, the strain isolated from blood being 20 times more invasive than the one isolated from CSF.

  13. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.

    Science.gov (United States)

    Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

    2011-07-01

    Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

  14. 78 FR 33843 - Request for Comments on Issues Related to Incidental Findings That Arise in the Clinical...

    Science.gov (United States)

    2013-06-05

    ... specific bioethical, legal, and social issues related to potential scientific and technological advances... related areas of science and technology. The Bioethics Commission is charged with identifying and... establishing ``no return'' policies, or stipulations in advance of clinical intervention, research, and/or...

  15. Privacy Issues in the Development of a Virtual Mental Health Clinic for University Students: A Qualitative Study.

    Science.gov (United States)

    Gulliver, Amelia; Bennett, Kylie; Bennett, Anthony; Farrer, Louise M; Reynolds, Julia; Griffiths, Kathleen M

    2015-01-01

    There is a growing need to develop online services for university students with the capacity to complement existing services and efficiently address student mental health problems. Previous research examining the development and acceptability of online interventions has revealed that issues such as privacy critically impact user willingness to engage with these services. To explore university student perspectives on privacy issues related to using an online mental health service within the context of the development of an online, university-based virtual mental health clinic. There were two stages of data collection. The first stage consisted of four 1.5-hour focus groups conducted with university students (n=19; 10 female, 9 male, mean age = 21.6 years) to determine their ideas about the virtual clinic including privacy issues. The second stage comprised three 1-hour prototype testing sessions conducted with university students (n=6; 3 male, 3 female, mean age = 21.2 years) using participatory design methods to develop and refine a service model for the virtual clinic and determine student views on privacy within this context. The students raised a number of issues related to privacy in relation to the development of the university virtual clinic. Major topics included the types of personal information they would be willing to provide (minimal information and optional mental health data), concern about potential access to their personal data by the university, the perceived stigma associated with registering for the service, and privacy and anonymity concerns related to online forums contained within the virtual clinic. Students would be more comfortable providing personal information and engaging with the virtual clinic if they trust the privacy and security of the service. Implications of this study include building the clinic in a flexible way to accommodate user preferences.

  16. Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

    Science.gov (United States)

    Mazzei, Lauren Giustti; Bergamaschi, Cristiane de Cássia; Silva, Marcus Tolentino; Lopes, Luciane Cruz

    2017-09-27

    Pain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologicchronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends six domains to be covered in evaluating the effectiveness of treatments for chronic pain. To check whether the methodological quality of outcome reporting in published trials has used IMMPACT recommendations in measuring CRCT-NOCP outcomes when acupuncture was used as a treatment. This is a methodological study. We will systematically search for eligible studies in specific databases with a defined strategy. We will use the MeSHterms of 'acupuncture', 'chronic pain' and similar terms, without restrictions on idiom. Eligible studies will include those which are randomised and chose NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture), recruited after September 2004, with ≥100 patients. The measured outcomes are to be the presence of outcome domains recommended by IMMPACT, domains reported by the patient or clinician, tools used to measure such domains, as well as other features of the studies. We shall conduct a regression analysis to explore factors which can be associated with the presence of outcome domains according to IMMPACT recommendations. This survey will be submitted for presentation at congresses and for publication in a scientific journal. The findings obtained in this study will allow us to measure the quality of the evidence and provide greater transparency in decisions regarding the use of acupuncture as a viable alternative to managing chronic pain. © Article author(s) (or their employer(s) unless otherwise

  17. Data-driven methodology illustrating mechanisms underlying word list recall: applications to clinical research.

    Science.gov (United States)

    Longenecker, Julia; Kohn, Philip; Liu, Stanley; Zoltick, Brad; Weinberger, Daniel R; Elvevåg, Brita

    2010-09-01

    Word list learning tasks such as the California Verbal Learning Test (CVLT; Delis, Kramer, Kaplan, & Ober, 1987) are widely used to investigate recall strategies. Participants who recall the most words generally employ semantic techniques, whereas those with poor recall (e.g., patients with schizophrenia) rely on serial techniques. However, these conclusions are based on formulas that assume that categories reflect semantic associations, bind strategy to overall performance, and neglect strategy changes over 5 trials. Therefore, we derived novel measures-independent of recall performance-to compute strategies across trials and identify whether diagnosis predicts recall strategy. Participants were included on the basis of performance on the CVLT (i.e., total words recalled over 5 trials). The 50 highest and 50 lowest performers among healthy volunteers (n = 100) and patients with schizophrenia (n = 100) were selected. Novel measures of recall and transition probability were calculated and analyzed by permutation tests. Recall patterns and strategies of patients resembled those of controls with similar performance levels: Regardless of diagnosis, low performers were more likely to recall the first 2 and last 4 items from the list; high performers increased engagement of semantically based transitions across the 5 trials, whereas low performers did not. Cognitive strategy must be considered independent of overall performance before attributing poor performance to degraded learning processes. Our results demonstrate the importance of departing from global scoring techniques, especially when working with clinical populations such as patients with schizophrenia for whom episodic memory deficits are a hallmark feature. Copyright 2010 APA, all rights reserved.

  18. Diffusion-weighted MR of the brain: methodology and clinical applications

    International Nuclear Information System (INIS)

    Mascalchi, Mario; Filippi, Massimo; Floris, Roberto; Fonda, Claudio; Gasparotti, Roberto; Villari, Natale

    2005-01-01

    Clinical diffusion magnetic resonance (MR) imaging in humans started in the last decade with the demonstration of the capabilities of this technique of depicting the anatomy of the white matter fibre tracts in the brain. Two main approaches in terms of reconstruction and evaluation of the images obtained with application of diffusion sensitising gradients to an echo planar imaging sequence are possible. The first approach consists of reconstruction of images in which the effect of white matter anisotropy is averaged -know as the isotropic or diffusion weighted images, which are usually evaluated subjectively for possible areas of increased or decreased signal, reflecting restricted and facilitated diffusion, respectively. The second approach implies reconstruction of image maps of the apparent diffusion coefficient (ADC), in which the T2 weighting of the echo planar diffusion sequence is cancelled out, and their objective, i.e. numerical, evaluation with regions of interest or histogram analysis. This second approach enables a quantitative and reproducible assessment of the diffusion changes mot only in areas exhibiting signal abnormality in conventional MR images, but also in areas of normal signal. A further level of image post-processing requires the acquisition of images after application of sensitive gradients along at least 6 different spatial orientations and consists of computation of the diffusion tensor and reconstruction of maps of the mean diffusivity (D) and of the white matter anisotropic properties, usually in terms of fractional anisotropy (FA). Diffusion-weighted imaging is complementary to conventional MR imaging in the evaluation of the acute ischaemic stroke. The combination of diffusion and perfusion MR imaging has the potential of providing all the information necessary for the diagnosis and management of the individual patient with acute ischaemic stroke. Diffusion-weighted MR, in particular quantitative evaluation based on the diffusion

  19. Optimizing supercritical carbon dioxide in the inactivation of bacteria in clinical solid waste by using response surface methodology

    Energy Technology Data Exchange (ETDEWEB)

    Hossain, Md. Sohrab [Department of Environmental Technology, School of Industrial Technology, Universiti Sains Malaysia, 11800 Penang (Malaysia); Nik Ab Rahman, Nik Norulaini [School of Distance Education, Universiti Sains Malaysia, 11800 Penang (Malaysia); Balakrishnan, Venugopal [Institute for Research in Molecular Medicine, Universiti Sains Malaysia, 11800 Penang (Malaysia); Alkarkhi, Abbas F.M. [Department of Environmental Technology, School of Industrial Technology, Universiti Sains Malaysia, 11800 Penang (Malaysia); Ahmad Rajion, Zainul [School of Dental Science, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan (Malaysia); Ab Kadir, Mohd Omar, E-mail: akmomar@usm.my [Department of Environmental Technology, School of Industrial Technology, Universiti Sains Malaysia, 11800 Penang (Malaysia)

    2015-04-15

    Highlights: • Supercritical carbon dioxide sterilization of clinical solid waste. • Inactivation of bacteria in clinical solid waste using supercritical carbon dioxide. • Reduction of the hazardous exposure of clinical solid waste. • Optimization of the supercritical carbon dioxide experimental conditions. - Abstract: Clinical solid waste (CSW) poses a challenge to health care facilities because of the presence of pathogenic microorganisms, leading to concerns in the effective sterilization of the CSW for safe handling and elimination of infectious disease transmission. In the present study, supercritical carbon dioxide (SC-CO{sub 2}) was applied to inactivate gram-positive Staphylococcus aureus, Enterococcus faecalis, Bacillus subtilis, and gram-negative Escherichia coli in CSW. The effects of SC-CO{sub 2} sterilization parameters such as pressure, temperature, and time were investigated and optimized by response surface methodology (RSM). Results showed that the data were adequately fitted into the second-order polynomial model. The linear quadratic terms and interaction between pressure and temperature had significant effects on the inactivation of S. aureus, E. coli, E. faecalis, and B. subtilis in CSW. Optimum conditions for the complete inactivation of bacteria within the experimental range of the studied variables were 20 MPa, 60 °C, and 60 min. The SC-CO{sub 2}-treated bacterial cells, observed under a scanning electron microscope, showed morphological changes, including cell breakage and dislodged cell walls, which could have caused the inactivation. This espouses the inference that SC-CO{sub 2} exerts strong inactivating effects on the bacteria present in CSW, and has the potential to be used in CSW management for the safe handling and recycling-reuse of CSW materials.

  20. Optimizing supercritical carbon dioxide in the inactivation of bacteria in clinical solid waste by using response surface methodology

    International Nuclear Information System (INIS)

    Hossain, Md. Sohrab; Nik Ab Rahman, Nik Norulaini; Balakrishnan, Venugopal; Alkarkhi, Abbas F.M.; Ahmad Rajion, Zainul; Ab Kadir, Mohd Omar

    2015-01-01

    Highlights: • Supercritical carbon dioxide sterilization of clinical solid waste. • Inactivation of bacteria in clinical solid waste using supercritical carbon dioxide. • Reduction of the hazardous exposure of clinical solid waste. • Optimization of the supercritical carbon dioxide experimental conditions. - Abstract: Clinical solid waste (CSW) poses a challenge to health care facilities because of the presence of pathogenic microorganisms, leading to concerns in the effective sterilization of the CSW for safe handling and elimination of infectious disease transmission. In the present study, supercritical carbon dioxide (SC-CO 2 ) was applied to inactivate gram-positive Staphylococcus aureus, Enterococcus faecalis, Bacillus subtilis, and gram-negative Escherichia coli in CSW. The effects of SC-CO 2 sterilization parameters such as pressure, temperature, and time were investigated and optimized by response surface methodology (RSM). Results showed that the data were adequately fitted into the second-order polynomial model. The linear quadratic terms and interaction between pressure and temperature had significant effects on the inactivation of S. aureus, E. coli, E. faecalis, and B. subtilis in CSW. Optimum conditions for the complete inactivation of bacteria within the experimental range of the studied variables were 20 MPa, 60 °C, and 60 min. The SC-CO 2 -treated bacterial cells, observed under a scanning electron microscope, showed morphological changes, including cell breakage and dislodged cell walls, which could have caused the inactivation. This espouses the inference that SC-CO 2 exerts strong inactivating effects on the bacteria present in CSW, and has the potential to be used in CSW management for the safe handling and recycling-reuse of CSW materials

  1. The Methodology of Syndrome Analysis within the Paradigm of “Qualitat ive Research” in Clinical Psychology

    Directory of Open Access Journals (Sweden)

    Elena I. Pervichko

    2012-01-01

    Full Text Available This article considers the potential for applying contemporary philosophical theories(which distinguish classical, nonclassical, and postnonclassical types of scientificrationality to the specification of theoretical methodological principles inthe study of clinical psychology. We prove that psychological syndrome analysis(developed by the Vygotsky–Luria–Zeigarnik school, taken as a system of principlesfor organizing research as well as for interpreting its results, conforms to theepistemological complexity of the object of study in clinical psychology, which isunderstood in the postnonclassical scientific view as a self-developing system.We present an example of the formation of a psychosomatic syndrome in 290patients with mitral-valve prolapse, applying methods of qualitative and statisticaldata analysis in a longitudinal clinical-psychological study. We prove that thesyndrome is system-defined and has a multilevel character, and that its structureis determined by several factors: the motivational factor (with the domination ofthe failure-avoidance motive and the unsatisfied self-approval need; the factor ofthe emotional-regulation disorders, represented by both excessive emotional repressionand lack of emotional control; and a psychophysiological factor. We arguethat a psychosomatic syndrome can be used as a means for approaching not onlydiagnostic but also prognostic tasks both in clinical psychology and in medicine.We conclude that the results of our empirical study, conducted within the frameworkof postnonclassical philosophy and using the methods of psychologicalsyndrome analysis, not only expand the scientific background on the nature of aparticular disease (mitral-valve prolapse but also pose further questions whoseinvestigation will broaden our view of the psychological mechanisms of psychosomatic-syndrome genesis.

  2. Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

    Science.gov (United States)

    Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

    2012-04-27

    An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. A great pioneer of clinical science remembered: introduction to the special issue in honor of Paul E. Meehl.

    Science.gov (United States)

    Lilienfeld, Scott O; Waller, Niels G

    2005-10-01

    In this special issue, the seminal contributions to clinical psychology of Paul E. Meehl, who passed away in 2003, are commemorated. The nine articles comprising this special issue chronicle Meehl's remarkable intellectual biography and examine his influence on diverse domains of psychology, including the clinical versus actuarial prediction debate, the cognitive activity of the clinician, personality assessment and trait theory, the etiology of schizophrenia, the shortcomings of statistical significance testing, and the use of metascientific methods to evaluate competing models of human nature. These articles illustrate not only Meehl's legendary brilliance but also his pivotal role in forcing clinical psychologists to think more clearly and incisively about their subject matter. 2005 Wiley Periodicals, Inc.

  4. The monitoring, evaluation, reporting, and verification of climate change mitigation projects: Discussion of issues and methodologies and review of existing protocols and guidelines

    Energy Technology Data Exchange (ETDEWEB)

    Vine, E.; Sathaye, J.

    1997-12-01

    Because of concerns with the growing threat of global climate change from increasing emissions of greenhouse gases, the US and other countries are implementing, by themselves or in cooperation with one or more other nations (i.e., joint implementation), climate change mitigation projects. These projects will reduce greenhouse gas (GHG) emissions or sequester carbon, and will also result in non-GHG impacts (i.e., environmental, economic, and social impacts). Monitoring, evaluating, reporting, and verifying (MERV) guidelines are needed for these projects in order to accurately determine their net GHG, and other, benefits. Implementation of MERV guidelines is also intended to: (1) increase the reliability of data for estimating GHG benefits; (2) provide real-time data so that mid-course corrections can be made; (3) introduce consistency and transparency across project types and reporters; and (4) enhance the credibility of the projects with stakeholders. In this paper, the authors review the issues and methodologies involved in MERV activities. In addition, they review protocols and guidelines that have been developed for MERV of GHG emissions in the energy and non-energy sectors by governments, nongovernmental organizations, and international agencies. They comment on their relevance and completeness, and identify several topics that future protocols and guidelines need to address, such as (1) establishing a credible baseline; (2) accounting for impacts outside project boundaries through leakage; (3) net GHG reductions and other impacts; (4) precision of measurement; (5) MERV frequency; (6) persistence (sustainability) of savings, emissions reduction, and carbon sequestration; (7) reporting by multiple project participants; (8) verification of GHG reduction credits; (9) uncertainty and risk; (10) institutional capacity in conducting MERV; and (11) the cost of MERV.

  5. Experimental radiotherapy and clinical radiobiology. Vol. 8, special issue 1. Proceedings

    International Nuclear Information System (INIS)

    Doerr, W.; Baumann, M.; Herrmann, T.

    1999-01-01

    The publication contains the abstracts of all papers and posters presented at the symposium. The headings were as follows: Radiobiology of the lung, mediation of radiation damage in the lung, clinical studies, future clinical directions, as well as documentation and management. (MG)

  6. Ethical, legal and clinical aspects of live surgery in urology - contemporary issues and a glimpse of the future.

    Science.gov (United States)

    Cumpanas, Alin Adrian; Ferician, Ovidiu Catalin; Latcu, Silviu Constantin; Pricop, Catalin; Bardan, Razvan Tiberiu

    2017-01-01

    Beside dry and wet lab training, simulators, video tapes, fellowships and clinical visits, live surgery has gained popularity during the last years, being an attraction point at large scientific meetings and at postgraduate courses as well. This type of surgical training raises both ethical and legal issues. Thus, there are professional societies that have banned such meetings, mainly due to safety reasons for the patient. The current article aims to identify and to discuss ethical and legal issues related to the topic, advantages, disadvantages and weak points of this emerging challenge for modern medicine, trying to analyze the issues from all relevant points of view: those of the patient, the surgeon and the session attendant.

  7. Issues in the assessment of personality disorder and substance abuse using the Millon Clinical Multiaxial Inventory (MCMI-II).

    Science.gov (United States)

    Flynn, P M; McCann, J T; Fairbank, J A

    1995-05-01

    Substance abuse treatment clients often present other severe mental health problems that affect treatment outcomes. Hence, screening and assessment for psychological distress and personality disorder are an important part of effective treatment, discharge, and aftercare planning. The Millon Clinical Multiaxial Inventory-II (MCMI-II) frequently is used for this purpose. In this paper, several issues of concern to MCMI-II users are addressed. These include the extent to which MCMI-II scales correspond to DSM-III-R disorders; overdiagnosis of disorders using the MCMI-II; accuracy of MCMI-II diagnostic cut-off scores; and the clinical utility of MCMI-II diagnostic algorithms. Approaches to addressing these issues are offered.

  8. The uses of emotion maps in research and clinical practice with families and couples: methodological innovation and critical inquiry.

    Science.gov (United States)

    Gabb, Jacqui; Singh, Reenee

    2015-03-01

    We explore how "emotion maps" can be productively used in clinical assessment and clinical practice with families and couples. This graphic participatory method was developed in sociological studies to examine everyday family relationships. Emotion maps enable us to effectively "see" the dynamic experience and emotional repertoires of family life. Through the use of a case example, in this article we illustrate how emotion maps can add to the systemic clinicians' repertoire of visual methods. For clinicians working with families, couples, and young people, the importance of gaining insight into how lives are lived, at home, cannot be understated. Producing emotion maps can encourage critical personal reflection and expedite change in family practice. Hot spots in the household become visualized, facilitating dialogue on prevailing issues and how these events may be perceived differently by different family members. As emotion maps are not reliant on literacy or language skills they can be equally completed by parents and children alike, enabling children's perspective to be heard. Emotion maps can be used as assessment tools, to demonstrate the process of change within families. Furthermore, emotion maps can be extended to use through technology and hence are well suited particularly to working with young people. We end the article with a wider discussion of the place of emotions and emotion maps within systemic psychotherapy. © 2014 The Authors. Family Process published by Wiley Periodicals, Inc. on behalf of Family Process Institute.

  9. Engaging Future Clinical Oncology Researchers: An Initiative to Integrate Teaching of Biostatistics and Research Methodology into Specialty Training.

    Science.gov (United States)

    Turner, S; Sundaresan, P; Mann, K; Pryor, D; Gebski, V; Shaw, T

    2016-05-01

    To evaluate the learner's perspectives on a novel workshop programme designed to improve skills in biostatistics, research methodology and critical appraisal in oncology. Trainees were surveyed anonymously at the completion of each annual workshop from 2012 to 2015. In total, 103 trainees in years 2-4 of training in radiation oncology responded, giving a 94% survey response rate. A 1 day workshop, designed by biostatisticians and radiation oncologist facilitators, is the central component of a programme teaching skills in biostatistics, research methods and critical appraisal. This links short didactic lectures about statistical concepts to interactive trainee discussions around discipline-related publications. The workshop was run in conjunction with the major radiation oncology clinical trials group meeting with alternating programmes (A and B). Most of the participants (44-47/47 for A and 48-55/56 for B), reported that their understanding of one or more individual topics improved as a result of teaching. Refinement of the workshop over time led to a more favourable perception of the 'optimal' balance between didactic/interactive teaching: nine of 27 (33%) 'optimal' responses seen in 2013 compared with 23 of 29 (79%) in 2015 (P research to illuminate key statistical concepts. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  10. Critical review of methodology and application of risk ranking for prioritisation of food and feed related issues, on the basis of the size of anticipated health impact

    NARCIS (Netherlands)

    Fels-Klerx, van der H.J.; Asselt, van E.D.; Raley, M.; Poulsen, M.; Korsgaard, H.; Bredsdorff, L.; Nauta, M.; Flari, V.; Agostino, D' M.; Coles, D.G.; Frewer, L.J.

    2015-01-01

    This study aimed to critically review methodologies for ranking of risks related to feed/food safety and nutritional hazards, on the basis of their anticipated human health impact. An extensive systematic literature review was performed to identify and characterize the available methodologies for

  11. Development and application of the Safe Performance Index as a risk-based methodology for identifying major hazard-related safety issues in underground coal mines

    Science.gov (United States)

    Kinilakodi, Harisha

    The underground coal mining industry has been under constant watch due to the high risk involved in its activities, and scrutiny increased because of the disasters that occurred in 2006-07. In the aftermath of the incidents, the U.S. Congress passed the Mine Improvement and New Emergency Response Act of 2006 (MINER Act), which strengthened the existing regulations and mandated new laws to address the various issues related to a safe working environment in the mines. Risk analysis in any form should be done on a regular basis to tackle the possibility of unwanted major hazard-related events such as explosions, outbursts, airbursts, inundations, spontaneous combustion, and roof fall instabilities. One of the responses by the Mine Safety and Health Administration (MSHA) in 2007 involved a new pattern of violations (POV) process to target mines with a poor safety performance, specifically to improve their safety. However, the 2010 disaster (worst in 40 years) gave an impression that the collective effort of the industry, federal/state agencies, and researchers to achieve the goal of zero fatalities and serious injuries has gone awry. The Safe Performance Index (SPI) methodology developed in this research is a straight-forward, effective, transparent, and reproducible approach that can help in identifying and addressing some of the existing issues while targeting (poor safety performance) mines which need help. It combines three injury and three citation measures that are scaled to have an equal mean (5.0) in a balanced way with proportionate weighting factors (0.05, 0.15, 0.30) and overall normalizing factor (15) into a mine safety performance evaluation tool. It can be used to assess the relative safety-related risk of mines, including by mine-size category. Using 2008 and 2009 data, comparisons were made of SPI-associated, normalized safety performance measures across mine-size categories, with emphasis on small-mine safety performance as compared to large- and

  12. Ethical and legal issues in the clinical practice of primary health care.

    Science.gov (United States)

    Maestro, Francisco Javier; Martinez-Romero, Marcos; Vazquez-Naya, Jose Manuel; Pereira, Javier; Pazos, Alejandro

    2013-01-01

    Since it was conceived, the notion of primary care has been a crucial concept in health services. Most health care is provided at this level and primary care clinicians have an essential role, both in terms of disease prevention and disease management. During the last decades, primary health care has evolved from a traditional paternalistic model, in which patients played the role of passive recipient of care, towards a situation in which patients are partners involved in the decision making-process. This new context opened a considerable number of new ethical and legal aspects, which need to be comprehensively analyzed and discussed in order to preserve the quality of primary health care all around the world. This work reviews the most important ethical and legal issues in primary health care. Legislation issues are explained in the context of the Spanish Health Services.

  13. Current trends in research and clinical issues in the study of personality and its disorders

    DEFF Research Database (Denmark)

    Simonsen, Erik; Sørensen, Per; Pedersen, Liselotte

    2014-01-01

    lecture (Simonsen), a young researchers' symposium (Hopwood, Sharp, and Kaess), and special lectures on the Danish philosopher Soeren Kierkegaard and the poet Hans Christian Andersen. In this article we will survey the presentations and highlight the important issues in order to underline the current......The International Society for the Study of Personality Disorders (ISSPD) celebrated its 25th anniversary in September 2013 in Copenhagen and commemorated the First International Congress at the same site. The overall theme of the congress was "Bridging Personality and Psychopathology: The Person...... Behind the Illness." More than 400 abstracts were submitted, and the program included 8 keynote presentations, 18 invited symposia, a debate on current controversial issues in the classification of personality disorders (Fossati, Tyrer, Livesley, and Krueger), an ISSPD award lecture (Silk), a jubilee...

  14. Pediatric clinical drug trials in low-income countries: key ethical issues.

    Science.gov (United States)

    MacLeod, S M; Knoppert, D C; Stanton-Jean, M; Avard, D

    2015-02-01

    Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which

  15. Critical issues with clinical research in children: The example of premature infants

    International Nuclear Information System (INIS)

    Welty, Stephen E.

    2005-01-01

    Research in pediatrics has led to marked improvements in survival in pediatric patients. In no other age group have these improvements been more dramatic than in neonatology, where antenatal steroid administration to mothers and postnatal utilization of surfactant have led to marked improvements in survival so that infants born at 24 weeks gestation now have a greater than 50% chance of survival. Unfortunately, more than 50% of these patients develop significant complications of prematurity with potential long-term impact on the health of these infants. Therefore, additional research must be done in these patients to prevent these complications or reduce the impact of these complications. There are many practical and some ethical issues that could impede research in the area. Interventional studies have succeeded because literally decades of research defined unequivocally the pathophysiology of diseases such as surfactant deficiency in RDS. Unfortunately, the pathophysiology leading to the complications of prematurity has been extrapolated from old concepts without verification as the population has become smaller and more premature than the previous era. Thus, an extremely important practical issue in pediatric research is whether to design interventions to address the extrapolated pathophysiology risking misinterpretations of the results of such studies. Or should our efforts be focused on defining endpoints associated with the development of diseases and complications which may define pathophysiology more completely but delay the design of interventions to improve the outcomes of patients. Another crucial practical issue in pediatric research is how to power studies so that interventions can be studied adequately. In the US, large neonatal networks have been formed so that large databases can be created and large multi-center trials can be performed. The practical issues associated with these network studies is the center to center variability in patient care

  16. Immune Monitoring in Cancer Vaccine Clinical Trials: Critical Issues of Functional Flow Cytometry-Based Assays

    Directory of Open Access Journals (Sweden)

    Iole Macchia

    2013-01-01

    Full Text Available The development of immune monitoring assays is essential to determine the immune responses against tumor-specific antigens (TSAs and tumor-associated antigens (TAAs and their possible correlation with clinical outcome in cancer patients receiving immunotherapies. Despite the wide range of techniques used, to date these assays have not shown consistent results among clinical trials and failed to define surrogate markers of clinical efficacy to antitumor vaccines. Multiparameter flow cytometry- (FCM- based assays combining different phenotypic and functional markers have been developed in the past decade for informative and longitudinal analysis of polyfunctional T-cells. These technologies were designed to address the complexity and functional heterogeneity of cancer biology and cellular immunity and to define biomarkers predicting clinical response to anticancer treatment. So far, there is still a lack of standardization of some of these immunological tests. The aim of this review is to overview the latest technologies for immune monitoring and to highlight critical steps involved in some of the FCM-based cellular immune assays. In particular, our laboratory is focused on melanoma vaccine research and thus our main goal was the validation of a functional multiparameter test (FMT combining different functional and lineage markers to be applied in clinical trials involving patients with melanoma.

  17. A novel registration-based methodology for prediction of trabecular bone fabric from clinical QCT: A comprehensive analysis.

    Directory of Open Access Journals (Sweden)

    Vimal Chandran

    Full Text Available Osteoporosis leads to hip fractures in aging populations and is diagnosed by modern medical imaging techniques such as quantitative computed tomography (QCT. Hip fracture sites involve trabecular bone, whose strength is determined by volume fraction and orientation, known as fabric. However, bone fabric cannot be reliably assessed in clinical QCT images of proximal femur. Accordingly, we propose a novel registration-based estimation of bone fabric designed to preserve tensor properties of bone fabric and to map bone fabric by a global and local decomposition of the gradient of a non-rigid image registration transformation. Furthermore, no comprehensive analysis on the critical components of this methodology has been previously conducted. Hence, the aim of this work was to identify the best registration-based strategy to assign bone fabric to the QCT image of a patient's proximal femur. The normalized correlation coefficient and curvature-based regularization were used for image-based registration and the Frobenius norm of the stretch tensor of the local gradient was selected to quantify the distance among the proximal femora in the population. Based on this distance, closest, farthest and mean femora with a distinction of sex were chosen as alternative atlases to evaluate their influence on bone fabric prediction. Second, we analyzed different tensor mapping schemes for bone fabric prediction: identity, rotation-only, rotation and stretch tensor. Third, we investigated the use of a population average fabric atlas. A leave one out (LOO evaluation study was performed with a dual QCT and HR-pQCT database of 36 pairs of human femora. The quality of the fabric prediction was assessed with three metrics, the tensor norm (TN error, the degree of anisotropy (DA error and the angular deviation of the principal tensor direction (PTD. The closest femur atlas (CTP with a full rotation (CR for fabric mapping delivered the best results with a TN error of 7

  18. Methodological issues related to studies of lead mobilization during menopause Consideraciones metodológicas relacionadas con estudios sobre movilización de plomo durante la menopausia

    Directory of Open Access Journals (Sweden)

    Gertrud S. Berkowitz

    1999-11-01

    Full Text Available While there has been a substantial decline in lead exposure in the United States during the past two decades, mobilization of existing lead stored in bone potentially represents an important endogenous source of exposure for menopausal women. It has been hypothesized that lead may be mobilized from skeletal stores during conditions of high bone turnover, such as during menopause. However, such mobilization has not been documented in prospective studies. This discussion is focussed on some of the methodological difficulties to be anticipated in longitudinal studies of lead mobilization specific to menopause and the issues that need to be taken into account when evaluating the results of such studies. To evaluate whether lead mobilization occurs during menopause, a prospective repeated measures design is needed using X-ray fluorescence analysis of lead in bone and serial measurements of blood lead. Potential confounders and effect modifiers also need to be taken into account in the statistical analysis.Mientras que la exposición a plomo ha declinado sustancialmente en Estados Unidos durante las dos décadas pasadas, la mobilización del plomo almacenado en los huesos representa potencialmente una importante fuente de exposición endógena en mujeres menopáusicas. No obstante, tal movilización no ha sido documentada por estudios prospectivos. La presente discusión se enfoca en algunas de las dificultades metodológicas a se anticipadas en estudios longitudinales de mobilización de plomo específicamente en la menopausia, y los aspectos que necesitan ser considerados cuando se evalúan los resultados de tales estudios. Para evaluar si durante la menopausia el plomo es mobilizado, se requiere de un diseño prospectivo con mediciones repetidas utilizando análisis de fluorescencia de rayos-X para determinar el plomo en hueso y una serie de mediciones de plomo en sangre. Los potenciales confusores y modificadores del efecto también deben tomarse

  19. A prospective study of existential issues in therapeutic horticulture for clinical depression.

    Science.gov (United States)

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil Wilhelm; Kirkevold, Marit

    2011-01-01

    Two studies with single-group design (Study 1 N = 18, Study 2 N = 28) addressed whether horticultural activities ameliorate depression severity and existential issues. Measures were obtained before and after a 12-week therapeutic horticulture program and at 3-month follow-up. In both studies, depression severity declined significantly during the intervention and remained low at the follow-up. In both studies the existential outcomes did not change significantly; however, the change that did occur during the intervention correlated (rho > .43) with change in depression severity. Participants' open-ended accounts described the therapeutic horticulture experience as meaningful and influential for their view of life.

  20. Suicide in Children Younger than Age Fourteen: Clinical Judgment and Assessment Issues.

    Science.gov (United States)

    Wise, Amy J.; Spengler, Paul M.

    1997-01-01

    Discusses the importance of accurate information about childhood suicide to prevent clinical judgment errors. Describes available methods for evaluating suicide risk in children. Looks at myths and misconceptions surrounding childhood suicide; risk factors, such as family dysfunction and distress; and evaluation techniques, such as interviews and…

  1. Emotional Intelligence: An Old Issue and a New Look in Clinical Teaching

    Directory of Open Access Journals (Sweden)

    Athar Omid

    2018-01-01

    Full Text Available In this paper, a novel model of clinical teachers with social and emotional competency which is emphasized on the importance of clinical teacher's social and emotional competence is presented. In this model, we supposed that a teacher with social and emotional competence can manage her/his emotions and has the ability to personal development and well-being. Such teacher has the competency of empathy, communication with the patients, teamwork, and collaboration to provide successful patient-centered care and relationship-centered care. He/she will be success in clinical supervision, role modeling, and mentoring by providing appropriate relationship with students. This teacher can influence and build bonds that will be effective for clinical management and leadership. In addition, it will affect the hidden and informal curriculum with the awareness of the context. These factors establish an appropriate learning environment to achieve students' academic, professional, social, and emotional outcomes and create an appropriate health care environment that influences the successful care of patient and patient's satisfaction. We reviewed a broad body of research to support our proposed model and finally proposed agendas for future research.

  2. A four-part working bibliography of neuroethics: Part 4 - Ethical issues in clinical and social applications of neuroscience.

    Science.gov (United States)

    Becker, Kira; Shook, John R; Darragh, Martina; Giordano, James

    2017-05-31

    As a discipline, neuroethics addresses a range of questions and issues generated by basic neuroscientific research (inclusive of studies of putative neurobiological processes involved in moral and ethical cognition and behavior), and its use and meanings in the clinical and social spheres. Here, we present Part 4 of a four-part bibliography of the neuroethics literature focusing on clinical and social applications of neuroscience, to include: the treatment-enhancement discourse; issues arising in neurology, psychiatry, and pain care; neuroethics education and training; neuroethics and the law; neuroethics and policy and political issues; international neuroethics; and discourses addressing "trans-" and "post-" humanity. To complete a systematic survey of the literature, 19 databases and 4 individual open-access journals were employed. Searches were conducted using the indexing language of the U.S. National Library of Medicine (NLM). A Python code was used to eliminate duplications in the final bibliography. When taken with Parts 1-3, this bibliography aims to provide a listing of international peerreviewed papers, books, and book chapters published from 2002 through 2016. While seeking to be as comprehensive as possible, it may be that some works were inadvertently and unintentionally not included. We therefore invite commentary from the field to afford completeness and contribute to this bibliography as a participatory work-in-progress.

  3. Common Issues Seen in Paediatric Diabetes Clinics, Psychological Formulations, and Related Approaches to Management

    Directory of Open Access Journals (Sweden)

    Asma Deeb

    2018-01-01

    Full Text Available Diabetes is a chronic disease and its management is associated with multiple challenges. This is particularly the case in children and adolescents. Factors that contribute to difficulties in managing diabetes in youth include psychological characteristics, family dynamics, and social behavior. The purpose of this article is to highlight some psychological issues in children and adolescents with diabetes. We aim to present selected case scenarios encountered by health professionals and to provide tips on strategies for managing psychological aspect of diabetes. We tackle the psychological issues related to diabetes under four main categories: maladaptive disorders, eating disorders, family psychopathology, and family dysfunction. Psychotherapy and psychoanalysis are useful modalities in diabetes management. The psychological intervention is aimed at supporting patients and families to reach a balance between a normal family routine and a good glycemic control. We demonstrate unique requirements in coordinating care for children and adolescents with diabetes and highlight the importance of encouraging a positive behavior. Managing diabetes in children and adolescents needs to be in the form of a collaborative work between health care professionals, children and adolescents, and their families. Caring, supportive family backed up by experienced multidisciplinary team is the best approach to prevent psychological difficulties.

  4. Common Issues Seen in Paediatric Diabetes Clinics, Psychological Formulations, and Related Approaches to Management.

    Science.gov (United States)

    Deeb, Asma; Akle, Mariette; Al Ozairi, Abdulla; Cameron, Fergus

    2018-01-01

    Diabetes is a chronic disease and its management is associated with multiple challenges. This is particularly the case in children and adolescents. Factors that contribute to difficulties in managing diabetes in youth include psychological characteristics, family dynamics, and social behavior. The purpose of this article is to highlight some psychological issues in children and adolescents with diabetes. We aim to present selected case scenarios encountered by health professionals and to provide tips on strategies for managing psychological aspect of diabetes. We tackle the psychological issues related to diabetes under four main categories: maladaptive disorders, eating disorders, family psychopathology, and family dysfunction. Psychotherapy and psychoanalysis are useful modalities in diabetes management. The psychological intervention is aimed at supporting patients and families to reach a balance between a normal family routine and a good glycemic control. We demonstrate unique requirements in coordinating care for children and adolescents with diabetes and highlight the importance of encouraging a positive behavior. Managing diabetes in children and adolescents needs to be in the form of a collaborative work between health care professionals, children and adolescents, and their families. Caring, supportive family backed up by experienced multidisciplinary team is the best approach to prevent psychological difficulties.

  5. Regional Implementation of a Pediatric Cardiology Syncope Algorithm Using Standardized Clinical Assessment and Management Plans (SCAMPS) Methodology.

    Science.gov (United States)

    Paris, Yvonne; Toro-Salazar, Olga H; Gauthier, Naomi S; Rotondo, Kathleen M; Arnold, Lucy; Hamershock, Rose; Saudek, David E; Fulton, David R; Renaud, Ashley; Alexander, Mark E

    2016-02-19

    Pediatric syncope is common. Cardiac causes are rarely found. We describe and assess a pragmatic approach to these patients first seen by a pediatric cardiologist in the New England region, using Standardized Clinical Assessment and Management Plans (SCAMPs). Ambulatory patients aged 7 to 21 years initially seen for syncope at participating New England Congenital Cardiology Association practices over a 2.5-year period were evaluated using a SCAMP. Findings were iteratively analyzed and the care pathway was revised. The vast majority (85%) of the 1254 patients had typical syncope. A minority had exercise-related or more problematic symptoms. Guideline-defined testing identified one patient with cardiac syncope. Syncope Severity Scores correlated well between physician and patient perceived symptoms. Orthostatic vital signs were of limited use. Largely incidental findings were seen in 10% of ECGs and 11% of echocardiograms. The 10% returning for follow-up, by design, reported more significant symptoms, but did not have newly recognized cardiac disease. Iterative analysis helped refine the approach. SCAMP methodology confirmed that the vast majority of children referred to the outpatient pediatric cardiology setting had typical low-severity neurally mediated syncope that could be effectively evaluated in a single visit using minimal resources. A simple scoring system can help triage patients into treatment categories. Prespecified criteria permitted the effective diagnosis of the single patient with a clear cardiac etiology. Patients with higher syncope scores still have a very low risk of cardiac disease, but may warrant attention. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  6. Non-Communicable Disease Clinical Practice Guidelines in Brazil: A Systematic Assessment of Methodological Quality and Transparency.

    Directory of Open Access Journals (Sweden)

    Caroline de Godoi Rezende Costa Molino

    Full Text Available Annually, non-communicable diseases (NCDs kill 38 million people worldwide, with low and middle-income countries accounting for three-quarters of these deaths. High-quality clinical practice guidelines (CPGs are fundamental to improving NCD management. The present study evaluated the methodological rigor and transparency of Brazilian CPGs that recommend pharmacological treatment for the most prevalent NCDs.We conducted a systematic search for CPGs of the following NCDs: asthma, atrial fibrillation, benign prostatic hyperplasia, chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease and/or stable angina, dementia, depression, diabetes, gastroesophageal reflux disease, hypercholesterolemia, hypertension, osteoarthritis, and osteoporosis. CPGs comprising pharmacological treatment recommendations were included. No language or year restrictions were applied. CPGs were excluded if they were merely for local use and referred to NCDs not listed above. CPG quality was independently assessed by two reviewers using the Appraisal of Guidelines Research and Evaluation instrument, version II (AGREE II."Scope and purpose" and "clarity and presentation" domains received the highest scores. Sixteen of 26 CPGs were classified as low quality, and none were classified as high overall quality. No CPG was recommended without modification (77% were not recommended at all. After 2009, 2 domain scores ("rigor of development" and "clarity and presentation" increased (61% and 73%, respectively. However, "rigor of development" was still rated < 30%.Brazilian healthcare professionals should be concerned with CPG quality for the treatment of selected NCDs. Features that undermined AGREE II scores included the lack of a multidisciplinary team for the development group, no consideration of patients' preferences, insufficient information regarding literature searches, lack of selection criteria, formulating recommendations, authors' conflict of

  7. Quality Assurance Issues in Conducting Multi-Institutional Advanced Technology Clinical Trials

    International Nuclear Information System (INIS)

    Purdy, James A.

    2008-01-01

    The National Cancer Institute-sponsored Advanced Technology Quality Assurance (QA) Consortium, which consisted of the Image-Guided Therapy QA Center, Radiation Therapy Oncology Group, Radiological Physics Center, Quality Assurance Review Center, and Resource Center for Emerging Technologies, has pioneered the development of an infrastructure and QA method for advanced technology clinical trials that requires volumetric digital data submission of a protocol patient's treatment plan and verification data. In particular, the Image-Guided Therapy QA Center has nearly 15 years experience in facilitating QA review for Radiation Therapy Oncology Group advanced technology clinical trials. This QA process includes (1) a data integrity review for completeness of protocol required elements, the format of data, and possible data corruption, and recalculation of dose-volume histograms; (2) a review of compliance with target volume and organ-at-risk contours by study chairs; and (3) a review of dose prescription and dose heterogeneity compliance by the Radiation Therapy Oncology Group Headquarters Dosimetry Group or the Radiological Physics Center dosimetrists (for brachytherapy protocols). This report reviews the lessons learned and the QA challenges presented by the use of advanced treatment modalities in clinical trials requiring volumetric digital data submission

  8. Use of amyloid PET across the spectrum of Alzheimer's disease: clinical utility and associated ethical issues.

    Science.gov (United States)

    Leuzy, Antoine; Zimmer, Eduardo Rigon; Heurling, Kerstin; Rosa-Neto, Pedro; Gauthier, Serge

    2014-09-01

    Abstract Recent advances have made possible the in vivo detection of beta-amyloid (Aβ) pathology using positron emission tomography. While the gold standard for amyloid imaging, carbon-11 labeled Pittsburgh compound B is increasingly being replaced by fluorine-18 labeled radiopharmaceuticals, with three already approved for clinical use by US and European regulatory bodies. Appropriate use criteria proposed by an amyloid imaging taskforce convened by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging recommend restricting use of this technology to the evaluation of patients with mild cognitive impairment or atypical dementia syndromes. While use among asymptomatic individuals is currently viewed as inappropriate due prognostic uncertainty, elevated levels of brain Aβ among asymptomatic individuals may represent preclinical Alzheimer's disease. Amyloid imaging is likewise expected to play a role in the design of clinical trials. Though preliminary results suggest amyloid imaging to possess clinical utility and cost-effectiveness, both domains have yet to be assessed systematically. As the field moves toward adoption of a pro-disclosure stance for amyloid imaging findings, it is imperative that a broad range of stakeholders be involved to ensure the appropriateness of emerging policies and protocols.

  9. Reflections on Ethics and Humanity in Pediatric Neurology: the Value of Recognizing Ethical Issues in Common Clinical Practice.

    Science.gov (United States)

    Ronen, Gabriel M; Rosenbaum, Peter L

    2017-05-01

    Our goals in this reflection are to (i) identify the ethical dimensions inherent in any clinical encounter and (ii) bring to the forefront of our pediatric neurology practice the myriad of opportunities to explore and learn from these ethical questions. We highlight specifically Beauchamp and Childress's principles of biomedical ethics. We use the terms ethics in common clinical practice and an ethical lens to remind people of the ubiquity of ethical situations and the usefulness of using existing ethical principles to analyze and resolve difficult situations in clinical practice. We start with a few common situations with which many of us tend to struggle. We describe what we understand as ethics and how and why developments in technology, novel potential interventions, policies, and societal perspectives challenge us to think about and debate ethical issues. Individual patients are not a singular population; each patient has their own unique life situations, culture, goals, and expectations that need to be considered with a good dose of humanity and humility. We believe that using an ethical lens-by which we mean making an explicit effort to identify and consider these issues openly-will help us to achieve this goal in practice, education, and research.

  10. Balancing the Need for Clinical Photography With Patient Privacy Issues: The Search for a Secure SmartPhone Application to Take and Store Clinical Photographs.

    Science.gov (United States)

    Dumestre, Danielle O; Fraulin, Frankie O G

    2017-11-01

    Physicians are increasingly using smartphones to take clinical photographs. This study evaluates a smartphone application for clinical photography that prioritizes and facilitates patient security. Ethics approval was obtained to trial a smartphone clinical photography application, PicSafe Medi. Calgary plastic surgeons and residents used the application to obtain informed consent and photograph patients. Surveys gauging the application's usability, consent process, and photograph storage/sharing were then sent to surgeons and patients. Over a 6-month trial period, 15 plastic surgeons and residents used the application to photograph 86 patients. Over half of the patients (57%) completed the survey. The majority of patients (96%) were satisfied with the application's consent process, and all felt their photographs were secure. The majority (93%) of surgeons/residents completed the survey. The application was felt to overcome issues with current photography practices: inadequate consent and storage of photographs (100%), risk to patient confidentiality (92%), and unsecure photograph sharing (93%). Barriers to regular use of the application included need for cellphone service/Internet (54%), sanitary concerns due to the need for patients to sign directly on the phone (46%), inability to obtain proactive/retroactive consent (85%), and difficulty viewing photographs (80%). The majority of surgeons (85%) believe a smartphone application would be suitable for clinical patient photography, but due to its limitations, only 23% would use the trialed application. A smartphone clinical photography application addresses the patient confidentiality risks of current photography methods; however, limitations of the trialed application prevent its broad implementation.

  11. Patient compliance with drug therapy in schizophrenia. Economic and clinical issues.

    Science.gov (United States)

    Lindström, E; Bingefors, K

    2000-08-01

    The effectiveness of drug treatment in clinical practice is considerably lower than the efficacy shown in controlled studies. The lower effectiveness in practice presumably leads to lower cost effectiveness of drug treatment in real-life situations compared with that demonstrated by studies based on results from controlled trials. Improved cost effectiveness in routine clinical practice would be a significant advantage in the treatment of schizophrenia, one of the most costly diseases in society. The aetiology of schizophrenia is unknown, and there is no cure. The main aims of therapy with antipsychotic medication include the effective relief of symptoms without the introduction of adverse effects or serious adverse events, improved quality of life, cost effectiveness and a positive long term outcome. The older classical antipsychotic drugs do not always meet these requirements because of their well-known limitations, such as a lack of response in a subgroup of individuals with schizophrenia and intolerable adverse effects. There has long been a need for new antipsychotics that can ameliorate more symptoms and have no or few adverse effects. Some of the recently introduced antipsychotics have been shown to be more effective in certain clinical situations and to have a more favourable adverse effect profile than the classical antipsychotics. A major factor contributing to the lower effectiveness of drug treatment is noncompliance, which may be very high in schizophrenia. There are several factors influencing compliance, including drug type and formulation, patient, disease status, physician, health care system, community care and family. There have been very few studies of compliance improvement strategies in schizophrenia or, indeed, in medicine in general. Current methods are relatively complex and there are differing opinions on their effectiveness. There are several ways to increase compliance in schizophrenia--the evidence is strongest for psychoeducative

  12. Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

    Science.gov (United States)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

    2015-02-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

  13. [Ethical issues in a market dispute between clinical laboratories and a health plan: case report].

    Science.gov (United States)

    Pinheiro, Malone Santos; de Brito, Ana Maria Guedes; Jeraldo, Verônica de Lourdes Sierpe; Pinheiro, Kariny Souza

    2011-01-01

    In Brazil the private health plans appear as an alternative to the public health assistance. This segment suffered great intensification in the seventies and eighties, culminating in the entry of large insurance company in the scenario of supplementary medicine. Quickly, the service providers associated with these insurance companies, consolidating them in the market and triggering a relationship of dependency. This article analyzed, in the form of a case report, a marketing dispute between clinical laboratories and a health plan, emphasizing the moral and ethical aspects involved in this episode.

  14. The development of a gender identity psychosocial clinic: treatment issues, logistical considerations, interdisciplinary cooperation, and future initiatives.

    Science.gov (United States)

    Leibowitz, Scott F; Spack, Norman P

    2011-10-01

    Few interdisciplinary treatment programs that tend to the needs of youth with gender nonconforming behaviors, expressions, and identities exist in academic medical centers with formal residency training programs. Despite this, the literature provides evidence that these youth have higher rates of poor psychosocial adjustment and suicide attempts. This article explores the logistical considerations involved in developing a specialized interdisciplinary service to these gender minority youth in accordance with the existing treatment guidelines.Demographic data will be presented and treatment issues will be explored. The impact that a specialized interdisciplinary treatment program has on clinical expansion, research development, education and training, and community outreach initiatives is discussed.

  15. [Exploring some clinical aspects of the issue of Québec paternity.].

    Science.gov (United States)

    Martinat, S

    1985-01-01

    This article is part of a P.R.D. Research in Clinical Psychology on the father and, on a broader base, on Fatherhood ir} Quebec. The research was initiated in 1979 by the Department of Psychology of Quebec University jointly with the creation of a research laboratory around the theme "the role of the father in the Quebec society in evolution". The question of the father's place and functions in the society of Quebec is raised. The emphasis of the maternal presence in the relationship between parents and children is examined as well as the function of certain cultural traditions, religious ones in particular, in the resolution of certain problems of fatherhood. According to the author, the socio-cultural past of Quebec has a distinct influence on the problem of fatherhood. In a Quebec family the father is traditionally absent and a figure of authority. What is the situation today? Some clinical examples taken from the research are used to illustrate better certain aspects of the paternal dynamics.

  16. [The clinic of apathy in schizophrenia: a critical review of the issue].

    Science.gov (United States)

    Yazbek, H; Raffard, S; Del-Monte, J; Pupier, F; Larue, A; Boulenger, J-P; Gély-Nargeot, M-C; Capdevielle, D

    2014-06-01

    Today the concept of apathy is subject to many questions. This psychological state is present and predominant in different disorders such as neurodegenerative and psychiatric diseases or neurological acquired disorders. Apathy is a part of the clinical vocabulary, however, we can note that in the literature there remains confusion in its definition, and we can find an amalgam with other clinical symptoms. The aim of this review is to provide a clarification of the concept of apathy in clinical practice in schizophrenia as well as to highlight the gaps that exist. Apathy belongs to the negative symptoms of schizophrenia. For its understanding, it is necessary to define apathy as a multidimensional syndrome (cognitive, emotional, and behavioral) manifesting as a quantitative reduction of voluntary behaviors directed toward one or several goals. However, at present, we are witnessing a reductionist and simplistic conception of the syndrome of apathy and this especially in the Anglo-Saxon literature. Several authors reduce apathy to its behavioral component, so in other words, to avolition/amotivation. Avolition refers to a loss of self-initiated and spontaneous behaviors. In this definition only observable behavior is taken into account and not the underlying mechanisms (cognitive and emotional). In order to understand the syndrome of apathy, it is necessary to have a holistic and multidimensional outlook. Some authors have proposed diagnostic criteria for apathy by taking into account the different dimensions of apathy. Moreover not only is apathy confused with avolition, but it is also still difficult to distinguish it from depression. Apathy and depression share common clinical signs (i.e. loss of interest), but they also have distinct clinical signs (lack of motivation for apathy, and suicidal ideation for depression). Authors have shown that the presence of one symptom (apathy or depression) does not predict the presence of the other. An apathetic patient does

  17. Reshaping clinical science: Introduction to the Special Issue on Psychophysiology and the NIMH Research Domain Criteria (RDoC) initiative.

    Science.gov (United States)

    Patrick, Christopher J; Hajcak, Greg

    2016-03-01

    The National Institute of Mental Health's (NIMH) Research Domain Criteria (RDoC) initiative seeks to establish new dimensional conceptions of mental health problems, through the investigation of clinically relevant "process" constructs that have neurobiological as well as psychological referents. This special issue provides a detailed overview of the RDoC framework by NIMH officials Michael Kozak and Bruce Cuthbert, and spotlights RDoC-oriented investigative efforts by leading psychophysiological research groups as examples of how clinical science might be reshaped through application of RDoC principles. Accompanying commentaries highlight key aspects of the work by each group, and discuss reported methods/findings in relation to promises and challenges of the RDoC initiative more broadly. © 2016 Society for Psychophysiological Research.

  18. Consumer direct access to clinical laboratory testing: what are the critical issues?

    Science.gov (United States)

    Wilkinson, David S; Pontius, C Anne

    2003-01-01

    Americans are demanding, independent people. In most aspects of our lives, we are used to walking into a store or other place of business with the expectation that the personnel working for the business will make every effort to satisfy our requests quickly and without the need for a third party to intervene or approve the transaction. Hence, the popularity of convenience stores, do-it-yourself stores and kits, and e-commerce. The delivery of health-care services, however, generally does not conform to this model. Before most diagnostic tests or treatments are ordered, patients usually consult a physician. In many cases, prior to tests or treatments being performed, additional consultations are required with insurance plans. But the winds of change, they are a-blowing. More and more, people demand an active role in managing their health care. One emerging trend is direct patient access to clinical laboratory testing (1).

  19. Tumour angiogenesis pathways: related clinical issues and implications for nuclear medicine imaging

    International Nuclear Information System (INIS)

    Wiele, Christophe van de; De Winter, Olivier; Dierckx, Rudi Andre; Oltenfreiter, Ruth; Slegers, Guido; Signore, Alberto

    2002-01-01

    Tumour angiogenesis is essential for growth, invasion and metastasis. Retrospective studies suggest that it is an independent prognostic factor that merits prospective validation. Furthermore, as tumour blood vessels show many differences from normal vessels and are not genetically unstable, they form a key area for therapy development. However, as anti-angiogenic therapy is primarily cytostatic and not cytotoxic, novel tailor-made specific end-points for treatment monitoring are required. In this regard, suitable molecular parameters for imaging tumour angiogenesis by means of nuclear medicine are being explored. Here we review current knowledge on the multiple pathways controlling tumour angiogenesis and try to assess which are the most clinically relevant for nuclear medicine imaging. Parameters that may influence the imaging potential of radiopharmaceuticals for angiogenesis imaging such as molecular weight and structure, their targeted location within the tumour and their usefulness in terms of specificity and constancy of the targeted molecular pathway are discussed. (orig.)

  20. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-02-01

    Feb 1, 2018 ... The main goal of this article is to analyze methodological issues in .... methodology and theory and historiology (theory of historic process) whose goal is to .... internal branches of sociology and interdisciplinary links of ...

  1. Pre-analytical issues in the haemostasis laboratory: guidance for the clinical laboratories.

    Science.gov (United States)

    Magnette, A; Chatelain, M; Chatelain, B; Ten Cate, H; Mullier, F

    2016-01-01

    Ensuring quality has become a daily requirement in laboratories. In haemostasis, even more than in other disciplines of biology, quality is determined by a pre-analytical step that encompasses all procedures, starting with the formulation of the medical question, and includes patient preparation, sample collection, handling, transportation, processing, and storage until time of analysis. This step, based on a variety of manual activities, is the most vulnerable part of the total testing process and is a major component of the reliability and validity of results in haemostasis and constitutes the most important source of erroneous or un-interpretable results. Pre-analytical errors may occur throughout the testing process and arise from unsuitable, inappropriate or wrongly handled procedures. Problems may arise during the collection of blood specimens such as misidentification of the sample, use of inadequate devices or needles, incorrect order of draw, prolonged tourniquet placing, unsuccessful attempts to locate the vein, incorrect use of additive tubes, collection of unsuitable samples for quality or quantity, inappropriate mixing of a sample, etc. Some factors can alter the result of a sample constituent after collection during transportation, preparation and storage. Laboratory errors can often have serious adverse consequences. Lack of standardized procedures for sample collection accounts for most of the errors encountered within the total testing process. They can also have clinical consequences as well as a significant impact on patient care, especially those related to specialized tests as these are often considered as "diagnostic". Controlling pre-analytical variables is critical since this has a direct influence on the quality of results and on their clinical reliability. The accurate standardization of the pre-analytical phase is of pivotal importance for achieving reliable results of coagulation tests and should reduce the side effects of the influence

  2. Illuminating a neglected clinical issue: societal costs of interpersonal dependency and dependent personality disorder.

    Science.gov (United States)

    Bornstein, Robert F

    2012-07-01

    To determine the degree to which patients with high levels of trait dependency or dependent personality disorder (DPD) engage in behaviors that harm themselves and others (e.g., domestic violence, child abuse). Six domains of literature were reviewed: (a) dependency as a risk factor for physical illness; (b) health care utilization and expenditures; (c) global and domain-specific functional impairment; (d) violence toward others; (e) victimization by others; and (f) self-harm. High levels of trait dependency and DPD are associated with elevated risk for physical illness, partner and child abuse, and suicidality, as well as with high levels of functional impairment and increased health care expenditure. Contrary to clinical lore, trait dependency and DPD are associated with behaviors that lead to myriad negative consequences for the dependent person, those close to them, and society as a whole. These patterns have noteworthy implications for assessment and treatment of dependent patients and suggest that DPD should be included as a diagnostic category in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition. © 2012 Wiley Periodicals, Inc.

  3. Computer-aided detection of lung nodules on chest CT: issues to be solved before clinical use

    International Nuclear Information System (INIS)

    Goo, Jin Mo

    2005-01-01

    Given the increasing resolution of modern CT scanners, and the requirements for large-scale lung-screening examinations and diagnostic studies, there is an increased need for the accurate and reproducible analysis of the large number of images. Nodule detection is one of the main challenges of CT imaging, as they can be missed due to their small size, low relative contrast, or because they are located in an area with complex anatomy. Recent developments in computer-aided diagnosis (CAD) schemes are expected to aid radiologists in various tasks of chest imaging. In this era of multidetector row CT, the thoracic applications of greatest interest include the detection and volume measurement of lung nodules (1-7). Technology for CAD as applied to lung nodule detection on chest CT has been approved by the Food and Drug Administration and is currently commercially available. The article by Lee et al. (5) in this issue of the Korean Journal of Radiology is one of the few studies to examine the influence of a commercially available CAD system on the detection of lung nodules. In this study, some additional nodules were detected with the help of a CAD system, but at the expense of increased false positivity. The nodule detection rate of the CAD system in this study was lower than that achieved by radiologist, and the authors insist that the CAD system should be improved further. Compared to the use of CAD on mammograms, CAD evaluations of chest CTs remain limited to the laboratory setting. In this field, apart from the issues of detection rate and false positive detections, many obstacles must be overcome before CAD can be used in a true clinical reading environment. In this editorial, I will list some of these issues, but I emphasize now that I believe these issues will be solved by improved CAD versions in the near future

  4. A Methodology for Validating Safety Heuristics Using Clinical Simulations: Identifying and Preventing Possible Technology-Induced Errors Related to Using Health Information Systems

    Science.gov (United States)

    Borycki, Elizabeth; Kushniruk, Andre; Carvalho, Christopher

    2013-01-01

    Internationally, health information systems (HIS) safety has emerged as a significant concern for governments. Recently, research has emerged that has documented the ability of HIS to be implicated in the harm and death of patients. Researchers have attempted to develop methods that can be used to prevent or reduce technology-induced errors. Some researchers are developing methods that can be employed prior to systems release. These methods include the development of safety heuristics and clinical simulations. In this paper, we outline our methodology for developing safety heuristics specific to identifying the features or functions of a HIS user interface design that may lead to technology-induced errors. We follow this with a description of a methodological approach to validate these heuristics using clinical simulations. PMID:23606902

  5. Methodology for developing evidence-based clinical imaging guidelines: Joint recommendations by Korea society of radiology and national evidence-based healthcare collaborating agency

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Sol Ji; Jo, Ae Jeong; Choi, Jin A [Div. for Healthcare Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, Seoul (Korea, Republic of); and others

    2017-01-15

    This paper is a summary of the methodology including protocol used to develop evidence-based clinical imaging guidelines (CIGs) in Korea, led by the Korean Society of Radiology and the National Evidence-based Healthcare Collaborating Agency. This is the first protocol to reflect the process of developing diagnostic guidelines in Korea. The development protocol is largely divided into the following sections: set-up, process of adaptation, and finalization. The working group is composed of clinical imaging experts, and the developmental committee is composed of multidisciplinary experts to validate the methodology. The Korean CIGs will continue to develop based on this protocol, and these guidelines will act for decision supporting tools for clinicians as well as reduce medical radiation exposure.

  6. Methodology for developing evidence-based clinical imaging guidelines: Joint recommendations by Korea society of radiology and national evidence-based healthcare collaborating agency

    International Nuclear Information System (INIS)

    Choi, Sol Ji; Jo, Ae Jeong; Choi, Jin A

    2017-01-01

    This paper is a summary of the methodology including protocol used to develop evidence-based clinical imaging guidelines (CIGs) in Korea, led by the Korean Society of Radiology and the National Evidence-based Healthcare Collaborating Agency. This is the first protocol to reflect the process of developing diagnostic guidelines in Korea. The development protocol is largely divided into the following sections: set-up, process of adaptation, and finalization. The working group is composed of clinical imaging experts, and the developmental committee is composed of multidisciplinary experts to validate the methodology. The Korean CIGs will continue to develop based on this protocol, and these guidelines will act for decision supporting tools for clinicians as well as reduce medical radiation exposure

  7. Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

    Science.gov (United States)

    Bruner, Deborah Watkins; Bryan, Charlene J.; Aaronson, Neil; Blackmore, C. Craig; Brundage, Michael; Cella, David; Ganz, Patricia A.; Gotay, Carolyn; Hinds, Pamela S.; Kornblith, Alice B.; Movsas, Benjamin; Sloan, Jeff; Wenzel, Lari; Whalen, Giles

    2016-01-01

    Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need

  8. Critical review of methodology and application of risk ranking for prioritisation of food and feed related issues, on the basis of the size of anticipated health impact

    DEFF Research Database (Denmark)

    van der Fels-Klerx, H. J.; van Asselt, E. D.; Raley, M.

    , an overarching framework was developed for selection of the appropriate method(s) that could be used for risk ranking of feed and food related hazards, on the basis of human health impact. This framework has the format of a decision tool, with which – given the characteristics of the risk ranking question...... at hand - the most appropriate method(s) can be selected. Application of this overall framework to several case studies showed it can be a useful tool for risk managers/assessors to select the most suitable method for risk ranking of feed/food and diet related hazards, on the basis of expected human......This study aimed to critically review methodologies for ranking of risks related to feed/food safety and nutritional hazards, on the basis of their anticipated human health impact. An extensive systematic literature review was performed to identify and characterize the available methodologies...

  9. Review: Heide von Felden (Ed. (2007. Methodendiskussion in der Biographieforschung [Methodological Issues in Biographical Research: Classical and Innovative Perspectives on Qualitative Analysis

    Directory of Open Access Journals (Sweden)

    Klaus Heuer

    2008-10-01

    Full Text Available This article assesses the extent to which the book under review lives up to the expectations raised by its title. The focus is thus on whether the results of interpreting the five featured case studies justify the methodological effort. The interaction between the text and the reader is left out and this is problematic when it comes to interpreting the memories of the Jewish emigrant who is at the centre of three out of the five essays. Furthermore, it is clear that on a formal level (relating to the shared analytical subject as well as in terms of content (relating to interconnectedness that the methodological discussion falls short of the requirements of the approach taken. URN: urn:nbn:de:0114-fqs0901193

  10. Methodological issues in the design of online surveys for measuring unethical work behavior: Recommendations on the basis of a split-ballot experiment

    NARCIS (Netherlands)

    Wouters, K.; Maesschalck, J.B.; Peeters, C.F.W.; Rosen, M.

    2014-01-01

    In recent years, there has been an increasing interest in unethical work behavior. Several types of survey instruments to collect information about unethical work behavior are available. Nevertheless, to date little attention has been paid to design issues of those surveys. There are, however,

  11. Experimental Economics: Some Methodological Notes

    OpenAIRE

    Fiore, Annamaria

    2009-01-01

    The aim of this work is presenting in a self-contained paper some methodological aspects as they are received in the current experimental literature. The purpose has been to make a critical review of some very influential papers dealing with methodological issues. In other words, the idea is to have a single paper where people first approaching experimental economics can find summarised (some) of the most important methodological issues. In particular, the focus is on some methodological prac...

  12. The research questions and methodological adequacy of clinical studies of the voice and larynx published in Brazilian and international journals.

    Science.gov (United States)

    Vieira, Vanessa Pedrosa; De Biase, Noemi; Peccin, Maria Stella; Atallah, Alvaro Nagib

    2009-06-01

    To evaluate the methodological adequacy of voice and laryngeal study designs published in speech-language pathology and otorhinolaryngology journals indexed for the ISI Web of Knowledge (ISI Web) and the MEDLINE database. A cross-sectional study conducted at the Universidade Federal de São Paulo (Federal University of São Paulo). Two Brazilian speech-language pathology and otorhinolaryngology journals (Pró-Fono and Revista Brasileira de Otorrinolaringologia) and two international speech-language pathology and otorhinolaryngology journals (Journal of Voice, Laryngoscope), all dated between 2000 and 2004, were hand-searched by specialists. Subsequently, voice and larynx publications were separated, and a speech-language pathologist and otorhinolaryngologist classified 374 articles from the four journals according to objective and study design. The predominant objective contained in the articles was that of primary diagnostic evaluation (27%), and the most frequent study design was case series (33.7%). A mere 7.8% of the studies were designed adequately with respect to the stated objectives. There was no statistical difference in the methodological quality of studies indexed for the ISI Web and the MEDLINE database. The studies published in both national journals, indexed for the MEDLINE database, and international journals, indexed for the ISI Web, demonstrate weak methodology, with research poorly designed to meet the proposed objectives. There is much scientific work to be done in order to decrease uncertainty in the field analysed.

  13. MR imaging of the articular cartilage of the knee with arthroscopy as gold standard: assessment of methodological quality of clinical studies

    International Nuclear Information System (INIS)

    Duchateau, Florence; Berg, Bruno C. vande

    2002-01-01

    The purpose of this study was to assess the methodological quality of articles addressing the value of MR imaging of the knee cartilage with arthroscopy as a standard. Relevant papers were selected after Medline review (MEDLINE database search including the terms ''cartilage'' ''knee'', ''MR'' and ''arthroscopy''). Two observers reviewed independently 29 selected articles to determine how each study had met 15 individual standards that had been previously developed to assess the methodological quality of clinical investigations. The following criteria were met in variable percentage of articles including adequate definition of purpose (100%), statistical analysis (90%), avoidance of verification bias (86%), patient population description (83%), reference standard (79%), review bias (79%), study design (66%), inclusion criteria (41%) and method of analysis (41.5%), avoidance of diagnostic-review bias (24%), exclusion criteria (21%), indeterminate examination results (17%), analysis criteria (14%), interobserver reliability (14%) and intraobserver reliability (7%). The assessment of the methodological quality of clinical investigations addressing the value of MR imaging in the evaluation of the articular cartilage of the knee with arthroscopy as the standard of reference demonstrated that several standards were rarely met in the literature. Efforts should be made to rely on clearly defined lesion criteria and to determine reliability of the observations. (orig.)

  14. Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

    Directory of Open Access Journals (Sweden)

    Humam Saltaji

    Full Text Available To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.Sequence generation was assessed to be inadequate (at unclear or high risk of bias in 68% (n = 367 of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%. Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154 and 40.5% (n = 219 of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427 of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95 of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%, while the method of blinding was appropriate in 53% (n = 286 of the trials. We identified a significant decrease over time (1955-2013 in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05 in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

  15. Temas ambientais como "temas geradores": contribuições para uma metodologia educativa ambiental crítica, transformadora e emancipatória Environmental issues as generating issues: contributions to a critical, transforming and emancipating environmental educating methodology

    Directory of Open Access Journals (Sweden)

    Marília Freitas de Campos Tozoni-Reis

    2006-06-01

    Full Text Available A educação ambiental crítica e emancipatória exige que os conhecimentos sejam apropriados, construídos, de forma dinâmica, coletiva, cooperativa, contínua, interdisciplinar, democrática e participativa, voltados para a construção de sociedades sustentáveis. Este artigo trata dos temas ambientais como temas geradores para a educação ambiental, inspirados na pedagogia Paulo Freire, para quem educar é um ato de conhecimento da realidade concreta, das situações vividas, um processo de aproximação crítica da própria realidade: compreender, refletir, criticar e agir são as ações pedagógicas pretendidas. Os temas geradores são, portanto, estratégias metodológicas de um processo de conscientização da realidade opressora vivida nas sociedades desiguais; são o ponto de partida para o processo de construção da descoberta, e, por emergir do saber popular, os temas geradores são extraídos da prática de vida dos educandos, substituindo os conteúdos tradicionais e buscados através da pesquisa do universo dos educandos. O caráter político da pedagogia freireana faz-se presente, de forma radical, nos temas geradores, isto é, temas geradores só são geradores de ação-reflexão-ação se forem carregados de conteúdos sociais e políticos com significado concreto para a vida dos educandos. Assim, as propostas educativas ambientais conscientizadoras podem tomar os temas ambientais locais como temas geradores desta ação conscientizadora, desde que estes temas contenham conteúdos socioambientais significativos para os educandos e sejam definidos coletiva e participativamente.The emancipating and critical environmental education demands that knowledge must be adequate, build up in a dynamic, collective, cooperating, continuous, interdisciplinary, democratic and participating way directed to the construction of self-maintaining societies. This paper deals with environmental issues as generating issues for an environmental

  16. Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues.

    Science.gov (United States)

    Edwards, Rhiannon Tudor; Charles, Joanna Mary; Lloyd-Williams, Huw

    2013-10-24

    If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Electronic databases and organisation websites were searched using a 22 year time horizon (1990-2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may find it useful to think in this broader

  17. Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues

    Science.gov (United States)

    2013-01-01

    Background If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Methods Electronic databases and organisation websites were searched using a 22 year time horizon (1990–2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. Results We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. Conclusions In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may

  18. Theory of mind and Verstehen (understanding) methodology.

    Science.gov (United States)

    Kumazaki, Tsutomu

    2016-09-01

    Theory of mind is a prominent, but highly controversial, field in psychology, psychiatry, and philosophy of mind. Simulation theory, theory-theory and other views have been presented in recent decades, none of which are monolithic. In this article, various views on theory of mind are reviewed, and methodological problems within each view are investigated. The relationship between simulation theory and Verstehen (understanding) methodology in traditional human sciences is an intriguing issue, although the latter is not a direct ancestor of the former. From that perspective, lessons for current clinical psychiatry are drawn. © The Author(s) 2016.

  19. Algunos aspectos metodológicos de la investigación en resolución de problemas en física: una revisión Some methodological issues involved in Physics problems solving: a review

    Directory of Open Access Journals (Sweden)

    Laura Buteler

    2008-01-01

    Full Text Available El trabajo presenta una revisión de los aspectos metodológicos involucrados en el estudio de las representaciones mentales puestas en juego por las personas para realizar ciertas tareas cognitivas. La revisión se acota al ámbito de la investigación en enseñanza de las ciencias y en particular, a un conjunto de investigaciones que abordan tareas estrechamente relacionadas con la resolución de problemas en Física. La revisión permite analizar y discutir los alcances y limitaciones de las decisiones metodológicas usuales para el estudio de la resolución de problemas en Física. Se ponen en consideración algunas directrices metodológicas plausibles de ser tenidas en cuenta para esta tarea.This work presents a review of the methodological issues involved in the studies of the representations used by people carrying out cognitive tasks. The review is based on literature dealing with cognitive tasks related to Physics problem solving. This review allows the analysis and discussion of the advantages and disadvantages of the usual methodological decisions in Physics problem solving. Methodological directions for physics problem solving are considered.

  20. Health Information Technologies-Academic and Commercial Evaluation (HIT-ACE) methodology: description and application to clinical feedback systems.

    Science.gov (United States)

    Lyon, Aaron R; Lewis, Cara C; Melvin, Abigail; Boyd, Meredith; Nicodimos, Semret; Liu, Freda F; Jungbluth, Nathaniel

    2016-09-22

    Health information technologies (HIT) have become nearly ubiquitous in the contemporary healthcare landscape, but information about HIT development, functionality, and implementation readiness is frequently siloed. Theory-driven methods of compiling, evaluating, and integrating information from the academic and commercial sectors are necessary to guide stakeholder decision-making surrounding HIT adoption and to develop pragmatic HIT research agendas. This article presents the Health Information Technologies-Academic and Commercial Evaluation (HIT-ACE) methodology, a structured, theory-driven method for compiling and evaluating information from multiple sectors. As an example demonstration of the methodology, we apply HIT-ACE to mental and behavioral health measurement feedback systems (MFS). MFS are a specific class of HIT that support the implementation of routine outcome monitoring, an evidence-based practice. HIT-ACE is guided by theories and frameworks related to user-centered design and implementation science. The methodology involves four phases: (1) coding academic and commercial materials, (2) developer/purveyor interviews, (3) linking putative implementation mechanisms to hit capabilities, and (4) experimental testing of capabilities and mechanisms. In the current demonstration, phase 1 included a systematic process to identify MFS in mental and behavioral health using academic literature and commercial websites. Using user-centered design, implementation science, and feedback frameworks, the HIT-ACE coding system was developed, piloted, and used to review each identified system for the presence of 38 capabilities and 18 additional characteristics via a consensus coding process. Bibliometic data were also collected to examine the representation of the systems in the scientific literature. As an example, results are presented for the application of HIT-ACE phase 1 to MFS wherein 49 separate MFS were identified, reflecting a diverse array of characteristics

  1. Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

    Directory of Open Access Journals (Sweden)

    Kátia Regina da Silva

    Full Text Available The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings.Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.We developed a device registry framework involving the following steps: (1 Data standards definition and representation of the research workflow, (2 Development of electronic case report forms using REDCap (Research Electronic Data Capture, (3 Data collection according to the clinical research workflow and, (4 Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5 Data quality control and (6 Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT we found 130 clinical trials which are potentially correlated with our pacemaker registry.This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to

  2. Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

    Science.gov (United States)

    da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V.

    2013-01-01

    Background The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Purpose Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. Methods and Results We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. Conclusion This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework

  3. Body composition in Nepalese children using isotope dilution: the production of ethnic-specific calibration equations and an exploration of methodological issues.

    Science.gov (United States)

    Devakumar, Delan; Grijalva-Eternod, Carlos S; Roberts, Sebastian; Chaube, Shiva Shankar; Saville, Naomi M; Manandhar, Dharma S; Costello, Anthony; Osrin, David; Wells, Jonathan C K

    2015-01-01

    Background. Body composition is important as a marker of both current and future health. Bioelectrical impedance (BIA) is a simple and accurate method for estimating body composition, but requires population-specific calibration equations. Objectives. (1) To generate population specific calibration equations to predict lean mass (LM) from BIA in Nepalese children aged 7-9 years. (2) To explore methodological changes that may extend the range and improve accuracy. Methods. BIA measurements were obtained from 102 Nepalese children (52 girls) using the Tanita BC-418. Isotope dilution with deuterium oxide was used to measure total body water and to estimate LM. Prediction equations for estimating LM from BIA data were developed using linear regression, and estimates were compared with those obtained from the Tanita system. We assessed the effects of flexing the arms of children to extend the range of coverage towards lower weights. We also estimated potential error if the number of children included in the study was reduced. Findings. Prediction equations were generated, incorporating height, impedance index, weight and sex as predictors (R (2) 93%). The Tanita system tended to under-estimate LM, with a mean error of 2.2%, but extending up to 25.8%. Flexing the arms to 90° increased the lower weight range, but produced a small error that was not significant when applied to children <16 kg (p 0.42). Reducing the number of children increased the error at the tails of the weight distribution. Conclusions. Population-specific isotope calibration of BIA for Nepalese children has high accuracy. Arm position is important and can be used to extend the range of low weight covered. Smaller samples reduce resource requirements, but leads to large errors at the tails of the weight distribution.

  4. Body composition in Nepalese children using isotope dilution: the production of ethnic-specific calibration equations and an exploration of methodological issues

    Directory of Open Access Journals (Sweden)

    Delan Devakumar

    2015-03-01

    Full Text Available Background. Body composition is important as a marker of both current and future health. Bioelectrical impedance (BIA is a simple and accurate method for estimating body composition, but requires population-specific calibration equations.Objectives. (1 To generate population specific calibration equations to predict lean mass (LM from BIA in Nepalese children aged 7–9 years. (2 To explore methodological changes that may extend the range and improve accuracy.Methods. BIA measurements were obtained from 102 Nepalese children (52 girls using the Tanita BC-418. Isotope dilution with deuterium oxide was used to measure total body water and to estimate LM. Prediction equations for estimating LM from BIA data were developed using linear regression, and estimates were compared with those obtained from the Tanita system. We assessed the effects of flexing the arms of children to extend the range of coverage towards lower weights. We also estimated potential error if the number of children included in the study was reduced.Findings. Prediction equations were generated, incorporating height, impedance index, weight and sex as predictors (R2 93%. The Tanita system tended to under-estimate LM, with a mean error of 2.2%, but extending up to 25.8%. Flexing the arms to 90° increased the lower weight range, but produced a small error that was not significant when applied to children <16 kg (p 0.42. Reducing the number of children increased the error at the tails of the weight distribution.Conclusions. Population-specific isotope calibration of BIA for Nepalese children has high accuracy. Arm position is important and can be used to extend the range of low weight covered. Smaller samples reduce resource requirements, but leads to large errors at the tails of the weight distribution.

  5. Problem-based learning versus a traditional educational methodology: a comparison of preclinical and clinical periodontics performance.

    Science.gov (United States)

    Rich, Sandra K; Keim, Robert G; Shuler, Charles F

    2005-06-01

    To evaluate efficacy of a problem-based learning (PBL) pedagogy in preclinical and clinical teaching, test scores of 234 undergraduate dental students from the conventionally taught classes of 2003 and 2004 were compared with scores of 274 dental students from the PBL classes of 2005 and 2006. Although the groups' means were close together, t-test analysis of scores revealed that PBL students performed significantly better than traditional (TRAD) students on midterm (p=.0001) and final (p=.015) examinations taken on student partner/mock patients. ANOVA comparing the classes with each other showed significant differences for the midterm and final, but not for the clinical examination. Further multiple comparison tests (Tukey HSD) for the midterm and final revealed that differences specifically reflected superior performance of PBL classes against one of the TRAD classes (2004). There was no difference in performance between PBL (n=134) and TRAD (n=233) students on examinations taken with actual clinical patients who were undergoing nonsurgical periodontal treatment. Over a two-year period, PBL students rated their program instructors at a mean of 4.41 on a Likert-type scale of 1 (not helpful) to 5 (outstanding). The program provides a PBL model for teaching preclinical and clinical skills supported by a four-year evaluation of manual skills outcomes.

  6. Towards an ICF-based clinical measure of functioning in people with ankylosing spondylitis: a methodological exploration.

    Science.gov (United States)

    Cieza, A; Hilfiker, R; Boonen, A; van der Heijde, D; Braun, J; Stucki, G

    2009-01-01

    To explore whether it is possible to construct clinical measures of functioning for patients with ankylosing spondylitis (AS) by integrating information obtained across categories of the International Classification of Functioning, Disability and Health (ICF). Sixty-eight ICF categories that were identified as relevant by patients with AS and that covered body functions, structures, and activity and participation were analysed based on the Rasch model for ordered response options. The following properties were studied: unidimensionality, reliability, fit of the ICF categories to the Rasch model, the appropriateness of the order of the response options of the ICF qualifier, and the targeting between the ICF categories and the person's abilities. After accounting for disordered thresholds and misfitting ICF categories, a clinical measure of functioning for AS was proposed that contained 64 ICF categories. On the basis of a transformation table, the raw scores obtained by adding the answers to the 64 ICF categories can be transformed to the Rasch logit scale and to a meaningful interval scale ranging from zero to 100. For the first time, it has been shown that clinical measures of functioning, in principle, can be constructed based on the comprehensive ICF framework covering body functions and structures and activities and participation domains. The results of this investigation are preliminary and must be validated, but they are promising and can contribute to the acceptance and usefulness of the ICF in clinical practice.

  7. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.

    2008-01-01

    of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  8. The Multidisciplinary Issue of Obesity: Epidemiological Studies, Company Strategies and Policy Actions: A Systematic and Methodological Review of the Research Approaches.

    Science.gov (United States)

    Paffarini, Chiara; Fioriti, Linda; Marchini, Laura

    2016-01-01

    The work is a review of studies carried out in recent years on the epidemic of obesity. The issue of obesity includes several disciplines: medical-health, socio-economic impacts and policy actions. This review focuses on the three main areas of study: the first area is about patent epidemiological researches, the second one analyzes the companies that focus on research and development towards less obesogenic foods and the third one investigates on the policies actions adopted by European governments to address the problem of obesity. This study underlined a more strong scientific production relative to US and UK countries compared with the southern countries of the world where the attention of scientists and politicians to the obesity is lower due to the problems of food security rather than to those of inappropriate lifestyle. The study of the cause and effects of this phenomenon through epidemiological researches is a good tool to counteract obesity. However, the development of policies controlling and contrasting obesogenic food production is fundamental like greater communication to consumers on the risks of obesity and foods processing.

  9. EULAR/PRINTO/PRES criteria for Henoch-Schönlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part I: Overall methodology and clinical characterisation

    DEFF Research Database (Denmark)

    Ruperto, Nicolino; Ozen, Seza; Pistorio, Angela

    2010-01-01

    To report methodology and overall clinical, laboratory and radiographic characteristics for Henoch-Schönlein purpura (HSP), childhood polyarteritis nodosa (c-PAN), c-Wegener granulomatosis (c-WG) and c-Takayasu arteritis (c-TA) classification criteria.......To report methodology and overall clinical, laboratory and radiographic characteristics for Henoch-Schönlein purpura (HSP), childhood polyarteritis nodosa (c-PAN), c-Wegener granulomatosis (c-WG) and c-Takayasu arteritis (c-TA) classification criteria....

  10. Development of standardized methodology for identifying toxins in clinical samples and fish species associated with tetrodotoxin-borne poisoning incidents

    Directory of Open Access Journals (Sweden)

    Tai-Yuan Chen

    2016-01-01

    Full Text Available Tetrodotoxin (TTX is a naturally occurring toxin in food, especially in puffer fish. TTX poisoning is observed frequently in South East Asian regions. In TTX-derived food poisoning outbreaks, the amount of TTX recovered from suspicious fish samples or leftovers, and residual levels from biological fluids of victims are typically trace. However, liquid chromatography–mass spectrometry and liquid chromatography–tandem mass spectrometry methods have been demonstrated to qualitatively and quantitatively determine TTX in clinical samples from victims. Identification and validation of the TTX-originating seafood species responsible for a food poisoning incident is needed. A polymerase chain reaction-based method on mitochondrial DNA analysis is useful for identification of fish species. This review aims to collect pertinent information available on TTX-borne food poisoning incidents with a special emphasis on the analytical methods employed for TTX detection in clinical laboratories as well as for the identification of TTX-bearing species.

  11. Critical reading and critical thinking--study design and methodology: a personal approach on how to read the clinical literature.

    Science.gov (United States)

    Lipman, Timothy O

    2013-04-01

    The volume of medical literature grows exponentially. Yet we are faced with the necessity to make clinical decisions based on the availability and quality of scientific information. The general strength (reliability, robustness) of any interpretation that guides us in clinical decision making is dependent on how information was obtained. All information and medical studies and, consequently, all conclusions are not created equal. It is incumbent upon us to be able to assess the quality of the information that guides us in the care of our patients. Being able to assess medical literature critically requires use of critical reading and critical thinking skills. To achieve these skills, to be able to analyze medical literature critically, takes a combination of education and practice, practice, and more practice.

  12. Influencing risk behavior of sexually transmitted infection clinic visitors: efficacy of a new methodology of motivational preventive counseling.

    Science.gov (United States)

    Kuyper, Lisette; de Wit, John; Heijman, Titia; Fennema, Han; van Bergen, Jan; Vanwesenbeeck, Ine

    2009-06-01

    A quasi-experimental study was conducted at a Dutch sexually transmitted infection (STI) clinic to compare the effects of educational counseling and motivational interviewing (MI)-based HIV/STI counseling on determinants of condom use and partner notification at 6-month follow-up. It also examined the feasibility of MI-based counseling in a busy real-life clinic. The counseling approaches were historically compared: respondents in the control condition were recruited between April and July 2005, those in the experimental condition between September and December 2005. The study involved 428 participants. These were all high-risk clients of the STI clinic. Their mean age was 33.7 years, and 39.6% were female. The study showed that MI-based counseling had a more positive effect on self-efficacy, intentions to use condoms with casual partners, and long-term condom use with steady partners. It had no adversarial outcomes on other social cognitions or behaviors compared to educational counseling. Furthermore, MI-based counseling is experienced as a more respectful and structured way of counseling. MI-based counseling was relatively easily implemented into the current clinic procedures. In addition to the implementation of the training, neither specialized staff nor additional or longer client visits were needed. However, some nurses indicated that the new method required more personal investment and effort. Limitations of the current study are the low response rates, the high educational level of most participants, and the small sample size regarding partner notification. Nonetheless, we conclude that MI-based counseling was a more effective approach to preventive counseling compared to educational counseling and feasible in the busy real-life setting.

  13. Clinical evidence of traditional vs fast track recovery methodologies after total arthroplasty for osteoarthritic knee treatment. A retrospective observational study

    Science.gov (United States)

    Castorina, Sergio; Guglielmino, Claudia; Castrogiovanni, Paola; Szychlinska, Marta Anna; Ioppolo, Francesco; Massimino, Paolo; Leonardi, Pietro; Maci, Christian; Iannuzzi, Maurizio; Di Giunta, Angelo; Musumeci, Giuseppe

    2017-01-01

    Summary Background During the last years, programs to enhance postoperative recovery and decrease morbidity after total knee arthroplasty, have been developed across a variety of surgical procedures and referred to as “Fast-Track Surgery”. In this study we aimed to find some answers in the management of osteoarthritic patients subjected to total knee arthroplasty, by using the Fast-Track methodology. To this purpose we evaluated parameters such as early mobilization of patients, better pain management, bleeding, possible complications, reduced hospitalization time, an overall improved recovery and patient satisfaction. Methods 132 patients were selected, of which, 95 treated with “Fast Track” method and 37 treated with traditional method (control group). All the patients were hospitalized and underwent the same rehabilitation program for the first three days after surgery. Results In both groups, the parameters of pain and deformity demonstrated the most rapid improvement, while those of function and movement were normalized as gradual and progressive improvement over the next 2 months. The different functional test used (Barthel, MRC, VAS) showed that the mean values were significantly greater in Fast Track group when compared to the control. Conclusion The results of the study confirm that the application of the Fast Track protocol in orthopaedics after total knee replacement results in rapid post-surgery recovery. Level of evidence IV. Case series, low-quality cohort or case-control studies. PMID:29387645

  14. Applying Lean Six Sigma methodologies to improve efficiency, timeliness of care, and quality of care in an internal medicine residency clinic.

    Science.gov (United States)

    Fischman, Daniel

    2010-01-01

    Patients' connectedness to their providers has been shown to influence the success of preventive health and disease management programs. Lean Six Sigma methodologies were employed to study workflow processes, patient-physician familiarity, and appointment compliance to improve continuity of care in an internal medicine residency clinic. We used a rapid-cycle test to evaluate proposed improvements to the baseline-identified factors impeding efficient clinic visits. Time-study, no-show, and patient-physician familiarity data were collected to evaluate the effect of interventions to improve clinic efficiency and continuity of medical care. Forty-seven patients were seen in each of the intervention and control groups. The wait duration between the end of triage and the resident-patient encounter was statistically shorter for the intervention group. Trends toward shorter wait times for medical assistant triage and total encounter were also seen in the intervention group. On all measures of connectedness, both the physicians and patients in the intervention group showed a statistically significant increased familiarity with each other. This study shows that incremental changes in workflow processes in a residency clinic can have a significant impact on practice efficiency and adherence to scheduled visits for preventive health care and chronic disease management. This project used a structured "Plan-Do-Study-Act" approach.

  15. Reliability of the U.S. Army Ambulatory Care Data Base (ACDB) Study: Methodology and Clinical Findings

    Science.gov (United States)

    1989-02-01

    medical record as Flu Symptoms and Inflammation of Mucous Membrane of the Nose. In such cases, the Principal Investigator, in consultation with staff...Nonavailability could have been caused by a patient’s clinical appointment or relocation, personal retention of records, selection of the record for a quality...8217, TENITtlS 233𔃻 CIS VULVA 6141 H1IONIC SAIPINGITIS/OOPHORITIS 2 i-.- 1 Nip"- HYEI;AVI, k 213 SYPILIS 𔃻 4CONSYLOMAIA 6201 CORPiiS LUTEUM CYST ,*N2’. f

  16. Addressing mental health disparities through clinical competence not just cultural competence: the need for assessment of sociocultural issues in the delivery of evidence-based psychosocial rehabilitation services.

    Science.gov (United States)

    Yamada, Ann-Marie; Brekke, John S

    2008-12-01

    Recognition of ethnic/racial disparities in mental health services has not directly resulted in the development of culturally responsive psychosocial interventions. There remains a fundamental need for assessment of sociocultural issues that have been linked with the expectations, needs, and goals of culturally diverse consumers with severe and persistent mental illness. The authors posit that embedding the assessment of sociocultural issues into psychosocial rehabilitation practice is one step in designing culturally relevant empirically supported practices. It becomes a foundation on which practitioners can examine the relevance of their interventions to the diversity encountered in everyday practice. This paper provides an overview of the need for culturally and clinically relevant assessment practices and asserts that by improving the assessment of sociocultural issues the clinical competence of service providers is enhanced. The authors offer a conceptual framework for linking clinical assessment of sociocultural issues to consumer outcomes and introduce an assessment tool adapted to facilitate the process in psychosocial rehabilitation settings. Emphasizing competent clinical assessment skills will ultimately offer a strategy to address disparities in treatment outcomes for understudied populations of culturally diverse consumers with severe and persistent mental illness.

  17. Connecting pre-marketing clinical research and medical practice : opinion-based study of core issues and possible changes in drug regulation

    NARCIS (Netherlands)

    Wieringa, N.F; Peschar, J.L.; Denig, P; de Graeff, P.A.; Vos, R

    2003-01-01

    Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap. Methods: Interviews with 47 physicians and pharmacists who

  18. Hipnose e dor: proposta de metodologia clínica e qualitativa de estudo Hypnosis and pain: proposal of a clinical and qualitative research methodology

    Directory of Open Access Journals (Sweden)

    Maurício da Silva Neubern

    2009-08-01

    Full Text Available O presente trabalho visa apresentar uma proposta metodológica clínica e qualitativa para o estudo da relação entre hipnose e dor. Inicialmente, critica-se a pretensão de atribuir legitimidade científica exclusivamente para propostas estatísticas sobre o tema. Em seguida, são destacados alguns pressupostos da metodologia clínica e qualitativa, como a construção da realidade e das informações, as dimensões estética e técnica da relação terapêutica e a concepção da dor enquanto processo subjetivo. Uma vinheta clínica é utilizada de forma ilustrativa de modo a destacar as etapas e processos da pesquisa, como o uso dos registros e os processos interpretativos. Conclui-se o artigo ressaltando que a pertinência dessa metodologia se dá, basicamente, por abordar a dimensão subjetiva da relação entre dor e hipnose e por conceber o contexto como um conjunto de processos que não devem ser isolados, mas integrados à pesquisa.The purpose of this work is to present a proposal of clinical and qualitative methodology for the study of the relationship between hypnosis and pain. Initially, the pretension of attributing scientific legitimacy exclusively to statistical approaches on the theme is criticized. Then, some premises of the clinical and qualitative methodology are underlined, such as the construction of reality and information, esthetic and technical dimensions of therapeutic relationship and conception of pain as a subjective process. An illustrative clinical vignette is used so as to highlight the steps and processes of the research, such as the use of records and interpretative processes. The article is concluded emphasizing that the pertinence of this methodology is, basically, on its approach of relationship subjective dimension between pain and hypnosis and in its conceiving of the context as a set of processes that should not be isolated, but integrated into the research.

  19. User requirements for innovative nuclear reactors and fuel cycle technologies in the area of economics, environment, safety, waste management, proliferation resistance and cross cutting issues, and methodology for innovative technologies assessment

    International Nuclear Information System (INIS)

    Kupitz, Juergen; Depisch, Frank; Allan, Colin

    2003-01-01

    The IAEA General Conference in 2000 has invited ''all interested Member States to combine their efforts under the aegis of the Agency in considering the issues of the nuclear fuel cycle, in particular by examining innovative and proliferation-resistant nuclear technology''. In response to this invitation, the IAEA initiated an ''International Project on Innovative Nuclear Reactors and Fuel Cycles'', INPRO. The overall objectives of INPRO is to help to ensure that nuclear energy is available to contribute in fulfilling in a sustainable manner energy needs in the 21st century, and to bring together all interested Member States, both technology holders and technology users, to consider jointly the international and national actions required to achieve desired innovations in nuclear reactors and fuel cycles that use sound and economically competitive technology. Phase-I of INPRO was initiated in May 2001. During Phase-I, work was subdivided in two sub phase: Phase 1A (finished in June 2003) and Phase 1B (started in June 2003). Phase 1A dealt with the definition of Basic Principles, User Requirements and Criteria, and the development of a methodology for the evaluation of innovative nuclear technologies. In Phase 1A, task groups for several areas were established: (a) Prospects and Potentials of Nuclear Power, (b) Economics; (c) Sustainability and Environment, (d) Safety of Nuclear Installations, (e) Waste Management, (f) Proliferation Resistance, (g) Crosscutting issues and (h) for the Methodology for Assessment. In Phase-IB evaluations of innovative nuclear energy technologies will be performed by Member States against the INPRO Basic Principles, User Requirements and Criteria. This paper summarizes the results achieved in the Phase 1A of INPRO and is a cooperative effort of the INPRO team, consisting of all INPRO cost free experts and task managers. (author)

  20. Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies.

    Science.gov (United States)

    Jayasinha, Yasangi

    2016-01-01

    Increasingly, health care quality indicators are focusing on patient-centeredness as an indicator of performance. The National Quality Forum lists assessment of patient experience, often conducted using patient surveys, as a top priority. We developed a patient-reported time stamp data collection tool that was used to collect cycle times in a safety net hospital-based outpatient pediatrics clinic. Data were collected using patient-reported survey to obtain cycle times in Pediatric clinic, as well as qualitative and quantitative patient satisfaction data. Several rapid-cycle improvements were performed using Lean Six Sigma methodologies to reduce cycle time by eliminating waste and revise unnecessary processes to improve operational effectiveness and patient and staff satisfaction. A total of 94 surveys were collected and revealed average cycle time of 113 minutes. Our measured patient satisfaction rating was 87%. Discharge and check-in processes were identified as the least efficient and were targeted for intervention. Following implementation, the overall cycle time was decreased from 113 to 90 minutes. Patient satisfaction ratings increased from 87% to 95%. We demonstrate that using Lean Six Sigma tools can be invaluable to clinical restructuring and redesign and results in measurable, improved outcomes in care delivery.

  1. Design and methodology of a randomized clinical trial of home-based telemental health treatment for U.S. military personnel and veterans with depression.

    Science.gov (United States)

    Luxton, David D; Pruitt, Larry D; O'Brien, Karen; Stanfill, Katherine; Jenkins-Guarnieri, Michael A; Johnson, Kristine; Wagner, Amy; Thomas, Elissa; Gahm, Gregory A

    2014-05-01

    Home-based telemental health (TMH) treatments have the potential to address current and future health needs of military service members, veterans, and their families, especially for those who live in rural or underserved areas. The use of home-based TMH treatments to address the behavioral health care needs of U.S. military healthcare beneficiaries is not presently considered standard of care in the Military Health System. The feasibility, safety, and clinical efficacy of home-based TMH treatments must be established before broad dissemination of home-based treatment programs can be implemented. This paper describes the design, methodology, and protocol of a clinical trial that compares in-office to home-based Behavioral Activation for Depression (BATD) treatment delivered via web-based video technology for service members and veterans with depression. This grant funded three-year randomized clinical trial is being conducted at the National Center for Telehealth and Technology at Joint-base Lewis-McChord and at the Portland VA Medical Center. Best practice recommendations regarding the implementation of in-home telehealth in the military setting as well as the cultural and contextual factors of providing in-home care to active duty and veteran military populations are also discussed. Published by Elsevier Inc.

  2. FACE Analysis as a Fast and Reliable Methodology to Monitor the Sulfation and Total Amount of Chondroitin Sulfate in Biological Samples of Clinical Importance

    Directory of Open Access Journals (Sweden)

    Evgenia Karousou

    2014-06-01

    Full Text Available Glycosaminoglycans (GAGs due to their hydrophilic character and high anionic charge densities play important roles in various (pathophysiological processes. The identification and quantification of GAGs in biological samples and tissues could be useful prognostic and diagnostic tools in pathological conditions. Despite the noteworthy progress in the development of sensitive and accurate methodologies for the determination of GAGs, there is a significant lack in methodologies regarding sample preparation and reliable fast analysis methods enabling the simultaneous analysis of several biological samples. In this report, developed protocols for the isolation of GAGs in biological samples were applied to analyze various sulfated chondroitin sulfate- and hyaluronan-derived disaccharides using fluorophore-assisted carbohydrate electrophoresis (FACE. Applications to biologic samples of clinical importance include blood serum, lens capsule tissue and urine. The sample preparation protocol followed by FACE analysis allows quantification with an optimal linearity over the concentration range 1.0–220.0 µg/mL, affording a limit of quantitation of 50 ng of disaccharides. Validation of FACE results was performed by capillary electrophoresis and high performance liquid chromatography techniques.

  3. Quantitative Analysis of Motor Status in Parkinson’s Disease Using Wearable Devices: From Methodological Considerations to Problems in Clinical Applications

    Directory of Open Access Journals (Sweden)

    Masahiko Suzuki

    2017-01-01

    Full Text Available Long-term and objective monitoring is necessary for full assessment of the condition of patients with Parkinson’s disease (PD. Recent advances in biotechnology have seen the development of various types of wearable (body-worn sensor systems. By using accelerometers and gyroscopes, these devices can quantify motor abnormalities, including decreased activity and gait disturbances, as well as nonmotor signs, such as sleep disturbances and autonomic dysfunctions in PD. This review discusses methodological problems inherent in wearable devices. Until now, analysis of the mean values of motion-induced signals on a particular day has been widely applied in the clinical management of PD patients. On the other hand, the reliability of these devices to detect various events, such as freezing of gait and dyskinesia, has been less than satisfactory. Quantification of disease-specific changes rather than nonspecific changes is necessary.

  4. [Advantages and disadvantages of incorporating qualitative methodology in the evaluation of health services. A practical case: evaluation of a high-resolution clinic].

    Science.gov (United States)

    Alvarez Del Arco, D; Rodríguez Rieiro, C; Sanchidrián De Blás, C; Alejos, B; Plá Mestre, R

    2012-01-01

    We examined the usefulness of incorporating a qualitative phase in the evaluation of the quality of care in a high-resolution medical service carried out with quantitative methods. A quantitative research was performed using a structured questionnaire and selecting interviewees by systematic randomized sampling methods (n=320). In addition, a qualitative research was carried on through semi-structured interviews with patients selected by convenience criteria (n=11), observations in the care assistance circuit, and a group interview with health professionals working in the service. A multidisciplinary research team conducted an individual analysis of the information collected in both quantitative and qualitative phases. Subsequently, three meetings based on group brainstorming techniques were held to identify the diverse contributions of each of the methodologies employed to the research, using affinity graphs to analyse the different results obtained in both phases and evaluate possible bias arising from the use of qualitative methods. Qualitative research allowed examining specific aspects of the health care service that had been collected in the quantitative phase, harmonizing the results obtained in the previous phase, giving in-depth data on the reasons for patient dissatisfaction with specific aspects, such as waiting times and available infrastructures, and identifying emerging issues of the service which had not been previously assessed. Overall, the qualitative phase enriched the results of the research. It is appropriate and recommendable to incorporate this methodological approach in research aimed at evaluating the quality of the service in specific health care settings, since it is provided first hand, by the voice of the customer. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

  5. Clinical audit on "Evaluation of special issues in adolescents with cancer treated in an adult cancer setting": An Indian experience

    Directory of Open Access Journals (Sweden)

    Naveen S Salins

    2012-01-01

    Results: Pain was the most common physical symptom seen in all 10 patients. 3 out of 10 patients were involved in decision making, 3 out of 10 patients had identity issues and 4 out of 10 patients had peer group isolation issues. Only 3 were aware of diagnosis and none were aware of treatment outcomes and mortality. 4 out of 10 had anxiety and depression and 3 out of 10 had body image issues. Sexuality, spiritual and existential issues were not explored in any of the patients studied. Conclusion: The outcomes of the study were in an adult oncology setting there was a poor recognition of key adolescent issues such as sexuality, body image, identity and peer group isolation. The psychosocial supports to these adolescents were minimal and spiritual and existential issues were not explored. The inferences drawn from this study suggested a need for multidisciplinary team approach oriented in handling adolescent care needs and preferably to have a dedicated space that will help the peer group to interact, bond and cope better with the illness.

  6. Meditation: Rationales, Experimental Effects, and Methodological Issues

    Science.gov (United States)

    1986-04-01

    mounted in bringing meditation to the West. It has after all, received the blessings of prominent figures as diverse as the Beatles , Ram Das. Hans Selye...Samuel R. Connally DAJA45-84-M-0439 . 9. PERFORMING ORGANIZATION NAME AND ADDRESS SO. PROGRAM ELEMENT, PROJECT, TASK AREA & WORK UNIT NUMBERS The ...different from Controlling Office) IS. SECURITY CLASS. (of this report) US Army Research Institute for the Behavioral Unclassified and Social Sciences

  7. Methodological issues in regional impacts research

    International Nuclear Information System (INIS)

    Cohen, S.J.

    1990-01-01

    Analysis of the literature concerning regional impacts of climatic change research reveals common elements. Global climatic change scenarios are used to derive regional climate change scenarios, but there is no standard approach for doing so. These scenarios are applied as inputs to impact models that have been used to describe past variations but may not be calibrated for global scenarios. The human element (technology, land use, population density) is generally assumed to remain unchanged. The general process of performing a study on the impacts of projected global warming on the physical and human environments involves three main steps: develop or specify a scenario for global warming for the study area; develop or specify an impact model for the activity in question; and apply the scenario to the impact model. Problems include defining a baseline, resolution of the scenarios, scenario data for regional-scale features, combination of model output with station data, and validation of impact models using archived climate data as inputs. A review of scenario application procedures indicates that four general approaches have been used: the study area baseline is combined with the scenario anomaly of the nearest center of the grid square; the scenario anomaly field is objectively interpreted and combined with the baseline value; the baseline field is objectively interpreted so that data are produced for the same points as the scenario anomaly field; and the baseline and several scenario's anomaly fields are interpolated and combined into one scenario using dynamical/empirical reasoning. 48 refs., 1 fig

  8. Educational neuroscience: definitional, methodological, and interpretive issues.

    Science.gov (United States)

    Byrnes, James P; Vu, Lien T

    2015-01-01

    In this study, we hope to accomplish three aims as follows: (1) provide greater clarity regarding the nature and scope of the field of educational neuroscience, (2) propose a framework for understanding when and how neuroscientific research could be informative for educational practice, and (3) describe some examples of neuroscientific findings from the domains of reading and mathematics that are informative according to this framework. We propose that psychological models of learning-related processes should be the basis of instructional decisions, and that neuroscientific evidence in combination with traditional evidence from psychological experiments should be used to decide among competing psychological models. Our review of the neuroscientific evidence for both reading and mathematics suggests that while much has been learned over the past 20 years, there is still a 'disconnect' between contemporary psychological models that emphasize higher level skills and neuroscientific studies that focus on lower level skills. Moreover, few researchers have used neuroscientific evidence to decide among psychological models, but have focused instead on identifying the brain regions that subtend component skills of reading and math. Nevertheless, neuroscientific studies have confirmed the intrinsic relationship between reading and spoken language, revealed interesting predictive relationships between anatomical structures and reading and math disabilities, and there is the potential for fruitful collaborations between neuroscientists and psychologists in the future. © 2015 John Wiley & Sons, Ltd.

  9. THE METHODOLOGICAL ISSUES OF ECONOMIC MANAGEMENT DECISIONS

    Directory of Open Access Journals (Sweden)

    R. I. Solopenko

    2007-09-01

    Full Text Available The necessity of economic ground of administrative decisions related to the operation, staff, financial, investment, information & telecommunication, innovative, marketing and international economic activities of an aviation enterprise is determined foe such an enterprise, and the procedure of economic substantiation of administrative decisions with use of economico-mathematical modelling in automated control system (ACS for an aviation enterprise is implemented.

  10. Issues, controversies, and clinical utility of combined PET/CT imaging: what is the interpreting physician facing?

    International Nuclear Information System (INIS)

    Blodgett, T.M.; Casagranda, B.; Townsend, D.W.; Meltzer, C.C.

    2005-01-01

    Objective: This article identifies the most commonly encountered issues of combined PET/CT and shows the wide variability in perceived possible solutions to these issues. This article will serve as a catalyst to stimulate discussion between experts in both radiology and nuclear medicine. Conclusion: Combining a PET tomography and CT scanner into a single unit amounts to advantages that are not merely additive, but synergistic. Even PET/CT skeptics will embrace the technology after becoming acquainted with the possibilities and will accept the reality that there is no return to PET only

  11. Issues in Selecting Methods of Evaluating Clinical Competence in the Health Professions: Implications for Athletic Training Education

    Science.gov (United States)

    Middlemas, David A.; Hensal, Carleton

    2009-01-01

    Objectives: To examine methods used to evaluate the clinical competence and proficiency of students in medicine and allied health professions. To identify factors that would be valuable to educators in athletic training and other medical and allied health professions in the development and use of clinical assessment methods. Data Sources: We…

  12. Clínica da atividade e cartografia: construindo metodologias de análise do trabalho Clinic of activity and cartography: constructing methodologies for analysis of the work

    Directory of Open Access Journals (Sweden)

    Danielle Vasconcelos Teixeira

    2009-04-01

    Full Text Available As questões formuladas no artigo foram disparadas por experiências vividas ao longo dos últimos anos em pesquisas que partem do princípio de que a temática saúde e trabalho, como objeto de investigação científica, tem uma especificidade que não pode ser tomada com posturas de exterritorialidade no que diz respeito à relação do pesquisador e do objeto a ser investigado. As questões dos mundos do trabalho não podem estar baseadas apenas em quadros analíticos construídos a partir de um distanciamento da complexidade engendrada onde o trabalho acontece. Propõe-se uma direção metodológica de pesquisa que articula investigação e intervenção na direção do diálogo, da interlocução entre os diferentes saberes - disciplinares ou não - com o objetivo de potencializar estratégias utilizadas pelos trabalhadores para lidar com a variabilidade das situações de trabalho. Com esse objetivo, traz a contribuição da Clínica da Atividade como importante ferramenta metodológica.The issues raised in this article were incited by experiences lived in the last years in studies that take as principle that Health and Work, as scientific research objects, have specificities that can not be considered from exterritoriality positions, regarding the relationship between the researcher and the object being investigated. Issues about work can not be based only on analytical views in a distant way of the complexity engendered where work happens. This article proposes a methodological direction of research that articulates research and intervention in a direction to dialogue, to the interchange between different knowledges - disciplinary or not - in order to strengthen strategies used by workers to deal with the variability of work situations. With that purpose, it brings the contribution of the Clinic of Activity as an important methodological tool.

  13. Reflecting on imagery: a clinical perspective and overview of the special issue of memory on mental imagery and memory in psychopathology.

    Science.gov (United States)

    Hackmann, Ann; Holmes, Emily A

    2004-07-01

    The authors provide an overview of the papers in the special issue of Memory on mental imagery and memory in psychopathology. The papers address emotional, intrusive mental imagery across a range of psychological disorders including post-traumatic stress disorder (PTSD), agoraphobia, body dysmorphic disorder, mood disorders, and psychosis. They include work on information processing issues including modelling cravings, conditioning, and aversions, as well as imagery qualities such as vividness and emotionality. The overview aims to place the articles in a broader context and draw out some exciting implications of this novel work. It provides a clinical context to the recent growth in this area from a cognitive behavioural therapy (CBT) perspective. We begin with PTSD, and consider links to imagery in other disorders. The clinical implications stemming from this empirical work and from autobiographical memory theory are discussed. These include consideration of a variety of techniques for eliminating troublesome imagery, and creating healthy, realistic alternatives.

  14. Management of the clinical issue of constipation with abdominal complaints in adults: a national survey of Primary Care physicians and gastroenterologists

    Directory of Open Access Journals (Sweden)

    Enrique Rey

    Full Text Available Irritable bowel syndrome and functional constipation represent a relevant and common health issue. However, real-world clinical practice includes patients with constipation who may or may not have other abdominal complaints (pain, bloating, abdominal discomfort with variable frequency. The goal of the present study was to obtain information on the workload entailed by patients with constipation and associated abdominal complaints, predominant clinical behaviors, education needs, and potential daily practice aids both in Primary Care and gastroenterology settings. The clinical behavior of doctors is generally similar at both levels, despite differences in healthcare approach: use of empiric therapies and clinically guided diagnostic tests, with some differences in colonoscopy use (not always directly accessible from Primary Care. Regarding perceptions, general support and osmotic laxatives are most valued by PC doctors, whereas osmotic laxatives, combined laxatives, and linaclotide are most valued by GE specialists. Furthermore, over half of respondents considered differentiating both diagnoses as challenging. Finally, considerable education needs are self-acknowledged at both levels, as is a demand for guidelines and protocols to help in managing this issue in clinical practice. A strength of this study is its providing a joint photograph of the medical approach and the perceptions of constipation with abdominal discomfort from a medical standpoint. Weaknesses include self-declaration (no formal validation and a response rate potentially biased by professional motivation.

  15. E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

    Science.gov (United States)

    Dainesi, Sonia Mansoldo; Goldbaum, Moisés

    2012-12-01

    The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

  16. What Ethical Issues Really Arise in Practice at an Academic Medical Center? A Quantitative and Qualitative Analysis of Clinical Ethics Consultations from 2008 to 2013.

    Science.gov (United States)

    Wasson, Katherine; Anderson, Emily; Hagstrom, Erika; McCarthy, Michael; Parsi, Kayhan; Kuczewski, Mark

    2016-09-01

    As the field of clinical ethics consultation sets standards and moves forward with the Quality Attestation process, questions should be raised about what ethical issues really do arise in practice. There is limited data on the type and number of ethics consultations conducted across different settings. At Loyola University Medical Center, we conducted a retrospective review of our ethics consultations from 2008 through 2013. One hundred fifty-six cases met the eligibility criteria. We analyzed demographic data on these patients and conducted a content analysis of the ethics consultation write-ups coding both the frequency of ethical issues and most significant, or key, ethical issue per case. Patients for whom ethics consultation was requested were typically male (55.8 %), white (57.1 %), between 50 and 69 years old (38.5 %), of non-Hispanic origin (85.9 %), and of Roman Catholic faith (43.6 %). Nearly half (47.4 %) were in the intensive care unit and 44.2 % died in the hospital. The most frequent broad ethical categories were decision-making (93.6 %), goals of care/treatment (80.8 %), and end-of-life (73.1 %). More specifically, capacity (57.1 %), patient's wishes/autonomy (54.5 %), and surrogate decision maker (51.3 %) were the most frequent particular ethical issues. The most common key ethical issues were withdrawing/withholding treatment (12.8 %), patient wishes/autonomy (12.2 %), and capacity (11.5 %). Our findings provide additional data to inform the training of clinical ethics consultants regarding the ethical issues that arise in practice. A wider research agenda should be formed to collect and compare data across institutions to improve education and training in our field.

  17. A systematic review of methodology applied during preclinical anesthetic neurotoxicity studies : important issues and lessons relevant to the design of future clinical research

    NARCIS (Netherlands)

    Disma, Nicola; Mondardini, Maria C.; Terrando, Niccolo; Absalom, Anthony R.; Bilotta, Federico

    Preclinical evidence suggests that anesthetic agents harm the developing brain thereby causing long-term neurocognitive impairments. It is not clear if these findings apply to humans, and retrospective epidemiological studies thus far have failed to show definitive evidence that anesthetic agents

  18. When fear of cancer recurrence becomes a clinical issue: a qualitative analysis of features associated with clinical fear of cancer recurrence.

    Science.gov (United States)

    Mutsaers, Brittany; Jones, Georden; Rutkowski, Nicole; Tomei, Christina; Séguin Leclair, Caroline; Petricone-Westwood, Danielle; Simard, Sébastien; Lebel, Sophie

    2016-10-01

    Fear of cancer recurrence (FCR) is a common experience for cancer survivors. However, it remains unclear what characteristics differentiate non-clinical from clinical levels of FCR. The goal of this study was to investigate the potential hallmarks of clinical FCR. A convenience sample of 40 participants (n = 19 female) was drawn from another study (Lebel et al. in Qual Life Res 25:311-321. doi: 10.1007/s11136-015-1088-2 , 2016). The semi-structured interview for fear of cancer recurrence (Simard and Savard in J Cancer Surviv 9:481-491. doi: 10.1007/s11764-015-0424-4 , 2015) was used to identify participants with non-clinical and clinical FCR and qualitative analysis of these interviews was performed. Individuals with clinical FCR reported the following features: death-related thoughts, feeling alone, belief that the cancer would return, experiencing intolerance of uncertainty, having cancer-related thoughts and imagery that were difficult to control, daily and recurrent, lasted 30 minutes or more, increased over time, caused distress and impacted their daily life. Triggers of FCR and coping strategies did not appear to be features of clinical FCR as they were reported by participants with a range of FCR scores. While features of clinical FCR found in this analysis such as intrusive thoughts, distress and impact on functioning confirmed previous FCR research, other features spontaneously emerged from the interviews including "death-related thoughts," "feeling alone," and "belief that the cancer will return." The participants' descriptions of cancer-specific fear and worry suggest that FCR is a distinct phenomenon related to cancer survivorship, despite similarities with psychological disorders (e.g., Anxiety Disorders). Future research investigating the construct of FCR, and the distinguishing features of clinical FCR across a range of cancer types and gender is required.

  19. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

    DEFF Research Database (Denmark)

    Dellson, P; Nilbert, M; Bendahl, P-O

    2011-01-01

    in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions...

  20. Archetype modeling methodology.

    Science.gov (United States)

    Moner, David; Maldonado, José Alberto; Robles, Montserrat

    2018-03-01

    Clinical Information Models (CIMs) expressed as archetypes play an essential role in the design and development of current Electronic Health Record (EHR) information structures. Although there exist many experiences about using archetypes in the literature, a comprehensive and formal methodology for archetype modeling does not exist. Having a modeling methodology is essential to develop quality archetypes, in order to guide the development of EHR systems and to allow the semantic interoperability of health data. In this work, an archetype modeling methodology is proposed. This paper describes its phases, the inputs and outputs of each phase, and the involved participants and tools. It also includes the description of the possible strategies to organize the modeling process. The proposed methodology is inspired by existing best practices of CIMs, software and ontology development. The methodology has been applied and evaluated in regional and national EHR projects. The application of the methodology provided useful feedback and improvements, and confirmed its advantages. The conclusion of this work is that having a formal methodology for archetype development facilitates the definition and adoption of interoperable archetypes, improves their quality, and facilitates their reuse among different information systems and EHR projects. Moreover, the proposed methodology can be also a reference for CIMs development using any other formalism. Copyright © 2018 Elsevier Inc. All rights reserved.

  1. Developing a Mental Health eClinic to Improve Access to and Quality of Mental Health Care for Young People: Using Participatory Design as Research Methodologies.

    Science.gov (United States)

    Ospina-Pinillos, Laura; Davenport, Tracey A; Ricci, Cristina S; Milton, Alyssa C; Scott, Elizabeth M; Hickie, Ian B

    2018-05-28

    Each year, many young Australians aged between 16 and 25 years experience a mental health disorder, yet only a small proportion access services and even fewer receive timely and evidence-based treatments. Today, with ever-increasing access to the Internet and use of technology, the potential to provide all young people with access (24 hours a day, 7 days a week) to the support they require to improve their mental health and well-being is promising. The aim of this study was to use participatory design (PD) as research methodologies with end users (young people aged between 16 and 25 years and youth health professionals) and our research team to develop the Mental Health eClinic (a Web-based mental health clinic) to improve timely access to, and better quality, mental health care for young people across Australia. A research and development (R&D) cycle for the codesign and build of the Mental Health eClinic included several iterative PD phases: PD workshops; translation of knowledge and ideas generated during workshops to produce mockups of webpages either as hand-drawn sketches or as wireframes (simple layout of a webpage before visual design and content is added); rapid prototyping; and one-on-one consultations with end users to assess the usability of the alpha build of the Mental Health eClinic. Four PD workshops were held with 28 end users (young people n=18, youth health professionals n=10) and our research team (n=8). Each PD workshop was followed by a knowledge translation session. At the conclusion of this cycle, the alpha prototype was built, and one round of one-on-one end user consultation sessions was conducted (n=6; all new participants, young people n=4, youth health professionals n=2). The R&D cycle revealed the importance of five key components for the Mental Health eClinic: a home page with a visible triage system for those requiring urgent help; a comprehensive online physical and mental health assessment; a detailed dashboard of results; a

  2. Breast ductal lavage for biomarker assessment in high risk women: rationale, design and methodology of a randomized phase II clinical trial with nimesulide, simvastatin and placebo

    International Nuclear Information System (INIS)

    Lazzeroni, Matteo; Radice, Davide; Bonanni, Bernardo; Guerrieri-Gonzaga, Aliana; Serrano, Davide; Cazzaniga, Massimiliano; Mora, Serena; Casadio, Chiara; Jemos, Costantino; Pizzamiglio, Maria; Cortesi, Laura

    2012-01-01

    and the safety blood tests do not show any significant liver toxicity. There is an urgent need to confirm in the clinical setting the potential efficacy of other compounds in contrasting hormone non-responsive breast cancer. This paper is focused on the methodology and operational aspects of the clinical trial. (ClinicalTrials.gov Identifier: NCT01500577)

  3. Using the time and motion method to study clinical work processes and workflow: methodological inconsistencies and a call for standardized research.

    Science.gov (United States)

    Zheng, Kai; Guo, Michael H; Hanauer, David A

    2011-01-01

    To identify ways for improving the consistency of design, conduct, and results reporting of time and motion (T&M) research in health informatics. We analyzed the commonalities and divergences of empirical studies published 1990-2010 that have applied the T&M approach to examine the impact of health IT implementation on clinical work processes and workflow. The analysis led to the development of a suggested 'checklist' intended to help future T&M research produce compatible and comparable results. We call this checklist STAMP (Suggested Time And Motion Procedures). STAMP outlines a minimum set of 29 data/ information elements organized into eight key areas, plus three supplemental elements contained in an 'Ancillary Data' area, that researchers may consider collecting and reporting in their future T&M endeavors. T&M is generally regarded as the most reliable approach for assessing the impact of health IT implementation on clinical work. However, there exist considerable inconsistencies in how previous T&M studies were conducted and/or how their results were reported, many of which do not seem necessary yet can have a significant impact on quality of research and generalisability of results. Therefore, we deem it is time to call for standards that can help improve the consistency of T&M research in health informatics. This study represents an initial attempt. We developed a suggested checklist to improve the methodological and results reporting consistency of T&M research, so that meaningful insights can be derived from across-study synthesis and health informatics, as a field, will be able to accumulate knowledge from these studies.

  4. Medical genetic issues in clinical of pediatric neurology practice:a history of pediatrics in Peking University First Hospital.

    Science.gov (United States)

    Wu, Xi-ru

    2006-02-18

    The Department of Pediatrics of Peking University First Hospital has a long term of outstanding history. It was established about 60 years ago. After the division of pediatric neurology (DPN) had been established in 1960s, it had been assigned to cover genetic disorders. During the recent 20 years, efforts have been put on three aspects: (1) Pediatric neurology clinical service and education; (2) research studies of childhood epilepsies and pediatric neurogenetic disorders; and (3) development of a strong DPN team to establish a comprehensive pediatric neurological program. In this paper, we reviewed the history of the pediatric neurology division in our department, our clinical and research work and achievements for neurogenetic diseases.

  5. Traditional Japanese Kampo Medicine: Clinical Research between Modernity and Traditional Medicine—The State of Research and Methodological Suggestions for the Future

    Directory of Open Access Journals (Sweden)

    Kenji Watanabe

    2011-01-01

    Full Text Available The Japanese traditional herbal medicine, Kampo, has gradually reemerged and 148 different formulations (mainly herbal extracts can be prescribed within the national health insurance system. The objective of this article is to introduce Kampo and to present information from previous clinical studies that tested Kampo formulae. In addition, suggestions on the design of future research will be stated. The literature search was based on a summary, up until January 2009, by the Japanese Society of Oriental Medicine and included only those trials which were also available in either Pubmed or ICHUSHI (Japan Medical Abstracts Society. We included 135 studies, half of these studies (n=68 used a standard control and 28 a placebo control. Thirty-seven trials were published in English [all randomized controlled trials (RCTs] and the remaining articles were in Japanese only. The sample size for most studies was small (two-third of the studies included less than 100 patients and the overall methodological quality appeared to be low. None of the studies used Kampo diagnosis as the basis for the treatment. In order to evaluate Kampo as a whole treatment system, certain aspects shoul