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Sample records for methodological aspects trials

  1. 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

  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. 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...

  4. Radioisotope methodology course radioprotection aspects

    International Nuclear Information System (INIS)

    Bergoc, R.M.; Caro, R.A.; Menossi, C.A.

    1996-01-01

    The advancement knowledge in molecular and cell biology, biochemistry, medicine and pharmacology, which has taken place during the last 50 years, after World War II finalization, is really outstanding. It can be safely said that this fact is principally due to the application of radioisotope techniques. The research on metabolisms, biodistribution of pharmaceuticals, pharmacodynamics, etc., is mostly carried out by means of techniques employing radioactive materials. Radioisotopes and radiation are frequently used in medicine both as diagnostic and therapeutic tools. The radioimmunoanalysis is today a routine method in endocrinology and in general clinical medicine. The receptor determination and characterization is a steadily growing methodology used in clinical biochemistry, pharmacology and medicine. The use of radiopharmaceuticals and radiation of different origins, for therapeutic purposes, should not be overlooked. For these reasons, the importance to teach radioisotope methodology is steadily growing. This is principally the case for specialization at the post-graduate level but at the pre graduate curriculum it is worthwhile to give some elementary theoretical and practical notions on this subject. These observations are justified by a more than 30 years teaching experience at both levels at the School of Pharmacy and Biochemistry of the University of Buenos Aires, Argentina. In 1960 we began to teach Physics III, an obligatory pregraduate course for biochemistry students, in which some elementary notions of radioactivity and measurement techniques were given. Successive modifications of the biochemistry pregraduate curriculum incorporated radiochemistry as an elective subject and since 1978, radioisotope methodology, as obligatory subject for biochemistry students. This subject is given at the radioisotope laboratory during the first semester of each year and its objective is to provide theoretical and practical knowledge to the biochemistry students, even

  5. Methodological Aspects of Architectural Documentation

    Directory of Open Access Journals (Sweden)

    Arivaldo Amorim

    2011-12-01

    Full Text Available This paper discusses the methodological approach that is being developed in the state of Bahia in Brazil since 2003, in architectural and urban sites documentation, using extensive digital technologies. Bahia has a vast territory with important architectural ensembles ranging from the sixteenth century to present day. As part of this heritage is constructed of raw earth and wood, it is very sensitive to various deleterious agents. It is therefore critical document this collection that is under threats. To conduct those activities diverse digital technologies that could be used in documentation process are being experimented. The task is being developed as an academic research, with few financial resources, by scholarship students and some volunteers. Several technologies are tested ranging from the simplest to the more sophisticated ones, used in the main stages of the documentation project, as follows: work overall planning, data acquisition, processing and management and ultimately, to control and evaluate the work. The activities that motivated this paper are being conducted in the cities of Rio de Contas and Lençóis in the Chapada Diamantina, located at 420 km and 750 km from Salvador respectively, in Cachoeira city at Recôncavo Baiano area, 120 km from Salvador, the capital of Bahia state, and at Pelourinho neighbourhood, located in the historic capital. Part of the material produced can be consulted in the website: < www.lcad.ufba.br>.

  6. State debt dynamics: the methodological aspect

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    Crijanovschi Stela

    2013-02-01

    Full Text Available In this article, it’s presented the methodological aspect of the state debt. The issue of supplementary money in order to cover the state debt is one of the factors that generate inflation, which respectively has a negative impact on the economic development

  7. STATE DEBT DYNAMICS: THE METHODOLOGICAL ASPECT

    Directory of Open Access Journals (Sweden)

    Stela CRIJANOVSCHI

    2013-02-01

    Full Text Available In this article, it’s presented the methodological aspect of the state debt. The issue of supplementary money in order to cover the state debt is one of the factors that generate inflation, which respectively has a negative impact on the economic development.

  8. Chronopolitics: methodological aspects of public policy research

    Directory of Open Access Journals (Sweden)

    O. A. Zubchyk

    2016-08-01

    Chronopolitics as methodology examines the role of the state in the political structure of the political entity in temporal conditions of political and administrative decisions. These issues have been discussed in the context of Chronopolitical study of historical forms of political organization. The study has proved that Chronopolitics functionally and structurally adds the conceptual and categorical apparatus of political sciences, science and public administration.

  9. Diuresis renography in children: methodological aspects

    International Nuclear Information System (INIS)

    Bonnin, F.; Le Stanc, E.; Busquet, G.; Saidi, L.; Lyonnet, F.

    1995-01-01

    In paediatrics, diuresis renography is used as a method to guide clinical management of hydronephrosis or hydro-uretero-nephrosis. Various pitfalls in the technique and other errors exist and may lead to a misinterpretation of the test. The methodology for performing and interpreting the diuresis renography is discussed. (authors). 12 refs., 4 figs

  10. An aspect-oriented methodology for designing secure applications

    NARCIS (Netherlands)

    Georg, Geri; Ray, Indrakshi; Anastasakis, Kyriakos; Bordbar, Behzad; Toahchoodee, Manachai; Houmb, S.H.

    We propose a methodology, based on aspect-oriented modeling (AOM), for incorporating security mechanisms in an application. The functionality of the application is described using the primary model and the attacks are specified using aspects. The attack aspect is composed with the primary model to

  11. METHODOLOGICAL ISSUES OF CLINICAL TRIALS IN THE PEDIATRIC POPULATION

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    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

  12. Methodological aspects of shift-work research.

    Science.gov (United States)

    Knutsson, Anders

    2004-01-01

    A major issue in shift-work research is to understand the possible ways in which shift work can impact performance and health. Nearly all body functions, from those of the cellular level to those of the entire body, are circadian rhythmic. Disturbances of these rhythms as well as the social consequences of odd work hours are of importance for the health and well-being of shift workers. This article reviews a number of common methodological issues which are of relevance to epidemiological studies in this area of research. It discusses conceptual problems regarding the use of the term "shift work," and it underscores the need to develop models that explain the mechanisms of disease in shift workers.

  13. [Hepatic cell transplantation. Technical and methodological aspects].

    Science.gov (United States)

    Pareja, Eugenia; Martínez, Amparo; Cortés, Miriam; Bonora, Ana; Moya, Angel; Sanjuán, Fernando; Gómez-Lechón, M José; Mir, José

    2010-03-01

    Hepatic cell transplantation consists of grafting already differentiated cells such as hepatocytes. Human hepatocytes are viable and functionally active. Liver cell transplantation is carried out by means of a 3-step method: isolation of hepatocytes from donor liver rejected for orthotopic transplantation, preparing a cell suspension for infusion and, finally, hepatocytes are implanted into the recipient. There are established protocols for the isolation of human hepatocytes from unused segments of donor livers, based on collagenase digestion of cannulated liver tissue at 37 degrees C. The hepatocytes can be used fresh or cryopreserved. Cryopreservation of isolated human hepatocytes would then be available for planned use. In cell transplant, the important aspects are: infusion route, number of cells, number of infusions and viability of the cells. The cells are infused into the patient through a catheter inserted via portal vein or splenic artery. Liver cell transplantation allows liver tissue to be used that would, otherwise, be discarded, enabling multiple patients to be treated with hepatocytes from a single tissue donor. Copyright 2009 AEC. Published by Elsevier Espana. All rights reserved.

  14. SOME METHODOLOGICAL ASPECTS OF TRAINING IT PROFESSIONALS

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    Svitlana Leshchuk

    2017-03-01

    Full Text Available The important task of higher educational establishments is preparation of competitive professional, man that easily feels in market conditions and informative society. Next to possessing of informatively-communication technologies necessary abilities to study in a group, skills of prosecution of general projects. The aim of the article is to show possibility of organization of educational activity of students with maintenance and form works that is required by modern industry of information technologies. An author is describe separate steps preparations of future specialists, that is required by a IT-sphere; specialists that own a modern tool are understood by modern approaches in programming; able to work in a command above a general project and to arrive at a result. The basic ideas of the object-oriented programming are considered, methodology of management projects for the flexible Scrum and possibilities of the use of control system by versions software development, as a powerful instrument that gives an opportunity simultaneously, swimmingly to each other, to conduct the prosecution of group projects. Description comes true on the basis of realization of the special course for specialists on the informatics of specialities «Applied mathematics», «Informatics» of physics-mathematics faculty (Ternopil Volodymyr Hnatyuk National Pedagogical University. The table of contents of material is extended also by an acquaintance with the architectural template of MVC and generalization of abilities of work with a programmatic tool, by a necessity for creation of web-projects. The practical achievement of educational activity of students is development of social web-project with the aim of increase of level of culture of society and benevolent atmosphere of city.

  15. METHODOLOGICAL ASPECTS OF THE INTERNAL CONTROL SYSTEM FORMATION

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    Larisa I. Egorova

    2014-01-01

    Full Text Available The methodological aspects of the internal control system formation are stated in the article. The great attention is focused on the problems of financial statements misrepresentation. The basic principles and structure of the internal control system are discussed in this article.

  16. The specific aspects for the ASSET methodology implementation in Romania

    Energy Technology Data Exchange (ETDEWEB)

    Serbanescu, D [National Commission for Nuclear Activities Control of Romania (Romania)

    1997-10-01

    The main aspects of the implementation of a root cause analysis methodology are as follows: The Test Operating Licence requires that a systematical root cause analysis method for the event analysis to clarify the three questions from the ASSET methodology has to be implemented; A Training seminar on the ASSET methodology for the plant staff was performed at Cernavoda 1 NPP in April 1997, with the IAEA support; The self assessment process for the events which occurred during commissioning phases has to be performed by the plant up to the end of this year; An ASSET Peer Review of the Plant Self Assessment is planned in 1998; The Regulatory Authority has the task to evaluated independently the plant conclusions on various events. The tool used by CNCAN is the ASSET methodology.

  17. The specific aspects for the ASSET methodology implementation in Romania

    International Nuclear Information System (INIS)

    Serbanescu, D.

    1997-01-01

    The main aspects of the implementation of a root cause analysis methodology are as follows: The Test Operating Licence requires that a systematical root cause analysis method for the event analysis to clarify the three questions from the ASSET methodology has to be implemented; A Training seminar on the ASSET methodology for the plant staff was performed at Cernavoda 1 NPP in April 1997, with the IAEA support; The self assessment process for the events which occurred during commissioning phases has to be performed by the plant up to the end of this year; An ASSET Peer Review of the Plant Self Assessment is planned in 1998; The Regulatory Authority has the task to evaluated independently the plant conclusions on various events. The tool used by CNCAN is the ASSET methodology

  18. Methodological Aspects of Depreciation as an Economic Category

    OpenAIRE

    Sigidov, Yuriy I.; Rybyantseva, Maria S.; Adamenko, Alexandr A.; Yarushkina, Elena A.

    2016-01-01

    Depreciation is a complex economic category, the essence of which is manifested in the duality: this cost element, and its own source of reproduction of fixed assets and intangible assets. The depreciation laid relationship with asset and liability balance sheet; it touches on aspects such as formation costs, taxation issues, and reproductive process. That is why a methodological study of the depreciation essence, the allocation of the classification of bases, principles and functions seems u...

  19. Methodology for studying social advertising: A sociological aspect

    Directory of Open Access Journals (Sweden)

    S B Kalmykov

    2014-12-01

    Full Text Available The article describes the author’s dynamic processual methodology for the sociological study of social advertising that combines the multiversion paradigmatic approach, legitimization procedures, methodological principles of interconnection, multilevel analysis and the principles of sociological data formalization developed by P. Lazarsfeld. The author explains the multi-stage strategy of the methodology and the research procedures that provide new sociological knowledge about the processes of social advertising. The first stage involves analysis of the social advertising as a number of institutional, communicative, socio-cultural and socio-technological processes. The second stage consists of the development of the substantive aspects of social advertising dynamics and its dependence on the features of different socio-demographic groups. The third stage of the methodology includes a comparative analysis of the social advertising theoretical and empirical aspects and the subsequent assessment of its fundamental and applied capabilities. The author identifies two types of research practices: the first one consists of three levels of complexity - the first one is to design the social advertising categories and concepts; the second one requires a higher level of generalization; the third one supposes justification of the universal categorization and the social advertising conceptualization for different social areas as well as a comparative analysis of the theory of the social advertising impact developed by O.O. Savel’eva with the research results for the aims of the promotion of the sociology of advertising. The article concludes with the demonstration of the proposed methodology universality for different spheres of social reality.

  20. Prevalence of neurological disorders in Al Quseir, Egypt: methodological aspects

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    El-Tallawy H

    2013-09-01

    Full Text Available Hamdy El-Tallawy,1 Wafa Farghaly,1 Nabil Metwally,2 Tarek Rageh,1 Ghaydaa A Shehata,1 Reda Badry,1 Esam El Moselhy,2 Mahmoud Hassan,2 Mohamed M Sayed,3 Ahmed A Abdelwarith,1 Y Hamed,2 I Shaaban,2 Talal Mohamed,4 Mohamed Abd El Hamed,1 MR Kandil1 1Department of Neurology, Faculty of Medicine, Assiut University, Assiut, Egypt; 2Department of Neurology and Public Health, Faculty of Medicine, Al-Azhar University (Assiut branch, Assiut, Egypt; 3Department of Neurology, Faculty of Medicine, Sohag University, Sohag, Egypt; 4Department of Neurology, Faculty of Medicine, Qena University, Qena, Egypt Abstract: Methodology and strategy play a very important role in epidemiological studies. Determination of the study area, geographical features, facilities, difficulties, and key personnel from the same area are important factors for successful methodology. Over 31 months (July 1, 2009 to January 31, 2012, a screening and an examination survey were carried out to ascertain the prevalence of epilepsy, stroke, dementia, cerebellar ataxia, migraine, cerebral palsy, Parkinsonism, chorea, athetosis, dystonia, trigeminal neuralgia, Bell's palsy, multiple sclerosis, spinal cord disorders, and attention deficit hyperactivity disorders in Al Quseir, Red Sea Governorate, Egypt. A total of 33,285 people were screened by three neurologists in a door-to-door manner, including every door, using a standardized Arabic questionnaire to detect any subject with a neurological disorder. The methodological aspects of this project were carried out through eight phases: (1 data collection; (2 preparation; (3 screening; (4 case ascertainment; (5 investigations; (6 classifications; (7 data entry; and (8 statistics and tabulations. The results of this study reveal that the total prevalence of neurological disorders in Al Quseir was 4.6% and higher among females (5.2% than males (3.9%. The highest prevalence was recorded in the elderly population (60+ years [8.0%] and among the age

  1. Philosophical and methodological aspects of the Schroedinger paradox

    International Nuclear Information System (INIS)

    Juha, L.; Krajca, R.; Smatera, M.

    1989-01-01

    Methodological aspects of the foundations of quantum theory are dealt with in relation to the quantum description of macroscopic systems, biological in particular. Attention is paid to the philosophical content of the problems of 1) the logical status of the reduction postulate in quantum mechanics, and 2) the paradox of Schroedinger's cat, whose physical solution has not yet been attained. The problem of the quantum description of complex macroscopic systems is also treated, as is Herbert Froehlich's important concept of the excitation of dominant modes in biological systems. (author). 61 refs

  2. The structuralist tradition in economics: methodological and macroeconomics aspects

    Directory of Open Access Journals (Sweden)

    FABRÍCIO MISSIO

    2015-06-01

    Full Text Available This paper examines the structuralist tradition in economics, emphasizing the role that structures play in the economic growth of developing countries. Since the subject at hand is evidently too large to cover in a single article, an emphasis has been brought to bear upon the macroeconomic elements of such a tradition, while also exploring its methodological aspects. It begins by analysing some general aspects of structuralism in economics (its evolution and origins associated with ECLAC thought, in this instance focusing on the dynamics of the center-periphery relationship. Thereafter, the macroeconomic structuralism derived from the works of Taylor (1983, 1991 is presented, followed by a presentation of neo-structuralism. Centred on the concept of systemic competitiveness, this approach defines a strategy to achieve the high road of globalization, understood here as an inevitable process in spite of its engagement being dependent on the policies adopted. The conclusions show the genuine contributions of this tradition to economic theory.

  3. Methodological and Technical Aspects of Power Sector Liberalisation of Latvia

    International Nuclear Information System (INIS)

    Petrov, B.; Viksna, I.; Zeltinsh, N.

    2001-01-01

    A successful liberalisation of energy markets is taking place in the Baltic countries (Estonia, Latvia, Lithuania), that is why it is important to investigate the methodological and technical aspects as well as the effect of this process upon the development of energy supply in the North European region. Energy supply to the Baltic countries is characterised by the fact that energy resources there are mainly supplied from the CIS, where there is a rather difficult prognostic energy market with sharp price fluctuations (sometimes supplies are completely cut). At the same time, by using the CIS energy resources, the development of the energy sector may significantly influence the total North European energy supplies. Energy saving measures and energy-efficient technologies in the following years will greatly influence energy market and energy consumption. This is an actual problem for such countries as Latvia, where the main part of its energy carriers is imported from neighbouring countries.(author)

  4. Methodological aspects of the 1993 Pelotas (Brazil) Birth Cohort Study

    Science.gov (United States)

    Victora, Cesar Gomes; Araújo, Cora Luiza Pavin; Menezes, Ana Maria Batista; Hallal, Pedro Curi; Vieira, Maria de Fátima; Neutzling, Marilda Borges; Gonçalves, Helen; Valle, Neiva Cristina; Lima, Rosangela Costa; Anselmi, Luciana; Behague, Dominique; Gigante, Denise Petrucci; Barros, Fernando Celso

    2010-01-01

    This paper describes the main methodological aspects of a cohort study, with emphasis on its recent phases, which may be relevant to investigators planning to carry out similar studies. In 1993, a population based study was launched in Pelotas, Southern Brazil. All 5,249 newborns delivered in the city’s hospitals were enrolled, and sub-samples were visited at the ages of one, three and six months and of one and four years. In 2004-5 it was possible to trace 87.5% of the cohort at the age of 10-12 years. Sub-studies are addressing issues related to oral health, psychological development and mental health, body composition, and ethnography. Birth cohort studies are essential for investigating the early determinants of adult disease and nutritional status, yet few such studies are available from low and middle-income countries where these determinants may differ from those documented in more developed settings. PMID:16410981

  5. 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.

  6. 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.

  7. Safety and efficacy of subretinal visual implants in humans: methodological aspects.

    Science.gov (United States)

    Stingl, Katarina; Bach, Michael; Bartz-Schmidt, Karl-Ulrich; Braun, Angelika; Bruckmann, Anna; Gekeler, Florian; Greppmaier, Udo; Hörtdörfer, Gernot; Kusnyerik, Akos; Peters, Tobias; Wilhelm, Barbara; Wilke, Robert; Zrenner, Eberhart

    2013-01-01

    Replacing the function of visual pathway neurons by electronic implants is a novel approach presently explored by various groups in basic research and clinical trials. The novelty raises unexplored methodological aspects of clinical trial design that may require adaptation and validation. We present procedures of efficacy and safety testing for subretinal visual implants in humans, as developed during our pilot trial 2005 to 2009 and multi-centre clinical trial since 2010. Planning such a trial requires appropriate inclusion and exclusion criteria. For subretinal electronic visual implants, patients with photoreceptor degeneration are the target patient group, whereas presence of additional diseases affecting clear optic media or the visual pathway must be excluded. Because sham surgery is not possible, a masked study design with implant power ON versus OFF is necessary. Prior to the efficacy testing by psychophysical tests, the implant's technical characteristics have to be controlled via electroretinography (ERG). Moreover the testing methods require adaptation to the particular technology. We recommend standardised tasks first to determine the light perception thresholds, light localisation and movement detection, followed by grating acuity and vision acuity test via Landolt C rings. A laboratory setup for assessing essential activities of daily living is presented. Subjective visual experiences with the implant in a natural environment, as well as questionnaires and psychological counselling are further important aspects. A clinical trial protocol for artificial vision in humans, which leads a patient from blindness to the state of very low vision is a challenge and cannot be defined completely prior to the study. Available tests of visual function may not be sufficiently suited for efficacy testing of artificial vision devices. A protocol based on experience with subretinal visual implants in 22 patients is presented that has been found adequate to monitor

  8. A Methodology for Equitable Performance Assessment and Presentation of Wave Energy Converters Based on Sea Trials

    DEFF Research Database (Denmark)

    Kofoed, Jens Peter; Pecher, Arthur; Margheritini, Lucia

    2013-01-01

    This paper provides a methodology for the analysis and presentation of data obtained from sea trials of wave energy converters (WEC). The equitable aspect of this methodology lies in its wide application, as any WEC at any scale or stage of development can be considered as long as the tests are p...... parameters influence the performance of the WEC can also be investigated using this methodology.......This paper provides a methodology for the analysis and presentation of data obtained from sea trials of wave energy converters (WEC). The equitable aspect of this methodology lies in its wide application, as any WEC at any scale or stage of development can be considered as long as the tests...... leads to testing campaigns that are not as extensive as desired. Therefore, the performance analysis should be robust enough to allow for not fully complete sea trials and sub optimal performance data. In other words, this methodology is focused at retrieving the maximum amount of useful information out...

  9. NEW CO-EVOLUTION STRATEGIES OF THIRD MILLENNIUM; METHODOLOGICAL ASPECT

    Directory of Open Access Journals (Sweden)

    E. K. Bulygo

    2006-01-01

    Full Text Available The paper is devoted to an application of the co-evolution methodology to the social space. Principles of instability and non-linearity that are typical for contemporary natural science are used as a theoretical background of a new social methodology. Authors try to prove that the co-evolution strategy has a long pre-history in the ancient oriental philosophy and manifests itself in forms of modem culture

  10. The main aspects of methodology of quality management system

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    Smirnova E.K.

    2017-03-01

    Full Text Available this article describes the formation and development of quality management as an integrated system. The author considers the theory and methodology of quality management since the early XXth century to the present day and describes the main problems encountered in the process of quality management system, as well as the ways to overcome them.

  11. Practical Aspects of Research Monitoring: Methodological and Functional Solutions

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    A A Onosov

    2013-12-01

    Full Text Available The article describes the experience of designing, testing and implementing the National system of monitoring the quality of meteorological services in Russia. Within the framework of this project a large-scale research program was carried out aimed to develop the conception, methodology, research tools and design of customer assessment of the Roshydromet services.

  12. O tratamento farmacológico do transtorno bipolar: uma revisão sistemática e crítica dos aspectos metodológicos dos estudos clínicos modernos The pharmacological treatment of bipolar disorder: a systematic and critical review of the methodological aspects of modern clinical trials

    Directory of Open Access Journals (Sweden)

    Elie Cheniaux

    2011-03-01

    Full Text Available OBJETIVO: Revisar sistematicamente os principais estudos clínicos sobre o tratamento farmacológico do transtorno bipolar e fazer uma análise crítica de seus aspectos metodológicos. MÉTODO: Realizou-se uma busca nas bases de dados Medline, ISI e PsycINFO, utilizando-se os seguintes termos de busca: "bipolar", "randomized", "placebo" e "controlled". Foram selecionados estudos clínicos randomizados, duplo-cegos e controlados por placebo sobre o tratamento farmacológico do transtorno bipolar. Além disso, de acordo com os nossos critérios, as amostras deveriam ser de no mínimo 100 pacientes e a substância testada deveria ser usada como monoterapia. RESULTADOS: 34 artigos se adequaram aos critérios de seleção. Todas as substâncias atualmente indicadas para mania, depressão bipolar e para o tratamento de manutenção foram mais eficazes que o placebo em pelo menos um estudo. Todavia, esses estudos tiveram amostras altamente selecionadas, altas taxas de abandono e baixas taxas de resposta clínica. CONCLUSÃO: Os modernos estudos clínicos sobre o tratamento farmacológico do transtorno bipolar apresentam algumas importantes limitações metodológicas. Assim, seus resultados devem ser considerados com cautela.OBJECTIVE: To review systematically the main clinical trials on the pharmacological treatment of bipolar disorder and to make a critical analysis of their methodological aspects. METHOD: A search in Medline, ISI and PsycINFO databases was conducted, using the following search terms: "bipolar", "randomized", "placebo" e "controlled". Randomized, double-blind, placebo-controlled clinical trials on the pharmacological treatment of bipolar disorder were selected. Besides, according to our criteria, samples had to consist of at least 100 patients and experimental drug had to be used as monotherapy. RESULTS: 34 articles met our selection criteria. All drugs currently indicated for mania, bipolar depression and maintenance treatment of

  13. Comparison of the sanitary effects of energy chains. Methodological aspects

    International Nuclear Information System (INIS)

    Fagnani, F.

    1979-01-01

    Beyond technical and economical matters, the development of an industrial technology involves more or less numerous indirect consequences. From this viewpoint, the author analysis the methodological problems raised in evaluating the sanitary and ecological problems of the different energy-producing lines and considers successively the matter of technical interdependences, protection and safety regulations and selection of sites, classification of risks and measuring problems in relation to sanitary effects [fr

  14. SEMANTIC NETWORKS: THEORETICAL, TECHNICAL, METHODOLOGIC AND ANALYTICAL ASPECTS

    Directory of Open Access Journals (Sweden)

    José Ángel Vera Noriega

    2005-09-01

    Full Text Available This work is a review of the methodological procedures and cares for the measurement of the connotative meanings which will be used in the elaboration of instruments with ethnic validity. Beginning from the techniques originally proposed by Figueroa et al. (1981 and later described by Lagunes (1993, the intention is to offer a didactic panorama to carry out the measurement by semantic networks introducing some recommendations derived from the studies performed with this method.

  15. Methodological Aspects of Modelling and Simulation of Robotized Workstations

    Directory of Open Access Journals (Sweden)

    Naqib Daneshjo

    2018-05-01

    Full Text Available From the point of view of development of application and program products, key directions that need to be respected in computer support for project activities are quite clearly specified. User interfaces with a high degree of graphical interactive convenience, two-dimensional and three-dimensional computer graphics contribute greatly to streamlining project methodologies and procedures in particular. This is mainly due to the fact that a high number of solved tasks is clearly graphic in the modern design of robotic systems. Automation of graphical character tasks is therefore a significant development direction for the subject area. The authors present results of their research in the area of automation and computer-aided design of robotized systems. A new methodical approach to modelling robotic workstations, consisting of ten steps incorporated into the four phases of the logistics process of creating and implementing a robotic workplace, is presented. The emphasis is placed on the modelling and simulation phase with verification of elaborated methodologies on specific projects or elements of the robotized welding plant in automotive production.

  16. Methodological aspects of EEG and Body dynamics measurements during motion.

    Directory of Open Access Journals (Sweden)

    Pedro eReis

    2014-03-01

    Full Text Available EEG involves recording, analysis, and interpretation of voltages recorded on the human scalp originating from brain grey matter. EEG is one of the favorite methods to study and understand processes that underlie behavior. This is so, because EEG is relatively cheap, easy to wear, light weight and has high temporal resolution. In terms of behavior, this encompasses actions, such as movements, that are performed in response to the environment. However, there are methodological difficulties when recording EEG during movement such as movement artifacts. Thus, most studies about the human brain have examined activations during static conditions. This article attempts to compile and describe relevant methodological solutions that emerged in order to measure body and brain dynamics during motion. These descriptions cover suggestions of how to avoid and reduce motion artifacts, hardware, software and techniques for synchronously recording EEG, EMG, kinematics, kinetics and eye movements during motion. Additionally, we present various recording systems, EEG electrodes, caps and methods for determination of real/custom electrode positions. In the end we will conclude that it is possible to record and analyze synchronized brain and body dynamics related to movement or exercise tasks.

  17. Urban Agglomerations in Regional Development: Theoretical, Methodological and Applied Aspects

    Directory of Open Access Journals (Sweden)

    Andrey Vladimirovich Shmidt

    2016-09-01

    Full Text Available The article focuses on the analysis of the major process of modern socio-economic development, such as the functioning of urban agglomerations. A short background of the economic literature on this phenomenon is given. There are the traditional (the concentration of urban types of activities, the grouping of urban settlements by the intensive production and labour communications and modern (cluster theories, theories of network society conceptions. Two methodological principles of studying the agglomeration are emphasized: the principle of the unity of the spatial concentration of economic activity and the principle of compact living of the population. The positive and negative effects of agglomeration in the economic and social spheres are studied. Therefore, it is concluded that the agglomeration is helpful in the case when it brings the agglomerative economy (the positive benefits from it exceed the additional costs. A methodology for examination the urban agglomeration and its role in the regional development is offered. The approbation of this methodology on the example of Chelyabinsk and Chelyabinsk region has allowed to carry out the comparative analysis of the regional centre and the whole region by the main socio-economic indexes under static and dynamic conditions, to draw the conclusions on a position of the city and the region based on such socio-economic indexes as an average monthly nominal accrued wage, the cost of fixed assets, the investments into fixed capital, new housing supply, a retail turnover, the volume of self-produced shipped goods, the works and services performed in the region. In the study, the analysis of a launching site of the Chelyabinsk agglomeration is carried out. It has revealed the following main characteristics of the core of the agglomeration in Chelyabinsk (structure feature, population, level of centralization of the core as well as the Chelyabinsk agglomeration in general (coefficient of agglomeration

  18. METHODOLOGICAL ASPECTS OF LOGISTIC SYSTEMS OF THE COMPANY

    Directory of Open Access Journals (Sweden)

    Lăpăduşi Mihaela Loredana

    2009-11-01

    Full Text Available Extremely complex issues including large scale logistics issue, whose solving depends on many sets of circumstances and political, economic, technical, cultural and environment factors can be approached by calling big systems theory. In the present stage of the development of new international economical activities of the scientific research, in the conceptualization plan it is impossible that when we call an inter and multidisciplinary approach of a complex technical-economical issue – and the logistics’ issue in the most general sense of the meaning is one of these - to build the appropriate theoretical structure other than starting from the system concept. Global economy, integrated as it currently works confronts itself more and more with complex problems (that have simultaneous technical, economical, ecological and social aspects and of broad dimensions drawing a large number of people, organisms and organizations.

  19. Methodological aspects to elaborate the management and procedure guides of severe accidents

    International Nuclear Information System (INIS)

    Gonzalez Gonzalez, F.; Jimenez Fernandez, A.

    1995-01-01

    The management guides in severe accidents are very important to know the procedures in these accidents. The present articles summarizes the methodological aspects to elaborate the management guides, in order to prevent the severe accidents

  20. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  1. Experience feedback from incidents: methodological and cultural aspects

    International Nuclear Information System (INIS)

    Perinet, R.

    2007-01-01

    EdF has designed some provisions to improve the reliability of human interventions: an increased number of training simulators, management of the quality of interventions, implementation of human factor consultants on each site, improvement in user documentation, development of communication practices, etc. However, despite efforts made in the right direction, the complexity of human behaviour and organisations make it obligatory to follow up the efficacy of these provisions over time in order to ensure that they produce the expected results on work practices. The in-depth analysis by IRSN of events that are significant for safety shows that experience feedback from incidents constitutes a real opportunity to ensure this follow-up. It also highlights the difficulty for licensees to define the temporal context of investigations to carry out, analysing errors committed more in depth and identifying ensuing problems. This article shows that these difficulties are the result of inappropriate methodologies and a lack of skills and availability to carry out the analysis. Finally, it shows that the incident leads to defensive behaviour among those participating in the system that blocks the compilation of information and limits the relevance of analyses. (author)

  2. APPETITE CONTROL: METHODOLOGICAL ASPECTS OF THE EVALUATION OF FOODS

    Science.gov (United States)

    Blundell, John; de Graaf, Cees; Hulshof, Toine; Jebb, Susan; Livingstone, Barbara; Lluch, Anne; Mela, David; Salah, Samir; Schuring, Ewoud; van der Knaap, Henk; Westerterp, Margriet

    2013-01-01

    This report describes a set of scientific procedures used to assess the impact of foods and food ingredients on the expression of appetite (psychological and behavioural). An overarching priority has been to enable potential evaluators of health claims about foods to identify justified claims, and to exclude claims that are not supported by scientific evidence for the effect cited. This priority follows precisely from the principles set down in the PASSCLAIM report. (4) The report allows the evaluation of the strength of health claims, about the effects of foods on appetite, which can be sustained on the basis of the commonly used scientific designs and experimental procedures. The report includes different designs for assessing effects on satiation as opposed to satiety,detailed coverage of the extent to which a change in hunger can stand-alone as a measure of appetite control, and an extensive discussion of the statistical procedures appropriate for handling data in this field of research. Since research in this area is continually evolving, new improved methodologies may emerge over time and will need to be incorporated into the framework. One main objective of the report has been to produce guidance on good practice in carrying out appetite research, and not to set down a series of commandments that must be followed. PMID:20122136

  3. Evaluating the Staff at Enterprise: Several Theoretical and Methodological Aspects

    Directory of Open Access Journals (Sweden)

    Girman Alla P.

    2017-03-01

    Full Text Available The article is aimed at generalizing and systematizing various knowledge, related to evaluation of staff, on a common theoretical-methodological basis. Concept, objectives, directions, methods, and indicators for evaluating staff in the contemporary economy were analyzed. The topicality of using the theoretical developments on staff evaluation in actual practice of functioning of enterprises has been substantiated. A new approach to the procedure of evaluation of the total human resource of enterprise, based on the life cycle of organization, has been proposed. On the basis of the proposed scientific algorithmic step-by-step approach to the evaluation of staff, managers of companies can design their own models for staff evaluation, develop its separate elements. Prospects for further researches in this direction involve relation of staff evaluation to the life cycle of employee no less than the life cycle of enterprise. Management of the life cycle of employee represents methods for management of his development that would change the level of the employee’s professional maturity as result of a system impact.

  4. Methodological aspects of serosurveillance in resource-poor settings.

    Science.gov (United States)

    Sternberg Lewerin, Susanna; Wolff, Cecilia; Masembe, Charles; Ståhl, Karl; Boqvist, Sofia; Franko, Mikael Andersson

    2018-01-01

    Animal production is important for the agricultural economy in low-income countries, but is threatened by infectious diseases. Serosurveys are conducted for different reasons such as disease detection, risk factor studies, disease monitoring and establishing disease-free status. Most reports on such serosurveys include some discussion about methodological constraints but still, by necessity, rely on serological results for case definition. This study uses a cross-sectional serosurvey for foot-and-mouth disease (FMD), Rift Valley fever (RVF) and contagious bovine pleuropneumonia (CBPP) in cattle in three districts in Western Uganda to illustrate the limitations of this approach, addressing the questions of what flaws can be expected in sampling and diagnostics and how these influence the results. The target was to collect blood samples from 60 cattle herds per district. To reflect the recent infection history of the herd, young animals (two to five years) were prioritised. The farmers were interviewed about management, cattle trade, cattle health and vaccination. Commercial ELISAs were used for serological analyses: for CBPP the IDEXX CBPP Mycoplasma mycoides subspecies mycoides antibody test kit, for RVF the ID Screen Rift Valley Fever competitive ELISA, and for FMD the PrioCHECK FMDV NS. Apparent prevalence, true prevalence and associations with herd characteristics were assessed. The sampling plans could not be entirely fulfilled, nor the number of tests run in the laboratory. There were reactors to all three diseases with an apparent prevalence of approximately 30 per cent for CBPP, 6 per cent for RVF and 7 per cent for FMD. Calculation of true prevalence based on test sensitivity and specificity resulted in a slightly higher prevalence figure for CBPP and lower figures for RVF and FMD. The study illustrates the importance of considering diagnostic test performance when interpreting results from serosurveys, and the challenge of representative sampling and

  5. Taking a Distributed Perspective: Epistemological and Methodological Tradeoffs in Operationalizing the Leader-Plus Aspect

    Science.gov (United States)

    Spillane, James P.; Camburn, Eric M.; Pustejovsky, James; Pareja, Amber Stitziel; Lewis, Geoff

    2008-01-01

    Purpose: This paper is concerned with the epistemological and methodological challenges involved in studying the distribution of leadership across people within the school--the leader-plus aspect of a distributed perspective, which it aims to investigate. Design/methodology/approach: The paper examines the entailments of the distributed…

  6. [The demographic consequences of austerity in Latin America: methodological aspects].

    Science.gov (United States)

    Hakkert, R

    1991-01-01

    This work reviews evidence in the literature of possible demographic effects of the austerity programs imposed on Latin American countries in the 1980s. The work focuses on methodological problems involved in assessing demographic changes and ascertaining that they were indeed attributable to the economic crisis. An introductory section describes the recession of the 1980s in Latin America, the declines in employment and living standards, and the health and social consequences of the deepening poverty. But the author argues that evaluation of health conditions, levels of nutrition, and especially factors such as infant mortality, fertility, marriage patterns, and migration as indicators of the impact of the economic depression is full of pitfalls that are not always obvious. Few Latin American countries have civil registration systems capable of providing accurate and up-to-date mortality and fertility data. Indirect methods currently in use were intended to analyze longterm levels and trends and are of little use for short-term fluctuations. Data on internal migration are scarce even in developed countries. Even when recent data are available it is often difficult or impossible to obtain data for comparison. Infant mortality and malnutrition levels, for example, are serious problems in many parts of Latin America, but series of data capable of demonstrating that they are truly consequences of the economic crisis are lacking. Another challenge is to separate the demographic effects of the debt crisis from longterm structural processes. The possibility of time lags and of different time frames may increase confusion. Almost a year must pass before effects on birth rates can be expected, for example. Neutralizing mechanisms may obscure the effects sought. Thus, the most impoverished urban sectors may return to the countryside to seek refuge in subsistence agriculture; their departure would in some measure diminish the consequences of recession in the urban economy

  7. 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.

  8. 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.

  9. Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.

    Science.gov (United States)

    Kubar, Olga

    2005-01-01

    The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.

  10. 2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects

    NARCIS (Netherlands)

    Rider, Lisa G.; Ruperto, Nicolino; Pistorio, Angela; Erman, Brian; Bayat, Nastaran; Lachenbruch, Peter A.; Rockette, Howard; Feldman, Brian M.; Huber, Adam M.; Hansen, Paul; Oddis, Chester V.; Lundberg, Ingrid E; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G.; Chung, Lorinda; Danko, Katalin; Fiorentino, David; García-De la Torre, Ignacio; Reed, Ann M.; Wook Song, Yeong; Cimaz, Rolando; Cuttica, Rubén J.; Pilkington, Clarissa A.; Martini, Alberto; van der Net, Janjaap; Maillard, Susan; Miller, Frederick W.; Vencovsky, Jiri; Aggarwal, Rohit

    2017-01-01

    Objective: The objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM. Methods: Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal,

  11. [Methodological controversies in chronic obstructive pulmonary disease therapeutic trials].

    Science.gov (United States)

    Suissa, Samy

    2009-03-01

    Pharmacological treatment of chronic obstructive pulmonary disease (COPD) relies principally on long-acting bronchodilators. Inhaled corticosteroids (ICS) were introduced for COPD two decades ago, despite the fact that no randomized trial had yet assessed their efficacy for this indication. Since then, the numerous randomized trials and meta-analyses performed to justify their use in COPD have been contradictory and controversial. Moreover, observational studies have reported efficacy rates so exceptional that they are almost too good to be true. These studies contain important methodological flaws that produce the appearance of efficacy. The randomized trials infringe the fundamental principle of intention-to-treat analysis, an analysis necessary to prevent important biases. Two other complications are the interruption of treatment at the moment of randomization and the use of a run-in period; in both cases, the withdrawal of treatment can introduce bias. The observational studies reporting phenomenal reductions in mortality with ICS were distorted by "immortal time" bias. Finally, recent data suggest that the effect of ICS/bronchodilator combinations is due mainly to the effect of the long-acting bronchodilator. Given the absence of proof of the efficacy of inhaled corticosteroids in COPD and their associated risks, especially of ocular damage and pneumonia, and particularly among the elderly, as well as the high doses currently prescribed in COPD, it is difficult to recommend their use in this indication. They should be prescribed in COPD for at most a limited population of patients.

  12. Evaluation of methodological aspects of digestibility measurements in ponies fed different haylage to concentrate ratios

    NARCIS (Netherlands)

    Schaafstra, F J W C; van Doorn, D A; Schonewille, J T; van Riet, M M J; Hendriks, W H

    2017-01-01

    Methodological aspects of digestibility measurements were studied in four Welsh pony geldings consuming haylage-based diets with increasing proportions of a pelleted concentrate according to a 4×4 Latin square design experiment. Ponies were fed four experimental, iso-energetic (net energy (NE)

  13. Evaluation of methodological aspects of digestibility measurements in ponies fed different haylage to concentrate ratios

    NARCIS (Netherlands)

    Schaafstra, F.J.W.C.; Doorn, van D.A.; Schonewille, J.T.; Riet, van M.M.J.; Visser, P.; Blok, M.C.; Hendriks, W.H.

    2017-01-01

    Methodological aspects of digestibility measurements were studied in four Welsh pony geldings consuming haylage-based diets with increasing proportions of a pelleted concentrate according to a 4×4 Latin square design experiment. Ponies were fed four experimental, iso-energetic (net energy (NE)

  14. The Development of the Foundations of Modern Pedagogy: Paradigmal and Methodological Aspects of Research

    Science.gov (United States)

    Dmitrenko, ?amara ?.; Lavryk, Tatjana V.; Yaresko, Ekaterina V.

    2015-01-01

    Changes in the various fields of knowledge influenced the pedagogical science. The article explains the structure of the foundations of modern pedagogy through paradigmal and methodological aspects. Bases of modern pedagogy include complex of paradigms, object and subject of science, general and specific principles, methods and technologies.…

  15. THEORETICAL-METHODOLOGICAL ASPECT OF THE CATEGORIES OF LAW, MORALITY AND POLITICS IN SOCIOLOGICAL KNOWLEDGE

    Directory of Open Access Journals (Sweden)

    Yu. V. Krasilnikova

    2010-01-01

    Full Text Available We consider the category of law, morality and politics in the sociological knowledge in the context of theoretical and methodological aspects. We give a detailed and incomplete, structural and content characteristics of these categories in the interpretation of their manifestation in thepolitical and social dimension of society.

  16. Evaluation of methodological aspects of digestibility meaurements in ponies fed different grass hays

    NARCIS (Netherlands)

    Schaafstra, F.J.W.C.; Doorn, van D.A.; Schonewille, J.T.; Wartena, F.C.; Zoon, van M.; Blok, M.C.; Hendriks, W.H.

    2015-01-01

    Methodological aspects of digestibility measurements of feedstuffs for equines were studied in four Welsh pony geldings consuming four grass-hay diets in a 4 × 4 Latin square design. Diets contained either a low (L), medium (M), high (H), or very high (VH) ADF content (264, 314, 375, or 396 g·kg-1

  17. A large-scale study of epilepsy in Ecuador: methodological aspects.

    Science.gov (United States)

    Placencia, M; Suarez, J; Crespo, F; Sander, J W; Shorvon, S D; Ellison, R H; Cascante, S M

    1992-01-01

    The methodology is presented of a large-scale study of epilepsy carried out in a highland area in northern Ecuador, South America, covering a population of 72,121 people; The study was carried out in two phases, the first, a cross-sectional phase, consisted of a house-to-house survey of all persons in this population, screening for epileptic seizures using a specially designed questionnaire. Possible cases identified in screening were assessed in a cascade diagnostic procedure applied by general doctors and neurologists. Its objectives were: to establish a comprehensive epidemiological profile of epileptic seizures; to describe the clinical phenomenology of this condition in the community; to validate methods for diagnosis and classification of epileptic seizures by a non-specialised team; and to ascertain the community's knowledge, attitudes and practices regarding epilepsy. A sample was selected in this phase in order to study the social aspects of epilepsy in this community. The second phase, which was longitudinal, assessed the ability of non-specialist care in the treatment of epilepsy. It consisted of a prospective clinical trial of antiepileptic therapy in untreated patients using two standard anti-epileptic drugs. Patients were followed for 12 months by a multidisciplinary team consisting of a primary health worker, rural doctor, neurologist, anthropologist, and psychologist. Standardised, reproducible instruments and methods were used. This study was carried out through co-operation between the medical profession, political agencies and the pharmaceutical industry, at an international level. We consider this a model for further large-scale studies of this type.

  18. EMS and process of identification and evaluation of environmental aspects: a proposal methodology

    International Nuclear Information System (INIS)

    Perotto, E.

    2006-01-01

    The Environmental Management System (EMS) is an instrument to manage the interaction between the organization and the environment. The scope od EMS is to reduce the environmental impact and to achieve improvements in overall performances. In particular, the focus point of EMS implementation is the method for identifying and assessing significant environmental aspects. The results of the literature and regulation reviews (Perotto 2006) have shown that rigourous repeatable and transparent methodologies do not exist. This paper presents a proposal method for identifying and assessing significant environmental aspects, that has all three of these important characteristics. In particular, the proposal methodology for assessing aspects is based on some criteria that are combined in a specific algorithm. It is important to specify that to make a correct application of the method a preliminary rigorous approach to investigating the environment and the activities of organizations is necessary [it

  19. Quantifying biopsychosocial aspects in everyday contexts: an integrative methodological approach from the behavioral sciences

    Science.gov (United States)

    Portell, Mariona; Anguera, M Teresa; Hernández-Mendo, Antonio; Jonsson, Gudberg K

    2015-01-01

    Contextual factors are crucial for evaluative research in psychology, as they provide insights into what works, for whom, in what circumstances, in what respects, and why. Studying behavior in context, however, poses numerous methodological challenges. Although a comprehensive framework for classifying methods seeking to quantify biopsychosocial aspects in everyday contexts was recently proposed, this framework does not contemplate contributions from observational methodology. The aim of this paper is to justify and propose a more general framework that includes observational methodology approaches. Our analysis is rooted in two general concepts: ecological validity and methodological complementarity. We performed a narrative review of the literature on research methods and techniques for studying daily life and describe their shared properties and requirements (collection of data in real time, on repeated occasions, and in natural settings) and classification criteria (eg, variables of interest and level of participant involvement in the data collection process). We provide several examples that illustrate why, despite their higher costs, studies of behavior and experience in everyday contexts offer insights that complement findings provided by other methodological approaches. We urge that observational methodology be included in classifications of research methods and techniques for studying everyday behavior and advocate a renewed commitment to prioritizing ecological validity in behavioral research seeking to quantify biopsychosocial aspects. PMID:26089708

  20. Importance of the lipid peroxidation biomarkers and methodological aspects FOR malondialdehyde quantification

    Directory of Open Access Journals (Sweden)

    Denise Grotto

    2009-01-01

    Full Text Available Free radicals induce lipid peroxidation, playing an important role in pathological processes. The injury mediated by free radicals can be measured by conjugated dienes, malondialdehyde, 4-hydroxynonenal, and others. However, malondialdehyde has been pointed out as the main product to evaluate lipid peroxidation. Most assays determine malondialdehyde by its reaction with thiobarbituric acid, which can be measured by indirect (spectrometry and direct methodologies (chromatography. Though there is some controversy among the methodologies, the selective HPLC-based assays provide a more reliable lipid peroxidation measure. This review describes significant aspects about MDA determination, its importance in pathologies and biological samples treatment.

  1. Performance Evaluation and Measurement of the Organization in Strategic Analysis and Control: Methodological Aspects

    OpenAIRE

    Živan Ristić; Neđo Balaban

    2006-01-01

    Information acquired by measuring and evaluation are a necessary condition for good decision-making in strategic management. This work deals with : (a) Methodological aspects of evaluation (kinds of evaluation, metaevaluation) and measurement (supposition of isomorphism in measurement, kinds and levels of measurement, errors in measurement and the basic characteristics of measurement) (b) Evaluation and measurement of potential and accomplishments of the organization in Kaplan-Norton perspect...

  2. [Types of medical registries - definitions, methodological aspects and quality of the scientific work with registries].

    Science.gov (United States)

    Mathis-Edenhofer, Stefan; Piso, Brigitte

    2011-12-01

    This work presents a comprehensive list of registry definitions including broader and narrower definitions. Compared to each other different methodological issues can be identified. Some of these issues are common for all registry types; some can be assigned more easily to a specific registry type. Instruments for evaluating the quality of registers reflect many of the mentioned aspects. Generally, and especially at registers with a descriptive or exploratory research dimension it is important to consider their intended purpose and in about it was achieved. This includes, for instance, whether the purpose and the methodology are coordinated. From the start of registration an initiator should be - based on the purpose - aware of the methodological dimension of the registry. This helps to apply the correct type of the registry, the appropriate guidance and, ultimately, the arguments for the effort (cost-benefit ratio).

  3. Evaluation of methodological aspects of digestibility measurements in ponies fed different haylage to concentrate ratios.

    Science.gov (United States)

    Schaafstra, F J W C; van Doorn, D A; Schonewille, J T; van Riet, M M J; Visser, P; Blok, M C; Hendriks, W H

    2017-11-01

    Methodological aspects of digestibility measurements were studied in four Welsh pony geldings consuming haylage-based diets with increasing proportions of a pelleted concentrate according to a 4×4 Latin square design experiment. Ponies were fed four experimental, iso-energetic (net energy (NE) basis) diets (i.e. 22 MJ NE/day) with increasing proportions of a pelleted concentrate (C) in relation to haylage (H). The absolute amounts of diet dry matter fed per day were 4.48 kg of H (100H), 3.36 and 0.73 kg of H and C (75H25C), 2.24 and 1.45 kg of H and C (50H50C) and 1.12 and 2.17 kg of H and C (25H75C). Diets were supplemented with minerals, vitamins and TiO2 (3.7 g Ti/day). Voluntary voided faeces were quantitatively collected daily during 10 consecutive days and analysed for moisture, ash, ADL, acid-insoluble ash (AIA) and Ti. A minimum faeces collection period of 6 consecutive days, along with a 14-day period to adapt the animals to the diets and become accustomed to the collection procedure, is recommended to obtain accurate estimations on dry matter digestibility and organic matter digestibility (OMD) in equids fed haylage-based diets supplemented with concentrate. In addition, the recovery of AIA, ADL and Ti was determined and evaluated. Mean faecal recovery over 10 consecutive days across diets for AIA, ADL and Ti was 124.9% (SEM 2.9), 108.7% (SEM 2.0) and 97.5% (SEM 0.9), respectively. Cumulative faecal recovery of AIA significantly differed between treatments, indicating that AIA is inadequate to estimate the OMD in equines. In addition, evaluation of the CV of mean cumulative faecal recoveries obtained by AIA, ADL and Ti showed greater variations in faecal excretion of AIA (9.1) and ADL (7.4) than Ti (3.7). The accuracy of prediction of OMD was higher with the use of Ti than ADL. The use of Ti is preferred as a marker in digestibility trials in equines fed haylage-based diets supplemented with increasing amounts of pelleted concentrate.

  4. The Evaluation of Innovation in the IT Service Sector: Methodological and Empirical Aspects

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    Eglė Kazlauskienė

    2013-08-01

    Full Text Available Purpose — Nowadays services are comprehended as the key factor for economic activity, growth and employment. Developed economies are service-dominated though little is known about the innovation details in the service sector and this study field has been neglected for a while. The innovation in service sector activities needs to be thoroughly evaluated because innovation is an interconnected process and cannot be defined using one or few indicators. IT services are an integral part of contemporary life, particularly for business. It can be introduced and implemented in all fields, especially when the world is becoming more multidimensional. Innovation performance in the IT sector has been under-researched, despite the fact that IT service sector plays the innovation disseminator role in other sectors by appliance of IT products. Design/methodology/approach — Based on scientific literature and methodological aspects analyses, an empirical research methodology was designed and the qualitative research on innovation in information technology service sector was accomplished. Findings — The article presents methodological aspects of innovation evaluation in service sector and empirical aspects on innovation implementation and development in the IT service companies in Lithuania. Research limitations/implications — For more comprehensive understanding of innovation in service sector, especially in IT services, the theory of service innovation is necessary. Deeper understanding and perspectives on how innovation benefits the information technology sector should be revealed in further researches and the multi-country analysis is needed. Practical implications — The finding of the paper can be used to improve the development of innovation in information technology service companies and create a model for more exhaustive multi-country empirical researches. Originality/value — The impact of innovation and its development in information

  5. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

    Science.gov (United States)

    2011-01-01

    Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

  6. Automated sleep stage detection with a classical and a neural learning algorithm--methodological aspects.

    Science.gov (United States)

    Schwaibold, M; Schöchlin, J; Bolz, A

    2002-01-01

    For classification tasks in biosignal processing, several strategies and algorithms can be used. Knowledge-based systems allow prior knowledge about the decision process to be integrated, both by the developer and by self-learning capabilities. For the classification stages in a sleep stage detection framework, three inference strategies were compared regarding their specific strengths: a classical signal processing approach, artificial neural networks and neuro-fuzzy systems. Methodological aspects were assessed to attain optimum performance and maximum transparency for the user. Due to their effective and robust learning behavior, artificial neural networks could be recommended for pattern recognition, while neuro-fuzzy systems performed best for the processing of contextual information.

  7. Physiological and methodological aspects of rate of force development assessment in human skeletal muscle.

    Science.gov (United States)

    Rodríguez-Rosell, David; Pareja-Blanco, Fernando; Aagaard, Per; González-Badillo, Juan José

    2017-12-20

    Rate of force development (RFD) refers to the ability of the neuromuscular system to increase contractile force from a low or resting level when muscle activation is performed as quickly as possible, and it is considered an important muscle strength parameter, especially for athletes in sports requiring high-speed actions. The assessment of RFD has been used for strength diagnosis, to monitor the effects of training interventions in both healthy populations and patients, discriminate high-level athletes from those of lower levels, evaluate the impairment in mechanical muscle function after acute bouts of eccentric muscle actions and estimate the degree of fatigue and recovery after acute exhausting exercise. Notably, the evaluation of RFD in human skeletal muscle is a complex task as influenced by numerous distinct methodological factors including mode of contraction, type of instruction, method used to quantify RFD, devices used for force/torque recording and ambient temperature. Another important aspect is our limited understanding of the mechanisms underpinning rapid muscle force production. Therefore, this review is primarily focused on (i) describing the main mechanical characteristics of RFD; (ii) analysing various physiological factors that influence RFD; and (iii) presenting and discussing central biomechanical and methodological factors affecting the measurement of RFD. The intention of this review is to provide more methodological and analytical coherency on the RFD concept, which may aid to clarify the thinking of coaches and sports scientists in this area. © 2017 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

  8. Non-inferiority trials: methodological and regulatory challenges

    NARCIS (Netherlands)

    Wangge, G.

    2012-01-01

    A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In such trials a drug can be compared with a placebo or with another active compound for the same indication. RCTs can be used to demonstrate that a drug is superior to placebo or an active comparator

  9. Methodological aspects of values for determining the physical load in sport.

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    Chernozub A.A.

    2012-09-01

    Full Text Available The main aspects of the control system of training in sport and identified two methodological concepts determine the amount of physical activity during the training sessions. It is established that the physical training and sports activities in the course of employment estimate the value of physical activity mainly due to the reaction rates of the functional systems of the body to an external stimulus. Such an assessment, especially in a narrow range of controllable parameters (for the reaction of the cardiovascular and respiratory systems, is more theoretical in nature and does not allow to clearly define the critical load levels for a particular organism. This problem highlights the need to use a single, integrated, suitable for precise mathematical analysis of the universal, possibly conditional, indicator or criteria for evaluating physical activity. Development of this criterion will optimize the training process at different stages of training opportunities tailored to individual athletes.

  10. Methodological aspects of fuel performance system analysis at raw hydrocarbon processing plants

    Science.gov (United States)

    Kulbjakina, A. V.; Dolotovskij, I. V.

    2018-01-01

    The article discusses the methodological aspects of fuel performance system analysis at raw hydrocarbon (RH) processing plants. Modern RH processing facilities are the major consumers of energy resources (ER) for their own needs. To reduce ER, including fuel consumption, and to develop rational fuel system structure are complex and relevant scientific tasks that can only be done using system analysis and complex system synthesis. In accordance with the principles of system analysis, the hierarchical structure of the fuel system, the block scheme for the synthesis of the most efficient alternative of the fuel system using mathematical models and the set of performance criteria have been developed on the main stages of the study. The results from the introduction of specific engineering solutions to develop their own energy supply sources for RH processing facilities have been provided.

  11. Methodological Aspects in Forecasting Innovation Development of Dairy Cattle Breeding in the Region

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    Natal’ya Aleksandrovna Medvedeva

    2016-07-01

    Full Text Available Due to the fact that Russia is now a member of the World Trade Organization, long-term forecasting becomes an objectively necessary condition that helps choose an effective science-based long-term strategy for development of dairy cattle breeding that would take into consideration intellectual and innovative characteristics. Current structure of available statistical information does not meet modern challenges of innovation development and does not reflect adequately the trends of ongoing changes. The paper suggests a system of indicators to analyze the status, development and prospects of dairy cattle breeding in the region; this system provides timely identification of emerging risks and threats of deviation from the specified parameters. The system included indicators contained in the current statistical reporting and new indicators of innovation development of the industry, the quality of human capital and the level of government support. When designing the system of indicators, we used several methodological aspects of the Oslo Manual, which the Federal State Statistics Service considers to be an official methodological document concerning the collection of information about innovation activities. A structured system of indicators shifts the emphasis in the analysis of the final results to the conditions and prerequisites that help achieve forecast performance indicators in the functioning of Russia’s economy under WTO rules and make substantiated management decisions

  12. The glycemic index: methodological aspects related to the interpretation of health effects and to regulatory labeling.

    Science.gov (United States)

    Aziz, Alfred

    2009-01-01

    The glycemic index (GI) is an experimental system that classifies carbohydrates (CHO) and CHO-containing foods according to their blood glucose-raising potential. It is based on the glycemic response following the ingestion of a test food containing a defined amount of available CHO relative to that of an equi-carbohydrate portion of either white bread or glucose. The concept has been extended to mixed meals and whole diets where the GI of the meal/diet is expressed as the weighted average of the GI of each food, based on the percentage of the total mealldiet CHO provided by each food. Over the last few decades, a substantial number of epidemiological and interventional studies have reported beneficial associationsleffects of lower GI diets across a wide spectrum of pathophysiological conditions, including diabetes, cardiovascular disease, obesity, and certain forms of cancer. This has prompted proponents of the GI to recommend its use for dietary planning and labeling purposes. However, the currently recommended GI methodology is not well standardized and has several flaws, which brings into question the strength of evidence attributed to the health effects of low-GI diets. This review focuses exclusively on the methodological aspects of the GI, how they might impact the interpretation of data related to the purported health benefits of low GI diets, and the considerations for the use of the GI in food labeling. In addition, alternative systems for classifying the glycemic effects of CHO-containing foods are briefly discussed.

  13. [Identification of circulatory diseases and their risk during medical examination of an adult population: methodological aspects].

    Science.gov (United States)

    Kalinina, A M; Ipatov, P V; Kaminskaya, A K; Kushunina, D V

    2015-01-01

    To study the efficiency of a methodology for the active detection of coronary heart disease (CHD) and cerebrovascular diseases (CVD) during medical examination and to determine the need and possible ways of its improvement. The medical examinations of 19.4 million people (94.6% of all the citizens who had undergone medical examinations in all the regions of Russia in 2013) were analyzed and the methodological aspects of identification of the circulatory diseases (CDs) that were induced by coronary and cerebral vessel atherosclerosis and had common risk factors, primarily CHD and CVD, were assessed. The medical examinations revealed 2,915,445 cases of CDs and their suspicions, during which its clinical diagnosis was established in 57.2%. The suspected disease requiring that its diagnosis should be further specified; off-medical examinations revealed hypertension in more than 770,000 cases, CHD in 232,000, and CVD in 146,000. The proportion of stable angina pectoris of all angina cases was much higher at a young age (25.6%) than at middle (15.6%) and elderly (11.3%) ages. Brachiocephalic artery stenoses were detected in almost 13,000 cases. According to the official health statistics, within the years preceding the introduction of large-scale medical examinations, there was a slight rise in new CD cases among the adult population of Russia, which was more significant in 2013 (according to the preliminary data) than in 2012. The methodology for the active detection of CDs through a two-step medical examination, which is used during a follow-up, makes it possible to substantially increase detection rates for CDs. There has been shown to be a need for the better quality and completeness of diagnostic examination in real practice.

  14. Certain Aspects concerning Trial under Admission of Guilt

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    Mihai OLARIU

    2014-03-01

    Full Text Available The trial under admission of guilt is an abbreviated procedure relying on a guilty plea, and it may be applied if the conditions stipulated in the New Criminal Procedure Code are fulfilled. One of these conditions is for the defendant to fully admit of the deeds presented by the prosecutor in the indictment (he must not, however, admit the same upon the legal classification of offences. Pursuant to the simplified procedure, in the case of conviction or postponement of the application of the sanction, the punishment limits stipulated under the law are reduced by one third for imprisonment, and by one fourth for fine sanctions. The present article is a a continuation of the author’s own research and it represents a clear comment regarding trial under admission of guilt according to the New Criminal Procedure Code, in the purpose of understanding the legislator’s intention and how the new regulations will apply.

  15. Methodological and ethical aspects of the sexual maturation assessment in adolescents

    Directory of Open Access Journals (Sweden)

    Eliane Rodrigues de Faria

    2013-09-01

    Full Text Available OBJECTIVE To analyze methodological and ethical aspects in the sexual maturation assessment of adolescents. DATA SOURCES Books and theses, articles and legislations on the Medline, SciELO, Science Direct databases, besides institutional documents of the World Health Organization and the Pediatric Societies of Brazil and São Paulo, considering the period from 1962 to 2012. The following keywords were used in Portuguese and English: "sexual maturation", "self-assessment", "ethics", "OBJECTIVE assessment of sexual maturation", "puberty", "adolescent", and "adolescentdevelopment". DATA SYNTHESIS The sexual maturation assessment is used in populatinal studies and in clinical daily care. The direct evaluation is performed by a specialized physician, whereas the self-assessment is carried out by the adolescent. This evaluation should be carefully performed in the appropriate place, taking into account the ethical aspects. The patient should not be constrained and the physician must respect the privacy and the confidentiality. Before this evaluation and independently of the used method, the adolescent should receive information and explanation about the procedure and the tools that will be applied. Furthermore, the patient has the right to want or not an adult close to him. CONCLUSIONS Validation studies showed that self-assessment is inferior to clinical assessment and should, therefore, be performed only when the direct examination by physicians is not possible.

  16. METHODOLOGICAL ASPECTS OF RATIONAL DESIGN FORMATION OF INFRASTRUCTURE OF AGRARIAN SECTOR OF UKRAINE

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    Ivan Korchynskyy

    2016-11-01

    Full Text Available Methodological aspects of formation of rational design of infrastructure of agrarian sector of Ukraine on the basis of the institutional approach and laws of architectonics are examined. It is shown that the agrarian sector of Ukraine is a complex socio-economic system, the formation and development of which is in the process of market transformation what is caused by institutional influences. In general the process of relations institutionalization imply their formalization and standardization, in other case the subject of public life could not predict the actions of other entities associated with him and ensure their cooperation. One of the specific characteristic of human society is formed institutional system that regulates behaviour. In the article the factors of influence on the conduct of being in charge subjects are considered in the conditions of development of market economy. The special attention is spared the institutional factors of the economy growing. Methodology. The meaning of “agricultural field” and “infrastructure” and their mutual consistency is classified. As the scientific method, the institutional approach of principles of architectonics has been used, which allowed to justify the creation of a rational approach to the design of infrastructure in agrarian sector as a whole on the basis, relation and interdependence of its elements, based on the fundamental laws of architectonics (law of equilibrium, law of the golden mean structuring. The article demonstrates a necessary of the choice of a theory of institutionalism as the main methodological basis for the study of the process of innovation development of economic system of Ukraine. It is determined that the inefficient activities of institutions in Ukraine are the main cause of the low level of innovation, which has a negative impact on the development of the economy as a whole. Results. Research points on new aspects of infrastructure as a part of the entire

  17. The Helicobacter Eradication Aspirin Trial (HEAT: A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care

    Directory of Open Access Journals (Sweden)

    Jennifer S. Dumbleton

    2015-09-01

    Discussion: HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.

  18. 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.

  19. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

    Directory of Open Access Journals (Sweden)

    Dreyhaupt, Jens

    2017-05-01

    Full Text Available An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”. Compared with studies with individual randomization, studies with cluster randomization normally require (significantly larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies.Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  20. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

    Science.gov (United States)

    Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

    2017-01-01

    An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  1. [Methodological aspects of the reconstitution and evaluation of the behavioral theories that underlie population policy].

    Science.gov (United States)

    Leeuw, F

    1991-09-01

    This work discusses methodological aspects of the articulation and evaluation of behavioral theories underlying demographic policies. Such theories, called "policy theories" among other terms, may be defined as a group of hypotheses explicitly translated into predictions about behavior that underlie policy measures and that concern the relations between the measure and the objective to be attained. Interest in policy theories has been reflected in the writings of such demographers as D. Bogue, J. Blake, and T. Burch, and of researchers from other social science disciplines. 2 examples of policy theories from the Netherlands are presented to illustrate the discussion, 1 describing family planning communication programs that were intended to reduce the number of unwanted and unplanned pregnancies, and the other describing measures to increase availability of child care services in order to facilitate labor force participation of women and ultimately to increase the birth rate. Both theories are found to be comprised of 2 main parallel theories and several related hypotheses. Because political authorities do not usually make explicit the hypotheses that support political measures, their hypotheses must be articulated and reconstituted through attention to debates, written communications, interviews, and other means. The reconstitution must be done as objectively as possible, which implies the need to follow some methodologic rules. Examples are cited of principles advanced by researchers in management science, market research, and political science. 7 methodological rules or steps are then suggested for articulating policy theories: 1) identify statements relative to the political problem, such as excessive or inadequate fertility rates; 2) use the sources to identify reasons for undertaking concrete policy measures; 3) describe the role of the official in the political process; 4) inventory all declarations concerning the relationship between the objective and the

  2. Diuresis renography in children: methodological aspects; Nephrogramme isotopique avec epreuve d`hyperdiurese chez l`enfant: aspects methodologiques

    Energy Technology Data Exchange (ETDEWEB)

    Bonnin, F.; Le Stanc, E. [Hopital Beaujon, 92 - Clichy (France); Busquet, G.; Saidi, L. [Hopital Mignot, 78 - Versailles (France); Lyonnet, F. [Hopital Lapeyronie, 34 -Montpellier (France)

    1995-12-31

    In paediatrics, diuresis renography is used as a method to guide clinical management of hydronephrosis or hydro-uretero-nephrosis. Various pitfalls in the technique and other errors exist and may lead to a misinterpretation of the test. The methodology for performing and interpreting the diuresis renography is discussed. (authors). 12 refs., 4 figs.

  3. methodological and technical aspects to be considered in the location of physical recreational sports facilities

    Directory of Open Access Journals (Sweden)

    Jesús I. Benítez Llanes

    2012-03-01

    Full Text Available Sometimes we wonder. Why practitioners of recreational physical activities do not make systematic use of a particular sports facility ?, Why some sports facility remains almost always empty? Why it is continued unnecessarily reversed large sums of material resources for maintenance? For the simple reason that sports facilities were from the beginning that were not well conceived and designed architecturally, where among other things, not sporting habits and population size of the place properly examined. Similarly, we have witnessed criteria issued regarding the performance of a specific sports field, far from contributing to the extension and improvement of the practice of recreational physical and sports activities in its various manifestations, its null or poor continuous maintenance contributing negatively to limit the sporting life and lacerate mental and physical welfare of the inhabitants of the environment. Justifications that led the author of this research to the development of methodological technical aspects regarding the location of recreational physical sports infrastructure, content which also form part of the subject and / or curricular unit "Spaces and Sports Facilities" currently teaches future professionals and managers of Physical Culture for the last two academic years at the University of the Sciences of Physical Culture and Sport Nancy Uranga Romagoza in Pinar del Río Cuba and the Iberoamerican University of Sport in Venezuela.

  4. Global health trials methodological research agenda:results from a priority setting exercise

    OpenAIRE

    Blazeby, Jane; Nasser, Mona; Soares-Weiser, Karla; Sydes, Matthew R.; Zhang, Junhua; Williamson, Paula R

    2018-01-01

    BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities however may not be reflected in the needs of similar research in low to middle income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological ...

  5. Methodological aspects in quantitative translational neuroimaging in central nervous system diseases with Positron Emission Tomography

    International Nuclear Information System (INIS)

    Müllauer, J.

    2013-01-01

    understanding of the transport mechanisms of radioligands across the BBB. Moreover, imaging artifacts, such as partial volume effect and spill over effect play a role in quantitative PET, in particular when imaging small anatomical structures. Phantom studies were conducted to evaluate these effects and correction methods were explored. Goal of this thesis is to reveal present and unattended methodological aspects of preclinical, as well as translational neuroimaging of CNS diseases with PET. (author) [de

  6. Environmental evaluation Methodology as part, of the project multi-aspect evaluation of the portfolio of ISAGEN options

    International Nuclear Information System (INIS)

    Ayala R, Ana Victoria

    2001-01-01

    ISAGEN designed and applied a multi-aspect methodology to classify and compare projects of the company's electricity generation options portfolio. It was developed from a holistic vision, integrating multidisciplinary information from the economic, environmental and technical aspects. This helped to classify the alternatives based on the sum of the values obtained for the different considered aspects. This document presents, in general form, the procedure adopted for the index formulation and selection of factors including the variables corresponding to the sub-aspects (or environmental dimensions) physical, biotic and social. The investigation's work, selection and classification of the variables were developed by an interdisciplinary group of experimented professionals in the environmental evaluation of projects. The integration of the three sub-aspects (physical, biotic and social) resulted in a hierarchy of projects based on environmental considerations, which were finally articulated with the respective values obtained from the technical and economical aspects. In general, the results obtained in each sub-aspect agreed with the hierarchy of projects based on an expert concept previous to the method application. In synthesis, it was observed that this technique is of great utility to make comparisons and general classifications because it allows to take advantage of information with different characteristics and include assumptions or artificial modifiable methodological items that reflect the structure of the deciding agents preferences at any given time

  7. Terminological and methodological aspects in investigating the preservation of rare library materials

    Directory of Open Access Journals (Sweden)

    Damir Hasenay

    2008-07-01

    efficient management and good organization of preservation presupposes a systematic and comprehensive approach applicable independent of the type of institution or type of material. The management and organization issues concerning the preservation of rare library materials is shown as an overview of their most important elements, with a critical evaluation of the most important achievements in theory in practice. The methodological aspect is also very important in investigating the preservation of rare library materials.The special emphasis is placed on the systematic investigation of the status of library holdings and the possibilities offered by the qualitative and quantitative description of holdings on the one hand, and the possibilities offered by the methods of interview and/or questionnaire on the other. Several practical examples that may serve as test models in the approach to this issue have been analyzed.The existing organization of the collection of historical newspapers from the city of Osijek area, and the organization of the collection of old books in the library of the Franciscan monastery in Mostar in relation to their status and protection activities have also been discussed. By comparing these models a significant difference in the material and content characteristics of the analyzed rare library holdings have been identified. This difference calls for the use of different methodologies for investigating the condition of the holdings. The information on the condition of the library holdings and approaches to their preservation serve as a starting point for planning further steps for the efficient preservation of rare library materials. The insights into the problem of preservation presented in this paper should be understood as a foundation for further implementation on similar examples.Key words : preservation of library materials, rare library materials, rare books, historical newspapers, organization and management of preservation, description of the

  8. 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

  9. 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.

  10. 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

  11. Development of methodology for evaluation of long-term safety aspects of organic cement paste components

    International Nuclear Information System (INIS)

    Andersson, M.; Holgersson, S.; Ervanne, H.

    2008-12-01

    Long-term safety aspects of superplasticizers (SP) and other cement paste components were studied in this joint Nagra - NUMO - SKB - Posiva project with aim to develop a methodology for the evaluation of the long-term safety aspects of superplasticizers (SP) and other organic components of cement pastes. The study also evaluated the effects of SPs and other cement paste components that have already been used or that are most likely to be used in the construction of the high-level nuclear waste repositories in Sweden, Switzerland, Finland and Japan. The main long-term safety issue of concern is whether the superplasticizers and/or other organic components of cement pastes might affect the transport properties of radionuclides. A full evaluation of whether the superplasticizers can be used in a high-level nuclear waste repository cannot be answered based on the studies but a classification of the superplasticizers based on their impact on sorption of radionuclides has been done. The basic methodology for testing, leaching and analyzing of leachants and solid samples of different types was developed at CRIEPI. Two different methodologies for studying the impact of SPs on the sorption of Eu on crushed rock were tested and developed by Helsinki University (HU) and Chalmers University of Technology (CTH). Methods for analyzing organics leaching from grouts were successfully tested by CRIEPI and CTH (Chalmers University of Technology). At CRIEPI the total organic content (TOC) of the leachants was analyzed by Infrared absorption spectrometry (IR) followed by Gel Permeation Chromatography (GPC) for the identification of the organic compounds. At CTH several different analytical methods were tested (e.g. IR, UV spectroscopy, NMR, MALDI-TOF), but these methods still require improvement. In addition to SPs, organics are present in several components of cement pastes, for example in cement grinding aid (CGA) and micro silica slurry. The results suggests that the main high

  12. 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.

  13. [Methodological aspects of a study of medical service satisfaction in patients with borderline mental disorders].

    Science.gov (United States)

    Malygin, Ya V; Tsygankov, B D

    The authors discussed a methodology of the study of medical service satisfaction and it's factors: moment of assessment, methodology of data collection, format of data, bench-marking, principles of inclusion of questions into a questionnaire, organizing and frequency of conducting studies.

  14. Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

    Science.gov (United States)

    Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M

    2017-07-01

    In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.

  15. The trials methodological research agenda: results from a priority setting exercise

    Science.gov (United States)

    2014-01-01

    Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with

  16. Methodological Aspects of Building Science-based Sports Training System for Taekwondo Sportsmen

    Directory of Open Access Journals (Sweden)

    Ananchenko Konstantin

    2016-10-01

    Full Text Available The authors have solved topical scientific problems in the article: 1 the research base in the construction of theoretical and methodological foundations of sports training, based on taekwondo has been analysed; 2 the organization and methodological requirements for the training sessions of taekwondo have been researched; 3 the necessity of interaction processes of natural development and adaptation to physical activity of young taekwondo sportsmen has been grounded; 4 the necessity of scientific evidence of building young fighters training loads in microcycles, based on their individualization has been proved.

  17. Randomized controlled trials of simulation-based interventions in Emergency Medicine: a methodological review.

    Science.gov (United States)

    Chauvin, Anthony; Truchot, Jennifer; Bafeta, Aida; Pateron, Dominique; Plaisance, Patrick; Yordanov, Youri

    2018-04-01

    The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

  18. Key Methodological Aspects of Translators' Training in Ukraine and in the USA

    Science.gov (United States)

    Skyba, Kateryna

    2015-01-01

    The diversity of international relations in the globalized world has influenced the role of a translator that is becoming more and more important. Translators' training institutions today are to work out and to implement the best teaching methodology taking into consideration the new challenges of modern multinational and multicultural society.…

  19. Methodological aspects of the use of materials from remote photographs in oil and gas search operations

    Energy Technology Data Exchange (ETDEWEB)

    Kostryukov, M I; Tsarenko, P T

    1981-01-01

    Presented are the methodological characteristics of the use of materials from remote probes in oil and gas search operations within the central part of the western Siberian plain. Examined briefly are ways to increase the effectiveness of interpreting deep structures and the necessity for an amplification in the development of automated systems for interpretation is show.

  20. A systematic methodology review of phase I radiation dose escalation trials

    International Nuclear Information System (INIS)

    Pijls-Johannesma, Madelon; Mastrigt, Ghislaine van; Hahn, Steve M.; De Ruysscher, Dirk; Baumert, Brigitta G.; Lammering, Guido; Buijsen, Jeroen; Bentzen, Soren M.; Lievens, Yolande; Kramar, Andrew; Lambin, Philippe

    2010-01-01

    Background and purpose: The purpose of this review is to evaluate the methodology used in published phase I radiotherapy (RT) dose escalation trials. A specific emphasis was placed on the frequency of reporting late complications as endpoint. Materials and methods: We performed a systematic literature review using a predefined search strategy to identify all phase I trials reporting on external radiotherapy dose escalation in cancer patients. Results: Fifty-three trials (phase I: n = 36, phase I-II: n = 17) fulfilled the inclusion criteria. Of these, 20 used a modified Fibonacci design for the RT dose escalation, but 32 did not specify a design. Late toxicity was variously defined as >3 months (n = 43) or > 6 months (n = 3) after RT, or not defined (n = 7). In only nine studies the maximum tolerated dose (MTD) was related to late toxicity, while only half the studies reported the minimum follow-up period for dose escalation (n = 26). Conclusion: In phase I RT trials, late complications are often not taken into account and there is currently no consensus on the methodology used for radiation dose escalation studies. We therefore propose a decision-tree algorithm which depends on the endpoint selected and whether a validated early surrogate endpoint is available, in order to choose the most appropriate study design.

  1. Methodological Aspects Regarding the Process of Estimating the Reserve for the Un-cleared Damages

    Directory of Open Access Journals (Sweden)

    Constantin Anghelache

    2007-07-01

    The analyzed theoretical aspects are accompanied by empirical examples meant to give the researcher (reader the opportunity of a clearer understanding the mechanism in discussion. The examples are of a scholastic nature to the extent they are aiming a more explicit approach of the used mechanism only, without representing elements of a case analysis.

  2. Scientifically-methodological aspects of agroecological estimation of farmlands in the conditions of radioactive pollution

    International Nuclear Information System (INIS)

    Tsybul'ko, N.N.; Misyuchik, A.A.

    2009-01-01

    Methodical aspects of adaptive land tenure in the conditions of radioactive pollution on the basis of an agroecological estimation of the earths under the radiating factor and an estimation of influence of soil-landscape conditions on migration radionuclide are proved. (authors)

  3. A methodology for the quantitative evaluation of NPP fault diagnostic systems' dynamic aspects

    International Nuclear Information System (INIS)

    Kim, J.H.; Seong, P.H.

    2000-01-01

    A fault diagnostic system (FDS) is an operator decision support system which is implemented both to increase NPP efficiency as well as to reduce human error and cognitive workload that may cause nuclear power plant (NPP) accidents. Evaluation is an indispensable activity in constructing a reliable FDS. We first define the dynamic aspects of fault diagnostic systems (FDSs) for evaluation in this work. The dynamic aspect is concerned with the way a FDS responds to input. Next, we present a hierarchical structure in the evaluation for the dynamic aspects of FDSs. Dynamic aspects include both what a FDS provides and how a FDS operates. We define the former as content and the latter as behavior. Content and behavior contain two elements and six elements in the lower hierarchies, respectively. Content is a criterion for evaluating the integrity of a FDS, the problem types which a FDS deals with, along with the level of information. Behavior contains robustness, understandability, timeliness, transparency, effectiveness, and communicativeness of FDSs. On the other hand, the static aspects are concerned with the hardware and the software of the system. For quantitative evaluation, the method used to gain and aggregate the priorities of the criteria in this work is the analytic hierarchy process (AHP). The criteria at the lowest level are quantified through simple numerical expressions and questionnaires developed in this work. these well describe the characteristics of the criteria and appropriately use subjective, empirical, and technical methods. Finally, in order to demonstrate the feasibility of our evaluation method, we have performed one case study for the fault diagnosis module of OASYS TM (On-Line Operator Aid SYStem for Nuclear Power Plant), which is an operator support system developed at the Korea Advanced Institute of Science and Technology (KAIST)

  4. More Than Just a Discursive Practice? Conceptual Principles and Methodological Aspects of Dispositif Analysis

    Directory of Open Access Journals (Sweden)

    Andrea D. Bührmann

    2007-05-01

    Full Text Available This article gives an introduction into the conceptual and practical field of dispositf analysis—a field that is of great importance but that is as yet underdeveloped. In order to render this introduction, we first explain the terms discourse and dispositif. Then we examine the conceptual instruments and methodological procedures of dispositf analysis. In this way, we define the relations between discourse and (a non discoursive practices (b subjectification, (c everyday orders of knowledge and (d institutional practices like societal changes as central issues of dispositif analysis. Furthermore, we point out the methodological possibilities and limitations of dispositif analysis. We demonstrate these possibilities and limitations with some practical examples. In general, this article aims to provide an extension of the perspectives of discourse theory and research by stressing the relations between normative orders of knowledge, their effects on interactions and individual self–reflections connected with them. URN: urn:nbn:de:0114-fqs0702281

  5. Environmental monitoring (water, soil, air, food) and some methodological aspects of radioactive decontamination

    International Nuclear Information System (INIS)

    Balanel, Vasile; Boldescu, Victoria; Mesina, Victor

    2013-01-01

    This paper presents research results of radiological samples taken from various media (water, soil, air and some food). The study showed that concentrations of radionuclides Cs 137 and Sr 90 did not exceed the maximum permissible. A high level of radionuclides but within the norm occurred in some imported food. The research describes methodology used in radioactive decontamination in practice of the modern world. (authors)

  6. Significant aspects of the external event analysis methodology of the Jose Cabrera NPP PSA

    International Nuclear Information System (INIS)

    Barquin Duena, A.; Martin Martinez, A.R.; Boneham, P.S.; Ortega Prieto, P.

    1994-01-01

    This paper describes the following advances in the methodology for Analysis of External Events in the PSA of the Jose Cabrera NPP: In the Fire Analysis, a version of the COMPBRN3 CODE, modified by Empresarios Agrupados according to the guidelines of Appendix D of the NUREG/CR-5088, has been used. Generic cases were modelled and general conclusions obtained, applicable to fire propagation in closed areas. The damage times obtained were appreciably lower than those obtained with the previous version of the code. The Flood Analysis methodology is based on the construction of event trees to represent flood propagation dependent on the condition of the communication paths between areas, and trees showing propagation stages as a function of affected areas and damaged mitigation equipment. To determine temporary evolution of the flood area level, the CAINZO-EA code has been developed, adapted to specific plant characteristics. In both the Fire and Flood Analyses a quantification methodology has been adopted, which consists of analysing the damages caused at each stage of growth or propagation and identifying, in the Internal Events models, the gates, basic events or headers to which safe failure (probability 1) due to damages is assigned. (Author)

  7. Cluster Randomised Trials in Cochrane Reviews: Evaluation of Methodological and Reporting Practice.

    Directory of Open Access Journals (Sweden)

    Marty Richardson

    Full Text Available Systematic reviews can include cluster-randomised controlled trials (C-RCTs, which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance.Criteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013, and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria.The 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24% of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33% provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38% excluded the unadjusted results from the meta-analyses.The methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating

  8. Quantitative renal cinescintigraphy with iodine-123 hippuran methodological aspects, kit for labeling of hippuran

    International Nuclear Information System (INIS)

    Mehdaoui, A.; Pecking, A.; Delorme, G.; Mathonnat, F.; Debaud, B.; Bardy, A.; Coornaert, S.; Merlin, L.; Vinot, J.M.; Desgrez, A.; Gambini, D.; Vernejoul, P. de.

    1981-08-01

    The development of an extemporaneous kit for the labeling of ortho-iodo-hippuric acid (Hippuran) with iodine 123 allows the performance of a routine quantitative renal cinescintigraphy providing in 20 minutes, and in an absolutely non-traumatic way, a very complete renal morphofunctional study including: a cortical renal scintigraphy, sequential scintigraphies of excretory tract, renal functional curves, tubular, global, and separate clearances for each kidney. This functional quantitative investigation method should take a preferential place in the routine renal balance. The methodology of the technique is explained and compared to classical methods for estimation of tubular, global and separate clearances [fr

  9. 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....

  10. Thermoregulatory responses in exercising rats: methodological aspects and relevance to human physiology.

    Science.gov (United States)

    Wanner, Samuel Penna; Prímola-Gomes, Thales Nicolau; Pires, Washington; Guimarães, Juliana Bohnen; Hudson, Alexandre Sérvulo Ribeiro; Kunstetter, Ana Cançado; Fonseca, Cletiana Gonçalves; Drummond, Lucas Rios; Damasceno, William Coutinho; Teixeira-Coelho, Francisco

    2015-01-01

    Rats are used worldwide in experiments that aim to investigate the physiological responses induced by a physical exercise session. Changes in body temperature regulation, which may affect both the performance and the health of exercising rats, are evident among these physiological responses. Despite the universal use of rats in biomedical research involving exercise, investigators often overlook important methodological issues that hamper the accurate measurement of clear thermoregulatory responses. Moreover, much debate exists regarding whether the outcome of rat experiments can be extrapolated to human physiology, including thermal physiology. Herein, we described the impact of different exercise intensities, durations and protocols and environmental conditions on running-induced thermoregulatory changes. We focused on treadmill running because this type of exercise allows for precise control of the exercise intensity and the measurement of autonomic thermoeffectors associated with heat production and loss. Some methodological issues regarding rat experiments, such as the sites for body temperature measurements and the time of day at which experiments are performed, were also discussed. In addition, we analyzed the influence of a high body surface area-to-mass ratio and limited evaporative cooling on the exercise-induced thermoregulatory responses of running rats and then compared these responses in rats to those observed in humans. Collectively, the data presented in this review represent a reference source for investigators interested in studying exercise thermoregulation in rats. In addition, the present data indicate that the thermoregulatory responses of exercising rats can be extrapolated, with some important limitations, to human thermal physiology.

  11. Methodological Aspects of Modeling Development and Viability of Systems and Counterparties in the Digital Economy

    Directory of Open Access Journals (Sweden)

    Vitlinskyy Valdemar V.

    2018-03-01

    Full Text Available The aim of the article is to study and generalize methodological approaches to modeling economic development and viability of economic systems with consideration for risk, changing their goals, status, and behavior in the digital economy. The definition of categories of economic development and viability is offered, the directions of their research by means of mathematical modeling are grounded. The system of characteristics and markers of the external economic environment under conditions of digitalization of economic activity is analyzed. The theoretical foundations and methodology for mathematical modeling of development of economic systems as well as ensuring their viability and security under conditions of introducing infrastructure of information society and digital economy on the principles of the information and knowledge approach are considered. It is proved that in an information society, predictive model technologies are a growing safety resource. There studied prerequisites for replacing the traditional integration concept of evaluation, analysis, modeling, management, and administration of economic development based on a threat-oriented approach to the definition of security protectors, information, and knowledge. There proposed a concept of creating a database of models for examining trends and patterns of economic development, which, unlike traditional trend models of dynamics, identifies and iteratively conceptualizes processes based on a set of knowledgeable predictors based on the use of data mining and machine learning tools, including in-depth training.

  12. METHODOLOGICAL ASPECTS OF CONTENT ANALYSIS OF CONVERGENCE BETWEEN UKRAINIAN GAAP AND INTERNATIONAL FINANCIAL REPORTING STANDARDS

    Directory of Open Access Journals (Sweden)

    R. Kuzina

    2015-06-01

    Full Text Available The objective conditions of Ukraine’s integration into the global business environment the need to strengthen the accounting and financial re-porting. At the stage of attracting investment in the country there is a need in the preparation of financial statements generally accepted basic prin-ciples of which are based on common international financial reporting standards (IFRS . Relevant is the assessment of convergence of national standards and International Financial Reporting Standards. However, before you conduct content analysis necessary to determine compliance with standards of methodological approaches to the selection of key indicators for the assessment of convergence. The article is to define the methodo-logical approaches to the selection and development of indicators IFRSs list of key elements for further evaluation convergence of national and international standards. To assess the convergence was allocated 187 basic key elements measuring the level of convergence to IFRS. Sampling was carried out based on the professional judgment of the author, the key indicators of the standard, based on the evaluation of the usefulness of accounting information. These figures make it possible to calculate the specific level of convergence of international and national standards and determine how statements prepared by domestic standards corresponding to IFRS. In other words, can with some certainty assert that Ukraine has made (“good practices in IFRS implementation” or not? This calculation will assess the regulatory efforts of government agencies (Ministry of Finance on the approximation of Ukrainian standards and IFRS.

  13. An update on technical and methodological aspects for cardiac PET applications

    International Nuclear Information System (INIS)

    PRESOTTO, Luca; BUSNARDO, Elena; GIANOLLI, Luigi; BETTINARDI, Valentino

    2016-01-01

    Positron emission tomography (PET) is indicated for a large number of cardiac diseases: perfusion and viability studies are commonly used to evaluate coronary artery disease; PET can also be used to assess sarcoidosis and endocarditis, as well as to investigate amyloidosis. Furthermore, a hot topic for research is plaque characterization. Most of these studies are technically very challenging. High count rates and short acquisition times characterize perfusion scans while very small targets have to be imaged in inflammation/infection and plaques examinations. Furthermore, cardiac PET suffers from respiratory and cardiac motion blur. Each type of studies has specific requirements from the technical and methodological point of view, thus PET systems with overall high performances are required. Furthermore, in the era of hybrid PET/computed tomography (CT) and PET/Magnetic Resonance Imaging (MRI) systems, the combination of complementary functional and anatomical information can be used to improve diagnosis and prognosis. Moreover, PET images can be qualitatively and quantitatively improved exploiting information from the other modality, using advanced algorithms. In this review we will report the latest technological and methodological innovations for PET cardiac applications, with particular reference to the state of the art of the hybrid PET/CT and PET/MRI. We will also report the most recent advancements in software, from reconstruction algorithms to image processing and analysis programs.

  14. Methodological aspects of modeling household solid waste generation in Japan: Evidence from Okayama and Otsu cities.

    Science.gov (United States)

    Gu, Binxian; Fujiwara, Takeshi; Jia, Renfu; Duan, Ruiyang; Gu, Aijun

    2017-12-01

    This paper presents a quantitative methodology and two empirical case studies in Japan on modeling household solid waste (HSW) generation based on individual consumption expenditure (ICE) and local waste policy effects by using the coupled estimation model systems. Results indicate that ICE on food, miscellaneous commodities and services, as well as education, cultural, and recreation services are mainly associated with the changes of HSW generation and its components in Okayama and Otsu from 1980 to 2014. The effects of waste policy measures were also identified. HSW generation in Okayama will increase from 11.60 million tons (mt) in 1980 to 25.02 mt in 2025, and the corresponding figures are 6.82 mt (in 1980) and 14.00 mt (in 2025) in Otsu. To better manage local HSW, several possible and appropriate implications such as promoting a green lifestyle, extending producer responsibility, intensifying recycling and source separation, generalizing composting, and establishing flexible measures and sustainable policies should be adopted. Results of this study would facilitate consumer management of low waste generation and support an effective HSW policy design in the two case cities. Success could lead to emulation by other Japanese cities seeking to build and maintain a sustainable, eco-friendly society. Moreover, the methodologies of establishing coupled estimation model systems could be extended to China and other global cities.

  15. Methodological aspects to be considered in evaluating the economics of service measures

    International Nuclear Information System (INIS)

    Bald, M.

    1987-01-01

    For the purposes of the report, service measures is used as a term denoting all those steps which exceed the framework of normal in-service maintenance and repair and serve to improve economics over the normal case. Positive impacts are to be achieved on such parameters as availability, efficiency, and service life. One of the aspects investigated is the effect, if any, of such measures on the residual service life of plants in operation for a long period of time already. Residual service life in this case means the remaining span of effective technical and economic operation which, in these model calculations, also includes part of the period of depreciation. (orig.) [de

  16. 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

  17. IFRS 9 implementation in banks and macroeconomic scenarios: Some methodological aspects

    Directory of Open Access Journals (Sweden)

    Brković Milan

    2017-01-01

    Full Text Available The International Financial Reporting Standard 9 - IFRS is another one in the series of global level initiatives undertaken with a view to fixing the consequences of the global economic and financial crisis, and preventing the future negative developments caused by inadequate recognition and presentation of credit losses on the part of banks. The IFRS 9 also represents a significant shift in relation to traditional accounting, given that it introduced the concept of expected credit losses to replace the concept of occurred credit losses. This task cannot be fulfilled by the traditional and conservative accounting without involving the macroeconomic assessment models, i.e. macroeconomic scenarios. This paper aims to highlight some specific methodological rudiments in macroeconomic analyses and forecasts as inputs for the accounting recognition and presentation of expected credit losses.

  18. Studies into abnormal aggression in humans and rodents: Methodological and translational aspects.

    Science.gov (United States)

    Haller, Jozsef

    2017-05-01

    Here we review the principles based on which aggression is rendered abnormal in humans and laboratory rodents, and comparatively overview the main methodological approaches based on which this behavior is studied in the two categories of subjects. It appears that the discriminating property of abnormal aggression is rule breaking, which renders aggression dysfunctional from the point of view of the perpetrator. We show that rodent models of abnormal aggression were created by the translation of human conditions into rodent equivalents, and discuss how findings obtained with such models may be "translated back" to human conditions when the mechanisms underlying aggression and its possibilities of treatment are investigated. We suggest that the complementary nature of human and rodent research approaches invite a more intense cross-talk between the two sides of aggression research than the one presently observed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Comorbidity and radiation: methodological aspects of health assessment of persons exposed to the Chornobyl accident factors.

    Science.gov (United States)

    Nosach, O V

    2013-01-01

    Comorbidity is one of the most challenging problems of a modern medicine. In a population exposed to the factors of the Chornobyl accident there is an obvious increase in the number of diseases occurring simultaneously against the background of rising prevalence of different classes of chronic medical nosology. The scientific data analysis are presented on the methodological approaches that can be used to create a specialized system for integrated assessment of the health of patients with comorbid disorders. Developing such a system it should be taken into account the trends of changes in the incidence, prevalence and structure of chronic disease, factors and regularities of comorbid disease in the cohorts of Chornobyl accident clean-up workers, evacuees and dwellers of contaminated territories. The system should provide a non-random selection of combinations (clusters) of the most common diseases with serious consequences for the survivors. Nosach O. V., 2013.

  20. ASPECTS OF BIODETERIORATION OF LAPIDEOUS SUBMERGED ARTEFACTS: 3D METHODOLOGIES APPLICATION

    Directory of Open Access Journals (Sweden)

    S. Ricci

    2015-04-01

    Full Text Available Submerged stone archaeological artefacts are bioeroded by endolithic microbiota (cyanobacteria, algae and fungi and macroborers (Porifera, Bivalvia and Sipuncula. Optical microscope and SEM observations permit to analyse the bioerosion traces and to identify bioeroders. Data obtained with these techniques cannot be used to estimate volumes of material bioeroded. This aspect require the need to collect three-dimensional, close-range data from artefact. In this work we illustrate two 3D imaging techniques used to study bioerosion phenomena of underwater Cultural Heritage. In particular Digital Video Microscope permit the elaboration of 3D images, which are widely employed for close-range acquisitions. Underwater Laser Scanner documents the in situ degradation of submerged artefacts. This research aims to sensitize specialist figures in the study 3D offering a starting point for future collaborations that could lead to interesting results.

  1. [Quality of life - methodology and clinical practice aspects with a focus on ocular medicine].

    Science.gov (United States)

    Franke, G H; Gall, C

    2008-08-01

    Due to the demographic development in western industrialised countries, the proportion of visually impaired persons is likely to increase in the future. Currently there is a shift in scientific recognition from relative neglect of psychopathological distress in the visually impaired to better notice of disease-related subjective impairments that are detectable with specific questionnaire measures. Visual acuity primarily determines the subjective rating of visual functioning independent from the eye disease. Ophthalmic patients who show only mild symptoms from a medical point of view normally suffer considerably diminished vision-related quality of life with respect to physical, functional, mental, and social aspects. Treatment effects have been shown using vision-related quality-of-life measures for different ophthalmic diseases, particularly cataract surgery. Assessment of vision-related quality of life provides a meaningful complement to objective data.

  2. Methodological aspects of market study on residential, commercial and industrial sectors, of the Conversion Project for natural gas of existing network in Sao Paulo city

    International Nuclear Information System (INIS)

    Kishinami, R.I.; Perazza, A.A.

    1991-01-01

    The methodological aspects of market study, developed at the geographical area served by existing network of naphtha gas, which will be converted to natural gas in a two years conversion program are presented. (author)

  3. 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.

  4. 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 ...

  5. ABOUT THE RELEVANCE AND METHODOLOGY ASPECTS OF TEACHING THE MATHEMATICAL MODELING TO PEDAGOGICAL STUDENTS

    Directory of Open Access Journals (Sweden)

    Y. A. Perminov

    2014-01-01

    Full Text Available The paper substantiates the need for profile training in mathematical modeling for pedagogical students, caused by the total penetration of mathematics into different sciences, including the humanities; fast development of the information communications technologies; and growing importance of mathematical modeling, combining the informal scientific and formal mathematical languages with the unique opportunities of computer programming. The author singles out the reasons for mastering and using the mathematical apparatus by teaches in every discipline. Indeed, among all the modern mathematical methods and ideas, mathematical modeling retains its priority in all professional spheres. Therefore, the discipline of “Mathematical Modeling” can play an important role in integrating different components of specialists training in various profiles. By mastering the basics of mathematical modeling, students acquire skills of methodological thinking; learn the principles of analysis, synthesis, generalization of ideas and methods in different disciplines and scientific spheres; and achieve general culture competences. In conclusion, the author recommends incorporating the “Methods of Profile Training in Mathematical Modeling” into the pedagogical magistracy curricula. 

  6. Theoretical and Methodological Aspects of Assessment of the Adaptation Potential of Personnel

    Directory of Open Access Journals (Sweden)

    Sesina Iryna M.

    2014-02-01

    Full Text Available The article is devoted to development of theoretical and methodological recommendations with respect to assessment of the adaptation potential of employees as an important prerequisite of development of employees and ensuring competitiveness of an enterprise. It contains the author’s interpretation of the adaptation potential as a possibility of adjusting to the environment with the aim of achieving socio-economic goals of an enterprise. Adaptation potential is a property of a person as a performer of labour functions and ability to master new methods of work, adjustment to new labour conditions, processing of information and also a communicative property. At the same time adaptation potential is an aggregate of motivational, professional, information and integration components of a person. For assessing the adaptation potential it is proposed to combine 360 degrees method and method of paired comparison, which facilitates increase of trustworthiness of results. The author marks out some criteria of assessment of the adaptation potential: ratio of professional experience, ratio of official experience, ratio of efficiency of work, independence in mastering new methods of work, fast adjustment to new labour conditions, ability to quickly process big volumes of information, mobility, high level of productivity under different labour conditions, sharpness of wit in different production situations, ability to form interpersonal relations in a collective and psychological features.

  7. Legal-Historical Aspects of Punishment of Nazi Criminals on the Background of the Adolf Eichmann Trial

    OpenAIRE

    Kohout, David

    2013-01-01

    in English Dissertation Thesis David Kohout: Legal-Historical Aspects of Punishment of Nazi Criminals on the Background of the Adolf Eichmann Trial This Dissertation on the topic of "Legal-Historical Aspects of Punishment of Nazi Criminals on the Background of the Adolf Eichmann Trial" seeks to analyze the main approaches to the prosecution and punishment of the Nazi crimes. It was chosen to use the trial of Adolf Eichmann in Jerusalem in years 1961 - 1962 as a connecting thread of this whole...

  8. Functional brain imaging with SPECT in normal again and dementia. Methodological, pathophysiological, and diagnostic aspects

    International Nuclear Information System (INIS)

    Waldemar, G.

    1996-03-01

    New developments in instrumentation, radiochemistry, and data analysis, particularly the introduction of 99m Tc-labeled brain-retained tracers for perfusion studies, have opened up a new era of single photon emission computed tomography (SPECT). In this review critical methodological issues relating to the SPECT instrument, the radioactive tracers, the scanning procedure, the data analysis and interpretation of data, and subject selection are discussed together with the changes in regional cerebral blood flow (rCBF) observed in normal aging. An overview is given of the topography and the pathophysiological and diagnostic significance of focal rCBF deficits in Alzheimer's disease and in other dementia disorders, in which SPECT is capable of early or preclinical disease detection. In Alzheimer's disease, the diagnostic sensitivity and specificity of focal rCBF deficits measured with SPECT and brain-retained tracers are very high, in particular when combined with medial temporal lob atrophy on CT. Together with neuropsychological testing, SPECT serves to map the topography of brain dysfunction. Thus, in the clinical setting, SPECT provides information that is supplemental to that obtained in other studies. Future applications include neuroreceptor studies and treatment studies, in which SPECT may serve as a diagnostic aid in the selection of patients and as a potential mean for monitoring treatment effects. Although positron emission tomography is the best characterized tool for addressing some of these clinical and research issues in dementia, only the less expensive and technically simpler SPECT technique will have the potential of being available as a screening diagnostic instrument in the clinical setting. It is concluded that, properly approached, functional brain imaging with SPECT represents an important tool in the diagnosis, management, and research of dementia disorders. (au) 251 refs

  9. PRACTICAL ASPECTS OF OSAI METHODOLOGY IN ASSESSING THE ORGANIZATIONAL CULTURE OF AN ENGINEERING COMPANY

    Directory of Open Access Journals (Sweden)

    Aleksandra Biletskaya

    2015-11-01

    Full Text Available This article is intended to generalize and highlight the practical application of certain science-based approaches to assessment of an engineering company’s organizational culture. The OSAI method application has enabled determining the type of the organizational culture existing within a company and the desirable type thereof, i.e. the one which would produce a positive effect on the competitive status of a company, as well as on the utilization of its human resources. This is important because an appropriate level of the organizational culture within a company would enhance the psychological climate within a company and would provide an opportunity for improving its performance. Methodology. In order to attain the goal of our research, it is necessary to diagnose the type of the organizational culture of some selected companies and draw a conclusion as to amendment of their organizational culture. In order to ensure the successful outcome of the corporate organizational culture diagnosing procedure, let us use the OSAI tool to determine the foundation of such culture. This organizational culture assessment tool helps to define the organizational culture which members of a company are to achieve in order to meet the demands and to respond to the dynamic changes in the business environment. The results showed that the assessment of organizational culture using the method made it possible to determine the OSAI required type of organizational culture on the test plants. Practical implications. Definition of recommendation type of organizational culture has enabled the leadership to change the style of his behavior and better motivate the labor collective. Pay attention to the existing problems and improve the psychological atmosphere in the team, as well as improve the efficiency of plant personnel. Value/originality. The data obtained for the four businesses lead to the conclusion that it is the method of evaluation the optimum procedure for

  10. A comparison of usability methods for testing interactive health technologies: methodological aspects and empirical evidence.

    Science.gov (United States)

    Jaspers, Monique W M

    2009-05-01

    Usability evaluation is now widely recognized as critical to the success of interactive health care applications. However, the broad range of usability inspection and testing methods available may make it difficult to decide on a usability assessment plan. To guide novices in the human-computer interaction field, we provide an overview of the methodological and empirical research available on the three usability inspection and testing methods most often used. We describe two 'expert-based' and one 'user-based' usability method: (1) the heuristic evaluation, (2) the cognitive walkthrough, and (3) the think aloud. All three usability evaluation methods are applied in laboratory settings. Heuristic evaluation is a relatively efficient usability evaluation method with a high benefit-cost ratio, but requires high skills and usability experience of the evaluators to produce reliable results. The cognitive walkthrough is a more structured approach than the heuristic evaluation with a stronger focus on the learnability of a computer application. Major drawbacks of the cognitive walkthrough are the required level of detail of task and user background descriptions for an adequate application of the latest version of the technique. The think aloud is a very direct method to gain deep insight in the problems end users encounter in interaction with a system but data analyses is extensive and requires a high level of expertise both in the cognitive ergonomics and in computer system application domain. Each of the three usability evaluation methods has shown its usefulness, has its own advantages and disadvantages; no single method has revealed any significant results indicating that it is singularly effective in all circumstances. A combination of different techniques that compliment one another should preferably be used as their collective application will be more powerful than applied in isolation. Innovative mobile and automated solutions to support end-user testing have

  11. Historical seismicity in Morocco: methodological aspects and cases of multidisciplinary evaluation

    International Nuclear Information System (INIS)

    Elmrabet, T.; Ramdani, M.; Tadili, B.

    1989-05-01

    Within the framework of a cooperative agreement between Sofratome and the Office National d'Electricite of Morocco, the Centre National de la Recherche of Rabat, with the collaboration of the French Institut de Protection et de Surete Nucleaire, was put in charge of compiling a revised catalogue of the historical seismicity of Morocco. The method adopted calls for the participation of several different disciplines in view of situating each earthquake in its own geographical and historical context. The approach entails, during the first stage involving primarily the historian, gathering together the original sources of data and subjecting them to a critical analysis in order to assess their reliability. The second stage consists in interpreting the information so as to define those earthquake characteristics that are requisite to seismic hazard studies. This latter evaluation must be the fruit of a multidisciplinary effort. This is particularly true for earthquakes of past centuries, the observations of which are frequently incompatible or biased and accordingly need to be substantiated by referring to information of a varying nature and, wherever possible, calibrated using accurate data from recent events. In a number of instances, duplications are encountered, or lumped effects for distinct events due to calendar misreckonings, erroneous copying, or misconceptions relative to the geological or historical context. A particularly significant example of the interference of these diverse aspects is afforded by the assessment of the destructive effects in Morocco of the 1755 'Lisbon' earthquake: a method is proposed for calibrating its intensities by comparing them with those of the recent 1969 event of similar origin

  12. Platform development for merging various information sources for water management: methodological, technical and operational aspects

    Science.gov (United States)

    Galvao, Diogo

    2013-04-01

    As a result of various economic, social and environmental factors, we can all experience the increase in importance of water resources at a global scale. As a consequence, we can also notice the increasing need of methods and systems capable of efficiently managing and combining the rich and heterogeneous data available that concerns, directly or indirectly, these water resources, such as in-situ monitoring station data, Earth Observation images and measurements, Meteorological modeling forecasts and Hydrological modeling. Under the scope of the MyWater project, we developed a water management system capable of satisfying just such needs, under a flexible platform capable of accommodating future challenges, not only in terms of sources of data but also on applicable models to extract information from it. From a methodological point of view, the MyWater platform obtains data from distinct sources, and in distinct formats, be they Satellite images or meteorological model forecasts, transforms and combines them in ways that allow them to be fed to a variety of hydrological models (such as MOHID Land, SIMGRO, etc…), which themselves can also be combined, using such approaches as those advocated by the OpenMI standard, to extract information in an automated and time efficient manner. Such an approach brings its own deal of challenges, and further research was developed under this project on the best ways to combine such data and on novel approaches to hydrological modeling (like the PriceXD model). From a technical point of view, the MyWater platform is structured according to a classical SOA architecture, with a flexible object oriented modular backend service responsible for all the model process management and data treatment, while the information extracted can be interacted with using a variety of frontends, from a web portal, including also a desktop client, down to mobile phone and tablet applications. From an operational point of view, a user can not only see

  13. Methodological Aspects of On-Farm Monitoring of Cropping Systems Management

    Directory of Open Access Journals (Sweden)

    Luca Bechini

    Full Text Available To conduct agro-environmental assessments at field and farm scale, detailed management data of crop and animal production systems are needed. However, this type of data is only rarely collected by public administrations. In the period 2005-2006, we made an experience of on-farm monitoring of cropping systems management, within a larger project aimed at assessing sustainability of agricultural systems in Italian Parks. In this paper, we describe and discuss the steps taken to carry out periodic face-to-face interviews in farms in the Sud Milano Agricultural Park (northern Italy. The first step was the selection of seven farms, which we identified by applying cluster analysis at a large database describing 733 farms of the Park. After having identified the most relevant agro-environmental issues in the studied area, we established a list of simple but sound indicators to evaluate the effects of agricultural management on the environment. The criteria used to select the indicators were that they should: be calculated on easily available data, not be based on direct measurements, make a synthesis of different aspects of reality, and be easily calculated and understood. The indicators selected evaluate nutrient management, fossil energy use, pesticide toxicity, soil management, and economic performance. Subsequently, we designed a data model to store input data used to calculate the indicators (farm configuration, flows of materials and money through the farm gate, animals and their rations, history of crop cultivation, crop management. The data model that we obtained is relatively complex, but adequate to store and analyse the large amount of data acquired during the two-year project. A questionnaire was developed to fully comply with the indicators selected and the data model. The questionnaire was used to carry out approximately six interviews per farm each year, with an investment of time of 1-2 hours per interview. Appropriate double checks of

  14. Investigation of Super Learner Methodology on HIV-1 Small Sample: Application on Jaguar Trial Data.

    Science.gov (United States)

    Houssaïni, Allal; Assoumou, Lambert; Marcelin, Anne Geneviève; Molina, Jean Michel; Calvez, Vincent; Flandre, Philippe

    2012-01-01

    Background. Many statistical models have been tested to predict phenotypic or virological response from genotypic data. A statistical framework called Super Learner has been introduced either to compare different methods/learners (discrete Super Learner) or to combine them in a Super Learner prediction method. Methods. The Jaguar trial is used to apply the Super Learner framework. The Jaguar study is an "add-on" trial comparing the efficacy of adding didanosine to an on-going failing regimen. Our aim was also to investigate the impact on the use of different cross-validation strategies and different loss functions. Four different repartitions between training set and validations set were tested through two loss functions. Six statistical methods were compared. We assess performance by evaluating R(2) values and accuracy by calculating the rates of patients being correctly classified. Results. Our results indicated that the more recent Super Learner methodology of building a new predictor based on a weighted combination of different methods/learners provided good performance. A simple linear model provided similar results to those of this new predictor. Slight discrepancy arises between the two loss functions investigated, and slight difference arises also between results based on cross-validated risks and results from full dataset. The Super Learner methodology and linear model provided around 80% of patients correctly classified. The difference between the lower and higher rates is around 10 percent. The number of mutations retained in different learners also varys from one to 41. Conclusions. The more recent Super Learner methodology combining the prediction of many learners provided good performance on our small dataset.

  15. A methodology for evacuation design for urban areas: theoretical aspects and experimentation

    Science.gov (United States)

    Russo, F.; Vitetta, A.

    2009-04-01

    This paper proposes an unifying approach for the simulation and design of a transportation system under conditions of incoming safety and/or security. Safety and security are concerned with threats generated by very different factors and which, in turn, generate emergency conditions, such as the 9/11, Madrid and London attacks, the Asian tsunami, and the Katrina hurricane; just considering the last five years. In transportation systems, when exogenous events happen and there is a sufficient interval time between the instant when the event happens and the instant when the event has effect on the population, it is possible to reduce the negative effects with the population evacuation. For this event in every case it is possible to prepare with short and long term the evacuation. For other event it is possible also to plan the real time evacuation inside the general risk methodology. The development of models for emergency conditions in transportation systems has not received much attention in the literature. The main findings in this area are limited to only a few public research centres and private companies. In general, there is no systematic analysis of the risk theory applied in the transportation system. Very often, in practice, the vulnerability and exposure in the transportation system are considered as similar variables, or in other worse cases the exposure variables are treated as vulnerability variables. Models and algorithms specified and calibrated in ordinary conditions cannot be directly applied in emergency conditions under the usual hypothesis considered. This paper is developed with the following main objectives: (a) to formalize the risk problem with clear diversification (for the consequences) in the definition of the vulnerability and exposure in a transportation system; thus the book offers improvements over consolidated quantitative risk analysis models, especially transportation risk analysis models (risk assessment); (b) to formalize a system

  16. Evaluating the statistical methodology of randomized trials on dentin hypersensitivity management.

    Science.gov (United States)

    Matranga, Domenica; Matera, Federico; Pizzo, Giuseppe

    2017-12-27

    The present study aimed to evaluate the characteristics and quality of statistical methodology used in clinical studies on dentin hypersensitivity management. An electronic search was performed for data published from 2009 to 2014 by using PubMed, Ovid/MEDLINE, and Cochrane Library databases. The primary search terms were used in combination. Eligibility criteria included randomized clinical trials that evaluated the efficacy of desensitizing agents in terms of reducing dentin hypersensitivity. A total of 40 studies were considered eligible for assessment of quality statistical methodology. The four main concerns identified were i) use of nonparametric tests in the presence of large samples, coupled with lack of information about normality and equality of variances of the response; ii) lack of P-value adjustment for multiple comparisons; iii) failure to account for interactions between treatment and follow-up time; and iv) no information about the number of teeth examined per patient and the consequent lack of cluster-specific approach in data analysis. Owing to these concerns, statistical methodology was judged as inappropriate in 77.1% of the 35 studies that used parametric methods. Additional studies with appropriate statistical analysis are required to obtain appropriate assessment of the efficacy of desensitizing agents.

  17. Methodological aspects and development of techniques for neutron activation analysis of microcomponents in materials of geologic origin

    International Nuclear Information System (INIS)

    Cohen, I.M.

    1982-01-01

    Some aspects of the activation analysis methodology applied to geological samples activated in nuclear reactors were studied, and techniques were developed for the determination of various elements in different types of matrixes, using gamma spectrometry for the measurement of the products. The consideration of the methodological aspects includes the study of the working conditions, the preparation of samples and standards, irradiations, treatment of the irradiated material, radiochemical separation and measurement. Experiments were carried out on reproducibility and errors in relation to the behaviour of the measurement equipment and that of the methods of area calculation (total area, Covell and Wasson), as well as on the effects of geometry variations on the results of the measurements, the RA-3 reactors's flux variations, and the homogeneity of the samples and standards. Also studied were: the selection of the conditions of determination, including the irradiation and decay times; the irradiation with thermal and epithermal neutrons; the measurement with the use of absorbers, and the resolution of complex peaks. Both non-destructive and radiochemical separation techniques were developed for the analysis of 5 types of geological materials. These methods were applied to the following determinations: a) In, Cd, Mn, Ga and Co in blende; b) La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb and Lu in fluorites; c) La, Ca, Eu, Tb, Yb, Se and Th in barites and celestites; d) Cu and Zn in soils. The spectral interferences or those due to nuclear reactions were studied and evaluated by mathematical calculation. (M.E.L.) [es

  18. How effective is the comprehensive approach to rehabilitation (CARe) methodology? A cluster randomized controlled trial.

    Science.gov (United States)

    Bitter, Neis; Roeg, Diana; van Assen, Marcel; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

    2017-12-11

    The CARe methodology aims to improve the quality of life of people with severe mental illness by supporting them in realizing their goals, handling their vulnerability and improving the quality of their social environment. This study aims to investigate the effectiveness of the CARe methodology for people with severe mental illness on their quality of life, personal recovery, participation, hope, empowerment, self-efficacy beliefs and unmet needs. A cluster Randomized Controlled Trial (RCT) was conducted in 14 teams of three organizations for sheltered and supported housing in the Netherlands. Teams in the intervention group received training in the CARe methodology. Teams in the control group continued working according to care as usual. Questionnaires were filled out at baseline, after 10 months and after 20 months. A total of 263 clients participated in the study. Quality of life increased in both groups, however, no differences between the intervention and control group were found. Recovery and social functioning did not change over time. Regarding the secondary outcomes, the number of unmet needs decreased in both groups. All intervention teams received the complete training program. The model fidelity at T1 was 53.4% for the intervention group and 33.4% for the control group. At T2 this was 50.6% for the intervention group and 37.2% for the control group. All clients improved in quality of life. However we did not find significant differences between the clients of the both conditions on any outcome measure. Possible explanations of these results are: the difficulty to implement rehabilitation-supporting practice, the content of the methodology and the difficulty to improve the lives of a group of people with longstanding and severe impairments in a relatively short period. More research is needed on how to improve effects of rehabilitation trainings in practice and on outcome level. ISRCTN77355880 , retrospectively registered (05/07/2013).

  19. 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).

  20. [Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

    Science.gov (United States)

    Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

    2018-02-01

    To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials (1.09%) reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials

  1. Field trials of the phenomena of concern for psychiatric/mental health nursing: proposed methodology.

    Science.gov (United States)

    Wilson, H S

    1989-10-01

    An important step in the development of the American Nurses' Association (ANA) Task Force's Classification of Phenomena of Concern for Psychiatric/Mental Health Nursing is a plan for conducting field trials to determine interrater diagnostic reliability using the classification system. The ANA Task Force identified field testing as stage two in a three-stage process for completion of our work. In this article, we identify methodologic directions that will allow us to answer two important questions. First, what is the interrater reliability of the system of psychiatric nursing diagnoses when applied to clients by psychiatric/mental health nurse clinicians in their practice, and second, how do the clinicians who use this system view its usefulness for planning and evaluating nursing care?

  2. [Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

    Science.gov (United States)

    Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

    2016-11-01

    To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Methodological Aspects of Strategic Development of Regional Socio-Economic System (Following the Example of Radio-Electronic Industry Enterprises in the Republic of Tatarstan)

    Science.gov (United States)

    Uraev, Nikolay N.; Mingaleev, Gaziz F.; Kushimov, Aleksandr T.; Kolesov, Nikolay A.

    2016-01-01

    This paper considers the methodological aspects of forming a development strategy for the regional socioeconomic system (by the example of radio-electronic enterprises in the Republic of Tatarstan). The paper suggests a conceptual scheme of the macro- and micro-factors' influence on the regional socioeconomic system. This scheme is based on the…

  8. Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

    Science.gov (United States)

    McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

    2018-03-08

    We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

  9. Methodological Aspects and Relevance of the Study of Vegetable Oil, Fat and Lipoprotein Oxidation Using Pancreatic Lipase and Arylesterase

    Directory of Open Access Journals (Sweden)

    Meritxell Nus

    2006-01-01

    Full Text Available Fats and oils as major dietary components are involved in the development of chronic diseases. In this paper the physiological relevance and some methodological aspects related to the determination of two enzymes enrolled in metabolism of fat – pancreatic lipase and arylesterase – are discussed. Pancreatic lipase has been extensively used to study the triacylglycerol fatty acid composition and the in vitro digestion of oils and fats. The action of this enzyme may be coupled to analytical methods as GC, HPLC, HPSEC, TLC- -FID, etc. as a useful tool for understanding the composition and digestion of thermal oxidized oils. Pancreatic lipase hydrolysis occurs in the water/oil interface, and it presents a behaviour that seems to be Michaelian, in which the apparent Km and the apparent Vmax of the enzymatic process depend more on the type of oil tested than on the degree of alteration. The kinetic behaviour of pancreatic lipase towards thermally oxidized oils also depends on the presence of natural tensioactive compounds present in the oil and surfactants formed during the frying. Arylesterase is an HDL binding enzyme that inhibits LDL oxidation. Low serum concentration of this enzyme has been related to increased cardiovascular disease risk. In this paper the most widely used methods for the determination of arylesterase activity are commented on. The importance of intrinsic factors (e.g. substrates, cofactors participating in the enzyme reaction is also discussed. Moreover, several suggestions about further researches on the influence of extrinsic factors (e.g. diet, oxidative stress upon the enzyme activity are proposed.

  10. Implementing the PAIN RelieveIt Randomized Controlled Trial in Hospice Care: Mechanisms for Success and Meeting PCORI Methodology Standards.

    Science.gov (United States)

    Ezenwa, Miriam O; Suarez, Marie L; Carrasco, Jesus D; Hipp, Theresa; Gill, Anayza; Miller, Jacob; Shea, Robert; Shuey, David; Zhao, Zhongsheng; Angulo, Veronica; McCurry, Timothy; Martin, Joanna; Yao, Yingwei; Molokie, Robert E; Wang, Zaijie Jim; Wilkie, Diana J

    2017-07-01

    This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.

  11. Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

    DEFF Research Database (Denmark)

    Miskowiak, K W; Burdick, K E; Martinez-Aran, A

    2017-01-01

    OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS...... of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy...

  12. [Estimating child mortality using the previous child technique, with data from health centers and household surveys: methodological aspects].

    Science.gov (United States)

    Aguirre, A; Hill, A G

    1988-01-01

    2 trials of the previous child or preceding birth technique in Bamako, Mali, and Lima, Peru, gave very promising results for measurement of infant and early child mortality using data on survivorship of the 2 most recent births. In the Peruvian study, another technique was tested in which each woman was asked about her last 3 births. The preceding birth technique described by Brass and Macrae has rapidly been adopted as a simple means of estimating recent trends in early childhood mortality. The questions formulated and the analysis of results are direct when the mothers are visited at the time of birth or soon after. Several technical aspects of the method believed to introduce unforeseen biases have now been studied and found to be relatively unimportant. But the problems arising when the data come from a nonrepresentative fraction of the total fertile-aged population have not been resolved. The analysis based on data from 5 maternity centers including 1 hospital in Bamako, Mali, indicated some practical problems and the information obtained showed the kinds of subtle biases that can result from the effects of selection. The study in Lima tested 2 abbreviated methods for obtaining recent early childhood mortality estimates in countries with deficient vital registration. The basic idea was that a few simple questions added to household surveys on immunization or diarrheal disease control for example could produce improved child mortality estimates. The mortality estimates in Peru were based on 2 distinct sources of information in the questionnaire. All women were asked their total number of live born children and the number still alive at the time of the interview. The proportion of deaths was converted into a measure of child survival using a life table. Then each woman was asked for a brief history of the 3 most recent live births. Dates of birth and death were noted in month and year of occurrence. The interviews took only slightly longer than the basic survey

  13. [The spa-health resort and touristic-recreational facilities of the region: the methodological aspects of their development].

    Science.gov (United States)

    Kirilina, V M; Kolesnikova, N V; Kolesnikov, N G

    2016-01-01

    The correction and optimization of the motor activity of the patients are currently the main priorities of all rehabilitative and recreational activities based at the spa and health resort facilities. The forms of such activities include walking tours and excursion trips. In other words, the excursion potential is one of the very important attributes of the recreational recourses. Under the current conditions characterized by the rapid socio-economic changes, the studies concerning the structural and functional transformation of spa and health resorts, recreational and tourist facilities acquire special importance, both from the humanitarian and economic points of view. The results of these studies may greatly contribute to the organization and the further development of rehabilitative and recreational activities based at the spa and health resort facilities, recreational and tourist centers taking into consideration their evolution. The objective of the present article is to analyze the structure and functions of the recreation and tourist centres as well as the modes of their cooperation with the spa and health resort facilities. In other words, these structures and their functions are both the object and the subject of the present study. The methodology of the study is based on the logical analysis of the development of the recreational and tourist systems in the framework of the evolutionary approach. (1) the notions of «tourist destination» and «recreation» have been substantiated; (2) the results of the studies carried out at the Institute of Physical Culture, Sports and Tourism and the Petrozavodsk State University have been used to elaborate the affiliate international Master Degree program «Project management in the tourism industry». The main emphasis in this program is placed on the necessity and methods of the improvement of recreational activities and more efficacious utilization of the climatic factors and the health resort infrastructure as

  14. 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...

  15. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  16. Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

    2018-01-01

    The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler's value model for the consumer. In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations.

  17. Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

    DEFF Research Database (Denmark)

    Miskowiak, K W; Burdick, K E; Martinez-Aran, A

    2017-01-01

    OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS...... symptoms and concomitant medication. Task force recommendations are to: (i) enrich trials with objectively measured cognitively impaired patients; (ii) generally select a broad cognitive composite score as the primary outcome and a functional measure as a key secondary outcome; and (iii) include remitted...... of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy...

  18. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

    Science.gov (United States)

    Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

    2018-05-01

    The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Estudo MONISA: características e aspectos metodológicos MONISA study: characteristics and methodological aspects

    Directory of Open Access Journals (Sweden)

    Thiago Ferreira de Sousa

    2012-12-01

    Full Text Available O objetivo é apresentar as características e os procedimentos metodológicos adotados no Estudo Monitoramento dos Indicadores de Saúde e Qualidade de Vida de Acadêmicos (MONISA. Trata-se de um estudo prospectivo, do tipo painel, com inquéritos bianuais em amostras representativas de estudantes de uma universidade pública do Estado da Bahia. Este estudo realizará cinco inquéritos, perfazendo 10 anos de monitoramento (2010 a 2018. A amostra é estratificada e proporcional aos cursos de graduação presenciais, período de estudo (noturno e diurno e ano de ingresso na universidade. Por fim, os estudantes universitários são selecionados em cada estrato, por meio da lista de matrícula em ordem alfabética. Para obtenção das informações é utilizado um questionário estruturado, com as seguintes seções: indicadores sociodemográficos; indicadores do estilo de vida e saúde; hábitos alimentares e controle do peso corporal; atividades físicas e opções de lazer; comportamentos preventivos; e, indicadores do ambiente e condições de aprendizagem. O pioneirismo do Estudo MONISA poderá auxiliar no esclarecimento de possíveis tendências relacionadas à saúde de estudantes universitários brasileiros e subsidiar informações para propor programas ou projetos de promoção da saúde e qualidade de vida em nível organizacional local.The objective is to present the characteristics and methodological procedures adopted in the MONISA Study (Surveillance of health and quality of life indicators of college students. This is a prospective, panel type study, with biannual surveys of representative samples of undergraduate students at a public university in the State of Bahia, Brazil. This study carried out five surveys, totaling 10 years of monitoring (2010-2018. The sample is stratified and proportional to the courses, study period (day and night and year of attending university. Finally, college students are selected at each stratum

  20. Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

    2018-01-01

    Introduction: The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. Material and Methods: This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Results: Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler’s value model for the consumer. Conclusion: In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations. PMID:29719318

  1. 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.

  2. Methodological aspect of research of the process of socialization in media-cultural space of information society

    Directory of Open Access Journals (Sweden)

    N. Y. Hirlina

    2016-03-01

    Full Text Available Integrated within the social and philosophical discourse interdisciplinary methodology, based on the classic philosophical methodology for the analysis of socio-cultural phenomena enables a holistic understanding of the studied phenomenon. From a methodological point of view it is important to determine the social and philosophical understanding of the impact medіa cultural space of personality in conditions of dynamically changing socio-cultural environment. important social and philosophical methodological guideline should be considered on a thesis constant presence in the media culture of human space as being due to the fact that man is a social being, and the information society without media culture as its attribute exists. Philosophical «core» study of the spiritual culture of youth is humanism in its broadest sense, that is, understanding of the studied phenomenon primarily as a multi-dimensional culturing of human values. Submission materialistic determinant factors medіa cultural spiritual space is only possible under the dominance of humanistic values. With all the variety to understanding the spiritual dimension of the relationship of the individual with the socio-cultural environment common dominant philosophical idea of guidelines is the recognition of the spiritual and cultural autonomy rights. Globalization and its associated civilization and processes are seen as foreign in relation to social rights, while the internal spiritual content is cultural processes. Anthropological oriented cultural space of socialization based on interpersonal cultural interaction that produces unique and distinctive personality.

  3. Methodological aspects of language processing research with adults and children : Reading research and the Visual World Paradigm

    NARCIS (Netherlands)

    Cozijn, Rein

    2012-01-01

    Research on language comprehension has benefited greatly from the use of eye-tracking methodology. However, the technique is not easy to use. In particular, the creation of (auditory and visual) stimuli and the analysis of eye-movement data are difficult and laborious. The presentation will deal

  4. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  5. Methodological challenges in designing dementia prevention trials - The European Dementia Prevention Initiative (EDPI)

    NARCIS (Netherlands)

    Richard, Edo; Andrieu, Sandrine; Solomon, Alina; Mangialasche, Francesca; Ahtiluoto, Satu; Moll van Charante, Eric P.; Coley, Nicola; Fratiglioni, Laura; Neely, Anna Stigsdotter; Vellas, Bruno; van Gool, Willem A.; Kivipelto, Miia

    2012-01-01

    Recent epidemiological studies have indicated numerous associations between vascular and lifestyle related risk factors and incident dementia. However, evidence from randomised controlled trials (RCT) showing effectiveness of interventions aimed at these risk factors in preventing or postponing

  6. A controlled clinical trial of implant-retained mandibular overdentures : Clinical aspects

    NARCIS (Netherlands)

    Boerrigter, EM; VanOort, RP; Raghoebar, GM; Stegenga, B; Schoen, PJ; Boering, G

    In a controlled clinical trial, treatment effects of mandibular overdentures on two different implant-systems in edentulous patients were compared one year after insertion of the new dentures. The implant-systems used were the Branemark system (Bra) and the IMZ-system. Treatment was randomly

  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. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial.

    Science.gov (United States)

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-11-06

    Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems) were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF) and activity limitation/participation restriction (LFISAP) subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ) score and walking speed (m/s) were also recorded. Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores), there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF) but not activity/participation (LFISAP) or function (walking speed) over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits) and 3 self-withdrew (lost to follow-up). Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3), foot orthoses (n = 9), footwear referral to the orthotist (n = 5), and ultrasound guided intra-articular steroid injection

  9. Methodology for the identification of significant environmental aspects of oil refining process; Metodologia para identifcacao de aspectos ambientais significativos nos processos de refino de petroleo

    Energy Technology Data Exchange (ETDEWEB)

    Ugaya, Cassia Maria Lie; Henschel, Jefferson [Centro Federal de Educacao Tecnologica do Parana (CEFET-PR), Curitiba, PR (Brazil)

    2004-07-01

    The oil-producing sector have been developing several actions in order to reduce its environmental impacts, an example is the implementation of the Environmental Management System (EMS). It requires the identification of the environmental aspects which are relevant, but it does not specify the methodology for it. Some authors suggest the Life Cycle Assessment (LCA) as it is a scientific, rigorous and possible subject to be reproduced. Life Cycle Assessment aims the reduction of the environmental impacts generated by a product, process or service, since the extraction of the natural resources until it's discard. This work seeks to adapt this methodology to the demands, needs and inherent reality of an oil-refinery. An analyses of the natural resources inputs and residues of the most common pollutants for each process has been carried out. After that, equations were gathered in order to create a computer software, based on Delphi. This program is been tested. (author)

  10. Design and Methodology of the Trial to Assess Chelation Therapy (TACT)

    Science.gov (United States)

    Lamas, Gervasio A.; Goertz, Christine; Boineau, Robin; Mark, Daniel B.; Rozema, Theodore; Nahin, Richard L.; Drisko, Jeanne A.; Lee, Kerry L.

    2011-01-01

    The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored, randomized, double blind, placebo-controlled, 2×2 factorial clinical trial testing the benefits and risks of 40 infusions of a multi-component Na2EDTA-chelation solution compared with placebo, and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow 1708 patients for an average of approximately 4 years. The primary endpoint is a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900 patient substudy will examine quality of life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary endpoint for each treatment factor. Enrollment began in September 2003 and completed in October 2010. PMID:22172430

  11. [Methodological aspects in the evaluation of turn-over and up/down sizing as indicators of work-related stress].

    Science.gov (United States)

    Veronesi, G; Bertù, L; Mombelli, S; Cimmino, L; Caravati, G; Conti, M; Abate, T; Ferrario, M M

    2011-01-01

    We discuss the methodological aspects related to the evaluation of turn-over and up-down sizing as indicators of work-related stress, in complex organizations like a university hospital. To estimate the active workers population we developed an algorithm which integrated several administrative databases. The indicators were standardized to take into account some potential confounders (age, sex, work seniority) when considering different hospital structures and job mansions. Main advantages of our method include flexibility in the choice of the analysis detail (hospital units, job mansions, a combination of both) and the possibility to describe over-time trends to measure the success of preventive strategies.

  12. Proposals for implementation of methodological aspects in the use of 18F-FDG in the Positron Emission Tomography

    International Nuclear Information System (INIS)

    Oliveira, Cássio Miri

    2013-01-01

    This work covered three objectives: to evaluate and implement methods for in vivo internal occupational monitoring of individuals involved during the 18 F-FDG process production; to suggest a national Diagnostic Reference Level (DRL) for 18 F-FDGPET oncologic procedures; and to obtain the 'Recovery Coefficients' (RCs) factors used to correct the radiopharmaceutical uptake in region of interest for a better quantification and evaluation of images. The methodology of internal monitoring was implemented in the radiopharmaceuticals production centers of Nuclear Technology Development Center (CDTN) in Belo Horizonte - MG and the Nuclear Science Regional Center, North-East (CRCN-NE) in Recife, PE, Brazil. The results demonstrated that the developed methodology was efficient to evaluate 18 F-FDG incorporations in both centers; additionally, the methodology showed that there was possibility of 18 F incorporation in the form of 18 F-FDG during non-routine actions performed in the radiopharmaceutical production process. DRLs were suggested based on a questionnaire that was used for the survey of 18 F-FDG administered activity in 72 Brazilian clinics currently licensed by the National Nuclear Energy Commission (CNEN). The results reported by 41 (57%) of the 18 F-FDG-PET clinics showed variations up to 100% in the administered activities among clinics for the same procedure. The calculated DRL from the third quartile was 5.54 MBq/kg or 387.7 MBq (for a 70 kg standard patient). For image analysis, two phantoms were used for obtaining the RCs, the NEMA/IEC Body Phantom, which has spherical capture areas and the modified Jaszczak, which has cylindrical capitation capture areas. Both phantoms were tested for different lesion:BG activity ratios, in the amount of 4:1 and 10:1; for different acquisition time. RCs obtained according to NEMA and IEC standards were applied to the SUVmax and SUVmed semi quantification tools. Values of SUVmed corrected by RCs presented

  13. THE RIGHT OF ACCESS TO A COURT AS AN ASPECT OF THE RIGHT TO A FAIR TRIAL

    Directory of Open Access Journals (Sweden)

    Dragan Elijaš

    2016-01-01

    Full Text Available The topic of this paper is the right of access to a court, as an aspect of the right to a fair trial guaranteed by Article 29 of the Constitution and Article 6 of the Convention. The paper highlights the fundamental significance of the protection offered by the Convention, which concerns the drawing up and implementation of standards for the protection of human rights within the territory of Europe, and, through the positions of the European Court of Human Rights, which the Constitutional Court of the Republic of Croatia has accepted and elaborated in its adjudication. The paper also emphasises the importance of the Constitutional Court’s activism concerning the protection of human rights. It stresses the view that the purpose of Article 29 of the Constitution and of Article 6 of the Convention is to secure fair proceedings, and not to examine the correct outcome of proceedings. The authors prove this thesis in this paper. The basic theme of the paper, the right of access to a court, is recognised by the authors as the key aspect of the constitutional right to a fair trial. The first part of the paper deals in general with the right to a fair trial and its various aspects, it provides an overview of the case law of the European Court of Human Rights and of its effect on the case law of the Constitutional Court in its specific aspects, and provides the standpoints of other States. This is followed by a detailed analysis of the positions of the Constitutional Court with regard to the right of access to a court and, in particular, the evolution of these positions over time in this area of protection. The positions of the Constitutional Court are presented both through an abstract and an individual review of constitutionality. The interpretation of constitutional rights, which the Constitutional Court provides through its decisions and rulings, is considered by the authors to be the most significant contribution to the development of

  14. 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)

  15. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  16. Descriptive analysis of bacon smoked with Brazilian woods from reforestation: methodological aspects, statistical analysis, and study of sensory characteristics.

    Science.gov (United States)

    Saldaña, Erick; Castillo, Luiz Saldarriaga; Sánchez, Jorge Cabrera; Siche, Raúl; de Almeida, Marcio Aurélio; Behrens, Jorge H; Selani, Miriam Mabel; Contreras-Castillo, Carmen J

    2018-06-01

    The aim of this study was to perform a descriptive analysis (DA) of bacons smoked with woods from reforestation and liquid smokes in order to investigate their sensory profile. Six samples of bacon were selected: three smoked bacons with different wood species (Eucalyptus citriodora, Acacia mearnsii, and Bambusa vulgaris), two artificially smoked bacon samples (liquid smoke) and one negative control (unsmoked bacon). Additionally, a commercial bacon sample was also evaluated. DA was developed successfully, presenting a good performance in terms of discrimination, consensus and repeatability. The study revealed that the smoking process modified the sensory profile by intensifying the "saltiness" and differentiating the unsmoked from the smoked samples. The results from the current research represent the first methodological development of descriptive analysis of bacon and may be used by food companies and other stakeholders to understand the changes in sensory characteristics of bacon due to traditional smoking process. Copyright © 2018 Elsevier Ltd. All rights reserved.

  17. Methodological aspects in the determination of the auditory filters and critical band at low and mid-frequencies

    DEFF Research Database (Denmark)

    Orellana, Carlos Andrés Jurado; Møller, Henrik; Pedersen, Christian Sejer

    2008-01-01

    or after the experiment, normally being applied afterwards. Due to the non-linear characteristics of the cochlear amplifier, it is arguable whether postexperimental weighting is a proper approach, or whether at low frequencies there will be any difference between pre or post stimuli weighting. Listening......In order to evaluate loudness or audibility of complex sounds, knowledge of the auditory filter characteristics is necessary. At low frequencies, where both the threshold of hearing and dynamic range become considerably frequency dependent, care must be taken to account for this both in the psycho......-acoustical model and the methodological approach. To account for variation in hearing sensitivity at low frequencies, equal loudness contours have been used to weight the stimuli accordingly. At mid and high frequencies, threshold of hearing curves have been used. These stimuli weightings can be applied before...

  18. 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

  19. Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

    Science.gov (United States)

    Reginster, Jean-Yves L; Arden, Nigel K; Haugen, Ida K; Rannou, Francois; Cavalier, Etienne; Bruyère, Olivier; Branco, Jaime; Chapurlat, Roland; Collaud Basset, Sabine; Al-Daghri, Nasser M; Dennison, Elaine M; Herrero-Beaumont, Gabriel; Laslop, Andrea; Leeb, Burkhard F; Maggi, Stefania; Mkinsi, Ouafa; Povzun, Anton S; Prieto-Alhambra, Daniel; Thomas, Thierry; Uebelhart, Daniel; Veronese, Nicola; Cooper, Cyrus

    2017-12-07

    To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need. The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) organized a working group under the auspices of the International Osteoporosis Foundation (IOF) and the World Health Organization (WHO). This consensus guideline is intended to provide a reference tool for practice, and should allow for better standardization of the conduct of clinical trials in hand OA. Hand OA is a heterogeneous disease affecting different, and often multiple, joints of the thumb and fingers. It was recognized that the various phenotypes and limitations of diagnostic criteria may make the results of hand OA trials difficult to interpret. Nonetheless, practical recommendations for the conduct of clinical trials of both symptom and structure modifying drugs are outlined in this consensus statement, including guidance on study design, execution, and analysis. While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  20. Automated Synthesis of 68Ga-DOTA-TOC: Methodological Aspects and Suitable Technical Solutions for a Cationic Purification System.

    Science.gov (United States)

    Uccelli, Licia; Boschi, Alessandra; Cittanti, Corrado; Martini, Petra; Lodi, Luca; Zappaterra, Elisa; Romani, Simona; Zaccaria, Samanta; Cecconi, Davide; Rambaldi, Ilaria; Santi, Ivan; Panareo, Stefano; Giganti, Melchiore; Bartolomei, Mirco

    2018-05-08

    The PET Gallium-68 isotope has the advantage of being produced from a generator, so it is also available in nuclear medicine departments without a cyclotron. The preparation of Ga-68 DOTA-labelled compounds is actually performed by remotely controlled automated systems developed in order to assure production efficiency, reproducibility of the results, guarantee fast reaction time, to facilitate the synthesis and minimize the radiation exposure. Many automatic synthesis systems are available on the radiopharmaceutical market, and each of these requires the realization of some technical adaptations for routine use. We reported the Ga-68 DOTATOC production by automated cassette-based theranostic synthesizer system used in combination with a disposable GMP grade cassette system for cationic purification. The synthesizer is integrated with the 68Ge/68Ga generator systems and it allows to perform elution, eluate purification and radiolabeling in about 38 minutes. We have performed between January 2016 and January 2017 over 100 [68Ga]Ga-DOTA-TOC preparation and of these only three have failed. The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the average radiochemical purity was 96.94 ± 0.74 %. The methodology and the technical solutions adopted have allowed to obtain a high quality radiopharmaceutical product as required by the European Pharmacopoeia. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  1. [Statistical (Poisson) motor unit number estimation. Methodological aspects and normal results in the extensor digitorum brevis muscle of healthy subjects].

    Science.gov (United States)

    Murga Oporto, L; Menéndez-de León, C; Bauzano Poley, E; Núñez-Castaín, M J

    Among the differents techniques for motor unit number estimation (MUNE) there is the statistical one (Poisson), in which the activation of motor units is carried out by electrical stimulation and the estimation performed by means of a statistical analysis based on the Poisson s distribution. The study was undertaken in order to realize an approximation to the MUNE Poisson technique showing a coprehensible view of its methodology and also to obtain normal results in the extensor digitorum brevis muscle (EDB) from a healthy population. One hundred fourteen normal volunteers with age ranging from 10 to 88 years were studied using the MUNE software contained in a Viking IV system. The normal subjects were divided into two age groups (10 59 and 60 88 years). The EDB MUNE from all them was 184 49. Both, the MUNE and the amplitude of the compound muscle action potential (CMAP) were significantly lower in the older age group (page than CMAP amplitude ( 0.5002 and 0.4142, respectively pphisiology of the motor unit. The value of MUNE correlates better with the neuromuscular aging process than CMAP amplitude does.

  2. Methodological aspects on international biofuels trade: International streams and trade of solid and liquid biofuels in Finland

    International Nuclear Information System (INIS)

    Heinimoe, J.

    2008-01-01

    The use of biomass for fuel is increasing in industrialised countries. Rapidly developing biomass markets for energy purposes along with weak information on biofuels trade that statistics offer have been incentives for several recently published studies investigating the status of biofuels trade. The comparison of the studies is often challenging due particularly to the various approaches to the indirect trade of biofuels and the diverse data sources utilised. The purpose of this study was to provide an overview of the Finnish situation with respect to the status of the streams of international biofuels trade. Parallel to this, the study aimed to identify methodological and statistical challenges in observing international biofuels trade. The study analysed available statistical information and introduced a procedure to obtain a clear overview on import and export streams of biofuels. In Finland, the total direct import and export of biofuels, being mainly composed of wood pellets and tall oil, is tiny in comparison with the total consumption of biofuels. Instead, the indirect trade has remarkable importance. Large import volumes of industrial raw wood make Finland a net importer of biofuels. In 2004, approximately 22% (64 PJ) of wood-based energy in Finland originated from imported wood. The study showed that the indirect trade of biofuels may be a significant sector of global biofuels trade. In the case of Finland, a comprehensive compilation of statistics on energy and forestry enabled the determination of the trade status satisfactory. However, national and international statistics should be further developed to take better into consideration international trade and to support continuously developing biofuels markets. (author)

  3. Methodological Aspects of Subjective Life Expectancy: Effects of Culture-Specific Reporting Heterogeneity Among Older Adults in the United States.

    Science.gov (United States)

    Lee, Sunghee; Smith, Jacqui

    2016-05-01

    Subjective life expectancy (SLE) has been suggested as a predictor of mortality and mortality-related behaviors. Although critical for culturally diverse societies, these findings do not consider cross-cultural methodological comparability. Culture-specific reporting heterogeneity is a well-known phenomenon introducing biases, and research on this issue with SLE is not established. Using data from the Health and Retirement Study, we examined reporting heterogeneity in SLE focusing on item nonresponse, focal points, and reports over time for five ethnic-cultural groups: non-Hispanic Whites, non-Hispanic Blacks, non-Hispanic other races, English-interviewed Hispanics, and Spanish-interviewed Hispanics. On item nonresponse, Spanish-interviewed Hispanics said, "I don't know," to SLE significantly more than any other groups. Nearly half of the respondents chose 0, 50, or 100, making them focal points. However, the focal points differed: 50 for Whites, 100 for Blacks, and 0 for Spanish-interviewed Hispanics. The relationship of SLE measured at two time points was higher for Whites than minorities. Moreover, those who said "I don't know" to SLE showed higher subsequent mortality than those who gave an answer. SLE was not a significant mortality predictor for Hispanics. Overall, SLE is not free from culture-specific reporting heterogeneity. This warrants further research about its culture-relevant measurement mechanisms. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. Randomised trial comparing hysterectomy with endometrial ablation for dysfunctional uterine bleeding: psychiatric and psychosocial aspects.

    Science.gov (United States)

    Alexander, D. A.; Naji, A. A.; Pinion, S. B.; Mollison, J.; Kitchener, H. C.; Parkin, D. E.; Abramovich, D. R.; Russell, I. T.

    1996-01-01

    OBJECTIVE: To compare in psychiatric and psychosocial terms the outcome of hysterectomy and endometrial ablation for the treatment of dysfunctional uterine bleeding. DESIGN: Prospective randomised controlled trial. SETTING--Obstetrics and gynaecology department of a large teaching hospital. SUBJECTS: 204 women with dysfunctional bleeding for whom hysterectomy would have been the preferred treatment were recruited over 24 months and randomly allocated to hysterectomy (99 women) or to hysteroscopic surgery (transcervical resection (52 women) or laser ablation (53 women). MAIN OUTCOME MEASURES: Mental state, martial relationship, psychosocial and sexual adjustment in assessments conducted before the operation and one month, six months, and 12 months later. RESULTS: Both treatments significantly reduced the anxiety and depression present before the operation, and there were no differences in mental health between the groups at 12 months. Hysterectomy did not lead to postoperative psychiatric illness. Sexual interest after the operation did not vary with treatment. Overall, 46 out of 185 (25%) women reported a loss sexual interest and 50 out of 185 (27%) reported increased sexual interest. Marital relationships were unaffected by surgery. Personality and duration of dysfunctional uterine bleeding played no significant part in determining outcome. CONCLUSIONS: Hysteroscopic surgery and hysterectomy have a similar effect on psychiatric and psychosocial outcomes. There is no evidence that hysterectomy leads to postoperative psychiatric illness. PMID:8611783

  5. Laboratory-scale trials of electrolytic treatment on industrial wastewaters: microbiological aspects.

    Science.gov (United States)

    Zanardini, E; Valle, A; Gigliotti, C; Papagno, G; Ranalli, G; Sorlini, C

    2002-09-01

    Animal, civil and industrial waste matter is a source of potential chemical, microbiological and air pollutants. In populated areas the presence of faecal bacteria and the production of malodorous compounds during waste storage and in the tanks of wastewater treatment plants, can cause concern. The general aim of the work was to study electrolytic waste treatment (recently applied on animal slurry) using low electric current across graphite and copper electrodes, determining its effect on the microflora of sludge, collected from the equalisation basin of an industrial aerobic wastewater treatment plant, and on odour emission abatement. Biochemical and enzymatic indicators like ATP content and a pool of 19 enzymatic activities were tested, comparing them with viable cell counts by traditional microbiological methods, to verify the validity of such indicators in monitoring the electrolytic treatment and to assess their correlation with odour reduction. The preliminary results of our laboratory-scale trials showed that in the presence of inert electrodes, such as graphite, metabolic activity is stimulated, whereas with copper electrodes the ATP content and some enzymatic activities are inhibited quite considerably after only four days, this being accompanied by a marked reduction in odour. Consideration was also given to the total copper released from the electrodes and its recovery using iron electrodes.

  6. Methodological Aspects of Analyzing and Assessing the Per Capita Consumption of Fish and Seafood in the Russian Federation

    Directory of Open Access Journals (Sweden)

    Vladimir Mikhailovich Selin

    2015-12-01

    Full Text Available Globalization of the economy and increased competition leads to the need to strengthen the functions of the Russian government to ensure food security of the country and, accordingly, the consolidation of mechanisms of state regulation of agricultural economy and food markets. The importance of solving the problems of information security, a high degree of reliability of the information provided by the Government of the relevant statistical authorities is growing. The relevance of obtaining high-quality statistical information for the adoption of timely and informed decisions by the government on the management of the national economy has increased significantly during the period of political and economic confrontation between Russia and the West in terms of sanctions and counter-sanctions. Taking fishing industry and its product – the water biological resources – as an example, the author of the present study carried out a structural analysis of the methodology for composing the balance of fish and fish products to determine the per capita level of consumption, described the different approaches to assessing the level of consumption of water biological resources, structured export indicators of water biological resources gathered from various official sources, on the basis of which the author revealed significant differences in the assessment of the situation. The subject of statistics as the problem was raised at the Presidium of the State Council from October 19, 2015 devoted to the development of the fishing industry of the Russian Federation and was reflected as a separate item in the Order of the President following the results of the State Council. Established by the Order of the Federal State Statistics Service dated October 21, 2013 No. 419, the new method of determining the level of per capita consumption of fish and fish products, based on the compilation of the balance of water biological resources, and composed after the

  7. Assessment of postural balance in community-dwelling older adults - methodological aspects and effects of biofeedback-based Nintendo Wii training

    DEFF Research Database (Denmark)

    Jørgensen, Martin Grønbech

    The overall purpose of this thesis was to examine selected methodological aspects and novel approaches for measuring postural balance older adults, and to examine the effects of biofeedback-based Nintendo Wii training on selected physiological, psychological and functional outcome variables...... in community-dwelling older adults. In Study I balance control was investigated using force plate analysis of Centre of Pressure (COP) excursion during static bilateral standing in 32 community-dwelling older adults at three different time-points (09:00, 12:30, and 16:00) throughout the day. An overall...... significant time-of-day effect was observed for all selected COP variables. The greatest change in all COP variables was observed (on average ~15%) between midday (12:30) and the afternoon (16:00), indicating that a systematic time-of-day influence on static postural balance exists in community-dwelling older...

  8. Can teaching research methodology influence students' attitude toward science? Cohort study and nonrandomized trial in a single medical school.

    Science.gov (United States)

    Vujaklija, Ana; Hren, Darko; Sambunjak, Dario; Vodopivec, Ivana; Ivanis, Ana; Marusić, Ana; Marusić, Matko

    2010-02-01

    Medical teaching aims to develop attitudes and behaviors underlying professional competence of future physicians. We investigated whether a mandatory course on scientific methodology in the second study year could affect students' attitudes toward science in medicine. In a longitudinal study, students (n = 241) enrolling in 2001-2002 academic year at a single medical school were followed up until graduation in 2006-2007. Each year, they filled out a Likert-type questionnaire of 18 statements evaluating attitude toward science. Direct influence of the course on students' attitudes was tested in a nonrandomized controlled trial with the 2006-2007 second year student cohort. Positive students' attitudes toward science increased during study years (mean [SD] score of the maximum score of 90): from 57.6 (6.0) in the first to 69.8 (10.4) in the sixth year. There was a significant trend of increase in attitudes with the years of study (cubic trend by polynomial contrasts analysis, P = 0.011). Attendance of a course on research methodology significantly increased positive attitudes (score, 67.0 [7.0] before and 70.8 [7.5] after course, P = 0.032 vs control group), regardless of grade point average. The intervention had an effect even when the influence of the initial attitude was accounted for (F1,140 = 9.25, P = 0.003; analysis of covariance). The attitude changes after the course was greatest in students with low initial attitude scores (Spearman rinitial score, score difference, -0.44). Medical students have positive attitudes toward science and scientific method in medicine. Attendance of a course on research methodology had positive short-term effect on students' attitudes toward science. This positive effect should be maintained by vertical integration of the course in the medical curriculum.

  9. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    Directory of Open Access Journals (Sweden)

    Burke Kylie

    2010-08-01

    Full Text Available Abstract Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a

  10. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  11. Methodological Proposal for Identification and Evaluation of Environmental Aspects and Impacts of IPEN Nuclear Facilities: A Case Study Applied to the Nuclear Fuel Center

    International Nuclear Information System (INIS)

    Mattos, Luis A. Terribile de; Filho, Tufic Madi; Meldonian, Nelson Leon

    2013-06-01

    This work presents an application of Failure Mode Effect Analysis (FMEA) to the process of identification of environmental aspects and impacts as a part of implementation and maintenance of an Environmental Management System (EMS) in accordance with the ISO 14001 standard. Also, it can contribute, as a complement, to the evaluation and improvement of safety of the installation focused. The study was applied to the Nuclear Fuel Center (CCN) of Nuclear and Energy Research Institute (IPEN), situated at the Campus of University of Sao Paulo, Brazil. The CCN facility has the objective of promoting scientific research and of producing nuclear fuel elements for the IEA-R1 Research Reactor. To identify the environmental aspects of the facility activities, products, and services, a systematic data collection was carried out by means of personal interviews, documents, reports and operation data records consulting. Furthermore, the processes and their interactions, failure modes, besides their causes and effects to the environment, were identified. As a result of a careful evaluation of these causes it was possible to identify and to classify the major potential environmental impacts, in order to set up and put in practice an Environmental Control Plan for the installation under study. The results have demonstrated the validity of the FMEA application to nuclear facility processes, identifying environmental aspects and impacts, whose controls are critical to achieve compliance with the environmental requirements of the Integrated Management System of IPEN. It was demonstrated that the methodology used in this work is a powerful management tool for resolving issues related to the conformity with applicable regulatory and legal requirements of the Brazilian Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment (IBAMA). (authors)

  12. Methodological aspects of mutation breeding

    International Nuclear Information System (INIS)

    Broertjes, C.; Roest, S.; Bokelmann, G.S.

    1980-01-01

    The authors discuss the development of the in vitro adventitious bud technique for Chrysanthemum morifolium, Solanum tuberosum, Begonia x hieemalis, Dianthus caryophyllus, Muscari, Euphorbia pulcherrima, and Forsythia intermedia. (G.T.H.)

  13. Methodology for a Trial of Brain-Centered versus Anti-cholinergic Therapy for Women with Urgency Urinary Incontinence

    Science.gov (United States)

    Komesu, Yuko M.; Ketai, Loren H.; Sapien, Robert E.; Rogers, Rebecca G.; Schrader, Ronald M.; Simmerman-Sierra, Timothy; Mayer, Andrew R.

    2016-01-01

    Introduction This paper describes the rationale and methodology a study which investigates mind-body treatment versus pharmacotherapy for women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy a mind-body intervention, will be at least as effective pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. Methods The purpose of this manuscript is to recount the development and design challenges of a study evaluating the efficacy of hypnotherapy compared to conventional pharmacotherapy in UUI treatment. The study randomizes women to either of these treatments and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a non-inferiority test (alpha=.025, beta=0.20), after considering drop-out/loss to follow-up, indicated approximately 150 woman would be required to test the hypothesis that hypnotherapy is non-inferior to pharmacotherapy within a 5% non-inferiority margin. The study will also evaluate fMRI change in a subset of participants before and after therapy. Study challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, confronting the reality that trials are time-consuming for participants and making appropriate accommodations. Results Study enrollment began March 2013 and is ongoing. Conclusions This manuscript details the design a of randomized controlled trial (RCT) comparing mind-body therapy to medications in treatment of UUI and describes the challenges encountered in its planning. PMID:27752750

  14. 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.

  15. 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

  16. A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

    Science.gov (United States)

    Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

    2017-07-18

    The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

  17. Methodological Aspects for Preclinical Evaluation of Gadolinium Presence in Brain Tissue: Critical Appraisal and Suggestions for Harmonization-A Joint Initiative.

    Science.gov (United States)

    Robert, Philippe; Frenzel, Thomas; Factor, Cécile; Jost, Gregor; Rasschaert, Marlène; Schuetz, Gunnar; Fretellier, Nathalie; Boyken, Janina; Idée, Jean-Marc; Pietsch, Hubertus

    2018-04-13

    Gadolinium (Gd)-based contrast agents (GBCAs) are pharmaceuticals that have been approved for 30 years and used daily in millions of patients worldwide. Their clinical benefits are indisputable. Recently, unexpected long-term presence of Gd in the brain has been reported by numerous retrospective clinical studies and confirmed in preclinical models particularly after linear GBCA (L-GBCA) compared with macrocyclic GBCA (M-GBCA). Even if no clinical consequences of Gd presence in brain tissue has been demonstrated so far, in-depth investigations on potential toxicological consequences and the fate of Gd in the body remain crucial to potentially adapt the clinical use of GBCAs, as done during the nephrogenic systemic fibrosis crisis. Preclinical models are instrumental in the understanding of the mechanism of action as well as the potential safety consequences. However, such models may be associated with risks of biases, often related to the protocol design. Selection of adequate terminology is also crucial. This review of the literature intends to summarize and critically discuss the main methodological aspects for accurate design and translational character of preclinical studies.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  18. Intraarticular Facet Injections for Low Back Pain: Design Considerations, Consensus Methodology to Develop the Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Mars, Tom; Ellard, David R; Antrobus, James H L; Cairns, Melinda; Underwood, Martin; Haywood, Kirstie; Keohane, Susie; Sandhu, Harbinder; Griffiths, Frances

    2015-01-01

    Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs). To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed. A consensus conference involving expert professionals and lay members. Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to

  19. Combined evaluations of competency to stand trial and mental state at the time of the offense: An overlooked methodological consideration?

    Science.gov (United States)

    Kois, Lauren; Wellbeloved-Stone, James M; Chauhan, Preeti; Warren, Janet I

    2017-06-01

    Combined evaluations of competency to stand trial (CST; competency) and mental state at the time of the offense (MSO; sanity) frequently co-occur. However, most research examines the 2 as discrete constructs without considering 4 potential combined evaluation outcomes: competent-sane, incompetent-sane, competent-insane, and incompetent-insane. External validity can be improved if research more closely mirrored practice. It may be incorrect to assume incompetent defendants are similar across CST-only and combined evaluations, and insane defendants are similar across MSO-only and combined evaluations. Using a sample of 2,751 combined evaluations, we examined demographic, clinical, offense, evaluation, and psycholegal characteristics associated with evaluators' combined evaluation opinions. Multinomial regression analyses revealed older defendants were more likely to be opined incompetent-insane. Defendants with psychotic disorders were more often opined insane, regardless of competency status. Affective diagnoses predicted competent-insane opinions. Developmental disorders were closely related to incompetence, regardless of sanity status. Defendants with organic disorders tended to have global psycholegal impairment, in that they were more often opined incompetent-insane, incompetent-sane, or competent-insane, relative to competent-sane. Prior hospitalization predicted competent-insane relative to competent-sane opinions. Defendants not under the influence of a substance during the offense or with no prior convictions were more likely to be opined insane, regardless of competency status. We interpret these findings in light of psycholegal theory and provide recommendations for research and practice. Collectively, results suggest incorporation of combined evaluations into CST and MSO research is an important methodological consideration not to be overlooked. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  20. Assessment of postural balance in community-dwelling older adults - methodological aspects and effects of biofeedback-based Nintendo Wii training.

    Science.gov (United States)

    Jørgensen, Martin Grønbech

    2014-01-01

    The overall purpose of this thesis was to examine selected methodological aspects and novel approaches for measuring postural balance older adults, and to examine the effects of biofeedback-based Nintendo Wii training on selected physiological, psychological and functional outcome variables in community-dwelling older adults. In Study I balance control was investigated using force plate analysis of Centre of Pressure (COP) excursion during static bilateral standing in 32 community-dwelling older adults at three different time-points (09:00, 12:30, and 16:00) throughout the day. An overall significant time-of-day effect was observed for all selected COP variables. The greatest change in all COP variables was observed (on average ~15%) between midday (12:30) and the afternoon (16:00), indicating that a systematic time-of-day influence on static postural balance exists in community-dwelling older adults. Consequently, longitudinal (i.e. pre-to-post training) comparisons of postural balance in in older adults with repeated assessments should be conducted at the same time-of-day. In Study II a novel approach for measuring postural balance (using the Nintendo Wii Stillness and Agility tests) was examined for reproducibility and concurrent validity in 30 community-dwelling older adults. While the Nintendo Wii Stillness test showed a high reproducibility, a systematic learning effect between successive sessions was observed for the Agility test. Moderate-to-excellent concurrent validity was seen for the Stillness test. In contrast, the Agility test revealed a poor concurrent validity. In conclusion, the Wii Stillness test seems to represent a low-cost objective reproducible test of postural balance in community-dwelling older adults and appears feasible in various clinical settings. A habituation (familiarization) period is necessary for the Wii Agility test to avoid a systematic learning effect between successive test sessions. Study III investigated the effect of ten

  1. SCIENTIFIC AND METHODOLOGICAL ASPECTS OF BUSINESS MANAGEMENT AND ORGANIZATIONAL DEVELOPMENT OF THE TOURISM SECTOR ENTERPRISES OF POLTAVA REGION IN THE CONTEXT OF SUSTAINABLE DEVELOPMENT

    Directory of Open Access Journals (Sweden)

    Iryna Chernysh

    2017-12-01

    Full Text Available The purpose of the paper is to summarise and present the scientific-methodological and conceptual aspects of business management and organizational development of tourist enterprises of Poltava region in the context of sustainable growth. Methodology. The methodological basis of the research is general scientific research methods: methods of scientific analysis and synthesis, in particular, system-logical analysis of the influence of modern information and innovative technologies on the organizational development of tourism enterprises that allows creating the prerequisites for sustainable development. The rationale for the introduction of a virtual cluster based on the process and system approaches, where the main source of information is the scientific works of foreign and domestic scientists and practitioners. Results. The structural-logical scheme of organizational and economic support of the virtual association of tourist enterprises of the Poltava region is formed. The main participants of the virtual association of tourist enterprises of the Poltava region are singled out. Scientific novelty. The expediency of creating a virtual association of tourist enterprises of the Poltava region as an instrument of organizational development in the context of modern, global trends in the development of the tourist sphere is substantiated. Participants of the virtual association, goals and objectives, principles are singled out. It is determined, which priority tasks of the Poltava region will the virtual association able to solve. Practical implications. It is determined by the possibility of using these research results in the development of regional tourism development programs in the Poltava region and the establishment of projects for the development of tourism enterprises. Conclusions. The choice of such a form as a voluntary tourist virtual association is due to the fact that, as world practice shows, it will help to reduce

  2. Current Evidence to Justify, and the Methodological Considerations for a Randomised Controlled Trial Testing the Hypothesis that Statins Prevent the Malignant Progression of Barrett's Oesophagus

    Directory of Open Access Journals (Sweden)

    David Thurtle

    2014-12-01

    Full Text Available Barrett’s oesophagus is the predominant risk factor for oesophageal adenocarcinoma, a cancer whose incidence is increasing and which has a poor prognosis. This article reviews the latest experimental and epidemiological evidence justifying the development of a randomised controlled trial investigating the hypothesis that statins prevent the malignant progression of Barrett’s oesophagus, and explores the methodological considerations for such a trial. The experimental evidence suggests anti-carcinogenic properties of statins on oesophageal cancer cell lines, based on the inhibition of the mevalonate pathway and the production of pro-apoptotic proteins. The epidemiological evidence reports inverse associations between statin use and the incidence of oesophageal carcinoma in both general population and Barrett’s oesophagus cohorts. Such a randomised controlled trial would be a large multi-centre trial, probably investigating simvastatin, given the wide clinical experience with this drug, relatively low side-effect profile and low financial cost. As with any clinical trial, high adherence is important, which could be increased with therapy, patient, doctor and system-focussed interventions. We would suggest there is now sufficient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

  3. A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations.

    Science.gov (United States)

    Achana, Felix; Petrou, Stavros; Khan, Kamran; Gaye, Amadou; Modi, Neena

    2018-01-01

    A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations.

  4. Methodological aspects of the 1993 Pelotas (Brazil birth cohort study Aspectos metodológicos da coorte de nascimentos de 1993 em Pelotas, RS

    Directory of Open Access Journals (Sweden)

    Cesar Gomes Victora

    2006-02-01

    Full Text Available This paper describes the main methodological aspects of a cohort study, with emphasis on its recent phases, which may be relevant to investigators planning to carry out similar studies. In 1993, a population based study was launched in Pelotas, Southern Brazil. All 5,249 newborns delivered in the city's hospitals were enrolled, and sub-samples were visited at the ages of one, three and six months and of one and four years. In 2004-5 it was possible to trace 87.5% of the cohort at the age of 10-12 years. Sub-studies are addressing issues related to oral health, psychological development and mental health, body composition, and ethnography. Birth cohort studies are essential for investigating the early determinants of adult disease and nutritional status, yet few such studies are available from low and middle-income countries where these determinants may differ from those documented in more developed settings.Descrever aspectos metodológicos do estudo da coorte de crianças que podem ser relevantes para pesquisadores que estejam planejando investigações semelhantes. Em 1993, uma coorte de base populacional foi recrutada em Pelotas, RS. Os 5.249 recém-nascidos nos hospitais da cidade foram acompanhados com um, três e seis meses, e com um e quatro anos de idade. Subestudos estão sendo realizados sobre saúde bucal, desenvolvimento psicológico e saúde mental, composição corporal e aspectos etnográficos. Em 2004-5 foi possível entrevistar 87,5% da coorte inicial, com a idade de 10-12 anos. Estudos de coortes de nascimentos são essenciais para investigar os determinantes precoces da morbidade e estado nutricional de adultos. No entanto, há poucos estudos com esta metodologia em países de renda média e baixa, e alguns dos determinantes da situação de saúde podem ser distintos daqueles observados em países ricos.

  5. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - a position paper endorsed by ESMINT and ESNR : part II: methodology of future trials.

    Science.gov (United States)

    Fiehler, Jens; Söderman, Michael; Turjman, Francis; White, Philip M; Bakke, Søren Jacob; Mangiafico, Salvatore; von Kummer, Rüdiger; Muto, Mario; Cognard, Christophe; Gralla, Jan

    2012-12-01

    Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines.

  6. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - A position paper endorsed by ESMINT and ESNR. Pt. 2. Methodology of future trials

    Energy Technology Data Exchange (ETDEWEB)

    Fiehler, Jens [University Medical Centre Hamburg-Eppendorf, Department of Neuroradiology, Hamburg (Germany); Soederman, Michael [Karolinska University Hospital, Department of Neuroradiology, Stockholm (Sweden); Turjman, Francis [Hopital neurologique, Centre de Neurosciences Cognitives, Department of Neuroradiology, Lyon (France); White, Philip M. [University of Edinburgh, Department of Clinical Neurosciences, Western General Hospital, Edinburgh (United Kingdom); Bakke, Soeren Jacob [Oslo University Hospital, Department of Neuroradiology, Oslo (Norway); Mangiafico, Salvatore [University Hospital Careggi, Interventional Neuroradiology Unit, Florence (Italy); Kummer, Ruediger von [University of Dresden, Department of Neuroradiology, Dresden (Germany); Muto, Mario [University of Naples, Department of Neuroradiology, Naples (Italy); Cognard, Christophe [Hopital Purpan, Service de Neuroradiologie, Toulouse (France); Gralla, Jan [Inselspital Bern, Department of Neuroradiology, Bern (Switzerland)

    2012-12-15

    Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines. (orig.)

  7. Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the Single-Case Experimental Design (SCED) Scale.

    Science.gov (United States)

    Tate, Robyn L; McDonald, Skye; Perdices, Michael; Togher, Leanne; Schultz, Regina; Savage, Sharon

    2008-08-01

    Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical

  8. Clinical aspects of a multicenter clinical trial of implant-retained mandibular overdentures in patients with severely resorbed mandibles

    NARCIS (Netherlands)

    Geertman, ME; Boerrigter, EM; VanWaas, MAJ; vanOort, RP

    In a multicenter clinical trial treatment, the effects of overdentures on different implant systems in patients with severely resorbed mandibles were compared 1 year after the insertion of new dentures. The implant systems used were the transmandibular implant (TMI), the IMZ (IMZ), and the Branemark

  9. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  10. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  11. Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

    Science.gov (United States)

    Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

    2015-11-01

    The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are

  12. A call for improved transparency in financial aspects of clinical trials: a case study of the CREATE-X trial in the New England Journal of Medicine.

    Science.gov (United States)

    Ozaki, Akihiko; Takita, Morihito; Tanimoto, Tetsuya

    2018-06-01

    Introduction Globally, laws and guidelines for managing conflict of interest are increasingly implemented to achieve transparency in financial ties between physicians and pharmaceutical and medical device industries, yet little information is available regarding the limitations of the current frameworks for disclosing these financial ties. Case In June 2017, the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial was published in the New England Journal of Medicine. In this study, which suggested the post-surgery addition of capecitabine would improve survival of high-risk breast cancer patients, the cost of capecitabine for off-label use was illegally claimed to the Japanese public health insurance system, rather than being covered by the research budget. This illegal claim led to the profit of more than 100,000,000 JPY (approximately 0.91 million USD) for Chugai Pharmaceutical Company (CPC), which manufactures capecitabine. Additional evidence suggests that the CPC made donations of at least 100,000,000 JPY (approximately 0.91 million USD) and 236,000,000 JPY (approximately 2.1 million USD) to the Japan Breast Cancer Research Group (JBCRG), the study's sponsor and funder where the majority of the Japanese authors served high-level positions, and the Advanced Clinical Research Organization, the other study funder, respectively, during the study period, though the total amount has not been clarified. Neither the CPC's involvement nor its undue profit was mentioned in the published article. Conclusion This case report highlights the lack of financial transparency in the CREATE-X trial, and discusses the potential limitations that may exist in the current frameworks for disclosing financial ties between physicians and relevant industries in clinical trials. Achieving improved transparency is essential to heighten credibility in the findings of clinical trials.

  13. Clinical trial methodology and clinical cohorts: the importance of complete follow-up in trials evaluating the virological efficacy of anti-HIV medicines

    DEFF Research Database (Denmark)

    Kirk, Ole; Lundgren, Jens Dilling

    2004-01-01

    -up is still likely to be discontinued at a premature switch from study medication in a large number of the randomized trials published in 2002-2003. However, some studies, all initiated by investigators, did follow patients throughout the study period. In three of the studies, the proportions of patients...

  14. Evidence for efficacy of acute treatment of episodic tension-type headache: methodological critique of randomised trials for oral treatments.

    Science.gov (United States)

    Moore, R Andrew; Derry, Sheena; Wiffen, Philip J; Straube, Sebastian; Bendtsen, Lars

    2014-11-01

    The International Headache Society (IHS) provides guidance on the conduct of trials for acute treatment of episodic tension-type headache (TTH), a common disorder with considerable disability. Electronic and other searches identified randomised, double-blind trials of oral drugs treating episodic TTH with moderate or severe pain at baseline, or that tested drugs at first pain onset. The aims were to review methods, quality, and outcomes reported (in particular the IHS-recommended primary efficacy parameter pain-free after 2 hours), and to assess efficacy by meta-analysis. We identified 58 reports: 55 from previous reviews and searches, 2 unpublished reports, and 1 clinical trial report with results. We included 40 reports of 55 randomised trials involving 12,143 patients. Reporting quality was generally good, with potential risk of bias from incomplete outcome reporting and small size; the 23 largest trials involved 82% of patients. Few trials reported IHS outcomes. The number needed to treat values for being pain-free at 2 hours compared with placebo were 8.7 (95% confidence interval [CI] 6.2 to 15) for paracetamol 1000 mg, 8.9 (95% CI 5.9 to 18) for ibuprofen 400mg, and 9.8 (95% CI 5.1 to 146) for ketoprofen 25mg. Lower (better) number needed to treat values were calculated for outcomes of mild or no pain at 2 hours, and patient global assessment. These were similar to values for these drugs in migraine. No other drugs had evaluable results for these patient-centred outcomes. There was no evidence that any one outcome was better than others. The evidence available for treatment efficacy is small in comparison to the size of the clinical problem. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  15. Intention to treat (ITT) analysis as reported in orthodontic randomized controlled trials-evaluations of methodology and recommendations for the accurate use of ITT analysis and handling dropouts.

    Science.gov (United States)

    Bondemark, Lars; Abdulraheem, Salem

    2017-10-21

    To systematically evaluate in five orthodontic journals how many randomized controlled trials (RCTs) use intention to treat (ITT) analysis and to assess the methodological quality of the ITT analysis, and finally, to demonstrate in an academic way how outcomes can be affected when not implementing the ITT analysis. A search of the database, Medline, was performed via PubMed for publication type 'randomized controlled trial' published for each journal between 1 January 2013 and 30 April 2017. The five orthodontic journals assessed were the American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontics, European Journal of Orthodontics, Journal of Orthodontics, and Orthodontics and Craniofacial Research. Two independent reviewers assessed each RCT to determine whether the trial reported an ITT or not or if a per-protocol analysis was accomplished. The initial search generated 137 possible trials. After applying the inclusion and exclusion criteria, 90 RCTs were included and assessed. Seventeen out of 90 RCTs (18.9%) either reported an ITT analysis in the text and/or supported the ITT by flow diagrams or tables. However, six RCTs applied and reported the ITT analysis correctly, while the majority performed a per-protocol analysis instead. Nearly all the trials that applied the ITT analysis incorrectly analysed the results using a per-protocol analysis, and thus, overestimating the results and/or having a reduced sample size which then could produce a diminished statistical power. © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

  16. Methodological characteristics and treatment effect sizes in oral health randomised controlled trials: Is there a relationship? Protocol for a meta-epidemiological study.

    Science.gov (United States)

    Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

    2014-02-25

    It is fundamental that randomised controlled trials (RCTs) are properly conducted in order to reach well-supported conclusions. However, there is emerging evidence that RCTs are subject to biases which can overestimate or underestimate the true treatment effect, due to flaws in the study design characteristics of such trials. The extent to which this holds true in oral health RCTs, which have some unique design characteristics compared to RCTs in other health fields, is unclear. As such, we aim to examine the empirical evidence quantifying the extent of bias associated with methodological and non-methodological characteristics in oral health RCTs. We plan to perform a meta-epidemiological study, where a sample size of 60 meta-analyses (MAs) including approximately 600 RCTs will be selected. The MAs will be randomly obtained from the Oral Health Database of Systematic Reviews using a random number table; and will be considered for inclusion if they include a minimum of five RCTs, and examine a therapeutic intervention related to one of the recognised dental specialties. RCTs identified in selected MAs will be subsequently included if their study design includes a comparison between an intervention group and a placebo group or another intervention group. Data will be extracted from selected trials included in MAs based on a number of methodological and non-methodological characteristics. Moreover, the risk of bias will be assessed using the Cochrane Risk of Bias tool. Effect size estimates and measures of variability for the main outcome will be extracted from each RCT included in selected MAs, and a two-level analysis will be conducted using a meta-meta-analytic approach with a random effects model to allow for intra-MA and inter-MA heterogeneity. The intended audiences of the findings will include dental clinicians, oral health researchers, policymakers and graduate students. The aforementioned will be introduced to the findings through workshops, seminars, round

  17. The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review

    Science.gov (United States)

    Aves, Theresa; Lawson, Daeria; Nieuwlaat, Robby; Beyene, Joseph; Mbuagbaw, Lawrence

    2017-01-01

    Introduction There has been increasing interest in pragmatic trials methodology. As a result, tools such as the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) are being used prospectively to help researchers design randomised controlled trials (RCTs) within the pragmatic-explanatory continuum. There may be value in applying the PRECIS-2 tool retrospectively in a systematic review setting as it could provide important information about how to pool data based on the degree of pragmatism. Objectives To investigate the role of pragmatism as a source of heterogeneity in systematic reviews by (1) identifying systematic reviews with meta-analyses of RCTs that have moderate to high heterogeneity, (2) applying PRECIS-2 to RCTs of systematic reviews, (3) evaluating the inter-rater reliability of PRECIS-2, (4) determining how much of this heterogeneity may be explained by pragmatism. Methods A cross-sectional methodological review will be conducted on systematic reviews of RCTs published in the Cochrane Library from 1 January 2014 to 1 January 2017. Included systematic reviews will have a minimum of 10 RCTs in the meta-analysis of the primary outcome and moderate to substantial heterogeneity (I2≥50%). Of the eligible systematic reviews, a random selection of 10 will be included for quantitative evaluation. In each systematic review, RCTs will be scored using the PRECIS-2 tool, in duplicate. Agreement between raters will be measured using the intraclass correlation coefficient. Subgroup analyses and meta-regression will be used to evaluate how much variability in the primary outcome may be due to pragmatism. Dissemination This review will be among the first to evaluate the PRECIS-2 tool in a systematic review setting. Results from this research will provide inter-rater reliability information about PRECIS-2 and may be used to provide methodological guidance when dealing with pragmatism in systematic reviews and subgroup considerations. On completion, this

  18. Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Soledad eBallesteros

    2014-10-01

    Full Text Available Age-related cognitive and brain declines can result in functional deterioration in many cognitive domains, dependency, and dementia. A major goal of aging research is to investigate methods that help to maintain brain health, cognition, independent living and wellbeing in older adults. This randomized controlled study investigated the effects of 20 1-hr non-action video game training sessions with games selected from a commercially available package (Lumosity on a series of age-declined cognitive functions and subjective wellbeing. Two groups of healthy older adults participated in the study, the experimental group who received the training and the control group who attended three meetings with the research team along the study. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. All participants were assessed individually before and after the intervention, or a similar period of time, using neuropsychological tests and laboratory tasks to investigate possible transfer effects. The results showed significant improvements in the trained group, and no variation in the control group, in processing speed (choice reaction time, attention (reduction of distraction and increase of alertness, immediate and delayed visual recognition memory, as well as a trend to improve in Affection and Assertivity, two dimensions of the Wellbeing Scale. Visuospatial working memory (WM and executive control (shifting strategy did not improve. Overall, the current results support the idea that training healthy older adults with non-action video games will enhance some cognitive abilities but not others. Trial Registration: ClinicalTrials.gov identifier NCT02007616http://clinicaltrials.gov/show/NCT02007616

  19. Methodology and recruitment for a randomised controlled trial to evaluate the safety of wahakura for infant bedsharing.

    Science.gov (United States)

    Tipene-Leach, David; Baddock, Sally; Williams, Sheila; Jones, Raymond; Tangiora, Angeline; Abel, Sally; Taylor, Barry

    2014-09-28

    Sudden Unexpected Death in Infancy (SUDI) has persistent high rates in deprived indigenous communities and much of this mortality is attributable to unsafe sleep environments. Whilst health promotion worldwide has concentrated on avoidance of bedsharing, the indigenous Māori community in New Zealand has reproduced a traditional flax bassinet (wahakura) designed to be used in ways that include bedsharing. To date there has been no assessment of the safety of this traditional sleeping device. This two arm randomised controlled trial is being conducted with 200 mother-baby dyads recruited from Māori communities in areas of high deprivation in the Hawkes Bay, New Zealand. They are randomised to wahakura or bassinet use and investigation includes questionnaires at baseline (pregnancy), when baby is 1, 3, and 6 months, and an overnight video sleep study at 1 month with monitoring of baby temperature and oxygen saturation, and measurement of baby urinary cotinine and maternal salivary oxytocin. Outcome measures are amount of time head covered, amount of time in thermal comfort zone, number of hypoxic events, amount of time in the assigned sleep device, amount of time breastfeeding, number of parental (non-feed related) touching infant events, amount of time in the prone sleep position, the number of behavioural arousals and the amount of time infant is awake overnight. Survey data will compare breastfeeding patterns at 1, 3, and 6 months as well as data on maternal mind-mindedness, maternal wellbeing, attachment to baby, and maternal sleep patterns. Indigenous communities require creative SUDI interventions that fit within their prevailing world view. This trial, and its assessment of the safety of a wahakura relative to a standard bassinet, is an important contribution to the range of SUDI prevention research being undertaken worldwide. Australian New Zealand Clinical Trials Registry: ACTRN12610000993099 Registered 16th November 2010.

  20. Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

    Science.gov (United States)

    Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

    2015-11-01

    One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

  1. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study

    Directory of Open Access Journals (Sweden)

    Flik Carla E

    2011-12-01

    Full Text Available Abstract Background Irritable Bowel Syndrome (IBS is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. Methods/Design The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65 with IBS (Rome-III criteria. Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo, with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. Discussion If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. Trial registration number ISRCTN: ISRCTN22888906

  2. 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.

  3. 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

  4. Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

    Science.gov (United States)

    2013-01-01

    Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p  0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test

  5. Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

    Science.gov (United States)

    Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

    2013-02-01

    Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p  0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six

  6. Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials.

    Science.gov (United States)

    McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte

    2010-03-21

    Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential

  7. A pragmatic trial in the Rio de Janeiro subway to capture smokers for a quitline: methodological challenges and opportunities.

    Science.gov (United States)

    Szklo, André Salem; da Silva Freire Coutinho, Evandro; Reichenheim, Michael Eduardo

    2012-01-01

    According to the World Health Organization, smoking is an important cause of death worldwide. To encourage smoking cessation, persuasive messages can be used to raise smokers' risk perception. This article discusses challenges and solutions in designing a study to evaluate the effect of two different communication strategies ("gains from quitting" vs. "losses from continuing smoking") in encouraging calls to a quitline. The authors conducted an intervention study in two subway stations for 4 weeks, considering only 1 strategy per station. Large posters containing non-age-specific images and texts, on the basis of the theme"shortness of breath," were displayed on central dividing columns on the boarding platforms. Call rates from the selected stations, and respective rate ratios, overall and per study week, were calculated. Passengers who were smokers, exposed to the positive-content message, called on average 1.7 times more often than did those exposed to the negative-content message (p = .01). Moreover, call rate ratios did not decline over the 4 weeks of the study (p = .40). The effectiveness findings suggest that antismoking campaigns could use positive-content messages in order to recruit a larger smoker population. The proposed methodology can also be used to evaluate effectiveness of messages for "capturing" individuals with other health problems (e.g., alcohol abuse), thereby increasing its potential impact.

  8. Methodological Aspects of the Potential Use of Dendrochronological Techniques When Analyzing the Long-Term Impact of Tourism on Protected Areas.

    Science.gov (United States)

    Ciapała, Szymon; Adamski, Paweł

    2015-01-01

    Intensification of pedestrian tourism causes damage to trees near tourist tracks, and likewise changes the soil structure. As a result, one may expect that annual amount of trees growing near tracks is significantly lower than deeper in the forest. However, during the study of the long-term impact of tourism on the environment (determined from tree increment dynamics), some methodological problems may occur. It is particularly important in protected areas where law and administrative regulations related to nature conservation force research to be conducted using small samples. In this paper we have analyzed the data collected in the Polish part of the Tatra National Park in the two study plots divided into two zones each: the area directly under the influence of the tourist's trampling and the control group. The aim of such analyses was to present the potential effects of the factors which may affect the results of dendrochronological analysis: (i) small size of samples that affects their representativeness, (ii) spatial differences in the rates of the process, as a result of spatial variability of environmental factors and (iii) temporal differences in the rates of the process. This study confirms that the factors mentioned above could significantly influence the results and should be taken into consideration during the analysis.

  9. Methodological Aspects of the Potential Use of Dendrochronological Techniques When Analyzing the Long-Term Impact of Tourism on Protected Areas.

    Directory of Open Access Journals (Sweden)

    Szymon Ciapała

    Full Text Available Intensification of pedestrian tourism causes damage to trees near tourist tracks, and likewise changes the soil structure. As a result, one may expect that annual amount of trees growing near tracks is significantly lower than deeper in the forest. However, during the study of the long-term impact of tourism on the environment (determined from tree increment dynamics, some methodological problems may occur. It is particularly important in protected areas where law and administrative regulations related to nature conservation force research to be conducted using small samples. In this paper we have analyzed the data collected in the Polish part of the Tatra National Park in the two study plots divided into two zones each: the area directly under the influence of the tourist's trampling and the control group. The aim of such analyses was to present the potential effects of the factors which may affect the results of dendrochronological analysis: (i small size of samples that affects their representativeness, (ii spatial differences in the rates of the process, as a result of spatial variability of environmental factors and (iii temporal differences in the rates of the process. This study confirms that the factors mentioned above could significantly influence the results and should be taken into consideration during the analysis.

  10. Methodology of clinical trials evaluating the incorporation of new drugs in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL): a critical review.

    Science.gov (United States)

    Iacoboni, G; Zucca, E; Ghielmini, M; Stathis, A

    2018-05-01

    The first-line treatment of diffuse large B-cell lymphoma (DLBCL) is the combination of rituximab with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy, curing approximately 60% of patients. Many clinical trials have been carried out over the last 10 years trying to improve the results of this treatment, but the appropriateness of their planning strategies could be rediscussed. Reports of phase III trials evaluating the addition of molecularly targeted agents or new monoclonal antibodies to the classic R-CHOP backbone in first-line induction or maintenance treatment were reviewed. The trial design, primary end point, number of patients enrolled, patient selection criteria, treatment schedule and results were registered for each one. In addition, the phases I and II trials which preceded these phase III trials were also reviewed. Among six phase III trials with results, only one trial evaluating lenalidomide maintenance after response to R-CHOP induction was positive and reached its primary end point. The other five trials did not show an improved outcome with the addition of the new agent. The preceding phases I and II trials were very heterogeneous in their end points and design. Even though most of these trials were considered positive, thus encouraging further investigation, so far they failed to predict the results of the subsequent phase III trials. The standard of care for DLBCL is still R-CHOP. Phase I/II trials failed to predict the results of subsequent phase III trials evaluating non-chemotherapeutic agents added to R-CHOP. The methodology of phase II trials evaluating new agents in DLBCL needs to be better defined in the future.

  11. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study).

    Science.gov (United States)

    Flik, Carla E; van Rood, Yanda R; Laan, Wijnand; Smout, André Jpm; Weusten, Bas Lam; Whorwell, Peter J; de Wit, Niek J

    2011-12-20

    Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. ISRCTN: ISRCTN22888906.

  12. An assessment of international trade related to bioenergy use in Austria—Methodological aspects, recent developments and the relevance of indirect trade

    International Nuclear Information System (INIS)

    Kalt, Gerald; Kranzl, Lukas

    2012-01-01

    Increasing international biomass trade for energy and concerns about sustainability of globally traded biomass have raised interest in assessments of cross-border trade related to bioenergy. Within this paper, approaches to overcome methodological difficulties related to biomass trade are proposed and applied for the case of Austria. Biomass currently has a share of 15.5% in Austria’s primary energy consumption of 1354 PJ (2009). According to energy statistics, the rate of self-sufficiency with biomass for energy (defined as the ratio of domestic production to inland consumption, with both imports and exports taken into account) is 91%. However, feedstock imports for transport fuel production and indirect imports of wood-based fuels (wood processing residues and waste liquor of the paper industry originating from imported wood) are not taken into account in energy statistics, but prove to be of some significance. Imports of agricultural commodities to the amount of 9.7 PJ can be attributed to domestic biofuel production, and indirect imports of wood-based fuels, account for 31 PJ. With these import streams taken into account, the share of domestic fuels in bioenergy use is only 67%, rather than 84%, as official energy statistics suggest. On the other hand, Austria is exporting more than 50% of its production of sawnwood, panelboard and paper products. - Highlights: ► We investigate biomass cross-border trade related to bioenergy use in Austria. ► International biomass trade for energy has increased significantly in recent years. ► A flow wood diagram is derived to identify indirect trade streams of wood fuels. ► Biofuel feedstock imports are about as important as direct biofuel imports. ► 33% of bioenergy in Austria originate from imported biomass (2009).

  13. Methodological Aspects of the IAEA State Level Concept and Acquisition Path Analysis: A State’s Nuclear Fuel Cycle, Related Capabilities, and the Quantification of Acquisition Paths

    International Nuclear Information System (INIS)

    Lance, K. Kim; Renda, Guido; Cojazzi, Giacomo G. M.

    2015-01-01

    Within its State Level Concept (SLC), the International Atomic Energy Agency (IAEA) envisions a State Level Approach (SLA) for safeguards implementation that considers, inter alia, a State’s nuclear and nuclear-related activities and capabilities as a whole when developing an annual implementation plan. Based on the assessed nuclear fuel cycle and related capabilities of a State, Acquisition Path Analysis (APA) identifies, characterizes, and prioritizes plausible routes for acquiring weapons-usable material to aid in safeguards implementation planning. A review of proposed APA methods and historical evidence indicates that assessments of pathway completion time can be fraught with uncertainty and subject to bias, potentially undermining safeguards effectiveness and efficiency. Based on considerations of theory and evidence, a number of methodological insights are identified to support consistent implementation and ongoing APA development. The use of algorithms to support APA and SLA processes in lieu of human judgement is a contentious issue requiring an evidence- based assessment and is also briefly discussed. This paper captures concepts derived primarily from open sources of information, including publications, presentations, and workshops on on-going APA development by the IAEA and various Member States Support Programs (MSSP) as well as relevant work found in the open literature. While implementation of the SLA has begun for a number of States, these SLAs are being updated and developed for other States. In light of these ongoing developments, the topics covered here should be considered a snapshot in time that does not reflect finished products and does not necessarily reflect official views.

  14. Methodological Approaches for Estimating Gross Regional Product after Taking into Account Depletion of Natural Resources, Environmental Pollution and Human Capital Aspects

    Directory of Open Access Journals (Sweden)

    Boris Alengordovich Korobitsyn

    2015-09-01

    Full Text Available A key indicator of the System of National Accounts of Russia at a regional scale is Gross Regional Product characterizing the value of goods and services produced in all sectors of the economy in a country and intended for final consumption, capital formation and net exports (excluding imports. From a sustainability perspective, the most weakness of GRP is that it ignores depreciation of man-made assets, natural resource depletion, environmental pollution and degradation, and potential social costs such as poorer health due to exposure to occupational hazards. Several types of alternative approaches to measuring socio-economic progress are considering for six administrative units of the Ural Federal District for the period 2006–2014. Proposed alternatives to GRP as a measure of social progress are focused on natural resource depletion, environmental externalities and some human development aspects. The most promising is the use of corrected macroeconomic indicators similar to the “genuine savings” compiled by the World Bank. Genuine savings are defined in this paper as net savings (net gross savings minus consumption of fixed capital minus the consumption of natural non-renewable resources and the monetary evaluations of damages resulting from air pollution, water pollution and waste disposal. Two main groups of non renewable resources are considered: energy resources (uranium ore, oil and natural gas and mineral resources (iron ore, copper, and aluminum. In spite of various shortcomings, this indicator represents a considerable improvement over GRP information. For example, while GRP demonstrates steady growth between 2006 and 2014 for the main Russian oil- and gas-producing regions — Hanty-Mansi and Yamalo-Nenets Autonomous Okrugs, genuine savings for these regions decreased over all period. It means that their resource-based economy could not be considered as being on a sustainable path even in the framework of

  15. Effect of Play-based Therapy on Meta-cognitive and Behavioral Aspects of Executive Function: A Randomized, Controlled, Clinical Trial on the Students With Learning Disabilities.

    Science.gov (United States)

    Karamali Esmaili, Samaneh; Shafaroodi, Narges; Hassani Mehraban, Afsoon; Parand, Akram; Zarei, Masoume; Akbari-Zardkhaneh, Saeed

    2017-01-01

    Although the effect of educational methods on executive function (EF) is well known, training this function by a playful method is debatable. The current study aimed at investigating if a play-based intervention is effective on metacognitive and behavioral skills of EF in students with specific learning disabilities. In the current randomized, clinical trial, 49 subjects within the age range of 7 to 11 years with specific learning disabilities were randomly assigned into the intervention (25 subjects; mean age 8.5±1.33 years) and control (24 subjects; mean age 8.7±1.03 years) groups. Subjects in the intervention group received EF group training based on playing activities; subjects in the control group received no intervention. The behavior rating inventory of executive function (BRIEF) was administered to evaluate the behavioral and cognitive aspects of EF. The duration of the intervention was 6 hours per week for 9 weeks. Multivariate analysis of covariance was used to compare mean changes (before and after) in the BRIEF scores between the groups. The assumptions of multivariate analysis of covariance were examined. After controlling pre-test conditions, the intervention and control groups scored significantly differently on both the metacognition (P=0.002; effect size=0.20) and behavior regulation indices (P=0.01; effect size=0.12) of BRIEF. Play-based therapy is effective on the metacognitive and behavioral aspects of EF in students with specific learning disabilities. Professionals can use play-based therapy rather than educational approaches in clinical practice to enhance EF skills.

  16. Estudo Pró-Saúde: características gerais e aspectos metodológicos The Pro-Saude Study: general characteristics and methodological aspects

    Directory of Open Access Journals (Sweden)

    Eduardo Faerstein

    2005-12-01

    Full Text Available Neste artigo, relatamos as motivações e características do Estudo Pró-Saúde enfatizando aspectos temáticos e metodológicos. Estudos longitudinais de populações "saudáveis" em idade laboral nas grandes metrópoles brasileiras são ainda escassos. Nessas metrópoles, a vida contemporânea pode modificar características de várias exposições e possivelmente seus efeitos; por outro lado, as condições vigentes de vida e trabalho de seus habitantes impõem dificuldades especiais à condução de estudos de coorte, com previsão de longo período de acompanhamento, em amostras da população geral. Populações de funcionários públicos apresentam patamar de escolaridade que permite a utilização de métodos eficientes de coleta de dados (por exemplo, autopreenchimento de questionários, heterogeneidade socioeconômica, e estabilidade do vínculo de trabalho que facilita o seguimento. Serão acompanhados 3.253 funcionários de uma universidade pública no Rio de Janeiro, que participaram da coleta de dados de base (fases 1 e 2, 1999-2001. Foram aplicados questionários autopreenchíveis e aferidos peso, altura, circunferência da cintura e pressão arterial. O estudo tem como foco principal a investigação de determinantes sociais da saúde. São detalhadamente investigados marcadores de posição socioeconômica, raça/etnia, religião, história conjugal e de migração. Enfatiza-se a aferição de indicadores relativos, como desigualdade e trajetórias sociais, e efeitos contextuais das áreas de residência e setores de trabalho. Finalmente, busca-se abordar temas ainda pouco explorados em nosso meio, como rede e apoio social, estresse no trabalho e experiência de discriminação.In his paper, we report the motivations and characteristics of the Pro-Saude Study with emphasis on its scope and methods. Longitudinal studies of "healthy" populations of working age in Brazilian large cities are still scarse. In these settings, aspects

  17. Health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California. Volume 9. Methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities

    International Nuclear Information System (INIS)

    Nero, A.V.; Quinby-Hunt, M.S.

    1977-01-01

    This report sets forth methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities for electric power generation. The review is divided into a Notice of Intention process and an Application for Certification process, in accordance with the structure to be used by the California Energy Resources Conservation and Development Commission, the first emphasizing site-specific considerations, the second examining the detailed facility design as well. The Notice of Intention review is divided into three possible stages: an examination of emissions and site characteristics, a basic impact analysis, and an assessment of public impacts. The Application for Certification review is divided into five possible stages: a review of the Notice of Intention treatment, review of the emission control equipment, review of the safety design, review of the general facility design, and an overall assessment of site and facility acceptability

  18. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene MH

    2017-01-01

    Background Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. Objective The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). Methods The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child’s postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. Results The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. Conclusions To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool

  19. Methodological proposal for identification and evaluation of environmental aspects and impacts of nuclear facilities of IPEN, Sao Paulo, SP, Brazil: a case study applied to the Nuclear Fuel Center

    International Nuclear Information System (INIS)

    Mattos, Luis Antonio Terribile de

    2013-01-01

    This work presents an application of Failure Mode Effect Analysis (FMEA) to the process of identification of environmental aspects and impacts as a part of implementation and maintenance of an Environmental Management System (EMS) in accordance with the NBR ISO 14001 standard. Also, it can contribute, as a complement, to the evaluation and improvement of safety of the installation focused. The study was applied to the Nuclear Fuel Center (CCN) of Nuclear and Energy Research Institute (IPEN), situated at the Campus of University of Sao Paulo, Brazil. The CCN facility has the objective of promoting scientific research and of producing nuclear fuel elements for the IEA-R1 Research Reactor. To identify the environmental aspects of the facility activities, products, and services, a systematic data collection was carried out by means of personal interviews, documents, reports and operation data records consulting. Furthermore, the processes and their interactions, failure modes, besides their causes and effects to the environment, were identified. As a result of a careful evaluation of these causes it was possible to identify and to classify the major potential environmental impacts, in order to set up and put in practice an Environmental Management System for the installation under study. The results have demonstrated the validity of the FMEA application to nuclear facility processes, identifying environmental aspects and impacts, whose controls are critical to achieve compliance with the environmental requirements of the Integrated Management System of IPEN. It was demonstrated that the methodology used in this work is a powerful management tool for resolving issues related to the conformity with applicable regulatory and legal requirements of the Brazilian Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment (IBAMA). (author)

  20. Notes on methodology and pitfalls in science and research and on communication of results. Some aspects related to EMF; Synpunkter paa metodik och fallgropar inom vetenskap och forskning samt hur resultaten kommuniceras. Naagra aspekter relaterade till EMF

    Energy Technology Data Exchange (ETDEWEB)

    Cedervall, Bjoern (Unit of Med. Radiation Physics and Med. Radiation Biology, Dept. Oncology and Pathology, Karolinska Inst., Stockholm (Sweden))

    2009-06-15

    There are many aspects of the controversy around EMF and potential risks that are largely unknown to the wider audience. Such aspects form the basis for the topics discussed in this report. More specifically focus has been on arguments related to possible cause-effect where linguistic barriers and societal 'filters' (for instance by uncritical media) may constitute a problem. Regardless of whether scientists are working with for example molecular biology or epidemiology they are confronted with a number of methodological problems that may be difficult or even impossible to master. Such difficulties are seldom seen in press releases, news media and so on but they may still be part of many scientists' daily challenges. The most difficult communication challenge is probably that if something is absolutely safe it cannot be proven. An unknown virus, bacterium, or chemical contaminant may completely ruin experiments in a molecular biology experiment but at least the experiments can be repeated and often measures can be taken once such a contamination has been found. For epidemiological studies there is always a specific challenge in that the investigations cannot be repeated as people never do the same things under the same conditions and in a predictable manner. It is with this background and context that the author has chosen to treat some methodological problems in science as well as the so-called Hill's criteria for cause-effects. A shorter comment has been made with reference to various aspects of the precautionary principle as it is often referred to in the EMF debate but most often, however, it has seldom been clarified what is meant by precautionary practices or actions. Precaution is closely related to human fear and therefore a corresponding chapter has been included. This report ends with a few looks into the historical rear-view mirror which illuminates the anticipated benefits with the invisible and mystical rather than the potential

  1. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  2. Methodology for astronaut reconditioning research.

    Science.gov (United States)

    Beard, David J; Cook, Jonathan A

    2017-01-01

    Space medicine offers some unique challenges, especially in terms of research methodology. A specific challenge for astronaut reconditioning involves identification of what aspects of terrestrial research methodology hold and which require modification. This paper reviews this area and presents appropriate solutions where possible. It is concluded that spaceflight rehabilitation research should remain question/problem driven and is broadly similar to the terrestrial equivalent on small populations, such as rare diseases and various sports. Astronauts and Medical Operations personnel should be involved at all levels to ensure feasibility of research protocols. There is room for creative and hybrid methodology but careful systematic observation is likely to be more achievable and fruitful than complex trial based comparisons. Multi-space agency collaboration will be critical to pool data from small groups of astronauts with the accepted use of standardised outcome measures across all agencies. Systematic reviews will be an essential component. Most limitations relate to the inherent small sample size available for human spaceflight research. Early adoption of a co-operative model for spaceflight rehabilitation research is therefore advised. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Understanding Clinical Trials

    Science.gov (United States)

    Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

  4. Destination image, image at destination. Methodological aspects

    Directory of Open Access Journals (Sweden)

    Pablo Díaz-Rodríguez

    2013-01-01

    Full Text Available Today, the part played by the image in the development of tourism, and, specially, as a diffe- rentiation element of a destination area is widely acknowledged. This is reflected to a great extent in the literature that focuses its interest on identifying the variables that motivate the purchase or stimulate the decision process. However, the reference to feedback processes or image control mechanisms as well as their creation, is surprising. An approach model to these processes will be exposed in this article.

  5. FINANCE CORPORATIONS: THEORETICAL AND METHODOLOGICAL ASPECT

    OpenAIRE

    Vitaly Yu. Zaitsev; Yurii I. Fedchishin

    2015-01-01

    The article deals with the essence of corporate Finance and the principles of their organization. The characteristic of the system of corporate financial management, describes its purpose, objectives and functions. Given the definition of a financial company policy. Review the organizational structure of corporate financial management from the current position.

  6. FINANCE CORPORATIONS: THEORETICAL AND METHODOLOGICAL ASPECT

    Directory of Open Access Journals (Sweden)

    Vitaly Yu. Zaitsev

    2015-01-01

    Full Text Available The article deals with the essence of corporate Finance and the principles of their organization. The characteristic of the system of corporate financial management, describes its purpose, objectives and functions. Given the definition of a financial company policy. Review the organizational structure of corporate financial management from the current position.

  7. Analysis of Corporate Environmental Management: Methodological Aspects

    DEFF Research Database (Denmark)

    Madsen, Henning; Ulhøi, John Parm

    2001-01-01

    in business presents a challenge to management, however, since it implies a fundamental change in some of the ways of operating a company. This paper will briefly discuss how information on the actual extent of environmental management in Danish companies and the way it is applied has been collected based......Human activities cannot avoid influencing conditions in the natural environment one way or the other. This includes as well common activities in the business sector. But during the past few decades, environmental disasters in Seveso and Bhopal, and the Exxon Valdes oil spill in Alaska have...... contributed to an increasing awareness of the effect of business activities on the physical environment. To assist companies reduce, evaluate, monitor and control their environmental impact the concept of corporate environmental and resource management has been developed. Implementation of this concept...

  8. THE RETIREMENT SYSTEM. FISCAL AND METHODOLOGICAL ASPECTS

    Directory of Open Access Journals (Sweden)

    MARINEL NEDELUŢ

    2013-10-01

    Full Text Available Currently, in most countries, but particularly in European and in the more developed world, heated discussions about reforming the current pension system. To address adequately the taxation of pension incomes in our country is very important to know and how this issue is regulated in different countries, but especially the European ones in the developed world. In terms of taxation of pensions, European countries are divided into three groups: 1. European countries where pension income is not taxed: Bulgaria, Slovakia and Lithuania. 2. European countries where pension income is subject to progressive taxation: Belgium, Cyprus, Greece, Finland, France, Ireland, Luxembourg, Malta, United Kingdom, Norway (not EU member, the Netherlands and Spain. 3. European countries where pension income is taxed based flat: Austria, Estonia, Germany, Latvia, Portugal, Romania, Sweden, Slovenia and Hungary.

  9. STRATEGY OF INTERNATIONAL ECONOMIC COOPERATION: METHODOLOGICAL ASPECTS

    Directory of Open Access Journals (Sweden)

    Aliona DANILIUC

    2013-01-01

    Full Text Available In the present article, the authors describe the essence of cooperation and those strategic problems that can be solved internationally only through cooperation efforts. In this context, the authors propose to understand cooperation as the actions of a few companies, corporations from one country or several countries that through their activities contribute to the achievement of goals of economic, ecological and social importance for a region, a country, many countries or for all humanity. Cooperation in such cases, contribute to realization of synergistic results and development of preconditions for each participant to carry out its activities according to its own optimization criteria. Cooperation generates productive systems based on principles and technologies, it can be multispectral, creates preconditions for demand increasing, solves some marketing problems, creates a comfortable space for the activities of all economic subjects.

  10. Methodological aspects on drug receptor binding analysis

    International Nuclear Information System (INIS)

    Wahlstroem, A.

    1978-01-01

    Although drug receptors occur in relatively low concentrations, they can be visualized by the use of appropriate radioindicators. In most cases the procedure is rapid and can reach a high degree of accuracy. Specificity of the interaction is studied by competition analysis. The necessity of using several radioindicators to define a receptor population is emphasized. It may be possible to define isoreceptors and drugs with selectivity for one isoreceptor. (Author)

  11. Eating frequency: methodological and dietary aspects.

    Science.gov (United States)

    Gatenby, S J

    1997-04-01

    It is commonly stated that 'snack' foods provide 'empty calories' and, therefore elevate energy intake whilst providing insignificant quantities of other nutrients. The data presented in the present review suggest that foods which contribute to the pattern of 'snacking' contribute significantly to the nutrient quality of the diet. Those who 'snack' frequently tend to eat more food in general. Part of the difficulty in identifying the nutritional implications of 'snacking' is related to the definitions of 'meals' and 'snacks' and subsequent categorization of individual patterns. The physiological definitions typically relating to energy content or the time of eating do not necessarily coincide with colloquial, cultural or individual perceptions of what constitutes a 'meal' or 'snack'. Clearly, a more consistent approach would facilitate interpretation of the literature and enable more effective health education messages about 'snacking' to be delivered.

  12. Methodological aspects of network assets accounting

    Directory of Open Access Journals (Sweden)

    Yuhimenko-Nazaruk I.A.

    2017-08-01

    Full Text Available The necessity of using innovative tools of processing and representation of information about network assets is substantiated. The suggestions for displaying network assets in accounts are presented. The main reasons for the need to display the network assets in the financial statements of all members of the network structure (the economic essence of network assets as the object of accounting; the non-additional model for the formation of the value of network assets; the internetworking mechanism for the formation of the value of network assets are identified. The stages of accounting valuation of network assets are allocated and substantiated. The analytical table for estimating the value of network assets and additional network capital in accounting is developed. The order of additional network capital reflection in accounting is developed. The method of revaluation of network assets in accounting in the broad sense is revealed. The order of accounting of network assets with increasing or decreasing the number of participants in the network structure is determined.

  13. Color of cyanobacteria: some methodological aspects

    International Nuclear Information System (INIS)

    Prieto, Beatriz; Sanmartin, Patricia; Aira, Noelia; Silva, Benita

    2010-01-01

    Although the color of cyanobacteria is a very informative characteristic, no standardized protocol has, so far, been established for defining the color in an objective way, and, therefore, direct comparison of experimental results obtained by different research groups is not possible. In the present study, we used colorimetric measurements and conventional statistical tools to determine the effects on the measurement of the color of cyanobacteria, of the concentration of the microorganisms and their moisture content, as well as of the size of the target area and the minimum number of measurements. It was concluded that the color measurement is affected by every factor studied, but that this can be controlled for by making at least 10 consecutive measurements/9.62 cm 2 at different randomly selected points on the surface of filters completely covered by films of cyanobacteria in which the moisture contents are higher than 50%.

  14. Cancer diagnosis by infrared spectroscopy: methodological aspects

    Science.gov (United States)

    Jackson, Michael; Kim, Keith; Tetteh, John; Mansfield, James R.; Dolenko, Brion; Somorjai, Raymond L.; Orr, F. W.; Watson, Peter H.; Mantsch, Henry H.

    1998-04-01

    IR spectroscopy is proving to be a powerful tool for the study and diagnosis of cancer. The application of IR spectroscopy to the analysis of cultured tumor cells and grading of breast cancer sections is outlined. Potential sources of error in spectral interpretation due to variations in sample histology and artifacts associated with sample storage and preparation are discussed. The application of statistical techniques to assess differences between spectra and to non-subjectively classify spectra is demonstrated.

  15. Strategy of International Economic Cooperation: methodological aspects

    Directory of Open Access Journals (Sweden)

    Maximilian Silvestru

    2013-01-01

    Full Text Available In the present article, the authors describe the essence of cooperation and those strategic problems that can be solved internationally only through cooperation efforts. In this context, the authors propose to understand cooperation as the actions of a few companies, corporations from one country or several countries that through their activities contribute to the achievement of goals of economic, ecological and social importance for a region, a country, many countries or for all humanity. Cooperation in such cases, contribute to realization of synergistic results and development of preconditions for each participant to carry out its activities according to its own optimization criteria. Cooperation generates productive systems based on principles and technologies, it can be multispectral, creates preconditions for demand increasing, solves some marketing problems, creates a comfortable space for the activities of all economic subjects.

  16. Methodological aspects on microdialysis sampling and measurements

    OpenAIRE

    Abrahamsson, Pernilla

    2010-01-01

    Background:     The microdialysis (MD) technique is widely spread and used both experi­mentally and in clinical practice. The MD technique allows continuous collection of small molecules such as glucose, lactate, pyruvate and glycerol. Samples are often analysed using the CMA 600 analyser, an enzymatic and colorimetric analyser.  Data evaluating the performance of the CMA 600 analysis system and associated sample han­dling are sparse. The aim of this work was to identify sources of variabilit...

  17. Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 2: methodological quality and effects.

    Science.gov (United States)

    Johansen, Monika Alise; Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

    2012-10-03

    We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12

  18. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  19. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial.

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene Mh; Utens, Elisabeth Mwj

    2017-09-11

    Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child's postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both

  20. 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...

  1. Methodology of sustainability accounting

    Directory of Open Access Journals (Sweden)

    O.H. Sokil

    2017-03-01

    Full Text Available Modern challenges of the theory and methodology of accounting are realized through the formation and implementation of new concepts, the purpose of which is to meet the needs of users in standard and unique information. The development of a methodology for sustainability accounting is a key aspect of the management of an economic entity. The purpose of the article is to form the methodological bases of accounting for sustainable development and determine its goals, objectives, object, subject, methods, functions and key aspects. The author analyzes the theoretical bases of the definition and considers the components of the traditional accounting methodology. Generalized structural diagram of the methodology for accounting for sustainable development is offered in the article. The complex of methods and principles of sustainable development accounting for systematized and non-standard provisions has been systematized. The new system of theoretical and methodological provisions of accounting for sustainable development is justified in the context of determining its purpose, objective, subject, object, methods, functions and key aspects.

  2. The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials.

    Science.gov (United States)

    Karpefors, Martin; Weatherall, James

    2018-03-21

    In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging. We introduce a new means of visualizing the adverse event data across an entire clinical trial. The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making. To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.

  3. An investigation into the use of recorded music as a surgical intervention: A systematic, critical review of methodologies used in recent adult controlled trials.

    Science.gov (United States)

    Williams, Courtney; Hine, Trevor

    2018-04-01

    While music is being increasingly used as a surgical intervention, the types of music used and the reasons underlying their selection remain inconsistent. Empirical research into the efficacy of such musical interventions is therefore problematic. To provide clear guidelines for musical selection and employment in surgical interventions, created through a synthesis of the literature. The aim is to examine how music is implemented in surgical situations, and to provide guidance for the selection and composition of music for future interventions. English language quantitative surgical intervention studies from Science Direct, ProQuest, and Sage Journals Online, all published within the last 10 years and featuring recorded music, were systematically reviewed. Variables investigated included: the time the intervention was performed, the intervention length, the outcomes targeted, music description (general and specific), theoretical frameworks underlying the selection of the music, whether or not a musical expert was involved, participant music history, and the participants' feedback on the chosen music. Several aspects contribute to the lack of scientific rigour regarding music selection in this field, including the lack of a theoretical framework or frameworks, no involvement of musical experts, failure to list the music tracks used, and the use of vague and subjective terms in general music descriptions. Patients are frequently allowed to select music (risking both choosing music that has an adverse effect and making study replication difficult), and patient music history and listening habits are rarely considered. Crucially, five primary theoretical frameworks underlying the effectiveness of music arose in the literature (distraction, relaxation, emotional shift, entrainment, and endogenous analgesia), however music was rarely selected to enhance any of these mechanisms. Further research needs to be conducted to ensure that music is selected according to a

  4. Aspectos metodologicos de la medición en el sitio de ocurrencia de lesiones por accidentes de tráfico Methodological aspects of measuring injuries from traffic accidents at the site of occurrence

    Directory of Open Access Journals (Sweden)

    Martha C. Híjar-Medina

    1997-02-01

    Full Text Available Os acidentes de trânsito de veículos a motor representam problema de saúde pública, em nível mundial. No México, a pesquisa, nesse campo, é limitada e a metodologia para seu estudo é pouco desenvolvida. Na literatura científica internacional são escassos os artigos que discutem os aspectos metodológicos de pesquisa nesse campo. Assim, realizou-se estudo com o objetivo de apresentar alguns aspectos metodológicos úteis para os interessados em pesquisar lesões por acidentes de trânsito. Foram discutidos aspectos sobre como medir, no local de ocorrência, as variáveis básicas para o estudo dessas lesões, tais como: se o motorista sofreu ou não lesões, uso de cinto de segurança, velocidade e consumo de álcool.Los accidentes de tráfico de vehículos de motor, representan un problema de Salud Pública a nivel mundial. En México la investigación en este campo es limitada y la metodología para su estudio está poco desarrollada. Por otro lado, son relativamente escasos los artículos publicados en revistas científicas internacionales que abunden, en la discusión sobre aspectos metodológicos de la investigación. El objetivo del trabajo es el presentar algunas consideraciones metodológicas que pueden ser de utilidad para los investigadores interesados en el tema de las lesiones por accidentes de tráfico. Se discuten aspectos que deben tenerse en cuenta cuando se miden en el sitio de ocurrencia algunas variables fundamentales para el estudio de las lesiones, como son: Si el conductor está o no lesionado, uso de cinturón de seguridad, velocidad y consumo de alcohol.Traffic accidents are a well-known public health problem worldwide. In Mexico research into risk factors for motor involving vehicles accidents and their consequences has recentlly been taken into account. The relevant literature does not normally describe the methodological aspects involved in the collection of primary data, since most studies have used secondary

  5. Financial aspects of decommissioning (key aspects of decommissioning costing)

    International Nuclear Information System (INIS)

    Danska, V.

    2009-01-01

    In this presentation the following aspects of NPPs decommissioning are discussed: Requirements and purpose of decommissioning costing; Decommissioning costing methodologies; Standardised decommissioning cost structure; Input data for cost estimate process; Waste management in cost estimate process; Grading aspects in cost estimating; Cost control in decommissioning projects; Summary of the cost estimation process; Conclusions and recommendations.

  6. The Counseling Older Adults to Control Hypertension (COACH) Trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults

    OpenAIRE

    Ogedegbe, Gbenga; Fernandez, Senaida; Luerassi, Leanne; Silver, Stephanie A.; Kong, Jian; Midberry, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A.

    2013-01-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 2...

  7. 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

  8. Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey.

    Science.gov (United States)

    Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Z; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

    2017-07-01

    Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. Of the 200 randomized controlled trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs. Copyright © 2017 Elsevier Inc. All rights

  9. Analysis of phase II methodologies for single-arm clinical trials with multiple endpoints in rare cancers: An example in Ewing's sarcoma.

    Science.gov (United States)

    Dutton, P; Love, S B; Billingham, L; Hassan, A B

    2018-05-01

    Trials run in either rare diseases, such as rare cancers, or rare sub-populations of common diseases are challenging in terms of identifying, recruiting and treating sufficient patients in a sensible period. Treatments for rare diseases are often designed for other disease areas and then later proposed as possible treatments for the rare disease after initial phase I testing is complete. To ensure the trial is in the best interests of the patient participants, frequent interim analyses are needed to force the trial to stop promptly if the treatment is futile or toxic. These non-definitive phase II trials should also be stopped for efficacy to accelerate research progress if the treatment proves to be particularly promising. In this paper, we review frequentist and Bayesian methods that have been adapted to incorporate two binary endpoints and frequent interim analyses. The Eurosarc Trial of Linsitinib in advanced Ewing Sarcoma (LINES) is used as a motivating example and provides a suitable platform to compare these approaches. The Bayesian approach provides greater design flexibility, but does not provide additional value over the frequentist approaches in a single trial setting when the prior is non-informative. However, Bayesian designs are able to borrow from any previous experience, using prior information to improve efficiency.

  10. Methodology for clinical trials involving patients with cancer who have febrile neutropenia: updated guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with emphasis on outpatient studies.

    Science.gov (United States)

    Feld, Ronald; Paesmans, Marianne; Freifeld, Alison G; Klastersky, Jean; Pizzo, Philip A; Rolston, Kenneth V I; Rubenstein, Edward; Talcott, James A; Walsh, Thomas J

    2002-12-15

    Two multinational organizations, the Immunocompromised Host Society and the Multinational Association for Supportive Care in Cancer, have produced for investigators and regulatory bodies a set of guidelines on methodology for clinical trials involving patients with febrile neutropenia. The guidelines suggest that response (i.e., success of initial empirical antibiotic therapy without any modification) be determined at 72 h and again on day 5, and the reasons for modification should be stated. Blinding and stratification are to be encouraged, as should statistical consideration of trials specifically designed for showing equivalence. Patients enrolled in outpatient studies should be selected by use of a validated risk model, and patients should be carefully monitored after discharge from the hospital. Response and safety parameters should be recorded along with readmission rates. If studies use these guidelines, comparisons between studies will be simpler and will lead to further improvements in patient therapy.

  11. A controlled clinical trial of implant-retained mandibular overdentures : 10 years' results of clinical aspects and aftercare of IMZ implants and Branemark implants

    NARCIS (Netherlands)

    Meijer, HJA; Raghoebar, GM; Van't Hof, MA; Visser, A

    The aim of this prospective randomized controlled clinical trial was to evaluate the clinical outcomes and prosthetic aftercare of edentulous patients with a mandibular overdenture retained by two IMZ implants or two Branemark implants during a 10-year period. Patients were allocated to the IMZ

  12. A controlled clinical trial of implantretained mandibular overdentures : 10 years’ results of clinical aspects and aftercare of IMZ implants and Bra°nemark implants

    NARCIS (Netherlands)

    Meijer, Henny J.A.; Raghoebar, Gerry M.; Van’t Hof, Martin A.; Visser, Anita

    2004-01-01

    The aim of this prospective randomized controlled clinical trial was to evaluate the clinical outcomes and prosthetic aftercare of edentulous patients with a mandibular overdenture retained by two IMZ implants or two Bra°nemark implants during a 10-year period. Patients were allocated to the IMZ

  13. Research Paper: Effect of Play-based Therapy on Metacognitive and Behavioral Aspects of Executive Function: A Randomized, Controlled, Clinical Trial on the Students With Learning Disabilities

    Directory of Open Access Journals (Sweden)

    Samaneh Karamali Esmaili

    2017-05-01

    Conclusion: Play-based therapy is effective on the metacognitive and behavioral  aspects of EF in students with specific learning disabilities. Professionals can use play-based therapy rather than educational approaches in clinical practice to enhance EF skills.

  14. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  15. Re-examining minimal luminal diameter relocation and quantitative coronary angiography - Intravascular ultrasound correlations in stented saphenous vein grafts: Methodological insights from the randomised RRISC trial

    NARCIS (Netherlands)

    O. Semeraro (Oscar); P. Agostoni (Pierfrancesco); S. Verheye (Stefan); G.J.J. van Langenhove (Glenn); P.A. van den Heuvel (Paul); C. Convens (Carl); F. van den Branden (Frank); N. Bruining (Nico); P. Vermeersch (Paul)

    2009-01-01

    textabstractAims: Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated. Methods and results: Using quantitative coronary angiography (QCA)

  16. Microphysics evolution and methodology

    International Nuclear Information System (INIS)

    Dionisio, J.S.

    1990-01-01

    A few general features of microscopics evolution and their relationship with microscopics methodology are briefly surveyed. Several pluri-disciplinary and interdisciplinary aspects of microscopics research are also discussed in the present scientific context. The need for an equilibrium between individual tendencies and collective constraints required by team work, already formulated thirty years ago by Frederic Joliot, is particularly stressed in the present conjuncture of Nuclear Research favouring very large team projects and discouraging individual initiatives. The increasing importance of the science of science (due to their multiple social, economical, ecological aspects) and the stronger competition between national and international tendencies of scientific (and technical) cooperation are also discussed. (author)

  17. Clinical trials of new drugs for the treatment of rheumatoid arthritis: focus on early disease

    NARCIS (Netherlands)

    Smolen, Josef S.; Collaud Basset, Sabine; Boers, Maarten; Breedveld, Ferdinand; Edwards, Christopher J.; Kvien, Tore K.; Miossec, Pierre; Sokka-Isler, Tuulikki; van Vollenhoven, Ronald F.; Abadie, Eric C.; Bruyère, Olivier; Cooper, Cyrus; Mäkinen, Heidi; Thomas, Thierry; Tugwell, Peter; Reginster, Jean-Yves

    2016-01-01

    The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial methodology to comment on the new draft 'Guideline on clinical investigation of medicinal products for

  18. Qualidade de vida e saúde bucal em crianças e adolescentes: aspectos conceituais e metodológicos Quality of life and oral health in children and adolescents: conceptual and methodological aspects

    Directory of Open Access Journals (Sweden)

    Taís de Souza Barbosa

    2010-01-01

    Full Text Available O interesse pela qualidade de vida e saúde bucal em crianças e adolescentes vem aumentando, já que as desordens orais provavelmente apresentam efeito negativo na qualidade de vida das mesmas. Neste sentido, questionários que visam a avaliar o impacto da saúde bucal no bem-estar têm sido desenvolvidos e adaptados para este grupo específico. O objetivo deste trabalho é descrever a relação entre qualidade de vida e saúde bucal em crianças e adolescentes, focalizando aspectos conceituais e metodológicos. Os instrumentos desenvolvidos para avaliar a qualidade de vida e saúde bucal em crianças e adolescentes são: o Child Perceptions Questionnaire (CPQ, para crianças de 8-10 (CPQ8-10 e 11-14 anos (CPQ11-14; o Child-Oral Impacts on Daily Performances, para a idade de 11-12 anos; o Child Oral Health Impact Profile, para crianças de 8-14 anos, e o Early Childhood Oral Health Impact Scale para a faixa etária de 2-5 anos. Apesar dos progressos nessa área, ainda existem muitas questões a serem debatidas e respondidas, como a necessidade de questionários específicos para diferentes idades, a participação dos responsáveis como respondentes secundários e a avaliação do impacto da saúde bucal da criança e do adolescente na família.There has been increasing interest in the oral health-related quality of life of children and adolescents, since pediatric oral disorders are likely to have a negative effect on children's quality of life. So the questionnaires that aim to assess the impact of oral health on child' and adolescent' quality of life has been developed or adapted to this specific group. The aim of this study was to describe the relationship between the quality of life and oral health in children and adolescents, focalizing conceptual and methodological aspects. The instruments developed to assess oral health-related quality of life in children and adolescents are: the Child Perceptions Questionnaire (CPQ, for children aged 8

  19. A pesquisa de intervenção na psicologia da educação matemática: aspectos conceituais e metodológicos Intervention research in the psychology of mathematics education: conceptual and methodological aspects

    Directory of Open Access Journals (Sweden)

    Maria Helena Fávero

    2011-01-01

    Full Text Available Focamos um dos grandes desafios atuais da psicologia: a pesquisa de intervenção tomada como geradora de transformação e que, ao mesmo tempo, evidencia o processo a ela subjacente. Expomos nossa linha teórico-metodológica de investigação e relatamos uma pesquisa de intervenção no contexto da psicologia da educação matemática. Consideramos quatro aspectos teórico-conceituais articulados: 1. a evidência das interações entre as regulações cognitivas e as sociais; 2. o papel da mediação semiótica no desenvolvimento psicológico humano; 3. os efeitos dos sistemas de signos no desenvolvimento psicológico e nas comunicações individuais; 4. a tomada de consciência de que as ações humanas não são aleatórias: trata-se de práticas sociais com um conteúdo que lhes dão fundamento. Tais aspectos fundamentam a Psicologia do conhecimento e o método adotado, com um duplo desafio: desenvolver um procedimento visando à tomada de consciência de uma professora licenciada em matemática sobre o paradigma que sustentava sua prática e o reformulasse assumindo um trabalho sistematizado de articulação entre intervenção psicopedagógica e pesquisa, que possibilitasse: 1. o estudo das aquisições conceituais dos alunos; e 2. a análise dos processos mediacionais das interações interpessoais, considerando a natureza do material utilizado e das atividades propostas. Os resultados evidenciaram a pertinência do procedimento: as atividades propostas e a qualidade da atividade mediada engendraram a aquisição de novas competências conceituais nos alunos e o desenvolvimento de novas competências para a professora como mediadora do conhecimento.We focus on one of the great current challenges in psychology: interventional research aimed at generating transformation while demonstrating its underlying process. We detail our theoretical and methodological approach and describe an interventional study in the psychology of mathematics

  20. Dosimetric methodology of the ICRP

    International Nuclear Information System (INIS)

    Eckerman, K.F.

    1994-01-01

    Establishment of guidance for the protection of workers and members of the public from radiation exposures necessitates estimation of the radiation dose to tissues of the body at risk. The dosimetric methodology formulated by the International Commission on Radiological Protection (ICRP) is intended to be responsive to this need. While developed for radiation protection, elements of the methodology are often applied in addressing other radiation issues; e.g., risk assessment. This chapter provides an overview of the methodology, discusses its recent extension to age-dependent considerations, and illustrates specific aspects of the methodology through a number of numerical examples

  1. Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: A randomized controlled trial in prostate cancer patients undergoing radiotherapy

    International Nuclear Information System (INIS)

    Pettersson, Anna; Johansson, Birgitta; Persson, Christina; Berglund, Anders; Turesson, Ingela

    2012-01-01

    Purpose: To study the effect of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life (HRQOL) in prostate cancer patients referred to radiotherapy. Materials and methods: A total of 130 patients were randomly assigned to one of two groups: an intervention group (IG, n = 64), instructed to reduce their intake of insoluble dietary fibres and lactose, a standard care group (SC, n = 66), instructed to continue their normal diet. Gastrointestinal side effects and other aspects of HRQOL were evaluated from baseline up to 2 months after completed radiotherapy, using the EORTC QLQ-C30 and QLQ-PR25 and the study-specific Gastrointestinal Side Effects Questionnaire (GISEQ). A scale indicating adherence to dietary instructions was developed from a Food Frequency Questionnaire (FFQ), with lower scores representing better compliance. Descriptive and inferential statistical analyses were conducted. Results: There was an interaction effect between randomization and time in the FFQ Scores (p < 0.001), indicating that both groups followed their assigned dietary instructions. The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. During radiotherapy, the percentage of patients with bowel symptoms and bloated abdomen was lower in IG compared to SC, but the between-group differences were not statistically significant. During radiotherapy, the percentage of patients with bowel symptoms, urinary symptoms, pain, fatigue and diminished physical and role functioning increased in both groups. Conclusions: The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. The tendency towards lower prevalence of bowel symptoms in IG may indicate some positive effect of the dietary intervention, but methodological refinements, clearer results and longer follow-up are needed before the value of diet change can be established with certainty.

  2. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

    Science.gov (United States)

    O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

    2014-06-01

    Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews

  3. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  4. Exotic aspects of black holes: an astronaut near the horizon (on the methodological note by A A Grib and Yu V Pavlov 'Is it possible to see the infinite future of the Universe when falling into a black hole?')

    International Nuclear Information System (INIS)

    Cherepashchuk, Anatolii M

    2009-01-01

    We comment on the methodological note by A A Grib and Yu V Pavlov [Phys. Usp. 52 257 (2009)] to show that its authors are incorrect in understanding a passage that they quote from A M Cherepashchuk's book Black Holes in the Universe (Fryazino: Vek-2, 2005, p.7) and which supposes an astronaut to be at rest in the vicinity of the horizon (not to fall freely into a black hole!). With this error corrected, Grib and Pavlov's note is quite useful methodologically. (letters to the editors)

  5. The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

    Science.gov (United States)

    Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A

    2013-05-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination. Copyright © 2013. Published by Elsevier Inc.

  6. Organization aspect

    NARCIS (Netherlands)

    Grefen, P.W.P.J.; Mehandjiev, N.; Mehandjiev, N.; Grefen, P.W.P.J.

    2010-01-01

    Following the BOAT framework discussed in Chapter 1, this chapter describes the organization aspect of the CrossWork approach. It shows how the business requirements identified in the previous chapter can be fulfilled by dynamic organization structures and business processes in Networks of

  7. The p-EVES study design and methodology: a randomised controlled trial to compare portable electronic vision enhancement systems (p-EVES) to optical magnifiers for near vision activities in visual impairment.

    Science.gov (United States)

    Taylor, John; Bambrick, Rachel; Dutton, Michelle; Harper, Robert; Ryan, Barbara; Tudor-Edwards, Rhiannon; Waterman, Heather; Whitaker, Chris; Dickinson, Chris

    2014-09-01

    To describe the study design and methodology for the p-EVES study, a trial designed to determine the effectiveness, cost-effectiveness and acceptability of portable Electronic Vision Enhancement System (p-EVES) devices and conventional optical low vision aids (LVAs) for near tasks in people with low vision. The p-EVES study is a prospective two-arm randomised cross-over trial to test the hypothesis that, in comparison to optical LVAs, p-EVES can be: used for longer duration; used for a wider range of tasks than a single optical LVA and/or enable users to do tasks that they were not able to do with optical LVAs; allow faster performance of instrumental activities of daily living; and allow faster reading. A total of 100 adult participants with visual impairment are currently being recruited from Manchester Royal Eye Hospital and randomised into either Group 1 (receiving the two interventions A and B in the order AB), or Group 2 (receiving the two interventions in the order BA). Intervention A is a 2-month period with conventional optical LVAs and a p-EVES device, and intervention B is a 2-month period with conventional optical LVAs only. The study adopts a mixed methods approach encompassing a broad range of outcome measures. The results will be obtained from the following primary outcome measures: Manchester Low Vision Questionnaire, capturing device 'usage' data (which devices are used, number of times, for what purposes, and for how long) and the MNRead test, measuring threshold print size, critical print size, and acuity reserve in addition to reading speed at high (≈90%) contrast. Results will also be obtained from a series of secondary outcome measures which include: assessment of timed instrumental activities of daily living and a 'near vision' visual functioning questionnaire. A companion qualitative study will permit comparison of results on how, where, and under what circumstances, p-EVES devices and LVAs are used in daily life. A health economic

  8. Modern dose-finding designs for cancer phase I trials drug combinations and molecularly targeted agents

    CERN Document Server

    Hirakawa, Akihiro; Daimon, Takashi; Matsui, Shigeyuki

    2018-01-01

    This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of tw...

  9. Regional Shelter Analysis Methodology

    Energy Technology Data Exchange (ETDEWEB)

    Dillon, Michael B. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Dennison, Deborah [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Kane, Jave [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Walker, Hoyt [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Miller, Paul [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2015-08-01

    The fallout from a nuclear explosion has the potential to injure or kill 100,000 or more people through exposure to external gamma (fallout) radiation. Existing buildings can reduce radiation exposure by placing material between fallout particles and exposed people. Lawrence Livermore National Laboratory was tasked with developing an operationally feasible methodology that could improve fallout casualty estimates. The methodology, called a Regional Shelter Analysis, combines the fallout protection that existing buildings provide civilian populations with the distribution of people in various locations. The Regional Shelter Analysis method allows the consideration of (a) multiple building types and locations within buildings, (b) country specific estimates, (c) population posture (e.g., unwarned vs. minimally warned), and (d) the time of day (e.g., night vs. day). The protection estimates can be combined with fallout predictions (or measurements) to (a) provide a more accurate assessment of exposure and injury and (b) evaluate the effectiveness of various casualty mitigation strategies. This report describes the Regional Shelter Analysis methodology, highlights key operational aspects (including demonstrating that the methodology is compatible with current tools), illustrates how to implement the methodology, and provides suggestions for future work.

  10. On methodology

    DEFF Research Database (Denmark)

    Cheesman, Robin; Faraone, Roque

    2002-01-01

    This is an English version of the methodology chapter in the authors' book "El caso Berríos: Estudio sobre información errónea, desinformación y manipulación de la opinión pública".......This is an English version of the methodology chapter in the authors' book "El caso Berríos: Estudio sobre información errónea, desinformación y manipulación de la opinión pública"....

  11. A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity: rationale, design and methodology of a randomized controlled trial in Nanjing city, China

    Directory of Open Access Journals (Sweden)

    Xu Fei

    2012-06-01

    Full Text Available Abstract Background The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. Methods/design We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group. Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a classroom curriculum, (including physical education and healthy diet education, b school environment support, c family involvement, and d fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. Discussion The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools’ regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. Trial registration Registration number: ChiCTR-ERC-11001819

  12. Validating the use of Hospital Episode Statistics data and comparison of costing methodologies for economic evaluation: an end-of-life case study from the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

    Science.gov (United States)

    Thorn, Joanna C; Turner, Emma L; Hounsome, Luke; Walsh, Eleanor; Down, Liz; Verne, Julia; Donovan, Jenny L; Neal, David E; Hamdy, Freddie C; Martin, Richard M; Noble, Sian M

    2016-04-29

    To evaluate the accuracy of routine data for costing inpatient resource use in a large clinical trial and to investigate costing methodologies. Final-year inpatient cost profiles were derived using (1) data extracted from medical records mapped to the National Health Service (NHS) reference costs via service codes and (2) Hospital Episode Statistics (HES) data using NHS reference costs. Trust finance departments were consulted to obtain costs for comparison purposes. 7 UK secondary care centres. A subsample of 292 men identified as having died at least a year after being diagnosed with prostate cancer in Cluster randomised triAl of PSA testing for Prostate cancer (CAP), a long-running trial to evaluate the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Both inpatient cost profiles showed a rise in costs in the months leading up to death, and were broadly similar. The difference in mean inpatient costs was £899, with HES data yielding ∼8% lower costs than medical record data (differences compatible with chance, p=0.3). Events were missing from both data sets. 11 men (3.8%) had events identified in HES that were all missing from medical record review, while 7 men (2.4%) had events identified in medical record review that were all missing from HES. The response from finance departments to requests for cost data was poor: only 3 of 7 departments returned adequate data sets within 6 months. Using HES routine data coupled with NHS reference costs resulted in mean annual inpatient costs that were very similar to those derived via medical record review; therefore, routinely available data can be used as the primary method of costing resource use in large clinical trials. Neither HES nor medical record review represent gold standards of data collection. Requesting cost data from finance departments is impractical for large clinical trials. ISRCTN92187251; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use

  13. Effect of green tea on metabolic and hormonal aspect of polycystic ovarian syndrome in overweight and obese women suffering from polycystic ovarian syndrome: A clinical trial.

    Science.gov (United States)

    Tehrani, Hatav Gasemi; Allahdadian, Maryam; Zarre, Farzane; Ranjbar, Hanie; Allahdadian, Fateme

    2017-01-01

    Polycystic ovarian syndrome (PCOS) is the common cause of Oligo-ovulation. This syndrome causes long-term metabolic issues as well as increase the risk of diabetes type 2, hypertension, dyslipidemia, and cardiovascular disease. The current research aimed to study the effect of green tea on weight and hormonal changes of women suffering from PCOS. This two group, double-blind, randomized clinical trial was conducted in Isfahan city. Overweight women suffering from PCOS ( n = 60) were randomly divided into two groups. Green tea was prescribed to the experimental group, and placebo was prescribed to the control group. Free testosterone hormones and fasting insulin were compared in both groups at the beginning and 12 weeks after the study commencement. The weight of participants of both groups was also measured before and after the study. The statistical data were analyzed by SPSS software and paired t -test. The paired t -test showed that there was no significant difference in the mean weight of both groups before the intervention ( P = 0.812), but the difference was significant after the intervention ( P = 0.031). There was no significant difference in the mean fasting insulin of both groups before the intervention ( P = 0.352), but the difference was significant after the intervention ( P < 0.0001). Moreover, there was no significant difference in the mean free testosterone level of both groups before the intervention ( P = 0.638), but the difference was significant after the intervention ( P < 0.0001). The consumption of green tea by overweight and obese women suffering from PCOS leads to weight loss, a decrease in fasting insulin, and a decrease in the level of free testosterone.

  14. Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 1: rationale and methodology for the impedance threshold device (ITD) protocol.

    Science.gov (United States)

    Aufderheide, Tom P; Kudenchuk, Peter J; Hedges, Jerris R; Nichol, Graham; Kerber, Richard E; Dorian, Paul; Davis, Daniel P; Idris, Ahamed H; Callaway, Clifton W; Emerson, Scott; Stiell, Ian G; Terndrup, Thomas E

    2008-08-01

    The primary aim of this study is to compare survival to hospital discharge with a modified Rankin score (MRS)CPR) plus an active impedance threshold device (ITD) versus standard CPR plus a sham ITD in patients with out-of-hospital cardiac arrest. Secondary aims are to compare functional status and depression at discharge and at 3 and 6 months post-discharge in survivors. Prospective, double-blind, randomized, controlled, clinical trial. Patients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers. EMS systems participating in the Resuscitation Outcomes Consortium. Based on a one-sided significance level of 0.025, power=0.90, a survival with MRSCPR and sham ITD, and two interim analyses, a maximum of 14,742 evaluable patients are needed to detect a 6.69% survival with MRSCPR and active ITD (1.36% absolute survival difference). If the ITD demonstrates the hypothesized improvement in survival, it is estimated that 2700 deaths from cardiac arrest per year would be averted in North America alone.

  15. A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674

    Directory of Open Access Journals (Sweden)

    Eperjesi Frank

    2003-10-01

    Full Text Available Abstract Background Age-related macular disease is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation, and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants, particularly the carotenoids lutein and zeaxanthin, in the prevention and treatment of this eye disease. Methods The aim of this randomised controlled trial is to determine the effect of a nutritional supplement containing lutein, vitamins A, C and E, zinc, and copper on measures of visual function in people with and without age-related macular disease. Outcome measures are distance and near visual acuity, contrast sensitivity, colour vision, macular visual field, glare recovery, and fundus photography. Randomisation is achieved via a random number generator, and masking achieved by third party coding of the active and placebo containers. Data collection will take place at nine and 18 months, and statistical analysis will employ Student's t test. Discussion A paucity of treatment modalities for age-related macular disease has prompted research into the development of prevention strategies. A positive effect on normals may be indicative of a role of nutritional supplementation in preventing or delaying onset of the condition. An observed benefit in the age-related macular disease group may indicate a potential role of supplementation in prevention of progression, or even a degree reversal of the visual effects caused by this condition.

  16. Methodological guidelines

    International Nuclear Information System (INIS)

    Halsnaes, K.; Callaway, J.M.; Meyer, H.J.

    1999-01-01

    The guideline document establishes a general overview of the main components of climate change mitigation assessment. This includes an outline of key economic concepts, scenario structure, common assumptions, modelling tools and country study assumptions. The guidelines are supported by Handbook Reports that contain more detailed specifications of calculation standards, input assumptions and available tools. The major objectives of the project have been provided a methodology, an implementing framework and a reporting system which countries can follow in meeting their future reporting obligations under the FCCC and for GEF enabling activities. The project builds upon the methodology development and application in the UNEP National Abatement Coasting Studies (UNEP, 1994a). The various elements provide countries with a road map for conducting climate change mitigation studies and submitting national reports as required by the FCCC. (au) 121 refs

  17. Methodological guidelines

    Energy Technology Data Exchange (ETDEWEB)

    Halsnaes, K.; Callaway, J.M.; Meyer, H.J.

    1999-04-01

    The guideline document establishes a general overview of the main components of climate change mitigation assessment. This includes an outline of key economic concepts, scenario structure, common assumptions, modelling tools and country study assumptions. The guidelines are supported by Handbook Reports that contain more detailed specifications of calculation standards, input assumptions and available tools. The major objectives of the project have been provided a methodology, an implementing framework and a reporting system which countries can follow in meeting their future reporting obligations under the FCCC and for GEF enabling activities. The project builds upon the methodology development and application in the UNEP National Abatement Coasting Studies (UNEP, 1994a). The various elements provide countries with a road map for conducting climate change mitigation studies and submitting national reports as required by the FCCC. (au) 121 refs.

  18. Sample size methodology

    CERN Document Server

    Desu, M M

    2012-01-01

    One of the most important problems in designing an experiment or a survey is sample size determination and this book presents the currently available methodology. It includes both random sampling from standard probability distributions and from finite populations. Also discussed is sample size determination for estimating parameters in a Bayesian setting by considering the posterior distribution of the parameter and specifying the necessary requirements. The determination of the sample size is considered for ranking and selection problems as well as for the design of clinical trials. Appropria

  19. Tumeurs mandibulaires : Aspects epidemiologiques et ...

    African Journals Online (AJOL)

    Objectives: Study the anatomopathological and epidemiological aspects of the tumors of the mandible in order to compare the literature data. Methodology: It is an analytic, descriptive and retrospective study conducted over a period of 10 years at the ENT and the Anatomo-pathology Departments of CHU in Lomé. Results: ...

  20. Transparent Guideline Methodology Needed

    DEFF Research Database (Denmark)

    Lidal, Ingeborg; Norén, Camilla; Mäkelä, Marjukka

    2013-01-01

    As part of learning at the Nordic Workshop of Evidence-based Medicine, we have read with interest the practice guidelines for central venous access, published in your Journal in 2012.1 We appraised the quality of this guideline using the checklist developed by The Evidence-Based Medicine Working ...... are based on best currently available evidence. Our concerns are in two main categories: the rigor of development, including methodology of searching, evaluating, and combining the evidence; and editorial independence, including funding and possible conflicts of interest....... Group.2 Similar criteria for guideline quality have been suggested elsewhere.3 Our conclusion was that this much needed guideline is currently unclear about several aspects of the methodology used in developing the recommendations. This means potential users cannot be certain that the recommendations...

  1. A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

    Directory of Open Access Journals (Sweden)

    Oberweis D

    2016-02-01

    Full Text Available Didier Oberweis,1 Patrick Madelenat,2 Michelle Nisolle,3 Etienne Demanet4 1Department of Gynecology and Obstetrics, CHU de Charleroi, Hôpital André Vésale, Montigny-le-Tilleul, Belgium; 2Private Consultation, Paris, France; 3Department of Gynecology and Obstetrics, CHR Citadelle, Liège, 4Clinical Research Unit, Charleroi, Belgium Abstract: Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and >30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients' quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture. The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or

  2. MIRD methodology

    International Nuclear Information System (INIS)

    Rojo, Ana M.; Gomez Parada, Ines

    2004-01-01

    The MIRD (Medical Internal Radiation Dose) system was established by the Society of Nuclear Medicine of USA in 1960 to assist the medical community in the estimation of the dose in organs and tissues due to the incorporation of radioactive materials. Since then, 'MIRD Dose Estimate Report' (from the 1 to 12) and 'Pamphlets', of great utility for the dose calculations, were published. The MIRD system was planned essentially for the calculation of doses received by the patients during nuclear medicine diagnostic procedures. The MIRD methodology for the absorbed doses calculations in different tissues is explained

  3. PSA methodology

    Energy Technology Data Exchange (ETDEWEB)

    Magne, L

    1997-12-31

    The purpose of this text is first to ask a certain number of questions on the methods related to PSAs. Notably we will explore the positioning of the French methodological approach - as applied in the EPS 1300{sup 1} and EPS 900{sup 2} PSAs - compared to other approaches (Part One). This reflection leads to more general reflection: what contents, for what PSA? This is why, in Part Two, we will try to offer a framework for definition of the criteria a PSA should satisfy to meet the clearly identified needs. Finally, Part Three will quickly summarize the questions approached in the first two parts, as an introduction to the debate. 15 refs.

  4. PSA methodology

    International Nuclear Information System (INIS)

    Magne, L.

    1996-01-01

    The purpose of this text is first to ask a certain number of questions on the methods related to PSAs. Notably we will explore the positioning of the French methodological approach - as applied in the EPS 1300 1 and EPS 900 2 PSAs - compared to other approaches (Part One). This reflection leads to more general reflection: what contents, for what PSA? This is why, in Part Two, we will try to offer a framework for definition of the criteria a PSA should satisfy to meet the clearly identified needs. Finally, Part Three will quickly summarize the questions approached in the first two parts, as an introduction to the debate. 15 refs

  5. A protocol for a three-arm cluster randomized controlled superiority trial investigating the effects of two pedagogical methodologies in Swedish preschool settings on language and communication, executive functions, auditive selective attention, socioemotional skills and early maths skills.

    Science.gov (United States)

    Gerholm, Tove; Hörberg, Thomas; Tonér, Signe; Kallioinen, Petter; Frankenberg, Sofia; Kjällander, Susanne; Palmer, Anna; Taguchi, Hillevi Lenz

    2018-06-19

    During the preschool years, children develop abilities and skills in areas crucial for later success in life. These abilities include language, executive functions, attention, and socioemotional skills. The pedagogical methods used in preschools hold the potential to enhance these abilities, but our knowledge of which pedagogical practices aid which abilities, and for which children, is limited. The aim of this paper is to describe an intervention study designed to evaluate and compare two pedagogical methodologies in terms of their effect on the above-mentioned skills in Swedish preschool children. The study is a randomized control trial (RCT) where two pedagogical methodologies were tested to evaluate how they enhanced children's language, executive functions and attention, socioemotional skills, and early maths skills during an intensive 6-week intervention. Eighteen preschools including 28 units and 432 children were enrolled in a municipality close to Stockholm, Sweden. The children were between 4;0 and 6;0 years old and each preschool unit was randomly assigned to either of the interventions or to the control group. Background information on all children was collected via questionnaires completed by parents and preschools. Pre- and post-intervention testing consisted of a test battery including tests on language, executive functions, selective auditive attention, socioemotional skills and early maths skills. The interventions consisted of 6 weeks of intensive practice of either a socioemotional and material learning paradigm (SEMLA), for which group-based activities and interactional structures were the main focus, or an individual, digitally implemented attention and math training paradigm, which also included a set of self-regulation practices (DIL). All preschools were evaluated with the ECERS-3. If this intervention study shows evidence of a difference between group-based learning paradigms and individual training of specific skills in terms of

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  7. Zooplankton Methodology, Collection & identyification - A field manual

    Digital Repository Service at National Institute of Oceanography (India)

    Goswami, S.C.

    and productivity would largely depend upon the use of correct methodology which involves collection of samples, fixation, preservation, analysis and computation of data. The detailed procedures on all these aspects are given in this manual....

  8. Pathological and Biological Aspects of Colorectal Cancer Treatment.

    NARCIS (Netherlands)

    Gosens, M.J.E.M.

    2008-01-01

    Pathological and biological aspects of colorectal cancer treatment. This thesis describes several pathological and biological aspects of colorectal cancer treatment. Different patient populations were investigated including patients with mobile rectal cancer enrolled in the Dutch TME trial, patients

  9. Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial.

    Science.gov (United States)

    Samuels, Aaron M; Awino, Nobert; Odongo, Wycliffe; Abong'o, Benard; Gimnig, John; Otieno, Kephas; Shi, Ya Ping; Were, Vincent; Allen, Denise Roth; Were, Florence; Sang, Tony; Obor, David; Williamson, John; Hamel, Mary J; Patrick Kachur, S; Slutsker, Laurence; Lindblade, Kim A; Kariuki, Simon; Desai, Meghna

    2017-06-07

    Most human Plasmodium infections in western Kenya are asymptomatic and are believed to contribute importantly to malaria transmission. Elimination of asymptomatic infections requires active treatment approaches, such as mass testing and treatment (MTaT) or mass drug administration (MDA), as infected persons do not seek care for their infection. Evaluations of community-based approaches that are designed to reduce malaria transmission require careful attention to study design to ensure that important effects can be measured accurately. This manuscript describes the study design and methodology of a cluster-randomized controlled trial to evaluate a MTaT approach for malaria transmission reduction in an area of high malaria transmission. Ten health facilities in western Kenya were purposively selected for inclusion. The communities within 3 km of each health facility were divided into three clusters of approximately equal population size. Two clusters around each health facility were randomly assigned to the control arm, and one to the intervention arm. Three times per year for 2 years, after the long and short rains, and again before the long rains, teams of community health volunteers visited every household within the intervention arm, tested all consenting individuals with malaria rapid diagnostic tests, and treated all positive individuals with an effective anti-malarial. The effect of mass testing and treatment on malaria transmission was measured through population-based longitudinal cohorts, outpatient visits for clinical malaria, periodic population-based cross-sectional surveys, and entomological indices.

  10. Formalizing the ISDF Software Development Methodology

    OpenAIRE

    Mihai Liviu DESPA

    2015-01-01

    The paper is aimed at depicting the ISDF software development methodology by emphasizing quality management and software development lifecycle. The ISDF methodology was built especially for innovative software development projects. The ISDF methodology was developed empirically by trial and error in the process of implementing multiple innovative projects. The research process began by analysing key concepts like innovation and software development and by settling the important dilemma of wha...

  11. Testing methodologies

    Energy Technology Data Exchange (ETDEWEB)

    Bender, M.A.

    1990-01-01

    Several methodologies are available for screening human populations for exposure to ionizing radiation. Of these, aberration frequency determined in peripheral blood lymphocytes is the best developed. Individual exposures to large doses can easily be quantitated, and population exposures to occupational levels can be detected. However, determination of exposures to the very low doses anticipated from a low-level radioactive waste disposal site is more problematical. Aberrations occur spontaneously, without known cause. Exposure to radiation induces no new or novel types, but only increases their frequency. The limitations of chromosomal aberration dosimetry for detecting low level radiation exposures lie mainly in the statistical signal to noise'' problem, the distribution of aberrations among cells and among individuals, and the possible induction of aberrations by other environmental occupational or medical exposures. However, certain features of the human peripheral lymphocyte-chromosomal aberration system make it useful in screening for certain types of exposures. Future technical developments may make chromosomal aberration dosimetry more useful for low-level radiation exposures. Other methods, measuring gene mutations or even minute changes on the DNA level, while presently less will developed techniques, may eventually become even more practical and sensitive assays for human radiation exposure. 15 refs.

  12. Testing methodologies

    International Nuclear Information System (INIS)

    Bender, M.A.

    1990-01-01

    Several methodologies are available for screening human populations for exposure to ionizing radiation. Of these, aberration frequency determined in peripheral blood lymphocytes is the best developed. Individual exposures to large doses can easily be quantitated, and population exposures to occupational levels can be detected. However, determination of exposures to the very low doses anticipated from a low-level radioactive waste disposal site is more problematical. Aberrations occur spontaneously, without known cause. Exposure to radiation induces no new or novel types, but only increases their frequency. The limitations of chromosomal aberration dosimetry for detecting low level radiation exposures lie mainly in the statistical ''signal to noise'' problem, the distribution of aberrations among cells and among individuals, and the possible induction of aberrations by other environmental occupational or medical exposures. However, certain features of the human peripheral lymphocyte-chromosomal aberration system make it useful in screening for certain types of exposures. Future technical developments may make chromosomal aberration dosimetry more useful for low-level radiation exposures. Other methods, measuring gene mutations or even minute changes on the DNA level, while presently less will developed techniques, may eventually become even more practical and sensitive assays for human radiation exposure. 15 refs

  13. Tourism Methodologies - New Perspectives, Practices and Procedures

    DEFF Research Database (Denmark)

    This volume offers methodological discussions within the multidisciplinary field of tourism and shows how tourism researchers develop and apply new tourism methodologies. The book is presented as an anthology, giving voice to many diverse researchers who reflect on tourism methodology in differen...... codings and analysis, and tapping into the global network of social media.......This volume offers methodological discussions within the multidisciplinary field of tourism and shows how tourism researchers develop and apply new tourism methodologies. The book is presented as an anthology, giving voice to many diverse researchers who reflect on tourism methodology in different...... in interview and field work situations, and how do we engage with the performative aspects of tourism as a field of study? The book acknowledges that research is also performance and that it constitutes an aspect of intervention in the situations and contexts it is trying to explore. This is an issue dealt...

  14. Pecan cultivation: general aspects

    Directory of Open Access Journals (Sweden)

    Diniz Fronza

    2018-02-01

    Full Text Available ABSTRACT: Given the increasing investment in the pecan production in southern Brazil, it becomes necessary researches, assisting in solve problems and proposition of technical and methodology to enhance this production chain. Thus, the present review aimed to survey the existing information about the culture, both on the world and the Brazilian scene. Issues related to botany, climate and soil requirements, alignment and planting density, cultivars, pests and diseases, among other technical aspects of this culture will be addressed. Pecan nut presents nutraceutical properties that are beneficial to human health, which has increased its demand from consumers. However, there are few research results with pecan nut in Brazil and there are many gaps in scientific knowledge about this culture, especially as regards the management of pests and diseases control, irrigation and nutrition, in Brazilian conditions.

  15. A new Methodology for Operations Strategy

    DEFF Research Database (Denmark)

    Koch, Christian; Rytter, Niels Gorm; Boer, Harry

    2005-01-01

    This paper proposes a new methodology for developing and implementing Operations Strategy (OS). It encompasses both content and process aspects of OS and differs thereby from many of the present OS methodologies. The paper outlines its paradigmatic foundation and presents aim, process, dimensions...

  16. The older people, omega-3, and cognitive health (EPOCH trial design and methodology: A randomised, double-blind, controlled trial investigating the effect of long-chain omega-3 fatty acids on cognitive ageing and wellbeing in cognitively healthy older adults

    Directory of Open Access Journals (Sweden)

    Wilson Carlene

    2011-10-01

    Full Text Available Abstract Background Some studies have suggested an association between omega-3 long-chain polyunsaturated fatty acids (n-3 LC PUFAs and better cognitive outcomes in older adults. To date, only two randomised, controlled trials have assessed the effect of n-3 LC PUFA supplementation on cognitive function in older cognitively healthy populations. Of these trials only one found a benefit, in the subgroup carrying the ApoE-ε4 allele. The benefits of n-3 LC PUFA supplementation on cognitive function in older normal populations thus still remain unclear. The main objective of the current study was to provide a comprehensive assessment of the potential of n-3 LC PUFAs to slow cognitive decline in normal elderly people, and included ApoE-ε4 allele carriage as a potential moderating factor. The detailed methodology of the trial is reported herein. Methods The study was a parallel, 18-month, randomised, double-blind, placebo-controlled intervention with assessment at baseline and repeated 6-monthly. Participants (N = 391, 53.7% female aged 65-90 years, English-speaking and with normal cognitive function, were recruited from metropolitan Adelaide, South Australia. Participants in the intervention arm received capsules containing fish-oil at a daily dosage of 1720 mg of docosahexaenoic acid and 600 mg of eicosapentaenoic acid while the placebo arm received the equivalent amount of olive oil in their capsules. The primary outcome is rate of change in cognitive performance, as measured by latent variables for the cognitive constructs (encompassing Reasoning, Working Memory, Short-term Memory, Retrieval Fluency, Inhibition, Simple and Choice-Reaction Time, Perceptual Speed, Odd-man-out Reaction Time, Speed of Memory Scanning, and Psychomotor Speed and assessed by latent growth curve modeling. Secondary outcomes are change in the Mini-mental State Examination, functional capacity and well-being (including health status, depression, mood, and self

  17. Current trends in Bayesian methodology with applications

    CERN Document Server

    Upadhyay, Satyanshu K; Dey, Dipak K; Loganathan, Appaia

    2015-01-01

    Collecting Bayesian material scattered throughout the literature, Current Trends in Bayesian Methodology with Applications examines the latest methodological and applied aspects of Bayesian statistics. The book covers biostatistics, econometrics, reliability and risk analysis, spatial statistics, image analysis, shape analysis, Bayesian computation, clustering, uncertainty assessment, high-energy astrophysics, neural networking, fuzzy information, objective Bayesian methodologies, empirical Bayes methods, small area estimation, and many more topics.Each chapter is self-contained and focuses on

  18. Methodological Choices in Muscle Synergy Analysis Impact Differentiation of Physiological Characteristics Following Stroke

    Directory of Open Access Journals (Sweden)

    Caitlin L. Banks

    2017-08-01

    Full Text Available Muscle synergy analysis (MSA is a mathematical technique that reduces the dimensionality of electromyographic (EMG data. Used increasingly in biomechanics research, MSA requires methodological choices at each stage of the analysis. Differences in methodological steps affect the overall outcome, making it difficult to compare results across studies. We applied MSA to EMG data collected from individuals post-stroke identified as either responders (RES or non-responders (nRES on the basis of a critical post-treatment increase in walking speed. Importantly, no clinical or functional indicators identified differences between the cohort of RES and nRES at baseline. For this exploratory study, we selected the five highest RES and five lowest nRES available from a larger sample. Our goal was to assess how the methodological choices made before, during, and after MSA affect the ability to differentiate two groups with intrinsic physiologic differences based on MSA results. We investigated 30 variations in MSA methodology to determine which choices allowed differentiation of RES from nRES at baseline. Trial-to-trial variability in time-independent synergy vectors (SVs and time-varying neural commands (NCs were measured as a function of: (1 number of synergies computed; (2 EMG normalization method before MSA; (3 whether SVs were held constant across trials or allowed to vary during MSA; and (4 synergy analysis output normalization method after MSA. MSA methodology had a strong effect on our ability to differentiate RES from nRES at baseline. Across all 10 individuals and MSA variations, two synergies were needed to reach an average of 90% variance accounted for (VAF. Based on effect sizes, differences in SV and NC variability between groups were greatest using two synergies with SVs that varied from trial-to-trial. Differences in SV variability were clearest using unit magnitude per trial EMG normalization, while NC variability was less sensitive to EMG

  19. Aspectos metodológicos do comportamento ingestivo de ovinos alimentados com capim-elefante amonizado e subprodutos agroindustriais Methodological aspects of feeding behaviour of sheep fed ammoniated elephantgrass and agro-industrial by-products

    Directory of Open Access Journals (Sweden)

    Gleidson Giordano Pinto de Carvalho

    2007-08-01

    Full Text Available Um experimento foi realizado com o objetivo de definir o intervalo de tempo de registro do comportamento de ovinos Santa Inês. Utilizaram-se 18 ovinos machos, não-castrados, com peso corporal médio inicial de 22,62 kg. Os animais foram alojados em baias individuais e distribuídos ao acaso em seis tratamentos, constituídos de dois volumosos (capim-elefante amonizado ou não com 5% de uréia e três concentrados (com 0% de farelo de cacau ou torta de dendê; com 40% de farelo de cacau; ou com 40% de torta de dendê em substituição ao milho e ao farelo de soja, fornecidos na proporção de 60:40 (volumoso:concentrado. O registro das atividades foi realizado durante dois períodos de 24 horas, no final do período experimental, registrando-se o tempo despendido em alimentação, ruminação, ócio e efetuando-se a discretização dessas séries. Foram testados os intervalos de observações de 5, 10, 15, 20, 25 e 30 minutos. Os tempos despendidos em alimentação, ruminação e ócio não diferiram em nenhum dos intervalos estudados, entretanto, na discretização das séries temporais, ou seja, no número de períodos e no tempo médio gasto por período, apresentaram diferenças significativas. Os tempos de alimentação, ruminação e ócio em ovinos Santa Inês podem ser obtidos com observações em intervalos de até 30 minutos. Para a discretização das séries temporais, recomenda-se o uso da escala de cinco minutos.The objective of this trial was to compare and determine the most adequate time interval to register chewing activity in Santa Inês sheep. The following time intervals were investigated: 5, 10, 15, 20, 25, and 30 minutes. Eighteen intact male sheep averaging 22.62 kg of body weight at the beginning of the study were used. Animals were housed in individual pens and randomly assigned to one of six treatments: ammonia-treated elephantgrass or elephatgrass supplemented with three concentrates sources (0% cocoa meal and palm

  20. A comparison of results of empirical studies of supplementary search techniques and recommendations in review methodology handbooks: a methodological review.

    Science.gov (United States)

    Cooper, Chris; Booth, Andrew; Britten, Nicky; Garside, Ruth

    2017-11-28

    The purpose and contribution of supplementary search methods in systematic reviews is increasingly acknowledged. Numerous studies have demonstrated their potential in identifying studies or study data that would have been missed by bibliographic database searching alone. What is less certain is how supplementary search methods actually work, how they are applied, and the consequent advantages, disadvantages and resource implications of each search method. The aim of this study is to compare current practice in using supplementary search methods with methodological guidance. Four methodological handbooks in informing systematic review practice in the UK were read and audited to establish current methodological guidance. Studies evaluating the use of supplementary search methods were identified by searching five bibliographic databases. Studies were included if they (1) reported practical application of a supplementary search method (descriptive) or (2) examined the utility of a supplementary search method (analytical) or (3) identified/explored factors that impact on the utility of a supplementary method, when applied in practice. Thirty-five studies were included in this review in addition to the four methodological handbooks. Studies were published between 1989 and 2016, and dates of publication of the handbooks ranged from 1994 to 2014. Five supplementary search methods were reviewed: contacting study authors, citation chasing, handsearching, searching trial registers and web searching. There is reasonable consistency between recommended best practice (handbooks) and current practice (methodological studies) as it relates to the application of supplementary search methods. The methodological studies provide useful information on the effectiveness of the supplementary search methods, often seeking to evaluate aspects of the method to improve effectiveness or efficiency. In this way, the studies advance the understanding of the supplementary search methods. Further

  1. Acoustic emission methodology and application

    CERN Document Server

    Nazarchuk, Zinoviy; Serhiyenko, Oleh

    2017-01-01

    This monograph analyses in detail the physical aspects of the elastic waves radiation during deformation or fracture of materials. I presents the  methodological bases for the practical use of acoustic emission device, and describes the results of theoretical and experimental researches of evaluation of the crack growth resistance of materials, selection of the useful AE signals. The efficiency of this methodology is shown through the diagnostics of various-purpose industrial objects. The authors obtain results of experimental researches with the help of the new methods and facilities.

  2. ASPECTS OF CRIMINALISTICS TACTICS RELATED TO WITNESS HEARING

    Directory of Open Access Journals (Sweden)

    Nicolae Mărgărit

    2017-12-01

    Full Text Available The article analyses some aspects related to witness statements, with regard to the actual tactics of hearing witnesses and the hearing of child witnesses. Judicial practice has well shown that giving evidence is the most important phase in the course of the activity carried out by judicial bodies, being the way for determining the facts, for finding the truth in the case referred for settlement. Giving the evidence in a correct and complete way, the value of the administered evidence and its correct and lawful evaluation are decisive for the judicial bodies to come to an intimate belief with regard to the factual reality on which the solution they pronounce should be based, the lawfulness itself of court rulings and other solutions given by the judicial bodies being dependant on these elements. In order to obtain the evidence and make the most of it in a criminal trial, legal activities or operations are necessary to discover it and to present it in a form which is perceptible for the judicial bodies, an aspect which is accomplished by legal means of evidence. Criminal doctrine and judicial practice alike have determined that for finding the truth in a criminal trial, besides the statements made by the suspect or the accused, the statements of the other parties in the trial have an appreciable contribution too. In this context, the contribution of Criminalistics – the science of crime investigation – to establishing the facts in a criminal trial is especially noticeable with the conclusions of forensic examinations and findings. The study put forward reveals some aspects of criminalistics tactics related to witness hearing in a criminal trial, as well as that the result of the investigation depends on how the activity of witness hearing is prepared and the compliance with all procedural rules. At the same time, as Criminalistics supports the witness hearing activity, it develops a particular tactical hearing procedure, starting precisely

  3. Methodological proposal for identification and evaluation of environmental aspects and impacts of nuclear facilities of IPEN, Sao Paulo, SP, Brazil: a case study applied to the Nuclear Fuel Center; Proposta metodologica para a identificacao e avaliacao de aspectos e impactos ambientais em instalacoes nucleares do IPEN: estudo de caso aplicado ao Centro do Combustivel Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Mattos, Luis Antonio Terribile de

    2013-07-01

    This work presents an application of Failure Mode Effect Analysis (FMEA) to the process of identification of environmental aspects and impacts as a part of implementation and maintenance of an Environmental Management System (EMS) in accordance with the NBR ISO 14001 standard. Also, it can contribute, as a complement, to the evaluation and improvement of safety of the installation focused. The study was applied to the Nuclear Fuel Center (CCN) of Nuclear and Energy Research Institute (IPEN), situated at the Campus of University of Sao Paulo, Brazil. The CCN facility has the objective of promoting scientific research and of producing nuclear fuel elements for the IEA-R1 Research Reactor. To identify the environmental aspects of the facility activities, products, and services, a systematic data collection was carried out by means of personal interviews, documents, reports and operation data records consulting. Furthermore, the processes and their interactions, failure modes, besides their causes and effects to the environment, were identified. As a result of a careful evaluation of these causes it was possible to identify and to classify the major potential environmental impacts, in order to set up and put in practice an Environmental Management System for the installation under study. The results have demonstrated the validity of the FMEA application to nuclear facility processes, identifying environmental aspects and impacts, whose controls are critical to achieve compliance with the environmental requirements of the Integrated Management System of IPEN. It was demonstrated that the methodology used in this work is a powerful management tool for resolving issues related to the conformity with applicable regulatory and legal requirements of the Brazilian Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment (IBAMA). (author)

  4. Intelligent systems engineering methodology

    Science.gov (United States)

    Fouse, Scott

    1990-01-01

    An added challenge for the designers of large scale systems such as Space Station Freedom is the appropriate incorporation of intelligent system technology (artificial intelligence, expert systems, knowledge-based systems, etc.) into their requirements and design. This presentation will describe a view of systems engineering which successfully addresses several aspects of this complex problem: design of large scale systems, design with requirements that are so complex they only completely unfold during the development of a baseline system and even then continue to evolve throughout the system's life cycle, design that involves the incorporation of new technologies, and design and development that takes place with many players in a distributed manner yet can be easily integrated to meet a single view of the requirements. The first generation of this methodology was developed and evolved jointly by ISX and the Lockheed Aeronautical Systems Company over the past five years on the Defense Advanced Research Projects Agency/Air Force Pilot's Associate Program, one of the largest, most complex, and most successful intelligent systems constructed to date. As the methodology has evolved it has also been applied successfully to a number of other projects. Some of the lessons learned from this experience may be applicable to Freedom.

  5. Artificial Intelligence Techniques and Methodology

    OpenAIRE

    Carbonell, Jaime G.; Sleeman, Derek

    1982-01-01

    Two closely related aspects of artificial intelligence that have received comparatively little attention in the recent literature are research methodology, and the analysis of computational techniques that span multiple application areas. We believe both issues to be increasingly significant as Artificial Intelligence matures into a science and spins off major application efforts. It is imperative to analyze the repertoire of AI methods with respect to past experience, utility in new domains,...

  6. AspectKE*

    DEFF Research Database (Denmark)

    Yang, Fan; Masuhara, Hidehiko; Aotani, Tomoyuki

    2010-01-01

    Enforcing security policies to distributed systems is difficult, in particular, when a system contains untrusted components. We designed AspectKE*, a distributed AOP language based on a tuple space, to tackle this issue. In AspectKE*, aspects can enforce access control policies that depend......KE*, and demonstrate usefulness of AspectKE* through a security aspect for a distributed chat system....

  7. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals

    Directory of Open Access Journals (Sweden)

    E.D. Moreira Jr.

    2001-11-01

    Full Text Available Results of subgroup analysis (SA reported in randomized clinical trials (RCT cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author's conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53% had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94%. Information on whether the SA preceded/followed the analysis was reported in only 7 (41% of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72%, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported.

  8. Funding source and the quality of reports of chronic wounds trials: 2004 to 2011.

    Science.gov (United States)

    Hodgson, Robert; Allen, Richard; Broderick, Ellen; Bland, J Martin; Dumville, Jo C; Ashby, Rebecca; Bell-Syer, Sally; Foxlee, Ruth; Hall, Jill; Lamb, Karen; Madden, Mary; O'Meara, Susan; Stubbs, Nikki; Cullum, Nicky

    2014-01-14

    Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality. A systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed. A total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered. This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must

  9. Methodological aspects in the analysis of spontaneously produced sputum

    NARCIS (Netherlands)

    Out, T. A.; Jansen, H. M.; Lutter, R.

    2001-01-01

    Analysis of sputum as a specimen containing inflammatory indices has gained considerable interest during the last decade with focus on chronic bronchitis (CB) with or without airway obstruction, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and asthma. The nature of the

  10. Memory during general anesthesia : Practical and methodological aspects

    NARCIS (Netherlands)

    Bonebakker, AE; Jelicic, M; Passchier, J; Bonke, B

    1996-01-01

    Evidence coming from several studies into memory and awareness during general anesthesia suggests that in surgical patients who seem to be adequately anesthetized (i.e., unaware of what happens in the operating theater), some form of cognitive functioning is preserved. This finding has important

  11. Theoretical and methodological aspects of strategic sales management of enterprise

    OpenAIRE

    Hurzhiy, N.

    2014-01-01

    In the article existing approaches to strategic management are analyzed, features and a concept of strategic sales management are defined. Also in the article there is encouraged to use processdesign approach in the implementation of strategic management. Also the principles which should be carried out by strategic management of sales activities are identified in relation to the elements of the systemsales activities, as consumers, state infrastructure software sales, competition and enterprise.

  12. Scientific-methodological aspects of communication management on industrial enterprises

    OpenAIRE

    L.Yu. Sager

    2012-01-01

    The article explains the purpose of communication management and proposes the scheme of communication process. The groups of potential obstacles of effective communication management and basic measures to overcome them are allocated.

  13. EXTREME SUBCULTURES: THEORETICAL AND METHODOLOGICAL ASPECTS OF THE STUDY

    Directory of Open Access Journals (Sweden)

    Alexander Sergeevich Shulgin

    2017-05-01

    Practical implications. The results of the research can be used in the scientific and practical sphere, as well as to expand scientific knowledge about the sociocultural foundations and forms of manifestation of extreme in modern society.

  14. The Methodological Aspect of the Diagnostics of Objects in Economics

    Directory of Open Access Journals (Sweden)

    Grynko Pavlo О.

    2017-12-01

    Full Text Available The article on the basis of morphological analysis defines the concept of «diagnostics in economics». The differences of diagnostics in economics, economic diagnostics, and analysis in economics were analyzed. The types, functions, principles of diagnostics in economics in modern conditions have been substantiated. The interrelationship of diagnostics with other functions of management in economics has been concretized. The logic and contents of stages of the diagnostic technology in economics have been clarified. The reliability of diagnostics in economics is determined by analytical tools, which are applicable in its implementation. Recommendations of analytical tools for realization of diagnostics in economics have been substantiated. A structural-logical scheme of diagnostics in economics, firming its scientific base and providing objectivity in practical implementation has been proposed.

  15. Methodologic and clinical aspects of free thyroid hormone assay

    International Nuclear Information System (INIS)

    Hermans, J.; Baldewyns, P.; Beauduin, M.

    1984-01-01

    The diagnostic value of free thyroid hormones measures depends on used technic. The results gived by two different kits are compared: - Kit Le Petit with chromatographic separation, - Kit Amersham which uses an analogue [fr

  16. Evidence and causality assessment in environmental epidemiology: methodological aspects

    International Nuclear Information System (INIS)

    Valleron, A.J.

    2000-01-01

    There are usually three major steps in the study of the possible impact of environmental factors on health: 1) to demonstrate that there is an association between exposure to the factor and the disease under study; 2) to demonstrate that this association is causal; 3) to evaluate the health benefit that could be obtained by removing the source of exposure. Statistical methods are commonly assumed to provide an objective way of achieving these three steps. This paper reviews some of the conditions that have to be met to allow proper interpretations and to avoid some of the controversies that are often found in health-environment studies. First, it should be remembered that the so-called P value which is used to qualify 'statistically significant' associations between risk factors and diseases does not give any indication of the probability that this association is actual, while far too often it is believed that it does. The probability that an association between an environmental factor and a disease is real could, however, be estimated by using Bayesian methods. These methods require that the a priori probabilities be stated, which is difficult to do in practice. Some directions to overcome this difficulty are presented. Second, the analysis of causality cannot be carried out on statistical grounds alone and the so-called 'causality criteria' are of limited practical interest. Definition of what is a cause, and upon which conditions a candidate factor of a disease can be considered as a cause, deserves much research effort, and careful consideration of the huge literature (mostly outside of the epidemiological field, for example in logic) which is devoted to this subject. Finally, the measurement of the role of a factor in a disease is very often assessed through the use of 'attributable fraction' or 'attributable mortality'. This should be done only when it is demonstrated that the considered factor is causal. Moreover, the interpretation of attributable fractions to a specific factor may be difficult in the (general) case where there are multiple causal factors implied in the development of the disease. Demographic measures of 'potential years (or days, etc.) of life lost' should in general be used, rather than 'numbers of deaths' to quantify the possible impact of environmental factors. Also, as the personal factors are generally extremely important in the determinism of the causes of death associated to environmental factors, and as they cannot be controlled through ecological studies, epidemiological designs where these cofactors can be evaluated individually on cases and controls should be preferred. (author)

  17. Economic growth factors system: theoretical and methodological aspect

    OpenAIRE

    H.Ya. Hlukha

    2014-01-01

    The aim of the article. The main objective of the article is to create theoretical grounds to build the system of economic growth factors, to modernize their classification, to define exogenous and endogenous factors, to analyze them within the state economic policy structure. The results of the analysis. The article focuses on economic growth factors theoretical studies: - economic growth factors classification characteristics have been highlighted; - various approaches to determine...

  18. Methodological aspects of accounting production cost of public sector entities

    Directory of Open Access Journals (Sweden)

    Людмила Геннадіївна Ловінська

    2015-09-01

    Full Text Available The necessity of obtaining objective information about the activities of the public sector in various areas of the production is defined. It is proved an expediency of development the Project of «Guidelines for the structure of production costs» on the basis of the approved in the public sector NP(SAPS 135 "Costs". The need for accounting costs by type of activity (operational, financial and investment is marked. The composition of production costs is defined

  19. METHODOLOGICAL ASPECTS OF LOGISTIC SYSTEMS OF THE COMPANY

    OpenAIRE

    Lăpăduşi Mihaela Loredana; Constantin Căruntu

    2009-01-01

    Extremely complex issues including large scale logistics issue, whose solving depends on many sets of circumstances and political, economic, technical, cultural and environment factors can be approached by calling big systems theory. In the present stage of the development of new international economical activities of the scientific research, in the conceptualization plan it is impossible that when we call an inter and multidisciplinary approach of a complex technic...

  20. Methodologic aspects of acetylcholine-evoked relaxation of rabbit aorta

    DEFF Research Database (Denmark)

    Larsen, Kirsten Vendelbo; Nedergaard, Ove A.

    1999-01-01

    The acetylcholine-evoked relaxation of rabbit isolated thoracic aorta precontracted by phenylephrine was studied. Phenylephrine caused a steady contraction that was maintained for 6 h. In the presence of calcium disodium ethylenediaminetetraacetate (EDTA) and ascorbic acid the contraction decreased...

  1. Selected methodological aspects of routine medical supervision of radiation workers

    International Nuclear Information System (INIS)

    Schuettmann, W.

    1981-01-01

    Examinations of the blood, skin, chromosomes, eyes and lungs provide an important means for detecting biological radiation effects in occupationally exposed workers. The diagnostic value of these five methods is discussed. (author)

  2. Radioimmunoassay for prostatic acid phosphatase in human serum. Methodologic aspects

    International Nuclear Information System (INIS)

    Pradalier, N.; Canal, P.; Pujol, A.; Fregevu, Y.; Soula, G.

    1982-01-01

    We propose a double antibody radioimmunoassay for human prostatic acid phosphatase (PAP) in serum for diagnosis and management of prostatic adenocarcinoma under treatment. The antigen is purified from human prostatic fluid by a gel-filtration on Sephadex G 100 followed by affinity chromatography on Con A Sepharose. A specific antibody is raised in rabbits and purified by immunoadsorption with a female serum. The described technique offers both radioisotopic sensibility and immunologic specificity. Physiological values determined in the serum of 125 healthy males are below 2 ng/ml. No significative differences are observed with age. The proposed technique also shows significant differences between values evaluated for benign prostatic hyperplasia and prostatic adenocarcinoma [fr

  3. Methodological aspects of core meltdown accidents frequency estimates

    International Nuclear Information System (INIS)

    Matthis, P.

    1984-01-01

    A survey is given of the work of the ecological institute relating to models and methods used in the German Risk Study for the assessment of core meltdown accident frequency. A statistical model used by the ecological institute for the estimation of the outage behaviour of components is taken as a comparison, which leads to the conclusion that no appropriate methods for the assessment of component reliability are available to date. Furthermore, there are no secured methods for error propagation computation. The lower limits for the ranges of reliability of components are calculated by approximation. As a result of imperfect modelling and of a number of methodical inaccuracies and neglects, the German Risk Study underestimates the ranges of component reliability by a factor of 3 to 70 (depending on the type of component). (RF) [de

  4. Radioimmunoassay for prostatic acid phosphatase in human serum. Methodologic aspects

    Energy Technology Data Exchange (ETDEWEB)

    Pradalier, N; Canal, P; Pujol, A; Fregevu, Y [Groupe de Recherches du Centre Claudius-Regaud, Toulouse (France); Soula, G [Faculte des Sciences Pharmaceutiques, Toulouse (France)

    1982-01-01

    We propose a double antibody radioimmunoassay for human prostatic acid phosphatase (PAP) in serum for diagnosis and management of prostatic adenocarcinoma under treatment. The antigen is purified from human prostatic fluid by a gel-filtration on Sephadex G 100 followed by affinity chromatography on Con A Sepharose. A specific antibody is raised in rabbits and purified by immunoadsorption with a female serum. The described technique offers both radioisotopic sensibility and immunologic specificity. Physiological values determined in the serum of 125 healthy males are below 2 ng/ml. No significative differences are observed with age. The proposed technique also shows significant differences between values evaluated for benign prostatic hyperplasia and prostatic adenocarcinoma.

  5. Homeopathic drug discovery: theory update and methodological aspect.

    Science.gov (United States)

    Khuda-Bukhsh, Anisur Rahman; Pathak, Surajit

    2008-08-01

    Homeopathy treats patient on the basis of totality of symptoms and is based on the principle of 'like cures like'. It uses ultra-low doses of highly diluted natural substances as remedies that originate from plants, minerals or animals. The objectives of this review are to discuss concepts, controversies and research related to understanding homeopathy in the light of modern science. Attempts have been made to focus on current views of homeopathy and to delineate its most plausible mechanism(s) of action. Although some areas of concern remain, research carried out so far both in vitro and in vivo validates the effects of highly diluted homeopathic medicines in a wide variety of organisms. The precise mechanism(s) and pathway(s) of action of highly diluted homeopathic drugs are still unknown.

  6. METHODOLOGICAL ASPECTS OF ECONOMIC EVENTS CYCLICITY METHOD CONSIDERATION

    Directory of Open Access Journals (Sweden)

    Yaskova Natalia Yur'ievna

    2017-07-01

    Full Text Available The cyclicity of economic phenomena is not only their immanent property but also the subject of economic analysis. The modern way of making managerial decisions requires analysis of a number of cycles that fill any kind of activity. Accounting and reconciliation of construction, design, investment, purchasing, reproduction, leasing and other cycles is important for the investment and construction sector, both from the point of view of the need for their synchronization and from the position of determining trends in sectoral development. The analysis has showed that three main types of development are characteristic for investment and construction activity. Increasing intensity is inherent in a high level of cyclic synchronization. The degradation trend arises as a result of mismatched cycles. The stabilization character is inherent in the regular modes of maintaining the established proportions and cyclical inter-conformity. The study of the cyclical nature of investment and building processes is impossible without understanding their co-ordination. The principles of synchronization and subordination of the cycles should be used not only for the construction of cost-effective systems but also for the development of management tools.

  7. Methodological aspects transparency financial statements of construction companies

    Directory of Open Access Journals (Sweden)

    O. V. Rozhnova

    2016-01-01

    Full Text Available In modern society, in terms of general information and integration of the economies, information is one of the main market products. There is becoming urgent task of improving financial statement transparency for enterprises in this situation. One of the most challenging in improving transparency can be considered the construction industry, because of the pursuit of privacy and a high degree of corruption. The paper analyzes the possible reasons for reducing the level of transparency in the construction industry companies. The paper highlighted the general and particular causes that affect the transparency of financial reporting of construction enterprises. Common causes are relevant for companies in any industry, and private causes show features characteristic of the construction itself. In addition, the paper analyzes the various methods of increasing the transparency used by companies all over the world. The analysis highlighted the internal and external methods for improving the transparency of financial statements and transparency of construction companies. Leadership and employees at the enterprise level providing transparency of financial reporting, and non-financial information about the company, having interest to stakeholders, carry out internal methods. External methods are applied at the macro level as the joint forces of the enterprises of the construction industry to form associations and the state. The analysis also considered the possibility of using these methods by the Russian construction companies and advantages and disadvantages of their application.

  8. METHODOLOGICAL ASPECTS OF RURAL DEVELOPMENT GOVERNANCE CASE STUDY

    Directory of Open Access Journals (Sweden)

    Vitalina TSYBULYAK

    2014-01-01

    Full Text Available The article discusses current approaches to the process of assessing rural development governance, reveals its advantages and disadvantages. The article as well presents performance system indicators of governance process by means of two elements of dynamics assessment, rural development (economic, financial, and social sphere, ecology and population health and management process (assessment of strategic plan (concept of development, program of socioeconomic development of rural areas, current activity of local authorities, in particular. More over, it is suggested to use typology of approaches (objective (evolutionary, command and control, economic (infrastructural, complex, and qualitative to definition of process essence of rural development governance and correlation of traditional functions, performed by the subjects of the governance process of rural development (state authorities institutions, local authorities institutions, economic entities, and community. Adjusting traditional functions, performed by governance subjects of local development, their supplementing with new ones, relevant to the present-to-date model of «shared governance» is an important element of analysis of assessment tools for effectiveness of rural development governance. In addition, the author defines functioning of two forms of rural population involvement into the process of rural development governance: active and passive. Active one suggests that rural population participate in making and implementing governance decisions (public meetings, organization of social discussions, and development of territory community self-governance; passive one suggests that the emphasis is placed only on information distribution among population (meetings with parliament members, direct phone lines with territory governors, publication of normative and legal acts and reports on budget execution

  9. Methodological aspects of journaling a dynamic adjusting entry model

    Directory of Open Access Journals (Sweden)

    Vlasta Kašparovská

    2011-01-01

    Full Text Available This paper expands the discussion of the importance and function of adjusting entries for loan receivables. Discussion of the cyclical development of adjusting entries, their negative impact on the business cycle and potential solutions has intensified during the financial crisis. These discussions are still ongoing and continue to be relevant to members of the professional public, banking regulators and representatives of international accounting institutions. The objective of this paper is to evaluate a method of journaling dynamic adjusting entries under current accounting law. It also expresses the authors’ opinions on the potential for consistently implementing basic accounting principles in journaling adjusting entries for loan receivables under a dynamic model.

  10. Los servicios de las bibliotecas de acceso público argentinas en entorno automatizado: aspectos teórico-metodológicos del Proyecto UBACYT F040 Services of public libraries in Argentina in an automated environment: theoretical-methodological aspects of UBACYT F40

    Directory of Open Access Journals (Sweden)

    E. Barber

    2002-06-01

    Full Text Available Se presenta el proyecto UBACYT F040 en sus aspectos teóricos y metodológicos. Su objetivo apunta a relevar la incidencia de la automatización bibliotecaria en la prestación de servicios orientados al uso de la tecnología de la información en las bibliotecas de acceso público argentinas. La metodología empleada consiste en la aplicación (restringida en una primera etapa al área de Capital Federal y Gran Buenos Aires de un cuestionario diseñado en función de variables seleccionadas acorde a la naturaleza de las bibliotecas estudiadas. A partir de la firma de un convenio de Cooperación y Asistencia Técnica con ONU- Ecuador se vislumbra la realización de estudios comparativos entre ambos países con miras a un diagnóstico regional.UBACYT F040 project is being presented in its theoretical and methodological aspects. It is aimed to exalt the incidence of library automation in the provision of services oriented to the use of information technology in public libraries of Argentina. The methodology is based on the application (restricted in a first stage to the Capital Federal and Gran Buenos Aires area of a questionnaire designed according to selected variables depending on the nature of the studied libraries. From the signature of a Cooperation and Technical Assistance Agreement with United Nations - Ecuador, it is foresaw the realization of comparative researches between both countries having in mind later regional diagnosis.

  11. Los servicios de las bibliotecas de acceso público argentinas en entorno automatizado: aspectos teórico-metodológicos del Proyecto UBACYT F040 = Services of public libraries in Argentina in an automated environment: theoretical-methodological aspects of UBACYT F40

    Directory of Open Access Journals (Sweden)

    E. Barber, N. Tripaldi

    2002-06-01

    Full Text Available Se presenta el proyecto UBACYT F040 en sus aspectos teóricos y metodológicos. Su objetivo apunta a relevar la incidencia de la automatización bibliotecaria en la prestación de servicios orientados al uso de la tecnología de la información en las bibliotecas de acceso público argentinas. La metodología empleada consiste en la aplicación (restringida en una primera etapa al área de Capital Federal y Gran Buenos Aires de un cuestionario diseñado en función de variables seleccionadas acorde a la naturaleza de las bibliotecas estudiadas. A partir de la firma de un convenio de Cooperación y Asistencia Técnica con ONU- Ecuador se vislumbra la realización de estudios comparativos entre ambos países con miras a un diagnóstico regional = UBACYT F040 project is being presented in its theoretical and methodological aspects. It is aimed to exalt the incidence of library automation in the provision of services oriented to the use of information technology in public libraries of Argentina. The methodology is based on the application (restricted in a first stage to the Capital Federal and Gran Buenos Aires area of a questionnaire designed according to selected variables depending on the nature of the studied libraries. From the signature of a Cooperation and Technical Assistance Agreement with United Nations – Ecuador, it is foresaw the realization of comparative researches between both countries having in mind later regional diagnosis.

  12. Aspects and Polymorphism in AspectJ

    DEFF Research Database (Denmark)

    Lorenz, David Harel; Ernst, Erik

    2003-01-01

    There are two important points of view on inclusion or subtype polymorphism in object-oriented programs, namely polymorphic access and dynamic dispatch. These features are essential for object-oriented programming, and it is worthwhile to consider whether they are supported in aspect-oriented......J as the basis for the presentation. The results are not exclusive to AspectJ---aspectual polymorphism may make aspects in any comparable AOSD language more expressive and reusable across programs, while preserving safety....

  13. HISTORICAL ASPECTS OF PHALLOPLASTY

    Directory of Open Access Journals (Sweden)

    P. S. Kyzlasov

    2017-01-01

    Full Text Available Reconstruction of the penis in transgender operations, amputation of the penis, congenital deformities and anomalies of the penis was and remains today an important issue in plastic surgery of the urogenital region. The only method to restore the penis is phalloplasty. In general, over the past decades, generations of clinicians have different ways and flaps for total fallouretheral reconstruction. Thus was formulated the characteristics of an ideal flap for the formation of neophallos, which should be safe, sensitive, without hair, and with long leg. However, despite the fact that the characteristics of a perfect flap, nowadays there is no “gold standard” in the formation of neophallos, as phalloplasty is a fairly complicated surgery, and the choice of method depends on many factors. The choice of methodology is determined by the plastics surgeon and to each patient is individual, depends on the etiology of the disease and the possibility of choosing the form of the donor’s transplant. This article presents a literature review devoted to the historical aspects of phalloplasty. In the article, in chronological order reflected the evolution of the different forming methods neofallos, phallourethrоplasty, describes their advantages and disadvantages.

  14. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  15. Biomechanical aspects of playing surfaces.

    Science.gov (United States)

    Nigg, B M; Yeadon, M R

    1987-01-01

    The purpose of this paper is to discuss some biomechanical aspects of playing surfaces with special focus on (a) surface induced injuries, (b) methodologies used to assess surfaces and (c) findings from various sports. The paper concentrates primarily on questions related to load on the athlete's body. Data from epidemiological studies suggest strongly that the surface is an important factor in the aetiology of injuries. Injury frequencies are reported to be significantly different for different surfaces in several sports. The methodologies used to assess surfaces with respect to load or performance include material tests and tests using experimental subjects. There is only little correlation between the results of these two approaches. Material tests used in many standardized test procedures are not validated which suggests that one should exercise restraint in the interpretation of these results. Point elastic surfaces are widely studied while area elastic surfaces have received little attention to date. Questions of energy losses on sport surfaces have rarely been studied scientifically.

  16. Network meta-analysis-highly attractive but more methodological research is needed

    Directory of Open Access Journals (Sweden)

    Singh Sonal

    2011-06-01

    Full Text Available Abstract Network meta-analysis, in the context of a systematic review, is a meta-analysis in which multiple treatments (that is, three or more are being compared using both direct comparisons of interventions within randomized controlled trials and indirect comparisons across trials based on a common comparator. To ensure validity of findings from network meta-analyses, the systematic review must be designed rigorously and conducted carefully. Aspects of designing and conducting a systematic review for network meta-analysis include defining the review question, specifying eligibility criteria, searching for and selecting studies, assessing risk of bias and quality of evidence, conducting a network meta-analysis, interpreting and reporting findings. This commentary summarizes the methodologic challenges and research opportunities for network meta-analysis relevant to each aspect of the systematic review process based on discussions at a network meta-analysis methodology meeting we hosted in May 2010 at the Johns Hopkins Bloomberg School of Public Health. Since this commentary reflects the discussion at that meeting, it is not intended to provide an overview of the field.

  17. Propuesta Metodológica del Entrenamiento de la Resistencia en Baloncesto mediante la Modificación de Factores Formales y Estructurales del Juego. [Methodological Proposals for Endurance Training in Basketball by Modifying Structural and Formal Aspects of the Game].

    Directory of Open Access Journals (Sweden)

    Arnau Sacot

    2017-10-01

    heart rate and game intensity depending on the game parameters used during the game situation. Different key words such as conditioning and basketball in different data bases such as Pub Med or ISI web of knowledge were checked throughout the selection process. Finally, 12 articles were included in the review showing that the modification of some game parameters such as number of players, space conditions, time aspects and game rules, can influence the orientation of the endurance training in basketball. Thereby, a methodological proposal was created to illustrate the usefulness of the different game parameters in order to control and plan the endurance training integrated with technical and tactical drills in basketball. However, the background studies of the methodological proposal should be considered since these studies only have analyzed the simple effects of the different parameters and due to the fact, future studies should study the interaction of the different parameters in order to validate the proposal. Nevertheless, it is believed that this methodological proposal can be helpful so as to integrate endurance training with technical and tactical drills.

  18. Public Politics of Health and Aspects of its Judicialization

    Directory of Open Access Journals (Sweden)

    Rafael Fernando dos Santos

    2015-12-01

    Full Text Available This article was elaborated in order to analyze issues relating to the judicialization of cases involving health, understanding health as a public policy aimed at to guarantee the fundamental right to it linked, that is, the concept of health that the authos intended to work is not far from that contained in the combined reading of Articles 6 and 196 of the Constitution, consecrators to be the health, universal right and duty of the state, guaranteed through social and economic policies aimed at to reduce the risk of disease and other becomes, ensuring also the universal and equal access to actions and services for its promotion, protection and recovery. With this approach it is intended to analyze the feasibility and consequences of judicial control of social and economic policies of promotion, protection and recovery, access, anyway, the effective flow to the fundamental right. Relating to the methodological aspects employed in the analysis of the issue concerning to the health, it was searched in the interpretation of constitutional provisions that secure the subjective right the starting point of the analysis as well as the unwavering appreciation of inseparability of judicial control in the context of public policy, assessing possible limits of the judicial branch, and then to realize a brief analysis of previous trial in the Supreme Court and extract from this jurisprudencial context the minimum goals for aspects of health judicialization.

  19. Nuclear power plant simulation facility evaluation methodology

    International Nuclear Information System (INIS)

    Haas, P.M.; Carter, R.J.; Laughery, K.R. Jr.

    1985-01-01

    A methodology for evaluation of nuclear power plant simulation facilities with regard to their acceptability for use in the US Nuclear Regulatory Commission (NRC) operator licensing exam is described. The evaluation is based primarily on simulator fidelity, but incorporates some aspects of direct operator/trainee performance measurement. The panel presentation and paper discuss data requirements, data collection, data analysis and criteria for conclusions regarding the fidelity evaluation, and summarize the proposed use of direct performance measurment. While field testing and refinement of the methodology are recommended, this initial effort provides a firm basis for NRC to fully develop the necessary methodology

  20. Formalizing the ISDF Software Development Methodology

    Directory of Open Access Journals (Sweden)

    Mihai Liviu DESPA

    2015-01-01

    Full Text Available The paper is aimed at depicting the ISDF software development methodology by emphasizing quality management and software development lifecycle. The ISDF methodology was built especially for innovative software development projects. The ISDF methodology was developed empirically by trial and error in the process of implementing multiple innovative projects. The research process began by analysing key concepts like innovation and software development and by settling the important dilemma of what makes a web application innovative. Innovation in software development is presented from the end-user, project owner and project manager’s point of view. The main components of a software development methodology are identified. Thus a software development methodology should account for people, roles, skills, teams, tools, techniques, processes, activities, standards, quality measuring tools, and team values. Current software development models are presented and briefly analysed. The need for a dedicated innovation oriented software development methodology is emphasized by highlighting shortcomings of current software development methodologies when tackling innovation. The ISDF methodology is presented in the context of developing an actual application. The ALHPA application is used as a case study for emphasizing the characteristics of the ISDF methodology. The development life cycle of the ISDF methodology includes research, planning, prototyping, design, development, testing, setup and maintenance. Artefacts generated by the ISDF methodology are presented. Quality is managed in the ISDF methodology by assessing compliance, usability, reliability, repeatability, availability and security. In order to properly asses each quality component a dedicated indicator is built. A template for interpreting each indicator is provided. Conclusions are formulated and new related research topics are submitted for debate.

  1. Clinical Trials

    Medline Plus

    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  2. Clinical Trials

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  3. Clinical Trials

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    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  4. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

  5. Clinical Trials

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    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  8. Pesquisa Mundial de Saúde: aspectos metodológicos e articulação com a Organização Mundial da Saúde World Health Survey: methodological aspects and interface with the World Health Organization

    Directory of Open Access Journals (Sweden)

    Célia Landmann Szwarcwald

    2008-05-01

    financing and in health status, the proposal received countless criticisms from both conceptual and methodological viewpoints. During the redesign phase, in order to provide information about the health status of the population, the WHO proposed the application of the World Health Survey (WHS. In Brazil, the WHS was carried in 2003 for establishing consistent parameters to evaluate heath status and health care responsiveness, in addition to measuring socioeconomic health inequalities. The survey interviewed 5,000 individuals, aged 18 and above, nationwide. The sample design had three selection stages. In the first stage, 250 census tracts were systematically selected with probability proportional to size. In the second stage, households were selected with equal probability using an inverse sample design to assure 20 interviews by sector. In each household, just one adult (18 years or more was selected with equal probability to respond to the individual questionnaire. A modular questionnaire was translated and adapted from the one originally proposed by the WHO. Sample weights were based on the inverse of probabilities of inclusion in the sample calculated for each selection stage. In this paper, we describe the methodological aspects of the survey and the interface process with the WHO to conduct the WHS in Brazil.

  9. Clinical Trials

    Medline Plus

    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  10. Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC).

    Science.gov (United States)

    Padberg, Frank; Kumpf, Ulrike; Mansmann, Ulrich; Palm, Ulrich; Plewnia, Christian; Langguth, Berthold; Zwanzger, Peter; Fallgatter, Andreas; Nolden, Jana; Burger, Max; Keeser, Daniel; Rupprecht, Rainer; Falkai, Peter; Hasan, Alkomiet; Egert, Silvia; Bajbouj, Malek

    2017-12-01

    Transcranial direct current stimulation (tDCS) has been proposed as novel treatment for major depressive disorder (MDD) based on clinical pilot studies as well as randomized controlled monocentric trials. The DepressionDC trial is a triple-blind (blinding of rater, operator and patient), randomized, placebo controlled multicenter trial investigating the efficacy and safety of prefrontal tDCS used as additive treatment in MDD patients who have not responded to selective serotonin reuptake inhibitors (SSRI). At 5 study sites, 152 patients with MDD receive a 6-weeks treatment with active tDCS (anode F3 and cathode F4, 2 mA intensity, 30 min/day) or sham tDCS add-on to a stable antidepressant medication with an SSRI. Follow-up visits are at 3 and 6 months after the last tDCS session. The primary outcome measure is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) scores at week 6 post-randomisation compared to baseline. Secondary endpoints also cover other psychopathological domains, and a comprehensive safety assessment includes measures of cognition. Patients undergo optional investigations comprising genetic testing and functional magnetic resonance imaging (fMRI) of structural and functional connectivity. The study uses also an advanced tDCS technology including standard electrode positioning and recording of technical parameters (current, impedance, voltage) in every tDCS session. Aside reporting the study protocol here, we present a novel approach for monitoring technical parameters of tDCS which will allow quality control of stimulation and further analysis of the interaction between technical parameters and clinical outcome. The DepressionDC trial will hopefully answer the important clinical question whether prefrontal tDCS is a safe and effective antidepressant intervention in patients who have not sufficiently responded to SSRIs. ClinicalTrials.gov Identifier NCT0253016.

  11. Comparative study on software development methodologies

    Directory of Open Access Journals (Sweden)

    Mihai Liviu DESPA

    2014-12-01

    Full Text Available This paper focuses on the current state of knowledge in the field of software development methodologies. It aims to set the stage for the formalization of a software development methodology dedicated to innovation orientated IT projects. The paper starts by depicting specific characteristics in software development project management. Managing software development projects involves techniques and skills that are proprietary to the IT industry. Also the software development project manager handles challenges and risks that are predominantly encountered in business and research areas that involve state of the art technology. Conventional software development stages are defined and briefly described. Development stages are the building blocks of any software development methodology so it is important to properly research this aspect. Current software development methodologies are presented. Development stages are defined for every showcased methodology. For each methodology a graphic representation is illustrated in order to better individualize its structure. Software development methodologies are compared by highlighting strengths and weaknesses from the stakeholder's point of view. Conclusions are formulated and a research direction aimed at formalizing a software development methodology dedicated to innovation orientated IT projects is enunciated.

  12. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  13. Butterfly valve torque prediction methodology

    International Nuclear Information System (INIS)

    Eldiwany, B.H.; Sharma, V.; Kalsi, M.S.; Wolfe, K.

    1994-01-01

    As part of the Motor-Operated Valve (MOV) Performance Prediction Program, the Electric Power Research Institute has sponsored the development of methodologies for predicting thrust and torque requirements of gate, globe, and butterfly MOVs. This paper presents the methodology that will be used by utilities to calculate the dynamic torque requirements for butterfly valves. The total dynamic torque at any disc position is the sum of the hydrodynamic torque, bearing torque (which is induced by the hydrodynamic force), as well as other small torque components (such as packing torque). The hydrodynamic torque on the valve disc, caused by the fluid flow through the valve, depends on the disc angle, flow velocity, upstream flow disturbances, disc shape, and the disc aspect ratio. The butterfly valve model provides sets of nondimensional flow and torque coefficients that can be used to predict flow rate and hydrodynamic torque throughout the disc stroke and to calculate the required actuation torque and the maximum transmitted torque throughout the opening and closing stroke. The scope of the model includes symmetric and nonsymmetric discs of different shapes and aspects ratios in compressible and incompressible fluid applications under both choked and nonchoked flow conditions. The model features were validated against test data from a comprehensive flowloop and in situ test program. These tests were designed to systematically address the effect of the following parameters on the required torque: valve size, disc shapes and disc aspect ratios, upstream elbow orientation and its proximity, and flow conditions. The applicability of the nondimensional coefficients to valves of different sizes was validated by performing tests on 42-in. valve and a precisely scaled 6-in. model. The butterfly valve model torque predictions were found to bound test data from the flow-loop and in situ testing, as shown in the examples provided in this paper

  14. Aspects of vulnerable patients and informed consent in clinical trials [Aspekte schutzbedürftiger Patienten sowie der Einwilligung nach Aufklärung in klinischen Prüfungen

    Directory of Open Access Journals (Sweden)

    Hundt, Ferdinand

    2013-01-01

    Full Text Available [english] Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google.Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. [german] Ziel: Diskussion der Aspekte der Einwilligung schutzbedürftiger Patienten nach Aufklärung zur Teilnahme an klinischen Prüfungen aus europäischem und deutschem Blick.Methoden: Wissenschaftliche Literaturrecherche via PubMed, Medline und Google. Ergebnis: Das

  15. Rationale, Design, and Methodology of the APOLLON trial: A comPrehensive, ObservationaL registry of heart faiLure with midrange and preserved ejectiON fraction.

    Science.gov (United States)

    Özlek, Bülent; Özlek, Eda; Çelik, Oğuzhan; Çil, Cem; Doğan, Volkan; Tekinalp, Mehmet; Zencirkıran Ağuş, Hicaz; Kahraman, Serkan; Ösken, Altuğ; Rencüzoğulları, İbrahim; Tanık, Veysel Ozan; Bekar, Lütfü; Çakır, Mustafa Ozan; Kaya, Bedri Caner; Tibilli, Hakan; Çelik, Yunus; Başaran, Özcan; Mert, Kadir Uğur; Sevinç, Samet; Demirci, Erkan; Dondurmacı, Engin; Biteker, Murat

    2018-05-01

    Although almost half of chronic heart failure (HF) patients have mid-range (HFmrEF) and preserved left-ventricular ejection fraction (HFpEF), no studies have been carried out with these patients in our country. This study aims to determine the demographic characteristics and current status of the clinical background of HFmrEF and HFpEF patients in a multicenter trial. A comPrehensive, ObservationaL registry of heart faiLure with mid range and preserved ejectiON fraction (APOLLON) trial will be an observational, multicenter, and noninterventional study conducted in Turkey. The study population will include 1065 patients from 12 sites in Turkey. All data will be collected at one point in time and the current clinical practice will be evaluated (ClinicalTrials.gov number NCT03026114). We will enroll all consecutive patients admitted to the cardiology clinics who were at least 18 years of age and had New York Heart Association class II, III, or IV HF, elevated brain natriuretic peptide levels within the last 30 days, and an left ventricular ejection fraction (LVEF) of at least 40%. Patients fulfilling the exclusion criteria will not be included in the study. Patients will be stratified into two categories according to LVEF: mid-range EF (HFmrEF, LVEF 40%-49%) and preserved EF (HFpEF, LVEF ≥50%). Regional quota sampling will be performed to ensure that the sample was representative of the Turkish population. Demographic, lifestyle, medical, and therapeutic data will be collected by this specific survey. The APOLLON trial will be the largest and most comprehensive study in Turkey evaluating HF patients with a LVEF ≥40% and will also be the first study to specifically analyze the recently designated HFmrEF category.

  16. Assessment of generalizability, applicability and predictability (GAP) for evaluating external validity in studies of universal family-based prevention of alcohol misuse in young people: systematic methodological review of randomized controlled trials.

    Science.gov (United States)

    Fernandez-Hermida, Jose Ramon; Calafat, Amador; Becoña, Elisardo; Tsertsvadze, Alexander; Foxcroft, David R

    2012-09-01

    To assess external validity characteristics of studies from two Cochrane Systematic Reviews of the effectiveness of universal family-based prevention of alcohol misuse in young people. Two reviewers used an a priori developed external validity rating form and independently assessed three external validity dimensions of generalizability, applicability and predictability (GAP) in randomized controlled trials. The majority (69%) of the included 29 studies were rated 'unclear' on the reporting of sufficient information for judging generalizability from sample to study population. Ten studies (35%) were rated 'unclear' on the reporting of sufficient information for judging applicability to other populations and settings. No study provided an assessment of the validity of the trial end-point measures for subsequent mortality, morbidity, quality of life or other economic or social outcomes. Similarly, no study reported on the validity of surrogate measures using established criteria for assessing surrogate end-points. Studies evaluating the benefits of family-based prevention of alcohol misuse in young people are generally inadequate at reporting information relevant to generalizability of the findings or implications for health or social outcomes. Researchers, study authors, peer reviewers, journal editors and scientific societies should take steps to improve the reporting of information relevant to external validity in prevention trials. © 2012 The Authors. Addiction © 2012 Society for the Study of Addiction.

  17. Hanford Site baseline risk assessment methodology

    International Nuclear Information System (INIS)

    1993-03-01

    This methodology has been developed to prepare human health and environmental evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act remedial investigations (RIs) and the Resource Conservation and Recovery Act facility investigations (FIs) performed at the Hanford Site pursuant to the Hanford Federal Facility Agreement and Consent Order referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies Site-specific risk assessment considerations and integrates them with approaches for evaluating human and environmental risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site

  18. Hanford Site Risk Assessment Methodology. Revision 3

    International Nuclear Information System (INIS)

    1995-05-01

    This methodology has been developed to prepare human health and ecological evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) remedial investigations (RI) and the Resource conservation and Recovery Act of 1976 (RCRA) facility investigations (FI) performed at the Hanford Site pursuant to the hanford Federal Facility Agreement and Consent Order (Ecology et al. 1994), referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies site-specific risk assessment considerations and integrates them with approaches for evaluating human and ecological risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site

  19. Posthumanism as Research Methodology: Inquiry in the Anthropocene

    Science.gov (United States)

    Ulmer, Jasmine B.

    2017-01-01

    The posthuman turn has radically--and rapidly--shifted what is possible in research methodology. In response, my aim in this conceptual paper is to suggest entry points into posthuman educational research methodology. I outline aspects of posthumanism while recognizing its multiplicity: there are many posthumanisms and each offers different…

  20. Criticality accident studies and methodology implemented at the CEA

    International Nuclear Information System (INIS)

    Barbry, Francis; Fouillaud, Patrick; Reverdy, Ludovic; Mijuin, Dominique

    2003-01-01

    Based on the studies and results of experimental programs performed since 1967 in the CRAC, then SILENE facilities, the CEA has devised a methodology for criticality accident studies. This methodology integrates all the main focuses of its approach, from criticality accident phenomenology to emergency planning and response, and thus includes aspects such as criticality alarm detector triggering, airborne releases, and irradiation risk assessment. (author)

  1. A theoretical and experimental investigation of propeller performance methodologies

    Science.gov (United States)

    Korkan, K. D.; Gregorek, G. M.; Mikkelson, D. C.

    1980-01-01

    This paper briefly covers aspects related to propeller performance by means of a review of propeller methodologies; presentation of wind tunnel propeller performance data taken in the NASA Lewis Research Center 10 x 10 wind tunnel; discussion of the predominent limitations of existing propeller performance methodologies; and a brief review of airfoil developments appropriate for propeller applications.

  2. Scenario development methodologies

    International Nuclear Information System (INIS)

    Eng, T.; Hudson, J.; Stephansson, O.

    1994-11-01

    In the period 1981-1994, SKB has studied several methodologies to systematize and visualize all the features, events and processes (FEPs) that can influence a repository for radioactive waste in the future. All the work performed is based on the terminology and basic findings in the joint SKI/SKB work on scenario development presented in the SKB Technical Report 89-35. The methodologies studied are a) Event tree analysis, b) Influence diagrams and c) Rock Engineering Systems (RES) matrices. Each one of the methodologies is explained in this report as well as examples of applications. One chapter is devoted to a comparison between the two most promising methodologies, namely: Influence diagrams and the RES methodology. In conclusion a combination of parts of the Influence diagram and the RES methodology is likely to be a promising approach. 26 refs

  3. Reliability Centered Maintenance - Methodologies

    Science.gov (United States)

    Kammerer, Catherine C.

    2009-01-01

    Journal article about Reliability Centered Maintenance (RCM) methodologies used by United Space Alliance, LLC (USA) in support of the Space Shuttle Program at Kennedy Space Center. The USA Reliability Centered Maintenance program differs from traditional RCM programs because various methodologies are utilized to take advantage of their respective strengths for each application. Based on operational experience, USA has customized the traditional RCM methodology into a streamlined lean logic path and has implemented the use of statistical tools to drive the process. USA RCM has integrated many of the L6S tools into both RCM methodologies. The tools utilized in the Measure, Analyze, and Improve phases of a Lean Six Sigma project lend themselves to application in the RCM process. All USA RCM methodologies meet the requirements defined in SAE JA 1011, Evaluation Criteria for Reliability-Centered Maintenance (RCM) Processes. The proposed article explores these methodologies.

  4. Microeconomic aspects of energy crops cultivation

    International Nuclear Information System (INIS)

    Bartolelli, V.; Mutinati, G.; Pisani, F.

    1992-01-01

    The topic of energy crops, namely of those crops designed to produce biomass to transform into ethanol, has been explored, in Italy and abroad, in all its technical and agronomical aspects. The microeconomic aspect, including the evaluation of convenience for the farmer in adopting such crops, is, on the contrary, less well researched. RENAGRI has developed a research methodology able to give information about the level of convenience of two energy crops (Sweet Sorghum and Topinambour) and has applied it to different Italian agricultural situations, in order to verify the existence of conditions favourable to the cultivation of the two crops, or to indicate the necessity of eventual subvention. (author)

  5. Health economic assessment: a methodological primer.

    Science.gov (United States)

    Simoens, Steven

    2009-12-01

    This review article aims to provide an introduction to the methodology of health economic assessment of a health technology. Attention is paid to defining the fundamental concepts and terms that are relevant to health economic assessments. The article describes the methodology underlying a cost study (identification, measurement and valuation of resource use, calculation of costs), an economic evaluation (type of economic evaluation, the cost-effectiveness plane, trial- and model-based economic evaluation, discounting, sensitivity analysis, incremental analysis), and a budget impact analysis. Key references are provided for those readers who wish a more advanced understanding of health economic assessments.

  6. Health Economic Assessment: A Methodological Primer

    Directory of Open Access Journals (Sweden)

    Steven Simoens

    2009-11-01

    Full Text Available This review article aims to provide an introduction to the methodology of health economic assessment of a health technology. Attention is paid to defining the fundamental concepts and terms that are relevant to health economic assessments. The article describes the methodology underlying a cost study (identification, measurement and valuation of resource use, calculation of costs, an economic evaluation (type of economic evaluation, the cost-effectiveness plane, trial- and model-based economic evaluation, discounting, sensitivity analysis, incremental analysis, and a budget impact analysis. Key references are provided for those readers who wish a more advanced understanding of health economic assessments.

  7. Risk-based methodology for USNRC inspections

    International Nuclear Information System (INIS)

    Wong, S.M.; Holahan, G.M.; Chung, J.W.; Johnson, M.R.

    1995-01-01

    This paper describes the development and trial applications of a risk-based methodology to enhance the inspection processes for US nuclear power plants. Objectives of risk-based methods to complement prescriptive engineering approaches in US Nuclear Regulatory Commission (USNRC) inspection programs are presented. Insights from time-dependent risk profiles of plant configurational from Individual Plant Evaluation (IPE) studies were integrated to develop a framework for optimizing inspection efforts in NRC regulatory initiatives. Lessons learned from NRC pilot applications of the risk-based methodology for evaluation of the effectiveness of operational risk management programs at US nuclear power plant sites are also discussed

  8. Aspect-Oriented Programming

    NARCIS (Netherlands)

    Bergmans, Lodewijk; Videira Lopes, Cristina; Moreira, Ana; Demeyer, Serge

    1999-01-01

    Aspect-oriented programming is a promising idea that can improve the quality of software by reduce the problem of code tangling and improving the separation of concerns. At ECOOP'97, the first AOP workshop brought together a number of researchers interested in aspect-orientation. At ECOOP'98, during

  9. Millennial Expectations and Constructivist Methodologies: Their Corresponding Characteristics and Alignment

    Science.gov (United States)

    Carter, Timothy L.

    2008-01-01

    In recent years, much emphasis has been placed on constructivist methodologies and their potential benefit for learners of various ages (Brandt & Perkins, 2000; Brooks, 1990). Although certain aspects of the constructivist paradigm have replaced several aspects of the behaviorist paradigm for a large contingency of stakeholders (particularly,…

  10. PsychotherapyPlus: augmentation of cognitive behavioral therapy (CBT) with prefrontal transcranial direct current stimulation (tDCS) in major depressive disorder-study design and methodology of a multicenter double-blind randomized placebo-controlled trial.

    Science.gov (United States)

    Bajbouj, Malek; Aust, Sabine; Spies, Jan; Herrera-Melendez, Ana-Lucia; Mayer, Sarah V; Peters, Maike; Plewnia, Christian; Fallgatter, Andreas J; Frase, Lukas; Normann, Claus; Behler, Nora; Wulf, Linda; Brakemeier, Eva-Lotta; Padberg, Frank

    2017-12-06

    Major Depressive Disorder (MDD) is one of the most prevalent psychiatric disorders worldwide. About 20-30% of patients do not respond to the standard psychopharmacological and/or psychotherapeutic interventions. Mounting evidence from neuroimaging studies in MDD patients reveal altered activation patterns in lateral prefrontal brain areas. Successful cognitive behavioral therapy (CBT) is associated with a recovery of these neural alterations. Moreover, it has been demonstrated that transcranial direct current stimulation (tDCS) is capable of influencing prefrontal cortex activity and cognitive functions such as working memory and emotion regulation. Thus, a clinical trial investigating the effects of an antidepressant intervention combining CBT with tDCS seems promising. The present study investigates the antidepressant efficacy of a combined CBT-tDCS intervention as compared to CBT with sham-tDCS or CBT alone. A total of 192 patients (age range 20-65 years) with MDD (Hamilton Depression Rating Scale Score ≥ 15, 21-item version) will be recruited at four study sites across Germany (Berlin, Munich, Tuebingen, and Freiburg) and randomly assigned to one of the following three treatment arms: (1) CBT + active tDCS; (2) CBT + sham-tDCS; and (3) CBT alone. All participants will attend a 6-week psychotherapeutic intervention comprising 12 sessions of CBT each lasting 100 min in a closed group setting. tDCS will be applied simultaneously with CBT. Active tDCS includes stimulation with an intensity of 2 mA for 30 min with the anode placed over F3 and the cathode over F4 according to the EEG 10-20 system, if assigned. The primary outcome measure is the change in Montgomery-Åsberg Depression Rating Scale scores from baseline to 6, 18, and 30 weeks after the first session. Participants also undergo pre- and post-treatment neuropsychological testing and functional magnetic resonance imaging (fMRI) to assess changes in prefrontal functioning and connectivity

  11. Clinical Trials

    Medline Plus

    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  4. Introduction to LCA Methodology

    DEFF Research Database (Denmark)

    Hauschild, Michael Z.

    2018-01-01

    In order to offer the reader an overview of the LCA methodology in the preparation of the more detailed description of its different phases, a brief introduction is given to the methodological framework according to the ISO 14040 standard and the main elements of each of its phases. Emphasis...

  5. Methodologies, languages and tools

    International Nuclear Information System (INIS)

    Amako, Katsuya

    1994-01-01

    This is a summary of the open-quotes Methodologies, Languages and Toolsclose quotes session in the CHEP'94 conference. All the contributions to methodologies and languages are relevant to the object-oriented approach. Other topics presented are related to various software tools in the down-sized computing environment

  6. 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.

  7. Menopause and Methodological Doubt

    Science.gov (United States)

    Spence, Sheila

    2005-01-01

    Menopause and methodological doubt begins by making a tongue-in-cheek comparison between Descartes' methodological doubt and the self-doubt that can arise around menopause. A hermeneutic approach is taken in which Cartesian dualism and its implications for the way women are viewed in society are examined, both through the experiences of women…

  8. VEM: Virtual Enterprise Methodology

    DEFF Research Database (Denmark)

    Tølle, Martin; Vesterager, Johan

    2003-01-01

    This chapter presents a virtual enterprise methodology (VEM) that outlines activities to consider when setting up and managing virtual enterprises (VEs). As a methodology the VEM helps companies to ask the right questions when preparing for and setting up an enterprise network, which works...

  9. Data Centric Development Methodology

    Science.gov (United States)

    Khoury, Fadi E.

    2012-01-01

    Data centric applications, an important effort of software development in large organizations, have been mostly adopting a software methodology, such as a waterfall or Rational Unified Process, as the framework for its development. These methodologies could work on structural, procedural, or object oriented based applications, but fails to capture…

  10. The Methodology of Magpies

    Science.gov (United States)

    Carter, Susan

    2014-01-01

    Arts/Humanities researchers frequently do not explain methodology overtly; instead, they "perform" it through their use of language, textual and historic cross-reference, and theory. Here, methodologies from literary studies are shown to add to Higher Education (HE) an exegetical and critically pluralist approach. This includes…

  11. Virginia Woolf's Literary Aesthetics: The Epistemological Aspect

    OpenAIRE

    Bartkuvienė, Linara

    2012-01-01

    The thesis focuses on the epistemological aspect of Virginia Woolf‘s literary aethetics. The research problem of the thesis is an attempt at the conceptualization of the nature of knowledge in Woolf‘s writing and Bertrand Russell‘s philosophy. Methodologically and theoretically, the semantic relationship between Woolf‘s aesthetics and Russell‘s epistemology is closely examined within the framework of the history of ideas. The thesis arrives at the conclusion that Woolf‘s understanding of real...

  12. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  13. Organisational aspects, research required, educational aspects

    International Nuclear Information System (INIS)

    Rueterjans, H.

    1987-01-01

    In addition to the clinical testing of NMR imaging, there were activities for studying the basic principles of NMR spectroscopy, also for routine applications in university clinics and larger hospitals. Equipment is available now at different places; research projects should be coordinated in order to ensure direct access to the equipment for a sufficient, task-specific period of time. There is demand for research in this field in the Federal Republic of Germany. Education and further training should be organised taking into account physical and medical aspects. (TRV) [de

  14. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  15. Methodological Reflections: Inter- ethnic Research

    DEFF Research Database (Denmark)

    Singla, Rashmi

    2010-01-01

    with both youth and the parental generation with ethnic minority background in Denmark. These reflections include implications and challenges related to researcher’s national, ethnic background and educational, professional position in encounter with   diverse ‘researched persons’ such as youth......This article reflects on the methodological and epistemological aspects of the ethical issues involved in encounters between researcher and research participants with ethnic minority background in contexts with diversity. Specific challenges involved in longitudinal research (10 - 15 years......) are also considered. The issues related to the social relevance of the research deriving from psycho political validity implying consideration of power dynamics in the personal, relational and collective domains are included. The primary basis for these reflections is a follow-up study concerning young...

  16. Inventory differences: An evaluation methodology

    International Nuclear Information System (INIS)

    Heinberg, C.L.; Roberts, N.J.

    1987-01-01

    This paper discusses an evaluation methodology which is used for inventory differences at the Los Alamos National Laboratory. It is recognized that there are various methods which can be, and are being, used to evaluate process inventory differences at DOE facilities. The purpose of this paper is to share our thoughts on the subject and our techniques with those who are responsible for the evaluation of inventory differences at their facility. One of the most dangerous aspects of any evaluation technique, especially one as complex as most inventory difference evaluations tend to be, is to fail to look at the tools being used as indicators. There is a tendency to look at the results of an evaluation by one technique as an absolute. At the Los Alamos National Laboratory, several tools are used and the final evaluation is based on a combination of the observed results of a many-faceted evaluation. The tools used and some examples are presented

  17. Directions for new developments on statistical design and analysis of small population group trials.

    Science.gov (United States)

    Hilgers, Ralf-Dieter; Roes, Kit; Stallard, Nigel

    2016-06-14

    Most statistical design and analysis methods for clinical trials have been developed and evaluated where at least several hundreds of patients could be recruited. These methods may not be suitable to evaluate therapies if the sample size is unavoidably small, which is usually termed by small populations. The specific sample size cut off, where the standard methods fail, needs to be investigated. In this paper, the authors present their view on new developments for design and analysis of clinical trials in small population groups, where conventional statistical methods may be inappropriate, e.g., because of lack of power or poor adherence to asymptotic approximations due to sample size restrictions. Following the EMA/CHMP guideline on clinical trials in small populations, we consider directions for new developments in the area of statistical methodology for design and analysis of small population clinical trials. We relate the findings to the research activities of three projects, Asterix, IDeAl, and InSPiRe, which have received funding since 2013 within the FP7-HEALTH-2013-INNOVATION-1 framework of the EU. As not all aspects of the wide research area of small population clinical trials can be addressed, we focus on areas where we feel advances are needed and feasible. The general framework of the EMA/CHMP guideline on small population clinical trials stimulates a number of research areas. These serve as the basis for the three projects, Asterix, IDeAl, and InSPiRe, which use various approaches to develop new statistical methodology for design and analysis of small population clinical trials. Small population clinical trials refer to trials with a limited number of patients. Small populations may result form rare diseases or specific subtypes of more common diseases. New statistical methodology needs to be tailored to these specific situations. The main results from the three projects will constitute a useful toolbox for improved design and analysis of small

  18. Radiotherapy of abdomen with precise renal assessment with SPECT/CT imaging (RAPRASI): design and methodology of a prospective trial to improve the understanding of kidney radiation dose response

    International Nuclear Information System (INIS)

    Lopez-Gaitan, Juanita; O’Mara, Brenton; Chu, Julie; Faggian, Jessica; Williams, Luke; Hofman, Michael S; Spry, Nigel A; Ebert, Martin A; Robins, Peter; Boucek, Jan; Leong, Trevor; Willis, David; Bydder, Sean; Podias, Peter; Waters, Gemma

    2013-01-01

    of the SPECT/CT provides the anatomical reference of the kidney’s position. The data is intended to reveal changes in regional kidney function over the study period after the radiotherapy. These SPECT/CT scans, co-registered with the radiotherapy treatment plan, will provide spatial correlation between the radiation dose and regional renal function as assessed by SPECT/CT. From this correlation, renal response patterns will likely be identified with the purpose of developing a predictive model. Australian New Zealand Clinical Trials Registry: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id

  19. Summary on Theoretical Aspects

    CERN Document Server

    Soffer, Jacques

    2010-01-01

    During the five days of this conference a very dense scientific program has enlighted our research fields, with the presentation of large number of interesting lectures. I will try to summarize the theoretical aspects of some of these new results.

  20. General safety aspects

    International Nuclear Information System (INIS)

    1998-01-01

    In this part next aspects are described: (1) Priority to safety; (2) Financial and human resources;; (3) Human factor; (4) Operator's quality assurance system; (5) Safety assessment and Verification; (6) Radiation protection and (7) Emergency preparedness

  1. Criminal aspects domestic violence

    OpenAIRE

    Smetanová, Kristina

    2013-01-01

    Smetanová, Kristina. Criminal aspects of domestic violence The topic of this thesis is the criminal aspects of domestic violence. The aim of the thesis is to describe this dangerous and complicated social problem and focus on outlining the possibilities of protection under Czech criminal law. The thesis consists of eight chapters. The first chapter explains what the domestic violence is and which sources, types and characters does it have.The second chapter shows who can be the violent person...

  2. Foundational aspects of security

    DEFF Research Database (Denmark)

    Chatzikokolakis, Konstantinos; Mödersheim, Sebastian Alexander; Palamidessi, Catuscia

    2014-01-01

    This Special Issue of the Journal of Computer Security focuses on foundational aspects of security, which in recent years have helped change much of the way we think about and approach system security.......This Special Issue of the Journal of Computer Security focuses on foundational aspects of security, which in recent years have helped change much of the way we think about and approach system security....

  3. Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.

    Science.gov (United States)

    Mahon, Susan; Krishnamurthi, Rita; Vandal, Alain; Witt, Emma; Barker-Collo, Suzanne; Parmar, Priya; Theadom, Alice; Barber, Alan; Arroll, Bruce; Rush, Elaine; Elder, Hinemoa; Dyer, Jesse; Feigin, Valery

    2018-02-01

    Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management. Health Wellness Coaching is an innovative, patient-focused and cost-effective, multidimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes and has been shown to improve health and enhance well-being. Aims and/or hypothesis To determine the effectiveness of Health Wellness Coaching for primary stroke prevention in an ethnically diverse sample including Māori, Pacific Island, New Zealand European and Asian participants. Design A parallel, prospective, randomized, open-treatment, single-blinded end-point trial. Participants include 320 adults with absolute five-year cardiovascular disease risk ≥ 10%, calculated using the PREDICT web-based clinical tool. Randomization will be to Health Wellness Coaching or usual care groups. Participants randomized to Health Wellness Coaching will receive 15 coaching sessions over nine months. Study outcomes A substantial relative risk reduction of five-year cardiovascular disease risk at nine months post-randomization, which is defined as 10% relative risk reduction among those at moderate five-year cardiovascular disease risk (10-15%) and 25% among those at high risk (>15%). Discussion This clinical trial will determine whether Health Wellness Coaching is an effective intervention for reducing modifiable risk factors, and hence decrease the risk of stroke and cardiovascular disease.

  4. Pesquisa qualitativa em Educação Matemática a distância: aspectos importantes do uso do Role Playing Game como procedimento metodológico de pesquisa Qualitative research in distance Mathematics Education: important aspects of the Role Playing Game as research methodological procedure

    Directory of Open Access Journals (Sweden)

    Maurício Rosa

    2012-09-01

    Full Text Available Este artigo evidencia aspectos do Role Playing Game (RPG, jogo de representação de personagens, que o tornam um importante procedimento de investigação em termos de Pesquisa Qualitativa em Educação (no caso, Educação Matemática a Distância. Esse jogo foi adotado em uma pesquisa (ROSA, 2008 que estudou as relações estabelecidas entre a construção de identidades online e o ensino e a aprendizagem do conceito de Integral Definida (conceito do Cálculo Diferencial e Integral em um curso a distância. Assim, a partir dessa investigação que utilizou o RPG jogado a distância, via chat, como procedimento de coleta de dados, discutimos a inserção desse jogo como procedimento metodológico de pesquisa em Educação Matemática a Distância e caracterizamos como esse processo liga-se a questões referentes à Pesquisa Qualitativa nesse novo cenário: o ciberespaço. Logo, assumimos que adotar o RPG como procedimento de pesquisa favorece tanto o pesquisador, quanto os sujeitos investigados, em termos de mostrarem-se como "diferentes" mesmo sendo "os mesmos" (ROSA, 2008 e isso potencializa a produção do conhecimento matemático, bem como a análise das ações e possibilidades educacionais vislumbradas pelo ser online que se apresenta no ambiente natural apresentado. Também apontamos a adoção do RPG como fator que impele e amplia a concepção pós-estruturalista de Educação que, em ambientes virtuais, cada vez mais, vem destacando e estabelecendo uma amplitude de investigação que transforma esse espaço imaginativo e surpreendente em um ambiente natural de pesquisa.This article highlights aspects of the Role Playing Game (RPG, which make an important procedure in terms of research on Qualitative Research in Distance Education (in this case, Mathematics Education. This game was used in a research (ROSA, 2008 that studied the relations between the construction of online identities and teaching and learning of the concept of

  5. Safeguarding the fuel cycle: Methodologies

    International Nuclear Information System (INIS)

    Gruemm, H.

    1984-01-01

    The effectiveness of IAEA safeguards is characterized by the extent to which they achieve their basic purpose - credible verification that no nuclear material is diverted from peaceful uses. This effectiveness depends inter alia but significantly on manpower in terms of the number and qualifications of inspectors. Staff increases will be required to improve effectiveness further, if this is requested by Member States, as well as to take into account new facilities expected to come under safeguards in the future. However, they are difficult to achieve due to financial constraints set by the IAEA budget. As a consequence, much has been done and is being undertaken to improve utilization of available manpower, including standardization of inspection procedures; improvement of management practices and training; rationalization of planning, reporting, and evaluation of inspection activities; and development of new equipment. This article focuses on certain aspects of the verification methodology presently used and asks: are any modifications of this methodology conceivable that would lead to economies of manpower, without loss of effectiveness. It has been stated in this context that present safeguards approaches are ''facility-oriented'' and that the adoption of a ''fuel cycle-oriented approach'' might bring about the desired savings. Many studies have been devoted to this very interesting suggestion. Up to this moment, no definite answer is available and further studies will be necessary to come to a conclusion. In what follows, the essentials of the problem are explained and some possible paths to a solution are discussed

  6. Methodological developments in searching for studies for systematic reviews: past, present and future?

    Science.gov (United States)

    Lefebvre, Carol; Glanville, Julie; Wieland, L Susan; Coles, Bernadette; Weightman, Alison L

    2013-09-25

    The Cochrane Collaboration was established in 1993, following the opening of the UK Cochrane Centre in 1992, at a time when searching for studies for inclusion in systematic reviews was not well-developed. Review authors largely conducted their own searches or depended on medical librarians, who often possessed limited awareness and experience of systematic reviews. Guidance on the conduct and reporting of searches was limited. When work began to identify reports of randomized controlled trials (RCTs) for inclusion in Cochrane Reviews in 1992, there were only approximately 20,000 reports indexed as RCTs in MEDLINE and none indexed as RCTs in Embase. No search filters had been developed with the aim of identifying all RCTs in MEDLINE or other major databases. This presented The Cochrane Collaboration with a considerable challenge in identifying relevant studies.Over time, the number of studies indexed as RCTs in the major databases has grown considerably and the Cochrane Central Register of Controlled Trials (CENTRAL) has become the best single source of published controlled trials, with approximately 700,000 records, including records identified by the Collaboration from Embase and MEDLINE. Search filters for various study types, including systematic reviews and the Cochrane Highly Sensitive Search Strategies for RCTs, have been developed. There have been considerable advances in the evidence base for methodological aspects of information retrieval. The Cochrane Handbook for Systematic Reviews of Interventions now provides detailed guidance on the conduct and reporting of searches. Initiatives across The Cochrane Collaboration to improve the quality inter alia of information retrieval include: the recently introduced Methodological Expectations for Cochrane Intervention Reviews (MECIR) programme, which stipulates 'mandatory' and 'highly desirable' standards for various aspects of review conduct and reporting including searching, the development of Standard Training

  7. Clinical Trials

    Medline Plus

    Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  10. Design Methodology - Design Synthesis

    DEFF Research Database (Denmark)

    Andreasen, Mogens Myrup

    2003-01-01

    Design Methodology is part of our practice and our knowledge about designing, and it has been strongly supported by the establishing and work of a design research community. The aim of this article is to broaden the reader¿s view of designing and Design Methodology. This is done by sketching...... the development of Design Methodology through time and sketching some important approaches and methods. The development is mainly forced by changing industrial condition, by the growth of IT support for designing, but also by the growth of insight into designing created by design researchers.......ABSTRACT Design Methodology shall be seen as our understanding of how to design; it is an early (emerging late 60ies) and original articulation of teachable and learnable methodics. The insight is based upon two sources: the nature of the designed artefacts and the nature of human designing. Today...

  11. GPS system simulation methodology

    Science.gov (United States)

    Ewing, Thomas F.

    1993-01-01

    The following topics are presented: background; Global Positioning System (GPS) methodology overview; the graphical user interface (GUI); current models; application to space nuclear power/propulsion; and interfacing requirements. The discussion is presented in vugraph form.

  12. Hazard classification methodology

    International Nuclear Information System (INIS)

    Brereton, S.J.

    1996-01-01

    This document outlines the hazard classification methodology used to determine the hazard classification of the NIF LTAB, OAB, and the support facilities on the basis of radionuclides and chemicals. The hazard classification determines the safety analysis requirements for a facility

  13. Nonlinear Image Denoising Methodologies

    National Research Council Canada - National Science Library

    Yufang, Bao

    2002-01-01

    In this thesis, we propose a theoretical as well as practical framework to combine geometric prior information to a statistical/probabilistic methodology in the investigation of a denoising problem...

  14. Multivariate temporal pattern analysis applied to the study of rat behavior in the elevated plus maze: methodological and conceptual highlights.

    Science.gov (United States)

    Casarrubea, M; Magnusson, M S; Roy, V; Arabo, A; Sorbera, F; Santangelo, A; Faulisi, F; Crescimanno, G

    2014-08-30

    Aim of this article is to illustrate the application of a multivariate approach known as t-pattern analysis in the study of rat behavior in elevated plus maze. By means of this multivariate approach, significant relationships among behavioral events in the course of time can be described. Both quantitative and t-pattern analyses were utilized to analyze data obtained from fifteen male Wistar rats following a trial 1-trial 2 protocol. In trial 2, in comparison with the initial exposure, mean occurrences of behavioral elements performed in protected zones of the maze showed a significant increase counterbalanced by a significant decrease of mean occurrences of behavioral elements in unprotected zones. Multivariate t-pattern analysis, in trial 1, revealed the presence of 134 t-patterns of different composition. In trial 2, the temporal structure of behavior become more simple, being present only 32 different t-patterns. Behavioral strings and stripes (i.e. graphical representation of each t-pattern onset) of all t-patterns were presented both for trial 1 and trial 2 as well. Finally, percent distributions in the three zones of the maze show a clear-cut increase of t-patterns in closed arm and a significant reduction in the remaining zones. Results show that previous experience deeply modifies the temporal structure of rat behavior in the elevated plus maze. In addition, this article, by highlighting several conceptual, methodological and illustrative aspects on the utilization of t-pattern analysis, could represent a useful background to employ such a refined approach in the study of rat behavior in elevated plus maze. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Update on TROG trials

    International Nuclear Information System (INIS)

    Joseph, D.

    2001-01-01

    Full text: Validation of treatment methodologies can only be achieved in the context of unambiguous, efficiently managed, randomised and controlled clinical trials. Since 1991, the Trans-Tasman Radiation Oncology Group (TROG) has coordinated over 29 protocols in radiation oncology, including several key randomised controlled trials. The impetus behind TROG is the establishment of an evidence base for particular approaches to radiotherapy and its adjunct use with alternative and complementary treatment methods. As the level of technology incorporated into radiotherapy continues to increase, as the need for improved accuracy in dose assessment increases and as the requirements of realistic quality assurance (QA) for clinical trials becomes more demanding it is imperative that all professionals involved in radiotherapy, including physicists, become actively involved in the QA of trials. This is particularly important for large scale multi-centre trials which intend to prove the benefits of particular treatment approaches on a national or international stage rather then in the context of a single clinic. This talk will: 1. Examine the outcomes of TROG trials to date in terms of the information obtained. 2. Briefly consider current and impending TROG trials and their requirements in terms of clinical and physics input. 3. Examine the results of international clinical trials in terms of the influence they have had on radiotherapy practice and health outcomes, and the advantages they have obtained by consistent co-operation between clinical and technological staff. 4. Consider the benefits of multi-centre clinical trials and the QA controls that are necessary to ensure accuracy of resulting recommendations. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  16. Symbiotic empirical ethics: a practical methodology.

    Science.gov (United States)

    Frith, Lucy

    2012-05-01

    Like any discipline, bioethics is a developing field of academic inquiry; and recent trends in scholarship have been towards more engagement with empirical research. This 'empirical turn' has provoked extensive debate over how such 'descriptive' research carried out in the social sciences contributes to the distinctively normative aspect of bioethics. This paper will address this issue by developing a practical research methodology for the inclusion of data from social science studies into ethical deliberation. This methodology will be based on a naturalistic conception of ethical theory that sees practice as informing theory just as theory informs practice - the two are symbiotically related. From this engagement with practice, the ways that such theories need to be extended and developed can be determined. This is a practical methodology for integrating theory and practice that can be used in empirical studies, one that uses ethical theory both to explore the data and to draw normative conclusions. © 2010 Blackwell Publishing Ltd.

  17. Cognitive aspects of color

    Science.gov (United States)

    Derefeldt, Gunilla A. M.; Menu, Jean-Pierre; Swartling, Tiina

    1995-04-01

    This report surveys cognitive aspects of color in terms of behavioral, neuropsychological, and neurophysiological data. Color is usually defined as psychophysical color or as perceived color. Behavioral data on categorical color perception, absolute judgement of colors, color coding, visual search, and visual awareness refer to the more cognitive aspects of color. These are of major importance in visual synthesis and spatial organization, as already shown by the Gestalt psychologists. Neuropsychological and neurophysiological findings provide evidence for an interrelation between cognitive color and spatial organization. Color also enhances planning strategies, as has been shown by studies on color and eye movements. Memory colors and the color- language connections in the brain also belong among the cognitive aspects of color.

  18. Organisational aspects of care.

    Science.gov (United States)

    Bloomfield, Jacqueline; Pegram, Anne

    2015-03-04

    Organisational aspects of care, the second essential skills cluster, identifies the need for registered nurses to systematically assess, plan and provide holistic patient care in accordance with individual needs. Safeguarding, supporting and protecting adults and children in vulnerable situations; leading, co-ordinating and managing care; functioning as an effective and confident member of the multidisciplinary team; and managing risk while maintaining a safe environment for patients and colleagues, are vital aspects of this cluster. This article discusses the roles and responsibilities of the newly registered graduate nurse. Throughout their education, nursing students work towards attaining this knowledge and these skills in preparation for their future roles as nurses.

  19. Assessing quality of reports on randomized clinical trials in nursing journals.

    Science.gov (United States)

    Parent, Nicole; Hanley, James A

    2009-01-01

    Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

  20. Methodology. Volume 3

    Science.gov (United States)

    1997-02-01

    and supporting technical architectures » Evolution with changing needs and technology » Maturation to achieve continuous improvement • Instituitional ...implementation issues » Institutional arrangements » Financial aspects » Scheduling matters – Such factors must be addressed to complete the

  1. TRANSCENDENTAL ASPECTS OF GENDER

    Directory of Open Access Journals (Sweden)

    Volodymyr V. Khmel

    2014-06-01

    Full Text Available This paper aims to analyze the basic principles of gender philosophy applying methodological tools of communicative pragmatics; to demonstrate how gender construct can provide gender humanism formation as one of the ideals of democratic society; to specify gender glossary terms such as “gender democracy”, “gender equality” and “gender justice”. Methodology. In order to investigate a theoretical framework in feminist philosophy, methodological tools of communicative pragmatics and discursive ethics that were elaborated by modern German philosophers J. Habermas, K.-O. Apel for analyzing ethical gender principles and their legitimation ways have been used in this research. Scientific novelty. Based on methodological differences in concepts of J. Habermas and K.-O. Apel, two opposite approaches to gender concept analysis – rational and pragmatic (Habermas and transcendental conceptual (K.-O. Apel have been found out. The article helps to specify the framework of categories and concepts. According to the legitimation way of gender ethical theory it was discovered that such notions as “gender democracy”, “gender equality” and “gender justice” do not have the same meanings. According to the analysis of communicative action program and consensus, the “gender equality” concept by Habermas is an artificial social construct that is methodologically grounded in cognitivism and diminishes the possibilities of gender values legitimation. According to K.-O. Apel, the concept of “gender justice” is based on transcendental moral and ethical sense of opposite genders unity and does not discharge unequal distribution of responsibilities and any invasion as well as represents certain extent of their difference. Conclusions. Fast growing gender changes in the society face ageold drawbacks of moral and spiritual principles of communities, taking into account social and cultural, national and gender identity. Thorough understanding of

  2. LETTERS TO THE EDITORS: Exotic aspects of black holes: an astronaut near the horizon(on the methodological note by A A Grib and Yu V Pavlov "Is it possible to see the infinite future of the Universe when falling into a black hole?")

    Science.gov (United States)

    Cherepashchuk, Anatolii M.

    2009-08-01

    We comment on the methodological note by A A Grib and Yu V Pavlov [Phys. Usp. 52 257 (2009)] to show that its authors are incorrect in understanding a passage that they quote from A M Cherepashchuk's book Black Holes in the Universe (Fryazino: Vek-2, 2005, p.7) and which supposes an astronaut to be at rest in the vicinity of the horizon (not to fall freely into a black hole!). With this error corrected, Grib and Pavlov's note is quite useful methodologically.

  3. Forty-five years of schizophrenia trials in Italy: a survey

    Directory of Open Access Journals (Sweden)

    Purgato Marianna

    2012-04-01

    Full Text Available Abstract Background Well-designed and properly executed randomized controlled trials (RCTs provide the best evidence on the efficacy of healthcare interventions. Mental health has a strong tradition of using trial to evaluate treatments, but the translation of research to clinical practice is not always easy. Even well-conducted trials do not necessarily address the needs of every day care and trials can reflect local needs and the specific culture in which they are undertaken. Generalizing results to other contexts can become problematic but these trials may, nevertheless, be very helpful within their own context. Moreover, pathways for drug approval can be different depending on local regulatory agencies. Local trials are helpful for decision-making in the region from which they come, but should not be viewed in isolation. National quantity and quality of trials may vary across nations. The aim of this study is to quantify trialing activity in Italy from 1948 until 2009 and to describe characteristics of these trials. In addition, we evaluated change over time in three keys aspects: sample size, follow-up duration, and number of outcomes. Methods We used the Cochrane Schizophrenia Group's register that contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness. Randomized controlled trials and controlled clinical trials undertaken in Italy and involving pharmacological interventions were included. Results The original search identified 155 records of potentially eligible studies, 74 of which were excluded because do not meet inclusion criteria. A total of 81 studies were included in the analysis. The majority of trials were conducted in north Italy, and published in international journals between 1981 and 1995. The majority of studies (52 out of 81 used standardized diagnostic criteria for schizophrenia disorder. They were defined as randomized and used blind methods to administer

  4. 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.

  5. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

    Science.gov (United States)

    Pyatak, Elizabeth A; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A; Wood, Jamie R; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L

    2017-03-01

    This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.

    Directory of Open Access Journals (Sweden)

    Felicity L Bishop

    Full Text Available Placebo groups are used in randomised clinical trials (RCTs to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.We conducted a content analysis of 45 Participant Information Leaflets (PILs using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database. Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%, but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001 and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001 or adverse effects (4 vs. 39, p<001. 8 PILs (18% explicitly stated that the placebo treatment was either undesirable or ineffective.PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled

  7. Tense, aspect, and modality

    NARCIS (Netherlands)

    Pfau, R.; Steinbach, M.; Woll, B.; Pfau, R.; Steinbach, M.; Woll, B.

    2012-01-01

    Cross-linguistically, the grammatical categories tense, aspect, and modality - when they are overtly expressed - are generally realized by free morphemes (such as adverbials and auxiliaries) or by bound inflectional markers. The discussion in this chapter will make clear that this generalization

  8. Toxicological aspects of water

    International Nuclear Information System (INIS)

    Garcia Puertas, P.

    1991-01-01

    Different toxicological aspects of water have been studied, remarking the activity of various chemical substances in the organism. These substances are divided in: trace metals (Sb, As, Cd, Zn, Cu, Cr, Fe, Mn, Hg, Ni, Pb, Se), other contaminants (CN-, polycyclic aromatic hydrocarbons, phenols, pesticides, detergents) and radioactivity. Finally, some considerations on this subject are made [es

  9. Aspects of strangeness

    International Nuclear Information System (INIS)

    Dover, C.B.

    1995-01-01

    We review various aspects of strangeness production in relativistic heavy ion collisions from AGS to CERN energies. The experimental data are briefly summarized and various possible theoretical interpretations of these data are evaluated, such as quark-gluon- plasma (QGP), hadron gas (HG) thermal models, or event generators (cascade models). Some comments on the production of strange clusters are offered

  10. Aspect-Oriented Programming

    NARCIS (Netherlands)

    Lopes, C.; Bergmans, Lodewijk; Lopes, C.

    1999-01-01

    Aspect-oriented programming is a promising idea that can improve the quality of software by reduce the problem of code tangling and improving the separation of concerns. At ECOOP’97, the first AOP workshop brought together a number of researchers interested in aspectorientation. At ECOOP’98, during

  11. Gout. Radiological aspects

    International Nuclear Information System (INIS)

    Restrepo Suarez, Jose Felix; Pena Cortes, Mario; Rondon Herrera, Federico; Iglesias Gamarra, Antonio; Calvo Paramo, Enrique

    2000-01-01

    In this paper we reviewed the clinical and radiological aspects of gout, showing the most frequent radiological findings that can guide to the correct diagnosis of the disease. The cases that we presented here have been analyzed for many years in our rheumatology service, Universidad Nacional de Colombia, Hospital San Juan de Dios, Bogota

  12. Medical Aspects of Surfing.

    Science.gov (United States)

    Renneker, Mark

    1987-01-01

    The medical aspects of surfing include ear and eye injuries and sprains and strains of the lower back and neck, as well as skin cancer from exposure to the sun. Treatment, rehabilitation, and prevention of these problems are discussed. Surfing is recommended as part of an exercise program for reasonably healthy people. (Author/MT)

  13. Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

    Science.gov (United States)

    Bradt, Joke

    2012-01-01

    Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

  14. Combining dosimetry and toxicity: analysis of two UK phase III clinical trials

    International Nuclear Information System (INIS)

    Gulliford, Sarah L

    2014-01-01

    There are many advantages to performing a clinical trial when implementing a novel radiotherapy technique. The clinical trials framework enables the safety and efficacy of the 'experimental arm' to be tested and ensures practical support, rigorous quality control and data monitoring for participating centres. In addition to the clinical and follow-up data collected from patients within the trial, it is also possible to collect 3-D dosimetric information from the corresponding radiotherapy treatment plans. Analysing the combination of dosimetric, clinical and follow-up data enhances the understanding of the relationship between the dose delivered to both the target and normal tissue structures and reported outcomes and toxicity. Aspects of the collection, collation and analysis of data from two UK multicentre Phase III radiotherapy trials are presented here. MRC-RT01 dose-escalation prostate radiotherapy trial ISRCTN47772397 was one of the first UK multi-centre radiotherapy trials to collect 3-D dosimetric data. A number of different analysis methodologies were implemented to investigate the relationship between the dose distribution to the rectum and specific rectal toxicities. More recently data was collected from the PARSPORT trial (Parotid Sparing IMRT vs conventional head and neck radiotherapy) ISRCTN48243537. In addition to the planned analysis, dosimetric analysis was employed to investigate an unexpected finding that acute fatigue was more prevalent in the IMRT arm of the trial. It can be challenging to collect 3-D dosimetric information from multicentre radiotherapy trials. However, analysing the relationship between dosimetric and toxicity data provides invaluable information which can influence the next generation of radiotherapy techniques.

  15. The policy trail methodology

    DEFF Research Database (Denmark)

    Holford, John; Larson, Anne; Melo, Susana

    of ‘policy trail’, arguing that it can overcome ‘methodological nationalism’ and link structure and agency in research on the ‘European educational space’. The ‘trail’ metaphor, she suggests, captures the intentionality and the erratic character of policy. The trail connects sites and brings about change......, but – although policy may be intended to be linear, with specific outcomes – policy often has to bend, and sometimes meets insurmountable obstacles. This symposium outlines and develops the methodology, but also reports on research undertaken within a major FP7 project (LLLIght’in’Europe, 2012-15) which made use......In recent years, the “policy trail” has been proposed as a methodology appropriate to the shifting and fluid governance of lifelong learning in the late modern world (Holford et al. 2013, Holford et al. 2013, Cort 2014). The contemporary environment is marked by multi-level governance (global...

  16. A história do ensinod e história da educação no Brasil:aspectos teórico-metodológicos de uma pesquisa (1930-2000 - The history of teaching the history of education in Brazil: theoretical and methodological aspects of research (1930-2000

    Directory of Open Access Journals (Sweden)

    Décio Gatti Júnior

    2011-03-01

    Full Text Available Resumo Reflexões sobre a hermenêutica e a heurística que fundamentam investigações sobre os saberes disseminados por meio do ensino da História da Educação nas instituições escolares e universitárias destinadas à formação de professores no Brasil entre 1930 e 2000. Do ponto de vista da hermenêutica parte-se das categorias de: presença, identidade, normas e finalidades, perfil docente e discente,perfil programático e materiais pedagógicos, com as variáveis correspondentes. Do ponto de vista heurístico há documentos variados: bibliografia (livros científicos e manuais pedagógicos, capítulos de livro, artigos etc.; impressos (legislação de ensino, grades curriculares, planos de ensino e de aula etc.; manuscritos (atas, diários de classe, cadernos de alunos etc.; orais (depoimentos de autores de manuais pedagógicos, ex-professores, ex-alunos etc.; iconografia. Preliminarmente, pode-se afirmar que esses aspectos da hermenêutica e da heurística apontam para os seguintes lugares passíveis de prospecção: 1 no ensino ginasial e secundário, tais como a Escola Normal (1932-1970, a Habilitação Específica em Magistério – HEM (1971-1996 e os Centros Específicos de Formação e Aperfeiçoamento do Magistério – CEFAM (décadas de1980-1990; 2 no ensino superior, sobretudo, nos cursos de Pedagogia, de 1939 a 1962 (formação de professores para a Escola Normal e de 1963 aos tempos atuais (formação de professores para a Escola Normal, para a HEM e para as séries iniciais do Ensino Fundamental, bem como, a partir de 1996, o Normal Superior(formação de professores para as primeiras séries do Ensino Fundamental; 3 na pós-graduação stricto sensu (mestrado e doutorado. Palavras-chave: história da educação; disciplina; hermenêutica; heurística.   THE HISTORY OF TEACHING THE HISTORYOF EDUCATION IN BRAZIL:THEORETICAL AND METHODOLOGICAL ASPECTSOF RESEARCH (1930-2000 Abstract Reflections on the hermeneutics and

  17. Changing methodologies in TESOL

    CERN Document Server

    Spiro, Jane

    2013-01-01

    Covering core topics from vocabulary and grammar to teaching, writing speaking and listening, this textbook shows you how to link research to practice in TESOL methodology. It emphasises how current understandings have impacted on the language classroom worldwide and investigates the meaning of 'methods' and 'methodology' and the importance of these for the teacher: as well as the underlying assumptions and beliefs teachers bring to bear in their practice. By introducing you to language teaching approaches, you will explore the way these are influenced by developments in our understanding of l

  18. Creativity in phenomenological methodology

    DEFF Research Database (Denmark)

    Dreyer, Pia; Martinsen, Bente; Norlyk, Annelise

    2014-01-01

    on the methodologies of van Manen, Dahlberg, Lindseth & Norberg, the aim of this paper is to argue that the increased focus on creativity and arts in research methodology is valuable to gain a deeper insight into lived experiences. We illustrate this point through examples from empirical nursing studies, and discuss......Nursing research is often concerned with lived experiences in human life using phenomenological and hermeneutic approaches. These empirical studies may use different creative expressions and art-forms to describe and enhance an embodied and personalised understanding of lived experiences. Drawing...... may support a respectful renewal of phenomenological research traditions in nursing research....

  19. Group sequential and confirmatory adaptive designs in clinical trials

    CERN Document Server

    Wassmer, Gernot

    2016-01-01

    This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods...

  20. Avaliação do impacto do Programa Nacional do Leite em Alagoas, através de métodos isotópicos: aspectos metodológicos e resultados preliminares Isotope methods for evaluating the impact of the National Nutritional Program in Alagoas: methodological aspects and preliminary results

    Directory of Open Access Journals (Sweden)

    Denise Petrucci Gigante

    2002-04-01

    Full Text Available OBJETIVOS: Descrever aspectos metodológicos e resultados preliminares de um estudo de intervenção planejado para medir o impacto de um programa de suplementação alimentar sobre a promoção do crescimento infantil de crianças desnutridas. MÉTODOS: Estudo longitudinal, controlado, desenvolvido no estado de Alagoas, com grupos comparados antes e depois da intervenção. Vinte municípios foram selecionados através de um indicador de cobertura do programa de suplementação alimentar. Essa cobertura foi estimada pela diferença entre a proporção de crianças desnutridas e a proporção de crianças atendidas pelo programa. Os dez municípios com indicador de alta cobertura foram selecionados para o grupo intervenção e aqueles de menor cobertura para o grupo controle. Em cada município do grupo intervenção foram selecionadas 15 crianças ingressando no Programa. Em cada município do grupo controle foram incluídas 15 crianças elegíveis, mas que não conseguiram vaga no Programa. RESULTADOS: Foram aplicados 111 e 102 questionários em crianças dos municípios do grupo intervenção e controle, respectivamente. A comparação em relação às características de base mostra que a distribuição das variáveis demográficas e nutricionais foi semelhante entre as crianças dos grupos intervenção e controle. Por outro lado, as crianças do grupo intervenção são provenientes de famílias com menor renda familiar e seus pais apresentaram menor escolaridade quando comparadas às do grupo controle. CONCLUSÕES: Os resultados preliminares mostram que os grupos são comparáveis em relação às variáveis demográficas e nutricionais e que as diferenças observadas quanto ao nível socioeconômico deverão ser consideradas na análise ajustada, na segunda fase do estudo.OBJECTIVE: To describe methodological aspects and preliminary results of an intervention designed to measure the impact on child growth of nutritional programs

  1. Addressing social aspects associated with wastewater treatment facilities

    International Nuclear Information System (INIS)

    Padilla-Rivera, Alejandro; Morgan-Sagastume, Juan Manuel; Noyola, Adalberto; Güereca, Leonor Patricia

    2016-01-01

    In wastewater treatment facilities (WWTF), technical and financial aspects have been considered a priority, while other issues, such as social aspects, have not been evaluated seriously and there is not an accepted methodology for assessing it. In this work, a methodology focused on social concerns related to WWTF is presented. The methodology proposes the use of 25 indicators as a framework for measuring social performance to evaluate the progress in moving towards sustainability. The methodology was applied to test its applicability and effectiveness in two WWTF in Mexico (urban and rural). This evaluation helped define the key elements, stakeholders and barriers in the facilities. In this context, the urban facility showed a better overall performance, a result that may be explained mainly by the better socioeconomic context of the urban municipality. Finally, the evaluation of social aspects using the semi-qualitative approach proposed in this work allows for a comparison between different facilities and for the identification of strengths and weakness, and it provides an alternative tool for achieving and improving wastewater management. - Highlights: • The methodology proposes 25 indicators as a framework for measuring social performance in wastewater treatment facilities. • The evaluation helped to define the key elements, stakeholders and barriers in the wastewater treatment facilities. • The evaluation of social aspects allows the identification of strengths and weakness for improving wastewater management. • It provides a social profile of the facility that highlights the best and worst performances.

  2. Addressing social aspects associated with wastewater treatment facilities

    Energy Technology Data Exchange (ETDEWEB)

    Padilla-Rivera, Alejandro; Morgan-Sagastume, Juan Manuel; Noyola, Adalberto; Güereca, Leonor Patricia, E-mail: lguerecah@iingen.unam.mx

    2016-02-15

    In wastewater treatment facilities (WWTF), technical and financial aspects have been considered a priority, while other issues, such as social aspects, have not been evaluated seriously and there is not an accepted methodology for assessing it. In this work, a methodology focused on social concerns related to WWTF is presented. The methodology proposes the use of 25 indicators as a framework for measuring social performance to evaluate the progress in moving towards sustainability. The methodology was applied to test its applicability and effectiveness in two WWTF in Mexico (urban and rural). This evaluation helped define the key elements, stakeholders and barriers in the facilities. In this context, the urban facility showed a better overall performance, a result that may be explained mainly by the better socioeconomic context of the urban municipality. Finally, the evaluation of social aspects using the semi-qualitative approach proposed in this work allows for a comparison between different facilities and for the identification of strengths and weakness, and it provides an alternative tool for achieving and improving wastewater management. - Highlights: • The methodology proposes 25 indicators as a framework for measuring social performance in wastewater treatment facilities. • The evaluation helped to define the key elements, stakeholders and barriers in the wastewater treatment facilities. • The evaluation of social aspects allows the identification of strengths and weakness for improving wastewater management. • It provides a social profile of the facility that highlights the best and worst performances.

  3. Clinical Trials

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    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

  4. Clinical Trials

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    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

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    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

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    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  12. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  17. Clinical Trials

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    Full Text Available ... needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ... phase I clinical trials test new treatments in small groups of people for safety and side effects. ...

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    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  19. Clinical Trials

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    Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  20. Clinical Trials

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    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  1. Clinical Trials

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    Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

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    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

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    Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  4. Clinical Trials

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    Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

  5. Clinical Trials

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    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  7. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  8. Clinical Trials

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    Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

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    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

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    Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...

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  20. Clinical Trials

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    Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...