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

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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.

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

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

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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.

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

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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.

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

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

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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…

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

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

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

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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

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

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

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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

[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

The structuralist tradition in economics: methodological and macroeconomics aspects

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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.

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

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.

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.

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

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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.

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....

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

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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.

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.

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...

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,

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 ...

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

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

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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

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...

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

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

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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.

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

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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.…

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

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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.

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)

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)

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.

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.

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.

[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

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.

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...

[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).

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

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

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.

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 ...

[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.

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.

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.

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.

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

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)

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

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...

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

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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

Methodological and ethical aspects of the sexual maturation assessment in adolescents

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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.

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.

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

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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.

Methodology of sustainability accounting

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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.

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

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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.

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.

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

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.

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

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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.

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

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

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.

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

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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.

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

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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.

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.

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

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

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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.

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.

ASPECTS OF CRIMINALISTICS TACTICS RELATED TO WITNESS HEARING

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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

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

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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

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

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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.

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

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

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

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.

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...

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...

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.

NEW CO-EVOLUTION STRATEGIES OF THIRD MILLENNIUM; METHODOLOGICAL ASPECT

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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

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

Chronopolitics: methodological aspects of public policy research

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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.

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

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)

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...

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.

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.

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…

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...

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...

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....

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...

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).

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.

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

Science.gov (United States)

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

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

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.

[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.

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...

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...

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?

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>.

[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.

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.

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.

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

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.

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.

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

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.

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.

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.

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)

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.

The main aspects of methodology of quality management system

Directory of Open Access Journals (Sweden)

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.

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

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

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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

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

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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

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

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

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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

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

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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).

Current trends in Bayesian methodology with applications

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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

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

Philosophers assess randomized clinical trials: the need for dialogue.

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Miké, V

1989-09-01

In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.

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

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…

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

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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.

A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995.

Science.gov (United States)

Dantas, F; Fisher, P; Walach, H; Wieland, F; Rastogi, D P; Teixeira, H; Koster, D; Jansen, J P; Eizayaga, J; Alvarez, M E P; Marim, M; Belon, P; Weckx, L L M

2007-01-01

The quality of information gathered from homeopathic pathogenetic trials (HPTs), also known as 'provings', is fundamental to homeopathy. We systematically reviewed HPTs published in six languages (English, German, Spanish, French, Portuguese and Dutch) from 1945 to 1995, to assess their quality in terms of the validity of the information they provide. The literature was comprehensively searched, only published reports of HPTs were included. Information was extracted by two reviewers per trial using a form with 87 items. Information on: medicines, volunteers, ethical aspects, blinding, randomization, use of placebo, adverse effects, assessments, presentation of data and number of claimed findings were recorded. Methodological quality was assessed by an index including indicators of internal and external validity, personal judgement and comments of reviewers for each study. 156 HPTs on 143 medicines, involving 2815 volunteers, produced 20,538 pathogenetic effects (median 6.5 per volunteer). There was wide variation in methods and results. Sample size (median 15, range 1-103) and trial duration (mean 34 days) were very variable. Most studies had design flaws, particularly absence of proper randomization, blinding, placebo control and criteria for analysis of outcomes. Mean methodological score was 5.6 (range 4-16). More symptoms were reported from HPTs of poor quality than from better ones. In 56% of trials volunteers took placebo. Pathogenetic effects were claimed in 98% of publications. On average about 84% of volunteers receiving active treatment developed symptoms. The quality of reports was in general poor, and much important information was not available. The HPTs were generally of low methodological quality. There is a high incidence of pathogenetic effects in publications and volunteers but this could be attributable to design flaws. Homeopathic medicines, tested in HPTs, appear safe. The central question of whether homeopathic medicines in high dilutions can

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

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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

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

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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.

[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.

Methodological aspects of EEG and Body dynamics measurements during motion.

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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.

Nutritional biomarkers and foodomic methodologies for qualitative and quantitative analysis of bioactive ingredients in dietary intervention studies.

Science.gov (United States)

Puiggròs, Francesc; Solà, Rosa; Bladé, Cinta; Salvadó, Maria-Josepa; Arola, Lluís

2011-10-21

Traditional dietary assessment methods, such as 24-h recalls, weighted food diaries and food frequency questionnaires (FFQs) are highly subjective and impair the assessment of successfully accomplished dietary interventions. Foodomic technologies offer promising methodologies for gathering scientific evidence from clinical trials with sensitive methods (e.g., GC-MS, LC-MS, CE, NMR) to detect and quantify markers of nutrient exposure or subtle changes in dietary patterns. This review provides a summary of recently developed foodomic methodologies for the detection of suggested biomarkers, including the food specificity for each suggested biomarker and a brief description of the key aspects of 24-h recalls that may affect marker detection and stability, such as mixed nutrients and cooking processes. The primary aim of this review is to contribute to the assessment of the metabolic effects of active ingredients and foods using cutting-edge methods to improve approaches to future nutritional programs tailored for health maintenance and disease prevention. Copyright © 2011 Elsevier B.V. All rights reserved.

Research methodological issues in evaluating herbal interventions

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Dipika Bansal

2010-02-01

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

A review of methodologies used in research on cadastral development

DEFF Research Database (Denmark)

Silva, Maria Augusta; Stubkjær, Erik

2002-01-01

to the acceptance of research methodologies needed for cadastral development, and thereby enhance theory in the cadastral domain. The paper reviews nine publica-tions on cadastre and identifies the methodologies used. The review focuses on the institutional, social political and economic aspects of cadastral......World-wide, much attention has been given to cadastral development. As a consequence of experiences made during the last decades, several authors have stated the need of research in the domain of cadastre and proposed methodologies to be used. The purpose of this paper is to contribute...... development, rather than on the technical aspects. The main conclusion of this paper is that the methodologies used are largely those of the social sciences. That agrees with the notion that cadastre relates as much to people and institutions, as it relates to land, and that cadastral systems are shaped...

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.

THE ASSESSMENT METHODOLOGIES PTELR, ADRI AND CAE – THREE METHODOLOGIES FOR COORDINATING THE EFFORTS TO IMPROVE THE ORGANIZATIONAL PROCESSES TO ACHIEVE EXCELLENCE

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Cristina Raluca POPESCU

2015-07-01

Full Text Available In the paper “The Assessment Methodologies PTELR, ADRI and CAE – Three Methodologies for Coordinating the Efforts to Improve the Organizational Processes to Achieve Excellence” the authors present the basic features of the assessment methodologies PTELR, ADRI and CAE that are designed to coordinate the efforts to improve the organizational processes in order to achieve excellence. In the first part of the paper (the introduction of the paper, the authors present the general background concerning the performance of management business processes and the importance of achieving excellence and furthermore correctly assessing/evaluating it. Aspects such as quality, quality control, quality assurance, performance and excellence are brought into discussion in the context generated by globalization, new technologies and new business models. Moreover, aspects regarding the methods employed to ensure the quality, maintaining it and continuous improvements, as well as total quality management, are also main pillars of this current research. In the content of the paper (the assessment methodologies PTELR, ADRI and CAE – as methodologies for coordinating the efforts to improve the organizational processes to achieve excellence, the authors describe the characteristics of the assessment methodologies PTELR, ADRI and CAE from a theoretical point of view.

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.

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.

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...

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

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.

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: ...

Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

Science.gov (United States)

Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

2018-01-08

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

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.

Subjective and objective outcomes in randomized clinical trials

DEFF Research Database (Denmark)

Moustgaard, Helene; Bello, Segun; Miller, Franklin G

2014-01-01

explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

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)

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.

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.

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.

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

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.

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....

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.

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

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.

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

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.

Series: Pragmatic trials and real world evidence : Paper 8 Data collection and management Data collection in Pragmatic Trials

NARCIS (Netherlands)

Meinecke, Anna Katharina; Welsing, Paco; Kafatos, George; Burke, Des; Trelle, Sven; Kubin, Maria; Nachbaur, Gaelle; Egger, Matthias; Zuidgeest, Mira

2017-01-01

Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific methodological, operational, regulatory and ethical

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,…

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

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)

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

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.

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

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.

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.

[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.

Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

Science.gov (United States)

Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

2016-01-01

The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. To assess the methodological quality of RCTs published in Spanish-language dermatology journals. By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Modelling and Formal Verification of Timing Aspects in Large PLC Programs

CERN Document Server

Fernandez Adiego, B; Blanco Vinuela, E; Tournier, J-C; Gonzalez Suarez, V M; Blech, J O

2014-01-01

One of the main obstacle that prevents model checking from being widely used in industrial control systems is the complexity of building formal models out of PLC programs, especially when timing aspects need to be integrated. This paper brings an answer to this obstacle by proposing a methodology to model and verify timing aspects of PLC programs. Two approaches are proposed to allow the users to balance the trade-off between the complexity of the model, i.e. its number of states, and the set of specifications possible to be verified. A tool supporting the methodology which allows to produce models for different model checkers directly from PLC programs has been developed. Verification of timing aspects for real-life PLC programs are presented in this paper using NuSMV.

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.

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)

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)

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

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

SOME METHODOLOGICAL ASPECTS OF TRAINING IT PROFESSIONALS

Directory of Open Access Journals (Sweden)

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.

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.

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)

Spanish methodological approach for biosphere assessment of radioactive waste disposal

International Nuclear Information System (INIS)

Agueero, A.; Pinedo, P.; Cancio, D.; Simon, I.; Moraleda, M.; Perez-Sanchez, D.; Trueba, C.

2007-01-01

The development of radioactive waste disposal facilities requires implementation of measures that will afford protection of human health and the environment over a specific temporal frame that depends on the characteristics of the wastes. The repository design is based on a multi-barrier system: (i) the near-field or engineered barrier, (ii) far-field or geological barrier and (iii) the biosphere system. Here, the focus is on the analysis of this last system, the biosphere. A description is provided of conceptual developments, methodological aspects and software tools used to develop the Biosphere Assessment Methodology in the context of high-level waste (HLW) disposal facilities in Spain. This methodology is based on the BIOMASS 'Reference Biospheres Methodology' and provides a logical and systematic approach with supplementary documentation that helps to support the decisions necessary for model development. It follows a five-stage approach, such that a coherent biosphere system description and the corresponding conceptual, mathematical and numerical models can be built. A discussion on the improvements implemented through application of the methodology to case studies in international and national projects is included. Some facets of this methodological approach still require further consideration, principally an enhanced integration of climatology, geography and ecology into models considering evolution of the environment, some aspects of the interface between the geosphere and biosphere, and an accurate quantification of environmental change processes and rates

Spanish methodological approach for biosphere assessment of radioactive waste disposal.

Science.gov (United States)

Agüero, A; Pinedo, P; Cancio, D; Simón, I; Moraleda, M; Pérez-Sánchez, D; Trueba, C

2007-10-01

The development of radioactive waste disposal facilities requires implementation of measures that will afford protection of human health and the environment over a specific temporal frame that depends on the characteristics of the wastes. The repository design is based on a multi-barrier system: (i) the near-field or engineered barrier, (ii) far-field or geological barrier and (iii) the biosphere system. Here, the focus is on the analysis of this last system, the biosphere. A description is provided of conceptual developments, methodological aspects and software tools used to develop the Biosphere Assessment Methodology in the context of high-level waste (HLW) disposal facilities in Spain. This methodology is based on the BIOMASS "Reference Biospheres Methodology" and provides a logical and systematic approach with supplementary documentation that helps to support the decisions necessary for model development. It follows a five-stage approach, such that a coherent biosphere system description and the corresponding conceptual, mathematical and numerical models can be built. A discussion on the improvements implemented through application of the methodology to case studies in international and national projects is included. Some facets of this methodological approach still require further consideration, principally an enhanced integration of climatology, geography and ecology into models considering evolution of the environment, some aspects of the interface between the geosphere and biosphere, and an accurate quantification of environmental change processes and rates.

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 ...

Compliance strategy for statistically based neutron overpower protection safety analysis methodology

International Nuclear Information System (INIS)

Holliday, E.; Phan, B.; Nainer, O.

2009-01-01

The methodology employed in the safety analysis of the slow Loss of Regulation (LOR) event in the OPG and Bruce Power CANDU reactors, referred to as Neutron Overpower Protection (NOP) analysis, is a statistically based methodology. Further enhancement to this methodology includes the use of Extreme Value Statistics (EVS) for the explicit treatment of aleatory and epistemic uncertainties, and probabilistic weighting of the initial core states. A key aspect of this enhanced NOP methodology is to demonstrate adherence, or compliance, with the analysis basis. This paper outlines a compliance strategy capable of accounting for the statistical nature of the enhanced NOP methodology. (author)

Value and Vision-based Methodology in Integrated Design

DEFF Research Database (Denmark)

Tollestrup, Christian

on empirical data from workshop where the Value and Vision-based methodology has been taught. The research approach chosen for this investigation is Action Research, where the researcher plays an active role in generating the data and gains a deeper understanding of the investigated phenomena. The result...... of this thesis is the value transformation from an explicit set of values to a product concept using a vision based concept development methodology based on the Pyramid Model (Lerdahl, 2001) in a design team context. The aim of this thesis is to examine how the process of value transformation is occurring within...... is divided in three; the systemic unfolding of the Value and Vision-based methodology, the structured presentation of practical implementation of the methodology and finally the analysis and conclusion regarding the value transformation, phenomena and learning aspects of the methodology....

Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

Science.gov (United States)

Schnyer, Rosa N; Allen, John J B

2002-10-01

An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

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...

Disposal criticality analysis methodology's principal isotope burnup credit

International Nuclear Information System (INIS)

Doering, T.W.; Thomas, D.A.

2001-01-01

This paper presents the burnup credit aspects of the United States Department of Energy Yucca Mountain Project's methodology for performing criticality analyses for commercial light-water-reactor fuel. The disposal burnup credit methodology uses a 'principal isotope' model, which takes credit for the reduced reactivity associated with the build-up of the primary principal actinides and fission products in irradiated fuel. Burnup credit is important to the disposal criticality analysis methodology and to the design of commercial fuel waste packages. The burnup credit methodology developed for disposal of irradiated commercial nuclear fuel can also be applied to storage and transportation of irradiated commercial nuclear fuel. For all applications a series of loading curves are developed using a best estimate methodology and depending on the application, an additional administrative safety margin may be applied. The burnup credit methodology better represents the 'true' reactivity of the irradiated fuel configuration, and hence the real safety margin, than do evaluations using the 'fresh fuel' assumption. (author)

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

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.…

Constituent aspects of workplace guidance in secondary VET

NARCIS (Netherlands)

Swager, Robert; Klarus, Ruud; Van Merriënboer, Jeroen; Nieuwenhuis, Loek

2018-01-01

Purpose – This paper aims to present an integrated model of workplace guidance to enhance awareness of what constitutes good guidance, to improve workplace guidance practices in vocational education and training. Design/methodology/approach – To identify constituent aspects of workplace guidance,

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.

From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

Science.gov (United States)

Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

2011-01-01

Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

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)

The Societal Nature of Subjectivity: An Interdisciplinary Methodological Challenge

Directory of Open Access Journals (Sweden)

Henning Salling Olesen

2012-09-01

Full Text Available The thematic issue presents a psycho-societal approach to qualitative empirical research in several areas of everyday social life. It is an approach which integrates a theory of subjectivity and an interpretation methodology which integrates hermeneutic experiences from text analysis and psychoanalysis. Its particular focus is on subjectivity—as an aspect of the research object and as an aspect of the research process. By the term "approach" is indicated the intrinsic connection between the theorizing of an empirical object and the reflection of the research process and the epistemic subject. In terms of methodology it revives the themes originally launched in FQS exactly ten years ago: "Subjectivity and Reflectivity in Qualitative Research" (BREUER, MRUCK & ROTH, 2002; MRUCK & BREUER, 2003. This editorial introduction presents the intellectual background of the psycho-societal methodology, reflects on its relevance and critical perspectives in a contemporary landscape of social science, and comments the way in which an international and interdisciplinary research group has developed this approach to profane empirical research. URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs120345

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

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

Science.gov (United States)

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

Diffraction or Reflection? Sketching the Contours of Two Methodologies in Educational Research

Science.gov (United States)

Bozalek, Vivienne; Zembylas, Michalinos

2017-01-01

Internationally, an interest is emerging in a growing body of work on what has become known as "diffractive methodologies" drawing attention to ontological aspects of research. Diffractive methodologies have largely been developed in response to a dissatisfaction with practices of "reflexivity", which are seen to be grounded in…

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...

What can qualitative research do for randomised controlled trials? A systematic mapping review

Science.gov (United States)

O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

2013-01-01

Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles 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, process 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 target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

How completely are physiotherapy interventions described in reports of randomised trials?

Science.gov (United States)

Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M

2016-06-01

Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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.

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,...

HIV vaccine trials: critical issues in informed consent.

Science.gov (United States)

Lindegger, G; Richter, L M

2000-06-01

Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.

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.

Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

Directory of Open Access Journals (Sweden)

Santos-Rey Koldo

2011-02-01

Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

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

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.

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)

Insights from implementation of a risk management methodology

International Nuclear Information System (INIS)

Mahn, J.A.; Germann, R.P.; Jacobs, R.R.

1992-01-01

In 1988, GPU Nuclear (GPUN) Corporation embarked on a research effort to identify or develop an appropriate methodology for proactively managing risks. The objective of this effort was to increase its ability to identify potential risks and to aid resource allocation decision making for risk control. Such a methodology was presented at a risk management symposium sponsored by GPUN in September of 1989. A pilot project based on this methodology has been conducted at GPUN to test and validate the elements of the methodology and to compare the results of its application with current corporate methods for guiding risk decision making. The pilot project also led to a follow-up policy-capturing study to elicit information about the various risk decision-making models of GPUN decision makers. The combination of these endeavors provided an opportunity to gain numerous insights with respect to understanding the real value of a risk management process, obtaining acceptance of and commitment to risk management and improving operational aspects of the methodology

Hypothermia after cardiac arrest should be further evaluated-A systematic review of randomised trials with meta-analysis and trial sequential analysis

DEFF Research Database (Denmark)

Nielsen, Niklas; Friberg, Hans; Gluud, Christian

2011-01-01

BACKGROUND: Guidelines recommend mild induced hypothermia (MIH) to reduce mortality and neurological impairment after out-of-hospital cardiac arrest. Our objective was to systematically evaluate the evidence for MIH taking into consideration the risks of systematic and random error and to GRADE...... the evidence. METHODS: Systematic review with meta-analysis and trial sequential analysis of randomised trials evaluating MIH after cardiac arrest in adults. We searched CENTRAL, MEDLINE, and EMBASE databases until May 2009. Retrieved trials were evaluated with Cochrane methodology. Meta-analytic estimates....... The substantial risk of bias and concerns with directness rated down the quality of the evidence to low. CONCLUSIONS: Evidence regarding MIH after out-of-hospital cardiac arrest is still inconclusive and associated with non-negligible risks of systematic and random errors. Using GRADE-methodology, we conclude...

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

Science.gov (United States)

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

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

Hanford Site baseline risk assessment methodology. Revision 2

Energy Technology Data Exchange (ETDEWEB)

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.

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

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

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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.

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool.

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Ho, Robin S T; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel Y S; Chung, Vincent C H

2015-01-08

Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. To assess the methodological quality of MAs on COPD treatments. A cross-sectional study on MAs of COPD trials. MAs published during 2000-2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods.

Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed

DEFF Research Database (Denmark)

Keus, Frederik; Wetterslev, Jørn; Gluud, Christian

2010-01-01

Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small-incision ......Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small...

Translating between social worlds of policy and everyday life: The development of a group-based method to support policymaking by exploring behavioural aspects of sustainable consumption.

Science.gov (United States)

Horlick-Jones, Tom; Prades, Ana

2015-10-01

A large international literature on how lay citizens make sense of various aspects of science and technology has been generated by investigations which utilise small group methods. Within that literature, focus group and other group-based methods have come to co-exist, and to some extent, hybridise, with the use of small groups in citizen engagement initiatives. In this article, we report on how we drew upon these methodological developments in the design and operationalisation of a policymaking support tool (STAVE). This tool has been developed to gain insight, in a relatively speedy and cost-effective way, into practical details of the everyday lived experience of people's lives, as relating to the sustainability of corresponding practices. An important challenge we faced was how, in Kuhn's terms, to 'translate' between the forms of life corresponding to the world of policymaking and the world of everyday domestic life. We examine conceptual and methodological aspects of how the tool was designed and assembled, and then trialled in the context of active real-world collaborations with policymaking organisations. These trials were implemented in six European countries, where they were used to support work on live policy issues concerned with sustainable consumption. © The Author(s) 2014.

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency

DEFF Research Database (Denmark)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis

2017-01-01

OBJECTIVE: To characterize and quantify barriers towards the publication of academic drug trials. STUDY DESIGN: We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates...... of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines...... agencies since 2004. RESULTS: A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were...

Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

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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.

Single-center trials in neonatology: Issues to consider.

Science.gov (United States)

Sinha, Ian P; Sinha, Sunil K

2015-12-01

Single-center randomized controlled trials confer certain advantages over multi-center trials, in that they are cheaper and easier to design and conduct. However, recent research suggests that single-center trials are likely to overestimate treatment effects. There are notable examples in neonatology where results from multi-center trials have contradicted results of single-center studies. In this paper we discuss issues around external generalizability of single-center studies, and methodological issues that may cause bias. Copyright © 2015 Elsevier Ltd. All rights reserved.

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...

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

Science.gov (United States)

Tavazzi, Luigi

2016-03-01

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

Multicriteria decision methodology for selecting technical alternatives in the Mixed Waste Integrated Program

International Nuclear Information System (INIS)

Ferrada, J.J.; Berry, J.B.

1993-11-01

The US Department of Energy (DOE) Mixed Waste Integrated Program (MWIP) has as one of its tasks the identification of a decision methodology and key decision criteria for the selection methodology. The aim of a multicriteria analysis is to provide an instrument for a systematic evaluation of distinct alternative projects. Determination of this methodology will clarify (1) the factors used to evaluate these alternatives, (2) the evaluator's view of the importance of the factors, and (3) the relative value of each alternative. The selected methodology must consider the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) decision-making criteria for application to the analysis technology subsystems developed by the DOE Office of Technology Development. This report contains a compilation of several decision methodologies developed in various national laboratories, institutions, and universities. The purpose of these methodologies may vary, but the core of the decision attributes are very similar. Six approaches were briefly analyzed; from these six, in addition to recommendations made by the MWIP technical support group leaders and CERCLA, the final decision methodology was extracted. Slight variations are observed in the many methodologies developed by different groups, but most of the analyzed methodologies address similar aspects for the most part. These common aspects were the core of the methodology suggested in this report for use within MWIP for the selection of technologies. The set of criteria compiled and developed for this report have been grouped in five categories: (1) process effectiveness, (2) developmental status, (3) life-cycle cost, (4) implementability, and (5) regulatory compliance

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

Science.gov (United States)

Ho, Vincent K Y

2011-01-01

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

Interfacing system LOCA risk assessment: Methodology and application

International Nuclear Information System (INIS)

Galyean, W.J.; Schroeher, J.A.; Hanson, D.J.

1991-01-01

The United States Nuclear Regulatory Commission (NRC) is sponsoring a research program to develop an improved understanding of the human factors hardware, and accident consequence issues that dominate the risk from an Interfacing Systems Loss-of-Coolant Accident (ISLOCA) at a nuclear power plant. To accomplish this program, a methodology has been developed for estimating the core damage frequency and risk associated with an ISLOCA. The steps of the methodology are described with emphasis on one step which is unique, estimation of the probability of rupture of the low pressure systems. A trial application of the methodology was made for a Pressurized Water Reactor (PWR). The results are believed to be plant specific and indicate that human errors during startup and shutdown could be significant contributors to ISLOCA risk at the plant evaluated. 10 refs

Constituent Aspects of Workplace Guidance in Secondary VET

Science.gov (United States)

Swager, Robert; Klarus, Ruud; van Merriënboer, Jeroen J. G.; Nieuwenhuis, Loek F. M.

2015-01-01

Purpose: This paper aims to present an integrated model of workplace guidance to enhance awareness of what constitutes good guidance, to improve workplace guidance practices in vocational education and training. Design/methodology/approach: To identify constituent aspects of workplace guidance, a systematic search of Web of Science was conducted,…

Quantitative aspects of transuranic and other radionuclide field studies

International Nuclear Information System (INIS)

Gilbert, R.O.

1982-01-01

The purpose of this project is to identify, develop, and communicate statistical methodology for environmental actinide studies. Significant accomplishments for FY 1981 included continued publication of TRAN-STAT (a periodical specializing in the statistical aspects of environmental contaminant studies), continued work on our computer simulation study for evaluating ratios, and review of statistical methodology applicable to environmental radionuclides. Related work for the DOE Division Office of Operational Safety included writing the statistical portion of a decommissioning and decontamination guide, expanding our expertise in Kriging and other spatial pattern statistical methodology applicable to the evaluation of potential environmental hazards, continuing statistical support for the Nevada Applied Ecology Group (NAEG), and providing statistical assistance to PNL's environmental radiological monitoring effort

Ongoing EEG phase as a trial-by-trial predictor of perceptual and attentional variability

Directory of Open Access Journals (Sweden)

Rufin eVanRullen

2011-04-01

Full Text Available Even in well-controlled laboratory environments, apparently identical repetitions of an experimental trial can give rise to highly variable perceptual outcomes and behavioral responses. This variability is generally discarded as a reflection of intrinsic noise in neuronal systems. However, part of this variability may be accounted for by trial-by-trial fluctuations of the phase of ongoing oscillations at the moment of stimulus presentation. For example, the phase of an EEG oscillation reflecting the rapid waxing and waning of sustained attention can predict the perception of a subsequent visual stimulus at threshold. Similar ongoing periodicities account for a portion of the trial-by-trial variability of visual reaction times. We review the available experimental evidence linking ongoing EEG phase to perceptual and attentional variability, and the corresponding methodology. We propose future tests of this relation, and discuss the theoretical implications for understanding the neuronal dynamics of sensory perception.

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

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.

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

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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

Ontological, Epistemological and Methodological Assumptions: Qualitative versus Quantitative

Science.gov (United States)

Ahmed, Abdelhamid

2008-01-01

The review to follow is a comparative analysis of two studies conducted in the field of TESOL in Education published in "TESOL QUARTERLY." The aspects to be compared are as follows. First, a brief description of each study will be presented. Second, the ontological, epistemological and methodological assumptions underlying each study…

Application of a Bayesian model for the quantification of the European methodology for qualification of non-destructive testing

International Nuclear Information System (INIS)

Gandossi, Luca; Simola, Kaisa; Shepherd, Barrie

2010-01-01

The European methodology for qualification of non-destructive testing is a well-established approach adopted by nuclear utilities in many European countries. According to this methodology, qualification is based on a combination of technical justification and practical trials. The methodology is qualitative in nature, and it does not give explicit guidance on how the evidence from the technical justification and results from trials should be weighted. A Bayesian model for the quantification process was presented in a previous paper, proposing a way to combine the 'soft' evidence contained in a technical justification with the 'hard' evidence obtained from practical trials. This paper describes the results of a pilot study in which such a Bayesian model was applied to two realistic Qualification Dossiers by experienced NDT qualification specialists. At the end of the study, recommendations were made and a set of guidelines was developed for the application of the Bayesian model.

Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

Science.gov (United States)

Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

2014-06-01

To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

Positive Aspects of International Student Transitions: A Qualitative Inquiry

Science.gov (United States)

Moores, Lisa; Popadiuk, Natalee

2011-01-01

Despite the considerable growth of the international student population, positive aspects of their experience have received little attention. The current study combines a Critical Incident Technique methodology and a positive psychology lens to explore the cross-cultural transition of seven international students, focusing on facilitative factors,…

The Theory of Effectiveness of the State: Institutional Aspect

Directory of Open Access Journals (Sweden)

Kolesnichenko Irina M.

2016-02-01

Full Text Available The article is devoted to one of the most urgent problems of modern economic theory and practice — effectiveness of the state. The aim of the paper is a comprehensive analysis of institutional aspects of the formation of a new economic theory of effectiveness of the state. To achieve this aim, the author first summarizes the evolution and theoretical and methodological characteristics of the economic theories of the state paying a special attention to the essence of the concept of “state” and focusing on “effectiveness of the state” as a major category of the new economic theory. Then he proceeds to institutional aspects of effectiveness of the state considering it as a specific organization and system of institutions of power and control; defines components of effectiveness of the state generalizing the existing methodological approaches and most importantly — the modern criteria for assessing the effectiveness of the state.

Six methodological steps to build medical data warehouses for research.

Science.gov (United States)

Szirbik, N B; Pelletier, C; Chaussalet, T

2006-09-01

We propose a simple methodology for heterogeneous data collection and central repository-style database design in healthcare. Our method can be used with or without other software development frameworks, and we argue that its application can save a relevant amount of implementation effort. Also, we believe that the method can be used in other fields of research, especially those that have a strong interdisciplinary nature. The idea emerged during a healthcare research project, which consisted among others in grouping information from heterogeneous and distributed information sources. We developed this methodology by the lessons learned when we had to build a data repository, containing information about elderly patients flows in the UK's long-term care system (LTC). We explain thoroughly those aspects that influenced the methodology building. The methodology is defined by six steps, which can be aligned with various iterative development frameworks. We describe here the alignment of our methodology with the RUP (rational unified process) framework. The methodology emphasizes current trends, as early identification of critical requirements, data modelling, close and timely interaction with users and stakeholders, ontology building, quality management, and exception handling. Of a special interest is the ontological engineering aspect, which had the effects with the highest impact after the project. That is, it helped stakeholders to perform better collaborative negotiations that brought better solutions for the overall system investigated. An insight into the problems faced by others helps to lead the negotiators to win-win situations. We consider that this should be the social result of any project that collects data for better decision making that leads finally to enhanced global outcomes.

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)

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

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

An Analytic Network Process approach for the environmental aspect selection problem — A case study for a hand blender

Energy Technology Data Exchange (ETDEWEB)

Bereketli Zafeirakopoulos, Ilke, E-mail: ibereketli@gsu.edu.tr; Erol Genevois, Mujde, E-mail: merol@gsu.edu.tr

2015-09-15

Life Cycle Assessment is a tool to assess, in a systematic way, the environmental aspects and its potential environmental impacts and resources used throughout a product's life cycle. It is widely accepted and considered as one of the most powerful tools to support decision-making processes used in ecodesign and sustainable production in order to learn about the most problematic parts and life cycle phases of a product and to have a projection for future improvements. However, since Life Cycle Assessment is a cost and time intensive method, companies do not intend to carry out a full version of it, except for large corporate ones. Especially for small and medium sized enterprises, which do not have enough budget for and knowledge on sustainable production and ecodesign approaches, focusing only on the most important possible environmental aspect is unavoidable. In this direction, finding the right environmental aspect to work on is crucial for the companies. In this study, a multi-criteria decision-making methodology, Analytic Network Process is proposed to select the most relevant environmental aspect. The proposed methodology aims at providing a simplified environmental assessment to producers. It is applied for a hand blender, which is a member of the Electrical and Electronic Equipment family. The decision criteria for the environmental aspects and relations of dependence are defined. The evaluation is made by the Analytic Network Process in order to create a realistic approach to inter-dependencies among the criteria. The results are computed via the Super Decisions software. Finally, it is observed that the procedure is completed in less time, with less data, with less cost and in a less subjective way than conventional approaches. - Highlights: • We present a simplified environmental assessment methodology to support LCA. • ANP is proposed to select the most relevant environmental aspect. • ANP deals well with the interdependencies between aspects

An Analytic Network Process approach for the environmental aspect selection problem — A case study for a hand blender

International Nuclear Information System (INIS)

Bereketli Zafeirakopoulos, Ilke; Erol Genevois, Mujde

2015-01-01

Life Cycle Assessment is a tool to assess, in a systematic way, the environmental aspects and its potential environmental impacts and resources used throughout a product's life cycle. It is widely accepted and considered as one of the most powerful tools to support decision-making processes used in ecodesign and sustainable production in order to learn about the most problematic parts and life cycle phases of a product and to have a projection for future improvements. However, since Life Cycle Assessment is a cost and time intensive method, companies do not intend to carry out a full version of it, except for large corporate ones. Especially for small and medium sized enterprises, which do not have enough budget for and knowledge on sustainable production and ecodesign approaches, focusing only on the most important possible environmental aspect is unavoidable. In this direction, finding the right environmental aspect to work on is crucial for the companies. In this study, a multi-criteria decision-making methodology, Analytic Network Process is proposed to select the most relevant environmental aspect. The proposed methodology aims at providing a simplified environmental assessment to producers. It is applied for a hand blender, which is a member of the Electrical and Electronic Equipment family. The decision criteria for the environmental aspects and relations of dependence are defined. The evaluation is made by the Analytic Network Process in order to create a realistic approach to inter-dependencies among the criteria. The results are computed via the Super Decisions software. Finally, it is observed that the procedure is completed in less time, with less data, with less cost and in a less subjective way than conventional approaches. - Highlights: • We present a simplified environmental assessment methodology to support LCA. • ANP is proposed to select the most relevant environmental aspect. • ANP deals well with the interdependencies between aspects

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

Science.gov (United States)

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

The Clinical Aspects of Mirror Therapy in Rehabilitation: A Systematic Review of the Literature

Science.gov (United States)

Rothgangel, Andreas Stefan; Braun, Susy M.; Beurskens, Anna J.; Seitz, Rudiger J.; Wade, Derick T.

2011-01-01

The objective of this study was to evaluate the clinical aspects of mirror therapy (MT) interventions after stroke, phantom limb pain and complex regional pain syndrome. A systematic literature search of the Cochrane Database of controlled trials, PubMed/MEDLINE, CINAHL, EMBASE, PsycINFO, PEDro, RehabTrials and Rehadat, was made by two…

Methodology for environmental audit of execution in gas-pipelines and pipelines

International Nuclear Information System (INIS)

Hurtado Palomino, Maria Patricia; Vargas Bejarano, Carlos Hernando

1999-01-01

In first instance the constructive aspects and the environmental impact related with the gas-pipes and pipelines construction are presented; then a methodology to make the environmental audit of execution in gas-pipes and pipelines, is showed. They contemplate four stages basically: planning, pre-auditory, execution and analysis, and post-auditory with their respective activities. Also, it is given to know, generalities of the practical case, to evaluate the applicability of the proposed methodology

Verbal protocols as methodological resources: research evidence

Directory of Open Access Journals (Sweden)

Alessandra Baldo

2012-01-01

Full Text Available This article aims at reflecting on the use of verbal protocols as a methodological resource in qualitative research, more specifically on the aspect regarded as the main limitation of a study about lexical inferencing in L2 (BALDO; VELASQUES, 2010: its subjective trait. The article begins with a brief literature review on protocols, followed by a description of the study in which they were employed as methodological resources. Based on that, protocol subjectivity is illustrated through samples of unparalleled data classification, carried out independently by two researchers. In the final section, the path followed to minimize the problem is presented, intending to contribute to improve efficiency in the use of verbal protocols in future research.

2015 Plan. Project 1: methodology and planning process of the Brazilian electric sector expansion

International Nuclear Information System (INIS)

1993-10-01

The Planning Process of Brazilian Electric Sector Expansion, their normative aspects, instruments, main agents and the planning cycles are described. The methodology of expansion planning is shown, with the interactions of several study areas, electric power market and the used computer models. The forecasts of methodology evolution is also presented. (C.G.C.)

Patient-centered outcomes research in radiology: trends in funding and methodology.

Science.gov (United States)

Lee, Christoph I; Jarvik, Jeffrey G

2014-09-01

The creation of the Patient-Centered Outcomes Research Trust Fund and the Patient-Centered Outcomes Research Institute (PCORI) through the Patient Protection and Affordable Care Act of 2010 presents new opportunities for funding patient-centered comparative effectiveness research (CER) in radiology. We provide an overview of the evolution of federal funding and priorities for CER with a focus on radiology-related priority topics over the last two decades, and discuss the funding processes and methodological standards outlined by PCORI. We introduce key paradigm shifts in research methodology that will be required on the part of radiology health services researchers to obtain competitive federal grant funding in patient-centered outcomes research. These paradigm shifts include direct engagement of patients and other stakeholders at every stage of the research process, from initial conception to dissemination of results. We will also discuss the increasing use of mixed methods and novel trial designs. One of these trial designs, the pragmatic trial, has the potential to be readily applied to evaluating the effectiveness of diagnostic imaging procedures and imaging-based interventions among diverse patient populations in real-world settings. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

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

Methodical principles of assessment of financial compensation for clinical trial volunteer participants

Directory of Open Access Journals (Sweden)

V. Ye. Dobrova

2013-10-01

Full Text Available Introduction. Due to the necessity to obtain the reliable results of a clinical trial and to distribute it to the general population of patients the problem of recruiting the adequate number of individuals to participate in the study as objects of observation in the group receiving the investigational medicinal product or as a member of the control group should to be solved. Aim of study. The aim of our study was to research and to justify practically the methodological approaches to determining financial compensation for participation of volunteers in the clinical trials and the appropriate methods of its calculation. Material and methods. For the purpose of determining the baseline factors for calculating the hourly compensation the survey of healthy volunteers and of expert professionals as well as the analysis of its results have been done. Questioning healthy volunteers regarding their attitudes towards inconvenience and discomfort during participation in clinical trials was held at the Ukrainian clinical research centers. Survey participants number was 99, they were healthy volunteers who took part in the first phase clinical trial or bioequivalence studies. The expert survey included questioning of the 193 professionals from Ukrainian clinical research centers, CRO, pharmaceutical manufacturers – research sponsors and collaborators State Expert Center Ministry of Health of Ukraine, who were involved in the planning, organization, implementation and evaluation of clinical trials as well as their regulatory control. Results of study. Using the method of pairwise comparisons and iterative refinement procedures the collective estimate of experts questionnaire results has been performed, by the results of which the nine indicators have been identified and the importance of each of them as units of discomfort have been established. Motivational factors of voluntary participation in clinical trials have been studied. Motivation system for

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

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

Science.gov (United States)

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

The meaning of dwelling features : Conceptual and methodological issues

NARCIS (Netherlands)

Coolen, H.C.C.H.

2008-01-01

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

Grey literature in meta-analyses of randomized trials of health care interventions.

Science.gov (United States)

Hopewell, S; McDonald, S; Clarke, M; Egger, M

2007-04-18

The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

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

Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview.

Science.gov (United States)

Jensen, Jakob Solgaard; Bielefeldt, Andreas Ørsted; Hróbjartsson, Asbjørn

2017-07-01

Active placebos are control interventions that mimic the side effects of the experimental interventions in randomized trials and are sometimes used to reduce the risk of unblinding. We wanted to assess how often randomized clinical drug trials use active placebo control groups; to provide a catalog, and a characterization, of such trials; and to analyze methodological arguments for and against the use of active placebo. An overview consisting of three thematically linked substudies. In an observational substudy, we assessed the prevalence of active placebo groups based on a random sample of 200 PubMed indexed placebo-controlled randomized drug trials published in October 2013. In a systematic review, we identified and characterized trials with active placebo control groups irrespective of publication time. In a third substudy, we reviewed publications with substantial methodological comments on active placebo groups (searches in PubMed, The Cochrane Library, Google Scholar, and HighWirePress). The prevalence of trials with active placebo groups published in 2013 was 1 out of 200 (95% confidence interval: 0-2), 0.5% (0-1%). We identified and characterized 89 randomized trials (published 1961-2014) using active placebos, for example, antihistamines, anticholinergic drugs, and sedatives. Such trials typically involved a crossover design, the experimental intervention had noticeable side effects, and the outcomes were patient-reported. The use of active placebos was clustered in specific research settings and did not appear to reflect consistently the side effect profile of the experimental intervention, for example, selective serotonin reuptake inhibitors were compared with active placebos in pain trials but not in depression trials. We identified and analyzed 25 methods publications with substantial comments. The main argument for active placebo was to reduce risk of unblinding; the main argument against was the risk of unintended therapeutic effect. Pharmacological

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)

Theory and methodology in predicting the religious tourism in Buddhist regions of Russia

Directory of Open Access Journals (Sweden)

Petr E. Tsarkov

2015-11-01

Full Text Available Article reviews the theoretical and methodological aspects of forecasting the touristic migrations. The theoretical approach is designed according to the anthropological theory of cultural exchange, tourism forecasting methodology developed by the author basing on an interdisciplinary approach. The author facilitates an original approach which assesses the touristic potential of Buddhist regions of Russia on the basis of their aesthetic appeal.

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

Solid oxide fuel cell field trial evaluation

Energy Technology Data Exchange (ETDEWEB)

Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.

2000-07-01

This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)

ISAM news. International programme on implementation of safety assessment methodologies for near surface disposal facilities for radioactive waste (ISAM 1997-1999)

International Nuclear Information System (INIS)

Torres, Carlos

1996-01-01

The scope of the programme will be the scientific and technical aspects related to the long term safety assessment of near disposal facilities. The primary focus of ISAM will be on the methodological aspects of safety assessment with emphasis on the practical application of these methodologies. Furthermore, practical application is necessary for for a thorough understanding of safety assessment methodologies. The programme will address important methodological issues associated with long term safety assessment of near surface disposal systems. At least three important areas will be covered: (1) scenario generation and justification; (2) modelling, data and tools; and (3) analysis of results and confidence building

Methodology is more than research design and technology.

Science.gov (United States)

Proctor, Robert W

2005-05-01

The Society for Computers in Psychology has been at the forefront of disseminating information about advances in computer technology and their applications for psychologists. Although technological advances, as well as clean research designs, are key contributors to progress in psychological research, the justification of methodological rules for interpreting data and making theory choices is at least as important. Historically, methodological beliefs and practices have been justified through intuition and logic, an approach known as foundationism. However, naturalism, a modern approach in the philosophy of science inspired by the work of Thomas S. Kuhn, indicates that all aspects of scientific practice, including its methodology, should be evaluated empirically. This article examines implications of the naturalistic approach for psychological research methods in general and for the current debate that is often framed as one of qualitative versus quantitative methods.

Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials

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Grimshaw Jeremy M

2006-03-01

Full Text Available Abstract This editorial introduces the new online, open access, peer-reviewed journal Trials. The journal considers manuscripts on any aspect of the design, performance, and findings of randomised controlled trials in any discipline related to health care, and also encourages the publication of protocols. Trialists will be able to provide the necessary detail for a true and complete scientific record. They will be able to communicate not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and honest reflections about what they learnt. Trials also encourages articles covering generic issues related to trials, for example focussing on the design, conduct, analysis, interpretation, or reporting.

Implementing diffusion-weighted MRI for body imaging in prospective multicentre trials. Current considerations and future perspectives

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DeSouza, N.M.; Winfield, J.M.; Weller, A.; Papoutsaki, M.V.; Doran, S.J.; Collins, D.J. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, CRUK Cancer Imaging Centre, Surrey (United Kingdom); Waterton, J.C.; Jackson, A. [University of Manchester, Manchester Academic Health Sciences Institute, Manchester (United Kingdom); Fournier, L. [Universite Paris Descartes Sorbonne Paris Cite, Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Radiology Department, Paris (France); Sullivan, D. [Duke Comprehensive Cancer Institute, Durham, NC (United States); Chenevert, T. [University of Michigan Health System, Department of Radiology, Ann Arbor, MI (United States); Boss, M. [National Institute of Standards and Technology (NIST), Applied Physics Division, Boulder, CO (United States); Trattnig, S. [Medical University of Vienna, Department of Biomedical Imaging and Image Guided Therapy, Vienna (Austria); Liu, Y. [European Organisation for Research and Treatment of Cancer, Brussels (Belgium)

2018-03-15

For body imaging, diffusion-weighted MRI may be used for tumour detection, staging, prognostic information, assessing response and follow-up. Disease detection and staging involve qualitative, subjective assessment of images, whereas for prognosis, progression or response, quantitative evaluation of the apparent diffusion coefficient (ADC) is required. Validation and qualification of ADC in multicentre trials involves examination of i) technical performance to determine biomarker bias and reproducibility and ii) biological performance to interrogate a specific aspect of biology or to forecast outcome. Unfortunately, the variety of acquisition and analysis methodologies employed at different centres make ADC values non-comparable between them. This invalidates implementation in multicentre trials and limits utility of ADC as a biomarker. This article reviews the factors contributing to ADC variability in terms of data acquisition and analysis. Hardware and software considerations are discussed when implementing standardised protocols across multi-vendor platforms together with methods for quality assurance and quality control. Processes of data collection, archiving, curation, analysis, central reading and handling incidental findings are considered in the conduct of multicentre trials. Data protection and good clinical practice are essential prerequisites. Developing international consensus of procedures is critical to successful validation if ADC is to become a useful biomarker in oncology. (orig.)

Evaluating the Staff at Enterprise: Several Theoretical and Methodological Aspects

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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.

GENERIC APPROACH IN CHOICE OF ADEQUATE METHODOLOGY FOR THE ASSESSMENT OF IT INVESTMENTS

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Melita Kozina

2012-07-01

Full Text Available Investments into information technology (IT, (hereinafter: IT investments havereached very high figures, which are still continually on the rise. IT potentials are being usedin an increasing number of ways. Various company managers have different approaches tothis issue. A large number of methods/models for the assessment of IT investments isavailable, so the question is posed of how to choose the adequate assessment category. Thesaid reasons have initiated a need for defining the generic approach in the choice ofadequate methodology for the assessment of IT investments, which was indeed the goal ofthis paper. General ideas to this approach stem from the fact that each IT investment has itspurpose and belongs to a certain type of IT investment (decision-making aspect whichdemands its relevant methodology for assessing IT investments. Two groups of demands(conditions have been defined in choosing relevant methodology. The first group pertains tomethodology analysis and determination of its compatibility with characteristics of thedefined decision-making aspect. The second group of conditions pertains to methodologyanalysis with respect to its possibilities (abilities of integrating quantity, quality and riskfactors of IT decision. Conducted field research shows that the assessment of IT investmentshas been done mainly using simpler methods/models and their combinations, and is focusedon quantity aspects of IT values.

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

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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

Quality and Safety Aspects of Cereals (Wheat) and Their Products.

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Varzakas, Theo

2016-11-17

Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

A Coorientational Analysis of Trial Lawyer and News Reporter Relationships.

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Lipschultz, Jeremy Harris

A study considered the relationships of trial lawyers and news reporters, using the coorientation measurement model and Q-methodology, and adapting an analysis of variance experimental design. Sixty statements were constructed and administered to 24 subjects (12 trial lawyers and 12 news reporters) in two large midwestern cities. It was found…

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

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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.

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

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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

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

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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.

BILINGUAL EDUCATION: LINGUO-DIDACTIC ASPECTS

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Natalia Zakordonets

2016-12-01

Full Text Available The article presents the research of linguo-didactic aspects and models of bilingual education. On the basis of the study of scientific literature the definition analysis of the notions «bilingualism» «bilingual teaching» and «bilingual education» has been carried out. Didactic-methodological bases and approaches to the content of bilingual teaching at higher educational institutions have been determined. This article considers theoretical and methodological foundations of the concept of bilingual teaching. There have been outlined the peculiarities and problems of the designing and implementing bilingual programs and curriculum materials development. It has been stated that characteristics of the latest stage of elaboration of theory and practice of bilingual education have been framed in terms of the transition to a multi-perspectival paradigm of polycultural education. This paper deals with the common didactic fundamentals of personality-oriented philosophy of higher education. The distinctions that require the formulation of specific principles of bilingual teaching have been considered.

Biomechanical aspects of playing surfaces.

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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.

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

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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.

Elderly Patients with Dementia-Related Symptoms of Severe Agitation and Aggression: Consensus Statement on Treatment Options, Clinical Trials Methodology, and Policy

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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

Critical velocity and anaerobic paddling capacity determined by different mathematical models and number of predictive trials in canoe slalom.

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Messias, Leonardo H D; Ferrari, Homero G; Reis, Ivan G M; Scariot, Pedro P M; Manchado-Gobatto, Fúlvia B

2015-03-01

The purpose of this study was to analyze if different combinations of trials as well as mathematical models can modify the aerobic and anaerobic estimates from critical velocity protocol applied in canoe slalom. Fourteen male elite slalom kayakers from Brazilian canoe slalom team (K1) were evaluated. Athletes were submitted to four predictive trials of 150, 300, 450 and 600 meters in a lake and the time to complete each trial was recorded. Critical velocity (CV-aerobic parameter) and anaerobic paddling capacity (APC-anaerobic parameter) were obtained by three mathematical models (Linear1=distance-time; Linear 2=velocity-1/time and Non-Linear = time-velocity). Linear 1 was chosen for comparison of predictive trials combinations. Standard combination (SC) was considered as the four trials (150, 300, 450 and 600 m). High fits of regression were obtained from all mathematical models (range - R² = 0.96-1.00). Repeated measures ANOVA pointed out differences of all mathematical models for CV (p = 0.006) and APC (p = 0.016) as well as R² (p = 0.033). Estimates obtained from the first (1) and the fourth (4) predictive trials (150 m = lowest; and 600 m = highest, respectively) were similar and highly correlated (r=0.98 for CV and r = 0.96 for APC) with the SC. In summary, methodological aspects must be considered in critical velocity application in canoe slalom, since different combinations of trials as well as mathematical models resulted in different aerobic and anaerobic estimates. Key pointsGreat attention must be given for methodological concerns regarding critical velocity protocol applied on canoe slalom, since different estimates were obtained depending on the mathematical model and the predictive trials used.Linear 1 showed the best fits of regression. Furthermore, to the best of our knowledge and considering practical applications, this model is the easiest one to calculate the estimates from critical velocity protocol. Considering this, the abyss between science

Examining emotional expressions in discourse: methodological considerations

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Hufnagel, Elizabeth; Kelly, Gregory J.

2017-10-01

This methodological paper presents an approach for examining emotional expressions through discourse analysis and ethnographic methods. Drawing on trends in the current literature in science education, we briefly explain the importance of emotions in science education and examine the current research methodologies used in interactional emotion studies. We put forth and substantiate a methodological approach that attends to the interactional, contextual, intertextual, and consequential aspects of emotional expressions. By examining emotional expressions in the discourse in which they are constructed, emotional expressions are identified through semantics, contextualization, and linguistic features. These features make salient four dimensions of emotional expressions: aboutness, frequency, type, and ownership. Drawing on data from a large empirical study of pre-service elementary teachers' emotional expressions about climate change in a science course, we provide illustrative examples to describe what counts as emotional expressions in situ. In doing so we explain how our approach makes salient the nuanced nature of such expressions as well as the broader discourse in which they are constructed and the implications for researching emotional expressions in science education discourse. We suggest reasons why this discourse orientated research methodology can contribute to the interactional study of emotions in science education contexts.

Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.

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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

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

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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

Changes in the reflectance of ex situ leaves: A methodological approach

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Ponzoni, Flavio Jorge; Inoe, Mario Takao

1992-04-01

The main aspects of the interaction between electromagnetic radiation and detached leaves are presented. An experiment with Eucalipto and Araucaria detached leaves is described, including the description of the methodologies utilized in the collection and storage of the reflectance.

A Quality-Driven Methodology for Information Systems Integration

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Iyad Zikra

2017-10-01

Full Text Available Information systems integration is an essential instrument for organizations to attain advantage in today’s growing and fast changing business and technology landscapes. Integration solutions generate added value by combining the functionality and services of heterogeneous and diverse systems. Existing integration environments tend to rely heavily on technical, platform-dependent skills. Consequently, the solutions that they enable are not optimally aligned with the envisioned business goals of the organization. Furthermore, the gap between the goals and the solutions complicates the task of evaluating the quality of integration solutions. To address these challenges, we propose a quality-driven, model-driven methodology for designing and developing integration solutions. The methodology spans organizational and systems design details, providing a holistic view of the integration solution and its underlying business goals. A multi-view meta-model provides the basis for the integration design. Quality factors that affect various aspects of the integration solution guide and inform the progress of the methodology. An example business case is presented to demonstrate the application of the methodology.

Application of the Biosphere Assessment Methodology to the ENRESA, 1997 Performance and Safety Assessment

International Nuclear Information System (INIS)

Pinedo, P.; Simon, I.; Aguero, A.

1998-01-01

For several years CIEMAT has been developing for ENRESA knowledge and tools to support the modelling of the migration and accumulation of radionuclides within the biosphere once those radionuclides are released or reach one or more parts of the biosphere (atmosphere, water bodies or soils). The model development also includes evaluation of radiological impacts arising from the resulting distribution of radionuclides in the biosphere. In 1996, a Methodology to analyse the biosphere in this context proposed to ENRESA. The level of development of the different aspects proposed within the Methodology was quite heterogeneous and, while aspects of radionuclide transport modelling were already well developed in theoretical and practical terms, other aspects like the procedure for conceptual model development and the description of biosphere system representatives of the long term needed further developments. At present, the International Atomic Energy Agency (IAEA) Programme on Biosphere Modelling and Assessment (BIOMASS) in collaboration with several national organizations, ENRESA and CIEMAT among them, is working to complete and augment the Reference Biosphere Methodology and to produce some practical descriptions of Reference Systems. The overall purpose of this document is to apply the Methodology, taking account of on-going developments in biosphere modelling, to the last performance assessment (PA) exercise made by ENRESA (ENRESA, 1997), using from it the general and particular information about the assessment context, radionuclide information, geosphere and geobiosphere interface data. There are three particular objectives to this work: (a) to determine the practicability of the Methodology in an application to a realistic assessment situation, (b) To compare and contrast previous biosphere modelling in HLW PA and, (c) to test software development related with data management and modelling. (Author) 42 refs

Methodology for the biosphere evaluation during the RRAA management. Application for the Mediterranean system

International Nuclear Information System (INIS)

Pinedo, P.; Simon, I.; Aguero, A.

1998-01-01

For several years CIEMAT has been developing for ENRESA knowledge and tools to support the modelling of the migration and accumulation of radionuclides within the biosphere once those radionuclides are released or reach one or more parts of the biosphere (atmosphere, water impacts arising from the resulting distribution of radionuclides in the biosphere. In 1996, a Methodology to analyse the biosphere in the context of high level waste repositories was proposed to ENRESA, where the issues mentioned above were considered and treated. The level of development of the different aspects proposed within the Methodology was quite heterogeneous and, while aspects of radionuclide transport modelling were already well developed in theoretical and practical terms, other aspects like the procedure for conceptual model development using the RES matrix and the description of biosphere systems representatives of the long term needed further developments. These own methodological developments have been developed in parallel with similar international developments within which there were and are an active participation, the BIOMOVS II international Project, finalized in 1996 and where it was developed the so called Reference Biosphere Methodology and, the International Atomic Energy Agency (IAEA) Programme on Biosphere Modelling and Assessment (BIOMASS), that is developed at present in collaboration with several national organizations, ENRESA and CIEMAT among them. The work described here takes account of these international developments. The overall purpose of this work is to apply the Methodology, to the last performance assessment (PA) exercise made by ENRESA, using form it the general and particular information about the assessment context, the source term, and the geo-biosphere interface data. (Author) 6 refs

Methodology for biosphere analysis in high level waste disposal. Application to the Mediterranean system

International Nuclear Information System (INIS)

Pinedo, P.; Simon, I.; Aguero, A.; Cancio, D.

2000-01-01

For several years CIEMAT has been developing for ENRESA a conceptual approach and tools to support the modelling of the migration and accumulation of radionuclides within the biosphere once those radionuclides are released or reach one or more parts of the biosphere (atmosphere, water bodies or soils). The model development also includes evaluation of radiological impacts arising from the resulting distribution of radionuclides in the biosphere. At the time when the methodology was proposed, the level of development of the different aspects proposed within it was quite heterogeneous and, while aspects of radionuclide transport modelling were already well developed in theoretical and practical terms, other aspects, like the procedure for conceptual model development and the description of biosphere systems representatives of the long term needed further developments. The developments have been performed in parallel to international projects, within which there were and are an active participation, mainly, the BIOphere Models Validation Study (BIOMOVS II) international Project, within which it was developed the so called Reference Biosphere Methodology and, the International Atomic Energy Agency (IAEA) Programme on BIOsphere Modelling and ASSessment methods (BIOMASS), that is under development at present. The methodology been made takes account of these international developments. The purpose of the work summarised herein is the application of the methodology to the 1997 performance assessment (PA) exercise made by ENRESA, using from it the general and particular information about the assessment context, the source term, and the geo-biosphere interface data. (author)

Lessons learned from IDeAl - 33 recommendations from the IDeAl-net about design and analysis of small population clinical trials.

Science.gov (United States)

Hilgers, Ralf-Dieter; Bogdan, Malgorzata; Burman, Carl-Fredrik; Dette, Holger; Karlsson, Mats; König, Franz; Male, Christoph; Mentré, France; Molenberghs, Geert; Senn, Stephen

2018-05-11

IDeAl (Integrated designs and analysis of small population clinical trials) is an EU funded project developing new statistical design and analysis methodologies for clinical trials in small population groups. Here we provide an overview of IDeAl findings and give recommendations to applied researchers. The description of the findings is broken down by the nine scientific IDeAl work packages and summarizes results from the project's more than 60 publications to date in peer reviewed journals. In addition, we applied text mining to evaluate the publications and the IDeAl work packages' output in relation to the design and analysis terms derived from in the IRDiRC task force report on small population clinical trials. The results are summarized, describing the developments from an applied viewpoint. The main result presented here are 33 practical recommendations drawn from the work, giving researchers a comprehensive guidance to the improved methodology. In particular, the findings will help design and analyse efficient clinical trials in rare diseases with limited number of patients available. We developed a network representation relating the hot topics developed by the IRDiRC task force on small population clinical trials to IDeAl's work as well as relating important methodologies by IDeAl's definition necessary to consider in design and analysis of small-population clinical trials. These network representation establish a new perspective on design and analysis of small-population clinical trials. IDeAl has provided a huge number of options to refine the statistical methodology for small-population clinical trials from various perspectives. A total of 33 recommendations developed and related to the work packages help the researcher to design small population clinical trial. The route to improvements is displayed in IDeAl-network representing important statistical methodological skills necessary to design and analysis of small-population clinical trials. The methods

Clinical trials. A pending subject.

Science.gov (United States)

Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

2018-04-01

Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Towards aspect-oriented functional–structural plant modelling

Science.gov (United States)

Cieslak, Mikolaj; Seleznyova, Alla N.; Prusinkiewicz, Przemyslaw; Hanan, Jim

2011-01-01

Background and Aims Functional–structural plant models (FSPMs) are used to integrate knowledge and test hypotheses of plant behaviour, and to aid in the development of decision support systems. A significant amount of effort is being put into providing a sound methodology for building them. Standard techniques, such as procedural or object-oriented programming, are not suited for clearly separating aspects of plant function that criss-cross between different components of plant structure, which makes it difficult to reuse and share their implementations. The aim of this paper is to present an aspect-oriented programming approach that helps to overcome this difficulty. Methods The L-system-based plant modelling language L+C was used to develop an aspect-oriented approach to plant modelling based on multi-modules. Each element of the plant structure was represented by a sequence of L-system modules (rather than a single module), with each module representing an aspect of the element's function. Separate sets of productions were used for modelling each aspect, with context-sensitive rules facilitated by local lists of modules to consider/ignore. Aspect weaving or communication between aspects was made possible through the use of pseudo-L-systems, where the strict-predecessor of a production rule was specified as a multi-module. Key Results The new approach was used to integrate previously modelled aspects of carbon dynamics, apical dominance and biomechanics with a model of a developing kiwifruit shoot. These aspects were specified independently and their implementation was based on source code provided by the original authors without major changes. Conclusions This new aspect-oriented approach to plant modelling is well suited for studying complex phenomena in plant science, because it can be used to integrate separate models of individual aspects of plant development and function, both previously constructed and new, into clearly organized, comprehensive FSPMs. In

Towards aspect-oriented functional--structural plant modelling.

Science.gov (United States)

Cieslak, Mikolaj; Seleznyova, Alla N; Prusinkiewicz, Przemyslaw; Hanan, Jim

2011-10-01

Functional-structural plant models (FSPMs) are used to integrate knowledge and test hypotheses of plant behaviour, and to aid in the development of decision support systems. A significant amount of effort is being put into providing a sound methodology for building them. Standard techniques, such as procedural or object-oriented programming, are not suited for clearly separating aspects of plant function that criss-cross between different components of plant structure, which makes it difficult to reuse and share their implementations. The aim of this paper is to present an aspect-oriented programming approach that helps to overcome this difficulty. The L-system-based plant modelling language L+C was used to develop an aspect-oriented approach to plant modelling based on multi-modules. Each element of the plant structure was represented by a sequence of L-system modules (rather than a single module), with each module representing an aspect of the element's function. Separate sets of productions were used for modelling each aspect, with context-sensitive rules facilitated by local lists of modules to consider/ignore. Aspect weaving or communication between aspects was made possible through the use of pseudo-L-systems, where the strict-predecessor of a production rule was specified as a multi-module. The new approach was used to integrate previously modelled aspects of carbon dynamics, apical dominance and biomechanics with a model of a developing kiwifruit shoot. These aspects were specified independently and their implementation was based on source code provided by the original authors without major changes. This new aspect-oriented approach to plant modelling is well suited for studying complex phenomena in plant science, because it can be used to integrate separate models of individual aspects of plant development and function, both previously constructed and new, into clearly organized, comprehensive FSPMs. In a future work, this approach could be further

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)

BATSE gamma-ray burst line search. 2: Bayesian consistency methodology

Science.gov (United States)

Band, D. L.; Ford, L. A.; Matteson, J. L.; Briggs, M.; Paciesas, W.; Pendleton, G.; Preece, R.; Palmer, D.; Teegarden, B.; Schaefer, B.

1994-01-01

We describe a Bayesian methodology to evaluate the consistency between the reported Ginga and Burst and Transient Source Experiment (BATSE) detections of absorption features in gamma-ray burst spectra. Currently no features have been detected by BATSE, but this methodology will still be applicable if and when such features are discovered. The Bayesian methodology permits the comparison of hypotheses regarding the two detectors' observations and makes explicit the subjective aspects of our analysis (e.g., the quantification of our confidence in detector performance). We also present non-Bayesian consistency statistics. Based on preliminary calculations of line detectability, we find that both the Bayesian and non-Bayesian techniques show that the BATSE and Ginga observations are consistent given our understanding of these detectors.

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)

OpenAIRE

Bidad, Natalie; MacDonald, Lindsay; Winters, Zoë E; Edwards, Sarah J L; Emson, Marie; Griffin, Clare L.; Bliss, Judith; Horne, Rob

2016-01-01

Background: Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (...

Ethical Dilemmas in Qualitative Research Methodology: Researcher's Reflections

Science.gov (United States)

Ngozwana, Nomazulu

2018-01-01

This article examines the ethical dilemmas that are specific to qualitative research methodology. These dilemmas concern the issues of withdrawal from the study, anonymity and confidentiality, which are discussed. Each aspect examines how it was dealt with using the researcher's reflections. The research was positioned within an interpretive…

History and theoretical-methodological fundaments of Community Psychology in Ceará.

Science.gov (United States)

Barros, João Paulo Pereira; Ximenes, Verônica Morais

2016-01-01

In this article we discuss the historical and theoretical-methodological aspects of the Community Psychology that has been developed in the state of Ceará, in northeastern Brazil, based on the praxis initiated by Professor Cezar Wagner de Lima Góis and further developed by the Community Psychology Nucleus (NUCOM) at the Federal University of Ceará. Important aspects of the beginning of this Community Psychology are presented, highlighting its academic and social perspectives. NUCOM is a space for the development of teaching, research, and outreach activities, which allows the systematization and deepening of this proposal for a different Community Psychology. Community Psychology is constituted by five theoretical-methodological marks: Popular Education, Biodance, Carl Rogers' Humanistic Approach, Cultural-Historical Psychology, and Liberation Psychology. Finally, the article describes the methods comprising this proposal for working in communities, which are sustained by pillars such as participation and problematizing dialogue.

Traditional Japanese Kampo Medicine: Clinical Research between Modernity and Traditional Medicine—The State of Research and Methodological Suggestions for the Future

Directory of Open Access Journals (Sweden)

Kenji Watanabe

2011-01-01

Full Text Available The Japanese traditional herbal medicine, Kampo, has gradually reemerged and 148 different formulations (mainly herbal extracts can be prescribed within the national health insurance system. The objective of this article is to introduce Kampo and to present information from previous clinical studies that tested Kampo formulae. In addition, suggestions on the design of future research will be stated. The literature search was based on a summary, up until January 2009, by the Japanese Society of Oriental Medicine and included only those trials which were also available in either Pubmed or ICHUSHI (Japan Medical Abstracts Society. We included 135 studies, half of these studies (n=68 used a standard control and 28 a placebo control. Thirty-seven trials were published in English [all randomized controlled trials (RCTs] and the remaining articles were in Japanese only. The sample size for most studies was small (two-third of the studies included less than 100 patients and the overall methodological quality appeared to be low. None of the studies used Kampo diagnosis as the basis for the treatment. In order to evaluate Kampo as a whole treatment system, certain aspects should be taken into account while designing studies. RCTs are the appropriate study design to test efficacy or effectiveness; however, within the trial the treatment could be individualized according to the Kampo diagnosis. Kampo is a complex and individualized treatment with a long tradition, and it would be appropriate for further research on Kampo medicine to take this into account.

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.

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.

Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

Directory of Open Access Journals (Sweden)

Jana Sawynok

2014-01-01

Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

Using Vignette Methodology to research the process of breach comparatively

NARCIS (Netherlands)

Boone, M.M.; Beyens, K.; Maguire, N.; Laurinavicius, A.; Persson, A.

2015-01-01

Comparative research related to any aspect of the process of breach in either the pre-trial, sentencing or release phases is relatively rare. Comparative studies of decision making in the specific context of breach process are particularly lacking. One reason for the dearth of research in this area

Base line definitions and methodological lessons from Zimbabwe

International Nuclear Information System (INIS)

Maya, R.S.

1995-01-01

The UNEP Greenhouse Gas Abatement Costing Studies carried out under the management of the UNEP Collaborating Centre On Energy and Environment at Risoe National Laboratories in Denmark has placed effort in generating methodological approaches to assessing the cost of abatement activities to reduce CO 2 emissions. These efforts have produced perhaps the most comprehensive set of methodological approaches to defining and assessing the cost of greenhouse gas abatement. Perhaps the most importance aspect of the UNEP study which involved teams of researchers from ten countries is the mix of countries in which the studies were conducted and hence the representation of views and concepts from researchers in these countries particularly those from developing countries namely, Zimbabwe, India, Venezuela, Brazil, Thailand and Senegal. Methodological lessons from Zimbabwe, therefore, would have benefited from the interactions with methodological experiences form the other participating countries. Methodological lessons from the Zimbabwean study can be placed in two categories. One relates to the modelling of tools to analyze economic trends and the various factors studied in order to determine the unit cost of CO 2 abatement. The other is the definition of factors influencing the levels of emissions reducible and those realised under specific economic trends. (au)

Economic evaluation in stratified medicine: methodological issues and challenges

Directory of Open Access Journals (Sweden)

Hans-Joerg eFugel

2016-05-01

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

Some global aspects regarding nuclear spent fuel management

International Nuclear Information System (INIS)

Ohai, Dumitru; Postoaca, Marius Marcel

2002-01-01

The globalization means the worldwide extension of certain aspects of social or economic processes, structural or environmental changes, or concerning working methodologies, technical activity, industrial production, etc. At present the emergence of global aspects is more frequently observed, being determined by the rapid development of computerized systems and of transfer of information, by the development of big transnational companies and due to the increasing international co-operation. Some of the manifested global aspects could be beneficial for the development of the human society, other could be not. It is necessary to perform an adequate analysis from this view point and to promote appropriate measures to enhance the positive global aspects and to mitigate the negative global aspects. These measures can have a good efficiency only if they are pursued at global level, but for this it is necessary to build an adequate international coordinating body, having the corresponding instruments for action. The global aspects identified in the field of nuclear power may be divided into two categories, namely: - related to the main features of nuclear power; - regarding the specific features of some subdivisions of the field, as for example, spent fuel management. In the paper both categories are discussed. The influence of the global aspects on the development of nuclear power and particularly on the back end activities of the fuel cycle, is also presented. At the same time, some possible actions for enhancing nuclear power development are proposed

San Luis Basin Sustainability Metrics Project: A Methodology for Evaluating Regional Sustainability

Science.gov (United States)

Although there are several scientifically-based sustainability metrics, many are data intensive, difficult to calculate, and fail to capture all aspects of a system. To address these issues, we produced a scientifically-defensible, but straightforward and inexpensive, methodolog...

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...

The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – A secondary analysis

Directory of Open Access Journals (Sweden)

Walach Harald

2005-08-01

Full Text Available Abstract Background and purpose Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. Methods We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out. Results We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p Conclusion Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.

Interrogating discourse: the application of Foucault's methodological discussion to specific inquiry.

Science.gov (United States)

Fadyl, Joanna K; Nicholls, David A; McPherson, Kathryn M

2013-09-01

Discourse analysis following the work of Michel Foucault has become a valuable methodology in the critical analysis of a broad range of topics relating to health. However, it can be a daunting task, in that there seems to be both a huge number of possible approaches to carrying out this type of project, and an abundance of different, often conflicting, opinions about what counts as 'Foucauldian'. This article takes the position that methodological design should be informed by ongoing discussion and applied as appropriate to a particular area of inquiry. The discussion given offers an interpretation and application of Foucault's methodological principles, integrating a reading of Foucault with applications of his work by other authors, showing how this is then applied to interrogate the practice of vocational rehabilitation. It is intended as a contribution to methodological discussion in this area, offering an interpretation of various methodological elements described by Foucault, alongside specific application of these aspects.

Searching for qualitative research for inclusion in systematic reviews: a structured methodological review.

Science.gov (United States)

Booth, Andrew

2016-05-04

Qualitative systematic reviews or qualitative evidence syntheses (QES) are increasingly recognised as a way to enhance the value of systematic reviews (SRs) of clinical trials. They can explain the mechanisms by which interventions, evaluated within trials, might achieve their effect. They can investigate differences in effects between different population groups. They can identify which outcomes are most important to patients, carers, health professionals and other stakeholders. QES can explore the impact of acceptance, feasibility, meaningfulness and implementation-related factors within a real world setting and thus contribute to the design and further refinement of future interventions. To produce valid, reliable and meaningful QES requires systematic identification of relevant qualitative evidence. Although the methodologies of QES, including methods for information retrieval, are well-documented, little empirical evidence exists to inform their conduct and reporting. This structured methodological overview examines papers on searching for qualitative research identified from the Cochrane Qualitative and Implementation Methods Group Methodology Register and from citation searches of 15 key papers. A single reviewer reviewed 1299 references. Papers reporting methodological guidance, use of innovative methodologies or empirical studies of retrieval methods were categorised under eight topical headings: overviews and methodological guidance, sampling, sources, structured questions, search procedures, search strategies and filters, supplementary strategies and standards. This structured overview presents a contemporaneous view of information retrieval for qualitative research and identifies a future research agenda. This review concludes that poor empirical evidence underpins current information practice in information retrieval of qualitative research. A trend towards improved transparency of search methods and further evaluation of key search procedures offers

Navigating the Process of Ethical Approval: A methodological note

Directory of Open Access Journals (Sweden)

Eileen Carey, RNID, BSc. (hons, MSc.

2010-12-01

Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

DEFF Research Database (Denmark)

Kruse, A Y; Kjaergard, L L; Krogsgaard, K

2000-01-01

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased...

Herbal Medicine for Xerostomia in Cancer Patients: A Systematic Review of Randomized Controlled Trials.

Science.gov (United States)

Park, Bongki; Noh, Hyeonseok; Choi, Dong-Jun

2018-06-01

Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.

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

Methodological pluralism in the teaching of Astronomy

Science.gov (United States)

de Macedo, Josué Antunes; Voelzke, Marcos Rincon

2015-04-01

This paper discusses the feasibility of using a teaching strategy called methodological pluralism, consisting of the use of various methodological resources in order to provide a meaningful learning. It is part of a doctoral thesis, which aims to investigate contributions to the use of traditional resources combined with digital technologies, in order to create autonomy for future teachers of Natural Sciences and Mathematics in relation to themes in Astronomy. It was offered an extension course at the "Federal Institution of Education, Science and Technology" in the North of Minas Gerais (FINMG), Campus Januaria, for thirty-two students of licentiate courses in Physics, Mathematics and Biological Sciences, involving themes of Astronomy, in order to search and contribute to improving the training of future teachers. The following aspects are used: the mixed methodology, with pre-experimental design, combined with content analysis. The results indicate the rates of students' prior knowledge in relation to Astronomy was low; meaningful learning indications of concepts related to Astronomy, and the feasibility of using digital resources Involving technologies, articulated with traditional materials in the teaching of Astronomy. This research sought to contribute to the initial teacher training, especially in relation to Astronomy Teaching, proposing new alternatives to promote the teaching of this area of knowledge, extending the methodological options of future teachers.

The Correction of Myopia Evaluation Trial: lessons from the study design.

Science.gov (United States)

Hyman, L; Gwiazda, J

2004-01-01

The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

Statistical aspects of fish stock assessment

DEFF Research Database (Denmark)

Berg, Casper Willestofte

for stock assessment by application of state-of-the-art statistical methodology. The main contributions are presented in the form of six research papers. The major part of the thesis deals with age-structured assessment models, which is the most common approach. Conversion from length to age distributions...... statistical aspects of fish stocks assessment, which includes topics such as time series analysis, generalized additive models (GAMs), and non-linear state-space/mixed models capable of handling missing data and a high number of latent states and parameters. The aim is to improve the existing methods...

[Economic analysis of multinational clinical trials in oncology].

Science.gov (United States)

Lejeune, Catherine; Lueza, Béranger; Bonastre, Julia

2018-02-01

In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Clinical trials in dentistry in India: Analysis from trial registry.

Science.gov (United States)

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

Historical aspects and causes of the synergy beginning as a science

Directory of Open Access Journals (Sweden)

Yakimtsov V. V.

2015-05-01

Full Text Available The article is dedicated to the historical aspects of the beginning and development of a new popular science – synergy, as a means of interdisciplinary communication among scholars. Using methodological apparatus of synergy here were considered the basics of studies. Historical aspects of the origin, beginning and formation of synergy as a science and its application in all aspects of human life were analyzed. Current research areas within synergy and nonlinear dynamics were presented. Was presented a question of order and organization of global issues (energetic, environmental, social and economic and systems, that were developed by human using synergy. The conclusion was made on the need for a synergistic approach to all aspects of human life and especially to the economy – it is undeniable in the science of human development in society and especially within the manufacturing process.

Methodological bases of innovative training of specialists in nanotechnology field

Directory of Open Access Journals (Sweden)

FIGOVSKY Oleg Lvovich

2016-10-01

Full Text Available The performance of innovative training system aimed at highly intellectual specialists in the area of nanotechnologies for Kazakhstan’s economy demands establishment and development of nanotechnological market in the country, teaching of innovative engineering combined with consistent research, integration of trained specialists with latest technologies and sciences at the international level. Methodological aspects of training competitive specialists for nanotechnological field are specific. The paper presents methodological principles of innovative training of specialists for science-intensive industry that were realized according to grant given by the Ministry of Education and Science of the Republic of Kazakhstan.

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.

Progress in the development of methodology for fusion safety systems studies

International Nuclear Information System (INIS)

Ho, S.K.; Cambi, G.; Ciattaglia, S.; Fujii-e, Y.; Seki, Y.

1994-01-01

The development of fusion safety systems-study methodology, including the aspects of schematic classification of overall fusion safety system, qualitative assessment of fusion system for identification of critical accident scenarios, quantitative analysis of accident consequences and risk for safety design evaluation, and system-level analysis of accident consequences and risk for design optimization, by a consortium of international efforts is presented. The potential application of this methodology into reactor design studies will facilitate the systematic assessment of safety performance of reactor designs and enhance the impacts of safety considerations on the selection of design configurations

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

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

Characteristics of Placebo Responders in Pediatric Clinical Trials of Attention-Deficit/Hyperactivity Disorder

Science.gov (United States)

Newcorn, Jeffrey H.; Sutton, Virginia K.; Zhang, Shuyu; Wilens, Timothy; Kratochvil, Christopher; Emslie, Graham J.; D'Souza, Deborah N.; Schuh, Leslie M.; Allen, Albert J.

2009-01-01

Objective: Understanding placebo response is a prerequisite to improving clinical trial methodology. Data from placebo-controlled trials of atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD) were analyzed to identify demographic and clinical characteristics that might predict placebo…

Juvenile offenders: competence to stand trial.

Science.gov (United States)

Soulier, Matthew

2012-12-01

This article details the legal background and assists the reader in the preparation and practical conduct of evaluations regarding juvenile adjudicative competency. The material is presented to be useful as a guide to direct questions of competency and covers aspects of evaluation that include: legal standard for competency to stand trial, developmental immaturity, current practice in juvenile competency to stand trial, forensic evaluation of juvenile competency to stand trial, organizing the evaluation, collateral sources of information, psychiatric evaluation of juvenile adjudicative competency, assessment of mental disorder and intellectual disability, assessment of developmental status, assessment of functional abilities for adjudicative competence, and reaching the forensic opinion. Copyright © 2012 Elsevier Inc. All rights reserved.

Practical aspects of protein co-evolution.

Science.gov (United States)

Ochoa, David; Pazos, Florencio

2014-01-01

Co-evolution is a fundamental aspect of Evolutionary Theory. At the molecular level, co-evolutionary linkages between protein families have been used as indicators of protein interactions and functional relationships from long ago. Due to the complexity of the problem and the amount of genomic data required for these approaches to achieve good performances, it took a relatively long time from the appearance of the first ideas and concepts to the quotidian application of these approaches and their incorporation to the standard toolboxes of bioinformaticians and molecular biologists. Today, these methodologies are mature (both in terms of performance and usability/implementation), and the genomic information that feeds them large enough to allow their general application. This review tries to summarize the current landscape of co-evolution-based methodologies, with a strong emphasis on describing interesting cases where their application to important biological systems, alone or in combination with other computational and experimental approaches, allowed getting new insight into these.

JUDGMENT OF POLITICAL PARTIES ACCOUNTABILITY OF THE RIO GRANDE DO NORTE STATE: WHICH ASPECTS RELATE WITH APPROVAL AND DISAPPROVAL?

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Stênnia Maria Ferreira de Brito

2016-03-01

Full Text Available The aim of this study is to identify factors that relate to the judgment of political parties accountability operating in the state of Rio Grande do Norte. Twenty-four political parties with directory in the state were selected considering those who have had their accounts judged between 2006 to 2013. In order to determine which factors are related to the trial of party accounts, logistic regression were considered for the analysis. Independent variables were the total revenues received by the party (in logarithm, dummy for political parties with or without the resources of the party fund and dummy for years that there were state elections, while the trial of the accounts of parties (approval / disapproval is dependent variable. The results show that only the dummy's Party Fund positively influence the judgments of the annual accounts parties. Thus, it is understood that the parties receiving public funds are more likely to provide better information and, therefore, have its accounts approved by the Unidade Técnica do Tribunal Regional Eleitoral do Rio Grande do Norte. Moreover, one can even say that the parties receiving such government help have a trend or an indication of concern with the concept of accountability, since the party fund is a public resource. It is recommended that future studies address other indicators, for example, liquidity, debt and profitability. Moreover, as also proxies related to the disclosure of financial statements, number of persons elected by party in relation to the number of candidates and party members number could become plausible indicators for future research that would use the same methodology. In addition, replicate this metodology to other states for comparative issues, and even use the same methodology at national level could be aspects of research to be worked for the future.

A Methodological Problem Associated with Researching Women Entrepreneurs

OpenAIRE

Beatrice E. Avolio

2011-01-01

This article highlights one of the most significant methodological problems of researching women entrepreneurs and understanding the female entrepreneurial experience, which is related to the definition of what is a women entrepreneur. The article outlines the state of research on women entrepreneurs, presents the diverse definitions used in research, conceptualizes the different aspects related to the definition of a woman entrepreneur, and proposes future directions for developing research ...

Methodologies for Quantitative Systems Pharmacology (QSP) Models: Design and Estimation.

Science.gov (United States)

Ribba, B; Grimm, H P; Agoram, B; Davies, M R; Gadkar, K; Niederer, S; van Riel, N; Timmis, J; van der Graaf, P H

2017-08-01

With the increased interest in the application of quantitative systems pharmacology (QSP) models within medicine research and development, there is an increasing need to formalize model development and verification aspects. In February 2016, a workshop was held at Roche Pharma Research and Early Development to focus discussions on two critical methodological aspects of QSP model development: optimal structural granularity and parameter estimation. We here report in a perspective article a summary of presentations and discussions. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

An Integrated Methodology for Emulsified Formulated Product Design

DEFF Research Database (Denmark)

Mattei, Michele

are mixed together to determine the desired emulsified product. They are still mainly designed and analysed through trial - and - error based exper- imental techniques, therefore a systematic approach , integrating model-based as well a s experiment - based techniques, for design of these products could......The consumer oriented chemical based products are used every day by millions of people. They are structured products constituted of numerous chemicals, and many of them, especially household and personal care products, are emulsions where active ingredients, solvents, additives and surfactants...... significantly reduce both time and cost connected to product development by doing only the necessary experi- ments , and ensuring chances for innovation . The main contribution of this project i s the development of an integrated methodology for the design of emulsified formulated products. The methodology...

Ethics of clinical trials in Nigeria.

Science.gov (United States)

Okonta, Patrick I

2014-05-01

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

The failure of anxiolytic therapies in early clinical trials: what needs to be done.

Science.gov (United States)

Stewart, Adam Michael; Nguyen, Michael; Poudel, Manoj K; Warnick, Jason E; Echevarria, David J; Beaton, Elliott A; Song, Cai; Kalueff, Allan V

2015-04-01

Anxiety spectrum disorders (ASDs) are highly prevalent psychiatric illnesses that affect millions of people worldwide. Strongly associated with stress, common ASDs include generalized anxiety disorder, panic, social anxiety, phobias and drug-abuse-related anxiety. In addition to ASDs, several other prevalent psychiatric illnesses represent trauma/stressor-related disorders, such as post-traumatic stress disorder and acute stress disorder. Anxiolytic drugs, commonly prescribed to treat ASDs and trauma/stressor-related disorders, form a highly heterogenous group, modulating multiple neurotransmitters and physiological mechanisms. However, overt individual differences in efficacy and the potential for serious side-effects (including addiction and drug interaction) indicate a need for further drug development. Yet, over the past 50 years, there has been relatively little progress in the development of novel anxiolytic medications, especially when promising candidate drugs often fail in early clinical trials. Herein, the authors present recommendations of the Task Force on Anxiolytic Drugs of the International Stress and Behavior Society on how to improve anxiolytic drug discovery. These recommendations cover a wide spectrum of aspects, ranging from methodological improvements to conceptual insights and innovation. In order to improve the success of anxiolytic drugs in early clinical trials, the goals of preclinical trials may need to be adjusted from a clinical perspective and better synchronized with those of clinical studies. Indeed, it is important to realize that the strategic goals and approaches must be similar if we want to have a smoother transition between phases.

A small perturbation based optimization approach for the frequency placement of high aspect ratio wings

Science.gov (United States)

Goltsch, Mandy

Design denotes the transformation of an identified need to its physical embodiment in a traditionally iterative approach of trial and error. Conceptual design plays a prominent role but an almost infinite number of possible solutions at the outset of design necessitates fast evaluations. The corresponding practice of empirical equations and low fidelity analyses becomes obsolete in the light of novel concepts. Ever increasing system complexity and resource scarcity mandate new approaches to adequately capture system characteristics. Contemporary concerns in atmospheric science and homeland security created an operational need for unconventional configurations. Unmanned long endurance flight at high altitudes offers a unique showcase for the exploration of new design spaces and the incidental deficit of conceptual modeling and simulation capabilities. Structural and aerodynamic performance requirements necessitate light weight materials and high aspect ratio wings resulting in distinct structural and aeroelastic response characteristics that stand in close correlation with natural vibration modes. The present research effort evolves around the development of an efficient and accurate optimization algorithm for high aspect ratio wings subject to natural frequency constraints. Foundational corner stones are beam dimensional reduction and modal perturbation redesign. Local and global analyses inherent to the former suggest corresponding levels of local and global optimization. The present approach departs from this suggestion. It introduces local level surrogate models to capacitate a methodology that consists of multi level analyses feeding into a single level optimization. The innovative heart of the new algorithm originates in small perturbation theory. A sequence of small perturbation solutions allows the optimizer to make incremental movements within the design space. It enables a directed search that is free of costly gradients. System matrices are decomposed

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.

Vitamin B6 in the treatment of the premenstrual syndrome--a review

NARCIS (Netherlands)

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

1990-01-01

A search of the literature yielded 12 controlled trials on vitamin B6 in the treatment of the premenstrual syndrome. These are discussed with emphasis on methodological aspects. A major drawback of the trials is the limited number of patients included. The existing evidence of positive effects of

Probabilistic risk assessment methodology for risk management and regulatory applications

International Nuclear Information System (INIS)

See Meng Wong; Kelly, D.L.; Riley, J.E.

1997-01-01

This paper discusses the development and potential applications of PRA methodology for risk management and regulatory applications in the U.S. nuclear industry. The new PRA methodology centers on the development of This paper discusses the time-dependent configuration risk profile for evaluating the effectiveness of operational risk management programs at U.S. nuclear power plants. Configuration-risk profiles have been used as risk-information tools for (1) a better understanding of the impact of daily operational activities on plant safety, and (2) proactive planning of operational activities to manage risk. Trial applications of the methodology were undertaken to demonstrate that configuration-risk profiles can be developed routinely, and can be useful for various industry and regulatory applications. Lessons learned include a better understanding of the issues and characteristics of PRA models available to industry, and identifying the attributes and pitfalls in the developement of risk profiles

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

Q and you: The application of Q methodology in recreation research

Science.gov (United States)

Whitney. Ward

2010-01-01

Researchers have used various qualitative and quantitative methods to deal with subjectivity in studying people's recreation experiences. Q methodology has been the most effective approach for analyzing both qualitative and quantitative aspects of experience, including attitudes or perceptions. The method is composed of two main components--Q sorting and Q factor...

Methodology of Economic Assessment of Corporate Finance Management Effectiveness

OpenAIRE

Juscu Nicolae Cristian

2011-01-01

“The methodology of economic assessment of corporate finance management effectiveness” deals with the analysis of the basic issues of economic aspects of corporate finance management effectiveness; the paper presents the essential issues of the existing methods for establishing the economic effectiveness of corporate finance management and control; it also proposes the improvement of the approach regarding the assessment of finance management effectiveness of a company.

Development of methodology and direction of practice administrative neuromarketing

OpenAIRE

Glushchenko V.; Glushchenko I.

2018-01-01

Development of methodology and practical aspects of application of administrative neuromarketing acts as a subject of work, subject of article is administrative neuromarketing in the organization, in article the concept and content of administrative neuromarketing, philosophy, culture, functions, tasks and the principles of administrative neuromarketing are investigated, the technique of the logical analysis of a possibility of application of methods of administrative neuromarketing for incre...

The ECOUTER methodology for stakeholder engagement in translational research

OpenAIRE

Murtagh, Madeleine J.; Minion, Joel T.; Turner, Andrew; Wilson, Rebecca C.; Blell, Mwenza; Ochieng, Cynthia; Murtagh, Barnaby; Roberts, Stephanie; Butters, Oliver W.; Burton, Paul R

2017-01-01

Abstract Background Because no single person or group holds knowledge about all aspects of research, mechanisms are needed to support knowledge exchange and engagement. Expertise in the research setting necessarily includes scientific and methodological expertise, but also expertise gained through the experience of participating in research and/or being a recipient of research outcomes (as a patient or member of the public). Engagement i...

Medicolegal aspects of iatrogenic root perforations

DEFF Research Database (Denmark)

Tsesis, I; Rosen, E; Bjørndal, L

2014-01-01

AIM: To retrospectively analyze the medico-legal aspects of iatrogenic root perforations (IRP) that occurred during endodontic treatments. METHODOLOGY: A comprehensive search in a professional liability insurance database was conducted to retrospectively identify cases of IRP following root canal...... treatment (p root perforation is a complication of root canal treatment and may result in tooth extraction...... and in legal actions against the treating practitioner. Mandibular molars are more prone to medico-legal claims related to root perforations. The patient should be informed of the risks during RCT and should get information on alternative treatments and their risks and prognosis...

Methodology features and problems of definition of the term «green business»

OpenAIRE

Stepanenko, Bohdana

2010-01-01

The term «green business» is defined. Theoretical and methodological principles of functioning of this type of activity are reflected. Basic aspects and main development stages of green business are marked out. The classification of green business enterprise is shown.

IS THERE A NEED FOR THE POST-NON-CLASSICAL METHODOLOGY IN PEDAGOGY?

Directory of Open Access Journals (Sweden)

Vladislav L. Benin

2014-01-01

Full Text Available  The publication continues the discussion, started by Yu.V. Larina in ≪Education in Search of the Congruity Principle≫ concerning the modern methodology of pedagogical science; and identifies the criteria of the given principle along with the limitations of the post-non-classical approaches to the humanities.Methods: The methodology involves the analysis of existing view points, formalization of characteristics of post-non-classical science, and reflection of pedagogical principle of cultural conformity.Results: The research outcomes demonstrate that the gradual undermining of the fundamental science results in erosion of methodological background. In case of interdisciplinary subjects, a researcher is forced to integrate different methods and techniques, which provokes further disruption of the methodology.Scientific novelty: The author classifies and extrapolates to the humanities sphere the main characteristics of post-non-classical science; and makes a conclusion about the gradual decline of researchers’ training quality due to the lack of methodological clarity, and aggressive forms of science vulgarization leading to spontaneous development of clipping methodology.The practical significance: Implementation of the research findings can activate both theoretical and methodological aspects of teacher’s training and selfeducation.

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study.

Science.gov (United States)

Healy, Patricia; Galvin, Sandra; Williamson, Paula R; Treweek, Shaun; Whiting, Caroline; Maeso, Beccy; Bray, Christopher; Brocklehurst, Peter; Moloney, Mary Clarke; Douiri, Abdel; Gamble, Carrol; Gardner, Heidi R; Mitchell, Derick; Stewart, Derek; Jordan, Joan; O'Donnell, Martin; Clarke, Mike; Pavitt, Sue H; Guegan, Eleanor Woodford; Blatch-Jones, Amanda; Smith, Valerie; Reay, Hannah; Devane, Declan

2018-03-01

Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology. This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop. A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was "How can randomised trials become

Methodological Foundations for the Empirical Evaluation of Non-Experimental Methods in Field Settings

Science.gov (United States)

Wong, Vivian C.; Steiner, Peter M.

2015-01-01

Across the disciplines of economics, political science, public policy, and now, education, the randomized controlled trial (RCT) is the preferred methodology for establishing causal inference about program impacts. But randomized experiments are not always feasible because of ethical, political, and/or practical considerations, so non-experimental…

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.

Science.gov (United States)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis; Poulsen, Henrik Enghusen; Dalhoff, Kim

2017-01-01

To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004. A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412). Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.

Standards and Methodological Rigor in Pulmonary Arterial Hypertension Preclinical and Translational Research.

Science.gov (United States)

Provencher, Steeve; Archer, Stephen L; Ramirez, F Daniel; Hibbert, Benjamin; Paulin, Roxane; Boucherat, Olivier; Lacasse, Yves; Bonnet, Sébastien

2018-03-30

Despite advances in our understanding of the pathophysiology and the management of pulmonary arterial hypertension (PAH), significant therapeutic gaps remain for this devastating disease. Yet, few innovative therapies beyond the traditional pathways of endothelial dysfunction have reached clinical trial phases in PAH. Although there are inherent limitations of the currently available models of PAH, the leaky pipeline of innovative therapies relates, in part, to flawed preclinical research methodology, including lack of rigour in trial design, incomplete invasive hemodynamic assessment, and lack of careful translational studies that replicate randomized controlled trials in humans with attention to adverse effects and benefits. Rigorous methodology should include the use of prespecified eligibility criteria, sample sizes that permit valid statistical analysis, randomization, blinded assessment of standardized outcomes, and transparent reporting of results. Better design and implementation of preclinical studies can minimize inherent flaws in the models of PAH, reduce the risk of bias, and enhance external validity and our ability to distinguish truly promising therapies form many false-positive or overstated leads. Ideally, preclinical studies should use advanced imaging, study several preclinical pulmonary hypertension models, or correlate rodent and human findings and consider the fate of the right ventricle, which is the major determinant of prognosis in human PAH. Although these principles are widely endorsed, empirical evidence suggests that such rigor is often lacking in pulmonary hypertension preclinical research. The present article discusses the pitfalls in the design of preclinical pulmonary hypertension trials and discusses opportunities to create preclinical trials with improved predictive value in guiding early-phase drug development in patients with PAH, which will need support not only from researchers, peer reviewers, and editors but also from

[The informed consent in international clinical trials including developing countries].

Science.gov (United States)

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

Elicitation of expert prior opinion: application to the MYPAN trial in childhood polyarteritis nodosa.

Directory of Open Access Journals (Sweden)

Lisa V Hampson

Full Text Available Definitive sample sizes for clinical trials in rare diseases are usually infeasible. Bayesian methodology can be used to maximise what is learnt from clinical trials in these circumstances. We elicited expert prior opinion for a future Bayesian randomised controlled trial for a rare inflammatory paediatric disease, polyarteritis nodosa (MYPAN, Mycophenolate mofetil for polyarteritis nodosa.A Bayesian prior elicitation meeting was convened. Opinion was sought on the probability that a patient in the MYPAN trial treated with cyclophosphamide would achieve disease remission within 6-months, and on the relative efficacies of mycophenolate mofetil and cyclophosphamide. Expert opinion was combined with previously unseen data from a recently completed randomised controlled trial in ANCA associated vasculitis.A pan-European group of fifteen experts participated in the elicitation meeting. Consensus expert prior opinion was that the most likely rates of disease remission within 6 months on cyclophosphamide or mycophenolate mofetil were 74% and 71%, respectively. This prior opinion will now be taken forward and will be modified to formulate a Bayesian posterior opinion once the MYPAN trial data from 40 patients randomised 1:1 to either CYC or MMF become available.We suggest that the methodological template we propose could be applied to trial design for other rare diseases.

Does convenience matter in health care delivery? A systematic review of convenience-based aspects of process utility.

Science.gov (United States)

Higgins, A; Barnett, J; Meads, C; Singh, J; Longworth, L

2014-12-01

To systematically review the existing literature on the value associated with convenience in health care delivery, independent of health outcomes, and to try to estimate the likely magnitude of any value found. A systematic search was conducted for previously published studies that reported preferences for convenience-related aspects of health care delivery in a manner that was consistent with either cost-utility analysis or cost-benefit analysis. Data were analyzed in terms of the methodologies used, the aspects of convenience considered, and the values reported. Literature searches generated 4715 records. Following a review of abstracts or full-text articles, 27 were selected for inclusion. Twenty-six studies reported some evidence of convenience-related process utility, in the form of either a positive utility or a positive willingness to pay. The aspects of convenience valued most often were mode of administration (n = 11) and location of treatment (n = 6). The most common valuation methodology was a discrete-choice experiment containing a cost component (n = 15). A preference for convenience-related process utility exists, independent of health outcomes. Given the diverse methodologies used to calculate it, and the range of aspects being valued, however, it is difficult to assess how large such a preference might be, or how it may be effectively incorporated into an economic evaluation. Increased consistency in reporting these preferences is required to assess these issues more accurately. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Science.gov (United States)

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

The effect of season on aspects of in vitro embryo production in sub ...

African Journals Online (AJOL)

The effect of season on aspects of in vitro embryo production in sub-fertile beef cows. ... Forty beef (40) cows of different breeds and parities were used in a trial ... in follicular populations could be established for different months of the year.

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

Science.gov (United States)

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

A computational methodology for formulating gasoline surrogate fuels with accurate physical and chemical kinetic properties

KAUST Repository

Ahmed, Ahfaz; Goteng, Gokop; Shankar, Vijai; Al-Qurashi, Khalid; Roberts, William L.; Sarathy, Mani

2015-01-01

simpler molecular composition that represent real fuel behavior in one or more aspects are needed to enable repeatable experimental and computational combustion investigations. This study presents a novel computational methodology for formulating

Socio-economic aspects of waste management facilities

International Nuclear Information System (INIS)

Ruetter, H.

2008-01-01

Besides technical aspects and those of safety, it is the economic and social environment of a future underground geologic repository which plays a major role. Compared to other large scale technical plants, facilities for radioactive waste management must overcome incomparably greater obstacles. All the more care must be taken in clarifying the issues affecting the public and the economy in the region of a potential site. On behalf of the Swiss Federal Office for Energy (BFE), Ruetter + Partner conducted a basic study which, in a number of case studies, dealt with the socio-economic aspects of experiences with existing and planned facilities in Switzerland and abroad. The study focused on these main points, which are outlined briefly in the article: - Socio-economic issues in the site selection procedure. - Methodological approach. - Findings made in the case studies. - Factors influencing the acceptance of a repository. (orig.)

Vitex agnus-castus extracts for female reproductive disorders: a systematic review of clinical trials.

Science.gov (United States)

van Die, M Diana; Burger, Henry G; Teede, Helena J; Bone, Kerry M

2013-05-01

Vitex agnus-castus L. (chaste tree; chasteberry) is a popular herbal treatment, predominantly used for a range of female reproductive conditions in Anglo-American and European practice. The objective of this systematic review was to evaluate the evidence for the efficacy and safety of Vitex extracts from randomised, controlled trials investigating women's health.Eight databases were searched using Latin and common names for Vitex and phytotherapeutic preparations of the herb as a sole agent, together with filters for randomised, controlled trials or clinical trials. Methodological quality was assessed according to the Cochrane risk of bias and Jadad scales, as well as the proposed elaboration of CONSORT for reporting trials on herbal interventions.Thirteen randomised, controlled trials were identified and twelve are included in this review, of which eight investigated premenstrual syndrome, two premenstrual dysphoric disorder, and two latent hyperprolactinaemia. For premenstrual syndrome, seven of eight trials found Vitex extracts to be superior to placebo (5 of 6 studies), pyridoxine (1), and magnesium oxide (1). In premenstrual dysphoric disorder, one study reported Vitex to be equivalent to fluoxetine, while in the other, fluoxetine outperformed Vitex. In latent hyperprolactinaemia, one trial reported it to be superior to placebo for reducing TRH-stimulated prolactin secretion, normalising a shortened luteal phase, increasing mid-luteal progesterone and 17β-oestradiol levels, while the other found Vitex comparable to bromocriptine for reducing serum prolactin levels and ameliorating cyclic mastalgia. Adverse events with Vitex were mild and generally infrequent. The methodological quality of the included studies varied, but was generally moderate-to-high. Limitations include small sample sizes in some studies, heterogeneity of conditions being treated, and a range of reference treatments.Despite some methodological limitations, the results from randomised

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

A data grid for imaging-based clinical trials

Science.gov (United States)

Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

2007-03-01

Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

Measuring the impact of methodological research: a framework and methods to identify evidence of impact.

Science.gov (United States)

Brueton, Valerie C; Vale, Claire L; Choodari-Oskooei, Babak; Jinks, Rachel; Tierney, Jayne F

2014-11-27

Providing evidence of impact highlights the benefits of medical research to society. Such evidence is increasingly requested by research funders and commonly relies on citation analysis. However, other indicators may be more informative. Although frameworks to demonstrate the impact of clinical research have been reported, no complementary framework exists for methodological research. Therefore, we assessed the impact of methodological research projects conducted or completed between 2009 and 2012 at the UK Medical Research Council Clinical Trials Unit Hub for Trials Methodology Research Hub, with a view to developing an appropriate framework. Various approaches to the collection of data on research impact were employed. Citation rates were obtained using Web of Science (http://www.webofknowledge.com/) and analyzed descriptively. Semistructured interviews were conducted to obtain information on the rates of different types of research output that indicated impact for each project. Results were then pooled across all projects. Finally, email queries pertaining to methodology projects were collected retrospectively and their content analyzed. Simple citation analysis established the citation rates per year since publication for 74 methodological publications; however, further detailed analysis revealed more about the potential influence of these citations. Interviews that spanned 20 individual research projects demonstrated a variety of types of impact not otherwise collated, for example, applications and further developments of the research; release of software and provision of guidance materials to facilitate uptake; formation of new collaborations and broad dissemination. Finally, 194 email queries relating to 6 methodological projects were received from 170 individuals across 23 countries. They provided further evidence that the methodologies were impacting on research and research practice, both nationally and internationally. We have used the information

The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials

Science.gov (United States)

McCambridge, Jim; Kypri, Kypros; Bendtsen, Preben; Porter, John

2013-01-01

Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these kinds of ethical issues that can arise in research on public health interventions. PMID:24161181

Therapeutic aspects of Tulsi unraveled: A review

Directory of Open Access Journals (Sweden)

Naveen Srinivas

2016-01-01

Full Text Available Introduction: The purpose of the paper was to review the diverse pharmaceutical aspects of Tulsi. Materials and Methods: Several publications and books were electronically searched in google using the keywords “Tulsi as a medicine,” “Tulsi as a medicinal plant,” “Medicinal properties of Ocimum sanctum,” and “Tulsi in dentistry.” The search was limited to articles and books in the English literature. To prepare a thorough review on the therapeutic aspects of Tulsi, the contents were screened between the year 1985 to 2015 by going through the title and abstracts, and further shortlisting articles for full text reading. Conclusion: The present review revealed that Tulsi has an extensive array of medicinal uses, as evidenced by various studies conducted, but its use in allopathic medicine is still limited because of the lack of clinical trials on humans.

The fairness of the PPS reimbursement methodology.

Science.gov (United States)

Gianfrancesco, F D

1990-01-01

In FY 1984 the Medicare program implemented a new method of reimbursing hospitals for inpatient services, the Prospective Payment System (PPS). Under this system, hospitals are paid a predetermined amount per Medicare discharge, which varies according to certain patient and hospital characteristics. This article investigates the presence of systematic biases and other potential imperfections in the PPS reimbursement methodology as revealed by its effects on Medicare operating ratios. The study covers the first three years of the PPS (approximately 1984-1986) and is based on hospital data from the Medicare cost reports and other related sources. Regression techniques were applied to these data to determine how Medicare operating ratios were affected by specific aspects of the reimbursement methodology. Several possible imbalances were detected. The potential undercompensation relating to these can be harmful to certain classes of hospitals and to the Medicare populations that they serve. PMID:2109738

The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

DEFF Research Database (Denmark)

Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

2013-01-01

on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between...... exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges...

Stable isotope methodology and its application to nutrition and gastroenterology

International Nuclear Information System (INIS)

Klein, P.D.; Hachey, D.L.; Wong, W.W.; Abrams, S.A.

1993-01-01

This report describes the activities of the Stable Isotope Laboratory in its function as a core resource facility for stable isotope applications in human nutrition research. Three aspects are covered: Training of visitors, assessment of new instrumentation, and development of new methodology. The research achievements of the laboratory are indicated in the publications that appeared during this period. (author). 23 refs

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.

Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials

Directory of Open Access Journals (Sweden)

Choi Sun-Mi

2010-01-01

Full Text Available Abstract Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation. This study aims to systematically review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain. Methods We searched 11 databases (without language restrictions: MEDLINE, Allied and Complementary Medicine (AMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL, Korean Studies Information (KSI, DBPIA, Korea Institute of Science and Technology Information (KISTI, KoreaMed, Research Information Service System (RISS, China National Knowledge Infrastructure (CNKI and the Cochrane Library. The search strategy was Guasha (OR scraping AND pain. Risk of bias was assessed with the Cochrane criteria (i.e. sequence generation, blinding, incomplete outcome measures and allocation concealment. Results Five randomized controlled trials (RCTs and two controlled clinical trials (CCTs were included in the present study. Two RCTs compared Guasha with acupuncture in terms of effectiveness, while the other trials compared Guasha with no treatment (1 trial, acupuncture (4 trials, herbal injection (1 trial and massage or electric current therapy (1 trial. While two RCTs suggested favorable effects of Guasha on pain reduction and response rate, the quality of these RCTs was poor. One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low methodological quality. Conclusion Current evidence is insufficient to show that Guasha is effective in pain management. Further RCTs are warranted and methodological quality should be improved.

Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP.

Science.gov (United States)

Lazar, Ann A; Bonetti, Marco; Cole, Bernard F; Yip, Wai-Ki; Gelber, Richard D

2016-04-01

Investigators conducting randomized clinical trials often explore treatment effect heterogeneity to assess whether treatment efficacy varies according to patient characteristics. Identifying heterogeneity is central to making informed personalized healthcare decisions. Treatment effect heterogeneity can be investigated using subpopulation treatment effect pattern plot (STEPP), a non-parametric graphical approach that constructs overlapping patient subpopulations with varying values of a characteristic. Procedures for statistical testing using subpopulation treatment effect pattern plot when the endpoint of interest is survival remain an area of active investigation. A STEPP analysis was used to explore patterns of absolute and relative treatment effects for varying levels of a breast cancer biomarker, Ki-67, in the phase III Breast International Group 1-98 randomized clinical trial, comparing letrozole to tamoxifen as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer. Absolute treatment effects were measured by differences in 4-year cumulative incidence of breast cancer recurrence, while relative effects were measured by the subdistribution hazard ratio in the presence of competing risks using O-E (observed-minus-expected) methodology, an intuitive non-parametric method. While estimation of hazard ratio values based on O-E methodology has been shown, a similar development for the subdistribution hazard ratio has not. Furthermore, we observed that the subpopulation treatment effect pattern plot analysis may not produce results, even with 100 patients within each subpopulation. After further investigation through simulation studies, we observed inflation of the type I error rate of the traditional test statistic and sometimes singular variance-covariance matrix estimates that may lead to results not being produced. This is due to the lack of sufficient number of events within the subpopulations, which we refer to as instability of

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.

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.

A Comparison of Various Software Development Methodologies: Feasibility and Methods of Integration

Directory of Open Access Journals (Sweden)

Samir Abou El-Seoud

2016-12-01

Full Text Available System development methodologies which have being used in the academic and commercial environments during last two decades have advantages and disadvantages. Researchers had tried to identify objectives, scope …etc. of the methodologies by following different approaches. Each approach has its Limitation, specific interest, coverage …etc. In this paper, we tried to perform a comparative study of those methodologies which are popular and commonly used in banking and commercial environment. We tried in our study to determine objectives, scope, tools and other features of the methodologies. We also, tried to determine how and to what extent the methodologies incorporate the facilities such as project management, cost benefit analysis, documentation …etc. One of the most important aspects of our study was how to integrate the methodologies and develop a global methodology which covers the complete span of the software development life cycle? A prototype system which integrates the selected methodologies has been developed. The developed system helps analysts and designers how to choose suitable tools or to obtain guidelines on what to do in a particular situation. The prototype system has been tested during the development of a software for an ATM “Auto Teller Machine” by selecting and applying SASD methodology during software development. This resulted in the development of high quality and well documented software system.

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.

[Sport as a profession: medical and social aspects].

Science.gov (United States)

Izmerov, N F

2011-01-01

The author analyses possible use of methods and achievements of industrial medicine in solving problems of acme in sports. The article covers theoretic, methodologic and practical basis for possible integration of industrial medicine and sports medicine. Mechanisms of such interdisciplinary integration include current legal basis, scientific research (mostly, concept of occupational risk, norm and pathology concept, doctrine of preventive medicine, etc), practical experience accumulated in this country and abroad. Some aspects of public health preservation in contemporary Russia are also tackled.

A methodology for sunlight urban planning: a computer-based solar and sky vault obstruction analysis

Energy Technology Data Exchange (ETDEWEB)

Pereira, Fernando Oscar Ruttkay; Silva, Carlos Alejandro Nome [Federal Univ. of Santa Catarina (UFSC), Dept. of Architecture and Urbanism, Florianopolis, SC (Brazil); Turkienikz, Benamy [Federal Univ. of Rio Grande do Sul (UFRGS), Faculty of Architecture, Porto Alegre, RS (Brazil)

2001-07-01

The main purpose of the present study is to describe a planning methodology to improve the quality of the built environment based on the rational control of solar radiation and the view of the sky vault. The main criterion used to control the access and obstruction of solar radiation was the concept of desirability and undesirability of solar radiation. A case study for implementing the proposed methodology is developed. Although needing further developments to find its way into regulations and practical applications, the methodology has shown a strong potential to deal with an aspect that otherwise would be almost impossible. (Author)

A comparison of methodological guides for creating microregional strategies of Central European rural areas. Case study: Czech Republic

Directory of Open Access Journals (Sweden)

Jakub Trojan

2012-05-01

Full Text Available This paper discusses the complementarity of methodological guides dealing with microregional development in Central Europe. As an example, the Czech Republic framework has been selected. This study compares seven common methodologies written in Czech, which the author has divided into three groups, namely manual-like methodologies, semi-scientific texts and hybrid texts dealing with other complementary aspects. The result is a comparison of methodologies, their usage and implications for the practices of regional development. The paper also includes a brief analysis of sustainable development elements incorporated into the methodological texts. The final part outlines links to the four-capital model of regional development.

Is the randomised controlled trial the best?

African Journals Online (AJOL)

The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

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

Qualitative case study methodology in nursing research: an integrative review.

Science.gov (United States)

Anthony, Susan; Jack, Susan

2009-06-01

This paper is a report of an integrative review conducted to critically analyse the contemporary use of qualitative case study methodology in nursing research. Increasing complexity in health care and increasing use of case study in nursing research support the need for current examination of this methodology. In 2007, a search for case study research (published 2005-2007) indexed in the CINAHL, MEDLINE, EMBASE, PsychINFO, Sociological Abstracts and SCOPUS databases was conducted. A sample of 42 case study research papers met the inclusion criteria. Whittemore and Knafl's integrative review method guided the analysis. Confusion exists about the name, nature and use of case study. This methodology, including terminology and concepts, is often invisible in qualitative study titles and abstracts. Case study is an exclusive methodology and an adjunct to exploring particular aspects of phenomena under investigation in larger or mixed-methods studies. A high quality of case study exists in nursing research. Judicious selection and diligent application of literature review methods promote the development of nursing science. Case study is becoming entrenched in the nursing research lexicon as a well-accepted methodology for studying phenomena in health and social care, and its growing use warrants continued appraisal to promote nursing knowledge development. Attention to all case study elements, process and publication is important in promoting authenticity, methodological quality and visibility.

Utilization of wheel dop based on ergonomic aspects

Science.gov (United States)

Widiasih, Wiwin; Murnawan, Hery; Setiawan, Danny

2017-06-01

Time is an important thing in life. People need a tool or equipment to measure time which is divided into two types, namely clock and watch. Everyone needs those kinds of tool. It becomes an opportunity for manufacturer to build a business. However, establishing a business by depending on the demand is not enough, it is necessary to take a consideration of making innovation. Innovation is a difficult thing to find out, but it is not impossible to do it. By creating an innovative product, it can be a strategy to win the competitive market. This study aimed to create an innovative product based on the ergonomic aspects, which was by utilizing wheel dop. This methodology consisted of pre-study, planning and product development, and product analysis. This product utilized wheel dop and was made based on the ergonomic aspects.

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.

Risk management in methodologies of information technology and communications projects

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Jonathan Carrillo

2013-12-01

Full Text Available (Received: 2013/10/02 - Accepted: 2013/12/13At present there are methodologies that have several alternatives and methods to manage projects of Information and Communication Technologies. However, these do not cover a solution for the technology events that can occur in the industry, government, education, among others. In the technology market there are several models to identify and analyze risks according to relevant aspects of their area of specialty e.g. projects, in software development, communications, information security and business alignment. For this reason, this research conducted an evaluation of risk management activities of the methodologies used mostly to know which of them includes more correspondence with basic elements of IT using a rating scale.

Research design considerations for single-dose analgesic clinical trials in acute pain

DEFF Research Database (Denmark)

Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C

2016-01-01

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials......, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay...... sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable...

Lung Cancer Clinical Trials: Advances in Immunotherapy

Science.gov (United States)

New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.

Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...

African Journals Online (AJOL)

Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...

A cost-effective methodology to internalize nuclear safety in nuclear reactor conceptual design

International Nuclear Information System (INIS)

Gimenez, M.; Grinblat, P.; Schlamp, M.

2003-01-01

A new methodology to perform nuclear reactor design, balancing safety and economics at the conceptual engineering stage, is presented in this work. The goal of this integral methodology is to take into account safety aspects in an optimization design process where the design variables are balanced in order to obtain a better figure of merit related with reactor economic performance. Design parameter effects on characteristic or critical safety variables, chosen from reactor behavior during accidents (safety performance indicators), are synthesized on Design Maps. These maps allow one to compare the safety indicator with limits, which are determined by design criteria or regulations, and to transfer these restrictions to the design parameters. In this way, reactor dynamic response and other safety aspects are integrated in a global optimization process, by means of additional rules to the neutronic, thermal-hydraulic, and mechanical calculations. An application of the methodology, implemented in Integrated Reactor Evaluation Program 3 (IREP3) code, to optimize safety systems of CAREM prototype is presented. It consists in balancing the designs of the Emergency Injection System (EIS), the Residual Heat Removal System (RHRS), the primary circuit water inventory and the containment height, to cope with loss of coolant and loss of heat sink (LOHS) accidental sequences, taking into account cost and reactor performance. This methodology turns out to be promising to internalize cost-efficiently safety issues. It also allows one to evaluate the incremental costs of implementing higher safety levels

European randomized lung cancer screening trials: Post NLST

DEFF Research Database (Denmark)

Field, JK; Klaveren, R; Pedersen, JH

2013-01-01

Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...

Damage assessment methodology for vehicles exposed to flooding in urban areas

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E. Martínez Gomariz

2017-10-01

Full Text Available Urban floods may provoke important damages to vehicles, usually not taken into account within most studies related to urban flood risks damage assessments. Herein a methodology to estimate damages to vehicles exposed to urban floods is presented. After a state-of-the-art review, the most recent damage curves for vehicles developed by the U.S. Army Corps of Engineers (USACE, 2009 are presented as the best adaptive and the most comprehensively performed so far. The proposed methodology is applied to the Spanish municipality of Badalona, framed in the H2020 European Project BINGO. In order to conduct this methodology some aspects such as the vehicular distribution are analyzed within the study area. Finally, Expected Annual Damage (EAD for flooded vehicles is calculated based on inundations related to design storms of different return periods (1, 10, 100 and 500 years.

Hybrid methodological approach to context-dependent speech recognition

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Dragiša Mišković

2017-01-01

Full Text Available Although the importance of contextual information in speech recognition has been acknowledged for a long time now, it has remained clearly underutilized even in state-of-the-art speech recognition systems. This article introduces a novel, methodologically hybrid approach to the research question of context-dependent speech recognition in human–machine interaction. To the extent that it is hybrid, the approach integrates aspects of both statistical and representational paradigms. We extend the standard statistical pattern-matching approach with a cognitively inspired and analytically tractable model with explanatory power. This methodological extension allows for accounting for contextual information which is otherwise unavailable in speech recognition systems, and using it to improve post-processing of recognition hypotheses. The article introduces an algorithm for evaluation of recognition hypotheses, illustrates it for concrete interaction domains, and discusses its implementation within two prototype conversational agents.

A methodology for evaluating land suitability for medicinal plants at a regional level

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Marco Barbaro

2011-12-01

Full Text Available Before introducing a new crop in an area, such as medicinal plant species, crop-land suitability analysis is a prerequisite to achieve an optimum exploitation of the available land resources for a sustainable agricultural production. To evaluate the land suitability it is important to take into account the habitats of the plant species. Moreover, agronomic, logistic and product quality aspects have to be considered. The importance of these aspects changes according to the stakeholders: the local government is more involved in supporting environmental suitability and production sustainability, farmers need areas which satisfy agronomic and logistic requirements, while industry is interested in the quality of production. A methodology was developed and implemented to create suitability maps for medicinal plants. Because of the generally limited information about medicinal plant adaptation, a simple methodology, based on a priori information has been developed, based on three different criteria: i environmental suitability (point of view of local government; ii agronomic, productivity and logistic suitability (point of view of the farmer; iii quality suitability (point of view of industry. For each of the three criteria, a specific macro-indicator, based on land characteristics, was calculated using membership functions. Here, a methodology to create maps for the introduction of such species was developed and implemented. This methodology can be repeated by command scripts in an easy-to-use freeware GIS. The structure of the evaluation model can be easily adapted to consider more detailed land information like climate and soil. The methodology (implemented by scripts in a freeware GIS, can be easily repeated and adapted for other situations.

Least-cost Paths - Some Methodological Issues

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Irmela Herzog

2014-06-01

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

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.

The Interdisciplinary Course in the Legal Aspects of Noise Pollution at Columbia University.

Science.gov (United States)

Harris, Cyril M.; Rosenthal, Albert J.

1981-01-01

A course in the legal aspects of noise pollution, cross-listed for students in Columbia University's Law and Engineering Schools, is described. Although noise is used as the major source of environmental pollution in this course, the principles and methodology discussed apply to other forms of environmental law. (MLW)

Project Inner Brick - Colorful Plastic Bricks in Psychotherapy - An Introduction to Methodology

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Neidert László

2015-06-01

Full Text Available PIB is a research project pertaining to the psychotherapeutic potential of Lego bricks. This is based on Lego Group’s own method called Lego Seriousplay and Eric Berne's transactional analysis as a theoretical background. If we see it from the Lego’s aspect, our plan is a training like LSP. It is only alike because of the special application. We made a lot of modifications according to the original methodology. In this document we would like to present details of our research we have been working on for almost two years. The characteristics of our methodology will be illustrated, too.

Mo(ve)ment methodology – Researching conflictual meanings, double-binds and change in extreme life situations

DEFF Research Database (Denmark)

Mørck, Line Lerche

2015-01-01

and change in conduct of life. This moment-movement methodology is developed in close collaboration with a former biker-gang member - involved as a research apprentice. Together we are developing the methodology, while researching concrete processes of change from biker gang member towards becoming......The social practice theoretical moment-movement methodology explores significant moments in depth, such as moments of frustration, anger, engagement and (be)longing. The moments are conceptualized as part of broader conflictual struggles and processes (movements), which include both continuity...... are reflected when methodological aspects from Collective Biography Work is integrated with a social phenomenological concept of double bind situations (R.D. Laing) into a social practice theoretical moment-movement ethnography....

ASPECTS REGARDING THE MECHANISM OF BANK LENDING FOR INDIVIDUALS

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David Delia

2012-01-01

Full Text Available The crediting transactions are very important within the intermediation activity which the commercial banks perform and these represent at the same time the main asset transactions. The manner of approach of this activity differs depending on the type of the client who can be an individual, a legal entity or a credit institution. We aim at emphasizing aspects related to the loans granted to individuals by commercial banks and especially at underlining the importance of the choice regarding the risk evaluation method when analyzing the credit file. In regards to the research methodology, we used the descriptive method. We conducted a qualitative research based on the observation of some aspects, as well as a quantitative one. The conclusions of the achieved study are presented at the end of this paper.

Methodology of environmental risk assessment management

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Saša T. Bakrač

2012-04-01

Full Text Available Successful protection of environment is mostly based on high-quality assessment of potential and present risks. Environmental risk management is a complex process which includes: identification, assessment and control of risk, namely taking measures in order to minimize the risk to an acceptable level. Environmental risk management methodology: In addition to these phases in the management of environmental risk, appropriate measures that affect the reduction of risk occurrence should be implemented: - normative and legal regulations (laws and regulations, - appropriate organizational structures in society, and - establishing quality monitoring of environment. The emphasis is placed on the application of assessment methodologies (three-model concept, as the most important aspect of successful management of environmental risk. Risk assessment methodology - European concept: The first concept of ecological risk assessment methodology is based on the so-called European model-concept. In order to better understand this ecological risk assessment methodology, two concepts - hazard and risk - are introduced. The European concept of environmental risk assessment has the following phases in its implementation: identification of hazard (danger, identification of consequences (if there is hazard, estimate of the scale of consequences, estimate of consequence probability and risk assessment (also called risk characterization. The European concept is often used to assess risk in the environment as a model for addressing the distribution of stressors along the source - path - receptor line. Risk assessment methodology - Canadian concept: The second concept of the methodology of environmental risk assessment is based on the so-called Canadian model-concept. The assessment of ecological risk includes risk arising from natural events (floods, extreme weather conditions, etc., technological processes and products, agents (chemical, biological, radiological, etc

A methodological review of qualitative case study methodology in midwifery research.

Science.gov (United States)

Atchan, Marjorie; Davis, Deborah; Foureur, Maralyn

2016-10-01

To explore the use and application of case study research in midwifery. Case study research provides rich data for the analysis of complex issues and interventions in the healthcare disciplines; however, a gap in the midwifery research literature was identified. A methodological review of midwifery case study research using recognized templates, frameworks and reporting guidelines facilitated comprehensive analysis. An electronic database search using the date range January 2005-December 2014: Maternal and Infant Care, CINAHL Plus, Academic Search Complete, Web of Knowledge, SCOPUS, Medline, Health Collection (Informit), Cochrane Library Health Source: Nursing/Academic Edition, Wiley online and ProQuest Central. Narrative evaluation was undertaken. Clearly worded questions reflected the problem and purpose. The application, strengths and limitations of case study methods were identified through a quality appraisal process. The review identified both case study research's applicability to midwifery and its low uptake, especially in clinical studies. Many papers included the necessary criteria to achieve rigour. The included measures of authenticity and methodology were varied. A high standard of authenticity was observed, suggesting authors considered these elements to be routine inclusions. Technical aspects were lacking in many papers, namely a lack of reflexivity and incomplete transparency of processes. This review raises the profile of case study research in midwifery. Midwives will be encouraged to explore if case study research is suitable for their investigation. The raised profile will demonstrate further applicability; encourage support and wider adoption in the midwifery setting. © 2016 John Wiley & Sons Ltd.

Vitamin D and cancer: Clinical aspects

Science.gov (United States)

Woloszynska-Read, Anna; Johnson, Candace S.; Trump, Donald L.

2015-01-01

There are substantial preclinical and epidemiologic data that suggest that vitamin D plays a role in the prevention and treatment of cancer. Numerous observational studies have shown that low blood levels of 25(OH) vitamin D (cholecalciferol), estimated by geographical location, diet and activity assessment or measured serum levels are associated with a higher risk of cancer and worse cancer-specific survival as well as numerous morbidities to e.g. cardiovascular disease, stroke, infection, autoimmune disease, and neuromuscular dysfunction among large populations. A considerable number of in vitro and in vivo studies indicate that the most active metabolite of vitamin D – 1,25-dihydroxycholecalciferol or calcitriol – has anti-proliferative, pro-apoptotic, pro-differentiating, and anti-angiogenic properties. Combined treatment of calcitriol and many types of cytotoxic agents has synergistic or at least additive effects. However, clinical trials testing these hypotheses have been less encouraging, though a number of methodological, pharmacological, and pharmaceutical issues confound all trials ever conducted. In order to properly assess the clinical value of vitamin D, its metabolites and analogs in cancer prevention and treatment, more studies are needed. PMID:21872802

COMPARING AND CONTRASTING THE ALTERNATIVE METHODOLOGIES AVAILABLE FOR EVALUATING THE IMPACT OF TOURISM

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Silvana DJURASEVIC

2007-06-01

Full Text Available Tourism has impacts upon a destination country. The aim of this work is to compare and contrast the alternative methodologies available for evaluating the impact of tourism. Tourism can be one of alternatives for development of a destination and sometimes the only possibility. For that reason it is very important to compare benefit and cost that tourism brings with corresponding valyes of alternative investment. Obtained results represent a very important input for planning and also for decision making policy. Different methodologies bring different results, different techniques have their own strenghts and weaknesses. For that reason, depending on the need, it is important to combine the methodologies in order to achieve the maximal benefit and minimal costs, from economical aspect, socio-cultural and environmental development.

Nuclear reactor conceptual design: methodology for cost-effective internalisation of nuclear safety

International Nuclear Information System (INIS)

Gimenez, M.; Grinblat, P.; Schlamp, M.

2002-01-01

A novel and promising methodology to perform nuclear reactor design is presented in this work. It achieves to balance efficiently safety and economics at the conceptual engineering stage. The key to this integral approach is to take into account safety aspects in a design optimisation process where the design variables are balanced in order to obtain a better figure of merit related with reactor economic performance. Design parameter effects on characteristic or critical safety variables, chosen from reactor behaviour during accidents and from its probabilistic safety assessment -safety performance indicators-, are synthesised on Safety Design Maps. These maps allow one to compare these indicators with limit values, which are determined by design criteria or regulations, and to transfer these restrictions to the design parameters. In this way, reactor dynamic response and other safety aspects are integrated in a global optimisation process, by means of additional rules to the neutronic, thermal-hydraulic and mechanical calculations. This methodology turns out to be promising to balance and optimise reactor and safety system design in an early engineering stage, in order to internalise cost-efficiently safety issues. It also allows one to evaluate the incremental costs of implementing higher safety levels. Furthermore, through this methodology, a simplified design can be obtained, compared to the resultant complexity when these concepts are introduced in a later engineering stage. (author)

The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial

DEFF Research Database (Denmark)

Leucht, Stefan; Winter-van Rossum, Inge; Heres, Stephan

2015-01-01

Commission sponsored "Optimization of Treatment and Management of Schizophrenia in Europe" (OPTiMiSE) trial which aims to provide a treatment algorithm for patients with a first episode of schizophrenia. METHODS: We searched Pubmed (October 29, 2014) for randomized controlled trials (RCTs) that examined...... switching the drug in nonresponders to another antipsychotic. We described important methodological choices of the OPTiMiSE trial. RESULTS: We found 10 RCTs on switching antipsychotic drugs. No trial was conclusive and none was concerned with first-episode schizophrenia. In OPTiMiSE, 500 first episode...

A Global Sensitivity Analysis Methodology for Multi-physics Applications

Energy Technology Data Exchange (ETDEWEB)

Tong, C H; Graziani, F R

2007-02-02

Experiments are conducted to draw inferences about an entire ensemble based on a selected number of observations. This applies to both physical experiments as well as computer experiments, the latter of which are performed by running the simulation models at different input configurations and analyzing the output responses. Computer experiments are instrumental in enabling model analyses such as uncertainty quantification and sensitivity analysis. This report focuses on a global sensitivity analysis methodology that relies on a divide-and-conquer strategy and uses intelligent computer experiments. The objective is to assess qualitatively and/or quantitatively how the variabilities of simulation output responses can be accounted for by input variabilities. We address global sensitivity analysis in three aspects: methodology, sampling/analysis strategies, and an implementation framework. The methodology consists of three major steps: (1) construct credible input ranges; (2) perform a parameter screening study; and (3) perform a quantitative sensitivity analysis on a reduced set of parameters. Once identified, research effort should be directed to the most sensitive parameters to reduce their uncertainty bounds. This process is repeated with tightened uncertainty bounds for the sensitive parameters until the output uncertainties become acceptable. To accommodate the needs of multi-physics application, this methodology should be recursively applied to individual physics modules. The methodology is also distinguished by an efficient technique for computing parameter interactions. Details for each step will be given using simple examples. Numerical results on large scale multi-physics applications will be available in another report. Computational techniques targeted for this methodology have been implemented in a software package called PSUADE.

Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

Science.gov (United States)

van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E

2014-06-01

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.

ACCOUNTING ASPECTS OF PRICING AND TRANSFER PRICING

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TÜNDE VERES

2011-01-01

Full Text Available The pricing methods in practice need really complex view of the business situation and depend on the strategy and market position of a company. The structure of a price seems simple: cost plus margin. Both categories are special area in the management accounting. Information about the product costs, the allocation methodologies in cost accounting, the analyzing of revenue and different level of the margin needs information from accounting system. This paper analyzes the pricing methods from management accounting aspects to show out the role of the accounting system in the short term and long term pricing and transfer pricing decisions.

CREATIVE ASPECTS OF USAGE OF INFORMATION AND COMMUNICATION TECHNOLOGIES IN DESIGNER EDUCATION

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A.A Polishchuk

2010-11-01

Full Text Available The basic approaches to the use of information technologies in educational process of visual art and design are analysed in the article. Methodological aspects of ICT integration and the artistic and educational activity as well as difficulties regarding the development of teaching materials for professional thinking formation and development of the creative person are considered.

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.

Methodological Considerations in Designing and Evaluating Animal-Assisted Interventions.

Science.gov (United States)

Stern, Cindy; Chur-Hansen, Anna

2013-02-27

This paper presents a discussion of the literature on animal-assisted interventions and describes limitations surrounding current methodological quality. Benefits to human physical, psychological and social health cannot be empirically confirmed due to the methodological limitations of the existing body of research, and comparisons cannot validly be made across different studies. Without a solid research base animal-assisted interventions will not receive recognition and acceptance as a credible alternative health care treatment. The paper draws on the work of four systematic reviews conducted over April-May 2009, with no date restrictions, focusing exclusively on the use of canine-assisted interventions for older people residing in long-term care. The reviews revealed a lack of good quality studies. Although the literature base has grown in volume since its inception, it predominantly consists of anecdotal accounts and reports. Experimental studies undertaken are often flawed in aspects of design, conduct and reporting. There are few qualitative studies available leading to the inability to draw definitive conclusions. It is clear that due to the complexities associated with these interventions not all weaknesses can be eliminated. However, there are basic methodological weaknesses that can be addressed in future studies in the area. Checklists for quantitative and qualitative research designs to guide future research are offered to help address methodological rigour.

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

Guidelines for controlled trials of drugs in tension-type headache: second edition

DEFF Research Database (Denmark)

Bendtsen, L; Bigal, M E; Cerbo, R

2010-01-01

and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments......The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality...... controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic...

[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

Planning and analyzing clinical trials with composite endpoints

CERN Document Server

Rauch, Geraldine; Kieser, Meinhard

2017-01-01

This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes requ...

Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

Directory of Open Access Journals (Sweden)

Vickers Andrew J

2012-02-01

Full Text Available Abstract Background Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. Although small differences would be worthwhile, an appropriately powered randomized trial would need to be very large, and thus of doubtful feasibility given the expense, complexity and regulatory burden of contemporary clinical trials. We have proposed a novel methodology, the clinically-integrated randomized trial, which dramatically streamlines trial procedures in order to reduce the marginal cost of an additional patient towards zero. We aimed to determine the feasibility of implementing such a trial for radical prostatectomy. Methods Patients undergoing radical prostatectomy as initial treatment for prostate cancer were randomized in a factorial design to involvement of the fascia during placement of the anastomotic sutures, urethral irrigation, both or neither. Endpoint data were obtained from routine clinical documentation. Accrual and compliance rates were monitored to determine the feasibility of the trial. Results From a total of 260 eligible patients, 154 (59% consented; 56 patients declined to participate, 20 were not approached on recommendation of the treating surgeon, and 30 were not approached for logistical reasons. Although recording by surgeons of the procedure used was incomplete (~80%, compliance with randomization was excellent when it was recorded, with only 6% of procedures inconsistent with allocation. Outcomes data was received from 71% of patients at one year. This improved to 83% as the trial progressed. Conclusions A clinically-integrated randomized trial was conducted at low cost, with excellent accrual, and acceptable compliance with treatment allocation and outcomes reporting. This demonstrates the feasibility of the methodology. Improved methods to ensure documentation of surgical procedures would be required before wider implementation

[Ethical principles of clinical trials in minors].

Science.gov (United States)

Koch, H J; Raschka, C

2002-12-05

Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

A systematic review of the use of an expertise-based randomised controlled trial design.

Science.gov (United States)

Cook, Jonathan A; Elders, Andrew; Boachie, Charles; Bassinga, Ted; Fraser, Cynthia; Altman, Doug G; Boutron, Isabelle; Ramsay, Craig R; MacLennan, Graeme S

2015-05-30

Under a conventional two-arm randomised trial design, participants are allocated to an intervention and participating health professionals are expected to deliver both interventions. However, health professionals often have differing levels of expertise in a skill-based interventions such as surgery or psychotherapy. An expertise-based approach to trial design, where health professionals only deliver an intervention in which they have expertise, has been proposed as an alternative. The aim of this project was to systematically review the use of an expertise-based trial design in the medical literature. We carried out a comprehensive search of nine databases--AMED, BIOSIS, CENTRAL, CINAHL, Cochrane Methodology Register, EMBASE, MEDLINE, Science Citation Index, and PsycINFO--from 1966 to 2012 and performed citation searches using the ISI Citation Indexes and Scopus. Studies that used an expertise-based trial design were included. Two review authors independently screened the titles and abstracts and assessed full-text reports. Data were extracted and summarised on the study characteristics, general and expertise-specific study methodology, and conduct. In total, 7476 titles and abstracts were identified, leading to 43 included studies (54 articles). The vast majority (88%) used a pure expertise-based design; three (7%) adopted a hybrid design, and two (5%) used a design that was unclear. Most studies compared substantially different interventions (79%). In many cases, key information relating to the expertise-based design was absent; only 12 (28%) reported criteria for delivering both interventions. Most studies recruited the target sample size or very close to it (median of 101, interquartile range of 94 to 118), although the target was reported for only 40% of studies. The proportion of participants who received the allocated intervention was high (92%, interquartile range of 82 to 99%). While use of an expertise-based trial design is growing, it remains uncommon

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

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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

Sample size determination in clinical trials with multiple endpoints

CERN Document Server

Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

2015-01-01

This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

Life cycle costing of food waste: A review of methodological approaches.

Science.gov (United States)

De Menna, Fabio; Dietershagen, Jana; Loubiere, Marion; Vittuari, Matteo

2018-03-01

Food waste (FW) is a global problem that is receiving increasing attention due to its environmental and economic impacts. Appropriate FW prevention, valorization, and management routes could mitigate or avoid these effects. Life cycle thinking and approaches, such as life cycle costing (LCC), may represent suitable tools to assess the sustainability of these routes. This study analyzes different LCC methodological aspects and approaches to evaluate FW management and valorization routes. A systematic literature review was carried out with a focus on different LCC approaches, their application to food, FW, and waste systems, as well as on specific methodological aspects. The review consisted of three phases: a collection phase, an iterative phase with experts' consultation, and a final literature classification. Journal papers and reports were retrieved from selected databases and search engines. The standardization of LCC methodologies is still in its infancy due to a lack of consensus over definitions and approaches. Research on the life cycle cost of FW is limited and generally focused on FW management, rather than prevention or valorization of specific flows. FW prevention, valorization, and management require a consistent integration of LCC and Life Cycle Assessment (LCA) to avoid tradeoffs between environmental and economic impacts. This entails a proper investigation of methodological differences between attributional and consequential modelling in LCC, especially with regard to functional unit, system boundaries, multi-functionality, included cost, and assessed impacts. Further efforts could also aim at finding the most effective and transparent categorization of costs, in particular when dealing with multiple stakeholders sustaining costs of FW. Interpretation of results from LCC of FW should take into account the effect on larger economic systems. Additional key performance indicators and analytical tools could be included in consequential approaches

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

Science.gov (United States)

Lo, Bernard; Parham, Lindsay

2010-01-01

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

Does Metformin Reduce Cancer Risks? Methodologic Considerations.

Science.gov (United States)

Golozar, Asieh; Liu, Shuiqing; Lin, Joeseph A; Peairs, Kimberly; Yeh, Hsin-Chieh

2016-01-01

The substantial burden of cancer and diabetes and the association between the two conditions has been a motivation for researchers to look for targeted strategies that can simultaneously affect both diseases and reduce their overlapping burden. In the absence of randomized clinical trials, researchers have taken advantage of the availability and richness of administrative databases and electronic medical records to investigate the effects of drugs on cancer risk among diabetic individuals. The majority of these studies suggest that metformin could potentially reduce cancer risk. However, the validity of this purported reduction in cancer risk is limited by several methodological flaws either in the study design or in the analysis. Whether metformin use decreases cancer risk relies heavily on the availability of valid data sources with complete information on confounders, accurate assessment of drug use, appropriate study design, and robust analytical techniques. The majority of the observational studies assessing the association between metformin and cancer risk suffer from methodological shortcomings and efforts to address these issues have been incomplete. Future investigations on the association between metformin and cancer risk should clearly address the methodological issues due to confounding by indication, prevalent user bias, and time-related biases. Although the proposed strategies do not guarantee a bias-free estimate for the association between metformin and cancer, they will reduce synthesis of and reporting of erroneous results.

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.

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...

Recent methodological advances in male hormonal contraception.

Science.gov (United States)

Liu, Peter Y; Swerdloff, Ronald S; Wang, Christina

2010-11-01

Landmark WHO-sponsored trials showed decades ago that male hormonal contraception (MHC) is an effective male-directed contraceptive approach. Considerable progress has been made particularly in the last 5 years, establishing for the first time the reversibility of MHC and its short-term safety. Methodological advances in recent years include the pooling of information and individual-level integrated analysis; the first-time use of centralized semen analysis and fluorescence to detect low sperm concentrations; the establishment of sperm quality reference ranges in fertile men; the measurement of blood steroid concentrations by gas chromatography/mass spectrometry; and the inclusion of placebo groups to delineate clearly possible adverse effects of androgens and progestins in men. We report integrated analyses of factors that are important in predicting suppression and recovery of spermatogenesis after MHC clinical trials for the past 15 years. These are the best data available and will provide guidance and reassurance for the larger-scale Phase III specific regimen efficacy studies that will be required to bring MHC to the population (market). Copyright © 2010 Elsevier Inc. All rights reserved.

Approaches to assessment of socio-demographic and economic aspects of nuclear power plant construction and operation

International Nuclear Information System (INIS)

Uvirova, E.

1984-01-01

The paper informs of solving the task of economic evaluation of transient and permanent social consequences of the construction and operation of nuclear power plants. The solution takes place in three stages: 1. drafting of methodology, 2. trial of methodology in localities of current nuclear power plant construction, 3. analysis of results and finalizing of methodology. The task is aimed at studying the questions of the return and profitability of investments, the evaluation of optimal economic lifetime, and the effective restoration of basic funds. Its model solution shows the national economy relations of nuclear power. Also discussed is the question of the use of non-balance heat from nuclear power plants. (E.S.)

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

Directory of Open Access Journals (Sweden)

Birtwhistle Richard

2003-12-01

Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

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.

Determination of the Territorial Sea Baseline - Measurement Aspect

Science.gov (United States)

Specht, Cezary; Weintrit, Adam; Specht, Mariusz; Dabrowski, Pawel

2017-12-01

Determining the course of the territorial sea baseline (TSB) of the coastal state is the basis for establishing its maritime boundaries, thus becoming indirect part of maritime policy of the state. Besides the following aspects: legal and methodological as described in the conventions, acts, standards and regulations, equally important is the issue of measurement methodology with respect to the boundaries of the territorial sea. The publication discussed accuracy requirements of the TSB measurement implementation, the relationship of sea level with a choice of the method of its determination, and discussed the implementation of such a measurement on a selected example. As the test reservoir was used the 400-meter stretch of the public beach in Gdynia. During the measurements they used the GNSS geodetic receiver operating in real time based on the geodetic network - VRSnet.pl. Additionally, a comparison was made of the applied method with analogous measurements of the TSB performed in 1999.

Modern methodology and applications in spatial-temporal modeling

CERN Document Server

Matsui, Tomoko

2015-01-01

This book provides a modern introductory tutorial on specialized methodological and applied aspects of spatial and temporal modeling. The areas covered involve a range of topics which reflect the diversity of this domain of research across a number of quantitative disciplines. For instance, the first chapter deals with non-parametric Bayesian inference via a recently developed framework known as kernel mean embedding which has had a significant influence in machine learning disciplines. The second chapter takes up non-parametric statistical methods for spatial field reconstruction and exceedance probability estimation based on Gaussian process-based models in the context of wireless sensor network data. The third chapter presents signal-processing methods applied to acoustic mood analysis based on music signal analysis. The fourth chapter covers models that are applicable to time series modeling in the domain of speech and language processing. This includes aspects of factor analysis, independent component an...

Alzheimer's Disease: Lessons Learned from Amyloidocentric Clinical Trials.

Science.gov (United States)

Soejitno, Andreas; Tjan, Anastasia; Purwata, Thomas Eko

2015-06-01

Alzheimer's disease (AD) is one of the most debilitating neurodegenerative diseases and is predicted to affect 1 in 85 people by 2050. Despite much effort to discover a therapeutic strategy to prevent progression or to cure AD, to date no effective disease-modifying agent is available that can prevent, halt, or reverse the cognitive and functional decline of patients with AD. Several underlying etiologies to this failure are proposed. First, accumulating evidence from past trials suggests a preventive as opposed to therapeutic paradigm, and the precise temporal and mechanistic relationship of β-amyloid (Aβ) and tau protein should be elucidated to confirm this hypothesis. Second, we are in urgent need of revised diagnostic criteria to support future trials. Third, various technical and methodological improvements are required, based on the lessons learned from previous failed trials.

HIV pre-exposure prophylaxis trials: socio-economic and ethical ...

African Journals Online (AJOL)

The advent of HIV pre-exposure prophylaxis (PrEP) as a HIV-prevention strategy has received optimistic support among HIV researchers. However, discourse on PrEP trials has tended to be dominated by the disputes arising between some activist groups and researchers about the research methodologies. Instead, this ...

Routine administration of standardized questionnaires that assess aspects of patients quality of life in medical oncology clinics: A systematic review

International Nuclear Information System (INIS)

Alsaleh, Kh.

2013-01-01

Purpose: Increasing interest in the Quality of Life outcomes in cancer patients led to increase implementation of their use in routine clinical practice. The aim of this systemic review is to review the scientific evidence behind recommending the use of quality of life (QoL) scales routinely in outpatient evaluation. Methods: Systematic review for all published randomized controlled trials in English language between January 1, 1990 till December 31, 2012. Out of 487 articles (476 identified by electronic search + 11 articles identified by manual search), six trials satisfied the eligibility criteria: (1) the study was a randomized controlled trial (RCT) with randomization of patients or health care providers; (2) the findings of the administered questionnaire or scale (the intervention) were given to health care provider, and compared to standard care with no questionnaire administered (the control); (3) study was conducted in outpatient oncology clinics; and (4) an outcome was measured that related to (i) QoL improvement, (ii) reduction in morbidity, (iii) reduction in stress for the patients, (iv) improvement in communication between patients and health care provider, or (v) improved patient satisfaction. Assessment for the quality of the study was done using the GRADE methodology. Results: Serious methodological issues were affecting most of the trials. Overall the evaluation of the quality of the evidence from these identified trials suggests that there is a weak recommendation to use QoL scales in routine oncology practice to improve communication between physicians and patients. Conclusion: The routine use of such tools in the outpatient settings at improving the patient outcome or satisfaction cannot be recommended based on the available evidence. The potential harm with the excess use of resources needed to implement, collect, store, analyse, and present such data to health care providers should be also considered. Further research and better designed

A Digital Ecosystem for the Collaborative Production of Open Textbooks: The LATIn Methodology

Science.gov (United States)

Silveira, Ismar Frango; Ochôa, Xavier; Cuadros-Vargas, Alex; Pérez Casas, Alén; Casali, Ana; Ortega, Andre; Sprock, Antonio Silva; Alves, Carlos Henrique; Collazos Ordoñez, Cesar Alberto; Deco, Claudia; Cuadros-Vargas, Ernesto; Knihs, Everton; Parra, Gonzalo; Muñoz-Arteaga, Jaime; Gomes dos Santos, Jéssica; Broisin, Julien; Omar, Nizam; Motz, Regina; Rodés, Virginia; Bieliukas, Yosly Hernández C.

2013-01-01

Access to books in higher education is an issue to be addressed, especially in the context of underdeveloped countries, such as those in Latin America. More than just financial issues, cultural aspects and need for adaptation must be considered. The present conceptual paper proposes a methodology framework that would support collaborative open…

ECSIN's methodological approach for hazard evaluation of engineered nanomaterials

Science.gov (United States)

Bregoli, Lisa; Benetti, Federico; Venturini, Marco; Sabbioni, Enrico

2013-04-01

The increasing production volumes and commercialization of engineered nanomaterials (ENM), together with data on their higher biological reactivity when compared to bulk counterpart and ability to cross biological barriers, have caused concerns about their potential impacts on the health and safety of both humans and the environment. A multidisciplinary component of the scientific community has been called to evaluate the real risks associated with the use of products containing ENM, and is today in the process of developing specific definitions and testing strategies for nanomaterials. At ECSIN we are developing an integrated multidisciplinary methodological approach for the evaluation of the biological effects of ENM on the environment and human health. While our testing strategy agrees with the most widely advanced line of work at the European level, the choice of methods and optimization of protocols is made with an extended treatment of details. Our attention to the methodological and technical details is based on the acknowledgment that the innovative characteristics of matter at the nano-size range may influence the existing testing methods in a partially unpredictable manner, an aspect which is frequently recognized at the discussion level but oftentimes disregarded at the laboratory bench level. This work outlines the most important steps of our testing approach. In particular, each step will be briefly discussed in terms of potential technical and methodological pitfalls that we have encountered, and which are often ignored in nanotoxicology research. The final aim is to draw attention to the need of preliminary studies in developing reliable tests, a crucial aspect to confirm the suitability of the chosen analytical and toxicological methods to be used for the specific tested nanoparticle, and to express the idea that in nanotoxicology,"devil is in the detail".

ECSIN's methodological approach for hazard evaluation of engineered nanomaterials